The Supreme Court could issue its decision in the Amgen v. Sandoz biosimilar patent dance case any day now. Last week I participated in a panel discussion with industry stakeholders considering how the decision might–or might not–impact originator and biosimilar developers.
The Next Drugs:
An Atlantic Policy Update on Biosimilars
The program was put together by The Altantic, underwritten by The Biosimilars Council, and filmed before a live audience at The Newseum. My co-panelists were Bruce Artim, Senior Director, Federal Government Affairs, at Eli Lilly and Company, and Phil Nickson, Associate General Counsel for IP at Momenta Pharmaceuticals. Olga Khazan, Staff Writer for The Atlantic, was our moderator.
You can watch the full session here:
I kicked off our panel with a summary of the issues before the Court, and an explanation of how they could impact stakeholders and the public.
Teeing off my observation that many biosimilar applicants are opting to participate in the patent dance, Phil Nickson expressed his views that the biosimilar patent dance should be optional. He explained that having the option to participate permits the biosimilar applicant to select a patent dispute resolution process that is best suited to the specific product/patent landscape at issue.
Bruce Artim responded that the BPCIA was negotiated with the understanding that the patent dance would be mandatory. He shared his recollections on the legislative process, and explained that the provisions were enacted without the usual level of review, so that the Court should give more consideration to the legislative history than it otherwise might. Interestingly, while Mr. Artim felt strongly that originator patent rights should be respected in the biosimilar approval process, he emphasized that Inter Partes Review proceedings–and the ability to invalidate a granted patent based on mere preponderance of the evidence–is a bigger issue facing innovator companies.
Read More About The Biosimilar Patent Dance Dispute
These articles discuss previous proceedings in Amgen v. Sandoz and explain the biosimilar patent dance issues in more detail:
- The district court decision in Amgen v. Sandoz
- The Federal Circuit decision in Amgen v. Sandoz
- The Sandoz petition for certiorari
- The Amgen opposition and conditional cross-petition for certiorari
- The Solicitor General’s amicus brief
- The Supreme Court oral arguments