Current status of patenting genes and microorganisms in india
Current Status of Patenting Genes and Microorganisms in India Asha K.
Intellectual Property It is a product of mind, created by the exercise ofintellectual 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 thegovernment for the commercial exploitation of inventionfor 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.
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 industryController 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 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.)
Different types of patent application • Ordinary application • Convention application • Application for patent of Addition • Divisional application • PCT application
PCT ApplicationPCT- 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
Patent application should contain... • Provisional or complete specification • Declaration as to inventorship • Priority document • Proof of right
Provisional SpecificationPriority Title of the invention Description of invention • Principle of invention • General statement of actual invention
Complete specificationTechno - legal documentContents 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 EXAMINATIONFormal Examination Technical examination First Examination report (FER)
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
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)
Patent Grant Procedure Filing of patent applicationEarly Publication Publication after 18 months Request for examination Examination: Grant or Refusal Publication of Grant of patent Opposition to the patent Decision by Controller
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)
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
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 IndiaMTCC centre at Chandigarh.Recognized as IDA in 2002Requirements for deposit Kind of organism Technical requirements Administrative requirements (Arora et al, 2005)
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.
Contd…Gene Sequences, DNA Sequences without disclosedfunction Essentially biological process for production of plantsand animalsAny biological material or a method causing seriousprejudice to human, plant life, health or environmentProcess of cloning human beings or animals .
Then, What we can patent………• Recombinant DNA, Plasmids.• Process of manufacturing. Recombinant microorganism DNA sequence whose function is disclosed
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 INDIVIDUALS 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)
Gene related patents in India Total no 146A METHOD FOR PRODUCING A VECTOR FOR INTRODUCING A 358/MAS/2003DESIRED GENE INTO A PLANTA METHOD FOR PRODUCING A VECTOR FOR INTRODUCING A 00594/DELNP/2003DESIRED GENE INTO A PLANTMETHOD FOR ACCUMULATING FOREIGN GENE PRODUCT AT A HIGH 00300/CHENP/2003LEVEL IN PLANT SEEDSA METHOD OF DETECTION OF SP A2 GENE VARIANTS USEFUL FOR 44/MAS/2003PREDICTION OF PREDISPOSTION OTO ASPERGILLUSISGENE ENCODING PROTEIN EXHIBITING AGARASE ACTIVITY 00160/CHENP/2003OBTAINED FROM AN INDIAN SOIL ISOLATEA NOVEL GENE OSISAP I OR RICE AND A METHOD OF INTRODUCINGSTRESS TOLERANCES IN PLANT SYSTEMS USIN G THE GENE OSISAP I 1317/DEL/2002 aTHE CHARACTERIZATION OF HUP B GENE ENCODING HISTONE LIKE 1274/DEL/2002PROTEIN OF MYCOBACTERIAL TUBERCULOSISNOVEL ENZYME AND THE GENE ENCODING THE ENZYME IN/PCT/2002/01387 (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