On November 15, Pfizer’s adalimumab product became the 25th biosimilar approved by FDA under the Biologics Price Competition and Innovation Act (BPCIA). The road to the 25th approval has been long and has involved some of the biggest companies and medications in the …›
We are pleased to announce the launch of the MoFo NDCal IP Resource Center. This complimentary resource is available to the public and provides insights on the judges, trends, and decisions for intellectual property cases for the last five years in the United States …›
In a recent decision, Ajinomoto v. ITC, the Federal Circuit addressed the issues of doctrine of equivalents and prosecution history estoppel as applied to patent claims reciting specific amino acid sequence of a biologic. On appeal, the Federal Circuit affirmed the decision by the …›
On July 3, 2019, in a 7-5 en banc decision, the Federal Circuit declined to reconsider its decision in Athena Diagnostics v. Mayo Collaborative Services,[1] finding that claims to a diagnostic method were patent ineligible for being directed to a law of nature. The …›
The United States Supreme Court finally clarified its 11-year-old “clear evidence” standard for pharmaceutical preemption. In its much-anticipated opinion delivered by Justice Breyer, the Court unanimously reversed the Third Circuit’s holding that questions of pharmaceutical preemption should be decided by juries. Merck …›
The EU General Court (“Court”) reduced the fines imposed on Servier SAS and its subsidiaries (“Servier”) from a total of €428 million to €315 million (see press release no. 194/18), thereby partially annulling a European Commission (“Commission”) decision. The Court confirmed the Commission’s finding that …›
On February 23rd, 2018, a panel of the Patent Trial and Appeal Board (PTAB or “Board”) decided that: (1) Indian tribal sovereignty did not apply to post-grant proceedings established under the America Invents Act (AIA) and (2) licensing agreements between a tribe and …›