D. Del. Says ANDA Specification Trumps All Else In Infringement Analysis

On February 8, 2022, U.S. District Court Judge Maryellen Noreika of the United States District Court for the District of Delaware granted the plaintiff's motion to exclude defendant's expert testimony for being "based on an erroneous legal theory" in a suit alleging defendants' proposed generic Abbreviated New Drug Application ("ANDA") product would infringe Exela's patents under the Hatch-Waxman Act.  Exela Pharma Sciences v. Eton Pharms., No. 20-cv-00365 (D. Del. Feb. 8, 2022). In so doing, Judge Noreika held that where the ANDA specification speaks to the claim limitation at issue, the ANDA specification, not other materials submitted to FDA describing the proposed ANDA product, controls the infringement analysis. Only where the ANDA specification itself does not speak to a claim limitation should the court consider other materials describing the ANDA product, such as biobatch data and actual samples, in order to assess infringement.