Biosimilar makers lose second shot at shortening biologics exclusivity


In a blow to biosimilar developers and consumers, the federal appeals court has again ruled that biosimilar makers must wait until they have an FDA approval in hand before giving the drugmakers a 6-month heads up that they intend to launch a knockoff.

The court was adamant in a ruling filed Tuesday that the biosimilar law “provides for two stages of litigation” and that drugmakers should get a second shot to make a last stand on patent issues after an FDA approval of a biosimilar. The ruling, while settling the question for now, will give the Supreme Court more to think about should it take up the issue, which it's been asked to do.

The U.S. Court of Appeals Tuesday again ruled in favor of Amgen in a fight over a biosimilar of one of its products, this time with Apotex, which has developed a copy of Neulasta. It said that even when a biosimilar developer has gone through all of the so-called patent dance preliminaries laid out in the federal biosimilars law, exchanging info on the biosimilar and patents on the reference drug, it can’t give notice until it has an FDA approval in hand. Apotex had served notice after first working through some of the patent issues with Amgen and then declaring the final patent was invalid, but before the FDA had approved its copy.

The court earlier ruled in favor of Amgen against Novartis’ Sandoz unit, which had developed a biosimilar of Amgen’s Neupogen. In that case, Sandoz had forgone the patent dance exchange of information and was preparing its launch when a court issued an injunction saying it must wait 6 months after its FDA approval.

But Novartis has not given up on the issue, and has asked the U.S. Supreme Court to rule on the question of when the 180-day notice must be given. Novartis has said it expects to have 5 biosimilars approved by 2020 and so figures there is a lot of money to be made or lost based on when the 6 months kick in.

It has argued to the top court that waiting for an FDA approval gives the makers of reference drugs an "exclusivity windfall," and “will delay the availability of all biosimilars for 180 days more than Congress intended--even if the sponsor has no valid patent claims and even if the sponsor already has had the opportunity to pursue any valid claims.”

Apotex made a similar argument to the court of appeals, saying that waiting for an FDA approval could mean drugmakers end up with 12½ years of exclusivity when their patents were only valid for 12. But the court dissed that argument, saying the FDA could always decide at 11½ years, or sooner, that patents are no longer binding and approve a knockoff.

The Supreme Court has not yet said whether it will take up the matter. Last month it invited the Obama Administration to first weigh in with its opinions. As the National Law Review said Wednesday, if the Supreme Court decides to hear the case, “the BPCIA 180-day notice issue will be back on the table.” But unless there is a rehearing, “one of the riddles of the BPCIA, ... appears to have been resolved by the Federal Circuit."

- here’s the National Law Review piece

Related Articles: 
Amgen stalls Apotex's Neulasta biosim launch with court victory 
Supreme Court invites administration into Amgen, Novartis biosimilar battle 
Sandoz asks Supreme Court to nix 'exclusivity windfall' delaying biosimilar launches