Patent Slides

PATENT DEFINED
 A patent is a limited monopoly that is granted in

return for the disclosure of technical information.
 The applicant is required to disclose his invention
so that it can be used (or worked) by a ‘person
skilled in the art’. In return, the State (in the guise
of the Patent Office) issues the applicant with a
patent that gives him the exclusive right to control
the way that his patented invention is exploited for
a 20-year period.
Patentability
 What is the standard for getting a patent?
New
Useful
Non-obvious
 What do you get if you meet the standard?
Right to exclude others from the invention for a limited time
Not a right to use the invention
 What do you give up by getting a patent?
You have to teach others how to make and use the invention
 What do you risk by not patenting your invention?
i.e., trying to keep it a trade secret
Someone else can patent it and exclude you from using it.
S U N N
least one new reactant
organisms, varieties and species
 Exceptions:
a) Ss. 29 to 34
b) S.64(2) & (3)
- Personal document or secret trial or secret use.
- Use/import for the purpose of reasonable trial or experiment.
- Use by the Govt. or any person authorized by the Govt. or
Govt. Undertaking.
- Without the consent or acquiescence of the applicant.
BISHWANANTH PRASAD RADHEY SHYAM V.
HINDUSTAN METAL INDUSTRIES
• Hindustan Metal Industries, a registered partnership firm

carrying on the business of manufacturing brass and
German silver utensils at Mirzapur claimed to have
invented a device and method for manufacturing utensils,
introducing improvement, convenience, speed, safety
and better finish, in the old prevalent method which was
fraught with risk to the workers, in as much as the
utensils used to fly off from the headstock, during the
manufacturing process.
• The plaintiff got the invention patented, as an assignee,
on May 6, 1951.
• In September 1952, the plaintiff learnt that the defendant

(Bishwanath Prasad Radhey Shyam, a concern carrying
on the business of manufacturing dishes and utensils in
Mirzapur) was using and employing the method under
the former's patent.
• The plaintiff served a notice upon the defendant asking
him to desist from infringing the plaintiff's patent and
further claimed damages to the tune of Rs. 3000.
• The validity of the patent was challenged by defendants
on the ground of lack of novelty and inventive step and
also a counter claim praying for the revocation of the
plaintiff's patent on the same ground.
(a) The method covered by Hindustan Metals’ Patent

namely that of lathe, was known and in common
commercial use for several decades before the plaintiff’s
patent.
(b) The alleged invention was not on the date of the patent, a
new manner of manufacture or improvement, nor did it
involve any inventive step or ingenuity with regard to what
was known or used prior to the date of the patent.
(c) The patent had no validity and therefore it was liable to
be revoked.
 In order for the improvement to be patentable it has to be more
than a mere ‘workshop improvement’.
 To fulfill the criteria of inventive step, the combination or
improvement should either result in a new process or
improved result or should be cheaper.
 The Supreme Court held that “Mere collection of more than
one integers or things, not involving the exercise of any
inventive faculty, does not qualify for the grant of a patent”.
 After considering the prior art in the case, the court stated that
the patented invention was merely an application of an old
invention, known for decades before 1951, for the traditional
purpose of scraping and turning utensils, with a slight change
in the mode of application (mere addition of a lever and
bracket), which was no more than a workshop improvement.
 The crucial test for the validity of a patent as to whether it

involves novelty and an inventive step goes against the
patentee, and therefore the contention that the patented
device had utility cannot be accepted.
BILSKI V. KAPPOS
 An application for a patent on a method of hedging

losses in one segment of the energy industry by making
investments in other segments of that industry
 The method included a simple mathematical concept and
familiar statistical approaches.
BILSKI V. KAPPOS (CONTD.)
 Petitioners, Bernard Bilski and Rand Warsaw applied for

a patent on their claimed invention- a method for hedging
risks for commodities trading, but the patent examiner
rejected the application, claiming it involved an abstract
idea and was not implemented on a specific apparatus.
 Petitioners appealed and the Federal Circuit affirmed.
 The Federal Circuit adopted the machine-or-
transformation test to judge patentability under § 101. A
patent applicant may show that-
(1) the claimed process was tied to a particular machine; or
(2) the process transformed an article into something else.
 One of the dissenting judges argued it failed because it

was a method of conducting business.
 A second dissenting judge argued the invention was an
abstract idea and therefore unpatentable.
 A third dissenter remanded to determine patentability
under other provisions.
 Petitioners appealed to the United States Supreme
Court.
 The U.S. Supreme Court affirmed the Federal Circuit’s
decision but overturned the "machine−or−transformation
test.“
 The Patent Act § 101 defines patent eligibility with
exceptions for “laws of nature, physical phenomena, and
abstract ideas.”
 Despite upholding the patentability of business methods,
the majority nonetheless rejected Petitioners' application
for "falling outside of § 101 because it claimed an
abstract idea.”
 A majority opinion authored by Justice Kennedy agreed
that the Federal Circuit’s “machine-or-transformation” test
at least “is a useful and important clue, an investigative
tool,” for patentability, but not the sole or exclusive test.
 Neither the text of the Patent Act nor Supreme Court

precedent supported the "machine−or−transformation"
test as the sole test for deciding which processes are
patent−eligible.
 The five-justice majority opinion also rejected a rule that
all business methods are unpatentable.
 By watering down the circuit court’s “machine-or-

transformation” test, the Supreme Court failed to provide
guidance in the future about business method patents.
 For example, suppose a patent claim is not clearly
unpatentable as just an abstract idea, but it does fail the
now-optional “machine-or-transformation” test.
 When will such a claim be patentable? The Court did not
answer that question, or provide details about how to
apply the test in such a case.
 If business methods could be patented, then many

business decisions, regardless of how small, could be
potential patent violations.
 Businesses would either live in constant fear of litigation
or would need to undertake the costs of searching
through patents that describe methods of doing business,
attempting to decide whether their innovation is one that
remains in the public domain.
 This would greatly inhibit business innovation and
competition. For these and other reasons, the Court
should have clearly stated that the claims at issue were
not patentable because business methods are not
patentable.
ALICE CORPORATION V. CLS BANK
 Alice Corporation (Alice) owned 4 patents('479,'510,'720, and
'375), all of which had to do with a computerized trading
platform that deals with financial transactions in which a third
party settles obligations between two others so as to eliminate
settlement risk.
 The concept of a third-party to confirm a complete transaction
is called escrow, and has been used in finance for thousands
of years.
 The patents in question described how the escrow function
could be performed by a general-purpose computer. However,
they did not describe how such a computer would work, and
did not include any source code or specifications.
 Alice alleged that
CLS Bank International and CLS Services Ltd. (collectively
"CLS Bank") began to use similar technology in 2002.
 Alice accused CLS Bank of infringement of Alice's
patents, and when the parties did not resolve the issue,
CLS Bank International (CLS) sued Alice and sought a
declaratory judgment of non-infringement and invalidity of
Alice’s patents in 2007.
 Alice countersued CLS Bank for infringement of the
patents.
 The DC held all claims to be patent ineligible because the
claims concerned abstract ideas.
 Alice appealed to the Federal Circuit. Divided judges;
separate opinions.
 The panel as a whole did not agree on a single standard to
determine whether a computer-implemented invention is a
patent-ineligible abstract idea
 SCOTUS had to answer the question- Is implementing an

idea on a computer enough to transform a non-
patentable, abstract idea into patentable subject matter?
 The keen interest of the software industry and patent
professionals in the issue was illustrated by the filing of
52 amicus curiae briefs urging the Supreme Court to
decide the issue of software patent eligibility.
 A software implementation of an escrow arrangement
was not patent eligible because it is an implementation of
an abstract idea.
 Escrow is not a patentable invention, and merely using a
computer system to manage escrow debts does not rise
to the level needed for a patent.
 The Supreme Court articulated a two-step process (Mayo
Framework) for assessing patent-eligible subject matter
in the context of computer-related inventions-
1. In the first Mayo step, the court must determine whether
the patent claim under examination contains an abstract
idea, such as an algorithm, method of computation, or
other general principle. If the answer is affirmative, the
court must proceed to the next step.
2. In the second step of analysis, the court must determine
whether the patent adds to the idea "something extra"
that embodies an "inventive concept.”
The Court described the second step as a search for an
“inventive concept” to ensure that the patent amounts to
“significantly more” than an abstract idea.
• For the second step, the Supreme Court

in Alice explained that “the mere recitation of a generic
computer cannot transform a patent-ineligible abstract
idea into a patent-eligible invention.”
• The Court held that Alice's claims did no more than
require a generic computer to implement this abstract
idea of intermediated settlement by performing generic
computer functions, which is not enough to transform an
abstract idea into a patent-eligible invention.
 "We need not labor to delimit the precise contours of the

'abstract ideas' category in this case." Justice Clarence
Thomas
 The court agreed with those filing amicus curiae briefs
and unanimously invalidated the patent.
 Although the Alice opinion did not mention software as
such, the case was widely considered as a decision on
software patents or patents on software for business
methods.
under PCT.
 The Patents (Amendment) Act, 2005: Patents for pharmaceutical and agro-chemical
products.
NOVARTIS AG V. UOI
 In 1997, Novartis filed an application seeking the grant of
a patent for an anticancer drug Glivec, used to treat
Chronic Myeloid Leukemia (CML) and Gastrointestinal
Stromal Tumours (GIST), on the basis that it invented the
beta-crystalline salt form (imatinib mesylate) of the free
base, imatinib.
 In 2006, the Madras Patent Office refused the patent
application for Glivec stating that the said drug did not
exhibit any major changes in therapeutic effectiveness
over its pre-existing form, which was already patented.
 The said decision was based on Section 3(d) of the
Indian Patents (Amendment) Act, 2005 which provides
for a known substance to be patented only if its new form
exhibits “enhanced efficacy”.
WHAT IS SECTION 3(d)?
 The sub-section states that inventions that are a mere
"discovery" of a "new form" of a "known substance" and
do not result in increased efficacy of that substance are
not patentable.
 This effectively means that if there is an old molecule in a
new substance you cannot patent it by making a minor
modification, and passing it off as a completely new
invention.
NOVARTIS AG V. UOI (CONTD.)
 In May 2006, Novartis filed two writ petitions under Article

226 of the Indian Constitution before the High Court of
Madras – one appealing against the order of Madras
Patent Office rejecting its patent request and the other
contesting that Section 3(d) of the Indian Patents Act is
not in compliance with TRIPS and is vague and arbitrary.
 The Madras High Court refused the writ petitions of
Novartis holding that it did not have jurisdiction to
determine whether a domestic law is contrary to
international treaty, so it cannot decide whether Section
3(d) is in compliance with TRIPS.
 The new phase of litigation started at the Intellectual Property Appellate
Board.
 The Appellate Board considered the beta-crystalline form of Imatinib
Mesylate as new and having an inventive step but refused to grant a
patent to the drug of Novartis since it was hit by Section 3(d) of the Act.
 The IPAB defined ”efficacy” for the purposes of S.3(d) to mean
”therapeutic effect in healing a disease or having a good effect on the
body”.
 The IPAB however, held that the appellant could not be denied the
process patent for preparation of Imatinib Mesylate in beta crystalline
form.
 It further held that the grant in such a case also attracted the provisions
of S.3(b) which prohibited grant of patent on inventions, exploitation of
which could create public disorder among other things.
 Novartis challenged the said order by filing a Special Leave Petition
before the Supreme Court.
The main issues that came up before the Supreme

Court were-
i. Whether the invention is inconsistent with Section
3(d) of the Patent Act?
ii. Interpretation of Section 3(d) of the Patent Act?
iii.Whether the invention qualifies for the test of
novelty and inventive step for the alleged
product?
i. The Court observed that the product was one of the new
forms of the substance and not the whole substance. It has
always existed in the original amorphous form. The product
thus has to qualify the test laid down in Section 3(d) of the
Patent Act.
ii. The Section clearly specifies that a new form of a known
substance is not patentable under Indian law unless it
enhances its “known efficacy”.
iii. Novartis contended that the physico-chemical properties of
the polymorph form of the Imatinib molecule, i.e. better flow
properties (more processable), better thermodynamic stability
(facilitating storage) and lower hygroscopicity (increased shelf
life), resulted in improved efficacy and hence was patentable
under Indian law.
 The Apex Court rejected this contention stating that in the
case of medicines, efficacy meant “therapeutic efficacy”
and these properties while they may be beneficial to
some patients, did not meet this standard.
 The Supreme Court held that neither the Act nor the
international practice gave a clear definition of efficacy.
 The true intention to enact Section 3(d) was to prevent
the concept of ever-greening and thus if the invention
does not fulfil the test of Section 3(d), it cannot be
granted a patent.
 With regard to the field of medicine especially in cases of
life-saving drugs, a great care and caution needs to be
taken so as to protect the right to life of the masses.
DIAMOND V. CHAKRABARTHY (CONTD.)
 The case was heard in the US Supreme Court in 1980.

 It entailed the patentability of genetically modified
organisms (GMOs).
 Ananda Mohan Chakrabarty, a microbiologist, developed
a bacterium called Pseudomona Putida, while working
with General Electric.
 The bacterium could break down crude oil which made it
suitable for treating future oil spills.
DIAMOND V. CHAKRABARTHY
(CONTD.)
 The application was rejected by the patent examiner and
the Board of Patent Appeals and Interferences agreed
with the original decision;
 However, the
United States Court of Customs and Patent Appeals
overturned the case in Chakrabarthy's favour.
 Sidney A. Diamond, Commissioner of Patents and
Trademarks, appealed to the Supreme Court.
 For purposes of patent law, the fact that micro-organisms
are alive is not relevant.
 Although it is true that naturally-occurring products may
not be patented, a genetically-engineered micro-
organism is not naturally occurring.
 Since the patent laws clearly include materials such as
are at issue here within their scope, and no specific law
exists to exclude them, the only appropriate holding is
that recombinant DNA-produced micro-organisms are
patentable.
 “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 therefor, subject to the conditions and
requirements of this title”
 Judged in this light, the respondent's micro-organism
plainly qualifies as patentable subject matter.
 His claim is ... to a non-naturally occurring manufacture
or composition of matter—a product of human ingenuity.
DIMMINACO AG V. CONTROLLER OF
PATENTS & DESIGNS
 Process for preparation of
live vaccine for protecting
poultry against Bursitis.
 The vaccine would
essentially protect the
contagious Bursitis
infection which was found
in poultry.
 However, the process for
the preparation of this
vaccine contained a living
virus in the end product.
PATENTS & DESIGNS (CONTD.)
 The patent application filed by Dimminaco A.G. was
examined by the Patent Examiner and he gave a finding
that the said patent application did not constitute an
invention under 2(j)(i) of the Patent Act, 1970.
 Dimminaco appealed to the Controller of Patents and
Designs and the Assistant Controller, acting under the
authority of the Controller, too, refused to accept the
patent application and upheld the objection.
 The appellants approached the Calcutta High Court.
DIMMINACO AG V. CONTROLLER OF PATENTS
& DESIGNS (CONTD.)
 During the arguments before the Court, the Patent Office

maintained that an inventive process must lead to an
article or a substance.
 An article according to the Patent Office implied a
material thing, item, a thing of a particular class or kind
as distinguished from a thing of any class or kind.
 It was further argued that only an inanimate object can be
denoted as a thing or item and not a living one.
 Thus, the controller concluded that a vaccine with the
living organism could not be considered a substance.
DIMMINACO AG V. CONTROLLER OF PATENTS
& DESIGNS (CONTD.)
 The appellant argued that the terms ‘manufacture’ and
‘substance’ had not been defined in the Act and therefore
one would have to rely on the dictionary meaning.
 The appellant also brought to the notice of the Court that
the Patent Office on earlier occasions had accepted
applications in respect of new processes which included
cells, viruses and other micro-organisms.
 The Calcutta HC held that the controller erred in law by
holding that merely because the end product contained live
virus, process involved was not an invention.
 The Court held that there is no statutory bar to accept a
manner of manufacture to be patentable if the end product
contains a living organism.
 To decide whether in a particular case, the process of
manufacture that is involved in the invention ought to be
patented or not, the vendibility test can be used.
 A vendible product is one that can be passed on from
one man to another upon the transactions of purchase
and sale.
 The vendibility test therefore is satisfied if either of the
following conditions are met-
1. The invention results in the production of some vendible
product; or
2. It improves/restores former conditions of a vendible
product; or
3. Its effect is the preservation and prevention from
deterioration of some vendible product.
 Since the claim process for patent, i.e., the manufacture of
a vaccine, led to a vendible product, it was certainly a
substance after going through the process of
manufacture.
 Therefore, the process was an invention and as a result,
patentable.
HARVARD COLLEGE V. CANADA (THE ONCOMOUSE CASE)
 Researchers at Harvard Medical School in the early 1980s produced a

genetically modified mouse that was highly susceptible to cancer, by introducing
an oncogene that can trigger the growth of tumours.
 Harvard College sought patent protection in the United States and several other
countries.
HARVARD COLLEGE V. CANADA
(CONTD.)
 In 1985, the President and Fellows of Harvard College
(Harvard) applied for a Canadian patent for a technology
for creating transgenic non-human mammals that are
prone to cancer.
 The patent was sought for a process for producing mice
that have cancer-promoting genes (oncomice), as well as
for the end product of the process, namely the "founder"
mice and the oncomice, offspring whose cells are
affected by the gene.
 Since oncomice have a heightened susceptibility to
cancer and tumour development, they are useful for
animal carcinogenic studies, such as tests for evaluating
suspected carcinogens or cancer-protective agents.
(CONTD.)
The disclosure portion of the patent application stated that:
(i) The desired oncogene is obtained from the genetic code
of a non-mammal source, such as a virus;
(ii) A vehicle for transporting the oncogene into the
mammal’s chromosomes is constructed using a small
piece of circular bacterial DNA referred to as a plasmid;
the plasmid is chemically cut and the oncogene is
chemically “spliced” into the plasmid;
(iii) The plasmid containing the oncogene is then
mechanically injected into fertilized eggs at a site called
the male pro-nucleus;
(CONTD.)
(iv) The eggs are then implanted in a host mammal or “foster
mother”;
(v) The eggs are permitted to develop and the offspring are
delivered by the foster mother;
(vi) After delivery, the offspring are tested for the presence of
the oncogene; the offspring that contain the oncogene are
called “founder” animals;
(vii) Founder animals are subsequently mated with ordinary
animals and the offspring are again tested for the
presence of the oncogene before the offspring are used in
research.
(CONTD.)
 The Patent Examiner rejected the product claims on the
ground that higher life forms were outside the definition of
"invention" in the Canadian Patent Act and were therefore
non-patentable subject matter. The process claims were
allowed.
 This decision was upheld by the Federal Court, Trial
Division, but was overturned by a majority of the Federal
Court of Appeal.
 The majority of the Court, in directing the Commissioner of
Patents to issue a patent, stated that the Patent Act does
not explicitly exclude living organisms such as non-human
mammals from the definition of "invention.”
(CONTD.)
 The majority concluded that the Oncomouse "must be
considered to be the result of both ingenuity and the laws
of nature" and is an invention, as it is both unobvious and
a new and useful "composition of matter”.
 The minority stated that in a morally divisive case such as
the one at hand, the court should defer to the
Commissioner's decision to refuse to grant a patent.
 Leave was granted for an appeal to the Supreme Court.
(CONTD.)
 Majority opinion- The Patent Act was not designed to apply to
higher life forms and cannot easily be applied to them. If we
decided that the Patent Act applied to higher life forms, there
would be no clear reason why it couldn't apply all the way up
to human beings. In summary, it is appropriate to let the
Patent Commissioner forbid this kind of patent until the
Parliament creates applicable legislation.
 Minority opinion- Even though Parliament may not have
anticipated the Patent Act's application to higher life forms
when they wrote the Act, this invention is nonetheless a
"profound and far-reaching" "scientific accomplishment" - the
kind of thing the Patent Act was meant to apply to. The
inventors deserve to have their work recognized, protected,
and rewarded.
(CONTD.)
 "The massive private sector investment in
biotechnological research is exactly the sort of research
and innovation that the Patent Act was intended to
promote."
 Many other jurisdictions have allowed this patent, and
important policy goals argue for our patent regime to be
consistent with that of the rest of the world. For these
reasons, the patent should be allowed.
ASSOCIATION FOR MOLECULAR PATHOLOGY
V. MYRIAD GENETICS
V. MYRIAD GENETICS (CONTD.)
 Breast cancer is a leading cause of cancer deaths in

women, second only to lung cancer. About 12% of
women in the United States develop breast cancer at
some point in their lives, and approximately 3% die from
the disease. During 2013, breast and ovarian cancer
claimed the lives of an estimated 53,000 women and
resulted in more than 250,000 new diagnoses.
 BRCA1 and BRCA2 are genes (i.e., pieces of DNA) that
normally help repair damaged DNA.
 A mutation in one of these genes means that cells are
more likely to develop genetic alterations that can lead to
cancer.
 Someone with mutations in the BRCA1 or BRCA2 genes

has a significantly higher risk of getting cancer, especially
breast, ovarian, and prostate cancer.
 Women with mutations in the BRCA1 and/or BRCA2
genes can take steps to mitigate the risk of cancer,
including enhanced screening, medications, and
preventive surgery to remove breasts and/or ovaries.
(Angelina Jolie suffered from the same disease)
 According to its court filings, Myriad Genetics was the
first company to discover the precise location and
sequence of the BRCA1 and BRCA2 genes, which
allowed it to determine their typical nucleotide sequence.
 Myriad's competitors disputed this history, arguing that

multiple researchers, many of whom are publicly funded,
contributed to the discovery of the locations of BRCA1
and BRCA2.
 Based on these discoveries, Myriad developed medical
tests to detect BRCA1 and BRCA2 gene mutations, the
presence of which would indicate an increased risk of
cancer.
 The tests involved two processes.
 The first process involved separating segments of DNA

containing the sequences of nucleotides (which comprise the
“ladder rings” in the double helix of DNA) typically found in the
BRCA1 and BRCA2 gene sequences.
 The second process involved creating a copy of the original
natural DNA sequence that contains only exons (i.e.,
nucleotides that code for amino acids, the building blocks of
proteins), called cDNA.
 After it identified the location and sequence of BRCA1 and
BRCA2 genes, Myriad obtained a number of patents.
 The patents covered the act of isolating the genes and the
creation of cDNA, giving Myriad exclusive rights to control
those processes for 20 years.
 Although the actions described in the patents are part of the
process of Myriad's BRCA1/2 testing, it is important to note
that Myriad's patents did not cover any unique testing
methods.
 When scientists at other institutions began offering BRCA
testing after Myriad had discovered the genes, Myriad ordered
them to stop, asserting that the testing infringed Myriad's
patents.
 One of the scientists who had been ordered to stop, Dr. Harry
Ostrer, sued to declare Myriad's patents invalid, joined by
other doctors, patients, and advocacy groups.
 The Federal District Court granted summary judgment to

Dr. Ostrer, finding that Myriad's patents were invalid
because they covered products of nature.
 On appeal, the Court of Appeals for the Federal Circuit
reversed, holding that both isolated DNA strands and
cDNA may be patented.
 The patents claimed by Myriad Genetics would, if upheld,
give it the exclusive right to isolate BRCA1 and BRCA2
genes, or any strand of 15 or more nucleotides within
them, and the exclusive right to create BRCA cDNA.
V. MYRIAD GENETICS
While asserting these patents to exclude other testing providers, Myriad was the only
company that could administer the BRCA1/2 test, for which it charged $3,000–
$4,000, yielding a profit of $57 million through June 2013.
ASSOCIATION FOR MOLECULAR
PATHOLOGY V. MYRIAD GENETICS
(CONTD.)
 The question before the Supreme Court was whether
Myriad's patents pertain to a “new and useful composition
of matter” or simply “naturally occurring phenomena.”
 In a unanimous decision of 9-0, the Court ruled that cDNA
is patentable, while segmented natural DNA is not.
 “A naturally occurring DNA segment is a product of nature
and not patent eligible merely because it has been
isolated…”
 Regarding segmented DNA, the Court explained that...
“Myriad did not create anything. To be sure, it found an
important and useful gene, but separating that gene from its
surrounding genetic material is not an act of invention.”
 Myriad's patents' description explained the iterative

process and extensive efforts that led to the identification
and isolation of the gene sequences.
 However, the process of discovery does not necessarily
yield a patentable product where the discovered item is
naturally occurring.
 Myriad attempted to argue that the act of severing
chemical bonds to isolate the DNA creates a non-
naturally occurring molecule.
 On the other hand, cDNA is not naturally occurring. In cDNA,

“The non-coding regions have been removed.”
 The petitioners argued that, despite this modification, cDNA
is not patent-eligible because the sequence of nucleotides is
dictated by nature, simply copied into an exons-only version.
 The Court disagreed, holding that even though the cDNA
follows the nucleotide sequence of the natural DNA segment
and retains its naturally occurring exons, the cDNA is a new
creation and, therefore, patentable.
 Immediately after the Supreme Court ruling invalidating
some of Myriad's patents, other companies began offering
lower-cost BRCA1/2 testing at approximately $1,000–$2,300
per test.
IN RE ROSLIN INSTITUTE: DOLLY THE SHEEP
CLONING CASE
 On July 5, 1996, Keith

Henry Stockman Campbell
(“Campbell”) and Ian
Wilmut (“Wilmut”) of the
Roslin Institute of
Edinburgh, Scotland
(“Roslin”), successfully
produced the first mammal
ever cloned from an adult
somatic cell: Dolly the
Sheep.
 BBC News and
Scientific American called
Dolly "the world's most
famous sheep”
IN RE ROSLIN INSTITUTE: DOLLY THE
SHEEP CLONING CASE (CONTD.)
 The cloning method Campbell and Wilmut
used to create Dolly constituted a
breakthrough in scientific discovery.
 Known as somatic cell nuclear transfer,
this process involves removing the nucleus
of a regular body cell and implanting that
nucleus into an egg cell that has had its
cell nucleus removed.
CLONING CASE (CONTD.)
 Dr. Campbell and Sir Ian

obtained a U.S. Patent for
the method they used to
produce Dolly: somatic
cell nuclear transfer, which
involves removing the
nucleus of a somatic cell
that has been arrested in
the quiescent (where the
cell is dormant and non-
replicating) phase of the
cell cycle and implanting
that nucleus into an
enucleated oocyte (an egg
cell prior to maturation)
 If implantation occurs at a certain stage, the resulting

fused cell will develop into an embryo, and ultimately a
baby animal, which is an exact genetic replica of the
adult mammal from which the somatic cell nucleus was
taken.
 Roslin is the assignee of the ’233 application, which
claims not the cloning method, but rather the cattle,
sheep, pigs, and goats that are the products of the
cloning method; cattle, sheep, pigs and goats.
Representative claim 155 recites:

155. A live-born clone of a pre-existing, non-embryonic,
donor mammal, wherein the mammal is selected from
cattle, sheep, pigs, and goats.
 The Examiner rejected the claims at issue as being
directed to non-statutory subject matter under 35 U.S.C. §
101, and as being anticipated and obvious under §§ 102
and 103.
 The Board affirmed the Examiner's rejections, finding that
the claimed subject matter was ineligible for patent
protection under § 101 because it constituted a natural
phenomenon that did not possess "markedly different
characteristics than any found in nature.”
 In affirming the Board's affirmance of the Examiner's

rejections, the Federal Circuit began by noting that
"[e]ven before the Supreme Court's decision
in Association for Molecular Pathology v. Myriad
Genetics, Inc. (2013), the Court’s opinion in Diamond
v. Chakrabarty (1980) made clear that naturally occurring
organisms are not patentable.”
 In Chakrabarty, however, a genetically engineered
bacterium that was capable of breaking down various
components of crude oil was found to be patent eligible
because "it was 'new' with 'markedly different
characteristics from any found in nature and one having
the potential for significant utility."
 From these two cases, the Court concluded that "discoveries that
possess 'markedly different characteristics from any found in nature'
are eligible for patent protection [and] any existing organism or newly
discovered plant found in the wild is not patentable.”
 In other words, the Court held that even if something is made by
man it is not patentable if what it results in is an exact copy of what
occurs in nature.
 On appeal, the Roslin Institute argued that unlike the donor sheep
used to create Dolly, clones like Dolly are eligible for protection
because they are "the product of human ingenuity" and "not nature's
handiwork, but [their] own."
 The Court disagreed, stating that "Dolly herself is an exact genetic
replica of another sheep and does not possess 'markedly different
characteristics from any [farm animals] found in nature,'" and thus,
"Dolly's genetic identity to her donor parent renders her
unpatentable."
 Analogizing the instant case to Myriad, the opinion states

that:
Roslin "did not create or alter any of the genetic information"
of its claimed clones, "[n]or did [Roslin] create or alter the
genetic structure of [the] DNA" used to make its
clones. Myriad, 133 S. Ct. at 2116. Instead, Roslin's chief
innovation was the preservation of the donor DNA such that
the clone is an exact copy of the mammal from which the
somatic cell was taken. Such a copy is not eligible for patent
protection.
 Roslin Institute also argued that its clones should be

patent eligible because they are distinguishable in at
least two respects from the donor mammals used to
create them.
 In particular, Roslin argued that:
(1) environmental factors lead to phenotypic differences
that distinguish the clones from their donor mammals,
and
(2) the clones are distinguishable from their original
donor mammals because of differences in mitochondrial
DNA, which originates from the donor oocyte rather than
the donor nucleus.
 In response to both arguments, the Court noted that

neither the phenotypic differences nor the differences in
mitochondrial DNA were claimed.
 Moreover, with respect to the phenotypic differences, the
opinion indicates that "Roslin acknowledges that any
phenotypic differences came about or were produced
'quite independently of any effort of the patentee.'"
 Thus, "[such] phenotypic differences do not confer
eligibility on their claimed subject matter because any
phenotypic differences between Roslin's donor mammals
and its claimed clones are the result of 'environmental
factors,' uninfluenced by Roslin's efforts"
 The Court did appear to leave the door slightly ajar for
other cloned animals, stating that:
“There is nothing in the claims, or even in the specification,
that suggests that the clones are distinct in any relevant
way from the donor animals of which they are copies. The
clones are defined in terms of the identity of their nuclear
DNA to that of the donor mammals. To be clear, having
the same nuclear DNA as the donor mammal may not
necessarily result in patent ineligibility in every case. Here
however, the claims do not describe clones that have
markedly different characteristics from the donor animals
of which they are copies.”
 As a result, the Federal Circuit affirmed the Board's

finding that the Roslin Institute's clones constitute
unpatentable subject matter under § 101.
FORM OF APPLICATION (SECTION 7)
 Every application for a patent shall be for one invention

only and shall be made in the prescribed form and filed in
the patent office
 Every international application under the Patent
Cooperation Treaty for a patent, as may be filed
designating India shall be deemed to be an application
under this Act, if a corresponding application has also
been filed before the Controller in India (1A).
 The filing date of an application referred to in sub-section
(1A) and its complete specification processed by the
patent office as designated office or elected office shall
be the international filing date accorded under the Patent
Cooperation Treaty.
FORM OF APPLICATION (SECTION 7)
 Every application under this section shall

state that the applicant is in possession of
the invention and shall name the person
claiming to be the true and first inventor;
and where the person so claiming is not
the applicant or one of the applicants, the
application shall contain a declaration that
the applicant believes the person so
named to be the true and first inventor
CONTENTS OF SPECIFICATIONS
(SECTION 10)
Every complete specification shall—

(a) fully and particularly describe the invention and its
operation or use and the method by which it is to be
performed;
(b) disclose the best method of performing the invention
which is known to the applicant and for which he is
entitled to claim protection;
(c) end with a claim or claims defining the scope of the
invention for which protection is claimed;
(d) be accompanied by an abstract to provide technical
information on the invention
PUBLICATION OF THE APPLICATION (SECTION
11-A)
 An application not ordinarily open to the public in the

prescribed period
 Can be published at the request of the applicant by the
Controller at any time before the expiry of the prescribed
period.
 Every application to be published on the expiry of the
prescribed period unless withdrawn or there being a
secrecy direction under S. 35
REQUEST FOR EXAMINATION (SECTION 11-B)
 Any application for a patent to be examined only at the

request of the applicant or any interested person in the
manner and period prescribed.
 If no request made in the prescribed period, application
to be considered as withdrawn.
EXAMINATION OF APPLICATION (SECTION 12)
 Application referred to an examiner for examination and

making a report to him of-
i. Whether the application and specification and other
documents are in accordance with the requirements of
the Act and rules;
ii. Whether there is any lawful ground of objection to the
grant of patent;
iii. The result of investigation made under Section 13;
iv. Any other matter which may be prescribed.
SEARCH FOR ANTICIPATION BY PREVIOUS
PUBLICATION AND BY PRIOR CLAIM (SECTION 13)
 The examiner has to make an investigation for the

purpose of ascertaining whether the invention as claimed
in the application-
i. Has been anticipated by publication prior to the filing
date
ii. Has been claimed in any claim of any other complete
application having priority date prior to the applicant’s
date of filling
OPPOSITION TO THE PATENT (SECTION 25)
 Pre-grant and post-grant opposition

 Pre-grant objection has to be filed after the publication of
the patent and before the grant of the patent
 Post-grant objection has to be filed within a period of 1
year from the grant of a patent
 Absence of any pre-grant opposition no bar to a post-
grant objection
DR. ALOYS WOBBEN V. YOGESH
MEHRA
 Dr. Aloys Wobben (Dr. Wobben) is a scientist engineer
and founder of Enercon GmBH, a German company
involved in wind turbine manufacturing.
 Dr. Wobben holds several patents in India for inventions in
the field of wind turbine generators and wind energy
converters.
 In India, the manufacturing operations were carried on
since 1994 by Enercon India Ltd (Enercon India), a joint
venture entity formed by Enercon GmBH with Yogesh
Mehra and Ajay Mehra.
 Licenses to Dr. Wobben’s Indian patents were granted to
Enercon India Ltd. on mutually agreed terms.
MEHRA
 The license agreements were renewed from time to time and
last such renewal was in 2006.
 In 2008, due to non-fulfilment of certain obligations under the
agreement, the agreement got terminated.
 In 2009, Enercon India Ltd filed 19 revocation petitions before
IPAB seeking revocation of Dr. Wobben’s Indian Patents under
Section 64(1) of the Patents Act, 1970 (Act).
 Thereafter, Dr. Wobben in retaliation filed 10 patent
infringement suits before the Delhi High Court against Enercon
India.
 Post filing of infringement suits, Enercon India further filed 4
revocation petitions before the IPAB.
MEHRA
 Thus, a total of 23 revocation petitions were filed by Enercon
India before the IPAB.
 In response to the patent infringement suit, Enercon India filed
counter claim seeking revocation of patents before the Delhi
High Court.
 The prayers in the revocation petition before the IPAB and the
counter claim were same.
 Enercon India and Dr. Wobben had consented to an order of
the Delhi High Court dated September 1, 2009 wherein both
parties had mutually agreed to follow a schedule for an
expedited trial in the patent infringement suit and the counter
claims filed therein.
 Post the consent order the IPAB had revoked 6 patents granted
to Dr. Wobben.
MEHRA
 Dr. Wobben alleged that all the 6 patents revoked were
also a part of the counter claim pending before the Delhi
High Court and the act of Enercon India in pursuing the
revocation petitions before the IPAB after consenting to
the Delhi High Court order dated September 1, 2009 was
an abuse of judicial process.
MEHRA
Under the current Indian patent law the validity of a patent
can be challenged:-
 Before grant of patent- Pre-grant opposition before the
patent office
 After grant of patent- Post grant opposition before the
patent office
 Revocation of patent before the Intellectual Property
Appellate Board (IPAB)
 Counter claim in patent infringement suit
MEHRA
 The main issue raised by Dr. Wobben was that in a patent
infringement suit, if a defendant files a counter claim
challenging the validity of the patent before the High
Court, only the High Court will have exclusive jurisdiction
to decide on the validity of the patent and the IPAB will
cease to have jurisdiction.
 The Act does not have a straightforward answer to the
above issue raised by Dr. Wobben. Thus the SC adopted
a layered approach.
 The SC first interpreted the provisions of the Act and then
looked at parallel legislations like the Civil Procedure
Code to find an answer to the above issue.
MEHRA
 It was contended by Dr. Wobben that according to Section
64 (1) of the Act either a counterclaim or a revocation
petition can be filed challenging the validity of the patent
and both of them cannot be perused simultaneously.
 This is very clear from the reading of Section 64 (1) of the
Act wherein the word “or” is used and this has to be
given disjunctive reading and not a conjunctive reading.
 If such an interpretation is not given, it could result in
conflicting findings in a revocation petition and a counter
claim.
REVOCATION OF PATENTS
(SECTION 64)
Subject to the provisions contained in this
Act, a patent, whether granted before or
after the commencement of this Act,
may, [be revoked on a petition of any
person interested or of the Central
Government by the Appellate Board or on a
counter-claim in a suit for infringement of
the patent by the High Court] on any of the
following grounds…
MEHRA
 The SC examined the locus of a person with regard to
who can file a post grant opposition under Section 25 (2)
and who can file a revocation petition or a counter claim
under Section 64 (1) of the Act.
 Under both sections a revocation petition or a post grant
opposition can be filed by “any person interested” and a
counter claim can be filed by a defendant in a patent
infringement suit.
 The SC observed that Section 64 was prefaced by the
words “Subject to the provisions of the Act”.
 Thus, the provisions of Section 64 are subservient
whenever there is a conflict with other provisions of the
Act.
MEHRA
 Hence, if a post grant opposition is filed under Section 25
(2), the same will eclipse the right to file a revocation
petition or a counter claim under Section 64 (1).
 The SC accepted the contention of Dr. Wobben and held
that both the counter claim and revocation petition cannot
be availed simultaneously under Section 64 (1).
GRANT OF PATENTS (SECTION 43)
 On the Controller being satisfied that the application is in

order, a patent shall be granted to the applicant.
 On the grant of the patent, the Controller has to publish
the fact that the patent has been granted.
 The application, specification and other documents
become open for public inspection.
LITERAL INFRINGEMENT
A product is said to be literally infringing if all

elements of a patent claim are present in the
product, and a process is said to be literally
infringing if all steps in a claim are present in the
process.
DOCTRINE OF EQUIVALENTS
1. Construe the scope of the "literal" language of the claims.

2. Compare the claims, as properly construed, with the
accused device or process, to determine whether there is
literal infringement.
3. If there is no literal infringement, construe the scope of the
claims under the doctrine of equivalents.
The doctrine of equivalents is an equitable doctrine which

effectively expands the scope of the claims beyond their
literal language to the true scope of the inventor's
contribution to the art.
DOCTRINE OF EQUIVALENTS (CONTD.)
 The doctrine of equivalents permits a finding of infringement
even if the accused device or method does not literally fall
within the scope of the construed patent claims.
 Instead, a device or method may infringe under the doctrine
of equivalents if it performs “substantially the same function
in substantially the same way to obtain the same result” as
the patented invention.
 Thus, the doctrine of equivalents permits an expansion of
patent rights beyond the literal scope of the patent claims.
 One purpose of the doctrine of equivalents is to protect
patentees from those who seek “to evade liability for
infringement by making only insubstantial changes to a
patented invention.”
RAVI KAMAL BALI V. KALA TECH
 The Plaintiff filed a patent application for an invention titled
“An improved tamper proof seal for directly locking the
container.”
 The application was allowed and patent was issued in
1994.
 The relevant claims with respect to Plaintiff’s invention were:
“...an improved tamper proof seal, for directly locking container
having a lock ring, comprising of metal strip bent near the
middle portion into a substantially ‘V’ form, each of the two
side arms being provided with at least one outwardly
directed inclined vane and an inwardly directed flap....... and
other top flap being large for completely covering the slit of
the lock ring from the outer side....”
(CONTD.)
 Subsequently on further research, the plaintiff is said to
have improved his invention thereof and applied for a
patent of addition “An improved tamper proof seal for
directly locking the container having a lock ring.”
 The patent of addition was issued in 1998.
 The relevant claims were:
“...the improvement in or modification of the main invention
as disclosed in Patent Application
126/BOM/91...comprises in providing one or more
additional outwardly directed inclined vanes in one of the
side arms, of the said seal, in another row at a
predetermined desired space...”
(CONTD.)
 The Plaintiff sold his products under the trademark
“TechLock”.
 The Plaintiff alleged that he came across a similar product
bearing the name “SealTech” which had constructional
and functional features similar to that of the Plaintiff’s
products.
 On investigation, the Plaintiff found out that a similar
product was being manufactured and sold by Defendant
No. 1 with the assistance of Defendant No.3.
 Defendant No. 3 had earlier worked with the Plaintiff from
1992 till 2002.
(CONTD.)
 The Hon’ble Bombay High court was posed with the
situation dealing with indirect infringement of the
Plaintiff’s patented product and patent of addition.
 The Plaintiff in the instant case had sought for an
injunction restraining the Defendants from making of,
using, selling or distributing tamper proof locks/ seals that
fell within the scope of plaintiff’s invention.
 With respect to the infringement issue, the Plaintiff
insisted on applying the Doctrine of Equivalents by which
a device is set to infringe a claim if it performs
substantially the same function in substantially the same
way to obtain the same result.
(CONTD.)
 It was submitted that it is not necessary that the infringing goods
must be identical in every respect to the patented goods and it is
sufficient if it is found that the essence of the invention was taken.
 The Plaintiff submitted the following similarities-
1. Function of both was to lock the open mouth Fibre drum.
2. Both products were made of a nearly identical material, Spring Steel.
TechLock was made of EN9/EN42, while SealTech was made of EN9.
3. The principle of working of TechLock was compression, SealTech
worked on a similar compression decompression/expansion.
4. The Construction features of the top flap and vanes were similar
5. Both products contained a stopper, and notch depression.
6. The place of locking the drums was similar in both products.
(CONTD.)
 On the other hand, the Defendants didn’t challenge the
validity of the Plaintiff’s patent. The Defendants had tried to
differentiate their product with the patented product.
The Defendants differentiated it through the following-
1. SealTech and TechLock worked on different principles, ie,

TechLock was compression and SealTech worked on a
compression decompression/expansion system.
2. TechLock requires physical pressure to compress the vanes,
whereas SealTech does not.
3. SealTech has an additional number of vanes.
4. SealTech is ‘V’ shaped but TechLock is a rectangular box type
seal with four walls.
(CONTD.)
 Justice Vasifdar favoured the plaintiff and applied the
Doctrine of Equivalents while determining the issue of
infringement.
 He opined that the two products, on comparison had the
same usage/purpose, nature of material and also worked
on the same principle.
 The Plaintiff’s products may be inserted without any use
of the physical force but even if some amount of force
was needed it wouldn’t make any difference.
 The Court further stated that the mere provision of top
flap is not the decisive matter but the manner in which
the top flap has been provided indicates the intent to
infringe the patented product.
(CONTD.)
 The difference of main structure of body makes no
difference and it does not imply a new invention.
 The provision of the vanes on the sides did not help
Defendants’ case.
 It was held the constructional and functional aspect of the
product had remained the same.
CATNIC COMPONENTS LTD. V HILL &
SMITH LTD.
 The court affirmed the use of purposive construction to
patent interpretation and found an infringement.
 The House of Lords held that a patent specification is a
unilateral statement by the patentee, in words of his own
choosing, addressed to those likely to have a practical
interest in the subject matter of his invention (i.e. "skilled
in the art"), by which he informs them what he claims to
be the essential features of the new product or process
for which the letters patent grant him a monopoly.
 It is called "pith and marrow" of the claim.
KIRIN-AMGEN INC V HOECHST MARION
ROUSSEL LTD
 The dispute between Amgen and Transkaryotic

Therapies Inc. (TKT) relates to the production of the
hormone, erythropoietin ("EPO").
 EPO is produced in the kidneys in minute quantities.
 It was discovered that EPO had the useful property that it
stimulated production of red blood cells and as a result it
was very valuable for the therapeutic treatment of
Anaemia.
 Amgen invented a process of producing EPO by
recombinant DNA technology and was granted a
European Patent.
 Amgen’s EPO was marketed under the name Epogen.
ROUSSEL LTD (CONTD.)
 Essentially, Amgen had discovered a way of inserting the

genetic code for the expression of EPO (or a part of the
EPO glycoprotein) into a host cell. The cell would then
take the genetic code for EPO and express the hormone
as part of its natural function.
 Amgen’s patent was directed to this invention.
 TKT developed a different method of producing EPO.
 Almost all cells within the human body contain the full
genetic code for the human body. In other words, the
cells contain all the information required to produce any
protein that the human body requires.
 However, although each cell is capable of producing any

protein the human body requires, the ability of a cell to
express most of the other proteins is suppressed so that
the cell only produces the proteins which are required for
that cell’s particular function.
 For example, a liver cell will only produce proteins which
are required for the functioning of the liver.
 TKT discovered a way to "switch on" a cell’s natural
ability to express EPO. This method was unknown at the
priority date of the patent and was called “gene
activation”.
 TKT’s EPO was marketed as Dynepo (GA-EPO).
KIRIN-AMGEN INC V HOECHST
MARION ROUSSEL LTD (CONTD.)
 Hoechst Marion Roussel Limited started importing EPO into
the UK.
 Amgen issued proceedings for infringement of its patent. As a
concerned party TKT also joined the proceedings.
The key Amgen claims in issue can be summarized as:
(1) a DNA sequence for use in securing the expression of EPO in
a host cell,
(26) EPO which is the product of the expression in a host cell of a
DNA sequence according to claim 1, and
(19) EPO which is characterized by being the product of
eucaryotic expression of an exogenous DNA sequence with
further characteristics that made it different from pre-existing
EPO.
 Only Claims 19 and 26 were alleged to have been

infringed because TKT did not make any of its EPO in the
UK.
 The alleged infringement was by importation.
Furthermore, Claim 26 cannot be understood without
interpretation of Claim 1.
 The principal issue in the case was whether TKT's EPO
fell outside the claims of Amgen's patent suit because of
the difference in the way it was made.
 In response, TKT claimed that its method was not within

Claim 19 or 26 and accordingly could not infringe them.
 In addition, it claimed that Claim 19 was bad for
insufficiency and further Claim 26 was anticipated (i.e.
not new) because the product which it claimed- EPO,
was known and formed part of the state of the art at the
priority date.
 According to the House of Lords the first step in
determining whether any infringement of the patent has
occurred is to correctly construe the claims of the patent.
 The claims of the patent required interpretation based on
Article 69 of the European Patent Convention (EPC)
 Article 69 of the European Patent Convention states that:

“the extent of the protection conferred by a European Patent or
a European Patent Application shall be determined by the
terms of the claims. Nevertheless, the description and
drawings shall be used to interpret the claims.”
 Determining the extent of protection requires that Article 69
should not be read as to mean that the claims are given a
literal meaning nor should the claims be treated as mere
guidelines.
 Rather the correct treatment is a position between the two
extremes which provides a fair protection for the patentee with
a reasonable degree of certainty for third parties.
 In construing the claims the correct approach to take is
the objective test of: what would a reasonable person to
whom the utterance was addressed have understood the
author to be using the words to mean?
 In other words: what would a person skilled in the art
understand the patentee to be using the language to
mean?
 This is the principle of "purposive construction" which
Lord Diplock proposed in Catnic Components Ltd v Hill &
Smith Ltd
 As regards minor variations to the invention, the

judgement makes it clear that the background knowledge
of the person skilled in the art is relevant to the
interpretation of the claims.
 The point here is whether or not the skilled person would
have understood that the patentee was intending to limit
its claims strictly so as not to encompass the variant. This
again is relevant to the purposive construction.
 After construing Claim 1 and Claim 19 the House of
Lords found that none of these claims were infringed.
 It had been the past practice in the UK to allow product-

by-process claims.
 A product-by-process claim is a claim which claims the
end product if that product is made by a patented
process.
 The reason for allowing such claims was purely historical.
Up until the enactment of the Patents Act 1977 the scope
of protection conferred by a patent was undefined.
 Thus a product-by-process claim had the advantage that
a patentee could pursue not only the user of its patent
process but any person who dealt in the resulting
product.
 The EPC in Article 64(2) removes the requirement for

product-by-process claims as it expressly states that
products directly obtained from a patented process are
protected.
 The UK enacted this provision in the Patents Act 1977.
 The result of Article 64 is that the European Patent Office
will reject product-by-process claims except in the limited
situation where the product is new (new in the sense of
never being discovered) and the product cannot be
described except by reference to its method of
manufacture
CLAIM INTERPRETATION
 Essentially, on the evidence presented before it, the
House of Lords found that a reasonable person skilled in
the art would have understood the claims to be
concerned with the protection of Amgen’s method of
producing EPO.
 The method used by both the companies to arrive at the
production of the same drug was different.
 The person skilled in the art would not have come to the
conclusion that the production of GA-EPO is the same as
that of Epogen.
 Accordingly, the House of Lords found there to be no
infringement.
ANTICIPATION
 The House of Lords then found that as a matter of
construction Claims 19 and 26 were product-by-process
claims.
 It essentially found that Claim 26 was attempting to claim
EPO. This claim could not be allowed because EPO was
a known product at the priority date and thus formed the
state of the art.
 The EPO produced by Amgen’s method was no different
from the EPO that had been isolated before from urine
even though it appeared that Amgen had convinced the
European Patent Office that its EPO was different (and
therefore new) when it prosecuted the patent application
INSUFFICIENCY
 Claim 19 tries to distinguish the EPO produced by the
Amgen method from the EPO obtained from urinary
sources by reference to its higher molecular weight when
measured by a standard technique applied in the field of
biotechnology.
 The problem here is that the molecular weight of EPO
obtained from urinary source varies according to the
source and the method of purification.
 Moreover, urinary EPO is extremely difficult to isolate in
any quantity.
 The specification did not give the person skilled in the art
any idea as to whether the EPO he was making would
fall within Claim 19 or not.
INSUFFICIENCY (CONTD.)
 Further, the use of the reference to Amgen’s EPO being
of a higher molecular weight was artificial so as to allow
the claim to be granted by the European Patent Office.
 As a result the specification did not enable the person
skilled in the art to perform the invention as provided in
Claim 19.
 Accordingly, Claim 19 was invalid for insufficiency.
Procedure for Dealing with
Applications (Section 87)
 Where the Controller is satisfied, upon
consideration of an application under section 84,
Or section 85, that a prima facie case has been
made out for the making of an order, he shall
direct the applicant to serve copies of the
application upon the patentee and any other
person appearing from the register to be
interested in the patent in respect of which the
application is made, and shall publish the
application in the official journal.
Procedure for Dealing with
Applications (Section 87)
 The patentee or any other person desiring to oppose the
application may, within such time as may be prescribed or
within such further time as the Controller may on
application (made either before or after the expiration of
the prescribed time) allow, give to the Controller notice of
opposition.
 Any such notice of opposition shall contain a statement
setting out the grounds on which the application is
opposed.
 Where any such notice of opposition is duly given, the
Controller shall notify the applicant, and shall give to the
applicant and the opponent an opportunity to be heard
before deciding the case,
Generic Drugs
 A generic drug is a pharmaceutical
product, usually intended to be
interchangeable with an innovator product,
which is manufactured without a licence
from the innovator company and marketed
after the expiry date of the patent or other
exclusive rights.
BAYER CORPORATION V. NATCO
(CONTD.)
 The drug was being sold by Bayer at Rs. 2,84,000- (USD 4500) per
month of therapy.
 In 2010, Natco approached Bayer for a voluntary license for
manufacturing and selling the patented drug in India for less than Rs.
10,000 per month of therapy.
 Bayer however, rejected Natco’s application. NATCO then,
applied to the controller for grant of Compulsory License under
Section 84 (1) of the Patents Act, after an expiry of three years
(2011), as stipulated under the Act.
 CIPLA on the other hand was already selling the drug as Soranib at
Rs. 30,000/- per month. It was undergoing litigation in Delhi High
Court for infringement of Bayer’s patent.
(CONTD.)
 In the Compulsory License order issued by the then
Controller General of Patent, a price of Rs. 8,800/- (per
120 tablets) was fixed.
 NATCO was directed to sell the patented drug at this
price and also pay a standard royalty at the rate of six
percent calculated at the net price /manufacture.
 NATCO could sell the drug only in India and had to
supply the drug to at least 600 needy patients each year
free of charge.
(CONTD.)
 The IPAB however rejected this contention holding that it
was not Bayer that was supplying the drug at a
reasonably affordable price, especially when Bayer had a
case pending against CIPLA for the same drug.
 The IPAB ruled against Bayer, holding that granting a
stay in favour of Bayer would jeopardize the interests of
public who are in need of the drug.
 However, the royalty rate was increased to 7 percent.
 The major legal question that arose before the Bombay
High Court therefore was, whether the supplies by
infringers of the patented drug (Cipla and NATCO in this
case) have to be taken into account to determine the
satisfaction of the reasonable requirement test?
(CONTD.)
 The High Court dismissed Bayer’s petition challenging
the grant of Compulsory License.
 The Court’s decision was rendered on the basis of the
fact that even after taking into account Cipla’s supplies,
the public requirement would not be met.
 The Court held that it had no reason to overturn the
Compulsory License granted to Natco by the Controller.
The Court reasoned that the Compulsory License should
not be overturned for the following reasons:
(CONTD.)
1. Natco had made efforts to obtain a voluntary license from Bayer under
Section 84(6) of the Act.
2. The reasonable requirement of the public for the patented drug had
not been satisfied by Bayer. The court pointed to evidence that 8,842
patients could require the drug, but only 593 boxes of the medicine
had been sold (around 200 patients).
3. Even after taking into account Cipla’s contribution (4686 boxes), the
reasonable requirements were not met (5279 boxes).
4. Bayer was not making the medicine available to the public at a
reasonably affordable price.
5. In order for the drug to work in India, it did not necessarily need to be
manufactured in India but could be imported.
6. There was no merit in the assertion that the Controller should have
stayed the application until Bayer had time to work the patented drug
on a commercial scale in India.
(CONTD.)
 In respect of medicines the adequate extent test has to be
100%, i.e. to the fullest extent possible. Medicine has to
be made available to every patient and this cannot be
deprived/scarified at the altar of rights of patent holder.
 The Court also held that with reference to Article 31 of
Trade Related Aspects of Intellectual Property Rights
(TRIPS), the patent holder had been granted adequate
remuneration for the grant of Compulsory License to
Natco.
 Bayer’s Special Leave Petition was dismissed by
the Supreme Court.

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PATENT DEFINED

 A patent is a limited monopoly that is granted in

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 Every application under this section shall

Every complete specification shall—

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 The examiner has to make an investigation for the

 Pre-grant and post-grant opposition

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