Supreme Court Oral Argument in Sandoz v. Amgen

Amgen v. Sandoz (filgrastim)  •  Approved Biosimilar Products  •  Biologics Litigation  •  Biosimilar News  •  BPCIA and Related U.S. Statutes  •  Patent Dance  •  U.S. Biosimilar Litigation News  •  U.S. Federal Circuit Decisions

The Supreme Court held a 70-minute oral argument in Sandoz v. Amgen this morning. Before beginning the argument, the Chief Justice announced that the Court would give each side five extra minutes–a highly unusual step reflecting the case’s complexity.

It was difficult to forecast the outcome because several members of the Court asked few or no questions (Justices Thomas and Alito were silent).

Both sides received skeptical questioning on a number of points, although Amgen’s counsel seemed to receive significantly fewer questions overall.

On the 180-day issue, questioning focused on two points: whether it is possible for a reference product sponsor (“RPS”) to craft a complaint in good faith before FDA makes a final licensure decision, and whether FDA could come up with a kind of tentative licensure (like tentative approval under Hatch-Waxman)  that would be given during the 12-year exclusivity and would allow notice of commercial marketing even under Amgen’s reading.

On the question whether the patent dance is mandatory, several Justices focused questioning on whether–even if “shall” means “shall”–a federal system this complex could be supplemented with an injunctive remedy under California state law, or maybe all fifty states’ laws.

The Court will now deliberate privately and issue a written opinion.  That decision will be issued by the end of June.  The Court does not announce in advance on what day it will decide a particular case, but it will hand down opinions at 10am on most Mondays between now and the end of June, plus a few additional dates in June that have not yet been announced.

A follow-up post will include specific questions and answers from today’s arguments.

Stay tuned to the Big Molecule Watch for coverage and analysis.

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