Patent In Molecular Biology

This presentation highlights the relevance of patents and the area under which patent could be sought

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. 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.
Cont……(Historical Perspective)

7. 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.
Cont…(Historical Perspective)

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. 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.

Cont…(Patentable Subject Matter)

10. 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.
Cont…(Patentable Subject Matter)

11. LIFE AS A PATENTABLE SUBJECT
MATTER in 1980’s in US
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 microorganisms-
not patentable, but allowed use of naturally
occurring microorganisms to produce new
product.

14. 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.
Cont…(Patenting Lower Life-Microorganism)

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. 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).
Cont…(Patent on Human Genetic Material)

19. Patent on DNA and cDNA encoding Heparin-
Binding 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
Cont…(Patent on Human Genetic Material)

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. 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.
Cont…(What is next)

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. Product patent : Proteins produced using
recombinant eukaryotic DNA.
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.
Cont… (Case Study)

24. 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
Cont… (Case Study)

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

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. 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. human genome
project
(ii)Disease diagnosis
(iii)PCR licensing programs
Cont…(PCR and Taq Polymerase)

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. 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
Cont…(Protein and DNA sequencing Instruments)

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