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 Atlantic, 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:

This blog is made available by Foley & Lardner LLP (“Foley” or “the Firm”) for informational purposes only. It is not meant to convey the Firm’s legal position on behalf of any client, nor is it intended to convey specific legal advice. Any opinions expressed in this article do not necessarily reflect the views of Foley & Lardner LLP, its partners, or its clients. Accordingly, do not act upon this information without seeking counsel from a licensed attorney. This blog is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Communicating with Foley through this website by email, blog post, or otherwise, does not create an attorney-client relationship for any legal matter. Therefore, any communication or material you transmit to Foley through this blog, whether by email, blog post or any other manner, will not be treated as confidential or proprietary. The information on this blog is published “AS IS” and is not guaranteed to be complete, accurate, and or up-to-date. Foley makes no representations or warranties of any kind, express or implied, as to the operation or content of the site. Foley expressly disclaims all other guarantees, warranties, conditions and representations of any kind, either express or implied, whether arising under any statute, law, commercial use or otherwise, including implied warranties of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Foley or any of its partners, officers, employees, agents or affiliates be liable, directly or indirectly, under any theory of law (contract, tort, negligence or otherwise), to you or anyone else, for any claims, losses or damages, direct, indirect special, incidental, punitive or consequential, resulting from or occasioned by the creation, use of or reliance on this site (including information and other content) or any third party websites or the information, resources or material accessed through any such websites. In some jurisdictions, the contents of this blog may be considered Attorney Advertising. If applicable, please note that prior results do not guarantee a similar outcome. Photographs are for dramatization purposes only and may include models. Likenesses do not necessarily imply current client, partnership or employee status.