Invidior UK Limited v. Dr. Reddy’s Laboratories S.A., et al.
Docket No. 2020-2073, -2142 (IPR2019-00329) (https://cafc.uscourts.gov/opinions-orders/20-2073.OPINION.11-24-2021_1870396.pdf)
DYK, O’MALLEY, HUGHES
November 24, 2021
Brief Summary: IPR decision affirmed due to lack of written description of claimed range and affirmed as to claim to particular percentage shown in the examples. Summary: Dr. Reddy’s (DRL) appealed USPTO Board final written decision (FWD) that claim 8 of Invidior’s US 9,687,454 directed to mucoadhesive films including “about 48.2 wt %” of a “water soluble polymeric matrix” was not anticipated by the 2009 Myers reference. Invidior appealed the finding that ‘454 claims 1-5, 7 and 9-14 were found anticipated. ‘454 claim 1 requires “about 40 wt% to about 60 wt % of a water-soluble polymeric matrix”, and claims 5, 7, and 9-14 require the same amount or amounts falling within the 40-60% range. The anticipation question turned on whether Invidior’s claims “can get the benefit of [the] 2009 filing date for the claims at issue” from Invidior’s 2009 priority application (the ‘571 application), which DRL argued does not describe the claimed limitations. “[T]he Board found that Tables 1 and 5 in the ’571 application disclose formulations from which a polymer weight of 48.2% could be calculated by a person of ordinary skill in the art” and, therefore, no anticipation by Myers. The Board did find, however, “that the ’571 application does not ‘discuss or refer to bounded or closed ranges of polymer weight percentages.’” Invidior argued the ‘571 application discloses “at least 25%” and examples showing 48.2 and 58.6 wt % polymer while DRL argued “that a skilled artisan would not have discerned the claimed ranges because the ’571 application does not disclose any bounded range, only a lower endpoint and some exemplary formulations” and “that a skilled artisan would not have discerned any upper range endpoint.” The FC panel agreed “with the Board that there is no written description support in the ’571 application for the range of “about 40 wt % to about 60 wt %” as “the range was not expressly claimed”, “the values of ‘40 wt %’ and ‘60 wt %’ are not stated in the ’571 application” and “[m]ost importantly, neither is a range of 40 wt % to 60 wt %” (citing Ariad, FC 2010). The FC panel explained that while “it is not necessary that the limitations of a claim be set forth in haec verba” but that “the specification must indicate with some clarity what the claim recites” (“various other indications of the polymeric content of the film are present in the ’571 application, rendering it even less clear that an invention of ‘about 40 wt % to about 60 wt %’ was contemplated as an aspect of the invention.””). “In the case of a claimed range,” the FC panel wrote, “a skilled artisan must be able to reasonably discern a disclosure of that range” as “the law requires a statement of an invention, not an invitation to go on a hunting expedition to patch together after the fact a synthetic definition of an invention” (Brenner, US 1966 (“not a hunting license”)). The FC panel therefore affirmed the Board’s invalidity decision as to claims 1-5, 7, and 9-14 (Judge Linn dissented (“overly demanding standard…for ranges”, citing Werthein, CCPA 1976 and Nalpropion, FC 2019). The FC panel found the ‘571 application discloses the 48.2 wt % limitation, “a specific amount, which can be derived by selection and addition of the amounts of selected, but identified, components” and affirmed the Board decision that claim 8 was not shown to be anticipated by Myers.