1.
Patent Potential in Molecular
Biology Research
Dr Karan Veer Singh,
Scientist
NBAGR, Karnal

2.
Patent
Novelty
Prior art
Inventiveness
Non-obviousness
Skilled Person
Usefulness

3.
Historical Perspective
 Patent Act 1970
 Amended in 1999, 2002 and recently in 2005
 The Act of 1970 has provision for
process
patent. Now amended
Act also covers product patents.
 British Era
 Patents and designs Act, 1911

4.
Cont…(Historical Perspective)
 India is socialist country. Constitution
of India guarantee social justice to all.
 Reverse Engineering
 Involves manipulating an existing process or
method to produce a new process or method.
India was alleged to encourage reverse
engineering by not providing product patents.

5.
Cont…(Historical Perspective)
 Product patent does not allow
manipulation of existing processes or
methods.
 General Agreement on Tariffs and Trade
(GAAT)
 Negotiations started in 1947 and ended in 1993
 GATT negotiations signed by WTO Member-States 1994

6.
Cont……(Historical Perspective)
 Agreement (WTO) including TRIPS came into
being on 1-1-1995.
 Article 27 of TRIPS Agreement provides blanket
permission for patents on all types of inventions
including product and process patents.
 Patent Act of India 1970 does not provide
granting of product patents. Further food and
pharmaceutical forms were an exception to
patenting.

7.
Cont…(Historical Perspective)
India was given 10 years transformation period
to implement provisions of TRIPS, which ended on
1-1-2005.
The objective of amendment was to grant
Exclusive Marketing Rights to the patent
applications claiming food products (agricultural
products) and pharmaceuticals.
The latest amendment to the Patent Act was in
27-3-2005 which brings Patent Act in conformity
with TRIPS Agreement.

8.
Patentable Subject Matter
 Patent system varies from country to
country.
 US Patent Law
What is 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”.

9.
Cont…(Patentable Subject Matter)
England Patent Law states
what is not patentable
“Inventions against public interest, public
policy and morality are not patentable”.
As a matter of practice, inventions relating
to life were kept outside the purview of
patentable subject matter.

10.
Cont…(Patentable Subject Matter)
 Living beings eg. Microorganisms, plants and
animals produced through natural or
biological processes are not patentable.
 Non-natural living beings produced through
non-biological
processes
like
biotechnological processes are patentable.
 Now genetically modified organisms, which
are non-natural can be patented.

11.
LIFE AS A PATENTABLE
MATTER in 1980’s in US
SUBJECT
Patent was filed on a method of breeding
of doves.
The patent was rejected on the ground
that the breeding method was not
repeatable.
The patent office did not answer
question whether living being is patentable
or not.

12.
LIFE FORMS
Lower Life Forms
Single cell organisms eg. bacteria, fungi,
algae
Certain multicellular organisms eg. Plants
High Life Forms
Multicellulaur organisms eg. animals and
human beings
Animals and human beings think and express
in contrast to plants

13.
Patenting Lower Life-Microorganism
 Till 1980’s life was not considered as
patentable.
 During that period, German Federal Court
upheld patent of new microorganisms.
 Australia- naturally occurring microorganismsnot patentable, but allowed use of naturally
occurring microorganisms to produce new
product.

14.
Cont…(Patenting Lower Life-Microorganism)
US Supreme Court
 Inventor Dr. Charabarty sought patent on “Genetically
modified bacteria” being capable of eating oil spills”.
It was permitted.
 Microorganism in its Claimed Form does not exist in
nature.
 It was a product of human ingenuity that can be
patented even if it encompass living being.
 This decision resulted in filing of large number of
patents for genetically modified organisms.

15.
Plant as Patentable Subject Matter
US patent office did not allow patent for
mutant of maize plant
Board of Patent Appeals
allowed patent of mutant maize

16.
Patent on Higher Life: Animal
US patent office allowed
Patenting of Oncomouse. The claim was
for genetically modified mouse susceptible to
cancer disease that is useful for cancer
research and drug development.
16 patents are granted on transgenic mice.
Patents for transgenic pig, rabbit, sheep are
also granted.

17.
Patent on Human Genetic Material
1984, human cell line producing cancer-fighter
proteins was isolated from the body of patient
name ‘Moore’.
Now, patents on methods to isolate human
genetic material and also on proteins produced by
human genetic material are allowed.
Patent has been granted for producing foreign
protein in transformed species of bacteria.

18.
Cont…(Patent on Human Genetic Material)
Patent has been granted on DNA sequence coding
human protein erythropoietin (EPO) on the
protein itself. (Erythropoietin is a protein that
boosts red blood cell production)
Patent on chimeric gene (combination of human
gene and animal gene) has been granted.
Patent on DNA and RNA for human insulin like
growth factors (mediation of somatic cell growth
on the administration of growth hormone).

19.
Cont…(Patent on Human Genetic Material)
Patent on DNA and cDNA encoding HeparinBinding growth factors and & HBGF stimulate cell
division and facilitate the repair or replacement of
damaged or diseased tissue
Human cloning methods of the therapeutic
purpose can be patented
Human cloning is prohibited

20.
What is Next.
 Will the non-natural human beings be
patented?
 European Union’s Directive prohibits
 patenting of invention of human cloning and
non-natural human being on ethical grounds
 Processes of cloning human being
 Processes for modifying the germ line genetic
identity of human being

21.
Cont…(What is next)
 Use of human embryos for industrial or
commercial purposes
 TRIPS agreement gives flexibility to
member-states to prohibit patents on the
basis of public order and morality.

22.
Case Study
Recombinant DNA
A patented Research tool, non-exclusively licensed
with low fees.
Cohen-Boyer Technology for recombinant DNA,
most successful patent in University licensing.
It has three patents
Process for making molecular chimeras
Product patent :proteins produced using recombinant
prokaryote DNA.

23.
Cont… (Case Study)
 Product patent : Proteins
recombinant eukaryotic DNA.
produced
using
 Application was filed by Stanford University in Nov.
1974.
 Stanley Cohen and Herbert Boyer at together
developed technique at Stanford and the
University of California, San Francisco respectively.
 Dec.1980, process patent for making molecular
chimeras was issued.

24.
Cont… (Case Study)
 In 1984, product patent for prokaryotic DNA was
issued.
 Licensing agreement generated $139 million (700
crore Rupee) royalties as on 13-02-1995.
 The technology was inexpensive and easy to use.
There was no alternative. The technology was
critical to research in molecular biology.
 Technology developed in Universities through
publicly funded research. Licenses inexpensive
and minimum rider. Tremendous volume of sale

25.
Cont… (Case Study)
Bayh-Dole
recommended
Act-
Exclusive
License
is
Nelson, Director of Technology Licensing office at
MIT was of view that Industry- sponsored researchuniversity will retain ownership but will give first
option to sponsor for an exclusive license.

26.
PCR and Taq Polymerase
 PCR allows specific and rapid amplification of target
DNA
 Taq polymerase, the heat stable DNA polymerase
used in the amplification
 Kary Mullis was primary inventor of PCR working at
Cetus corporation. He won Noble prize in 1985. PCR
is developed in corporate environment.
 Cetus corporation sold PCR patent to Hoffman-La
Roche for $300 million in 1991.

27.
Cont…(PCR and Taq Polymerase)
The products are to be purchased to provide
rights to use technology.
The product license policy was instituted by
cetus.
Roche established three categories of licences
(i) Research application eg.
project
(ii) Disease diagnosis
(iii) PCR licensing programs
human genome

28.
Protein and DNA sequencing Instruments
 Highly sensitive DNA and protein sequencers
were developed at California Institute of
Technology. But it required help of substantial
private investment.
 Prototype was developed in Hood’s laboratory
during 1970-1986. this laboratory sequenced
lymphokines, platelet-derived growth factor
and interferons. Since middle of 1990’s the
technology became widely available.

29.
Cont…(Protein and DNA sequencing Instruments)
 Funds for instrumentation by NIH was denied. Dr.
Hood approached 19 companies; all declined
support. Publication by Nature derived and treated it
as a speculation.
 Finally Applied Bio System agreed to fund but for
exclusive license. ABI has sold more 3000 DNA
sequencers and more than 1,000 protein sequencers.
 LI-COR developed infrared fluorescence DNA
sequencer. The company negotiated cross-licenses to
develop its product

30.
Patents for genetic inventions
Three categories
CloningProduction of therapeutic proteins
Advances in plant biotechnology: improving
agricultural productivity
Genes as diagnostic tools: Diagnosis of
genes implicated in disease
of DNA coding sequence enables

31.
Molecular Biology Related Patents
Jawaharlal Nehru Centre for Advanced Scientific
Research
Process for extraction of superior quality of DNA
A high sensitivity assay for molecular tying of
biological samples, Probes and a kit thereof
Tat DNA sequences, Gene constructs, Vaccine
and processes thereof

32.
Patenting of Biotechnological Inventions
DNA sequence patents:
• EPO: European Patent Office
• USPTO: United States Patent and Trademark Office
• JPO: Japan Patent Office.
Common position on DNA sequence patents
-Mere determination of DNA sequence is not patentable
- Inventor to identify gene, its useful function, to isolate and
clone the gene and thereby make synthetic copies of gene
that are unavailable for use in diagnosis or therapy – this
can be patented.

33.
THANKS