Case Name: Bristol-Myers Squibb Co. v. Nanocopoeia, LLC, No. 22-cv-1283, 2023 WL 2867945 (D. Minn. Apr. 10, 2023) (Menendez, J.) 

Drug Product and Patent(s)-in-Suit: Sprycel® (dasatinib); U.S. Patents Nos. 7,491,725 (“the ’725 patent”) and 8,680,103 (“the ’103 patent”)

Nature of the Case and Issue(s) Presented: BMS’s Sprycel is indicated to treat certain types of leukemia and contains dasatinib in the crystalline monohydrate form. The patents-in-suit claim the crystalline form of dasatinib. Nanocopoeia filed a motion for judgment on the pleadings, arguing that it did not infringe the patents-in-suit, which the court denied.  

Why BMS Prevailed: BMS raised several procedural challenges, arguing: (i) it can survive a motion for judgement on the pleadings in the Hatch-Waxman context simply by pleading the elements of artificial infringement; and (ii) the court cannot consider documents attached to, and necessarily embraced by, the pleadings, such as Nanocopoeia’s NDA. The court rejected both arguments.

The court explained that there are two types of hypothetical infringement cases under Hatch-Waxman: those in which the specifications in the defendant’s NDA directly answer the question of infringement and those in which the NDA specifications are ambiguous and do not directly answer the infringement inquiry. In a highly redacted opinion, the court found that Nanocopoeia’s NDA did not directly address infringement and found that there were disputes of material fact that precluded judgment on the pleadings.