In landmark Amgen v. Sandoz ruling, biosim makers can give notice before FDA nod

Biosim makers scored a big win on Monday as the Supreme Court ruled with Sandoz in a much-watched legal dispute with Amgen.

Biosim makers scored a big win Monday as the Supreme Court ruled with Sandoz in a much-watched legal dispute against Amgen. The landmark decision, set to leave a distinct mark on the budding field, allows biosim makers to give marketing notice before FDA approval, meaning their products can launch faster.

Amgen and Novartis’ Sandoz made their arguments in the case back in April. During the arguments, Amgen’s attorneys maintained that the notice to market a biosim can’t happen until FDA approval because the exact indications and other details wouldn’t be known until that point.

Sandoz, plus other biosim developers and organizations through amicus briefs, argued that such an interpretation would mean an extra six-month “exclusivity windfall” that Congress didn’t intend to create with the BPCIA. The marketing notice starts the clock ticking on a 180-day waiting period ahead of a biosim launch.

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After the arguments, several IP experts believed Amgen held an edge based on the questioning.

But in their opinion Monday, the justices said Amgen’s “arguments are unpersuasive, and its various policy arguments cannot overcome the statute’s plain language.”

Further, the Supreme Court ruled that violations of a portion of the Biologics Price Competition and Innovation Act that require biosim developers to disclose their full applications to branded drugmakers, dubbed the “patent dance,” aren’t enforceable by injunction at the federal level, according to the Monday opinion.

In a statement, Novartis global media relations head Eric Althoff said the “unanimous ruling on the notice of commercial marketing will help expedite patient access to life-enhancing treatments.”

“We also appreciate the clarity provided on the patent dance, which will help the biosimilars industry move forward,” Althoff said.

Reacting to Monday's news, McDonnell Boehnen Hulbert & Berghoff partner Kevin Noonan told FiercePharma the court ruled in a way that will allow branded drugmakers and their lobby to ask Congress to adjust the BPCIA. As lawmakers work through the Obamacare overhaul, Noonan said, they could tweak portions of the BPCIA and revisit these questions affecting biosim launches.

“I think the court felt that these were issues that they could interpret, because it’s statutory interpretation; that’s their job.”

But, Noonan said, the court “reminded people that the real place for this to be worked out is in Congress.”

RELATED: As Supreme Court steps into tangled biosimilars law, IP experts weigh in

The Supreme Court took on the case after a Federal Circuit court ruled with Amgen on one issue and with Sandoz on another. In a 2015 decision, the appeals panel ruled that Sandoz was required to share its abbreviated biologics license application (aBLA), and could provide marketing notice only after its biosim won FDA approval. Still, that decision described the statute a “riddle wrapped in a mystery inside an enigma.”

Sandoz eventually waited out the six-month delay and launched its biosim of Amgen’s Neupogen back in 2015 after a legal war. The company asked the Supreme Court to weigh in on the issue last year in an effort to win reprieve for future biosim launches.

Shortly after the opinion went live, Express Scripts released a statement saying the decision “should help expand access and lower prescription drug costs for employers, health plans, labor unions, and Medicare.”