Last week, Sandoz, the generic pharmaceuticals division of Novartis, petitioned the Supreme Court to review a Federal Circuit decision concerning a case involving Zarxio, its biosimilar version of Amgen’s Neupogen. At issue is the court’s interpretation of the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA establishes an alternative pathway for FDA approval of biosimilars and patent-dispute resolution, allowing litigation prior to FDA approval and marketing of biosimilars.
In July, the Federal Circuit ruled in a split decision that the BPCIA requires Sandoz to give Amgen notice 180 days before marketing its biosimilar product. The kicker is that if one follows the Federal Circuit’s rationale, this marketing “injunction” can begin only after a drug has received FDA approval. Sandoz contends that licensure of the product, which is public information, should not affect the timing of the notice provision.
It is difficult to predict whether the Supreme Court will take up this case. If not, the lower court has created the perverse situation where the marketing of a biosimilar is effectively delayed six months longer than Congress originally intended. The language of the BPCIA is clear. The notice of commercial marketing only needs to be made 180 days before a biosimilar is marketed. There is no requirement that that notice be given after FDA approval. Nevertheless, this is the current interpretation by a fractured Federal Circuit panel.
If taken up by the High Court, this case will have implications for both biosimilar manufacturers and the makers of the original products.