Tag Archives: Genentech

Will The Avastin Biosimilar Patent Dance Go On?

Judge Sleet of the U.S. District Court for the District of Delaware has dismissed Genentech’s complaint against Amgen for allegedly failing to comply with the the Biologics Price Competition and Innovation Act (BPCIA), but the Avastin biosimilar patent dance still may go on. Judge Sleet dismissed the complaint without prejudice and gave Genentech 45 days to amend its complaint. … Continue reading this entry

Will You, Won't You Join The Biosimilar Patent Dance?

In the latest dispute surrounding the “patent dance” provisions of the Biologics Price Competition and Innovation Act (BPCIA), Genentech, Inc. has filed a complaint against Amgen, Inc., alleging that after opting into the BPCIA’s information exchange procedures, Amgen withheld relevant confidential information and unreasonably refused expert consultant review of Amgen’s Abbreviated Biologic License Application (aBLA). … Continue reading this entry

Sanofi Seeks IPR Of Cabilly Patent

On July 27, 2015, Sanofi-aventis U.S. LLC and Regeneron Pharmaceuticals, Inc. filed a petition for Inter Partes Review (IPR) of the “Cabilly II” patent, U.S. Patent No. 6,331,415. The Cabilly II patent granted shortly after I started my career as an attorney, and has stayed in the news almost ever since. Will this IPR make its final headlines?… Continue reading this entry

India IP Board Invalidates Roche Hepatitis C Patent, Cites KSR

In a decision issued November 2, 2012, the Intellectual Property Appellate Board of India (IPAB) determined in a post-grant opposition proceeding that Roche’s patent covering its Pegasys® (pegylated interferon alfa-2a) product for the treatment of Hepatitis C, is invalid as obvious. The IPAB determined that an NGO had standing to challenge the patent, and cited U.S. case law, … Continue reading this entry