USA Law and Practice Contributed by: Rob Cerwinski, Michael Johnson, Heather M Schneider and Michael B Cottler, Gemini Law LLP
1.10 Doctrine of Equivalents US patent law recognises the Doctrine of Equivalents (DoE), which permits a finding of infringement even where an accused product or process does not liter ‑ ally meet every claim limitation. Warner-Jenkinson Co. v Hilton Davis Chem. Co. , 520 US 17, 29–30 (1997). Courts assess equivalence using the function–way– result test or the insubstantial differences test, and the analysis must be conducted on an element-by- element basis rather than by reference to the invention as a whole. Graver Tank & Mfg. Co. v Linde Air Prods. Co ., 339 US 605, 608–09 (1950). DoE is subject to important limitations. Prosecution history estoppel prevents a patentee from recapturing subject matter surrendered during prosecution. Festo Corp. v Shoketsu Kinzoku Kogyo Kabushiki Co. , 535 US 722, 733–34 (2002). Ensnarement bars a patentee from asserting equivalents that would encompass the prior art. Jang v Boston Sci. Corp. , 872 F.3d 1275, 1285–86 (Fed. Cir. 2017). Claim vitiation precludes application of DoE where it would effectively eliminate a claim limitation. Edgewell Pers. Care Brands, LLC v Munchkin, Inc. , 998 F.3d 917, 923–25 (Fed. Cir. 2021). 1.11 Clearing the Way There is no obligation to “clear the way” ahead of a new product launch. Freedom to operate (FTO) analy ‑ ses, however, are often conducted before launches by obtaining opinions from outside counsel. Accused infringers may rely on those opinions later in litigation to defend against allegations of wilful infringement – although such use will typically result in waiver of attorney–client privilege. A finding that a defendant wilfully infringed a patent can result in enhanced (eg, treble) damages. Producing an opinion of counsel can mitigate the risk of a wilful infringement finding by showing that the accused infringer acted reason ‑ ably, not recklessly or intentionally, after getting notice of the patent at issue. Additionally, a party can petition for IPR or PGR of a patent at the USPTO, alleging that one or more claims of the patent is unpatentable. A party can bring such challenges before launching to help clear the way for a product launch, although it is not obligated to do so.
1.12 Experts The use of experts is common in US life sciences patent litigation, which may involve several technical experts and economists. When a case is presented to a jury (or to the court in a bench trial), the court acts as “gatekeeper” to ensure that the expert’s opinion is based on scientific knowledge and a reliable method ‑ ology, which is referred to as the Daubert standard. Daubert v Merrell Dow Pharmaceuticals Inc. , 509 US 579 (1993). In addition to satisfying Daubert, expert opinions are governed by the disclosure requirements of FRCP 26 (a)(2), which require testifying experts to submit writ ‑ ten reports disclosing certain information. Most patent cases in the life sciences include expert discovery, in which experts submit competing reports on infringement, invalidity, unenforceability, secondary considerations of non-obviousness (such as commer ‑ cial success), and damages, if at issue. The experts are deposed by the opposing party. Experts often testify at trial using demonstratives or other ways of explaining technical or economic issues. Parties often make “Daubert motions” during the pre-trial period, particularly before jury trials, seeking to exclude the other side’s experts based on providing unreliable opinions. 1.13 Use of Experiments In the United States, experts can engage in experi ‑ mental testing and present their results in their written reports and/or at trial. These may cover infringement issues, such as testing the accused product to see if it meets certain patent claims, or invalidity issues, such as recreating the prior art to show inherency. Sometimes parties hire non-testifying, consulting experts to conduct testing that is not used in litigation and does not have to be disclosed. For example, this may be done to test out an infringement or invalidity theory before having a testifying expert conduct such tests, since that testifying expert is required to dis ‑ close, and may be deposed about, their own testing. 1.14 Discovery/Disclosure In the USA, the scope of discovery is broad. Parties may obtain discovery for any non-privileged matter
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