Posts Tagged: "Glaxo v. Novopharm"

The Federal Circuit’s Approach to the Infringement Analysis in Hatch-Waxman Cases

35 U.S.C. § 271(e)(2) provides that it shall be an act of infringement to submit an Abbreviated New Drug Application (“ANDA”) “if the purpose of such submission is to obtain approval … to engage in the commercial manufacture, use, or sale of a drug … claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.” 35 U.S.C. § 271(e)(2). The statute requires that the infringement analysis focus on what is likely to be sold following FDA approval. Bayer AG v. Biovail Corp., 279 F.3d 1340, 1346 (Fed. Cir. 2002). The governing case law holds that this hypothetical inquiry is grounded in the ANDA application itself, the materials submitted in support thereof, as well as any other relevant evidence submitted by the applicant or patent holder. However, as reflected in the below discussion of key Federal Circuit case law examining the appropriate analytical approach, and the sorts of evidence properly considered, when assessing infringement in the ANDA context, these seemingly bedrock legal principles in reality fall by the way side and, therefore, neither patentees nor ANDA applicants should allow themselves to be lulled into a false sense of security through reliance on such verbiage.