{"id":95374,"date":"2018-04-03T08:15:52","date_gmt":"2018-04-03T12:15:52","guid":{"rendered":"https:\/\/ipwatchdog.com\/?p=95374"},"modified":"2018-07-10T17:14:45","modified_gmt":"2018-07-10T21:14:45","slug":"federal-circuit-approach-infringement-analysis-hatch-waxman","status":"publish","type":"post","link":"https:\/\/ipwatchdog.com\/2018\/04\/03\/federal-circuit-approach-infringement-analysis-hatch-waxman\/id=95374\/","title":{"rendered":"The Federal Circuit\u2019s Approach to the Infringement Analysis in Hatch-Waxman Cases"},"content":{"rendered":"
<\/a>35 U.S.C. \u00a7 271(e)(2) provides that it shall be an act of infringement to submit an Abbreviated New Drug Application (\u201cANDA\u201d) \u201cif the purpose of such submission is to obtain approval \u2026 to engage in the commercial manufacture, use, or sale of a drug \u2026 claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.\u201d 35 U.S.C. \u00a7 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.<\/em>, 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. See, e.g., Bayer AG v. Elan Pharm. Res. Corp<\/a>.<\/em>, 212 F.3d 1241, 1248-49 (Fed. Cir. 2000) (citing Glaxo, Inc. v. Novopharm, Ltd<\/em><\/a>., 110 F.3d 1562, 1570 (Fed. Cir. 1997)). In a manner analogous to the role of intrinsic evidence in a claim construction analysis, however, the case law is, on the surface at least, also very clear that where the ANDA specification directly addresses and resolves the infringement question, then that analysis will control the infringement determination. See, e.g.,<\/em> Elan Pharm. Res. Corp.<\/em>, 212 F.3d at 1248-50; Ferring B.V. v. Watson Labs<\/em><\/a>., 764 F.3d 1382, 1389-90 (Fed. Cir. 2014) (\u201cFerring I<\/em>\u201d); Ferring B.V. v. Watson Labs.<\/em>, 764 F.3d 1401, 1408-09 (Fed. Cir. 2014) (\u201cFerring II<\/em>\u201d). 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.<\/p>\n In perhaps the most frequently cited case on this issue, Glaxo v. Novopharm<\/em><\/a>, the Federal Circuit affirmed the district court\u2019s finding of no infringement. Glaxo<\/em>, 110 F.3d at 1570. The relevant patent claims at issue were directed to Form 2 ranitidine HCl (\u201cRHCl\u201d). (RHCl exists in multiple crystalline forms and mixtures thereof, among which forms are those termed Forms 1 and 2 ranitidine.) The API in Novopharm\u2019s ANDA product was Form 1 RHCl, but the finished product specification allowed for a product having purity as low as 90%. Id<\/em>. at 1564. As the infringement issue was focused on whether or not Novopharm\u2019s proposed ANDA product would contain Form 2 RHCl, the Federal Circuit held that the ANDA did not resolve the infringement issue. Id<\/em>. at 1569. The Federal Circuit held that, in light of the ambiguity left open by the ANDA itself, the district court was justified in considering biobatch data and analysis of product samples and, based on such data, finding that Novopharm\u2019s ANDA product did not infringe the relevant patent claims. Id<\/em>. at 1569-70.<\/p>\n In\u00a0Pharms. Inc. v. Teva Pharms. USA, Inc<\/em>., the Federal Circuit held that Dr. Reddy\u2019s proposed ANDA product infringed patent claims directed to the molecule zopiclone in its dextrorotatory form and containing less than 0.25% of the levorotatory isomer. Sunovion Pharms. Inc. v. Teva Pharms. USA, Inc<\/em>.<\/a>, 731 F.3d 1271, 1273 (Fed. Cir. 2013). The product specifications in Dr. Reddy\u2019s ANDA allowed for 0.0-0.6% of the levorotatory form of zopiclone. Id<\/em>. at 1278. The Federal Circuit held that, in this instance, the ANDA directly addressed and resolved the infringement issue in favor of the patentee. Id<\/em>. at 1278-79. The Sunovion<\/em> opinion attempts to distinguish Glaxo<\/em> on the grounds that in Glaxo <\/em>\u201cthe ANDA specification itself did not resolve the question of infringement in the first instance.\u201d Id<\/em>. at 1279-80. It is unclear, however, how in Sunovion<\/em> the ANDA specification was said to resolve the infringement inquiry while in Glaxo<\/em> the ANDA specification was said not to resolve the infringement inquiry. In both cases, the ANDA specification allowed for an infringing product potentially.<\/p>\nGlaxo v. Novopharm<\/em><\/h2>\n
Sunovion Pharms. Inc. v. Teva Pharms. USA, Inc<\/em>.<\/h2>\n
Bayer v. Elan<\/em><\/h2>\n