Coim PRSNT

“Patenting in Biotech & Pharma
Industry – An Industry Perspective”
Presentation by
Sandeep K. Rathod,
Head: Corporate & Formulations IP,
Matrix Laboratories Limited
[Subsidiary of Mylan Laboratories Inc.]
At:
NGM College, Pollachi, Coimbatore.
http://genericpharmaceuticals.blogspot.com 1
OBJECTIVES/
Contents for the day
1. Understand basic IPR concepts; and
their usage to our Industry.
2. Basics of a Patent and underlying concepts

within the Indian law;
and finally
3. Understand patenting in the Pharmaceutical and

Biotech arena, within the framework of Patents
Act, 1970 [India]
Intellectual Property:
An introduction
The property or product of one’s
mind or intellect.
Difference between intellectual property and
other forms of property:
Intellectual property is intangible i.e. it cannot
be defined or identified by physical parameters
but it needs to be expressed in some
discernible way to be protected
In business terms - proprietary knowledge
Intellectual Property
& it’s Types
IP can be traded/ protected/
enforced using legal means.
Types of Intellectual Property in
India:
Trademarks [including geog.
indications]
Patents
Copyrights
Designs
Undisclosed Information
IPR Laws in India
The Patents Act, 1970
[Act last amended in 2005]
The Designs Act, 2000.
The Copyright Act, 1957
Trade & Merchandise Marks Act, 1999
The Geographical Indications of Goods Act, 1999
Patent
A patent is:
a grant of a limited time monopoly
by the State to an inventor to stop others from
use, sell, distribute, license of his invention
in return of it’s full disclosure which can be
used by the public after the expiry of its term.
A patent provides protection for the invention
to the owner of the patent for a limited period.
Duration: 20 years.
Copyright
The right of a person over an original work of art
is called as Copyright.
For e.g. Books/ Paintings etc.
Duration: Life of author + 60 years.
Design
Copyright in the external shape of an

object is protected by Design Rights.
The shape must be novel and possess
artistic merit.
Duration: 14 years
Undisclosed Information
Information that is kept and used as a

secret by a person and not open to
public is undisclosed information. Eg.
Coca-Cola Formula.
Duration: Till the information is kept a
secret.
Trademarks
The name by which an
entity sells a good or
delivers a service is
called “Trade-mark”.
Duration:
Continuous protection
till the proprietor uses
the same.
Geographical Indications
Simply put, a GI is similar to a trade mark.
Just like a TM indicates origin, a GI too assures a

buyer that the particular product has come from
a particular region [i.e. indicates origin].
But unlike a TM which is owned by one person/

company, a GI is usually owned by the Govt. or a
society/ group of producers.
Comprehensive Approach to the
Protection of Intellectual Property
Suppose you invent a pen, then the possibilities

are:
A Patent for any new technology underlying it,
Design for the appearance,
Trade Mark for its brand &
Copyright for the accompanying literature.
Now you will be in a position to

comprehensively cover your product by IP
rights.
Understanding Patent basics
CAPABLE OF
INVENTIVE STEP plus INDUSTRIAL EQUALS INVENTION
APPLICATION
GIVES
INVENTIONS NOT
PATENT GETS LESS NEW INVENTION
PATENTABLE
Patent Basics: Indian perspective [1]
“Inventive step”
means a feature that involves technical
advance [1] as compared to the existing
knowledge
or having economic significance [2]
or both
and that makes the invention not obvious [3]
to a person skilled in the art.
Obviousness – details [1]
Based on sum total of knowledge
available on the relevant field
Whether the "Invention" in question

will be obvious to a "Person Skilled in
the Art”
Obviousness – details [2]
An invention will not be obvious:
Even if it does not solve a particular
problem
BUT
results in unexpected advantages.
An invention will also not be obvious:
a) If there existed a long-felt problem
b) There was no known previous solution
c) Previous attempts to solve the
problem were unsuccessful
“Capable of industrial application”

in relation to an invention means that the
invention is capable of being made or used in
an industry.
“Invention”
means a new product [1] or process [2]
involving an inventive step [3] and capable of
industrial application [4].
KINDS OF INVENTIONS
PROCESSES/
METHODS
ARTICLES
SUBSTANCES DEVICES
“New Invention”
Means any invention or technology which
has not been anticipated by publication in
any document or used in the country or
elsewhere in the world before the date of
filing of patent application with complete
specification, i.e. the subject matter has not
fallen in public domain or that it does not
form part of the state of the art.
“Patent”
Means a patent for any invention granted
under the Patents Act.
Improvements: Invention?
Is an ‘Improvement’ an invention?
Inventiveness is a question of degree.
Simplest improvements may be inventive and
patentable.
Where the product is an improvement over a known

product.
E.g. An improved detergent and method for making
such an improved detergent having anti-static
properties
Inventions not patentable -1
The following are not inventions
within the meaning of the Patents Act:
(a) an invention which is frivolous or which claims anything obvious
contrary to well established natural laws;
(b) an invention the primary or intended use or commercial
exploitation of which would be contrary to public order or morality or
which causes serious prejudice to human, animal or plant life or
health or to the environment;
(e) a substance obtained by a mere admixture resulting only in the
aggregation of the properties of the components thereof or a process
for producing such substance;
(f) the mere arrangement or re-arrangement or duplication of known
devices each functioning independently of one another in a known
way;
Inventions not patentable - 2
The following are not inventions within the
meaning of the Patents Act:
(k) a mathematical method or a business method or a computer
program per se or algorithms
(l) a literary, dramatic, musical or artistic work or any other
aesthetic creation whatsoever including cinematographic works
and television productions;
(m) a mere scheme or rule or method of performing mental act or
method of playing game;
(n) a presentation of information;
(o) topography of integrated circuits;
(p) an invention which, in effect, is traditional knowledge or which is
an aggregation or duplication of known properties of traditionally
known component or components.
4. Inventions relating to atomic energy not
patentable
No patent shall be granted in respect of an invention
relating to atomic energy falling within sub-section (1) of
Section 20 of the Atomic Energy Act, 1962.
Inventions not patentable -4
(d) the mere discovery of a 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 at least one
new reactant.
Explanation.—For the purposes of this clause, salts, esters,
ethers, polymorphs, metabolites, pure form, particle size,
isomers, mixtures of isomers, complexes, combinations and
other derivatives of known substance shall be considered to be
the same substance, unless they differ significantly in
properties with regard to efficacy;
Synergistic Compositions and S. 3d
admixtures of two or more components

combined in a predetermined proportion
which do not chemically react with each
other, BUT
physically interact
to evince an improved or unexpected
property when put to use.
(c) the mere discovery of a scientific principle or the
formulation of an abstract theory or discovery of any
living thing or non-living substance occurring in nature;
(h) a method of agriculture or horticulture;
(i) any process for the medicinal, surgical, curative, prophylactic,
diagnostic, therapeutic or other treatment of human beings or any
process for a similar treatment of animals to render them free of
disease or to increase their economic value or that of their products.
(j) Plants and animals in whole or any part thereof other
than micro-organisms but including seeds, varieties and
species and essentially biological processes for
production or propagation of plants and animals;
Some ray of hope… YES
A METHOD FOR PREPARING A DNA CONSTRUCT WITH
GLYPHOSATE TOLERANCE
Application: 477/MAS/2001, Patent: 194265,
Patentee: MONSANTO
PROCESS FOR EXTRACTION OF SUPERIOR-QUALITY

PLASMID DNA
Application: 614/MAS/99, Patent: 193223,
Patentee: JAWAHARLAL NEHRU CENTRE FOR ADVANCED
SCIENTIFIC RESEARCH
An in-vitro method for inserting a desired DNA

Application: 300/DEL/2002, Patent: 199927
Patentee: IDEC
Understanding Patent basics
CAPABLE OF
INVENTIVE STEP plus INDUSTRIAL EQUALS INVENTION
APPLICATION
GIVES
INVENTIONS NOT
PATENT GETS LESS NEW INVENTION
PATENTABLE
Biotech patent litigation in India
INFECTIOUS BURSITIS VACCINE
Application 136/CAL/98
Invention is concerned with a vaccine which is capable
of protecting poultry against Infectious Bursitis Infections,
characterized in that it contains an Infectious Bursitis
virus which has the combined properties of upon
administration to a chicken causing a reduction in the
size of the bursal size, expressed as bursa/body weight
ratio, of less than 55% and the capability to protect
poultry having an ELISA antibody titer of at least about
500 and with viruses having the above characteristics.
Q&A
This completes my version of today’s talk.
I open the floor to Questions and Answers.
Site for Pharmaceutical news:

http://genericpharmaceuticals.blogspot.com
IP course for beginners [FREE]

http://academy.wipo.int [Check for DL 101]
Later on you could move to DL 204 [IP and biotech]
EMAIL ME AT <rathodsandeep@gmail.com>
THANK YOU.

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“Patenting in Biotech & Pharma

Industry – An Industry Perspective”

2. Basics of a Patent and underlying concepts

3. Understand patenting in the Pharmaceutical and

In business terms - proprietary knowledge

Copyright in the external shape of an

Information that is kept and used as a

Just like a TM indicates origin, a GI too assures a

But unlike a TM which is owned by one person/

Suppose you invent a pen, then the possibilities

Now you will be in a position to

to a person skilled in the art.

Whether the "Invention" in question

“Capable of industrial application”

Where the product is an improvement over a known

admixtures of two or more components

PROCESS FOR EXTRACTION OF SUPERIOR-QUALITY

An in-vitro method for inserting a desired DNA

Site for Pharmaceutical news:

IP course for beginners [FREE]

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