On Monday, a Delaware federal jury awarded $155 million to Bayer for infringement of U.S. Patent No. 9,364,520, which covers several of Bayer’s hemophilia medications, including Kogenate, Kogenate FS, and Kovaltry. The ‘520 patent claims full-length Factor VIII that is pegylated at its B-domain site and compositions thereof.
The verdict was entered against defendant Baxalta, a division of Takeda Pharmaceutical, based on sales of its competing hemophilia product Adynovate. Both Bayer’s and Baxalta’s products are approved pursuant to BLAs. In other words, the suit was not brought under the BPCIA and does not involve a biosimilar manufacturer.
Another company, Nektar Therapeutics, was also named as a defendant in the suit. According to the complaint, filed in late 2016, Nektar worked with Baxalta to develop Adynovate using Nektar’s proprietary pegylation technology. The complaint alleged that Nektar had been aware of Bayer’s ‘520 patent prior to its work with Baxalta, as Nektar and Bayer had previously engaged in a joint research project and Nektar had sued Bayer in Germany for ownership rights in a patent related to the ‘520 patent as a result.