Patenting of life forms

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Patenting of life forms

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Patenting of life forms

  1. 1. CHENNAI 3rd Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com WEBSITE www.altacit.com PATENTING OF LIFE FORMS P.ILANANGAI IP CONSULTANT PATENT DEPARTMENT
  2. 2. CHENNAI 3rd Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com WEBSITE www.altacit.com • A life form is an entity or being that is living or alive. A life form can be anything from a virus or a plant to a human being. • Traditionally, patents have applied solely to inventions, granted as a reward for ingenuity and to encourage innovation. Naturally occurring substances, like DNA, were exempt from such laws. • Now the issue is should living things be patented? • Cells from a human spleen … mice that are genetically predisposed to get cancer … bacteria that can digest oil … an extract from a tree native to India … There are at least two features that these all have in common: they are derived from living organisms they all have been patented as “human inventions” INTRODUCTION
  3. 3. CHENNAI 3rd Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com WEBSITE www.altacit.com • First life form to receive a patent: Patenting a living form • Diamond Vs Ananda Mohan Chakrabarty [1980] • The Court wrote “The fact that micro-organisms are alive is without legal significance for the purpose of Patent law”. • contd….. EVOLUTION IN THE UNITED STATES
  4. 4. CHENNAI 3rd Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com WEBSITE www.altacit.com • Since 1980, life forms were no longer considered a natural product but a commodity. • It is now possible to patent entire species of microorganisms. • Patents on animal life: Harvard Onco-mouse- dependable animal cancer model for scientists to employ as a test subject in experimental cancer treatments. A white mouse was injected with a gene to make it more likely to get cancer. The Onco mouse was good for testing anti cancer drugs. • contd….
  5. 5. CHENNAI 3rd Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com WEBSITE www.altacit.com • Patents on human life: DNA that had been altered to produce specific  proteins, such as the insulin. • Someone else may own your genes, cell lines, or tissues. • Cell  line  taken  from  the  spleen  of  a  human,  which  was  valuable  for  producing antibacterial and cancer fighting proteins. • The fact is that human genetic material is unambiguously patentable.  • Patents on food crops: Exchange of certain seeds and plants is no longer possible because they have been patented.                                                                                                                        contd….
  6. 6. CHENNAI 3rd Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com WEBSITE www.altacit.com • Drawbacks: • “A  patent  on  a  product  of  Nature  would  authorize  the  patent  holder  to  exclude  everyone from observing, characterizing or analyzing, by any means whatsoever,  the product of Nature,”  • One cannot study a product of Nature if one cannot legally possess it.” • When a company patents a gene, it also patents the rights to what that gene (or any  fragment  of  its  DNA)  might  tell  us  about  our  health,  including  our  chances  of  living or dying. • Ex: A  recent  high  profile  case  that  received  extensive  media  coverage  involved  Myriad Genetics Inc., a biotechnology company, and their patents on two genes  linked to ovarian and breast cancer, BRCA1 and BRCA2. • Granting monopoly on a DNA sequence through gene patenting has direct impact  on various other areas of worldwide medical research such as, drug designing, etc.
  7. 7. CHENNAI 3rd Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com WEBSITE www.altacit.com EUROPE • EP does not prohibit patent on any living beings produced out of  a non-biological process. • Genentech- I/Polypeptide expression  • Production  of  vaccines,  polypeptides  and  antibodies  through  a  biotechnological process which would help fight the Hepatitis C  virus.  • Human H-2 relaxin, a hormone involved in reproduction, and a  DNA sequence coding for the hormone.
  8. 8. CHENNAI 3rd Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com WEBSITE www.altacit.com INDIA • The Patent Act, 1970 states that an invention that satisfies the universally accepted  requirements  of  patentability  such  as  novelty,  inventive  step  and  industrial  application is patentable. • Amendment in Patent Act in 2002 brought in changes allowing the patenting of  products  of  chemical,  biochemical,  biotechnological  processes  as  well  as  micro- organism. • Sec 3 of Indian Patent Act, 1970 which provides exceptions to patentability has  also been amended in the light of Art 27(1) of TRIPS agreement; adding clauses  like  an  invention  with  the  primary  object  being  commercial  exploitation  which  would  be  contrary  to  public  order,  morality,  or  which  might  cause  injury  or  prejudice  to  plant  or  animal  health  or  environment,  the  mere  discovery  of  a  naturally  occurring  living  or  non-living  thing,  plants  and  animals  other  than  “micro-organisms”.
  9. 9. CHENNAI 3rd Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com WEBSITE www.altacit.com • The exclusion of “micro-organisms” from Sec 3 or rather the affirmation of its patentability is an important feature of this amendment. • The basic fact about genes/gene products being patentable is that when a genetically engineered gene/DNA/amino acid sequence is novel and holds an inventive step thereby ensuring its industrial application, the patents can be claimed as: – Gene sequence/amino acid sequence. – A method of expressing the above sequence. – An antibody against that sequence/protein. – A kit made from the antibody/sequence. • Dimminaco A.G v Controller of Patents and Designs and Others • contd…
  10. 10. CHENNAI 3rd Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com WEBSITE www.altacit.com • The Calcutta High Court held that there is no statutory bar to accept a manner of manufacture as a patentable item, even if the end product of the manufacture contains living organism. Therefore it can be said with reasonable certainty that India also recognizes life form patents. • Indian Patent No. 243373 assigned to Sichuan Biotechnology Research Center, discloses artificial gene sequence for encoding recombinant super compound interferon with enhanced activity.
  11. 11. CHENNAI 3rd Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com WEBSITE www.altacit.com BIOTECHNOLOGY IN AGRICULTURE • In India, biotechnology research and development is in progress particularly in crop improvement. The most promising benefit from genetic engineering is the use of recombinant DNA techniques. Because it is possible to break through natural species barriers systematically by moving genes from one species to another that do not combine in nature. • The genetically modified (GM) crops:
  12. 12. CHENNAI 3rd Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com WEBSITE www.altacit.com
  13. 13. CHENNAI 3rd Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com WEBSITE www.altacit.com PROS AND CONS • Pros: • Genetic research would help developing treatments for diseases and in discovering new pharmaceuticals for a wider range of diseases. • Encourages research and development in private industry. • Provides opportunities for investment in research and development. • Companies, as well as individuals, can invest in a patented gene. • Cons: • Hinders research. • Leads to monopolization of genes. • Slows down medical results. • Patenting and owning genetic materials is often considered by many to be tantamount to human slavery.
  14. 14. CHENNAI 3rd Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com WEBSITE www.altacit.com CONCLUSION • New innovations are inevitable in any field of Technology. • The monopoly granted to a patent holder over life form can exorbitantly elevate the costs of research and further development of new therapies. • The patenting process should not be neither prohibitive nor accept loose principles allowing discrepancy to standards of patentability for making companies undue profits. • So, there is need of definite and consistent standards of patentability for acceleration of technological advancement and there by the economical development and scientific progress of the country.
  15. 15. CHENNAI 3rd Floor, ‘Creative Enclave’, 148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com WEBSITE www.altacit.com

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