Biotechnology and IP - A Presentation by Dr. Kalyan Kankanala

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Biotechnology and IP - A Presentation by Dr. Kalyan Kankanala

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Biotechnology and IP - A Presentation by Dr. Kalyan Kankanala

  1. 1. Biotechnology and IP By Dr. Kalyan Kankanala Blog: www.bananaip.com/sinapse-blog
  2. 2. US Patent Law and Biotechnology
  3. 3. Overview • Article 1 Section 1 Clause 8 • Quid Pro Quo • Incentives • Title 35 • www.uspto.gov • www.fedcir.gov
  4. 4. Patentability requirements • Patentable subject matter • Utility • Novelty • Nonobviousness • Specification
  5. 5. INVENTIONS Subject Matter Usefulness Novelty Non-obviousness Specification PATENTS Kalyan’s Patent Filter Model
  6. 6. Patentable Subject Matter • Section 101 - Process, machine, manufacture, composition of matter and Improvements • Funk Bros. v. Kalo • Diamond v. Chakrabarty • Pioneer Hibebred v. J.E.M. Arguments and Issues
  7. 7. Funk Bros • Rhizobium bacteria • Innoculum of mutually inhibiting bacteria • Is it a product of nature?
  8. 8. Chakrabarty's case • Psuedomonas bacteria • Four different plasmids inserted. • Is it a product of Nature?
  9. 9. Utility • Current • Substantial • Credible • Brenner v. Manson • Gene/protein sequences
  10. 10. Novelty • Section 102 • Known or used • Patented or published • Public use or On sale • Abandoned • Foreign Priority • Patented in another country
  11. 11. Novelty • Derived • Suppressed or Concealed • Diligence • Single prior art reference • Isolated or purified- activity • Hybritech v. Monoclonal
  12. 12. Nonobviousness • Scope of prior art • Differences- invention and prior art • Level of ordinary skill • Secondary Indicia • At the time of conception • Obvious to try
  13. 13. Hybritech v. Monoclonal • immunometric assays using monoclonal antibodies
  14. 14. Prior Art • a. Kohler and Milstein's Nobel Prize-Winning Work for Producing Monoclonal antibodies in vitro; • b. The Work of Drs. Oi and Herzenberg, in which they used monoclonal antibodies to "map" epitopes or determine the number and location of different antibody binding sites on a known quantity of IgE antigen by attaching to it an antibody bound to a carrier and exposing that antigen to other monoclonal antibodies; • c. The Frankel Article that disclosed Monoclonal Antibodies Having Affinities of 109 liters/mole; and • d. Articles "Predicting" Widespread Use of Monoclonal antibodies.
  15. 15. In re Deuel: • Isolated and purified DNA and cDNA sequences encoding heparin-binding growth factors ("HBGFs")
  16. 16. Prior Art • Bohlen's patent application disclosed a group of protein growth factors designated as heparin-binding brain mitogens ("HBBMs") useful in treating burns and promoting the formation, maintenance, and repair of tissue, particularly neural tissue. Bohlen determined the first 19 amino acids of the proteins' N- terminal sequences, which were found to be identical for human and bovine HBBMs. He provided no teachings concerning DNA or cDNA coding for HBBMs in his application.
  17. 17. Prior Art • Maniatis described a method of isolating DNAs or cDNAs by screening a DNA or cDNA library with a gene probe. The reference outlined a general technique for cloning a gene but did not describe how to isolate a particular DNA or cDNA molecule.
  18. 18. Recent Developments • KSR Vs. Teleflex • In re Kubin
  19. 19. Specification • Written Description • Enablement • Best Mode • Claims • Object: Notice and Dissemination
  20. 20. Example • A stent coated with taxol for "treating or preventing recurrent stenosis. • Prior ArtStents Existing • Taxol known for Tumor treatment by angiogenesis • Article - Re-stenosis dangers and need for a treatment - suggests various options
  21. 21. Have a nice day For more information: www.bananaip.com www.bananaip.com/sinapse-blog Email: contact@bananaip.com

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