Now that the U.S. solicitor general has been invited to share its views regarding Amgen v. Sandoz, the biosimilars market must wait even longer to learn if the Federal Circuit’s decision will be reviewed by the U.S. Supreme Court. At stake is the interpretation of two key provisions of the Biologics Price Competition and Innovation Act (BPCIA), the statute establishing an abbreviated regulatory pathway for biosimilar approval. Fenwick litigator Ewa Davison, Ph.D. spoke with Scrip about the case.
Dr. Davison observed that despite the delay, "both sides may take some comfort from the fact that the Supreme Court seems to be taking the case seriously," and did not simply deny the parties’ petitions for certiorari. Sandoz has challenged the Federal Circuit’s finding that a biosimilar applicant must wait for FDA approval of its product before providing the required 180-day notice of intent to market. Amgen, in turn, has conditionally challenged the Federal Circuit’s finding that a biosimilar applicant need not provide its application and manufacturing information as part of the so-called “patent dance” intended to channel patent disputes with the biologic competitor.
Although Amgen v. Sandoz is the first appellate decision to interpret the BPCIA, Dr. Davison also noted that similar issues have subsequently arisen in biosimilar cases currently making their way through various district courts. The Federal Circuit has since also issued a decision in Amgen v. Apotex, its second BPCIA case.
The full article is available through the Scrip website (subscription required). Additional analysis by Dr. Davison and her colleagues of the Federal Circuit’s Amgen v. Apotex decision, and its implications for whether the Supreme Court will hear Amgen v. Sandoz, can be found here.