On March 31, 2014, Celltrion Healthcare Co., Ltd. and Celltrion, Inc. became the second company developing a biosimilar to file a declaratory judgment action before filing a licensure application with FDA when it filed suit against Janssen Biotech, Inc. in the District of Massachusetts. The suit asks the court to declare three of Janssen's patents for arthritis therapy REMICADE® (infliximab) invalid and unenforceable. Celltrion alleges that its product "will become the first biosimilar of an antibody drug ever approved in the United States." Celltrion intends to apply for marketing approval this year and "expects to face infringement allegations from Janssen."
A similar suit was filed on June 24, 2013 by Sandoz, Inc. against Amgen, Inc. and Hoffman-La Roche, Inc. in the Northern District of California seeking a declaratory judgment of invalidity and noninfringement of two patents directed to Amgen's psoriasis and arthritis therapy ENBREL® (etanercept), also before filing a licensure application with the FDA. In that case, the district court granted a motion to dismiss on the basis that "neither a reference product sponsor, such as Amgen, nor an applicant, such as Sandoz, may file a lawsuit unless and until they have engaged in a series of statutorily-mandated exchanges of information" under the Biologics Price Competition and Innovation Act (BPCIA).
Enacted as part of the Affordable Care Act in 2010, the BPCIA created an abbreviated regulatory pathway for biosimilars, including a complicated procedure for patent litigation which some commentators have referred to as the "patent dance." Thus far, these are the only two lawsuits involving biosimilars that have been filed. The Sandoz v. Amgen case is currently on appeal to the Federal Circuit.
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