Tagged as: BPCIA

Special Master Appointed to Decide Requests to Seal and Redact in Genentech v. Amgen BPCIA Litigations

On March 30, in the Genentech v. Amgen trastuzumab and bevacizumab biosimilar patent litigations, Delaware District Judge Connolly ordered the appointment of a special master to handle the parties’ requests to seal various court filings.  Judge Connolly stated that “[r]ecent sealed and redacted filings in these related cases make clear that…

Read More

The Ten-Year Anniversary of the Enactment of the BPCIA

Today, March 23, 2020, marks ten years since President Barack Obama signed the Biologics Price Competition and Innovation Act (BPCIA) into law as part of the Affordable Care Act.  The BPCIA—whose legislation certain members of the Big Molecule Watch team were involved in drafting—created an abbreviated regulatory pathway for seeking…

Read More

Amgen petitions for rehearing en banc following Federal Circuit decision

On June 7, 2019, Amgen filed a petition for rehearing en banc of the Federal Circuit’s recent affirmance of summary judgment of non-infringement in favor of Sandoz in the BPCIA litigation regarding Sandoz’s ZARXIO (filgrastim-sndz) biosimilar and pegfilgrastim biosimilar candidate.  As we previously reported, on May 8, 2019, a Federal…

Read More

US DOJ Urges Striking Down Entire ACA

As previously reported, in December 2018, the District Court for the Northern District of Texas in Texas v. United States issued an order declaring that the individual mandate of the Affordable Care Act (ACA) is unconstitutional, that the remaining provisions of the ACA are not severable from the mandate provision,…

Read More

Proposed Amendment to Hatch-Waxman and BPCIA Could Curb IPRs by Generic and Biosimilar Applicants (Updated)

  On June 13, Senator Orrin Hatch (R-UT), co-author of the Drug Price Competition and Patent Term Restoration Act (aka the “Hatch-Waxman Act”), proposed an amendment in the Senate Judiciary Committee to modify the inter partes review (IPR) process for pharmaceuticals.  The amendment, titled the Hatch-Waxman Integrity Act of 2018, would require…

Read More

Goodwin’s Elaine Blais and Alex Valenti to host a Biosimilars Market Update Webinar

On November 6th, Goodwin’s Elaine Blais and Alex Valenti will be hosting a Biosimilars Market Update webinar, discussing key issues and recent legal and regulatory developments in the biosimilars space. Topics will include recent antitrust claims filed against biologic manufacturers, new strategies in BPCIA litigation, updates on legal developments affecting validity…

Read More