Patent In Molecular Biology

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This presentation highlights the relevance of patents and the area under which patent could be sought

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Patent In Molecular Biology

  1. 1. Patent Potential in Molecular Biology Research Dr Karan Veer Singh, Scientist NBAGR, Karnal
  2. 2. Patent Novelty Prior art Inventiveness Non-obviousness Skilled Person Usefulness
  3. 3. Historical Perspective  Patent Act 1970  Amended in 1999, 2002 and recently in 2005  The Act of 1970 has provision for process patent. Now amended Act also covers product patents.  British Era  Patents and designs Act, 1911
  4. 4. Cont…(Historical Perspective)  India is socialist country. Constitution of India guarantee social justice to all.  Reverse Engineering  Involves manipulating an existing process or method to produce a new process or method. India was alleged to encourage reverse engineering by not providing product patents.
  5. 5. Cont…(Historical Perspective)  Product patent does not allow manipulation of existing processes or methods.  General Agreement on Tariffs and Trade (GAAT)  Negotiations started in 1947 and ended in 1993  GATT negotiations signed by WTO Member-States 1994
  6. 6. Cont……(Historical Perspective)  Agreement (WTO) including TRIPS came into being on 1-1-1995.  Article 27 of TRIPS Agreement provides blanket permission for patents on all types of inventions including product and process patents.  Patent Act of India 1970 does not provide granting of product patents. Further food and pharmaceutical forms were an exception to patenting.
  7. 7. Cont…(Historical Perspective) India was given 10 years transformation period to implement provisions of TRIPS, which ended on 1-1-2005. The objective of amendment was to grant Exclusive Marketing Rights to the patent applications claiming food products (agricultural products) and pharmaceuticals. The latest amendment to the Patent Act was in 27-3-2005 which brings Patent Act in conformity with TRIPS Agreement.
  8. 8. Patentable Subject Matter  Patent system varies from country to country.  US Patent Law What is patentable “whoever invents or discovers any new and useful process, machine, manufacture or composition of matter, or any new and useful improvement thereof, may obtain a patent”.
  9. 9. Cont…(Patentable Subject Matter) England Patent Law states what is not patentable “Inventions against public interest, public policy and morality are not patentable”. As a matter of practice, inventions relating to life were kept outside the purview of patentable subject matter.
  10. 10. Cont…(Patentable Subject Matter)  Living beings eg. Microorganisms, plants and animals produced through natural or biological processes are not patentable.  Non-natural living beings produced through non-biological processes like biotechnological processes are patentable.  Now genetically modified organisms, which are non-natural can be patented.
  11. 11. LIFE AS A PATENTABLE MATTER in 1980’s in US SUBJECT Patent was filed on a method of breeding of doves. The patent was rejected on the ground that the breeding method was not repeatable. The patent office did not answer question whether living being is patentable or not.
  12. 12. LIFE FORMS Lower Life Forms Single cell organisms eg. bacteria, fungi, algae Certain multicellular organisms eg. Plants High Life Forms Multicellulaur organisms eg. animals and human beings Animals and human beings think and express in contrast to plants
  13. 13. Patenting Lower Life-Microorganism  Till 1980’s life was not considered as patentable.  During that period, German Federal Court upheld patent of new microorganisms.  Australia- naturally occurring microorganismsnot patentable, but allowed use of naturally occurring microorganisms to produce new product.
  14. 14. Cont…(Patenting Lower Life-Microorganism) US Supreme Court  Inventor Dr. Charabarty sought patent on “Genetically modified bacteria” being capable of eating oil spills”. It was permitted.  Microorganism in its Claimed Form does not exist in nature.  It was a product of human ingenuity that can be patented even if it encompass living being.  This decision resulted in filing of large number of patents for genetically modified organisms.
  15. 15. Plant as Patentable Subject Matter US patent office did not allow patent for mutant of maize plant Board of Patent Appeals allowed patent of mutant maize
  16. 16. Patent on Higher Life: Animal US patent office allowed Patenting of Oncomouse. The claim was for genetically modified mouse susceptible to cancer disease that is useful for cancer research and drug development. 16 patents are granted on transgenic mice. Patents for transgenic pig, rabbit, sheep are also granted.
  17. 17. Patent on Human Genetic Material 1984, human cell line producing cancer-fighter proteins was isolated from the body of patient name ‘Moore’. Now, patents on methods to isolate human genetic material and also on proteins produced by human genetic material are allowed. Patent has been granted for producing foreign protein in transformed species of bacteria.
  18. 18. Cont…(Patent on Human Genetic Material) Patent has been granted on DNA sequence coding human protein erythropoietin (EPO) on the protein itself. (Erythropoietin is a protein that boosts red blood cell production) Patent on chimeric gene (combination of human gene and animal gene) has been granted. Patent on DNA and RNA for human insulin like growth factors (mediation of somatic cell growth on the administration of growth hormone).
  19. 19. Cont…(Patent on Human Genetic Material) Patent on DNA and cDNA encoding HeparinBinding growth factors and & HBGF stimulate cell division and facilitate the repair or replacement of damaged or diseased tissue Human cloning methods of the therapeutic purpose can be patented Human cloning is prohibited
  20. 20. What is Next.  Will the non-natural human beings be patented?  European Union’s Directive prohibits  patenting of invention of human cloning and non-natural human being on ethical grounds  Processes of cloning human being  Processes for modifying the germ line genetic identity of human being
  21. 21. Cont…(What is next)  Use of human embryos for industrial or commercial purposes  TRIPS agreement gives flexibility to member-states to prohibit patents on the basis of public order and morality.
  22. 22. Case Study Recombinant DNA A patented Research tool, non-exclusively licensed with low fees. Cohen-Boyer Technology for recombinant DNA, most successful patent in University licensing. It has three patents Process for making molecular chimeras Product patent :proteins produced using recombinant prokaryote DNA.
  23. 23. Cont… (Case Study)  Product patent : Proteins recombinant eukaryotic DNA. produced using  Application was filed by Stanford University in Nov. 1974.  Stanley Cohen and Herbert Boyer at together developed technique at Stanford and the University of California, San Francisco respectively.  Dec.1980, process patent for making molecular chimeras was issued.
  24. 24. Cont… (Case Study)  In 1984, product patent for prokaryotic DNA was issued.  Licensing agreement generated $139 million (700 crore Rupee) royalties as on 13-02-1995.  The technology was inexpensive and easy to use. There was no alternative. The technology was critical to research in molecular biology.  Technology developed in Universities through publicly funded research. Licenses inexpensive and minimum rider. Tremendous volume of sale
  25. 25. Cont… (Case Study) Bayh-Dole recommended Act- Exclusive License is Nelson, Director of Technology Licensing office at MIT was of view that Industry- sponsored researchuniversity will retain ownership but will give first option to sponsor for an exclusive license.
  26. 26. PCR and Taq Polymerase  PCR allows specific and rapid amplification of target DNA  Taq polymerase, the heat stable DNA polymerase used in the amplification  Kary Mullis was primary inventor of PCR working at Cetus corporation. He won Noble prize in 1985. PCR is developed in corporate environment.  Cetus corporation sold PCR patent to Hoffman-La Roche for $300 million in 1991.
  27. 27. Cont…(PCR and Taq Polymerase) The products are to be purchased to provide rights to use technology. The product license policy was instituted by cetus. Roche established three categories of licences (i) Research application eg. project (ii) Disease diagnosis (iii) PCR licensing programs human genome
  28. 28. Protein and DNA sequencing Instruments  Highly sensitive DNA and protein sequencers were developed at California Institute of Technology. But it required help of substantial private investment.  Prototype was developed in Hood’s laboratory during 1970-1986. this laboratory sequenced lymphokines, platelet-derived growth factor and interferons. Since middle of 1990’s the technology became widely available.
  29. 29. Cont…(Protein and DNA sequencing Instruments)  Funds for instrumentation by NIH was denied. Dr. Hood approached 19 companies; all declined support. Publication by Nature derived and treated it as a speculation.  Finally Applied Bio System agreed to fund but for exclusive license. ABI has sold more 3000 DNA sequencers and more than 1,000 protein sequencers.  LI-COR developed infrared fluorescence DNA sequencer. The company negotiated cross-licenses to develop its product
  30. 30. Patents for genetic inventions Three categories CloningProduction of therapeutic proteins Advances in plant biotechnology: improving agricultural productivity Genes as diagnostic tools: Diagnosis of genes implicated in disease of DNA coding sequence enables
  31. 31. Molecular Biology Related Patents Jawaharlal Nehru Centre for Advanced Scientific Research Process for extraction of superior quality of DNA A high sensitivity assay for molecular tying of biological samples, Probes and a kit thereof Tat DNA sequences, Gene constructs, Vaccine and processes thereof
  32. 32. Patenting of Biotechnological Inventions DNA sequence patents: • EPO: European Patent Office • USPTO: United States Patent and Trademark Office • JPO: Japan Patent Office. Common position on DNA sequence patents -Mere determination of DNA sequence is not patentable - Inventor to identify gene, its useful function, to isolate and clone the gene and thereby make synthetic copies of gene that are unavailable for use in diagnosis or therapy – this can be patented.
  33. 33. THANKS

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