Sandoz has filed a petition for a writ of certiorari in Amgen v. Sandoz, seeking Supreme Court review of the Federal Circuit’s ruling that it could not market Zarxio, its biosimilar version of Amgen’s cancer medicine Neupogen, until at least 180 days after Zarxio received FDA approval. The petition was expected, since Sandoz last month sought an extension of the cert deadline.
Amgen v. Sandoz is the first and, to date, only Federal Circuit decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), which governs patent disputes related to biosimilars. It was a split decision, with Amgen prevailing on one issue and Sandoz prevailing on another. The issue that Sandoz lost concerns when a biosimilar applicant can provide an effective “notice of commercial marketing,” which the BPCIA states must issue at least 180 days before the biosimilar enters the market. The Federal Circuit held that a biosimilar maker can only give effective notice of commercial marketing after the FDA has licensed its product, meaning that the first sale cannot be sooner than six months after approval.
In its cert petition, Sandoz largely reprises the arguments it made to the Federal Circuit. First, Sandoz argues that the text and purpose of the statute allow the notice of commercial marketing to be given at any time as long as it comes at least 180 days before the first sale, and that the Federal Circuit misinterpreted the statute when it concluded that the statutory reference to a “licensed” product means that the product must be licensed at the time of the notice. Second, Sandoz contends that Federal Circuit turned a “mere notice provision into a grant of 180 days of additional exclusivity for all biological products beyond the exclusivity period Congress expressly provided – delaying the launch of all future biosimilars by six months.” Sandoz contends that the Federal Circuit was mistaken when it stated that its ruling would not ordinarily lead to a six month delay. Third, Sandoz argues that even if the Federal Circuit was correct that the notice of commercial marketing must come after approval, it was wrong to order Sandoz to observe the statutory 180-day period. According to Sandoz, the Federal Circuit “disregarded the only remedy provided by Congress – the right to initiate patent litigation – and instead created its own extra-statutory injunctive remedy to bar the launch of FDA-approved biosimilars.”
Interestingly, one argument that Sandoz does not renew is its contention that its request for a bond prevents the case from being moot. The issue of mootness arises because the Federal Circuit’s 180-day injunction has already expired and Sandoz has already launched Zarxio. In its unsuccessful petition for en banc review, Sandoz argued that the launch of Zarxio would not moot the case because of the possibility of recovery on a bond (which Sandoz requested but the Federal Circuit did not require) and because the controversy fell within the “capable of repetition, yet evading review” exception to the mootness doctrine. In its cert petition, Sandoz argues only that the case fits within the “capable of repetition” exception.
It is certainly true that the 180-day issue is capable of repetition; indeed, it has already arisen in subsequent cases. Most notably, the Federal Circuit will soon hear arguments on the issue in Amgen v. Apotex, on appeal from the Southern District of Florida (Patterson Belknap represents one of the amici supporting Amgen). If the Supreme Court were interested in Sandoz’s arguments, it may nevertheless prefer to wait for the Amgen v. Apotex case.
In light of Sandoz’s petition, Amgen now has another opportunity to seek review of the issue that it lost in Amgen v. Sandoz. Last month, Amgen declined to seek cert on the Federal Circuit’s other holding in the case, namely that the BPCIA’s “patent dance” dispute resolution procedures are optional. Now that Sandoz has petitioned for cert, however, Amgen can, if it wishes, file a conditional cross-petition on the patent-dance issue along with its opposition to Sandoz’s petition.