Fortifying Life Science Patents: Eligibility and Enablement

​​Patently Strategic - Patent Strategy for Startups

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The life sciences are currently facing at least two major plagues in our patent world. The first is that many life science innovations have been deemed ineligible in terms of patentable subject matter. In other words, the courts and the patent office believe that the patent laws are not meant to protect these innovations. The second plague is that the courts believe that many life sciences patents are not enabled. In other words, they are not described in sufficient detail to enable one of skill in the art to make and use the invention.
These subject matter eligibility and enablement plagues manifest in dreaded Section 101 and 112 rejections. In this month’s episode, Dr. Ashley Sloat, President and Director of Patent Strategy at Aurora, leads a discussion, along with our all star patent panel, delving deeply into these rejections and, in the interest of avoiding a podcast 101 rejection, provides some very practical application tips that will help to fortify your life science patent applications.
Ashley is also joined today by our always exceptional group of IP experts including:
⦿ Kristen Hansen, Patent Strategist at Aurora
⦿ Daniel Wright, Patent Strategist
⦿ David Jackrel, President of Jackrel Consulting
⦿ Shelley Couturier, Patent Strategist and Search Specialist
⦿ David Cohen, Principal at Cohen Sciences
⦿ Amy Fiene, Patent attorney at Vancott and adjunct professor at BYU
⦿ Steve Stupp, Partner at Stupp Associates, LLC.
** Resources **
⦿ Show Notes
⦿ Slides
⦿ The Death of the Genus Claim
⦿ Final office action rejection frequency for life science patents
⦿ Examiner statistics (not an endorsement)

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And as always, thanks for listening!
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Note: The contents of this podcast do not constitute legal advice.

Chapitres

1. Intro (00:00:00)

2. Sections 101 and 112 explained (00:02:45)

3. Genus ad Species defined (00:06:10)

4. Wands Factors defined (00:09:04)

5. Estoppel defined (00:09:35)

6. RISE winners announcement (00:10:24)

7. First Plague: Section 101 (00:13:00)

8. Subject matter eligibility guidance (00:16:38)

9. Second Plague: Section 112 (00:17:43)

10. Section 101 meets life sciences (00:27:34)

11. MOT Claims: active treatment step (00:28:07)

12. Case Law: Vanda Pharmaceuticals v. West-Ward Pharmaceuticals (00:28:43)

13. Case Law: Endo Pharmaceuticals Inc. v. Teva Pharms USA, Inc. (00:29:29)

14. Case Law: Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC (00:30:04)

15. Natural Product Claims (00:30:52)

16. Case Law: Roche Molecular Systems, Inc. v. Cepheid (00:31:19)

17. Case Law: Natural Alternatives v. Creative Compounds (00:32:48)

18. Drafting tricks to avoid (00:41:16)

19. Drafting Solutions (00:42:07)

20. The Other Part of 101 - Specific, Substantial, and Credible (00:44:28)

21. The USPTO is not the FDA (00:49:33)

22. Examples where utility failed (00:55:55)

23. Outro (01:08:37)