USA Law and Practice Contributed by: Rob Cerwinski, Michael Johnson, Heather M Schneider and Michael B Cottler, Gemini Law LLP
that is relevant to any party’s claims or defences and is proportional to the needs of the case taking into consideration factors such as whether the burden or expense of the proposed discovery outweighs its likely benefits. FRCP 26 (b)(1). In life sciences cases, discovery commonly includes technical descriptions of accused products or pro ‑ cesses, inventor lab notebooks, batch records, regula ‑ tory submissions, internal research and development documents, and related communications. Parties typically use requests for production (FRCP 34), inter ‑ rogatories (FRCP 33), requests for admission (FRCP 36), and fact witness depositions, including corpo ‑ rate designees under FRCP 30 (b)(6). Expert discov ‑ ery proceeds through written reports and depositions under FRCP 26 (b)(2). Many districts with significant patent dockets require early exchange of infringement and invalidity con ‑ tentions under local patent rules, which structure the scope and sequencing of discovery. Discovery is commonly governed by protective orders due to the sensitivity of proprietary scientific and regulatory information. 1.15 Defences and Exceptions to Patent Infringement A defendant has several categories of defences and statutory exemptions available, which can potentially defeat liability altogether, limit available remedies, or render the patent unenforceable. At the most basic level, a defendant may establish non-infringement. Patent infringement is assessed on a claim-by-claim basis, and the patentee bears the burden of proving that every limitation of an asserted claim is met by the accused product or process. If one claim element is missing, either literally or under DoE, the claim is not infringed. 1.16 Stays and Relevance of Parallel Proceedings US district court litigation may be stayed in view of an IPR or PGR proceeding either pursuant to statute or under the court’s inherent discretionary authority to manage its docket.
For PGRs, Congress provided a statutory mechanism favouring stays. Once a PGR is instituted, a district court is required to consider a stay upon motion by the accused infringer, with a presumption that litiga ‑ tion should be stayed during the PTAB proceeding. The court considers whether a stay will simplify the issues in the case, whether discovery is complete and a trial date has been set, whether a stay would unduly prejudice the non-moving party or present a clear tac ‑ tical disadvantage, and whether a stay will reduce the burden of litigation on the parties and the court. By contrast, there is no statutory right to a stay dur ‑ ing an IPR. When an IPR is filed or instituted, district courts rely on their inherent authority to control their dockets and decide whether a stay is appropriate. In exercising that discretion, courts typically apply a multi-factor balancing test. The most important con ‑ siderations are the stage of the district court litigation, the likelihood that the IPR will simplify the issues, and whether a stay would cause undue prejudice to the patent owner or provide an unfair tactical advantage to the accused infringer. District court proceedings can also be impacted if a proceeding is instituted in the ITC. Pursuant to 28 USC 1659, district courts must stay litigation at the request of any respondent to an ITC proceeding until a final decision, so long as the request is made within 30 days of the district court action’s filing or after a party is named as a respondent in the ITC proceeding. When IPR or PGR proceedings result in a final written decision, 35 USC 315 (e)(2) and 325 (e)(2) preclude petitioners from raising invalidity grounds in district court litigation that they raised or reasonably could have raised during that review. California Inst of Tech v Broadcom Ltd , 25 F.4th 976, 989 (Fed. Cir. 2022). ITC decisions have no preclusive effect on district courts but may have persuasive value. Texas Instruments Inc v Cypress Semiconductor Corp , 90 F.3d 1558, 1569 (Fed Cir 1996). 1.17 Patent Amendment A federal court does not have the authority to amend patent claims in litigation, but it can correct an error when the following factors are met: (i) the error must be evident from the patent’s face to a skilled artisan;
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