USA Law and Practice Contributed by: Jim Hurst, Jeanna Wacker, Sam Kwon and Ashley Ross, Kirkland & Ellis
1. Life Sciences and Pharma/ Biopharma Patent Litigation 1.1 Claimants/Plaintiffs to an Action In the US, all parties with substantial rights must be named for plaintiffs to have statutory stand - ing in patent infringement actions. Generally, a party with substantial rights will not have statu - tory standing if any co-owner is not named in the suit (AntennaSys, Inc v AQYR Techs, Inc, 976 F.3d 1374, 1378 (Fed Cir 2020)). Those with less than all substantial rights in pat - ents may need permission from the patentees to bring suit. Non-exclusive licensees need to bring suit with the licensor to have standing. How - ever, exclusive licensees can establish stand - ing alone (Aspex Eyewear, Inc v Miracle Optics, Inc, 434 F.3d 1336, 1340 (Fed Cir 2006)). The relevant licence does not need to be registered but the licensee must, at the minimum, hold the exclusive right to sue. The Federal Circuit also requires joinder of any exclusive licensee, given that exclusive licensees are usually necessary parties in actions in equity (BASF Plant Sci, LP v Nuseed Americas Inc, 2017 WL 3573811, at *5 (D Del 17 August 2017)). Generally, courts will also join a patentee, either voluntarily or invol - untarily, in any patent infringement suit brought by a party with fewer than all substantial pat - ent rights (Lone Star Silicon Innovations LLC v Nanya Tech Corp, 925 F.3d 1225, 1238 (Fed Cir 2019)). Those seeking freedom to operate (FTO) around another’s patents can file a declaratory judg - ment action. Federal courts have discretion as to whether to exercise jurisdiction over a declara - tory judgment action under 28 USC Section 2201, even when the suit satisfies subject matter jurisdictional requirements (Wilton v Seven Falls Co, 515 US 277, 282 (1995)). The scope of this
discretion is unclear, but the Federal Circuit has emphasised that there must be well-founded reasons to decline exercising jurisdiction over a declaratory judgment action (Mitek Sys, Inc v United Services Auto Ass’n, 34 F.4th 1334, 1347 (Fed Cir 2022)). To establish standing in declaratory judgment actions: • the plaintiff must have suffered an injury in fact; • there must be a causal connection between the injury and the defendant’s conduct; and • it must be likely that the plaintiff’s injury would be redressed by a favourable decision (3M Co v Avery Dennison Corp, 673 F.3d 1372, 1377 (Fed Cir 2012)). There is no standing requirement for an inter partes review (IPR) before the Patent Trial and Appeal Board. However, there is a standing requirement to appeal a PTAB’s decision in an IPR. Specifically, parties appealing to the Fed - eral Circuit must show (and maintain throughout the appeal): • injury in fact; • that is “fairly traceable to the challenged action”; and • it is likely that “a favourable judicial decision will redress the injury” (Lujan v Defenders of Wildlife, 504 US 555, 560 (1992)). Such standing may be lost if there is an inter - vening abandonment of the controversy, such as settlement (ModernaTx, Inc v Arbutus Biop - harma Corp, 18 F.4th 1352, 1362 (Fed Cir 2021)). Therefore, a petitioner may not be able to chal - lenge the PTAB’s decision – even if they could have at the outset of the petition.
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