Expectations for the Supreme Court’s Biosimilar Decision Have Changed


The Supreme Court’s biosimilar ruling may not provide clarity after all, attorneys say.

I’ve covered the dispute between Amgen and Sandoz over interpretations of the biosimilar statute since the litigation was first filed through oral argument. The ruling by the U.S. Court of Appeals for the Federal Circuit, which the Supreme Court is reviewing, was about as fractured as you could get. Some said that, if there was ever a case for which the Supreme Court would make things clearer, this was it because the high court couldn’t make interpretation of the statute more uncertain than the Federal Circuit had.

The Biologics Price Competition and Innovation Act (BPCIA), provides an abbreviated approval pathway for biosimilars to get these highly similar and less expensive versions of biologic drugs on the market as quickly as possible. It creates obligations for both the biosimilar applicant and the owner of the original biologic drug.

In the Federal Circuit’s rulings by a three-judge panel, Judge Pauline Newman dissented in part, disagreeing with the majority's interpretation that the BPCIA’s exchange of manufacturing and patent information between the biosimilar applicant and the patent owner of the original biologic is optional. Judge Raymond T. Chen also dissented in part, disagreeing with the majority’s ruling that the BPCIA’s 180 days' notice the biosimilar applicant must give the biologic patent owner of the planned release of the biosimilar to market can’t start until the Food and Drug Administration approves the biosimilar. So, the vote was split, and there was a split within the split.

When the Supreme Court agreed to review the Federal Circuit’s decision, analysts predicted that the court would surely make it clear what Congress meant when it created the BPCIA. But during oral arguments April 26, expectations changed. In their questions, some of the justices seemed uncertain about the science behind biosimilars and appeared to want to send the case to the FDA for the agency to provide the needed clarification.

In my story on the oral arguments, which you can read here, I quoted Charles Steenburg, a shareholder at the intellectual property law firm of Wolf, Greenfield & Sacks, P.C., Boston, who suggested the court could “conclude that Sandoz’s petition concerning the 180-day notice provision is moot because Sandoz has now already launched its product” and that Amgen’s cross-petition on the information exchange could similarly be dismissed.

A few days later in the SCOTUSblog, John Duffy reached a similar conclusion: “There is, I believe, a real chance that the court might decline to rule on some or even all of the issues presented in these consolidated cases. You read that correctly: The justices may not decide any of the issues but instead might dismiss as improvidently granted the petitions for certiorari in the case (a so-called ‘DIG’ of the petitions).”

It’s all speculation now. The court could still reach a firm conclusion that provides clarity. But the expectation mood has definitely changed. The court will likely reach its decision before the end of June, and Bloomberg BNA will cover it.

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