USA Law and Practice Contributed by: Rob Cerwinski, Michael Johnson, Heather M Schneider and Michael B Cottler, Gemini Law LLP
(ii) the correction cannot be subject to reasonable debate based on the claim language, specification, and prosecution history; and (iii) the correction must involve only obvious minor typographical or clerical errors. Canatex Completion Solutions, Inc. v Wellmat- ics , LLC, No 24-1466 (Fed. Cir. 12 November 2025). While a case is pending, a patentee can also request a certificate of correction from the USPTO under 35 USC 254 (USPTO’s mistake) or 255 (Applicant error). A USPTO certificate of correction, however, is only effective for causes of action arising after it was issued (absent the federal court correcting an error, as dis ‑ cussed above). See H-W Tech, LC v Overstock.com, Inc , 758 F.3d 1329, 1334 (Fed. Cir. 2014). Patent claims can be substantively amended at the USPTO during a re-examination (under 35 USC 302), in a reissuance proceeding (under 35 USC 251), or during IPR or PGR proceedings (under 35 USC 311- 319). But like a certificate of correction, the amended claims can only define the scope of future infringe ‑ ment. If they are substantially changed, infringers may have intervening rights, meaning that they cannot be held liable for infringement of the original claims before the amendment. Such amendments may result in dismissal of ongoing suits and the filing of new suits based on the newly amended claims. For that reason, ongoing litigations may be stayed during the penden ‑ cy of the USPTO proceedings. 1.18 Court Arbiter Life sciences patent cases are heard in the first instance in US federal district courts, which have exclusive jurisdiction over patent actions. 28 USC 1338 (a). Judges are generalist Article III judges rather than specialist patent judges. Cases may be tried either to the bench or to a jury. Pre-launch Hatch-Waxman cases are typically bench trials because damages are not available prior to com ‑ mercial launch. 35 USC 271 (e)(2). Jury trials are more common in post-launch pharmaceutical and biologics cases where damages are sought, consistent with the Seventh Amendment. Venue and personal jurisdiction constrain forum selec ‑ tion in patent cases. Patent venue is governed by TC
Heartland LLC v Kraft Foods Grp. Brands LLC , 137 S. Ct. 1514, 1519–20 (2017), and personal jurisdiction must satisfy constitutional due-process requirements. Practical differences nevertheless remain between districts with established patent dockets, particularly in judicial experience and case management prac ‑ tices. The ITC can also hear certain patent cases, in par ‑ ticular those relating to imported goods, focusing on whether those imports infringe on valid US patents and cause injury to a domestic industry. The Hatch-Waxman Act provides a framework for producers of brand-name and generic small-molecule drugs to resolve patent issues around their products. It requires an RPS to list patents for which a reasonable claim of infringement could be asserted if a generic producer made, used, or sold the drug in question in the Orange Book. As noted in 1.6 Stays and Rel- evance of Parallel Proceedings , manufacturers are required to list patents covering the drug, formulations of the drug, and methods of using the drug, but not manufacturing patents. If a company wants to sell a generic version of that drug, it must submit an ANDA that contains a certifica ‑ tion to each patent in the Orange Book: • Paragraph I: no patent information has been filed for the reference listed drug (RLD) under the Orange Book; • Paragraph II: the listed patent has expired; • Paragraph III: the applicant does not intend to market its ANDA product until after the expiration of the listed patent; or • Paragraph IV: the ANDA product will not infringe or the listed patent is invalid or unenforceable. 2. Generic Market Entry 2.1 Infringing Acts ANDA applicants can also file “section viii” statements that they will leave a patented indication off their label (ie, they will “carve out” the patented indication). See GlaxoSmithKline LLC v Teva Pharms. USA, Inc. , 7 F.4th 1320, 1327 (Fed. Cir. 2021); 21 USC 355 (j)(2)(A)(viii).
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