Will SCOTUS take up Sandoz' pivotal biosim case? New briefs call on court to weigh in

Biosimilars advocates are lining up behind Sandoz to persuade the U.S. Supreme Court to take up its case against Amgen ($AMGN). The closely watched legal tussle, over Sandoz's biosim copy Amgen's blockbuster Neupogen, could define the timeline for biosimilars' paths to market.

At particular issue is a provision of the Biologics Price Competition and Innovation Act (BPCIA) requiring a biosim maker to notify the original drug company of its plans to launch the copycat drug. The law requires 6 months' advance warning.

Amgen says--and the U.S. Court of Appeals for the Federal Circuit agreed last year--that the clock starts when the biosim product gets FDA approval. Sandoz had to wait out a 180-day injunction before launching Zarxio, its Neupogen biosim, last year.

Sandoz, a Novartis ($NVS) unit focused on generics and biosims, disagrees. That interpretation of the law would give branded drugmakers an extra six months of exclusivity on the market, Sandoz says. The legal argument is more subtle, but in essence, the Sandoz position is that Congress didn't intend to grant 6 months' additional exclusivity when it passed the BPCIA legislation.

The two sides are also fighting over the "patent dance" designed to resolve any patent infringement issues that might apply. The biosimilars advocates contend that the Federal Circuit's decision directly conflicts with BPCIA's framework designed to resolve those arguments before a biosim is FDA-approved.

According to Sandoz, the maker of the original product--the "reference product," as styled by the law--can't sue to defend some patent rights until after the marketing notice happens, company says in its petition for a Supreme Court hearing. That sequence of events is "entirely inconsistent with a statute structured to maximize the chance that any patent disputes will be resolved before FDA approval."

According to the Supreme Court's docket in the case, two biosim makers and an industry group have filed amicus briefs supporting Sandoz's argument. Generics giant Mylan ($MYL) and Hospira, an injectables drug specialist and biosims maker that's now part of Pfizer ($PFE), both disagree with Amgen's timeline, as does the Biosimilars Council, an arm of the Generic Pharmaceuticals Association.

"[I]t is inconceivable that Congress intended to disrupt the BPCIA's carefully-crafted exclusivity compromise--and to further delay patients' access to affordable medicines--by adding sub silentio six additional months to the express 12- year exclusivity period," the Biosimilars Council says in its brief.

The council also says that the Federal Circuit's decision in this case has already affected action in other biosimilar legal battles. It delayed the launch of one biosimilar drug, the group says, and similar delays are possible in two others.

This fight with Sandoz isn't Amgen's only outstanding attempt to protect its blockbuster drugs from biosimilar competition. The company sued Sandoz earlier this month claiming that the biosim maker's version of Enbrel, filed with the FDA last fall, steps on its patents. Amgen is seeking an injunction that would block Sandoz's copy if and when it's approved.

- read the brief from the Biosimilars Council
- see the Supreme Court docket

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