USA Law and Practice Contributed by: Jim Hurst, Jeanna Wacker, Sam Kwon and Ashley Ross, Kirkland & Ellis
interrogatories or requests for production – to obtain information. However, it is possible to use pre-action dis - covery materials obtained in other jurisdictions – provided there is no restriction from the origi - Declaratory relief is available both to life scienc - es patentees and patent challengers. Exemplary types of declaratory relief available in life sci - ences patent proceedings are: • declarations of non-infringement; • declarations of invalidity; and • declarations regarding damages issues, such as a finding that a case is exceptional pursu - ant to 35 USC Section 285. In BPCIA actions, however, if an aBLA holder does not participate in the patent dance or fails to follow the patent dance disclosure require - ments, they may not bring a declaratory judg - ment action against the RPS (42 USC Section 262(l)(9)). 1.10 Doctrine of Equivalents If an accused infringer does not literally infringe, they may still infringe under the Doctrine of Equivalents (DoE), which is typically analysed as follows: nator court on such use. 1.9 Declaratory Relief • function–way–result (“whether the accused product performs substantially the same function in substantially the same way to obtain the same result”); and • insubstantial differences (“whether the accused product or process is substantially different from what is patented”) (Mylan Insti - tutional LLC v Aurobindo Pharma Ltd, 857 F.3d 858, 866-67 (Fed Cir 2017)).
“The doctrine of equivalents must be applied to individual elements of the claim, not to the inven - tion as a whole.” (Warner-Jenkinson Co, Inc v Hilton Davis Chem Co, 520 US 17, 29 (1997).) Other considerations for DoE include the follow - ing. • Ensnarement – this bars a patentee from asserting an infringement claim that would ensnare the prior art (Jang v Boston Sci Corp, 872 F.3d 1275 (Fed Cir 2017)). • Claim vitiation – this prevents the application of DoE if it would eliminate a claim element (Edgewell Pers Care Brands, LLC v Munchkin, Inc, 998 F.3d 917, 923 (Fed Cir 2021)). • Prosecution history estoppel – this prevents a patentee from recapturing equivalents surren - dered during prosecution to procure issuance of the patent (Festo Corp v Shoketsu Kinzoku Kogyokabushiki Co, 535 US 722, 723 (2002)). 1.11 Clearing the Way There is no obligation, per se, to “clear the way” ahead of a new product launch. However, FTO analyses are often conducted before launches in the form of formal opinions from counsel, which are used by business persons to weigh whether to launch a product. Such formal opinions may be used later in litigation to defend against alle - gations of wilful infringement – although such use will also result in waiver of attorney–client privilege. 1.12 Experts It is common for courts to use expert evidence to determine infringement and validity issues, as well as occasionally during claim construc - tion. The use of expert evidence may even be required in some contexts – for example, expert evidence is usually required for means-plus-
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