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Claire Laporte, "Health IP"

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December 12, 2017

The Sixth Annual Health Law Year in P/Review symposium featured leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event covered hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

For more information, visit our website at: http://petrieflom.law.harvard.edu/events/details/sixth-annual-health-law-year-in-p-review

Published in: Health & Medicine
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Claire Laporte, "Health IP"

  1. 1. Life Sciences IP 2017 … and 2018 in Preview Claire Laporte December 12, 2017
  2. 2. © 2017 Foley Hoag LLP. All Rights Reserved. 1 Agenda Biosimilars Written description
  3. 3. © 2017 Foley Hoag LLP. All Rights Reserved. 2 Biologics Price Competition & Innovation Act (BPCIA) Generic equivalents of biologic drugs For small molecules, Hatch-Waxman Act provides an abbreviated approval pathway Until BPCIA, there was no abbreviated pathway for biologics
  4. 4. © 2017 Foley Hoag LLP. All Rights Reserved. 3 Biologics Complex biomolecules such as antibodies Manufactured in genetically modified living cells High price, high profit Costly to develop
  5. 5. © 2017 Foley Hoag LLP. All Rights Reserved. 4 BPCIA Establishes Biosimilars Pathway Biosimilar applicant must establish that its drug is “biosimilar” to a “reference product” based on analytical, animal, and clinical studies. FDA cannot approve a biosimilar under the BPCIA pathway until 12 years after it licenses the reference product.  But a biosimilar applicant can obtain a new biologics license. 8 biosimilars are now approved  But most are not yet on the market because of patent litigation.
  6. 6. © 2017 Foley Hoag LLP. All Rights Reserved. 5 And Now, the IP Dimension … Statute sets up a “patent dance” to define scope of patent litigation:
  7. 7. © 2017 Foley Hoag LLP. All Rights Reserved. 6 Patent Dance But when it was time for Sandoz to put on its dancing shoes … Sandoz did not want to dance. But it did want to go to the Supreme Court.
  8. 8. © 2017 Foley Hoag LLP. All Rights Reserved. 7 Patent Dance? Sandoz (and others) asserted that patent dance is OPTIONAL. What do you think?  BPCIA (42 U.S.C. §262(l)(2)(A)): Biosimilar applicant “shall provide to the reference product sponsor a copy of the application … and such other information that describes the process or processes used to manufacture the biological product.”  But BPCIA (§262(l)(9)(C)): “If a [biosimilar] applicant fails to [initiate the patent dance], the reference product sponsor, … may bring an action … for a declaration of infringement, validity, or enforceability of any patent that claims the biological product or a use of the biological product.”
  9. 9. © 2017 Foley Hoag LLP. All Rights Reserved. 8 The Supreme Court Decides Supreme Court in Amgen, Sandoz cases:  Requirement to participate in the patent dance is not enforceable by injunction.
  10. 10. © 2017 Foley Hoag LLP. All Rights Reserved. 9 And There’s More Reference product gets 12 years of exclusivity…. BUT: BPCIA (l)(8)(A): “The [biosimilar] applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).” Amgen argued that the biosimilar could only “provide notice” after the FDA licensed its product. Amgen lost on this point too.
  11. 11. © 2017 Foley Hoag LLP. All Rights Reserved. 10 What Lies Ahead in 2018 and Beyond Will any applicants join in the patent dance? How will political pressure for cheaper drugs affect doctrines of patent litigation? How will approval of biosimilars affect pricing models? Will biosimilars obtain “interchangeable” status?
  12. 12. © 2017 Foley Hoag LLP. All Rights Reserved. 11 Agenda Biosimilars Written description
  13. 13. © 2017 Foley Hoag LLP. All Rights Reserved. 12 The Antibody Problem Most biologics are engineered antibodies An antibody “binds” to its “target,” an “antigen.” Once target is determined, antibodies are made by:  Using genetically engineered mice  “Immunizing” the mice with the target antigen  Screening resulting antibodies for Strong binding Inhibition of target
  14. 14. © 2017 Foley Hoag LLP. All Rights Reserved. 13 Target-Based Research Research focus has been on targets Construction of antibodies to targets has been routine Patent Office training materials recognized that applicants would obtain patents covering a genus of all antibodies to a particular target Many Federal Circuit cases did too.
  15. 15. © 2017 Foley Hoag LLP. All Rights Reserved. 14 The Antibody Problem: AbbVie v. Janssen AbbVie v. Janssen (2014):  Invalidated AbbVie antibody patent covering all human antibodies that bound to human IL-12 at or above a particular affinity Basis for invalidation: written description requirement means that one must have a specific, structural description of one’s invention. Nobody noticed.
  16. 16. © 2017 Foley Hoag LLP. All Rights Reserved. 15 Battle Over PCSK9 Antibodies Blocking enzyme PCSK9 can lower LDL (“bad” cholesterol) Amgen developed evolocumab (Repatha®) Sanofi/Regeneron developed alirocumab (Praluent®) Amgen had obtained a broad patent covering antibodies to PCSK9. And then it got a preliminary injunction against Praluent. People noticed!
  17. 17. © 2017 Foley Hoag LLP. All Rights Reserved. 16 Federal Circuit Doubles Down: Amgen v. Sanofi Federal Circuit reverses and vacates preliminary injunction. Federal Circuit distinguishes its prior cases validating the target-based approach: they’re all dicta! Fully characterizing a target does not give you any rights to anti-target antibodies. No more broad antibody patents Difficulty of protecting new antibodies without genus claims
  18. 18. © 2017 Foley Hoag LLP. All Rights Reserved. 17 Questions?
  19. 19. Life Sciences IP 2017 … and 2018 in Preview Claire Laporte December 12, 2017

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