The patent provisions of the Hatch-Waxman Act are familiar to both sides of the branded-generic fence by now. Not so when it comes to similar procedures related to biosimilars. In fact, as a lawsuit over Sandoz's knockoff version of the Amgen ($AMGN) therapy Neupogen shows, the two sides don't even agree on the rules.
Here's the background. Sandoz, the Novartis ($NVS) generics unit, filed for FDA approval of its version of the white blood cell stimulator in July. It issued a press release trumpeting the filing as the first biosimilar application in the U.S. under the new pathway to approval.
So, the public was duly notified. Amgen says it should have been notified, too, under the Biologics Price Competition and Innovation Act (BCPIA). The Sandoz filing should have triggered an entire series of events designed to resolve any patent disputes over a bioimilar--and it didn't, Amgen says. Hence the lawsuit, which asks the court to stop the Sandoz effort in its tracks.
There's been some previous legal wrangling over biosimilar applications, but this is the first lawsuit over an application that's already been filed, the FDA Law Blog notes. Sandoz "made a deliberate decision not to provide Amgen with a copy" of its application for approval and a required description of the manufacturing processes involved, Amgen claims, at least not by the statutory deadline of 20 days after the filing.
What Sandoz did do, the lawsuit claims, is propose a different method for resolving any patent issues, in a letter dated July 8. The two companies could exchange info without following the step-by-step process. Amgen said no. Sandoz then wrote Amgen to say that it had decided not to hand over its application--in fact, it had decided not to get into the BCPIA's "patent dance" at all.
Sandoz did decide to follow one of the rules, however--the one that requires biosimilar applicants to give the branded drugmaker 180 days advance notice of an intended launch. According to Amgen, Sandoz figures that the July 8 letter suffices.
Essentially, Amgen is saying that Sandoz isn't handing over info as it's supposed to under BCPIA, and that, in turn, prevents Amgen from digging through to see whether it has a patent-infringement case against the biosim maker. In any case, Amgen went ahead and claimed that Sandoz's biosim steps on a Neupogen method patent--along with allegations of unfair competition and theft.
Amgen wants the court to not only prevent a launch of Sandoz's biosim, but to stop its application from moving forward at the FDA until the two companies resolve patent disagreements. And the company wants the court to say that Sandoz can't notify Amgen of its intention to market the product until after it wins FDA approval. That, in essence, would delay any launch for 6 months after the FDA gives Sandoz a thumbs up.
The company has good reason to want to block the Sandoz knockoff. Novartis' version is on the market as Zarzio in more than 40 countries where biosimilar regulations are already in force. Sandoz says it's the top-selling copy of Amgen's drug around the world--and it's just wanting to crack the market waiting in the U.S.
But as the FDA Law Blog notes, the legal wrangle isn't a two-company spat. It's a court fight that promises to help shape the way all biosimilars are approved and launched. Despite the fact that Congress thinks it's already written the rules on that.
- read the FDA Law Blog post
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