Supreme Court will rule on the validity of the timing.
If the Acting US Solicitor General’s recommendation is accepted, the US Supreme Court will rule on the validity of the timing of the 180-day notification rule as well as on the so-called patent dance itself.
The amicus brief was filed on December 7, in response to a lower court decision on Sandoz v. Amgen, in which the plaintiff did not take actions consistent with the patient dance in readying Zarxio for the market. The lower court ruling, which stated that Sandoz could not file the 180-day notification of its intent to market Zarxio until it received FDA approval, prevented the biosimilar manufacturer from launching until September 2015, 6 months after receiving approval. Immaterial to patent litigation, which begins years before FDA approval (and seems to extend well beyond the notification period in most US cases), this was essentially an additional 6-month period of exclusivity, which was not the intent of the Biologic Price Competition and Innovation Act. In other words, if a manufacturer wanted to launch while still embroiled in patent litigation, that drug maker should be able to do so, “at risk,” which is the position taken by Pfizer and Celltrion in launching Inflectra™. The argument was made that the 180-day notification should be permitted earlier in the process, for instance, when it applies for FDA approval, so it does not interfere with product launch.
Although Zarxio is already on the market, Sandoz has other biosimilars in various stages of approval and development that are still subject to the lower court ruling (e.g., its etanercept biosimilar has been approved, but is awaiting the 180-day period before marketing in 2017).
If the Supreme Court takes up the recommendation, it is likely to hear the case during the current term and vote on it by July 2017.