SCOTUS in Focus: Amgen v. Sanofi and the Future of Pharma Patents

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We’re leading off Season 3 with a close look at a Supreme Court patent case that could have profound impacts on the invention enablement problems we covered heavily in Season 2. SCOTUS is set to hear opening arguments in Amgen v. Sanofi on March 27th. For the first time in over 75 years, the Supreme Court is evaluating the meaning and scope of the enablement requirement. For those who’ve been following along, you’ll know that this has become one of the bigger issues plaguing patenting and especially so in the life sciences.
Dr. Ashley Sloat, President and Director of Patent Strategy at Aurora, leads our discussion today along with our all star patent panel, exploring the scientific background around antibodies necessary to understand the claims, a brief case history of Amgen v. Sanofi, an overview of the enablement factors and tests that have been historically applied in courts and how they might apply to this case, and a discussion around open questions and the potential unintended consequences of the Supreme Court only taking up one-half of the two-sided enablement coin. This ends up being a really great, spirited conversation with panel members coming down strongly on both sides of the case with very compelling arguments – really highlighting the complexities and fundamental issues the court will have to face.
Ashley is joined today by our always exceptional group of IP experts including:
⦿ David Cohen, Principal at Cohen Sciences
⦿ Kristen Hansen, Patent Strategist at Aurora
⦿ David Jackrel, President of Jackrel Consulting
⦿ Ty Davis, Patent Strategy Associate at Aurora
** Aurora is Hiring! **
Join us in the trenches and on this podcast! Aurora is looking for a part-time Biomedical Sciences Patent Agent to help with patent portfolio management, application drafting, prosecution, and strategy. This is a salaried, fully remote position with a flexible work week and benefits. Work where you want, when you want, with a great team, on engaging subject matter, and even get the opportunity to be heard on this Podcast and featured on IPWatchdog! Learn more and apply at https://www.aurorapatents.com/careers.html.
** Resources **
⦿ Show Notes: https://www.aurorapatents.com/blog/scotus-in-focus-amgen-v-sanofi
⦿ Slides: https://www.aurorapatents.com/uploads/9/8/1/1/98119826/amgenvsanofi.pdf
⦿ Apply: https://www.aurorapatents.com/careers.html
** Follow Aurora Consulting **
⦿ Home: https://www.aurorapatents.com/
⦿ Twitter: https://twitter.com/AuroraPatents
⦿ LinkedIn: https://www.linkedin.com/company/aurora-cg/
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⦿ Instagram: https://www.instagram.com/aurorapatents/

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

فصل ها

1. Intro (00:00:00)

2. Panel survival skills icebreaker (00:11:48)

3. Strategy tidbits: Inclusion of embodiments section (00:15:27)

4. Strategy tidbits: Slowing prosecution with suspension of action (00:21:12)

5. 35 USC 112(a): Written Description and Enablement (00:23:28)

6. Discussion outline (00:25:45)

7. In re Wands (00:26:36)

8. Antibody basics (00:27:00)

9. Antibody design (00:34:10)

10. In re Wands case history (00:36:42)

11. Wands Factors - enablement test (00:38:54)

12. Written description tests (00:39:12)

13. Purpose of Amgen patents (00:40:07)

14. Amgen v. Sanofi case history (00:42:20)

15. Amgen claims analysis (00:44:20)

16. Amgen Wands Factors analysis (01:02:59)

17. Amgen Written Description Test analysis (01:07:19)

18. Separating enablement from written description (01:08:58)

19. Panel questions (01:12:19)

20. MPEP standard mismatch (01:22:30)

21. Outro (01:24:39)