On August 6, 2015, Amgen filed a complaint against Apotex in what appears to be the first biosimilar litigation in which the parties have actually danced the entire “patent dance” through the “first wave.”
The complaint alleges that Apotex submitted a BLA “pursuant to 42 U.S.C. § 262(k)” seeking “authorization from FDA to market a biosimilar version of Amgen’s Neulasta® (pegfilgrastim) product.” It further alleges that “[b]eginning in December 2014, the parties engaged in the exchange of information and statements as required by the BPCIA. As a result of these exchanges, the parties have agreed to the inclusion of two U.S. patents in this action: the ’138 Patent [U.S. Patent No. 8,952,138] and the ’784 Patent [U.S. Patent No. 5,824,784].” Paragraphs 44-51 contain further details about the parties’ exchanges under the dance.
Interestingly, the complaint also alleges that Apotex has provided Amgen with a “Notice of Commercial Marketing pursuant to 42 U.S.C. § 262(l)(8)(A)” stating that it intends to launch “immediately upon receiving FDA approval,” but that Apotex’s product “has not yet been licensed by FDA.” Amgen has sought a declaratory judgment that Apotex’s notice is “ineffective.” This would seem to squarely raise some of the questions that have been raised in the wake of the Federal Circuit’s recent panel decision in Amgen v. Sandoz, which held that notice before licensure is ineffective when the parties do not engage in the patent dance. For example, is a 180-day injunction after FDA licensure automatic if the parties actually engaged in the dance? We here at Big Molecule Watch will track this case for our readers. Stay tuned . . .
And for more insights and analysis on the Federal Circuit’s recent opinion in Amgen v. Sandoz, please join us for a webinar discussion next Wednesday, August 12, 2015 at 12:30pm EDT: Goodwin Procter partners and Big Molecule Watch editors Elaine Herrmann Blais and Robert Cerwinski will discuss the recent decision and its likely impact on the biosimilars world. To register for the webinar, please click here.
UPDATE (Aug. 7, 2015): This case has been scheduled for a 2-week trial beginning July 11, 2016. (Order here).