USA Law and Practice Contributed by: Jim Hurst, Jeanna Wacker, Sam Kwon and Ashley Ross, Kirkland & Ellis
suit, infringement inquiry under Section 271(e)(2) considers “whether the probable ANDA product would infringe once it is made, used or sold” (Par Pharm, Inc v Eagle Pharms, Inc, 44 F.4th 1379, 1383 (Fed Cir 2022)). If the FDA specification of the generic challenger defines the accused product in a manner that clearly resolves the question of infringement, then the specification controls the inquiry. If a specification does not full resolve the question of infringement “clearly and directly”, courts may consider “other relevant evidence, such as data or samples the ANDA filer has submitted to the FDA”. A drug applicant may exclude a patented use from its label by submitting its proposed label to the FDA and “carving out” those methods of use which are claimed in patents (GlaxoSmith - Kline LLC v Teva Pharms USA, Inc, 7 F.4th 1320, 1327 (Fed Cir 2021); see 21 USC Section 355(j) (2)(A)(viii)). An applicant may also be liable for induced or contributory infringement under 35 USC Section 271(b) and (c). To show induced infringement, a plaintiff must demonstrate that “the alleged infringer’s actions induced infringing acts and that [they] knew or should have known [their] actions would induce actual infringements” (GlaxoSmithKline LLC v Teva Pharms USA, Inc, 7 F.4th 1320, 1327 (Fed Cir 2021)). Where alle - gations of inducement are based on an ANDA applicant’s label as well as its public statements and/or marketing materials, the totality of the allegations must be considered (Amarin Pharma, Inc. v Hikma Pharms. USA Inc., 104 F.4th 1370, 1377 (Fed Cir 2024)). An ANDA applicant may be liable for contribu - tory infringement if it sells or offers to sell a mate -
rial or apparatus for use in a patented combina - tion or process where the ANDA product is a material part of the patented invention and has no substantial non-infringing uses. (See BTG Int’l Ltd v Amneal Pharms LLC, 352 F Supp 3d 352, 399 (D NJ 2018).) An ANDA applicant’s launch prior to conclu - sion of Hatch-Waxman litigation is sometimes referred to as an “at-risk” launch. In such cases, the applicant may be liable under 35 USC Sec - tion 271(a). 2.2 Regulatory Data and Market Exclusivity The FD&C Act and the Code of Federal Regula - tions set out the following categories of exclu - sivities available to pharmaceutical product applicants, with varying lengths and protections. • New drug product exclusivity grants limited exclusivity for drug products with new chemi - cal entities or approved active moieties that were subject to new and essential clinical investigations. This exclusivity bars the FDA from reviewing any NDA or ANDA for any drug containing the same active moiety for four years from the date of approval of the first-approved drug application if the NDA or ANDA contains a paragraph IV certification or for five years if it does not (21 CFR Section 314.108(a)–(b)). • New clinical investigation exclusivity confers three years from the date of approval of an NDA that includes investigations in humans with results that were not previously relied upon by the FDA to demonstrate substantial evidence of effectiveness for a previously approved drug product. • Orphan drug exclusivity confers seven years of exclusivity to drugs designated and approved to treat rare diseases – ie, those
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