Federal Court Weighs in on Biosimilar Patent Dance

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A Federal Circuit court ruled biosimilar makers must wait 180 days after receiving FDA approval before bringing drugs to market.

Biosimilar makers may have to wait an additional 180 days after receiving FDA approval before they can bring their drugs to market, according to a United States Federal Circuit Court ruling. On July 5, 2016 the court ruled in Amgen v. Apotex that after a biosimilar receives FDA approval, companies must notify reference product sponsors and wait 180 days before bringing the drug to market, a requirement in the Biologics Price Competition and Innovation Act.

According to the court, after receiving FDA approval, applicants have 20 days to hand over the marketing application and manufacturing information to the reference product sponsor. The 180-day waiting period, the court says, should give sponsors enough time to notify applicants of any patent issues. The applicant then has the opportunity to respond to any alleged infringements.

This ‘patent dance’ has been a longstanding issue for biosimilar makers, many of whom feel the process is unclear. In the case of Sandoz v. Amgen, Sandoz argued that it could notify Amgen of its marketing plans for biosimilar filgrastim, before receiving FDA approval. The court ruled against Sandoz, and the company asked the Supreme Court to review the case. While the Supreme court has not indicated whether or not it will review Sandoz v. Amgen, in June, the court asked the Solicitor General to provide clarification on the patent dance.

Unless the Supreme Court decides to review Amgen v. Sandoz, the decision in the Amgen v. Apotex case may set a legal precedent for pharmaceutical companies. In this case, Apotex, the maker of a biosimilar to Amgen’s Neulasta (pegfilgrastim), provided Amgen with information on its pegfilgrastim biosimilar before receiving FDA approval. Amgen filed a motion in October 2015 asking the court to issue a preliminary injunction requiring Apotex to provide notice when it receives approval, and delaying commercial marketing 180 days from that date. Apotex argued that it did not have to wait 180 days after FDA approval, because it provided Amgen with the biologics license application and manufacturing information. In this case, the circuit court ruled against Apotex, saying the company would have to wait the additional 180 days after FDA approval to bring the biosimilar to market.


Biosimilars cost less than expensive biologics and, according to a STAT News report, are estimated to save approximately $44 billion in US healthcare costs over the next 10 years. This ruling could delay cheaper medications from coming to market and simultaneously extend exclusivity for brand-name biologics, STAT reported. This is particularly relevant for biologics that are reaching the end of the 12-year exclusivity period, and could extend the rights a company has to exclusively sell its product for an additional six months.

Source: US Federal Circuit Court