USA Law and Practice Contributed by: Rob Cerwinski, Michael Johnson, Heather M Schneider and Michael B Cottler, Gemini Law LLP
Gemini Law LLP 32 W 39th Street New York, NY 10018 USA Tel: +1 917 915 8832 Email: info@geminilaw.com Web: www.geminilaw.com
1. Life Sciences and Pharma/ Biopharma Patent Litigation 1.1 Claimants/Plaintiffs to an Action
A party can also challenge a patent before the US Pat ‑ ent and Trademark Office (USPTO) in an inter partes review (IPR), post-grant review (PGR), or business method review. Because these are conducted before the USPTO rather than an Article III court, there is no standing requirement. Any person or entity may file an IPR to challenge the validity of a patent. 35 USCS. 311 (a). However, because appeals from USPTO pro ‑ ceedings are heard at the US Court of Appeals for the Federal Circuit, which is an Article III court, the chal ‑ lenger must have standing to appeal an adverse deci ‑ sion if necessary. JTEKT Corp. v GKN Auto. Ltd. , 898 F.3d 1217, 1219 (Fed. Cir. 2018). The appellant must show that it is engaged or will likely engage in some activity that would give rise to a possible infringement suit. Id. at 1220. Finally, a party may seek an exclusion order at the International Trade Commission (ITC) by bringing an action under Section 337 of the Tariff Act. 19 USC 337. The party must allege an unlawful act of trade, such as patent infringement, and satisfy a “domestic industry” requirement. This requires the complainant to show “an industry” as defined by Section 337 (a)(3) (commonly called the “economic prong”) and relation to the patented article (commonly called the “techni ‑ cal prong”). Lashify, Inc. v Int’l Trade Comm’n , 130 F.4th 948, 951 (Fed. Cir. 2025). 1.2 Defendants/Other Parties to an Action In general, the defendants named in life sciences law ‑ suits include those that submit US Food and Drug Administration (FDA) filings such as New Drug Appli ‑ cations (NDAs), Abbreviated New Drug Applications (ANDAs), abbreviated Biologics Licence Applications (aBLAs), and Biologics Licence Applications (BLAs).
Standing to assert rights in US courts comes from Article III of the US Constitution. The Federal Circuit has recognised three categories of parties with rights in a patent that can be considered in the standing analysis: (i) those that have standing to sue in their own name, (ii) those that have standing to sue if joined with the patent owner; and (iii) those that do not have standing to sue at all. Rite-Hite Corp. v Kelley Co. , 56 F.3d 1538, 1551-52 (Fed. Cir. 1995) (en banc); Lone Star Silicon Innovations LLC v Nanya Tech. Corp. , 925 F.3d 1225, 1228 (Fed. Cir. 2019). The first category includes the patent owner or an exclusive licensee that has “all substantial rights” in the patent. Lone Star , 925 F.3d at 1229. The second category includes exclusive licensees or others with “exclusionary rights” that have standing to assert pat ‑ ents if they join the patent owner. Id. The third cat ‑ egory covers non-exclusive or “bare” licensees, who never have standing to sue, even if a contract pur ‑ ports to give them that right. Textile Productions, Inc. v Mead Corp. , 134 F.3d 1481, 1485 (Fed. Cir. 1998), cert. denied, 525 US 826 (1998). A party may seek a declaration of invalidity, unen ‑ forceability, or non-infringement of a patent under the Declaratory Judgment Act, 28 USC 2201. To have standing, the party must establish a live case or con ‑ troversy between the parties. However, a patent licen ‑ see is not required to break or terminate its licence before seeking a declaratory judgment. MedImmune, Inc. v Genentech, Inc. , 549 US 118, 137 (2007).
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