May 14, 2021
Terry Mahn Quoted in Biosimilar Development Article, "The Rules Of Engagement For Biosimilar Legal Battles"
Terry Mahn (Principal) was quoted in Biosimilar Development article, "The Rules Of Engagement For Biosimilar Legal Battles?" on May 10, 2017.
Are there any particular litigation strategies or patterns emerging in the biosimilar industry that have you particularly concerned? Why are they concerning?
Terry Mahn, Fish & Richardson: While there have only been a limited number of Biologics Price Competition and Innovation Act (BPCIA) litigations to date, it is notable that some biosimilar participants are choosing to dance, but for only half the song. In other words, biosimilar applicants begin the patent dance procedures but waive subsequent steps in the dance. For example, in the Immunex v. Sandoz dispute involving a biosimilar of Enbrel, Sandoz waived its right to receive a statement by Immunex pursuant to 42 USC 262(l)(3)(C) and declared negotiations pursuant to 262(l)(4) and (5) regarding the list of patents to be litigated were unnecessary. Sandoz then insisted Immunex file suit within 30 days. Sandoz behaved similarly in its litigation with Amgen involving its biosimilar of Neulasta.
The ability of a party to waive steps of the dance appears to be an attempt to speed up the patent dance process. Regardless of whether or not the Supreme Court finds the patent dance optional or not, it remains unclear how much compliance with the dance provisions is sufficient.
Is there anything biosimilar companies can do to ensure they adequately approach these legal challenges?
Mahn: Work with counsel in advance to determine your strategy going forward, which should take into consideration:
- Which side of the fence will you be on? If you envision working as a biologics manufacturer one day, your approach may be different. Arguments made from the point of view of an abbreviated biologics license application (aBLA) applicant may be used against you when you are in the position of a BLA holder.
- Understand how communications from your company regulatory, Securities & Exchange Commission (SEC) filings, etc. may clue in biologics manufacturers to the status of your aBLA, triggering lawsuits. For example, a biosimilar applicant may have a duty to inform its shareholders when it files aBLA applications and/or when the FDA accepts such filings for review, which would be a public disclosure. Any other press releases or announcements by the company could also provide information regarding the aBLA.
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