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Presentations in the IIM(Amd) Course July 3-4, 2003

Presentations in the IIM(Amd) Course July 3-4, 2003. Prabuddha Ganguli Advisor “VISION-IPR” 103 B SENATE, Lokhandwala Township, Akurli Road, Kandivli East, Mumbai 400101 Tel: 91-22-28873766 e-mail: ramugang@vsnl.com. Session 1. Analytical Framework. Knowledge. trade. access. create.

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Presentations in the IIM(Amd) Course July 3-4, 2003

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  1. Presentations in the IIM(Amd) Course July 3-4, 2003 Prabuddha Ganguli Advisor “VISION-IPR” 103 B SENATE, Lokhandwala Township, Akurli Road, Kandivli East, Mumbai 400101 Tel: 91-22-28873766 e-mail: ramugang@vsnl.com

  2. Session 1 Analytical Framework

  3. Knowledge trade access create application generate protection IPR Info. security The Knowledge Canopy

  4. T B T T R I P S S P S K n o w l e d g e D i f f e r e n t i a t o r s Govt. control on technology transfer

  5. ACCESSIBILITY vis-a-vis AFFORDABILITY

  6. Key issue :Ownership of Knowledge versus IPR plays a decisive role Knowledge Prospecting Knowledge Piracy

  7. Rationale for IP Protection • Organise in the best possible way human, economic and social relations thereby providing a framework for a fair distribution of the limited human resources available • Stimulate creativity and inventiveness • Protection for investments • Recognition to inventors and enhance ethical standards in society

  8. Motivation for IP Protection and Management • IPR Management helps to integrate the institution’s innovation process with a wide range of R&D partnerships • Institutional IPR encourages partnership with other developers especially with SMEs in the innovation supply chain. • Optimal use of extra-institutional knowledge. Avoid duplication and manage funs for R&D effectively

  9. Motivation for IP Protection and Management • Create and retain R&D and Market Leadership. • Freedom to operate in a global environment • Enhance institutional image • Protection/Management of Institutional Knowledge Assets • Competence and Knowledge Building • Earnings from innovations to pay for further research and acquiring other technologies ( e.g. structuring contracts, licensing and cross-licensing) • Contribute to long term growth

  10. A PATENT IS A GRANT BY SOVEREIGN OR STATE TO A PERSON GIVING EXCLUSIVE RIGHT TO “MAKE., USE EXERCISE AND VEND” AN INVENTION FOR A LIMITED PERIOD, IN EXCHANGE FOR DISCLOSING IT IN A PATNET SPECIFCATIONSuch that any one trained in the art can reproduce the invention. RIGHT TO EXCLUDE OTHERS USING YOUR INVENTIONOWNER HAS A QUALIFIED RIGHT TO USE THE INVENTION WHAT IS A PATENT

  11. TODAY YESTERYEARS RESEARCH MODELS TOMORROW……. • ISSUES • RESEARCH PROCESS“APPROACHES” • SOCIETAL IMPACT • KNOWLEDGE OWNERSHIP • BENEFITS SHARING

  12. TODAY TOMORROW. RESEARCH MODELS YESTERYEARS DOWNSTREAM RESEARCH UPSTREAM RESEARCH • Typically Applications • Private Funded Institutions • Targeted End Points • Optimised use of “Public Domain Knowledge” • Value Addition as measure of competitive edge • Profits,Market dominance • Proprietary Issues • Typically Conceptual • State Funded Institutions • “Open-Ended” Knowledge Generation • Enrichment of “Public Domain knowledge • Credits: Enhanced Peer Recognition

  13. TOMORROW YESTERYEARS RESEARCH MODELS TODAY MIDSTREAM • Partial Funding By Private Enterprises in Upstream Research • Issues on knowledge Flow • Benefits Sharing • Publications Research Schemes, Peer Group Recognition etc. • Free use by Funding Agency • Diffused Ownership

  14. TODAY YESTERYEARS RESEARCH MODELS TOMORROW……. TURBULENCE RAPIDS • Blurring of boundaries between Upstream & Downstream Research • Overlap between disciplines • Quantification of Ownership • Formalized benefit Sharing by Partners • Overlapping Claims by different owners • Challenges to Ownership Criteria • Anti competition or Monopolistic Issues • IRP Multi-tier innovation process • Optimized use of global knowledge base • Intra-Enterprise resources • Extra-Enterprise inputs • Global/National licensing issues • Intricate exclusive/non-exclusive benefits Sharing • Organisational frameworks for rapid diffusion of innovation to business

  15. Demand for Patents Worldwide Total Filings First Filings Ref: Intellectual Property Rigths.. Unleashing the Knowledge Economy P. Ganguli ( Tata McGraw Hill, New Delhi 2001)

  16. Ref: Intellectual Property Rigths.. Unleashing the Knowledge Economy P. Ganguli ( Tata McGraw Hill, New Delhi 2001)

  17. Route 2 CK 3 CK 4 CK 5 CK 1 Route 1 CK 2 CONCEPTS PRODUCTS PROTECTED TOOLS, SOFTWARE, REAGENTS, GENE FRAGMENTS, SPECIALITY MATERIALS, LINKED TECHNOLOGIES , OF VARIOUS KNOWLEDGE OWNERS Check Posts Check Posts on the Innovation Highway

  18. Case Studies • Honeywell in 1993 won $ 96 million from Minolta for infringement of Honeywell’s auto-focus technology for cameras. Then got licensing deals worth $ 400 million from other manufacturers. • Historic judgement of 1990 . Polaroid awarded $ 900 million from Kodak. Of this $455 was as lost interest on the damage of $ 454.

  19. Case Study • Fonar vs. General Electric (small v big)Fonar filed several patents on Magnetic Resonance Imaging Techniques in 1970s.Subsequently GE and Hitachi entered the marketFonar filed infringement suits.Hitachi reached out of court settlements.GE in 1995 was ordered to pay $ 128.7 million.Interestingly Fonar’s annual revenue was only $17 million.

  20. Case Study • Fonar vs. GEBasis of damages calculation :Fonar claimed lost profits for 600 MRI instruments.After argument from both sides the judge concluded the Fonar could sell only 75 instruments. • Award therefore on lost profits for 75 instruments @ 371,000 per machine and royalty for 575 machines @ 65,000 per machine.

  21. Technology has generally preceded Law Law has always been challenged by Technology Law has been changed to accommodate technology change and societal needs

  22. Some Landmark Judgements • Diamond v. Chakravarti (in a matter dealing with biotechnology; 447 US 303 [1980]) • Diamond v. Diehr (concerning patenting of computer related inventions; 450 US 175, 209 USPQ97 (1981)) • State Street Bank & Trust Co v. Signature Financial Group (related to patenting of business methods; 47 USPQ 2d 1596 [Fed. Cir.1998], cert. Denied (US 1999 No. 98-657) • Silhoutte International Schmredgesellschaft mbh & Co v. Hartlauer Handelsgesselschaft mbh ( related to parallel imports; 1998 in ECJ)

  23. Managing Intellectual Property CONCEPTS INNOVATION PROCESS OUTPUT MARKET • Working through the • IP grid • Patents & other IPR Filings/Registrations • Strategy for Foreign Filings • Licensing Options • Joint Developments • Product Lifecycle • Managing IPR Portfolio • Monitoring IPR • Policing IPR • Enforcing IPR • Business Opportunities • Technology Options( mapping exercise ) • Strategic Options • Fit in IPR Portfolio • Marketing tieups Record Maintenance & Updating IPR Information

  24. Beware !!!! Premature disclosure of information Seek usage clearance Public Testing of Inventions

  25. Session 2 Patent Drafting

  26. Invention to satisfy • NoveltyNon-ObviousnessUtilityto qualify for a patent

  27. Dissecting a Patent TEXT OBJECT OF INVENTION PRIOR ART DISCLOSE / DESCRIBE INVENTION WITH SUPPORTING DATA EXAMPLES CLAIMS DEFINING THE MONPOLY CLAIMED THIS HELPS IN THE FINDING OF WHAT CONSTITUTES INFRINGMENT ALSO SEPARATELY INCLUDE DIAGRAMS / FORMULAE IF NECESSARY IN THE SPECIFICATION. BUT NOT IN THE MAIN TEXT. NOTE: What is disclosed and not claimed is effectively disclaimed

  28. PATENT DOCUMENT BIBLOGRAPHIC INFORMATION ABSTRACT TEXT WITH DESCRIPTION & CLAIMS DRAWINGS

  29. Patent Document PRIOR ART - PUBLIC (NOT PRIVATE) KNOWLEDGE - LITERATURE - PATENT SPECIFICATION - TEXT BOOKS - BORCHURES - JOURNALS - BROADCASTS - LECTURES - PRODUCT SALES - USE IN PUBLIC

  30. Patent Document

  31. Patent Document BIBLOGRAPHIC INFORMATION COUNTRY OF PUBLICATION NATIONAL PATENT CLASSIFICATION INT. PAT. CLASSIFICATION TITLE ABSTRACT INVENTOR APPLICANT APPLICATION NO. SERIAL NO. OF PATENT DATE OF APPLICATION PRIORITY DATE PRIORITY NO. PRIORITY COUNTRY REFERNCE CITED BY EXAMINER

  32. Patent Document

  33. Session 3 Biotechnology Directive

  34. Patenting life forms • It should not be forgotten that Louis Pasteur was awarded U.S Patent Number 141,072 in 1873 for a yeast • A man-made of microorganism was awarded in 1980. The US Supreme Court took a historic 5-4 decision in the case of Chakrabarty v. Diamond for the genetically engineered Pseudomonas aeruginosa bacterium that is capable of breaking down the four major components of crude oil.

  35. Patenting life forms • The next major discontinuity in this direction was the award U.S Patent Number 4,736,866 for the “Harvard onco mouse” to Philip Leder and Tinothy A. Stweart of Harvard University on April 12, 1988. The claim in this patent was “ A transgenic non-human mammal all of whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into the said mammal, or an ancestor of the said animal, at an embryonic stage.” • In a recent decision in Canada onco mouse failed to get as patent in Canada

  36. Patenting of life forms • The rat race continued and at least 16 patents have been awarded on inventions related to transgenic mice as models exhibiting specific pathologies such as ulcers, polio, Parkinson’s syndrome, inflamation, sickle cell anemia, Alzheimer’s Disease, Neuronal HIV infection, Cutaneous melanoma, Leukemia, Thrombocytopenia, etc.

  37. Patenting of life forms • The patenting movement then took on to higher order animals with one of the first patents to be issued was U.S. Patent Number 5,476,995 for an invention that claimed a transgenic sheep that expressed the transgene in the mammary gland so as to produce the target protein in its milk. Since then there has been a spate of patents expressing diverse proteins in pig, sheep, goat, cattle (Fibrinogin, Protein C), Sheep (Blood coagulation), mouse (human antibodies), pig (human hemoglobin ) etc

  38. Hello Dolly !!! • In January 2000 PPL Therapeutics, with Roslin Institute and Geron Corporation were granted two UK patents covering [March 2000 Volume 18 Number 3 pp 256 – 257] • the methodology of nuclear transfer using a quiescent donor cell to produce cloned nonhuman animals and animal (human or nonhuman) cells (GB2318578), as well as • the embryos, animals, and cell lines made using the technology (GB2331751). his technology resulted in the wold’s first cloned animal (the sheep Dolly). • This technology does enable the cloning of a human embryo (and its growth to an early blastocyst stage), and the UK patent grants rights of ownership to those embryos.

  39. Share of Patents Claiming DNA Sequences in Plant Species Data Source : Nature 399, 405 - 406 (1999)

  40. Patent Applications claiming DNA sequences in Plant Species % of Applications filed Data Source : Nature 399, 405 - 406 (1999)

  41. Nutrition (20%) :Genes that determine the amount or type of sugar starch, oil or protein in the plant, encode enriched proteins, and reduce the level of allogenic proteins in rice. • Pathogen resistance (20%): Encode a wide variety of enzymes including chitinases. • Regulatory DNA sequences (18%):Transcriptional promoters are claimed that are in general tissue-specific. The gene sequences regulated by these promoters are also claimed in some cases.

  42. Plant development, :Several concern modification of Male sterility (18%) reproduction and ethylene production and the extent and pattern of flowering Herbicide tolerance( 7% ) :Genes encoding glutathione S-transferase IIIc, acetolactate synthase, lycopene cyclase and a protein conferring glyphosate resistance. The complexity of gene function is well illustrated by the acetyl- CoA carboxylase gene, which confers herbicide tolerance in monocotyledon but is claimed primarily for regulating oil content.

  43. New Guidelines by USPTO for Patenting of Genes • www.access.gpo.gov/su_docs/aces/fr-cont.html • A gene can be patented but it must have a specific use. To show utility the applicant must show it had a credible and specific use(s) • One of the features is that it must demonstrate a substantial use. This would hopefully restrict the patenting of frivolous attempts to patent genes.

  44. EUROPEAN BIOTECHNOLOGY DIRECTIVE “DIRECTIVE ON THE LEGAL PORTECTION OF BIOTECHNOLOGICAL IVENTIONS”

  45. DEFINITIONS • BIOLOGICAL MATERIAL • Any material - containing genetic information and capable of reproducing itself or being reproduced in a biological system. [Article 2.1a] • A MICROBIOLOGICAL PROCESS • Any process involving, or performed upon or resulting in a microbiological material [ Article 2.1 b] N.B: - Microbiologically process are contrasted with “Essentially Biological Process”. - Essentially Biological processes for production of plants & animals are specifically excluded from patentability [Article 4.3]

  46. PATENTABLE PATENTABLE - NOVELTY, INVENTIVENES & [ARTICLE 3.1]INDUSTRIAL APPLILCABILITY even if they comprise of BIOLOGICAL MATERIAL or ARE PRODUCTED BY MEANS OF A MICROBIOLOGICAL PROCESS - where material is isolated from its natural environment or produced by means of a technical process, it may be the subject of an invention even if it previously occurred in nature [Article 3.2]

  47. PATENTABLE PATENTABLE [Article 5.2] • Elements isolated from the human body [including gene sequences & partial gene sequences] despite the fact that the isolated gene is identical to its naturally occuring counterpart. WHY? • Because identification, purification & classification of a gene & the reproduction of it outside the human body requires techniques & intellectual inputs. HOWEVER • Such inventions must disclose industrial applicability

  48. EXCLUDED FROM PATENTABILITY • Plant & animal varieties and essentially biological process for production of plants & animals. • Essentially Biological Process. One which consists entirely of natural phenomena such as crossing or selection • Human Body at any stage of its formation or development including germ cells • Simple discovery of a human gene without reference to specific function of gene or its protein • Inventions on grounds of public morality.

  49. EXCLUSIONS • Use of human embryos for commercial purposes. These exclusions do not affect inventions for diagnostic or therapeutic purposes which are applied to the human embryo for its benefit. Techniques for the coloring of non-human animals are excluded. • Process for • Cloning Human Beings • Modifying germ line identity of Human Beings • Modifying genetic identity of animals which are likely to cause them suffering without any substantial benefit to man or animal. Animals resulting from such modifications are excluded from patentability.

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