Tag Archives: Patent Dance

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

Supreme Court Will Judge Biosimilar Patent Dance

The U.S. Supreme Court has agreed to review some of the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). The Court granted certiorari in the dispute between Amgen and Sandoz, where the Federal Circuit decided that the biosimilar patent dance provisions are optional, but pre-marketing notice always is required.… Continue reading this entry

AbbVie Sues Amgen On 10 Of 100 Humira Patents

On August 4, 2016, Abbvie Inc. filed a complaint against Amgen, Inc. under the Biologics Price Competition and Innovation Act (BPCIA), asserting that Amgen’s application for approval of a biosimilar version of HUMIRA® infringes a number of AbbVie patents. The complaint specifically asserts infringement of ten HUMIRA® patents, but indicates that 51 others may be … Continue reading this entry

Biosimilar Pre-Marketing Notice Always Required

Judge Cohn of the U.S. District Court for the Southern District of Florida has issued another decision interpreting the complicated provisions of the Biologics Price Competition and Innovation Action (BPCIA), ruling that the statute requires a biosimilar applicant to give 180 days’ pre-marketing notice after FDA approval even if it has engaged in the BPCIA’s patent … Continue reading this entry