Bayer takes pre-emptive strike to protect haemophilia treatment

Bayer HealthCare has filed a lawsuit against Nektar Therapeutics and Baxalta seeking a declaration that a treatment for haemophilia A does not infringe their patent.

The German company filed the case yesterday, August 30, at the US District Court for the Northern District of California, where it also sought to invalidate the patent, US number 7,858,749.

According to the claim, Bayer 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.

It said that 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.

However, shortly afterwards, Nektar “secretly” filed provisional patent application number 60/450,578, to which the ‘749 patent claims priority.

Following further research in the field, Bayer developed BAY 94, a pegylated recombinant human Factor VIII. It filed Biologics License Application number 125661 for BAY 94 on August 30 (the same day the lawsuit was filed), seeking approval for the treatment of haemophilia A.

Bayer claimed 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”.

As a result, “there is a substantial controversy between Bayer and defendants, whose legal interests are adverse to Bayer”, the lawsuit said.

“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,” it added.

According to the filing, hemophilia A affects approximately 400 newborn babies each year in the US and over 400,000 people worldwide.