Federal Circuit Patent Watch: Allegations of induced infringement can be based on skinny label in combination with public statements and marketing materials

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Precedential and Key Federal Circuit Opinions

1.  BETEIRO, LLC v. DRAFTKINGS INC. [OPINION] (2022-2275, 06/21/2024) (Dyk, Prost, Stark)

Stark, J. The Court affirmed the district court’s dismissal of multiple, related patent infringement cases for failure to state a claim based on subject matter ineligibility of the patent claims. The Court found that the claims are directed to the abstract idea of “exchanging information concerning a bet and allowing or disallowing the bet based on where the user is located.” The Court noted that the claims exhibit several features that are “indicators of abstractness.” First, the claims broadly recite generic steps of a kind that are frequently held as abstract: detecting information, generating and transmitting a notification based on the information, receiving a message (bet request), determining (whether the bet is allowed based on location data), and processing information (allowing or disallowing the bet). Second, the claims are drafted using largely result-focused functional language, containing no specificity about how the purported invention achieves those results. Third, the claims involve methods of providing particularized information to individuals based on their locations, which have been held to be abstract. Fourth, the claims are directed to a fundamental and longstanding economic activity, which has been held to be an abstract idea. The Court also found that the claims failed to provide an inventive concept because they achieved the abstract steps using generic computer components, including GPS on a mobile phone.

2.  AMARIN PHARMA, INC. v. HIKMA PHARMACEUTICALS USA INC. [OPINION] (2023-1169, 06/25/2024) (Moore, Lourie, Albright)

Lourie, J. The Court reversed the district court’s dismissal of the complaint for failure to state a claim for induced infringement. Allegations of inducement must be reviewed as a whole, not piecemeal. Here, the defendant’s ANDA had already been approved by the FDA and the defendant had already launched its generic product. The allegations of the complaint transformed this case from a pre-approval, label-only induced infringement claim to one where the alleged infringement was based on the generic manufacturer’s skinny label as well as its public statements and marketing of its already-approved generic product. Because many of the allegations depend on what the label and public statements would communicate to physicians and the marketplace, their sufficiency was a question of fact, not law, and was not proper for resolution on a motion to dismiss.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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