Supreme Court Weighs Biosimilar Patent Dance

Regulatory NewsRegulatory News | 26 April 2017 |  By 

All nine justices of the US Supreme Court gathered Wednesday to hear oral arguments from the lawyers of Novartis subsidiary Sandoz and Amgen, who took sides on what's known as the biosimilar "patent dance," and whether a notice of licensure 180 days prior to marketing is necessary.

Neither side seemed to come away with a decisive win. Sandoz began the arguments on why the additional six months would further delay biosimilars from launching, also explaining why the "patent dance," which involves providing a biosimilar application to a reference product sponsor, is optional.

"The Biosimilars Act created a comprehensive and self-contained scheme for the early resolution of patent disputes. Regardless of the actions an applicant or sponsor take along the way, the end result is the same: patent litigation. Courts should apply that comprehensive scheme as written. They shouldn't look elsewhere for consequences," Sandoz's Deanne Maynard told the justices.

Associate Justice Sonia Sotomayor quizzed Maynard on the length of time it takes to win US Food and Drug Administration (FDA) approval, and whether or not FDA can announce its intent to approve a biosimilar as it can with tentative approvals for generic drugs.

Associate Justice Anthony Kennedy noted that the 180-day notice period "has to start from somewhere," while Associate Justice Stephen Breyer said he would like a better explanation from FDA on how to define what the term "notice" means.

"I would find an explanation far more convincing as a layperson, if, in fact, there had been notice and comment proceedings before an expert agency, which, in fact, having heard all the different views on what that word 'notice' means," Breyer said.

But Sandoz's Maynard said she doesn't "believe FDA would have -- or the patent office has rule-making authority to interpret these provisions."

Associate Justice Anthony Kennedy said he believes it would be within FDA's authority to interpret the Biologics Price Competition and Innovation Act, which created the biosimilar approval pathway, "or it would be a sensible thing for it to say -- and they have a regulation -- if you don't do that and we've told you to do that, we're going to delay the review process."

Chief Justice John Roberts also questioned how the reference product sponsor would know the specifics of a biosimilar application without the biosimilar applicant going through the patent dance and providing the application. "You're suing saying, this thing infringes our patent. We don't even know what 'this thing' is." 

Seth Waxman, Amgen’s lawyer, followed Anthony Wang, assistant to the solicitor general of the Department of Justice, and made distinctions between biosimilars and generic drugs, noting the complexity of the manufacturing of biosimilars and the length of time it takes FDA to inspect such facilities.

"Until FDA decides what the biosimilar will be and authorizes it for specific therapeutic uses," and evaluates its manufacturing process, "you can’t give notice of anything," Waxman said.

Newly confirmed Associate Justice Neil Gorsuch and Sotomayor also both centered around "what the remedy is."

Waxman said: "The remedy question is who -- who, if anybody, can do anything about it, if you don't comply with 'shall,' right?"

But Sotomayor countered: "It's not quite that. 'Shall' is if you want to invoke this federal process, this is what you have to do."

Breyer later offered that if "shall means shall" (ie. That a biosimilar company "shall" provide its application to the reference product sponsor as part of the patent dance) stopping himself to note that the exchange of patent information prior to approval isn’t "the only remedy."

"'Shall' means 'shall.' Okay? But let's stop there because, first, the federal part, which you just read, doesn't say that's the only remedy or that there are others," Breyer told Waxman. "But even if it did, we wouldn't know whether California law picked up just the substantive part, or the substantive plus the remedy. And even if we knew that, we wouldn't know whether some other state would be free to pick up in their own state law 'shall,' but not exclusivity as to remedy."

Roberts also noted: "In terms of the preemption question, it seems to me that it's very hard to give a comprehensive answer to the questions presented without considering whether, well, thanks for your opinion on what federal law does, but, in fact, state law, you can get the same injunction. It's really asking us to put together a puzzle where a big piece is missing."

But Yang said he does not think state law "is a piece of the puzzle. Congress does not have the habit of enacting comprehensive statutes and then allowing states to fill it."

Nearing the end of the hour and ten minutes, which the Big Molecule Watch Blog noted was a rare extension of time, Sandoz’s Maynard explained that Congress explicitly negotiated over the 12 years of exclusivity provided to biologics and that it should not be extended "in a bizarre way" with the 180-day notice occuring after approval.



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