Novo Nordisk Ordered to Correct Overly Broad Orange Book Use Code

Defendant was entitled to a mandatory injunction requiring plaintiff to change the Orange Book use code for the patent-in-suit. "[Defendant's] ANDA covers repaglinide. [Plaintiff's] patent which is the subject of this patent action does not cover repaglinide; it covers repaglinide only in combination with metformin. The U-968 use code narrative for the [patent-in-suit] states 'a method for improving glycemic control in adults with type 2 diabetes mellitus.' It is so broad as to incorrectly suggest that the [patent-in-suit] generically covers three (3) different FDA-approved methods of use of repaglinide . . . Because the FDA does not review use code narratives . . . it has required [defendant] as part of its ANDA to 'submit an updated patent certification addressing the [patent-in-suit] and its associated Use Code 968.' . . . [Defendant] has therefore been seriously disadvantaged by the improper U-968 use code narrative. . . . [Plaintiff], by the change in the use code narrative is attempting to extend the life of an expired patent."

Novo Nordisk A/S et al. v. Caraco Pharm. Lab., Ltd.,
2-05-cv-40188 (MIED September 24, 2009, Decision) (Cohn, J.).