Care to ‘Patent Dance’?

Sandoz’s biosimilar version of Amgen’s Neupogen (filgrastim) is expected to be the first biosimilar to be approved in the US, but not if Amgen has anything to say about it; it’s suing Sandoz for refusing to follow rules laid out in the Biologics Price Competition and Innovation Act (BCPIA). The complexity in the case lies in the fact that the companies are interpreting the rules in different ways – and the result of the lawsuit could serve to shape the US landscape for biosimilars.

Amgen says that the BPCIA required Sandoz to disclose its FDA application and manufacturing information to the innovator within 20 days of filing. The aim of this process is to let the innovator dig through the information to check for any potential patent disputes – regulatory bloggers have nicknamed it the ‘patent dance’. But Sandoz has a different interpretation; it claims the information disclosure is optional. The company did offer to share limited information under certain terms, which Amgen refused. In response, Sandoz said it wouldn’t be sharing anything at all, leaving Amgen all alone on the dance floor, so to speak. Amgen has now filed a lawsuit in California and has submitted a citizen’s petition to the FDA, in which it describes Sandoz’s conduct as “pernicious”.

The lawsuit accuses Sandoz of patent infringement, unfair competition and conversion. An article from law firm K&L Gates says that the conversion aspect is particularly interesting since it’s not commonly seen in this context (1). It refers to treating someone else’s property as your own. “In particular, Amgen asserts that Sandoz’s biosimilar application uses Amgen’s prior demonstration of the safety, purity, and potency of Neupogen without Amgen’s permission and without satisfying the BPCIA procedures,” says the article. Sandoz’s biosimilar launch could now be delayed by several months. Amgen is asking the court to prevent the launch of the biosimilar and to stop the application from moving forward at all until the dispute is resolved. In addition, Amgen wants the court to rule that Sandoz can’t notify Amgen of its intention to launch the biosimilar until after FDA approval has been granted.

This isn’t the first time that the two companies have butted heads over biosimilars. In 2013, Sandoz asked a US court to rule that a biosimilar version of Amgen and Roche’s Enbrel (etanercept) wouldn’t infringe certain patents. Sandoz had been developing its biosimilar so that the planned launch would coincide with patent expiries, but was caught off guard by other patent applications that it claimed were unpublished and not publicly available. The court ruled against Sandoz, saying that patent litigation couldn’t be initiated unless the biosimilar application had already been filed with the FDA. How would you interpret the BCPIA?
Let us know by commenting online at www.themedicinemaker.com.

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