First Biosimilar Application Kicks Off Legal Battle

In a landmark lawsuit over the first biosimilar application, Amgen is suing Sandoz for unlawfully refusing to follow the patent resolution protocol laid out by the rules of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). According to the rules of BPCIA, Sandoz was required to share with Amgen its 351(k) biologics license application (BLA) for filgrastim and its manufacturing processes and dossier for the product within 20 days of FDA’s decision to approve the product. Instead, FDA Law Blog reports Sandoz apparently proposed an alternative procedure in a July 8, 2014 letter to Amgen that did not directly follow the decree from BPCIA. Sandoz offered to share its application with Amgen, but not its manufacturing information, which Amgen alleges in court filings, “was an attempt to prevent Amgen from learning the details of their process(es) for manufacture, to avoid patent infringement litigation on any manufacturing patents, and to avoid the patent exchanges required by the statute.” Amgen refused Sandoz’s offer to follow an alternate procedure.

Because Sandoz allegedly made a deliberate decision not to share the required information, Amgen is suing the company, alleging patent infringement (covering a method of using filgrastim to treat a disease requiring peripheral stem cell transplantation), unfair competition, and conversion. Amgen asserts that the infringement portion of the suit is a result of Sandoz submitting its BLA to FDA without providing the required BLA and manufacturing information to Amgen.

The conversion accusation relates to theft, or wrongful dominion exerted over another's personal property. FDA Law Blog reports that Amgen stated, “Without Amgen’s efforts, the information relied on by Defendants for the safety, purity, and potency of the Sandoz biosimilar product would not exist.”

Amgen wants the court to prevent Sandoz from commercially marketing its filgrastim copy and requested an injunction to prevent Sandoz from moving the product through the FDA regulatory process until the company has been granted permission by Amgen to use the license for the product. Amgen is also requesting compensatory damages and the acknowledgement that the “Defendants have committed a statutory act of infringement.”

Source:
FDA Law Blog