current status of patenting genes and microorganisms in india
TRANSCRIPT
Current Status of Patenting Genes and Microorganisms in India
Asha K.
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
Different Intellectual Property Rights
Patents
Copyright
Trade marks
Industrial design
Geographical indication
Trade secrets
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
Why do we need a patent system….
Induce inventor to disclose his invention
Encourage research activities
Reasonable assurance for commercialization
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.
Novelty
Inventiveness
Industrial applicability
Criteria for patentability
Who can be an applicant?
True and first inventor
His \her assignee
Legal representative
Where to apply?
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
Patent office Territorial Jurisdiction
MumbaiGujarat, Maharastra, M.P, Goa, Chattisgarh,
Daman and Diu, Dadra and Nager Haveli
DelhiHaryana, Himachal Pradesh, J.K., U.P.,
Punjab, Rajasthan, Uttaranchal, Chandigarh
Chennai A.P., Karnataka, Kerala, Tamil Nadu,
Pondicherry and Lakshadweep
Kolkata(H. O.)
Rest of India
Ordinary application
Convention application
Application for patent of Addition
Divisional application
PCT application
Different types of patent application
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
Processing of PCT Application
Formal examination.
International search
International publication
Provisional or complete specification
Declaration as to inventorship
Priority document
Proof of right
Patent application should contain...
Provisional Specification
Priority
Title of the invention
Description of invention
• Principle of invention
• General statement of actual invention
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
Claims makes the picture clear....
Single sentences
Possible equivalent variations
Not be too wide
Must be specific
The attractiveness and importance
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
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
STAGES OF EXAMINATION
First Examination report (FER)
Formal Examination Technical examination
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
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
Grant of patent
(Chandrasekaran, 2005)
Patent Grant ProcedurePatent Grant Procedure
Filing of patent application
Request for examination
Examination: Grant or Refusal
Publication of Grant of patent
Opposition to the patent
Decision by Controller
Early Publication Publication after 18 months
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
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
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/
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)
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
A Landmark Decision for India
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
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)
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.
Non Patentables in Biotechnology Indian status
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 .
Contd…
Then, What we can patent………
Recombinant DNA, Plasmids.
Process of manufacturing.
Recombinant microorganism
DNA sequence whose function is disclosed
(Saha, 2004)
Biotechnology patents in India by area of filing 1999-2003
Major applicants
(Saha, 2004)
A PROCESS FOR THE ISOLATION AND ACCLIMATION OF BACTERIA FOR LIGNIN DEGRADATION
LACTIC ACID BACTERIA CAPABLE OF REDUCING AN I INDIVIDUAL'S TENDENCY TO DEVELOP ALLERGIC REACTIONS
BIO POWE MICRONISED COMPOUND MICROPOUND 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
MODIFICATION OF BACTERIA
EXPRESSION OF AN ANTIMICROBIAL PEPTIDE VIA THE PLASTID GENOME TO CONTROL PHYTOPATHOGENIC BACTERIA
BEVERAGES CONTAINING LIVE LACTIC BACTERIA
374/DEL/03
00404/CHENP/2003
1096/MUM/2002
IN/PCT/2002/01972/CHE
IN/PCT/2002/01370
IN/PCT/2002/01087
MICROORGANISM RELATED PATENTS IN INDIA Total no : 600
(Saha, 2004)
A METHOD FOR PRODUCING A VECTOR FOR INTRODUCING A DESIRED GENE INTO A PLANT
A METHOD FOR PRODUCING A VECTOR FOR INTRODUCING A DESIRED GENE INTO A PLANT
METHOD FOR ACCUMULATING FOREIGN GENE PRODUCT AT A HIGH LEVEL IN PLANT SEEDS
A METHOD OF DETECTION OF SP A2 GENE VARIANTS USEFUL FOR PREDICTION OF PREDISPOSTION OTO ASPERGILLUSIS
GENE ENCODING PROTEIN EXHIBITING AGARASE ACTIVITY 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
THE CHARACTERIZATION OF HUP B GENE ENCODING HISTONE LIKE PROTEIN OF MYCOBACTERIAL TUBERCULOSIS
NOVEL ENZYME AND THE GENE ENCODING THE ENZYME
358/MAS/2003
00594/DELNP/2003
00300/CHENP/2003
44/MAS/2003
00160/CHENP/2003
1317/DEL/2002 a
1274/DEL/2002
IN/PCT/2002/01387
Gene related patents in India Total no 146
(Saha, 2004)
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
Present Needs
Patent awareness programmes
Patent cell for biological material
Increase the number of depositories