Case Book on Patents

M.Padmavati

Note: This is an unedited version of the case book

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 1. Harvard Oncomouse
Subject matter under dispute:
1. Method for producing transgenic non-human mammals with a predisposition to develop
cancer.
2. Further generations of rodent produced by biological process
3. Process of producing transgenic non-human mammals with a predisposition to develop cancer

Details of Claim under dispute:

1) Claim 1:- A method for producing a transgenic non human mammalian animal having an
increased probability of developing neoplasms, said method comprising introducing an activated
oncogene sequence into a non-human mammalian animal at a stage no later than 8 cell stage.
2) Claim 17 :- A transgenic non-human mammalian animal whose germic cells and somatic cells
contain an activated oncogene sequence introduced into said animal, or an ancestor of said
animal , at a stage no later than 8-cell stage, said oncogene optionally being further defined
accordingly to any one of claims 3 to 10.
3) Claim 18:- An animal as claimed in Claim 17 which is a rodent.

Relevant provisions applicable:

1) Article 53: Exceptions to patentability
a) Inventions the publications or exploitation of which would be contrary to ‘odre public’ or
morality, provided that the exploitation shall not be deemed to be so contrary merely
because it is prohibited by law or regulation in some or all of contracting states.
b) Plant or animal varieties or essentially biological processes for the production of plants
and animals, this provision does not apply to neurobiological processes or products
thereof.
2) Article 83: Disclosure of the invention, European patent application must disclose the
invention in a manner sufficiently clean and complete for it to be carried out by a person skilled
in the art.
3) Article 123(2): A European patent application, a European patent may not be amended in
such a way that it contains subject matter which intends beyond content of application filed.

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4) Article 52(1): patents shall be granted for any inventions which are susceptible of industrial
application, new & involve inventive step.

Court Decisions:
1. The use of word a non human mammalian species led to confusion that claim is broad & it
would be arbitrary to infer that all rodents would react in similar manner to claimed invention.
But board held that there is no reason why application should be refused on ground that it
involves an extrapolation from mice- to mammals in general and held invention has been
sufficiently disclosed as per required by section 83 of EPC.
2. Due to difference in meaning and explanation of ‘animal’ in articles in English, German
& French, board rejected ‘Examination Divisions’ interpretation of article 53(b) as excluding
Not only certain group of animals but in fact, animals as such.
53(b) is an exception to 52(1) - invention useful in industrial applications.
Board also mentioned legislation history of 53(b), its interpretation in light of recent changes &
stated that it was now task of EPO to strike a balance between interest of inventors in this field
and society’s interest in excluding certain categories of animals from patent protection. So this
would also hold that Art 53(b) of EPC can be applied in respect of animals which are genetically
manipulated.
3) Board concluded transfected mouse is not an “essentially biological process”. So it does not
come under purview of article 53(b) EPC
4) Examining Division took the new that by artificially combining a non biological and breeding
process, the applicant was seeking to circumvent exclusion under 53(b) because two processes
would give rise to two different products. But constitution held that reproductive process could
be other than sexual or other than biological , example by clone by asexual reproduction or
technical means.
5) Court held on point of suffering caused to animals and potential danger of accidental release
of genetically modified animals that whether 53(a) EPC is a ban to patenting present invention or
not would depend mainly on careful weighing up of suffering of animals & possible risks to
environment on one hand and invention usefulness to mankind on another.
6) Appellants requested for two questions to put before Enlarged Board of Appeal-
 Extent of patent protection for animals possible under 53(b)

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  Extent of disclosure required within meaning of art. 83 EPC in a case of present kind.
Board rejected and held it would be premature to refer these questions to EBA, before
department of first instance had reconsidered basic problem of interpreting 53(a) & (b)
EPC in light of Board’s present decision.

2. Howard Florey Institute v. Fraktion der Grunen in European

Parliament Paul Lannoye

Subject matter under dispute:

The following oppositions were filed:-
a) The claimed invention was not novel, since the gene encoding relaxin had always been
present in the female human body
b) There was no inventive step, because a conventional method was used to isolate thye
DNA
c) Relaxin was a mere discovery and as such “no more patentable than the moon or a new
animal found in a remote area”
d) The patent was contrary to morality or public order
e) Isolating a gene from tissue taken from a pregnant woman was an offence to human ,
dignity, as it used pregnancy for a technical profit oriented process
f) Patenting human genes would amount to patenting human life and hence immoral

Claims under dispute:

1) Synthetic human H2 preprorelaxin having the given amino acid sequence (claim 19)
2) Synthetic human H2 preprorelaxin having the given amino acid se4quence with the
exception that the signal sequence is excluded (claim 20)
3) A polypeptide having human H2 relaxin activity, said polypeptide having a disulphide
bonded A-chain and B-chain (claim 21)

Articles and rules (EPC)

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1) Article 54(1)- An invention shall be considered to be new, if it does not form part of the
state of the art
Article 54(2)- The state of the art shall be held to be comprised of everything made
available to the public by means of a written or oral description, by use, or in any other
way, before the date of filing of the European Patent Application
2) Article 56- An invention shall be considered as involving an inventive step, if having
regard to the state of the art, it is not obvious to the person skilled in the art.
3) Article 52(2)(a)- The following in particular shall not be regarded as inventions
a) Discoveries , scientific theories and mathematical method

4) Article 53(a)- European patents shall not be granted in respect of-

a) Inventions the publication or exploitation of which would be contrary to “order
public” or morality, provided that the exploitation shall not be deemed to be so contrary,
merely because it is prohibited by law or regulation in some or all of the contracting states.

Summary of Judgement
A. Novelty and inventive step – The opponent contended that the subject matter of the
opposed patent lacks novelty as gene coding relaxin was always present in female
body and it was isolated in a conventional way.
However, since the claimed DNA fragment encoding relaxin were cDNA and single
cDNA is not present in humans, the said invention is novel. Further, the form of
relaxin that it coded for was also unknown until the inventor isolated it for the first
time.
As the inventor was providing to the public for the first time a product whose
existence was previously unknown, the method used for its extraction was
immaterial.
B. Discovery- The opponent asserted that the subject matter of the patent represents a
discovery and is hence not patentable under article 52(2)(a) EPC. However, according
to Guidelines, C-IV; 2.3, if a substance found in nature has first to be isolated from its
surroundings and a process for btaini8ng it is developed, that process is patentable.
Moreover, if this substance can be properly characterized by all structure and it is

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 new in the absolute sense of having no previously recognized existence, then the
substance per se is patentable.
Since, Human H2 relaxin had no previously recognized existence and proprietor had
developed a process of obtaining H2 relaxin and the DNA encoding it, also. He has
characterized these products by their chemical structure and found the use of the
protein. Therefore, the product is patentable under Article 52(2) EPC.

C. Patent was contrary to morality or public order and isolating ba gene from
tissue taken from a pregnant woman was an offence to human dignity-
To the objection raised as to the said patent is immortal. The court held that the patent
would not be viewed as abhorrent by public as it does not involve the patenting of
human life or an abuse of pregnant woman or a return to slavery and the piecemeal
sale of women to industry. This it does not fall under Article 53(a).
Further, since the tissue was donated with consent within the frame work of
gynecological operations and many live saving substances were isolated in this way.
The said patent does not offend human dignity.
D. Patenting of human gene would amount to patenting of human life-
“DNA is not life”, it is a chemical substance which carries genetic information and
can be used for production of protein which may be medically useful. The court held
that patenting of a single human gene has nothing to do with patenting of human life.
Even if every gene in human genome were cloned, it would be impossible to
reconstitute a human out of it. No normal distinction was seen between the patenting
of genes and the patenting of other important human substances, such as adrenaline.
In short, a DNA fragment encoding a human protein i.e., human H2 relaxin or its
precursors does not lack novelty by virtue of having been always present in human
body. Further, the isolation and characterization of a DNA fragment encoding a
human protein does not represent a discovery. Moreover, the isolation of mRNA
encoding a human protein is not immoral, if it is isolated from human tissues nor is
the patenting of a DNA fragment encoding human proteins universally unethical.

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 3. Parker v. Flook 437 US 584
Subject matter under dispute:
“Method for updating Alarm limits”
Details of the claim under dispute:
1) A method for updating the value of at least one alarm limit or at least one process
valuable involved in a process. Comparing the catalytic chemical conversion of
hydrocarbon wherein the said alarm limit has the current value of , B o+k, where Bo is the
current alarm base and k is the predetermined alarm offset which comprises,
a) Determining the preserve value of the said process variable said present value
being defamed as PUL.
b) Determining a new alarm base B, using the following equation
B1= Bo (1.0-F) + PUL (F)
Where ‘F’ is a predetermined number greater than zero, but less than 1.
c) Determining an updated alarm limit which is defined as B1+k, and after.
d) Adjusting said alarm limit to said updated alarm limit value

Relevant provisions applicable

US patent laws U.S.C.T.35 section 101- whoever invents or discovers any new and useful
process , machine, manufacture or, composition of matter or any new and useful improvement –
thereof may obtain a patent, therefore, subject to the conditions and requirements of thirty fifth
section 102 and 103-(“provisions relating to novelty and inventiveness among many others”)

Patent office court decisions

a) Appeal on decision of Patent and Trademark office board of Appeals- “Method for
updating Alarm limits” not a statutory subject matter
b) Court of Customs and Patent Appeals- patentable post solution. Application did not pre-
empt formula/Algorithm used
c) Supreme Court- CelEiorari
The identification of post solution applications of the formula did not make the method
eligible for patent protection; the application simply provided a better method of calculating

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 alarm limit value in which the one novel feature was the formula/algorithm- not patentable
subject matter.

4. Arrythmia Research Tech., Inc v Corazonix Corporation

[958 F.2d1053]

Abstract: Appeal against the summary judgment declaring us patent NO- 4422549 invalid for
failure to claim statutory subject matter within the meaning of 35 u.s.c S-101. Appeal granted,
the judgment of invalidity was reversed.

Facts: Appellant is the holder of US patent No- 4422549 which is directed to

electrocardiographic means and method for detecting Potential Ventricular Tachycardia.
Appellant brought a suit of infringement against the appellee. Appellee contended that the claims
(1 & 7) defines no more than a mathematical algorithm and that these claims are not directed to
statutory subject matter. The United States District Court for the Northern District of Texas
declared the said patent invalid for the aforesaid reason. The court did not decide the question of
infringement. Consequently an appeal was made by the appellant against this judgment whereby
the appellant contends that the combination of physical, mechanical and electrical steps
described and claimed in his patent are essentially directed to a process and apparatus for
detecting specific heat activity which indicates risk of tachycardia and do not merely preempt
mathematical algorithms. Thus they constitute statutory subject matter.

Subject Matter Under Dispute: - The subject matter disputed in this case pertains to the
electrocardiographic means and methods for detecting potential ventricular tachycardia.
Majority of myocardial infract (heart attack) patients are exposed to the risk of certain death due
to ventricular tachycardia. Therefore a reproducible and reliable method and apparatus was
needed to predict an infract patient’s chances of falling prey to ventricular tachycardia.
It was known that in patients of ventricular tachycardia certain anomalous waves having very
low amplitude and high frequency, known as “late –potentials” appear towards the end of the
QRS segment of the Electrocardiographic (ECG) signal. However it is technically very difficult

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to Bolate these late potentials because these are always accompanied by other lower frequency
portions of the signals. Generally a filter must be used to eliminate them but this has another
disadvantage of “ringing” that hides or masks the late potentials.
Dr.Simon invented a method and apparatus to process and filter “late potentials” in a reverse
time manner which devoid of the filter “ringing”. Thus Simon’s method of detecting and
measuring these late potentials and associated apparatus are subject matter here.

Details of claims under dispute: - Here claim 1 and 7 are in dispute.

Claim 1- A method /process for analyzing ECG signals to determine the presence or absence of
a predetermined level of “ late potentials” comprising the steps of : converting a series of QRS
signals to time segments, each segment having a digital value equal to analog value of said
signals at the said time; applying a portion of said time segments in reverse time order to high
pass filter means, determining an arithmetic value of the amplitude of the output of said filters ;
and comparing the obtained value with predetermined value.
Claim 7- An apparatus for analyzing ECG signals to determine the late potentials. The
composition and working of this apparatus is as such explained below:
X, Y, Z lead E.C.G input signal (Analog)

A to D converter

X, Y, Z digital signals
Identification or QRS Storage or QRS

Reference Mini Disc memory

comparator computer unit

Identification and selection of QRS waveform portions from digital X, Y, Z signals

&
Production of composite digital X, Y, and Z QRS waveforms.

High pass
Critical
filter
Feature of the Simson invention

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Backward filtering of the composite QRS waveforms by high pass filter to obtain wave
having very low amplitude and high frequency (late potentials) free of ringing and artifact.

Mini
computer

Comparator &
plotter
Comparison of late potentials (output) with a predetermined level to ensure tachycardia.

Relevant Provisions applicable

35 u.s.c. S101- whoever invents or discovers any new and useful process, machine, manufacture,
or composition of matter, or any new and useful improvement thereof, may obtain a patent there
for, subject to the conditions and requirements of this title.

35 u.s.c. S100(b)- The term “process” means process, art, or method, and includes a new use of a
known process, machine, manufacture, composition of matter or material.

Court Decision:-
The judgment of invalidity on the ground that claimed method and apparatus do not define
statutory subject matter was reversed. Thus it was declared that the claims of this patent define
an apparatus and method (process) and both are patentable subject matter within the language of
S101.
Pauline Newman, Circuit judge, The court of Appeals declared as mentioned above.
Rader, Circuit judge, filed concurring opinion.

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 5. State Street Bank & Trust co. v Signature Financial group, Inc

Subject matter:
1) Signature is the assignee of patent No. 5193056 entitled, “Data processing system for Web
and Spoke Financial Services Configuration”- directed to a data processing system for
implementing an investment structure which was developed for use in signature’s business as an
administrator and accounting agent for mutual funds.
2) The patent facilitates a structure whereby mutual funds pool their assets in an investment
portfolio organized as a partnership, which provides the administrator of the fund with the
advantageous combination of economics of sale in administering investments coupled with the
tax advantages of a partnership
3) State Street negotiated with Signature for a license to use its patented data processing system
described and claimed in the patent.

Claims:
A data processing system for managing a financial services configuration of a portfolio
established as a partnership, each partner being a plurality of funds comprising
 Computer processing means for processing data
 Storage means for storing data on a storage medium
 First means for initializing the storage medium
 Second means for processing data regarding assets in the portfolio and each of the funds
from a previous day and data regarding increases or decreases in each of the funds, assets
and allocating the percentage share that each fund holds in the portfolio
 Third means for processing data regarding daily incremental income, expenses and net
realized gain or loss for the portfolio and allocating such data among each fund
 Fourth means for processing data regarding daily net unrealized gain or loss for the
portfolio and allocating such data among each fund; and
 Fifth means for processing data regarding aggregate year end income, expenses and
capital gain or loss for the portfolio and each of the funds

Relevant Provisions:
35 u.s.c 101 – Inventions patentable- whoever discovers or invents any new and useful
process, machine, manufacture or composition of matter, or any new and useful kind
improvement, thereof, may obtain a patent, therefore, subject to conditions and requirements
of this title.

Federal Court:
The Court of Appeals held that,
 Patent was directed to machine and not process
 Invention was not unpatentable under the mathematical algorithm exception

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  No “business method” exception to patentability
The Court held that –
“….. Transformation of data, representing discrete dollar amounts by a machine through a
series of mathematical calculations into a final share price constitutes a practical
application of a mathematical algorithm, formula or calculation because it produces a
“useful, concrete or tangible” result a final share price momentarily fixed for recording and
reporting purposes and even accepted and relied upon by regulatory authorities and in
subsequent trades….”
7. Case: AT & T Corp v. Excel Communications, 1993 (1338), Fed Crt
Patent in Issue:
CALL MESSAGE RECORDING FOR TELEPHONE SYSTEMS
Assignee: AT & T Bell Labs Number: 5,333,184
(Now granted)
Brief description of Invention:
AT &T intended to enhance standard exchange message interface (EMI) message record generated for
interexchange telephone toll calls by addition of primary interexchange carrier (PIC) indicator, whose
valves provides an indication as to whether a terminating subscribes has particular interexchange carrier
as its PIC. This indicator was intended to be used for more detailed activities and simplifying processes
related to subscribers like billing, call rating etc.
It also claimed to operate in telecommunication system with multiple long distance service providers.
The local Exchange carriers (LEC) and which provide local telephone services and local telephone
services & long distance service (interchange) carriers (LXC), which are selected by customers
individually which is subsequently accessed by LECs.
Thus the calling method in such system has 3 steps in case of long distance calls:
1) Call transmitted over the LEC’s network to switch, while it identifies the “customer’s”
PIC & routes over the identified PIC’s facilities.
2) PIC takes call to LEC’s network of recipient.
3) Which delivers call to recipient?
Such switching used to have a ‘Automatic Message Account’ (AMA) which was suggested by
patent to appended by a date filed identifying the PIC.
Subject matter
Intl Cl. No.
H04 M : Telephonic Communication, including operators for control, switching etc
15/00 : Melting, Time- control/indicating arrangements
7/00 : Interconnection arrangements between switching centers’
3/00 : Automatic or semi automatic exchanger
-The first application was rejected (all 41 claims) in 1992 by USPTO
-The claims in present form filed in 1994 having 6 independent claims: 5 method claims & 1
Apparatus claim.

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Dispute
Excel claimed that these claims do not explain or claim the apparatus or method properly and that
the method is nothing but a mathematical algorithm.
All the independent claims well sought to be outside scope of patentable subject matter, as defined
by 35 USC Section 101,

Claim 1 was read as:

“A method for use in a telecommunication system in which interexchange cells initiated by each
subscribed are automatically routed over the facilities of a particular one of a plurality of
interexchange carriers associated with that subscribes, said method comprising the steps of:
Generating a message record for an interexchange call between an originating subscribes & a
terminating subscribes and including, is said message record, a primary interexchange carrier
indicator having a valve which is a function of whether or not the interexchange carrier associated
with said terminating subscribes in a predetermined one of the said interexchange carriers.

35 USC Section 101

Whoever invents or discovers any new and useful process, machine manufacture or composition of
matter, or any new and useful improvement, therefore, may obtain a patent , subject to condition and
requirements of this title.

Arguments given (using case laws)

1. Subject matter includes ‘everything made under sun by man’. Diamond v. Chakraborty
2.Though above statement is limited by identification of 3 categories of subject matter by Court as
unpatentable, viz, ‘laws of nature, natural phenomena, & abstract ideas’. Diamond v. Diehr
3. Court has held that any step-by-step process be it electronic, chemical or mechanical involves an
“algorithm” in broad sense of term. State Street Bank v. Signature Fin Group
4. Also, mathematical algorithms may be an integral part of p.s. matter such as machine or process if
the ‘claimed’ invention as a whole is applied in ‘useful’ manner. Ib:d
5. mere fact that a claimed invention involves in putting numbers, calculating numbers, outputting
numbers and storing numbers, in and of itself would not tender it a non statutory subject matter,
unless, of course its operation does not produce a ‘useful, concrete and tangible’ result. In Re
Alappat.
Thus following Alappat & State Street, where both claimed a machine which achieved certain
results.
It was clear that the patent claimed a “process that uses the Boolean Principle to determine the value
of the PIC indicator”.
This principle is useful, non abstract and produces tangible results, without preempting other uses of
mathematical principle.
Decision:
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District Court’s summary Judgment of Invalidity is reversed, Rough remanded for further
proceedings consisted with this opinion.

6. Merril Lynch Application [1989] R.P.C.561

UK Patent Application(19) GB(11) 2180380(13) A

Subject Matter under Dispute: The dispute brought the question of law fundamental to
software patenting. The suit was by way of appeal by Merril Lynch, Pierce, Fenner &
Smith Co. to the Court of Appeal from ma decision of Falconer J. in the Patents Court
[1988] R.P.C 1 dismissing on appeal from a decision by Mr. M.F. Pilgrim, principal
examiner who acted for Controller for the application No. 85273-46. The subject matter
concerns with a business method which was done through software. The invention as
described in the application is of an improved data processing system for implementing an
automated trading market for one or more securities. It was claimed that system could
retrieve and stores best current bid and asked prices; qualities customer and to national
stock price reporting system. It was also claimed to monitor stock inventory and profit for
market maker. It further claimed “an improved data processing apparatus for making an
automated market for one and more securities”.

Details of Claim under dispute:

The principal examiner held that claim1 as filed, didn’t define a patentable invention, nor
did the first amended claim1. The application went for the refusal of original claim1 which
stated as: “In combination in a data processing system for making a trading market in at
least one security in which system proprietor is acting, as a principal; said system including
means for receiving trade orders for said at least one security from system customers--------
and post executing and at least one of said stored parameters upon execution of trade
orders.
Overall the claim consisted of a software which was functional in interpreting data through
a logic involved for tapping security market needs.

Relevant Provision Applicable:

The application was evaluated on the anvil of section 1(2)(C) OF Patent Act 1977 states 1
(2)(C) : It is hereby declared that the following (among other things) are not inventions for
the purpose of this Act: a scheme, rule or method for performing mental act, playing game,
doing business or program for a computer from ambit of “inventions”.

Decision of Court:
Court, apart from distinguishing the case from Genentech Inc.’s Patent [1989] R.P.C. 147
[(A)], and Vicom System Inc.’s Application [1987] Official Journal EPO 14 (E.P.O.
Technical Board of Appeal) tried to explain the matter with test which is similar to
arbitration-filtration test of copyright. The Court emphasized the clauses “to the extent” s
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“as such” as found in section 1(2)(C) of Patent Act 1977 and interpreted the same. Court
held that the software patent’s can’t be denied prime facie and it is required to see if
software is patented as such, (which is not subject matter of Patents) or if there is a new
development or other physical enhancement or a technical enhancement has resulted from
it. The Court distinguished the case from Vicom’s application that there was enhancement
of technical parameters as result of software and hence it was granted.
Court went on stating that a test can be applied to check if the application is within the
subject matter of patents. Court suggested to overlook all matter and details which is
expressly enunciated in statue from domain of patent for the application. If at last of such
extraction there remains a subject matter which can be counted as patentable, the
application is patent.
Such extraction for Merril Lynch application lead to the scheme and a computer system
with no enhanced efficiency. The subject matter didn’t qualify for patent and hence it was
dismissed.

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 9. IBM’s application/ Computer Program (1999) RPC861,
EPOR 301 Tech Bd App. (EPO767419B1: Method and System in a data processing
System windowing environment for displaying previously obscured information)

Subject matter under dispute:

Subject matter concerned a computer program which was excluded from patentability under
the European Patent Convention, 1973. IBM’s claims were directed towards computer
program code which instructed a computer to execute a procedure to display information in a
first window, and which could respond to obstruction of that information by a second
window.

Details of the claim under dispute:

A method in a data processing system for displaying information, wherein said data
processing system includes a display and an operating system, said method comprising the
steps of:
Displaying information within a first window in said display using information display
software; detecting a second window displayed in said display of a location that obscures a
portion of said information displayed in said first window; notifying said information display
software of the detection; displaying in said first window said portion of said information that
had been obscured by said second window, including moving said portion of said info that
had been obscured by said second window to a location within said first window that is not
obscured by said second window, using said info display software.

Relevant provision applicable:

 European Patent Convention 1973, Article 52(2):- The following in particular shall not be
regarded as inventions within the meaning of paragraph 1(European Patents shall be
granted for any inventions which are new and which involve an investive step.
C) Schemes, Rules and methods for performing mental acts, playing games or doing business,
and programs for computers.
 Vienna Convention, Article 31, “ General rule of interpretation”, states in paragraph I that “
A treaty shall be interpreted in good faith in accordance with the ordinary meaning to be
given to the terms of the treaty in their context and in the light of its object and purpose”,
and in paragraph 4 that “ A special meaning shall be given to a term if it is established that
the parties so intented”.
 Article 27(1) of TRIPS states that “ Patents shall be available for any inventions, whether
product or processes, in all fields of technology, provided they are new, involve an
invented step and are capable of industrial application”.

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 Patents office or Court decision:
Physical modifications to the hardware resulting from the execution of the instructions
given by the program could not, in themselves, provide the technical character necessary to
avoid the exclusion, since those were a common feature of computer programs. However,
where the further effects derived from the hardware’s execution of the instructions given by
the program had a technical character or caused the software to solve a technical problem
such products would be patentable. Such technical efforts were not directly disclosed by
the program itself, but could only be seen when the program was run on a computer.
11. Unilever Ltd. Patent Application [1983] R.P.C 219

Subject matter under dispute: medical therapy

Facts of the case:

The present case arises from an appeal against the decision of Patent examiner. Applicant seeks
to patent a method of immunising poultry by adding substance to their feed. The application
consisted of five claims; out of which only claim No.1 was the Independent Claim. Claim 1 reads
as:
“A method for immunising poultry against Coccidiosis, wherein the poultry are reared on a diet
comprising nutrient feed material containing added viable sporulated oocysts of at least one
species of Coccidia to which the poultry are susceptible, the oocysts being present in a
concentration sufficient only to induce sub-clinical infection in the poultry.”

Relevant Provisions Applicable: This is an application under 1977 Patents Act. Following
provisions are applicable:
 Section 1(1): “A patent may be granted for an invention in respect of which the following
conditions are satisfied, that is to say: (a) the invention is new; (b) it involves an
inventive step;(c) it is capable of industrial application;(d) the grant of a patent for it is
not excluded by subsections (2) & (3) below; and references in this act to a patentable
invention shall be construed accordingly.”
 Section 4 deals with what is capable of “industrial application”. It provides:
4(1): Subject to subsection (2) below, an invention shall be taken to be capable of
industrial application if it can be made or used in any kind of industry including
agriculture.
4(2): An invention of a method of treatment of the human or animal body by surgery or
therapy or of diagnosis practised on the human or animal body shall not be taken and be
capable of industrial application.

Decision by Patent Examiner: Dismissed the Patent application due to lack of industrial
application. An appeal against examiner’s decision lies in Patent Court.

Decision of Patent Court:

 Interpretation of the word ‘therapy’
 Laws of interpretation’s
 Precedents and legislator’s intent.

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 12. In Re Bernald L. Bilski and Rand A. Wasaw

Appeal: from the United States Patent and Trade mark office, Board of Patent Appeals and
Interferences in the United States Court of Appeals for the Federal Circuit.

Decided on: October 30, 2008 (9 Judges)

This is an appeal from the final decision of the Board of Patents and Interferences sustaining the
rejection of all eleven claims of this US Patent Application Serial No. 08/833, 892 on March 8,
2006. (Appeal No- 2002-2257).
Application for patent was filed on April 10, 1997, entitled “Energy Risk Management
Method” which claims the priority benefit under 35 USC Section 119(e) of provisional
application 6/015,756, filed April 16, 1996.

Background:
The invention relates to a method practiced by commodity provides for managing (i.e., hedging)
the consumption risks associated with a commodity sold at a fixed price. It is disclosed that
energy consumers face two kinds of risks:
1) Price risk and 2) consumption risk.
The proliferation of price risk management tools over the last 5 years before the filling date
allows easy management of price risk. However consumption risk (e.g. the need to use more or
less energy than planned due to the weather) is said to be not currently managed in energy
markets, which is the problem addressed by the invention.
Claim 1:
A method for managing the consumption risk costs of a commodity sold by a commodity
provides at a fixed price comprising the steps of:
 Initiating a series of transactions between said commodity provides and consumes of said
commodity wherein said consumers purchase said community a fixed rate based upon
historical coverage’s, said fixed price rate corresponding to a risk position of said
consumer
 Identifying market participants for said commodity having a counted risk position to said
consumers and
 Initiating a series of transactions between said commodity provides said market
participants at a second fixed rate such that said series of market participations balances
the risk position of said series of consumer transactions.

Issues:
(1) The issues is whether the subject matter of claims 1-11 is directed to a statutory
“process” under 35 USC Section 101 (2) And what test should be applied in determining
statutory subject matter.

Decision:
We begin with the words of the Statue i.e., Section 101:
Whoever invents or discovers any new and useful process, machine, manufacture, or
composition of matter, or new and useful improvement thereof, may obtain a patent
therefore, subject to the conditions thereof, may obtain a patent thereof, subject to the
conditions and requirements of this title.

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 It is undisputed that the applicants claim involves what the term “process” is.
 In Diamond v. Diehr Court specifically held that a claim is not a patent eligible
“process” if it claims “laws of nature, natural phenomenon, or abstract ideas.
 In Benson, phenomena of nature, though just discovered, mental processes and abstract
intellectual concepts not patentable, as they are basic tools of scientific and technological
work
 In Comiskey, holding that “mental processes”, “processes of human thinking” and
systems that depend for their operation on human intelligence alone are not patent
eligible subject matter.
 In Mackay Radio & Tel.Co v. Radio Corp. of America 1939, Court held that a
scientific truth or the mathematical expression of it is not a patentable invention.

The Court held that the application was:

 An abstract idea and solving a purely mathematical art rendering it to be non statutory.
Therefore, the rejection was on the “abstract idea” and a failure on a “Technological
arts” test for statutory subject matter.
 In order to qualify as “Technological art”, the steps shall be performed by machine or
computer. Otherwise the steps performed by human means does not “improve human
efficiency” as required by the definition of Technology.
 The present claim was a non machine implemented subject matter. In recent years the
USPTO was flooded with claims of “processes”. “Business methods” have long been
considered statutory subject matter when performed by a machine. (State Street, 149. F
3d at 1377, 47, USPQ 2d at 1600 also AT&T, 172 F. 3d at 1350, 50 USPQ 2d at
1452).

Transformation Test:
The transformation or reduction of an article to a different state or thing is a statutory practical
application. The subject matter can be physical, yet intangible, phenomena such as electrical
signals. (In Re Schrader, 22 F 3d 240, 295 n,12).

The “useful, concrete and tangible” reduction test of State Street is general test for patentable
subject matter holding the fact that State Street was qualified by transformation of data by a
machine. Machines inherently act to transform physical subject matter (tangible or intangible)
into a different state or thing.

There is always some form of physical transformation within a computer because a computer
acts or signals and transforms them during operation and changes the state of its components
during execution.

14. Novartis Application in India on Imatinib mesylate

Before 1995 Indian Patent law granted only process patent. Process patent is the patent or rights
given to the means how the product is obtained. Product patent is the rights including exclusive
manufacturing and marketing rights relating to the object.
In 1995 TRIPS agreement (Trade Related Aspects of Intellectual Property) was signed. One of the
clause was that developing country were given 10yrs of transition period to implement product

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patent. Within that transition period all the product patent applications will go into a mailbox
known as mailbox application and they would be examined after 2005. For that period of time that
is on the date of application till 2005 the person will be granted Exclusive Marketing Right
(EMR) in India. To get an EMR the condition was to have a patent granted in any other Country
and a patent application filed in India.

Novartis AG v. Union of India

R. Balasubramanian J.

In November 2003, the Controller General of Patents Trademarks of India granted exclusive
marketing right (EMR) of Glivec, the blood cancer drug to Norvatis AG, a multinational based in
Switzerland for a period of 5 yrs.
The EMR was the first such granted in the country and it gave Novartis the right to be the only
company that can produce and market the drug in India. Novartis began enforcing the EMR for
Glivec by shutting down productions by generic manufacturers of the drug, such as Cipla,
Ranbaxy & Sun from manufacturing , selling, distributing or exporting the drug.

Once the generic manufacturers stopped producing the Glivec, the price of the drug jumped from
approximately Rs 10, 000 for a month requirements (by use of generics) to around Rs 1, 20, 000
(by use of Novartis Glivec).

The generic makers & several NGO’s contended in Madras HC that Novartis had obtained a
patent in US and Canada in respect of ‘Pyramadine derivatives & processes for preparation there
of imatinib mesylate long before 1995. The EMR has been fiercely challenged in courts by
generic producers of the drug on the grounds that the compound was lacking Novelty being
known much before 1995.

In 2005, the patent act was amended. The Amendment Act 2005 granting product patent,
provides that EMRs would either be replaced by patents (if granted) or cancelled (if patents were
rejected).
By way of oppositions, generic producers and specially Cipla Ltd. Filed their pre-grant
opposition [representation under Sec 25(1)] raising objections that the applied invention was not
an invention under the Patent Act and was barred from patentability under Sec 3(d) of the Act.
The Assistant Controller held imatinib mesylate is already known from prior publications from
a US Patent Claims which mentioned imatinib mesylate as the product , and thus rejected the
application on section 3(d) grounds. It is important to note here that Novartis had made an
application for ‘beta crystalline form of imatinib mesylate’ and claimed that it had 30%
increased bio-availability. Controller concluded that increase in bio-availability was due to
the increase in water solubility of the beta crystals and nothing more. It did not amount to
increase in known efficacy and was very obvious.

Sec 3(d) as amended by Patents Amendment Act, 2005 with effect from 01.01.2005.
“The mere discovery of new form of a known substance which does not result in the
enhancement of the known efficacy of that substance or the mere discovery of any new property
or new use for a known substance or of the mere use of a known process, machine or apparatus
unless such known process results in a new product or employs atleast one new reactant.”

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Explanation:
For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle
size isomers, mixture of isomers, complexes, combinations and other derivatives of known
substances shall be considered to be the same substance, unless they differ significantly in
properties with regard to efficacy.
Aggrieved by the decision of the Indian Patent Office in Chennai, Novartis has filed a writ
petition before the Chennai High Court in Jan 2006.
Novartis contended by a writ petition that Sec 3(d) was:
 Not TRIPS complaint as TRIPS does not authorize insertion of any clause like that of
3(d), and
 Unconstitutional as it was arbitrary allowing the Controller arbitrary power to decide
what formed “differ significantly in the properties with regard to efficacy” and
“enhancement of known efficacy”.
On Aug 7, 2007 the Madras HC dismissed the petition filed by the Swiss pharma. The
court held that Section 3(d) of the Patents Act as amended in 2005 along with its explanation is
valid. It gave the following reasons:
1. TRIPS allowed sufficient space for the national legislators to enact their laws keeping in
mind their specific need and requirement of the Public. And as such the enhancement of
Sec 3(d) was against “ever greening” and not at all against TRIPS.
2. To objectively define “enhancement of known efficacy” or significant difference with
regard to efficacy” was not possible in future inventions and their competence could not
be for seen. Moreover just vesting the discretionary power was not amounting to
violation of Art 14 of the Indian Constitution and was not at all arbitrary. It was the only
practical way the legislators could have enacted the disputed section.
The decision of Madras HC rejected the issue to the IPAB (it was 1 st instance of IPAB’s
functioning) which held the rejection and its grounds valid.

Ever greening: The objective of the section is to prevent the ‘ever greening’ of patents, a
practice followed by pharmaceutical industry players to extend patent monopoly even after
the expiry of the original patent. They achieve it by claiming insignificance improvements of
the same active ingredients of a drug say some ester or salt or by showing new use of the
same drug.

Subject matter issue: The ‘beta crystalline form of imatinib mesylate’ and claimed that it
had 30% increased bio-availability.

Relevant provision: Sec 3(d) of the Indian Patent Act.

15. Symbian Limited (Appellant) v. Comptroller General of Patents (Defendant)

Patentable Subject Matter:

A software application which will split DLL’s (Dynamic Linking Liabraries) into two parts-
fixed and extension part to avoid the potential unreliability of the prior function link-by- ordinal
system.

Details of Claims under Dispute:

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Claim1: A method of accessing data in a computing device and, in particular to a method of
accessing data held in a dynamic link library in the computing device. The present invention also
relates to a computing device controlled by the method.

Relevant Provisions Applicable:

Article 52(2) Patentable inventions,
 European patents shall be granted for any inventions which are susceptible of industrial
applications, which are new and which involve an inventive step.
 The following in particular shall not be regarded as inventions within the meaning of
paragraph 1,
a) Discoveries, scientific theories and mathematical methods;
b) Aesthetic creations;
c) Schemes, rules and methods for performing mental acts, playing games or doing
business; and programs;
d) Presentation of information’s.
 The provisions of paragraph 2 shall exclude patentability of the subject matter or
activities referred to in that provision only to the extent to which a European patent
application or European patent relates to such subject matter or activities as such.

Case Decision:
1. The important question was whether the claimed subject matter made a “technical”
contribution to the state of art. Despite an attack by the Patent Office on the vagueness
and arbitrariness of the term “technical”, that question embodied the consistent
jurisprudence of the EPO Appeal Boards (even though the precise meaning given to the
term has not been consistent), and it has been applied by the UK Court of Appeal itself in
Merrill Lynch’s Application, Gale’s Application, Fujitsu Limited’s Application and
Aerotel.
2. The most reliable guidance as to the meaning of the term “technical” was found to be
given in Computer related invention/VICOM.
3. It states that “the boundary line between what is and what is not technical is imprecise (as
Nicholls L.J said in Gale, and was echoed by Aldous L.J in Fujitsu) might be attributable
to three cases:
a) National tribunals and the Board may still being at an intermediate stage of
working out and identifying the precise location of the line to be drawn;
b) The problem being inherent and never wholly satisfactorily soluble;
c) Competing views based on different philosophies (the “open source” movement
representing one extreme; that of companies such as the present applicant)
4. The uncertainty was well demonstrated by the elusiveness of the meaning of “technical”,
the change of attitude manifested in the more recent decisions of the EPO Board, the
contrasting outcomes in Vicom & Fujitsu, and indeed possible reconsideration of the
corrective view of computer program patents in United states.
However, bearing in mind the multifarious features of computer programs and the
unpredictable developments which will no doubt occur in IT field, the court believed that
it would be dangerous to suggest that there was a clear rule available to determine
whether or not a program was excluded by Art 52(2)(c) EPC. Each case must be

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 determined by reference to its particular facts and features, bearing in mind the guidance
given in the decisions given in previous paragraphs.

Based on these principles, the Court of Appeal concluded that Patten J. Was right and
that the claimed invention did make a technical contribution, and was not therefore
precluded from registration by Art. 52(2)(c) EPC for the following reasons:

1. To start with a defensive point, the program in this case did not embody any of the items
specifically excluded by the other categories in Art. 52 EPC; thus, it was not a method of
doing business (as in Merrill Lynch), or a mathematical method(as in Gale), or a method
for performing mental acts (as was probably the case in Fujitsu)
2. More positively, not only would a computer containing the instructions in question “be a
better computer”, as in Gale, but, unlike in that case, it could also be said that the
instructions “solved a technical problem lying within the computer itself.” Indeed, the
effect of the instant alleged invention was not merely within the computer programmed
with the relevant instructions. The beneficial consequences of those instructions would
feed into the cameras and other devices and products, which, as mentioned above,
included such computer systems. Further, the fact that the improvement might have been
to software programmed into the computer rather than the hardware forming part of the
computer could make a difference.
3. In Aerotel Jacob L.J. when considering the earlier Gale decision said that in order to
avoid the reach of the Art. 52(2)(c) exclusion, “more is needed” than “a code as
embodied on physical medium which causes the computer to operate in accordance with
that code”, and then gave as an example “a change is the speed with which the computer
works”. The effect of the alleged invention in the present case improved the speed and
the reliability of the functioning of the computer so that a computer with the present
program operated better than a similar prior art computer. To say “oh but that is only
because it is a better program- the computer itself is unchanged” gave no credit to the
practical reality of what was achieved by the program. As a matter of fact there was more
than just a “better program”, there was a faster and more reliable computer.
4. It was difficult to see a logical or principal basis for holding that the contribution in the
present case should not be treated as technical given the contribution in the two claimed
inventions in the IBM Corp. decisions of the Board which were held to be technical. In
particular in Data processor Network/IBM Corp, the “technical” contribution identified
by the Board was “the removal of limitations of prior art Systems” with the result that the
data processing system was more flexible and had more improved communication
systems between programs and files”. It appeared that upholding the conclusion of the
Comptroller General in this case, would involve the English courts departing from all the
decisions of the Board to which it had referred.

In particular the court considered that it would be inconsistent with the reasoning of the
Board in T1543/06 game machine/GAME ACCOUNT if this appeal was allowed. In the
case, the Board said that there must be “further technical advantages or effects associated
with specific features of implementation over and above the effects & advantages
inherent in the excluded subject matter”.

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 That cannot mean that any technical advantage attributable to a computer program is
excluded, as it would make nonsense of Art.52 (3) and all of the previous Board
decisions. Therefore, it must mean, consistently with Vicom and the two IBM Corp.
Cases, that a technical innovation, whether within (as in the last mentioned cases) or
outside the computer will normally suffice to ensure patentability (subject of course to
the claimed invention not falling foul of any other exclusion in Art. 52(2) EPC).

The court concluded by observing that there would be cases where the EPO would grant
patents in this field when UKIPO should not, at least so long as the view in ‘Pension
Benefit’ and ‘Hitachi’ is applied by the Board and is not applied by the UKIPO. The fact
that the two offices and their supervisory courts have their own responsibilities means
that discrepancy, even in approach or principle, an occasionally inevitable. However, it
was strongly desirable that the approaches and principles in the two offices should not
march together as far as possible. There is a need for a two way dialogue between
national tribunals and the EPO, coupled with degree of mutual compromise. More
directly relevant to the present appeal, where there may be a difference of approach or of
principal, decision makers must try to minimize the consequent differences in terms of
the outcome in particular cases.

18. Chiron Corporation & Others v. Murex Diagonistic Ltd

Claims:
A polypeptide in substantially isolated from comprising of contiguous sequence of at least 10
amino acids encoded by the genome of HCV and comprising an antigenic determinant, wherein
HCV is characterized by:
1. A positive stranded RNA genome
2. Said genome comprising an open reading frame (ORF) encoding a polyprotein; and
3. Said polyprotein comprising an amino acid sequence having at least 40% homology to
the 859 amino acid sequence in figure 14.
An immunoassay for detecting antibody against HCV, which immunoassay comprises: a)
providing a polypeptide comprising an antigenic determinant bind able by said anti HCV
antibody, wherein said antigenic determinant comprises a contiguous amino acid sequence
encoded by said genome; b) incubating a biological sample with said polypeptide under
conditions that allow for the formation of antibody-antigen complex; and c) detecting antigen-
antibody complex of the said polypeptide.
The patent discloses the nature of the major causative agent of NANBH, namely HCV and that it
is a virus with RNA genome. The patent also discloses a family of cDNA sequences for portions
of the genome. That sequence was used to prepare immunoassay kits for detection of blood
samples infected with HCV.
The patent in dispute is a substantial document which embodied 167 pages of description, 63
pages of figures & 87 claims.
The specification opens up with the description of the technical field to which the invention is
directed: “The invention relates to materials and methodologies for managing the spread of non-
A, non- B hepatitis virus infection. More specifically it relates to diagnostic DNA fragments,
diagnostic antibodies & protective antigens & antibodies for an etiologic agent of NANBH.

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The relevant provisions impugned are:
UK Patents Act 1977
Sec 1(2): It is hereby declared that the following (among other things) are not inventions for the
purpose of this Act, that is to say, anything which consists of-
a) A discovery, scientific theory or mathematical method
b) A literary, dramatic, musical or artistic work or any other artistic creation whatsoever.
c) A scheme, rule or method for performing a mental act, playing a game or doing business,
or a program for a computer a presentation of information
But the foregoing provision shall prevent anything from being treated as an invention for the
purpose of this Act only to the extent that a patent or application for a patent relates to that thing
as such”.

Sec 4(2):
An invention of a method of treatment of the human or animal body by surgery or therapy or of
diagnosis practiced on the human or animal body shall not be taken to be capable of industrial
application.”

Held:
1. Not a discovery

2. Not a method of diagnosis practised on human beings.

19. Vicom’s application [1987] OJEPO 14 Tech Bd App (EP 79300903)

O.J. EPO issue: 1987, 014
Case law reports : CLBA 1996

Subject matter under the dispute:

Mathematical method/Computer program

Details of the Claim under dispute:

The appellants filed 12 claims on 11.11.85. Claims 1 and 8 of which are as follows
1. A method of digitally processing images in the form of two dimensional data array
having elements arranged in rows and columns in which an operator matrix of a size
smaller than the size of the data array is convolved with the data array, including
sequentially scanning the elements of the data array with the operator matrix,
characterised in that the method includes repeated cycles of sequentially scanning
the entire data array with a small generating kernel operator matrix to generate a
convolved array and then replacing the data array as a new data array; the small
generating kernel remaining the same to any single scan of the entire data array and
although comprising at least a multiplicity of elements, nevertheless being of a size
substantially smaller than is required of a conventional operator matrix in which the
operator matrix is convolved with the data array only one, and the cycle being repeated
for each previous new data array by selecting the small generating kernel operator
matrices and the number of cycles according to conventional error minimisation technical

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 dues until the last new data array generated is substantially the required convolution of
the original data array with the conventional operator matrix.
2. Apparatus to carrying out the method in above Claim (claim1) including data input
means (10) for receiving said data array, and said data array to generate an operator
matrix for scanning said data array to generate the required convolution of the operator
matrix and the data array, characterised in that there are provided feedback means (50)
for transferring the output of the mask means (20) to the data input means, and control
means (30) for causing the scanning and transferring of the output of the mask means
(20) to the data input means to be repeated predetermined number of times.

Relevant provision applicable:

1) Article 52(1) EPC: (for Applicant)
European patents shall be granted for any invention which is susceptible of industrial
application, which are new and which involve an inventive step

2) Article 52 (2) (a) and (3) in rule 29 (1) (for EP) 52(2)- The following in particular shall
not be regarded as inventions within the meaning of paragraph-1, discoveries, scientific
theories and mathematical methods
52(3) (for Applicant)- the provisions of paragraph-2 shall exclude patentability of the
subject matter or activities referred to in that provisions only to the extent to which
European patent application or European patent relates to such subject matter or activities
as such.
3) 52(2)(c) and (3)
52(2) - see 52(2) (page 3)
52(2)(c) schemes, rules, and methods for performing mental acts, playing games or doing
business, and programs for computers.
52(3)- see 52(3) (page 3)
4) Article 54
 An invention shall be considered to be new if it does not form part of the state of
the art
 The state of the art shall be held to comprise everything made available to the
public by means of a written or oral description, by use, or in any other way,
before the date of the filing of European patent application
 Additionally, the content of European patent application as filed, of which the
dates of filing are prior to the date referred to in paragraph 2 and which were
published under article 93 on or after that date, shall be considered as
compromised in the state of the art
 Paragraph 3 shall be applied only in so far as a contracting State designated in
respect of the later application, who also designated in respect of the earlier
application as published
 The provisions of paragraph 1 to 4 shall not exclude the patentability of any
substance or composition, compromise in the state of the art, for use in a method
referred to in Article 52, paragraph 4, provides that its use for any method referred
to in that paragraph is not compromise in the state of the art.

5) Article 54(2) EPC

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 See page 4
6) Article 57 EPC (for Applicant)
An invention shall be considered as susceptible of industrial application if it can be made
or used in any kind of industry, including agriculture.
7) Article 83 EPC n Rule 29 (for EP)
The European patent application must disclose the invention in a manner sufficiently
clear and complete for it to be carried out by a person skilled in the art.
8) Article 84 EPC n Rule 29 (for EP)
The claim shall define the matter for which the protection is sought, they shall be clear
and concise and be supported by the description.

Rules:
1. Rule 27 EPC (content of the description)
The description shall:
a. Specify the technical field to which the invention relates;
b. Indicate the background art which, as far as known to the applicant, can be
regarded as useful for understanding the invention, for drawing up the European
search report and for the examination, and, preferably, cite the documents
reflecting such art;
c. Disclose the invention, as claimed, in such terms that the technical problem (even
if not expressing stated as such) and its solution can be understood, and state any
advantageous effects of the invention with reference to the background art;
d. Briefly describe the figures in the drawings if, any;
e. Describe in detail at least one way of carrying out the invention claimed using
examples where appropriate and referring to the drawings if any;
f. Indicate explicitly, when it is not obvious from the description or nature of the
invention, the way in which the invention is capable of exploitation in industry
2. The description shall be presented in the manner and order specified in paragraph1,
unless because of the nature of the invention, a different manner or a different order
would afford a better understanding and more economic presentation.
3. Rule 29(1) (from and content of claims)
The claims shall define the matter for which protection is sought in terms of the technical
features of the invention wherever appropriate claims shall contain
 A statement indicating the designation of the subject matter of the invention and
those technical features which are necessary for the definition of claimed subject
matter but which, in combination, are part of the prior art;
 A characterising portion preceded by the expression “characterised in that” or
“characterised by” stating the technical features which, in combination with the
features stated in sub paragraph (a), it is desired to protect.

Patent office decision:

For these (above mentioned) reasons, it is decided that
1. The decision of the Examining Division dated 13 April 1984 is set aside
2. The case is remitted to Examining Division for further prosecution on the basis of claims
1-12 filed in November 1985.

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 20. PBS Partnership v. Pension Benefit System
Subject matter under dispute:
The subject matter under dispute is a business method. Put in simple words, it involved a method
for controlling a pension benefits program and another for an apparatus programmed to carry out
the same. The patent application under dispute comprised a method of controlling a pension
benefits program which involved the successive steps of providing employee’s personal and
employment information to data processing means. This included method for determining
average employee age, method of life insurance cost computing means, and method of
estimating employee expenses by administrative cost computing means. Patent was also claimed
for an apparatus controlling the system which comprised of a data processing means which is
arranged to receive information into a memory from each subscriber employer defining the
number, earnings and ages of all employees. The said data processing means includes a
processor which includes average age computing means for determining the average age of all
employees, means for computing life insurance cost of all enrolled employees and also means for
computing all administrative, legal, trustee and government premium yearly expenses for said
subscriber employer.

Claims under dispute:

The claims which were under dispute are the following:
 Claim for method of Controlling a pension benefits program by administering at least
one subscriber employer account on behalf of each subscriber employer’s enrolled
employees each of whom is to receive periodic benefits payments, said method
comprising: providing to a data processing means information from each said subscriber
employer defining the number, earnings and ages of all enrolled employees of the said
employer; determining the average age of employees, determining periodic cost of life
insurance for all enrolled employees and method for estimating all administrative, legal,
trustee and government premiums yearly expenses for said subscriber employer by
administrative cost computing means
 Claim for apparatus which comprises data processing means to process all the aforesaid
employee information. The apparatus also comprises of a processor which does all the
previously mentioned computations namely average age computation, life insurance cost
computation and administrative cost –computation.

Relevant legal provisions:

Article 52- European Patent Convention

Patentable inventions
Article 52(1) - European patents shall be granted for any inventions which are susceptible of
industrial application, which are new and involve an inventive step.

28 | P a g e
Article 52(2) – The following in particular shall not be regarded as inventions within the
meaning of Section 52(i)
52(2)(C) – Schemes, rules and methods for performing mental acts, playing games or doing
business.
52(3) – The provisions of 52(2) shall exclude patentability of the subject matter or activities
referred to in the provision only to the extent to which a European patent application or European
patent relates to such subject matter or activities as such.
Article 56 – Inventive Step- An invention shall be considered as involving an inventive step if
having regard to the state of the art, it is not obvious to a person skilled in the art.

Judgment:
The main question in front of Court regarding the claim 1 was whether the method given therein
represents a method of doing business as such. If the method is technical or in other words has s
technical character it may be a method for doing business but not a method of doing business as
such. The court decided that all features of this claim are steps of processing and producing
information having purely administrative and financial character. Processing and producing
such information are typical steps of business and economic methods. Court also held that the
feature of using technical means for a purely non technical purpose for processing purely
non technical information does not confer technical character to individual steps. Thus
claim 1 does not go beyond a method for doing business and as such it is not patentable
under Art. 52(2)(C) read with respect to Art. 52(3). Therefore the court concluded that
methods only involving economic concepts and practices of doing business are not
inventions within the meaning of Art. 52(1) EPC.

The second claim was regarding the apparatus controlling the pensions benefit system. The court
cleared this particular subject matter as patentable. The court noted that a computer system
suitably programmed for use in particular field even if that is the field of business and
economy has the character of a concrete apparatus in the sense of a physical entity, man
made for a utilitarian purpose and is thus an invention within the meaning of Art. 52(1)
EPC. However the court observed that this claim does not involve an inventive step in the sense
of Art.56 EPC. The assessment of inventive step has to be carried out from the point of view of a
person skilled in the art (e.g.: an S/w professional). The court held that the technical features of
the apparatus claimed can be said to form part of the knowledge of the skilled person and the
court also considered the popularity of computer applications at the filing date of the application.
Hence the court concluded that the claimed subject matter does not involve an inventive step
under Art.56 (EPL).

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21. Ivax Pharmaceutical UK Ltd v. Akzo Nobel BV (No.2)

Subject matter and dispute:

The dispute in the present case is about a patent which claims a monopoly for polymorphous
tibolene of a specified mean particle size. Akzo & Ivax attack the patent pn the ground that the
claimed invention is obvious, both in the light of common general knowledge at its primary date;
and also in the light of particular prior art.

Claims under dispute:

1. Claim 1 of the patent was as follows:
“An immediate release pharmaceutical dosage form comprising, as the active
substance, polymorphous tibolene and pharmaceutically acceptable excipients,
wherein the polymorphous tibolene has a mean particle size of below 22.8 µm in the
dosage form.”
1. Claim 2 claimed a dosage form according to claim 1, where the mean particle size
was below 20µm and
2. Claim 7 was directed to the use of polymorphous tibolene for the manufacture of a
medicaments used for the treatment or prevention of menopausal or post menopausal
complaints wherein the polymorphous tibolene had a mean particle size below
22.3µm in the dosage form.

Relevant Provisions:
An invention shall be taken to involve an inventive step if it is not obvious to a person skilled in
the art, having regard to any matter which forms a part of the state of the art by virtue only of
section 2(2).

Decision:
1. Commercial considerations were not completely irrelevant to the world of patents.
Obstacles to marketing were part of the reason why the skilled person would consider
whether there was any technically obvious alternative to crystalline pure tibolene.
Richardson- Vicks Inc’s patent [1997] R.P.C. 333, CA considered.
Biogen Inc. v. medeva Plc [1997] R.P.C. 1, H.L referred to.
2. Commercial considerations could deter a person from following a particular path and
they could also be relevant in considering whether he should follow a particular path.
There was no reason why commercial reasons should exclude the desire to emulate a
successful product, w/o infringing a patent, if the means to do so were technically
obvious.
Dyson Appliances Ltd. v. Hoover Ltd [2001] R.P.C. 22, CA referred to.
3. There was no doubt that the overcoming of an existing prejudice was capable of being
inventive. The real question was one of fact: was the alleged prejudice so strong that
overcoming it was inventive.
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 Union Carbide Corp. v. BP Chemical Ltd [1993] R.P.C. 1, Pat. Ct referred to.
4. Information which would be accepted generally once discovered by the skilled addressee
doing his job as a matter of identifying the publications which were necessary to use as a
starting point for tackling the new problem and which would form part of the basis of the
skilled person’s approach other disclosures. It was to be treated in the same way as
information forming part of the common general knowledge. If that happened in the real
world, as a matter of the routine of a skilled but unimaginative person, there was no
reason why it should not happen in the world of patents. In so far this process consisted
of linking one piece of existing knowledge with another, it was ininventive linkage.
Nutrinova Nutrition Specialities & Food Ingredients GmbH. v. Scanchem UK Ltd
[2001] F.S.R. 42, Pat. Ct followed.
Smithkline Beecham Plc. v. Apotex Europe Ltd [2005] F.S.R. 2, CA distinguished.
5. Whilst it was true that the “035” patent was silent as to certain aspects of tibolene
formulations including particle size or metabolism, it was part of routine formulation to
carry out tests on the drug that the formulator was asked to formulate, in order to discover
its properties. In the course of such routine work the formulator would discover all he
needed to know about tibolene in order to put into effect the techniques of formulation
that formed part of his stock in trade. This would include the bioavailability of both
polymorphs.
6. Although the claims of the patent suit did not refer to bioequivalence with the
commercially available tibolene, it was clear from the specifications that the reason why
the particular size was chosen was its bioequivalence with the commercially available
tibolene. That bioequivalence was an important part of the claimed inventive concept was
the correct one.
7. In the light of claimants’ expert’s evidence, there was no prejudice against the
formulation of a polymorphous mixture such that the mindset of an unimaginative
formulation would have been deterred by technical problems from formulating a
polymorphous mixture. Whilst there was a preference for a single polymorph, it was not
strong enough to amount to a prejudice. Overcoming the preference was not inventive.
8. Although it might have been obvious to formulate a crystalline pure form of tibolene, it
was equally obvious to formulate a polymorphous mixture. Give the two equally
technical possibilities, which one was chosen might well depend on commercial
considerations such as the monopoly claimed by “035” looked at from the technical
perspective of a skilled but unimaginative formulator, the choice between the two was a
matter of indifference.
9. Once the decision had been taken to formulate polymorphous tibolene, finding a particle
size with bioequivalence equal to the marketed product, was not more than a matter of
routine testing. It would have been obvious to the skilled but unimaginative formulator to
have formulated polymorphous tibolene of the claimed particle size.

Final Verdict:
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The attack on the validity of the patent on the ground that the claimed inventive step was obvious
to a person skilled in the art therefore succeeds. I will, in principle, revoke the patent.

23. Dimminaco A.G v. Controller Of Patents (2002) IPLR (255)

Dimminaco AG is a Switzerland based company which filed a patent application on

28.1.1998 for- “process for preparation of infectious bursitis vaccine”. Brusitis is a
desease of the poultry and patent was sought for the live vaccine.

Subject matter under dispute: The patent to this vaccine was refused stating that the term
‘manufacture’ does not include a process that has its end product as a line substance.
Ayyangar Report had said that only process patents must be granted to food, pharmaceutical
companies etc. Therefore, the Patent was denied to processes which had their end products as
‘lining organisms’.
Restriction interpretation of the word manufacture under patent act, the bar against patent
claiming life has its origin in a 1991 circular issued by the Controller of Patents. The thrust was
that lining entities were not patentable under patent act. Based on this, patent office denied
protection to several claiming processes whose end products were living organisms.

Relevant provision applicable: Sec 2(1)(j) of the patent act gives definition of invention as a
manner of manufacture. But no definition of the word manufacture was given.

Patent Office Decision:

The patent office claimed the term ‘manufacture’ doesn’t include a process that has its end
product as a living substance. They by themselves thought it should mean a tangible non living
substance.
They rejected the patent saying statutory definition of manufacture did not include a process
resulting in a living organism and as the end product of the process resulted in a living organism
therefore the process is not patentable.

Decision of the Calcutta High Court:

The Calcutta High Court said-
i. In absence of a clear definition, the dictionary meaning of the word manufacture must be
accepted.
ii. It also said that there is no statutory bar in the Act to accept a manner of manufacture as
patentable even if end product contains a living organism.
iii. It also directed the patent office to reconsider the applicable in light of this observation.
Finally, patent was granted, IN 187970
This was a landmark judgment in consonance with world patent practice. This way,
most processes in biotech field become patentable.

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 The judgment opened up new opportunities for obtaining patents in India on micro
organism’s related inventions.

24. Scherings Application [1971] R.P.C 337

This application was given to patent the discovery of applicant that a known type of oral
contraceptive a particular gestagen, could effectively be administered in much smaller doses than
had previously been given. This reduced undesirable sideeffects.

Claim:
A method of contraception without suppression of ovulation, where in there is administered to
human body (female) parentally or by implantation a gestagen. The gestagen being free from
Oestrogens and being administered in a dose as herein before defined.

Subject matter: The applicant say that a process for contraception is not a process for “medical
treatment” in the sense of treatment to cure or prevent disease and that the established practice
relates only to medical treatment. In the broader sense this does not of course relate to treatment
but it is a prevention.
Claims to method of abortion or termination of pregnancy are considered to be unpatentable as
they will always be carried out under medical supervision but methods of contraception are not
therapy and may be patented. Pregnancy is not an illness or disorder. An so contraception is not
medical treatment.

Relevant Article:
Article 52(4)
Methods for treatment of human body or animal body by surgery or therapy and diagonistic
methods practiced on human body or animal shall not be regarded as inventions which are
susceptible of industrial application.
Art 56
An invention hall be considered as involving an inventive step if having regard to the state of the
art it is not obvious to the person skilled in the art.

Summary of discussion of Patent:

Appeal Tribunal in bar court
Contraception does not amount to treatment of disease. A known contraceptive substance in
dosages was reduced to appropriate amount such reduction having benefit of avoiding
suppression of ovulation.
The present claim is to a process involving chemical treatment which will suppress conception.
Unless any treatment to human body as opposed to medical treatment to cure or prevent disease
is to be considered outside the scope of patent protection, there seems to be no reason why patent
should not be allowed.
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The application was permitted to proceed for grant.

25. KIRIN AMGEN INC. v. ROCHE DIAGNOSTICS [2002] R.P.C 1

Subject Matter Under Dispute:

Natural human glycoprotein Erythropoietin (EPO) is a hormone which circulates in the blood
stream of healthy people. It is a circulating glycoprotein which stimulates erythrocyte
formation in higher organisms. The life of human erythrocytes is destroyed daily in the
reticulo-endothelial system. Erythrocytes are produced by the maturation and differentiation of
the erythroblasts in bone marrow, and EPO is a factor which acts on less differentiated cells
and induces their differentiation to erythrocytes.
EPO is a promising therapeutic agent for the clinical treatment of anaemia or in particular,
renal anaemia. Due to antigenicity problems, EPO must preferable be prepared from a raw
material of human origin. For example, human blood or urine from patients suffering aplastic
anaemia or diseases in which excessive EPO is secreted. These raw materials are not available
in abundance. A problem in the use of urine from healthy humans is the low content of EPO.
Thus, while EPO is a desirable therapeutic agent, conventional isolation and purification
techniques, used with natural supply sources, are inadequate for the mass production of this
compound.
The present invention is directed to the cloning of EPO genes and to the production of
EPO by the in-vitro expression of those genes. This invention led to expressing
surprisingly high levels of human EPO, the expression thereof, and the mass production
in-vitro of active human EPO there from. Describe also are suitable expression vectors for
the production of EPO, expression cells, purification schemes and related processes.

Parties Involved:
AMGEN:
1. In the early 1980’s Dr.Lin, an Amgen scientist succeeded in cloning the DNA responsible
for the manufacture of EPO which in turn allowed the production of recombinant EPO.
Mixed oligonucleotides were made to probe a genomic DNA (‘g DNA’) library. A genomic
library is a collection of DNA sections derived from cutting up the genome of a cell using
restriction enzymes. An expression vector carrying the human EPO DNA sequence was
made. Host Chinese Hamster Ovary (CHO) cells were transfected with the expression
vector. The transfected CHO cells use the EPO DNA sequence to form a protein with 166
amino acid sequence of EPO. Prior to secretion of EPO from the cell, the final amino acid,
or the C-terminal amino acid, of the 166 amino acid sequence is cleaved of, leaving a 165
amino acid protein. Also prior to secretion, carbohydrates are attached to certain sites on
EPO by glycosylation, which results in a glycoprotein. Recombinant EPO produced in this
manner can bind to the EPO receptor and stimulate erythropoiesis. This work eventually
became the subject of EP0148605B2, commonly known as ‘605’.

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2. 605 disclosed for the first time the DNA sequence for the human EPO gene and the
corresponding amino acid sequence of the human EPO protein.
3. Amgen contended that its invention not only provided the DNA sequence that codes for
EPO, but also new glycoprotein products, which are therapeutically useful pharmaceutical
compositions, cells and processes to make EPO available in sufficient quantity and quality
to treat the hundreds of thousands of patients worldwide suffering from various types of
anaemia.
4. Recombinant EPO reverses the most debilitating effect of renal failure.

ROCHE:
Roche scientists used different route involving a copy DNA (“c-DNA”) library. A c-DNA
library was made by using DNA prepared by reverse transcription from messenger RNA.
Roche were eventually successful, but subsequently to Amgen.

Claims Under Dispute:

Claim1 is in the following terms:
A DNA sequence for use in a securing expression in a prokaryotic or eukaryotic host cell of a
polypeptide product having at least part of the primary structural conformation of that of
erythropoietin to allow possession of the biological property of causing bone marrow cells to
increase production of reticulocytes and red blood cells and to increase hemoglobin synthesis
or iron uptake, said DNA sequence selected from the group consisting of:
a) The DNA sequences set out in Tables V and VI or their complementary strands;
b) DNA sequences which hybridize under stringent conditions to the protein coding regions of
the DNA sequences defined in (a) or fragments thereof; and
c) DNA sequences which, but for the degeneracy of the genetic code would hybridize to the
DNA sequences defined in (a) and (b)

Relevant Provision Applicable:

Section 1(2) of the 1977 Act provides:
It is hereby declared that the following (among other things) are not inventions for the purposes
of this Act, that is to say, anything which consists of –
a) A discovery, scientific theory or mathematical method;
b) A literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever;
c) A scheme, rule or method for performing a mental Act, playing a game or doing business, or
a program for a computer;
d) The presentation of information;
But the foregoing provision shall prevent anything from being treated as an invention for the
purposes of this Act only to the extent that a patent or application for a patent relates to that
thing as such.

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 Decision of The Court:
Roche contended that, in so far as claim1 of 605 claims genomic DNA, it is not an invention it
is simply a discovery of what existed in nature, and therefore cannot properly be claimed. They
in support for the reasoning relied on the case Genentech Inc’s Patents [1989] R.P.C. 147 in
which it was held that a particular DNA sequence was an ‘ existing fact of nature, newly
discovered’.
In his judgment, Justice Neuberger of the English Patents Court held that, “while it is
obviously the case that the essential feature of 605, and in particular of claim1, is a
“discovery”, namely that of the DNA sequence of the EPO gene, or at least a substantial part of
that gene, it was a discovery which clearly made a technical contribution”. He further observed
that his judgment in allowing the claims on the isolated gene, was justified by the practice of
the EPO and the USPTO in the previous 20 years.

26. Supreme Court of United States

Robert Gottschalk, Acting Commissioner of Patents
v
Gary R. Benson & Arthur C. Tabbot
409 U.S. 63

The case is regarding an application for a patent for a method for converting binary numerals
on general purpose digital computer. The patent examiner at USPTO rejected the application
as being directed to a mathematical expression. Tracing to the history, pure mathematical
expressions has been held to be unpatentable in Mackay Co. v Radio Corporation, 306. U.S. 86
(1939).

Basic claim of the applicant: The inventor in the case Gottschalk v. Benson, claimed a ‘method
for converting BCD numerals into pure binary numerals for use with general purpose digital
computer.
The contention here was relating to the subject matter of the patent applicant that “whether the
claimed invention was a ‘process’ under the law”.

What is patentable subject matter: Under US Patent Act 1952, section 101, governs the same.
What can be patented is called statutory subject matter under Section 101 of US Patent Act,
which states the following to be process, machine, manufacture or composition of matter:
“Whosoever invents or discovers any new & useful process, machine, manufacture or
composition of matter or any other new, useful improvement thereof, may obtain a patent,
subject to conditions of and requirement of this title”.

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The US Supreme Court held that invention was no more than an abstract mathematical
formula. Also, the invention did not qualify as a process because it did not result in any
transformation or reduction of anything ‘to a different state or thing’. It was held that a
mathematical algorithm itself is not patentable, but added that it may be that patent law should be
extended to cover computer programs.
 In Parker v Flook the Supreme Court once again rejected patent protection for software.
It was held that while a process may be patentable even though it contained a law of
nature or mathematical algorithm, “the process itself, not merely the mathematical
algorithm, must be new and useful. Here the inventor had discovered only the
mathematical algorithm and not the process; consequently the invention contained no
patentable invention.
 Hopes for software patents became brighter following the S.C in 1980 in Diamond v
Chakraborty, that patentable subject matter ‘included anything under the sum that is
made by man’.
 In 1981, in the case Diamond v Diehr, S.C finally granted patent on software system
when it ordered the USPTO to grant patent on invention that utilized computer software.
(Invention was patentable because it was a process for moulding rubber and not
merely a mathematical algorithm).

When is an invention, merely an unpatentable mathematical algorithm, and when is it

patentable invention that has embedded in a mathematical algorithm?
In early 1990’s Courts clarified, if invention in actuality is only a mathematical algorithm such as
computer program designed to convert BCD into binary numbers, then invention was not
patentable. However, if a computer is used in an invention to transform numbers that represent
concrete real world values (such as program to interpret electrocardiograph signals to predict
arrhythmia (Arrhythmia Research Technology v Carazonix Corp, Fed Circuit 1992) or a
program to analyze seismic measurements (In Re Johnson) then invention is a process
relating to real world concepts and is patentable.
 Software can be considered a process or a component of a machine (when programmed
into a computer). Even than software- was not patentable per se- rather what had to be
patented was machine, or process.
In the case In Re Alappat (Fed Cir 1994), involved a patent application where the issue
was whether a rasterizer for graphical images was a statutory subject matter or not. The
court madea a significant statement, “We have held that such programming creates a new
machine, because a general purpose computer in effect because a special computer
for a purpose, once it programmed to perform particular functions pursuit to instructions
from program software.”
Thus ‘mathematical algorithm’ exception to statutory subject matter first discussed by
S.C in Gottschalk v Benson is limited to abstract mathematical concepts, not
mathematics applied to practical problem, machines, even though they carry out

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 mathematical operators, are patentable, since cash registers which do mathematical
operations are patentable.
In Re Loury (1994)- a memory containing a data structure should be considered
patentable subject matter and the particular data structure claimed should be considered
in determining whether the invention is new and non- obvious.
In Re Bilski- in 2008 by Fed Cirt, there was expectation that the decision would alter the
scope of patentable subject matter especially as it is related to business methods &
software. Instead the majority ruled on the patentability of processes where the process
steps are not necessarily performed on computer. The decisions was based on a single
test for determining the patentability of process-
1) It is tied to a particular machine or apparatus
2) It transforms the particular article into different states or things

The test applies to process claims but not clear on that it applies on apparatus claims
(such as computer implanted software claims).

Whether a patent can be issued for claimed invention designed for business world:
Bilski v Kappos- June 2010. S.C rejected F.C’s holding in In Re Bilski that machine or
transformation process test is the sole test to determine subject matter for patent. Instead the test
should be viewed as “clue” to the analysis. The majority decided that Bilski invention was not
patentable as it’s a mere attempt to preempt an abstract idea.
(How commodity buyers & sellers in the energy market can protect, hedge, against the risk
of prize size. Invention was not implanted an specific apparatus).

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27. Fujitsu Limited’s Application
[1997] R.P.C 608, CA

The patent application related to a method and apparatus for modeling a synthetic crystal
structure for designing inorganic materials. The apparatus in question involved a computer
program so that an operator could select an atom, a lattice vector and a crystal face in each of 2
crystal structure displayed by the computer. The computer then converted data representing the
physical layout of the 2 crystal structure into data representing the crystal structure that would
have been obtained by combining the original 2 structure in that way. The resulting data was
then displayed to give an image of the resulting combined structure.
Whether any technical contribution or no more than a program for a computer or a
method for performing a mental act.

Details of Claim Under Dispute:

Claims 9 and 10 read as follows:
9. A method of manufacturing a structure which is a crystalline combination of 2 crystal
structure, the method comprising an investigation of the effects of combining the two crystal
structures using a method according to any one of the preceding claims.
10. A computer apparatus for creating a computer image of a synthetic crystal structure formed
of a just crystal structure having a plurality of atoms and lattices and a second crystal structure
having a plurality of atoms and lattices, said apparatus comprising:
Computer storage means for. .
Selection means for selecting from. .
Specifying means, coupled to said selecting means, for specifying. .
Transformation means for transforming said. .
Computer display means for displaying.

Relevant Statutory Provision Applicable:

Section 1 of the Patent Act 1977, defines what are patentable inventions and also lists some
things that are not patentable. The relevant parts:
1. A patent may be granted only for an invention in respect of which the following condition are
satisfied-
a) The invention is new
b) It involves an inventive step
c) It is capable of industrial application
d) The grant of a patent for it is not concluded by subsection (2) and (3) below; and reference in
this Act to a patentable invention shall be construed accordingly
2. It is hereby declared that the following are not invention for the purpose of this Act, this is to
say, anything which consists of:
a) A discovery, scientific theory or mathematical method
b) A literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever
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c) A scheme, rule or method for performing a mental act, playing a game or doing business, or a
program for a computer
d) The presentation of information;

Judgment:
Aldous L.J
Computer program as such or any technical contribution:
 There is difficulty in identifying clearly the boundary line between what is and what is
not a technical contribution
 2 grounds were forwarded
1. Relying on Vicom, the technical contribution was provided by the processing of Real
images or structures
Vicom decision was not rigid and each case decided on its own facts.
2. Application provided a new tool for modeling crystal structure combinations which
relived the chemist of the laborious task of building a model
But these are just advantages that are obtained by use of a computer program.

Method of Performing a Mental Act:

- Referring to Merrill Lynch and Gale.
A claim to a computer operating in a particular way is no more patentable than a claim to a
computer program. A claim to a method of carrying out a calculation is no more patentable
when claimed as being done by a computer. Method of performing mental acts, which means
methods of the types performed mentally, are unpatentable, unless some concept of technical
contribution is present.

The creation of diagrammatic images of physical objects on the visual display units of
computers which can be turned, revolved and altered at the bidding of the computer operator
is not new. In my opinion what the appellants have done here is no more than to produce,
brilliant though it may be, a new computer program. The invention may be new but as it is no
more than a computer program and it is not patentable.

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 28. Ciba- Geigy’s Propagating Material Application [1984]
O.J. EPO 112, Tech. Bd. App

Claim in dispute:
“Claim 13”:- Propagating material for cultivated plants, treated with an oxime derivative
according to formula 1 in claim 1.
“Claim 14”:- Propagating material according to claim 13, characterized in that it consists of
seed.

Definition of cultivated plants in the description includes all plants which yield substances in
any form, & propagating material from such cultivated plants comprises all reproductive plant
components, including plants & plantings which have begun to be germinated, but particularly
seeds.

Claims relate to any cultivated plants in the form of their propagating material which have been
chemically treated in a certain way. However, EPC Article 53(b) prohibits only the patenting of
plants or their propagating material in the genetically fixed form of the plant variety.

EPC Article 53(b)- Prohibits the granting of Patents for Certain biological inventions:-
- Says that patents shall not be granted in respect of plant varieties or essentially biological
processes for the production of plants.
- Plant varieties mean a multiplicity of plants which are largely the same in their
characteristics and remain the same within the specific tolerances after every propagation
or every propagation cycle,
- This definition is reflected in the International Convention for the protection of New
Varieties of plants of December 2, 1961, which is intended to give the breeder of a new
plant variety a protective right. Plant varieties in this sense are all cultivated varieties,
clones, lines, strains and hybrids which can be grown in such a way that they are clearly
distinguishable from other varieties sufficiently homogeneous, and stable in their
essential characteristics.
- The legislator did not wish to afford patent protection under the European Patent
Convention to Plant varieties of this kind, whether in the form of propagating material or
of the plant itself.
- The innovation claimed here does not lie within the sphere of plant breeding, which is
concerned with the genetic modification of plants. Rather, it acts on the propagating
material by means of chemical agents in order to make it resistant to agricultural
chemicals. The new parameter for the propagating material, namely treatment with an
oxime derivative, is not a criteria which can be characteristic of a plant variety as far as
the protection of varieties is concerned. There is therefore no conflict between the
protection of varieties or the patent as different forms of Protection for propagating
material treated in this way. In fact, Patent protection is the only possibility.
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- It is immaterial to the question of patentability that the propagating material which is
treated can also be, or primarily, a patent variety. As plant varieties have been excluded
from patent protection. Innovations which cannot be given the protection afforded to
varieties are still patentable if the general prerequisites are met.
- Moreover, the propagating material claimed is not the result of an essentially biological
process for the breeding of plants- which would be excluded from patent protection- but
the result of treatment with chemical agents.
- Therefore, EPC Article 53(b) is not an obstacle to the patenting of the propagating
material claimed in the present case.

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29.

Subject matter under dispute

The current invention relates to a method of and a device for the flow measurements of
small liquid volumes through a thin tube. The measurements of small liquid volumes are
important for the production and application in the medical dispenser devices and other
medical drug administration device to that effect.

Details of exams under dispute:

The main claims that are under dispute are the claim 1 to claim 4 that narrates that the
patent production is sought for the method in which electrically conductive liquid,
containing a drug such as Insulin and is introduced into the body through an implantable
pump device for a controlled drug administration.
Another disputed claim is that of the claim 4 that contains a functional link between flow
rate management and the provided feed pump to that effect for a controlled and
automated drug administration.

Relevant Provision Applicable:

European Patent Convention
Article 52- Patentable Invention
Article 52 (a) - Methods for the treatment of human or animal body parts by surgery or
therapy or diagnostic methods practiced on human or animal body shall
not be treated/ regarded as inventions which are susceptible to the industrial application
within the meaning of paragraph 1.
Article 52 (1) – European patents shall be granted for the inventions which are
susceptible to industrial applications, which are new and which involve an inventive step.

Office Decision:
The Board held that introduction of the drug into the human body by means of the device
for controlled administration that has already been implanted is clearly unconnected with
either a surgical or a diagnostic method.
Further the court held that the initialization of a system for ensuring that it is in working
order needs to be exclusively with production of the said effect on that structures and not
on the is not influenced by the effects that are produced on the body. The check on the
device therefore requires no medical knowledge
The court further held/ observed that the measurement of the flow rate require no medical
knowledge and has no medical therapeutic effect whatsoever.
The court further held that the flow rate device does not in any way alter the quality or
the quantity of the said drug and therefore has no therapeutic or medically diagnostic
relevance in the said matter whatsoever to that effect.
Order: The contested decision is therefore set aside.
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 Section 101 Whoever invents or discovers any new and useful process, machine,
manufacture, or composition of matter, or any new & useful improvement thereof may
obtain a patent thereof, subject to the conditions & requirement of this title.

Facts of case: The applicants had discovered a method of using known compounds as
selective week links in a particular locus & files two complete specifications each
containing a claim to such a compound in a container bearing instructions for use in
selectively combating weeds at such locus.
I. The examiner rejected the claim on ground of Section 101.
II. Superintending examiner upheld the objection
III. Applicant appeal to the Patents Appeal Tribunal was dismissed
IV. Appeal to Court f Appeal

Held: There was nothing inventive in parceling a known material in convenient package or
container having written there on the information that it can be used for the stated purpose in
stated loci; there was therefore no manner of new manufacture involved in two claims to which
objection had been made on that ground.

Cases referred:
i. Mullard Radio Valve Co v Philco Radios TV Corp 1936
ii. L’oreal’s Application 1970
iii. Organon Laboratories Ltd’s Application 1970
iv. Dow Coming Corporations Applications 1974
Graham, J – The matter concerns the use of 4 isopropyl-phenyl urea’s for dealing with weeds in
grain crops, rice, maize, cotton, & soya as the original disclosure and claims set out. As I
understand it, the applicants discovered what no doubt may turn out to be meritorious invention
namely that these particular urea’s, which were already known as herbicides, could in fact be
used as selective herbicides for killing weeds in particular crops mentioned.
Justice found by examining first CS that claim is in effect to a pack or package of the urea
material.
MR. WALTON: It is customary to write instructions on a container for sale of substance. It lack
in subject matter & devoid of any invention. Dow case one sees that the first task of the tribunal
which has to decide this question of manner of manufacturing is to construe the claim in
question.

L’oreal case:
The conclusion may depend, & in our judgment in this case does depend, on the form & scope
of the claim circumstances. Two bottle for hair treatment.
Organon Case: It is again seen that it is necessary in order to establish the presence of valid
manner of manufacturing to show that there are some modification of package in question

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introduced by some limitation in claim so that the package is suitable for some particular purpose
when modified in that way. Plls arranged in certain manner- Not granted.
The discovery of new method of treatment which may itself be very meritorious even though not
patentable
1) Something novel in card itself
2) General public are in possession of idea that pills can usefully be arrange on a card in order
Even if card is new if pills are not be taken in order than what is the use of card (Basic discover
lies in method of treatment).
Dow Case: Game+ Rules of Playing
Pack + Instruction
Problem well known already
Benefit- Instructions

It becomes clear from language of claims that modified or qualified it so that its shape is useful
for the purpose whether amendments allowed or not?
It requires more discussion
Russel, L.J, It is know that by crop spraying with particular compounds dicotyledonous weeds
can be destroyed without damage to monocotyledonous crops.

Discovery: If you spray the locus of certain crops with a known compound it is possible also to
destroy monocotyledonous weeds (grass) without damage to monocotyledonous crops.
Discovery qualifies as an invention to NRDC case.

Warner Jenkins v Hilton Davis,520 U.S. 17

Facts of the case

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  Petitioner and Defendants are manufacturers of dyes. The respondent “746”,
patent which issued in 1985 discloses an improved purification process involving
an ultra filtration process thro’ a porous membrane at PH levels between 6.0 &
9.0. The inventors limited their claim’s PH levels because of a perceived overlap
with earlier “Booth” patent which disclosed an ultra filtration process which
operated at a PH level of 9.0.
 The petitioner developed an ultra filtration process operating at 5.0 PH
 The respondent sued for infringement of the 746 patent

Analysis

The question that arose during the case was

I. Was there any infringement of ‘746’ patent?

II. What was the scope of the prosecution history estoppels in this case?

The ‘doctrine of equivalents’ is a test that tests for equivalents action of a particular element
of the invention on its replacement with its equivalent, performs the same function is a similar
way and achieves the result of the claimed element thereof.

Will the test of equivalence, show the result of the equivalent element, the objective of
equivalence is to replace the claimed element with the equivalent element and perform the
test.

Thus it was held that the infringement analysis on the basis of doctrine of equivalents has to
be done claim by claim and not of the invention as a whole. The particular claim has to be
taken to constitute and test of equivalence action has to be performed.

The action of equivalence is applied, the knowledge of ‘PHOSITA’ is not relevant but what
are the necessary similarities and differences that arise between the elements is the central
crux of the analysis.

The doctrine of equivalents is applied when the legal action for infringement arises but is not
considered when the patent was issued.

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Application of prosecution history in this case, the Court felt would bung about a practice, so
Coo Oden who had no idea that prosecution history estoppels would be applied in this regard.
To prove the same is evidence would be very difficult and the court remanded the same to the
Federal Court.

Comments
 The scope of Doctrine of Equivalents as in this case after the 1950 amendment was
affirmed in this case after considering the necessary factors on application of the doctrine
by 35 US 112.
 Another important change the case brought into focus was on application of ‘doctrine of
equivalents’. After Grayer’s, the Courts had mis-applied “equivalents” doctrine which
brought the conceptual flaw and its application to the invention as the whole rather than
the element by element basis.

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Biogen Inc v. Medeva Plc

Decided On:
The House of Lord delivered its judgement on 31st October 1996. The appeal in this case was
the law lord’s first opportunity to consider the validity of a patent for a product of genetic
engineering.

Subject Matter:
The patent in suit was an artificial molecule of DNA (recombinant DNA) coded to induce
production of Hepatitis B antigens for use in diagnostic and production of a vaccine against the
disease.
In 1970s, recombinant DNA technology was in its infancy. Hepatitis B virus (HBV) had
been isolated and partially characterised, but unfortunately, its genome had not been sequenced.
Prof. Sir Kenneth Murray (Edinburgh University, UK) decided to attempt expression of HBV
genomic DNA bacteria, even though he had no knowledge of the DNA sequence.
In 1978, he used ‘Shotgun method’ for the expression of viral antigens in bacterial colonies.
Prof. Murray successfully expressed both the core and surface antigens of the virus. What Prof.
Murray did not do, because at the time the technology did not exist, was express either antigen in
a non-bacterial host.

Six months later, the HBV genome was sequenced and was found to contain no introns.
Earlier in 1970s, it was thought that because HBV infected only higher eukaryotic organisms, its
genomic DNA would have introns and would not be expressed in a bacterial host.

Legal Background:
In 1978, Biogen applied for a patent in UK (Biogen 1) for a method of producing HBV antigens
from recombinant DNA, based on Prof. Murray’s work.

This application formed the basis of a claim to priority in respect of a later application filed with
the EPO (EP B-1 182442) on 1979.

The later patent covered the expression of both the core and the surface protein in any host. In
addition, it also covered DNA molecules coding for both surface and core antigens.

This patent was granted on July 1990 though it was subjected to opposition proceedings which
was dismissed on appeal by EPO on 1994.

Meanwhile, in 1992, Biogen sued Medeva for infringing its patent for proposing a third
generation hepatitis B vaccine made by Recombinant DNA technology in mammalian cell
colonies.

Judge Aldons, in High Court, found that Biogen’s patent was valid and had been infringed

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After that Medeva counterclaimed for revocation in Court of appeal

It alleged that the patent was invalid under UK Patent Acts and European Patent Convention:
(Article 52- Patentable inventions
Article 83- Disclosure of the invention
Article 84- The claims).

Claims under dispute:

The principal claim for the appeal concerned a product claim in which the molecule was
identified partly by the way it had been made (rDNA techniques) and partly by the way it was
expressed to produce HBV antigens. Subsequent claims, based on the principle claims, covered
both the distinct HBV ‘surface’ and ‘core’ antigens and their expression in bacterial, yeast and
mammalian host cells.

The principal claim read as follows:

“A recombinant DNA molecule characterised by a DNA sequence coding for a polypeptide or a
fragment thereof displaying HBV antigen specificity, said DNA sequence being operatively
limbed to an expression control sequence in the recombinant DNA molecule and being expressed
to produce a polypeptide displaying HBV antigen specificity when a suitable host cell
transformed with said recombinant molecule is cultured, the transformed host cell not producing
any human serum proteins and any primate serum proteins other than the polypeptide displaying
HBV antigen specificity”.

Grounds on which the patent was invalid are:

 Claimed invention was obvious (under section 1(1)(b) and 3) both at the date of
application for patent in suit and at the date of Biogen 1
 Biogen was entitled to the priority date of Biogen 1 because it did not support the
invention claimed in the patent (under sec 5(2)(a)).
 Claimed invention was not an invention (under Sec 1(1)).
 Description in the specification was insufficient (under sec 12(1)(c))

Decisions:
In this case, Judge Aldons in the High Court defined the inventive concept as: “the idea or
decision to express a polypeptide displaying HBV antigen specificity in a suitable host”.

On that basis, Judge Aldons found that patent was not obvious. He decided that: “there is no
evidence to suggest that anyone, other than Biogen, contemplated expression of HBV in
December 1978; despite the fact that (knowing rat preproinsuline had been expressed in bacteria)
there was an incentive to do so.”

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The Court of Appeal held that Biogen’s patent was obvious, because eukaryotic DNA (rat
preproinsuline) had already been expressed in bacteria.

According to the Court of Appeal this inventive concept was merely a commercial goal that had
been shared by others in the field and the decision to adopt the method had been a commercial
one.
House of Lords disapproved the Court of Appeal’s reasoning. The House of Lords held that such
commercial considerations were irrelevant, saying:
The fact that a given experimental strategy was adopted for commercial reasons,
because the anticipated rewards seemed to justify the necessary expenditure, is no reason why
that strategy should not involve an inventive step. An inventor need not pursue his experiments
untouched by thoughts of gain. Most patents are the result of research programmes undertaken
on the basis of hard headed cost benefit analysis.
Further, the House of Lords agreed with the Court of Appeal that the inventive concept was
obvious because the idea was shared by others in the field being the pursuit of an identifiable
goal by known means.
Therefore, the House of Lords held that the inventive concept could be redefined as: “the
idea of trying to express unsequenced eukaryotic DNA in a prokaryotic host”.

By redefining the inventive concept, the House of Lords said that- Prof. Murray’s invention was
not a goal, but a method of achieving that goal. Therefore, the House of Lords were ‘content to
assume’ that Biogen’s patent would not have been obvious in 1978.

Thus, the House of Lords overturned the Court of Appeal’s finding that Prof. Murray had chosen
to pursue an identified goal by known mean. By referring back to the problem that it required
invention to overcome, a patent may be non-obvious as long as the method of obtaining the goal
was not an obvious choice.

The second ground on which Biogen’s patent was attacked that of insufficiency. To
define the minimum disclosure required, Judge Aldons, in the High Court, had applied the ‘one-
way’ rule, as expounded by the EPO Board of Appeal in Genentech I/ Polypeptide Expression.
In this case, the Board of Appeal ruled:
“An invention is sufficiently disclosed if at least one way is clearly indicated enabling the skilled
person to carry out the invention.”

Judge Aldons found that Prof. Murray’s method had produced both antigens in E.Coli, and that
expression would also be achievable in other hosts. Therefore, the Judge found the patent not to
be insufficient.

On other hand, the Court of Appeal in Biogen v. Medeva preferred the reasoning
advanced in the case of Exxon/Fuel Oils. In this case the Board of Appeal said:
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“The disclosure of one way of performing the invention is only sufficient within the meaning of
(the sufficiency requirement) if it allows the person skilled in the art to perform the invention in
the whole range that is claimed.”

The Court of Appeal in Biogen v. Medeva decided that there were four separate
inventions- expression of both core and surface antigens in bacterial and non-bacterial host, and
that Prof. Murray had only expressed core antigen in bacteria. Therefore, the patent was
insufficient.

The House of Lords by referring various relevant cases, decided that Prof. Murray’s technical
contribution, though brilliant it was, did not justify such a wide claim. The patent was, therefore,
said to be insufficient.

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 Regents of the University of California v. Eli Lily and Company

119 F. 3d 1559, 43 USPQ 2d 1398

University of California applied for patent no. US 4,652,525 in May 1977 and was based on the
determination of the PI and PPI cDNA sequences found in rats. Furthermore in the year 1979
September UC filed another patent US 4431740 claiming the cDNA sequences and development
of tailoring techniques for the incorporation of human PI cDNA into a recombinant plasmid.
Using this technique the human pro insulin cDNA and plasmid can be incorporated to form the
stable recombinant plasmid.
Lily made human PI using a semi-synthetic DNA to yield a cleanable protein (fusion protein)
consisting of a single methionine residue and human PI. After the fusion protein is produced the
desired PI is produced by the cleavage of the fusion protein.
The district Court for the Southern District of Indiana need that Eli Lily did not infringe the ‘525
and 740’ patents in its manufacture of human insulin and asserted claims of ‘525 are invalid and
both the patents are unenforceable.

Issues raised by UC in appeal:

Validity of claims:
The district court ruled that all claims of ‘525 patent UC asserted against Eli Lily viz claims
1,2,4,7 are invalid as per S.112 p1 because the complete written description regarding cDNA to be
used was not provided.
To fulfil the written description requirement, a patent invention specification must describe an
invention and do so in sufficient detail that one skilled in the art can conclude that “inventor
invented the claim invention.” Thus an applicant should comply written description requirements
by describing the invention, with all its claimed limitations and by using descriptive means such as
words, structures, figures, diagrams and formulas. Accordingly, an adequate written description
of a DNA requires more than a mere statement that it is the part of the invention and
reference to a potential method for isolating it.

Claim 5 of the ‘525 patent refers to a recombinant prokaryotic micro-organisms modified so

that it contains a nucleotide sequence with the cDNA (human) encoding for insulin.

What claim 5 provided was the definition of the claimed microorganism but does not provide a
written description of the cDNA encoding human insulin, no discrete information regarding
identity, structural or physical characteristics etc.

Claim1:
 A recombinant plasmid replicable in prokaryotic host containing a sequence of
mRNA coding for insulin.
 Recombinant prokaryotic micro organism

Thus the court of Appeal rejected the UC’s argument that the district court erred in
finding claims 1,2,4,6 and 7 invalid for failure to provide an adequate written description.
And assumed the district court’s rulings.

Enforceability:
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The district court ruled out that’525 patent unenforceable on the ground of inequitable conduct.
The based finding was that UC had violated NIH guidelines in order to develop the patented
invention as soon as possible and falsified material in its patent application. The court noted that
at the time of application of ‘525, NIH had certified 3 plasmids for use with mammalian DNA.
But UC used pBR322 plasmid to hasten the determination of rat PI and PPI sequences.
But the patent was not heed unenforceable stating that the same has not been done for any
misrepresentation and neither the other company stated that the plasmid stated in the
patent became inoperable.

The 740 Patent:

Infringement: The district court ruled those plasmid and transfer vectors are genetic constructs.
Accordingly the court found that Lily which does not make or use such construct but expresses a
recombinant fusion protein to be cleaved to human PI, which does not literally infringe the
asserted claims.
The determination of the infringement is based on the two patents-
 Claim construction, a question of law which we review de novo the proper construction
of claim is based on the claim language the specification, the prosecution.
 Whether a particular device infringe a properly construed claim is a question of facts

A DNA transfer vector comprising an inserted cDNA consisting essentially of DNA

sequence coding for human PI.
The UC 740 patent claims were rejected on the issue of the prior art and UC amended claims and
narrowed its claimed in response to prior art rejection and thus uncovered fusion protein.
Thus the decisions of the district court that Lily did not infringe the 740 patent either
literally or under the doctrine of equivalents.

Note: when a claim has been narrowed down for a substantial reason related to
patentability, such as to avoid the prior art rejection, the patentee may not assert that the
surrendered subject matter is within the range of equivalents.
Claim 2: a DNA transfer vector comprising an inserted cDNA consisting of DNA
cDNA coding for pre insulin

Enforceability: The district court ruled that ‘740 patent was unenforceable due to inequitable
conduct. The court based its finding that UC failed to disclose to the PTO a highly material
reference entitled ‘Plasmid for Transforming Bacterial Host to render it capable of polypeptide
expression in which the example of Human insulin is used. The court said that UC was made
aware of the materiality of EPA- 1929 when cited as prior art by EPO during prosecution of the
application that led to ‘740 patent.

The district court collectively found that UC knew of EPA-1929 because EPO considers EPA-
1929 to be the material to the examination of 740 applications. Therefore UC’s failure to cite it
will not support the inequitable conduct as one is justified in not submitting the cumulative art.
What is relevant is whether EPA- 1929 disclosed the subject matter relevant to the
examination of the 740 patent applications. It does not.
The district court’s finding was erroneous and the conclusion that 740’ patent is unenforceable
for inequitable conduct is based clearly on the erroneous findings.

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Conclusion:
 The 525 patent does not provide an adequate written description of the subject matter of
the asserted claim
 The claims 1,2,5,6,7 of 525 patent are invalid
 Eli lily did not infringe the ‘740 patent’s claims
 The court abused its discretion in holding the patent 525 and 740 unenforceable

Section 112- The specification shall contain a written description of the invention, and the
process of making it, in such full, clean, concise and exact terms as to enable the person
skilled to make and use the invention.

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F. Hoffman La Roche Ltd and Anr v. Cipla Limited
Citation- MANU/DE/0517/2008
2008 (37) PTC 71 (Del)

Subject matter under dispute:

In this case plaintiff asked for an ad-interim injunction against the defendant to restrain the
defendant from manufacturing, offering for sale, selling, and exporting the drug Erlotinib for
which the plaintiff holds a patent. Plaintiff oriduced the drug ‘Tarceva’ made from Erlotinib , the
drug is very helpful in the treatment of lung cancer. The defendant started making and selling the
generic version of Erlotinib since December 2007 under the brand ‘Erlocip’.

Details of the claim under dispute:

The plaintiff was granted patent in respect of Erlotinib on 23/02/2007, Patent No. being 196774.
In the claim the plaintiff claimed as follows:
i. A novel [6,7-bis (2 methoxyethoxy) quinazoli-4-yl]-3-ethynylphenyl hydrochloride
compound of the formula ‘A’ novel [6,7 bis (2-methoxyethoxy) quinazolin-4-yl] amine
hydrochloride compound of the formula A.
ii. A process for preparing the compound as claimed in claim 1, wherein;
a) The stated compounds react in the presence of isoproponal and pyridine under an
inert atmosphere of dry nitrogen and under conditions more specifically described
and
b) The obtained product is isolated from the reaction mixture
The summary of the invention which is a part of the body of the claim described it interalia as
directed to pharmaceutical compositions for treating a hyper proliferative disease in mammals
which comprise a hyper proliferative disease treating amount of a compound of the formula 1
and a pharmaceutically acceptable carrier.

Relevant Provision applicable:

Sec 2, 2(1), 5, 5(2), 8, 10, 11A, 11A (3), 11A (7), 11B, 12, 13, 13(4), 14 to 21, 25, 43, 45(1), 47,
48, 53, 54(1). Article 21 of Indian Constitutions.

Court’s Decision: The defendant’s arguments were based on following contentions:

i. The defendant contended that the plaintiff’s patent claim lacks an inventive step. Because
Erlotinib, being a quinazolin derivative only seeks to improve from the existing prior
article.
ii. Defendant also argued that plaintiff has failed to prove that its drug has increased efficacy
than other drugs available in the market. Hence, the patent is liable to be revoked US
3(d).
iii. Defendant also argued that the plaintiff’s claim does not fulfil the condition of non
obviousness.
Court held that the test of obviousness cannot be that the material or formula was published, but
that having regard to the existing state of prior art or the published material, was it possible to a
normal but unimaginative person skilled in the art to discern the step on the basis of the general
common knowledge of the art at priority date.
The argument of the plaintiff that the invention has been patented in various countries and it has
not been challenged anywhere, was rejected by the court.

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Court took the notice of the fact, that the plaintiff’s tablet costs Rs 3200/ per tablet while that of
defendant’s cost Rs1600/. Also, the plaintiff does not have a manufacturing unit in India while
the defendant has. Court held that the price difference in case of a life saving drug is an
important factor which cannot be ignored by the Court. Court also held that if the injunction is
granted then the court would be denying the fundamental right under Article 21. Because of the
above reasons, Court denied the plaintiff an ad interim injunction as it would cause an irreparable
injury to the public.

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Perfect Web Technologies Inc v. Infousa Inc

Subject matter:
The “400 patent” claims method of managing bulk e-mail distribution to group of targeted
consumers. The Patent recognizes a e-mail in an often used component of internet. Patent
explains that distributors’ access lists of customers who express subject matter preferences for
Commercial e-mail. US Patent No: 6, 631, 400.

Details of Claims:
Claim 1:
 Matching a target recipient profile with a group of Target recipients
 Transmitting a set of bulk e-mail to said target recipients in said matched group.
 Calculations a quantity of e-mails in said set of bulk e-mails which have successfully
received by said target recipients
 It said quantity doesn’t exceed a prescribed minimum quantity of successful received e-
mails, (A) to (C) steps repeated until said quantity exceeds, said minimum quantity.
Claim 2: step of choosing a subset of targeted group for e-mail distribution.
Claim 5: depends on claim 1 & specifies that list of targeted recipients is an “opt-in.urt”.
Claim 11: independent apparatus claim to a “machine readable storage” with a “Computer
programme” that performs the method of Claim 1.
Claim 12 & 15: depend from claim 11 & mirror claims 2 & 5 respectively.

Relevant provision Applicable:

 Claim 1 is obvious under 35 U.S.C Sec 103 because steps (A) to (C) of claimed methods
appears in prior art & Step (1) is obvious to virtually anyone.
 More over Court band that Claim 1 was anticipated under 35 USC Sec 102 (b) by a
Company called Emoril Channel, which allegedly performed the claimed method in
public before Patent’s Critical date.
 Court considered Claim 1 didn’t constitute Patent Subject matter under 35 USC Sec 101
because it was a merely a series of algorithms
 Finally Court concluded that all of the dependent Claim were also invalid as obvious,
anticipated, and/or directed to intelligible subject matter.
 Perfect Web appealed, under Jurisdiction 28 USC Sec 1295 (a) (1) (2006).

Discussion: Court considered is obvious stating that “the art of e-mail marketing” is that person
of ordinary skill in that art possessed claims proficiency with computer & email programmes. It
then found that Claim 1 (methods) were previously known. (Prior Art) considered (A) to (C) on
repetitive & (D) on logical result of Common sense application “try, try again”.
Long felt need: Court said that any proof of long belt need would be insufficient to overcome
strong Prima facie showing of obviousness.

Court Decision: For the above reasons District Court contend that claim 1,2,5,11,12 & 15 of the
“400 patent” delve invalid for obviousness. An appeal, the Federal Circuit upheld the
obviousness finding and left the alternative reasons decided.

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Bayer Corporation and Ors. v. Cipla, Union of India and Ors. 2009 (41) PTC 634 (Del)

Subject matter:
The writ petitioner in the case was Bayer Corporation. The second respondent in the case was the
Drug Controller General of India (DCGI) and the third respondent was Cipla. The Indian Patent
Office had granted the petitioner, patent number, 215758 on 3rd March, 2008. Hence, by virtue of
the Patents Act, 1970, Bayer got the exclusive right to prevent third parties, from the acts of
making, using, offering for sale, selling or importing the patented product in India, without its
consent. Bayer filed the petition seeking directions to, inter alia, restrain grant of drug license in
regard to an application by the third respondent for the license to manufacture, sell and distribute
its drug “Soranib”. The petitioner, claimed, that the said drug was an imitation of, or substitute
for, its patented drug, “Sorafenib tosylate” (Nexanar tablet).

Issues for consideration:

a) Whether the DCGI can grant marketing approval under the Drugs and Cosmetics Act,
1940 (DCA) to generic versions of patented drugs.
b) Whether the grant of such marketing approvals to generic versions of a patented drug is
in derogation of the Patents Act, 1970.
c) Whether generic drugs are spurious drugs in terms of the DCA.
d) Is there a patent linkage in terms of the Patents Act, 1970 and the DCA.

Relevant applicable Provisions:

The Patents Act, 1970
Section 13: Search for anticipation by previous publication and by prior claim
13(4): The examinations and investigations required under section 12 and this section shall not
be deemed in any way to warrant the validity of any patent, and no liability shall be incurred by
the Central Government or any Officer, thereof, by reason of, or in connection with, any such
examination or investigation or any report or other proceedings consequent thereon.
Section 48: Rights of patentees
1. Subject to the other provisions contained in this Act, a patent granted before the
commencement of this Act, shall confer on the patentee the exclusive right by himself,
his agents or licensees to make, use, exercise, sell, or distribute the invention in India.
2. Subject to the other provisions contained in this Act and the conditions specified in
section 47, a patent granted after the commencement of this Act shall confer upon the
patentee-
a) Where the patent is for an article or substance, the exclusive right by himself, his
agents or licensees to make, use, exercise, sell or distribute such article or
substance in India.
b) Where a patent is for a method or process of manufacturing an article or
substance, the exclusive right by himself, his agents, or licensees to use, or
exercise the method or process in India.
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 Section 156: Patent to bind government
Subject to the other provisions contained in this Act, a patent shall have to all intents
the like effect as against government as it has against any person.
The Drugs and Cosmetics Act, 1940
Section 2: Application of other laws not barred- The provisions of this act shall be in
addition to, and not in derogation of, the Dangerous Drugs Act, 1930, and any other
law for the time being in force.
Section 17B: Spurious drugs- for the purposes of this chapter, a drug shall be deemed
to be spurious,-
a) If it is manufactured under a name which belongs to another drug, or
b) If it is an imitation of, or is a substitute for, another drug or resembles another
drug in a manner likely to deceive or bears upon it or upon its label or
container the name of another drug unless it is plainly and conspicuously
marked so as to reveal its true character and its lack of identity with such other
drug; or
c) If the label or container bears the name of an individual or company
purporting to be the manufacturer of the drug, which individual or company is
fictitious or does not exist; or
d) If it has been substituted wholly or in part by another drug or substance ;or
e) If it purports to be the product of a manufacturer of whom it is not truly a
product.

Decision of the Court:

A. In granting marketing approval, the DCGI is by no means itself infringing any patent
or abetting the infringement of any patent by the applicant in whose favor the
marketing approval is being granted. The object of the DCA is to regulate the import,
manufacture, distribution and sale of drugs and cosmetics. The introduction of the
concept of “spurious drugs” by the 1982 amendment to the DCA did not require the
DCGI to itself enforce a patent granted under the Patents Act, 1970 ad deny
marketing approval to a generic version of a patented drug manufactured by a non
patentee.
B. The scheme of the DCA envisages that when an application is made for grant of
marketing approval for generic version of a patented drug, in respect of which
marketing approval has already been granted to the patent holder, the applicant has
only to satisfy the DCGI that its drug is bio-available and bio-equivalent to the
patented drug. The role of the DCGI is clearly cut out under the DCA. There is no
scope for the DCGI to travel beyond the DCA and ensure protection of a patent by
refusing marketing approval to a generic manufacturer only because the drug in
question is patented.
C. If Bayer’s contention of Cipla’s drug being “spurious” were to prevail, every generic
drug, would ipso facts amount to a spurious drug, since they were deemed substitutes
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 of the originator (patented) drugs. Such an interpretation was contrary to the DCA.
The key element of spurious drugs was deception, in the manner of presentation of
the drug concerned and in the sense that it imitated or represented itself to be
something that it was not. A declaration by the drug agency, entrusted with the task of
deciding applications seeking marketing approval, that someone not holding a patent
was attempting to get clearance for a “spurious drug” would be pre-emptive and
would negate the provisions which required that the enforcers should follow certain
mandatory procedures, and prosecute potential offenders. For these reasons, the Court
held that unpatented drugs, per se, were not spurious drugs.
D. The court highlighted the inherent differences between the objectives of the two
statutes, i.e. the Patents Act, 1970 and the DCA and that there could no interplay
between them. The DCA was a public regulatory Measure, which prescribed
standards of safety before introduction of a drug in the market. The Patents Act, had
put in place a regime containing standards for conferring private monopoly rights in
favor of inventors. It was held that a system of patent linkage could not read into the
provisions of the DCA and the Patents Act and such a system was undesirable in the
Indian context for the following reasons: (1) placement of patent right policing on
regulatory authorities; (2) transformation of Patent rights, which are private rights that
depend on the owners’ desire to enforce them, into public rights; (3) undermining of
the ‘Bolar’ provision; and finally, although Article 27 of the TRIPS agreement
requires that patents are made available without discrimination by the field of
technology, yet the patent linkage was specific to the pharmaceutical sector only.

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