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Federal Circuit Upholds 180-Day Notice Period for Biosimilars

July 06, 2016
Post by Blog Staff

On Tuesday, the Federal Circuit sustained an injunction preventing generic drug maker Apotex, Inc. from selling a similar version of Amgen Inc's Neulasta drug without a 180 day notice period after being approved by the FDA. The drug is used to boost white blood cell counts in cancer patients and is made using living cells. Because of the nature of biologic drugs such as Neulasta, it is exceedingly difficult to create exact copycat drugs. Instead, near-copies--such as the version of the drug made by Apotex--are referred to as biosimilars.

The Biologics Price Competition and Innovation Act of 2009 creates a process for the approval of new biosimilar drugs. Under the law, both parties (applicant and sponsor) negotiate which patents to litigate during the pendency of the application. The law also provides for a 180 day notice period before the applicant can market their biosimilar drug, giving the sponsor time to assert other patents.  Last July, the Federal Circuit ruled in a similar dispute between Amgen and Sandoz, holding that the 180 day notice period did not begin until FDA approval was obtained.

Apotex applied for FDA approval of the biosimilar in 2014, which is still pending. Amgen brought a lawsuit in August asserting two patents, and in October filed for an injunction to enforce the 180 day notice period after FDA approval. Apotex then argued that they were not subject to an injunction because they followed the dispute resolution process, and that Amgen's sole remedy was to sue for declaratory judgment of infringement. In a unanimous panel, the Federal Circuit rejected Apotex's argument and upheld the injuction for the 180 day notice period after obtaining FDA approval, making that time period mandatory for all biosimilar drugs prior to commercial marketing.

The decision can be found here.


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