Terry Mahn Quoted in Biosimilar Development Article, "Amgen Vs. Sandoz: Who Will Win Over The Supreme Court?"

Terry Mahn (Principal) was quoted in Biosimilar Development article, "Amgen Vs. Sandoz: Who Will Win Over The Supreme Court?” on April 26, 2017.

What are your predictions for the Supreme Court case Amgen vs. Sandoz? Who do you expect will win, and why?

Terry Mahn, Fish & Richardson: We think the Supreme Court will uphold the U.S. Court of Appeals for the Federal Circuit (CAFC) ruling that the BPCIA patent dance is optional, and will clarify that the 180-day notice of commercial marketing must come after FDA acceptance of the abbreviated biologics license application (aBLA) for review but prior to formal aBLA approval.

We believe that the BPCIA statute is clear on the patent dance being optional, and that a "balanced" reading of the statute would require commercial notice to come after the aBLA is ready for formal FDA review, but prior to formal approval. Requiring notice after approval would give the pioneer innovator an additional six months of exclusivity, which is very hard to read into the intent of the statute.

Based off of your prediction, how do you expect this will impact the biosimilar market moving forward?

Mahn: The market is dealing right now with the U.S. Court of Appeals for the Federal Circuit (CAFC) holding on the patent dance being optional, and several courts have ruled that the notice of commercial marketing is not optional. A Supreme Court ruling that notice of commercial marketing can precede formal approval will speed the second wave of litigation up by six months, but the impacts on the market will be small in cases where entry will nonetheless be blocked or delayed by patent litigation.

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