On June 29, 2018, Justice Fothergill of the Federal Court granted Shire’s application under the pre-amended Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) for an order prohibiting the Minister of...more
Canada has historically been a much less active jurisdiction for patent litigation compared to the United States, which can be explained in part by the simple fact that the United States’ market is almost 10 times the size of...more
In borrowing a page from the '80s band "Men Without Hats," on June 12, 2017, the U.S. Supreme Court brought greater certainty for both biosimilar applicants and originator companies. In Sandoz Inc. v. Amgen Inc., the Supreme...more
The Supreme Court’s ruling in Impression Products v. Lexmark will force patentees to get what they can in their initial sale or licensing of patented products in both the U.S. and abroad, knowing that they will have to rely...more
Recently, the U.S. District Court of Delaware dismissed a complaint filed by Genentech under the Biologics Price Competition and Innovation Act (“BPCIA”). The complaint was filed in response to Amgen seeking FDA approval to...more
Judge Chesler of the U.S. District Court for the District of New Jersey has dismissed one of Amgen’s pending lawsuits against Sandoz under the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act...more
On July 22, 2016, the District Court for the District of New Jersey granted Sandoz’s motion to dismiss Amgen’s declaratory judgment action related to Sandoz’s biosimilar of Amgen’s Neulasta (pegfilgrastim). As...more
Since the Biologics Price Competition and Innovation Act of 2009 (BPCIA) was signed into law in 2010, only a small handful of abbreviated Biologics Licensing Applications (“aBLAs”) have been filed and of those the FDA has...more
Merck Sharp & Dohme Corp. has challenged Genentech’s U.S. Patent No. 7,923,221 (Cabilly III) with a complaint for declaratory judgment in the Central District of California. The patent relates to methods to produce antibody...more
As we reported earlier, Amgen recently filed suit under the BPCIA against Sandoz and Lek Pharmaceuticals in the Northern District of California. Amgen alleges that Sandoz’s submission of an aBLA for its pegfilgrastim product...more
A Second Circuit 3-judge panel affirmed a district court decision denying a request for declaratory and injunctive relief while subsequently compelling arbitration in a licensing infringement suit. On appeal, LG Electronics,...more
Last month, a divided panel of the Federal Circuit issued a split decision in Amgen v. Sandoz (summary; opinion). Amgen (in which Patterson Belknap represented one of the amici supporting Amgen) is the court’s first decision...more
Decision Date: March 3, 2015 - Court: Northern District of California - Patents: D653,215 - Holding: Defendant’s motion for summary judgment GRANTED - Opinion: On June 26, 2014, Kreative Power, LLC...more