Significant U.S. cases in 2010

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Presented at the Canadian Institute's 9th Annual Forum on Pharma Patents

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Significant U.S. cases in 2010

  1. 1. Significant U.S. Cases in 2010 Brian R. Dorn, Ph.D. November 4, 2010
  2. 2. Cases 1. Bilski v. Kappos 2. Ariad v. Eli Lilly & Co. 3. ACLU v. USPTO (“Myriad”) 4. Daiichi Sankyo Co., Ltd. v. Matrix Labs., Ltd.
  3. 3. Bilski v. Kappos 561 U.S. ___ (2010) • Machine or Transformation (MoT) test is a good test but not the only test • A claimed process is patentable under 35 U.S.C. § 101 if (a) the process is tied to a particular machine or apparatus, or (b) the process transforms a particular article into a different state or thing
  4. 4. Bilski • Not patentable subject matters – Abstract ideas – Natural phenomenon – Laws of Nature • Involvement of the machine or transformation must not be insignificant, extra-solution activity, such as gathering data (CAFC)
  5. 5. Bilski • MoT test may not apply to “advanced diagnostic medicine [sic] techniques” being part of the “information age” • To be further elucidated in Prometheus and Classen
  6. 6. Prometheus Patentable Transformation (CAFC): 1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising: (a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and (b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
  7. 7. Classen Not patentable subject matter (CAFC): 1. A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals, which comprises immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens, according to said immunization schedule, and comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.
  8. 8. Assoc. Mol. Pathol. v. USPTO 702 F.Supp.2d 181 (SDNY, 2010) • The “Myriad Case” • Potential seismic shift in the biotech industry • Decision granting Plaintiffs’ motion on Summary Judgment that the claims to isolated DNA sequences coding for BRCA1/BRCA2 polypeptides are invalid because the subject matter of the claims is not patentable subject matter because the claims cover natural products or abstract mental processes
  9. 9. The Myriad Case ‘282 & ‘492 patents • Claim 1: An isolated DNA molecule coding for the [BRCA1/BRCA2] polypeptide, said DNA molecule comprising a nucleic acid sequence encoding the amino acid sequence set forth in SEQ ID NO:2 • SEQ ID NO:2 is the BRCA1/BRCA2 polypeptide
  10. 10. The Myriad Case • Markedly Different Test— derived from Chakrabarty • Does purification/isolation of a natural product render the product patentable? • Is isolated DNA markedly different than DNA found in nature?
  11. 11. The Myriad Case • Judge Sweet characterizes DNA as “physical embodiment of information”; ignores physical/chemical differences • Finds that “none of the structural and functional differences…render the claimed DNA markedly different”
  12. 12. Ariad Pharm., Inc. v. Eli Lilly & Co. (Fed. Cir. 2010) (en banc) • Reaffirmed that the Written Description requirement is separate from the enablement requirement • Also reaffirmed the “possession” standard
  13. 13. Ariad • Constructive RTP that ID’s claimed subject matter is sufficient; Actual RTP is not necessary • Sufficient examples demonstrating common features to members of the genus
  14. 14. Daiichi Sankyo Co. v. Matrix Labs. Ltd. Fed. Cir. 2010 CAFC affirmed that olmesartan medoxomil (Benicar® ) is not obvious over lead compounds such as losartan
  15. 15. Daiichi Sankyo v. Matrix
  16. 16. Lead Compound • Known prior art compound • Closest prior art compound • Most structurally similar prior art compound • Most active prior art compound • Most promising prior art compound to modify • Most preferred prior art compound
  17. 17. Daiichi Sankyo v. Matrix Proof of obviousness based on structural similarity requires clear and convincing evidence that a medicinal chemist of ordinary skill would have been motivated to select and then to modify a prior art compound (e.g., a lead compound) to arrive at a claimed compound would have similar or improved properties compared with the old.”
  18. 18. Daiichi Sankyo v. Matrix “proving a reason to select a compound as a lead compound depends on more than just structural similarity, but also knowledge in the art of the functional properties and limitations of the prior art compounds. Potent and promising activity in the prior art trumps mere structural relationships.”
  19. 19. Daiichi Sankyo v. Matrix “While the lead compound analysis must, in keeping with KSR, not rigidly focus on the selection of a single, best lead compound, the analysis still requires the challenger to demonstrate by clear and convincing evidence that one of ordinary skill in the art would have had a reason to select a proposed lead compound or compounds over other compounds in the prior art.”
  20. 20. Thank you! Feel free to contact me at bdorn@merchantgould.com www.twitter.com/biotechpatent www.linkedin.com/in/briandornphd

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