IPR obviousness decision vacated and remanded as patent expired and Sumimoto had no “interest in any forward-looking exclusion” or past infringement by unlicensed sales (IPR addresses “patient” vs. population but not discussed here)

Sumitomo Pharma Co., Ltd. v. USPTO (Intervenor)

Docket No. 2022-2276 (IPR2020-01053) (https://cafc.uscourts.gov/opinions-orders/22-2276.OPINION.4-5-2024_2296961.pdf)

TARANTO, HUGHES, CUNNINGHAM

April 5, 2024

Brief Summary:  Sumimoto’s appeal of IPR obviousness decision vacated and remanded for dismissal as the disputed patent was expired as of the appeal and Sumimoto had no interest in past or future infringement.

Summary:   Sumimoto appealed IPR decision finding all 75 claims of US 5,532,372 directed to “[a] method for treating schizophrenia in a patient without a clinically significant weight gain” (“weight gain being a recognized adverse side-effect of many antipsychotic drugs”) using lurasidone.  The FC panel opinion is focused on the Board’s construction of “a patient” (and “the patient”) to have its “ordinary and customary meaning of ‘one or more patients,’ as opposed to a ‘patient population’” and its finding that the prior art did not “affirmatively disclos[] the claimed result for a patient so treated, but it noted a suggestion of favorable weight-gain effects for lurasidone” in some, in part because “Sumitomo acknowledged that ‘there will always be some outliers’ in side-effects in a pool of patients.”  In this appeal, Sumimoto argued “that the Board did not properly consider certain safety-related evidence” or the prior art “and that it made an erroneous, or at least unclear, use of inherency doctrine in addressing at least the motivation-to-modify, reasonable-expectation-of success, and unexpected-results components of the obviousness analysis.”  The FC panel explained that the patent expired “[j]ust before appeal” and found Sumimoto lacked an “interest in any forward-looking exclusion based on the patent” (ABS, FC 2021; MOAC Mall, US 2023; TransUnion, US 2021) or “a concrete interest in pursuing damages for pre-expiration infringement” (Sony, FC 2019; Munsingwear, US 1950).  For instance, “Sumitomo expressed no interest in seeking damages for direct infringement from any persons who engaged in pre-expiration use of the claimed methods, including those who may have acquired lurasidone from a firm that had not labeled it for a use covered by the ’827 patent’s claims” and admitted “there was only a theoretical possibility that…firms” that made unlicensed sales “even existed”.  The Board decision was therefore vacated and remanded for dismissal.