Sandoz too quick off the mark in Amgen suit: US court

Novartis’s generic arm Sandoz has failed to win a patent case regarding its biosimilar version of Amgen’s psoriasis and arthritis drug Enbrel (etanercept).

Sandoz had asked the US Court of Appeals for the Federal Circuit to overturn a lower court decision that said the company had filed a lawsuit against Amgen prematurely.

Sandoz sued Amgen last year at the US District Court for the Northern District of California, seeking a judgment that its planned biosimilar version of Enbrel would not infringe two Amgen patents because they should be declared invalid.

The patents at issue, which were licensed to Amgen by pharmaceutical company Roche, are US numbers 8,063,182 and 8,163,522—a composition and a method patent.

The district court rejected Sandoz’s claims and said it had filed the lawsuit prematurely, sparking an appeal from the Switzerland-based company.

But, in a decision released on Friday (December 5), the Federal Circuit upheld the decision.

Judge Richard Taranto said the lawsuit was premature because Sandoz had not sought approval for the generic version from the US Food and Drug Administration (FDA).

In the judgment, Taranto explained that Sandoz said it was conducting a Phase III trial of a drug “it hopes to make the subject of an FDA application”.

He added: “Sandoz’s Phase III trial may fail in material ways. If so, perhaps Sandoz will not file for approval, thereby eliminating altogether the patent dispute it has asked the district court to adjudicate.

“At a minimum, that scenario could alter the content of any patent dispute,” Taranto wrote, dismissing the appeal.

Biosimilars are similar to generic drugs but are biopharmaceutical products only. The system for allowing them in the US was created by the Biologics Price Competition and Innovation Act, implemented in March 2010.

The FDA accepted its first biosimilar application in July this year. That application involved both Sandoz and Amgen, with Sandoz obtaining approval to market a biosimilar of Amgen’s Neupogen (filgrastim) drug.

Sandoz and Amgen did not immediately respond to a request for comment.