Patent and Patent Laws

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Welcome Dileep Kumar Verma

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Dileep Kumar Patel Sardar Vallabh Bhai Patel University Of Agriculture And Technology B.Tech Biotechnology

What is Patenting:

What is Patenting Patenting has become common in molecular breeding. Patenting of genes may actually kill the use of GMO . Legal issues become difficult to handle, and focus attention from biology. It will be too difficult and risky to commercialise a good project, if it must be combined with 100 other patents. “Resting patents” which may be vitalised if a successful commercialisation seems in sight is one threat. If something is “published” it cannot be patented. I feel strongly that Universities and Research supporting agencies should encourage publishing instead of patenting. But they act opposite!!

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GMO is a powerful research tool with much future development potential. GMO leads to a biased research, where too much resources are invested in fancy looking biotech projects with the hope of applications to practical forestry in the near future GMO s can be used to study the function of genes, e.g. by transferring a pine gene to Arabidopsis .

Obtaining a patent:

Obtaining a patent File an application for patent With one of the patent offices based on territorial jurisdiction of the place of office or residence of the applicant /agent. Pay the required fee Information concerning application form and details of fee available at www.ipindia.nic.in Guidelines for applicants also available on this website

STAGES - FILING TO GRANT OF PATENT:

STAGES - FILING TO GRANT OF PATENT PUBLICATION OF APPLICATION REQUEST FOR EXAMINATION GRANT OF PATENT 3rd Party Representation Revocation/Amendment OPPOSITION PROMPTLY AFTER 18 MONTHS FROM P.D. WITHIN 48 MONTHS FROM F.D . ALL OBJECTIONS TO BE COMPLIED WITHIN 12 MONTHS IF P.S.IS FILED C.S. TO BE FILED WITHIN 12MONTHS WITHIN 12 MONTHS FILING OF APPLICATION PROVNL. / COMPLETE Decision of Controller EXAMINATION-ISSUE OF FER Appeal Appellate Board

Patent Law - Salient Features:

Patent Law - Salient Features Both product and process patent provided Term of patent – 20 years Examination on request Both pre-grant and post-grant opposition Fast track mechanism for disposal of appeals Provision for protection of bio-diversity and traditional knowledge Publication of applications after 18 months with facility for early publication Substantially reduced time-lines

Safeguards in the Patent Law:

8 Safeguards in the Patent Law Compulsory license to ensure availability of drugs at reasonable prices Provision to deal with public health emergency Revocation of patent in public interest and also on security considerations

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CONTROLLER GENERAL OF PATENTS, DESIGNS AND TRADEMARKS (CGPDTM) T M REGISTRY DESIGN OFFICE G.I. REGISTRY Head Office KOLKATA Branch DELHI Branch CHENNAI Branch MUMBAI Head Office MUMBAI DELHI KOLKATA CHENNAI A’BAD IPTI ,NIIPM, P.I.S. Nagpur KOLKATA PATENT OFFICE CHENNAI

Impacts of Genetic Modification:

Impacts of Genetic Modification 1.4 billion farmers in developed countries depend on “ saved seeds ” and seed exchanges (50% of crops) 1998 Monsanto sued 100 US soybean growers and hired “Pinkerton” agents to track down “seed savers” “Pineland Seed Company” was granted patent in 1998 for “terminator technology” seeds do not germinate if planted for second time

Impacts of Genetic Modification:

Impacts of Genetic Modification WR Grace patent on extracts from “ Neem ” tree destroyed southern Indian farmers market Locals could no longer not grow Neem w/o license from Grace 1995 attempt by 2 Doctors to patent “ tumeric ” as healing powder opposed by India b/c discovery not original. In traditional Indian texts

Other Impacts:

Other Impacts 1997 “ Ricetec , Inc.” granted patent for crossing Indian basmati rice with semi-dwarf varities . Patent covered Basmati rice grown “anywhere” in Western Hemisphere. Patent gave Ricetec exclusive right to market any blend of the 22 farmer-bred varieties of Pakistan or Indian basmati rice with Ricetec’s other seeds and right to use Basmati names. Indian Government challenged Ricetec’s claim which threatened 277 million dollar Indian rice market and Punjabi farmers.

Legislative Framework of IP Administration:

Legislative Framework of IP Administration Department of IP &P covers The Patents Act, 1970 (as amended in 2005) The Patents Rules, 2003 (as amended in 2006) The Designs Act, 2000 The Designs Rules, 2001 (as amended in 2008) The Trade Marks Act 1999 The Trade Marks Rules 2002 The Geographical Indications of Goods (Registration & Protection) Act, 1999 The Geographical Indications of Goods (Registration & Protection) Rules, 2002, Department of Education covers The Copyrights Act 1957 (amended in 1999)

Legislative Measures -Patents:

Legislative Measures -Patents From 1.1.1995 Mail-Box for pharmaceutical and agrochemicals products Exclusive Marketing Rights From 1.1.2000 Patent term increased to 20 years Definition of invention – inclusion of inventive step Reversal of burden of proof – on the infringer Mandatory compulsory licence provision for food, drugs and chemicals removed Right of patentee (importation also included) From 1.1.2005 Product patents for food, chemical and pharmaceutical We have met our international commitments

Law and Regulations:

Law and Regulations Patents Act, 1970 Amended in 1999 2002 2005 Patents Rules, 2003 Amended in 2005 2006

Scope of Patentability Under The Patents Act :

Scope of Patentability Under The Patents Act

Patentable subject matter:

Patentable subject matter Invention must relates to a Process or Product or both be new (Novel) involves an inventive step be Capable of industrial application not fall under Section 3 and 4

Checks and Balances :

Checks and Balances Section 3(b) Excludes patents on GMOs-Exploitation of which could be contrary public order or morality or prejudicial to human, animal or plant life or health or to the environment Effect : Only genetically modified micro-organisms (GMOs) which do not fall under section 3 (b) are patentable .

Checks and Balances :

Checks and Balances Section 3(c) Excludes patents on Naturally occurring Micro-organisms Effect Genetically modified microorganisms (GMOs) are however, patentable.

Checks and Balances:

Checks and Balances Section 3 (d) Explanation Effect Salts, esters, ethers, polymorphs, metabolite, pure forms, particle size, isomers, complexes, combinations and derivatives of a known substance with enhanced efficacy are patentable.

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Problems associated with Patenting Patent and legal problems must be overcome. A GMO cultivar may depend on hundreds of genetic patents, each potentially able to stop all use; there may lurk not evident patents. There is a plant breeders rights system (UPOV, International Union for the Protection of New Varieties of Plants), which is not implemented into forestry (at least not often ). UPOV does not stop further developing protected cultivars in the way GMO-patents do. UPOV conflicts with patents and is not in harmony with GMO, and this is also an issue of problems.

Doubtful profitability in patenting:

For forestry there is little potential profit for patents. A patent is valid only 20 years. Seedlings planted year 2006 reflect decisions, selections, and investments 40 years ago, which much exceeds the length of a patent. Doubtful profitability in patenting

The BIG risks:

The BIG risks GMO properly used with reasonable safety precautions does not seem biologically risky. But there are other dangers...   GMO is a powerful research tool. But over-trust in its near practical application creates a biased research. By far too much resources are invested in fancy looking biotech projects today. Other research, which would benefit practical forestry more, is not done. The biotech done becomes more inefficient, because its emphasise is too much on practical applications (e.g. patents).

No. of patent by Country:

No. of patent by Country Country No of patent USA 50 Argentina 17 Brazil 9 Canada 6 Paraguay 2 China 3 India 1 All others (14) 2 Americas dominate!!, USA alone more than half! No European country >0.1, but share in Europe raises rapidly

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GMO Crops Approved for Sale Soybeans Corn, not blue corn Canola Papaya Potatoes Tomatoes Some Approved GMO Products Yellow crook-neck squash Red-hearted chicory (radicchio) Cotton Dairy products from cows injected with the genetically altered hormone Eecombinant bovine growth hormone ( rBGH )

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