Updates
June 2017
Supreme Court’s Patent Dance Decision: Victories & Uncertainties

The U.S. Supreme Court’s recent ruling in a landmark biosimilars case represents two victories for biosimilar applicants. 1) The conclusion that the information-sharing requirements of Section 262(l)(1)-(2) are effectively optional, at least under federal law, is an advantage for biosimilar applicants because it provides additional strategic options under the BPCIA. And 2) The Supreme Court’s holding that a biosimilar applicant may provide effective 180-day notice of commercial marketing before FDA licensure is also a win for biosimilar applicants.

While this landmark Supreme Court decision in Amgen v. Sandoz is an overall positive development for biosimilar applicants, it should not be viewed as final or conclusive, since the question of whether state law may provide an equitable remedy for the RPS to compel sharing of information has yet to be decided by the Federal Circuit.

In view of the Supreme Court’s decision, biosimilar applicants should:
  • Consider filing the 180-day notice of commercial marketing at the earliest possible opportunity and at least 180 days prior to the end of the RPS exclusivity period, to reduce or eliminate lag to market. Until the Federal Circuit further weighs in, consider newly available strategic options for participating in all, part, or none of the patent dance. 
  • Similarly, RPS companies should prepare diligently for the possibility of a biosimilar application by developing a robust patent portfolio, and watching for opportunities to license-in patents that complement the portfolio.

To view the full e-alert, click here.

To learn more about Polsinelli's Biosimilars practice, click here.