1. Current Status of Patenting Genes and
Microorganisms in India
Asha K.

2. Intellectual Property
It is a product of mind, created by the exercise of
intellectual faculty.
Similar to movable or immovable properties
Protected by the appropriate national legislations

3. Different Intellectual Property Rights
• Patents
Copyright
Trade marks
Industrial design
Geographical indication
Trade secrets

4. What is a Patent?
A patent is an exclusive right granted by the
government for the commercial exploitation of invention
for a specific period of time
Right to prevent the use by a third party

5. Why do we need a patent system….
• Induce inventor to disclose his invention
• Encourage research activities
• Reasonable assurance for commercialization

6. History……..
1856 - First provision in nature of Patent Right.
1872 - The patents and Design Protection Act
1911 - The Indian patents and Design Act
1970 - Patent Act
1999 - First Amendment of Patent Act
2002 - Second Amendment of Patent Act.
2005 - Third Amendment of Patent Act.

7. Criteria for patentability
• Novelty
• Inventiveness
• Industrial applicability

8. Who can be an applicant?
 True and first inventor
 His her assignee
 Legal representative
Where to apply?

9. Patent Administration in India
Ministry of commerce and industry
Controller general of Patents, Designs, Trademark & GI
Senior joint controller of Patents and Designs
Deputy controller of Patents and Designs
Assistant controller of Patents and Designs
Examiners of Patents and Designs

10. Patent office Territorial Jurisdiction
Gujarat, Maharastra, M.P, Goa, Chattisgarh,
Mumbai Daman and Diu, Dadra and Nager Haveli
Haryana, Himachal Pradesh, J.K., U.P.,
Delhi Punjab, Rajasthan, Uttaranchal,
Chandigarh
A.P., Karnataka, Kerala, Tamil Nadu,
Chennai Pondicherry and
Lakshadweep
Kolkata Rest of India
(H. O.)

11. Different types of patent application
• Ordinary application
• Convention application
• Application for patent of Addition
• Divisional application
• PCT application

12. PCT Application
PCT- Patent Cooperation Treaty
India became a member of PCT in 1998
Agreement for international cooperation in the
field of Patents.
Single application in a single language in a single
patent office is sufficient

13. Processing of PCT Application
 Formal examination.
 International search
 International publication

14. Patent application should contain...
• Provisional or complete specification
• Declaration as to inventorship
• Priority document
• Proof of right

15. Provisional Specification
Priority
Title of the invention
Description of invention
• Principle of invention
• General statement of actual invention

16. Complete specification
Techno - legal document
Contents
A Title
Field of invention
State of the art in field
Objects of the invention
Detailed description of invention
Claims
Abstract

17. Claims makes the picture clear....
Single sentences
Possible equivalent variations
Not be too wide
Must be specific
The attractiveness and importance

18. PUBLICATION OF INVENTION
 After 18 months from priority date
 Early publication possible on request
 Form 9 Fee: Rs.2500 /- or 10,000/-
What is published?
Date of application
Number of application
Name and address of applicant
Abstract of invention

19. Request for Examination
• Form 18
• Fee: Rs.2000/- or 10,000/-
• Request within 48 months from the Priority date
No request : Application is treated as withdrawn

20. STAGES OF EXAMINATION
Formal Examination Technical examination
First Examination report
(FER)

21. Opposition to the grant of Patent
• Form 15, fees Rs.300/-
• Within 4 months from acceptance of the
complete specification
The Controller, notifies the applicant.
The opponent and the applicant are required to
file their statements

22. Grant of patent
• Granted by the controller
• 6 months from the period of FER
• No need to make a separate request
Term of Patent
20 years as per patent amendment act 2002
(Chandrasekaran, 2005)

23. Patent Grant Procedure
Filing of patent application
Early Publication Publication after 18
months
Request for examination
Examination: Grant or Refusal
Publication of Grant of patent
Opposition to the patent
Decision by Controller

24. Patenting of Life Forms as per TRIPs
Article 27.3(b) explains……….
Members may exclude from patentability
Plants and animals other than microorganisms and
essentially biological process for the production of plants
and animals other than nonbiological and
microbiological process

25. On dissecting article 27.3(b)
• Can exclude plants, animals and essentially
biological process
Must allow patents for microorganisms and
microbiological process.
Must provide protection for plant varieties

26. First patent based on microorganisms
Louis US Patent No 141072 in 1873 for a process of
fermenting Beer Pasture was awarded using a yeast
www.uspto.gov/

27. Diamond v/s Chakrabarty Case
• Developed a bacterium capable of breaking down
crude oil.
US patent office refused to give the patent
“Living organism is patentable since it involved a
human intervention”
(Eisenberg, 2006)

28. A Landmark Decision for India
Dimminaco A.G filed a process patent of preparing
infectious Bursitis vaccine
The application was turned down by the Patent
Office
In 2002 Kolkata High Court granted patent for the
invention involving microorganism

29. Budapest Treaty
• Union for the international recognition of the deposit of
microorganisms.
Signed in Budapest, Hungary in1977
Administrated by WIPO.
India become a signatory from 2001.
Purpose
• Sufficiency of disclosure of biological material

30. International Depository Authority for India
MTCC centre at Chandigarh.
Recognized as IDA in 2002
Requirements for deposit
Kind of organism
Technical requirements
Administrative requirements
(Arora et al, 2005)

31. Non Patentables in Biotechnology Indian status
• Living entities of Natural origin
• Any process of manufacture or production of living
entities
Any method of treatment to human beings or
animals
Transgenic plants and animals
Biological materials such as organs , tissues ,cells,
viruses and process of preparing them.

32. Contd…
Gene Sequences, DNA Sequences without disclosed
function
Essentially biological process for production of plants
and animals
Any biological material or a method causing serious
prejudice to human, plant life, health or environment
Process of cloning human beings or animals .

33. Then, What we can patent………
• Recombinant DNA, Plasmids.
• Process of manufacturing.
Recombinant microorganism
DNA sequence whose function is disclosed

34. (Saha, 2004)

35. Biotechnology patents in India by area of filing 1999-2003

36. Major applicants
(Saha, 2004)

37. MICROORGANISM RELATED PATENTS IN INDIA Total no : 600
A PROCESS FOR THE ISOLATION AND ACCLIMATION OF 374/DEL/03
BACTERIA FOR LIGNIN DEGRADATION
LACTIC ACID BACTERIA CAPABLE OF REDUCING AN I 00404/CHENP/2003
INDIVIDUAL'S TENDENCY TO DEVELOP ALLERGIC
REACTIONS
BIO POWE MICRONISED COMPOUND MICROPOUND 1096/MUM/2002
FROM THE ACTIVE PRINCIPLES OF INACTIVATED SOIL
BENEFICIAL BACTERIA FORTIFIED WITH BLUE GREEN
ALGAE FOR IMPROVING SOIL CONDITION TO MOBILIZE
NUTREINTS FOR ABSORPTION OF PLANT
IN/PCT/200
MODIFICATION OF BACTERIA 2/01972/CH
E
EXPRESSION OF AN ANTIMICROBIAL PEPTIDE VIA THE IN/PCT/2002/01370
PLASTID GENOME TO CONTROL
PHYTOPATHOGENIC BACTERIA
BEVERAGES CONTAINING LIVE LACTIC BACTERIA IN/PCT/2002/01087
(Saha, 2004)

38. Gene related patents in India Total no 146
A METHOD FOR PRODUCING A VECTOR FOR INTRODUCING A 358/MAS/2003
DESIRED GENE INTO A PLANT
A METHOD FOR PRODUCING A VECTOR FOR INTRODUCING A 00594/DELNP/2003
DESIRED GENE INTO A PLANT
METHOD FOR ACCUMULATING FOREIGN GENE PRODUCT AT A HIGH 00300/CHENP/2003
LEVEL IN PLANT SEEDS
A METHOD OF DETECTION OF SP A2 GENE VARIANTS USEFUL FOR 44/MAS/2003
PREDICTION OF PREDISPOSTION OTO ASPERGILLUSIS
GENE ENCODING PROTEIN EXHIBITING AGARASE ACTIVITY 00160/CHENP/2003
OBTAINED FROM AN INDIAN SOIL ISOLATE
A NOVEL GENE OSISAP I OR RICE AND A METHOD OF INTRODUCING
STRESS TOLERANCES IN PLANT SYSTEMS USIN G THE GENE OSISAP I 1317/DEL/2002 a
THE CHARACTERIZATION OF HUP B GENE ENCODING HISTONE LIKE 1274/DEL/2002
PROTEIN OF MYCOBACTERIAL TUBERCULOSIS
NOVEL ENZYME AND THE GENE ENCODING THE ENZYME IN/PCT/2002/01387
(Saha, 2004)

39. Websites for patent search
http://www.uspto.gov/
http://www.ipindia.nic.in
http://www.indianpatents.org.in/
http://www.pctgazette.wipo.int
http://www.pk2id.delhi.nic.in

40. Present Needs
Patent awareness programmes
Patent cell for biological material
Increase the number of depositories