In what many are calling a pre-emptive move, Bayer HealthCare Pharmaceutical has filed a lawsuit against Nektar Therapeutics and Baxalta for a declaration that a treatment for haemophilia A does not infringe their patent.
The case, which was filed on August 30, at the US District Court for the Northern District of California, seeks to invalidate the U.S. Patent number 7,858,749.
Bayer claims that it has been researching and developing the role of Factor VIII—a complex protein that is critical for proper blood coagulation and control of bleeding—and treatments for hemophilia A, a genetic blood coagulation disorder.
According to Bayer, sometime in 2003, Bayer’s legal predecessor, Bayer Corporation, signed a confidential disclosure agreement with Nektar allowing Bayer to share information on its proprietary research with Nektar. Following the disclosure, Nektar “secretly” filed provisional patent application number 60/450,578, to which the ‘749 patent claims priority.
Bayer states that further research on its part led to the development of BAY 94, a pegylated recombinant human Factor VIII. It filed Biologics License Application number 125661 for BAY 94 on August 30, seeking approval for the treatment of haemophilia A.
Bayer further alleges that while Nektar was assisting it with creating a commercially viable pegylated Factor VIII product, “Nektar secretly sought out a partnership with Baxter, Baxalta Inc’s corporate predecessor, to develop its own pegylated Factor VIII replacement therapy. At this time, Baxter and Bayer had competing Factor VIII replacement products”.
“…there is a substantial controversy between Bayer and defendants, whose legal interests are adverse to Bayer. The controversy is of sufficient immediacy and reality to warrant the issuance of a declaratory judgment that Bayer has not infringed and will not infringe any valid claim of the ‘749 patent and that the ‘749 patent is at least invalid,” the claim stated.
The case is currently pending.