Novartis has crossed all of the legal hurdles and launched its biosimilar of Neupogen, but its patent fight with Amgen was extended when the Swiss drugmaker asked the U.S. Supreme Court to get involved. Instead of saying whether it will consider the case, the court has invited the Obama Administration to first weigh in with its opinions.
The Supreme Court Monday invited the Solicitor General “to file a brief in this case expressing the views of the United States.” In question are a number of issues that are key to Novartis’ ($NVS) ambitious biosimilars plans going forward; those issues will determine in whose pocket, branded drugmaker or biosimilar maker, billions of dollars in revenues will go. With Novartis announcing this week that it expects to get 5 biosimilars approved in the next four years, including a copy of Amgen’s Enbrel, it has a lot at stake--as does the entire industry.
Novartis earlier this year asked the court to review a federal appeals court ruling that went against its Sandoz generics unit in its fight with Amgen ($AMGN). Courtenay Brinckerhoff, intellectual property lawyer at Foley & Lardner, points out in a blog post that the central issue is when a biosimilar maker has to give the required 180-day notice of its copy. Sandoz did it before it received approval for Zarxio, its Neupogen knockoff. Amgen sued saying the law required biosimilar makers to wait to give notice until their drug had been granted FDA approval, giving drugmakers one last shot to raise patent issues. The appeals court agreed.
That left Zarxio on the sidelines for another 6 months while Amgen raked in additional revenues. And that, Sandoz has argued to the top court, 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.”
The position of the Obama Administration has been pretty clear when it comes to biosimilars: get them to market as soon as possible so that that consumers, and Medicare, can benefit from as much savings as possible. The president has made the case that the exclusivity period for biologics should be cut from 12 years to 7, for just that purpose.
The fight between Sandoz and Amgen on the 180-day notice is not the only one on that question. Amgen is fighting with Apotex over a slightly different take on the procedures. Apotex, which is developing a biosimilar of Amgen’s Neulasta, went through the entire “patent dance” with Amgen, fighting out each intellectual property issue. As a result, Apotex argued to a court, it does not have to give notice to Amgen, because it leaves no last-stand issues to be resolved. But Amgen won that fight as well and Apotex appealed.
If either side in that fight asks the Supreme Court to jump in on their battle, Brinckerhoff said, the Supreme Court could knock down two birds with one stone and provide the industry with an answer to the 180-day conundrum.
- here’s the court notice
- read the blog post
Sandoz asks Supreme Court to nix 'exclusivity windfall' delaying biosimilar launches
Novartis' Sandoz aims for 5 biosim launches by 2020
Amgen doubles down on bid to block Novartis' biosimilar Neupogen
Amgen stalls Apotex's Neulasta biosim launch with court victory