Clinical Trials Conducted With A Reasonable Expectation Of Confidentiality Do Not Constitute Public Use Under 35 U.S.C. § 102(B)

In Dey, L.P. v. Sunovion Pharmaceuticals, Inc., No. 12-1428 (Fed. Cir. May 20, 2013), the Federal Circuit reversed the district court's grant of SJ of invalidity based on prior public use and remanded the case for further proceedings.

Dey, L.P., Dey, Inc., and Mylan, Inc. (collectively "Dey") and Sunovion Pharmaceuticals, Inc. ("Sunovion") own patents and sell products concerning the treatment of chronic obstructive pulmonary disease ("COPD") by the compound formoterol. Shortly before Sunovion was to launch its commercial formoterol product, Brovana, Dey brought suit against Sunovion for infringement of patents in two of its patent families.

Sunovion moved for partial SJ of invalidity, arguing that a Sunovion clinical trial constituted a prior public use of Dey's inventions within the meaning of 35 U.S.C. § 102(b). During the Sunovion clinical trial, participants took home and self-administered one of three batches of formoterol medication. The participants in the trial were given the identity of the active ingredient, and signed consent forms stating that only the intended person would take the medication and that the study could be discussed with the participant's regular doctor. The participants were not prohibited from speaking with others about the study. The parties stipulated that one of the batches was identical to the Bronava formulation ("Batch 3501A"), and Sunovion conceded for purposes of the motion that the Batch 3501A composition fell within Dey's asserted claims. One percent of the Batch 3501A vials were lost and not returned. The district court granted SJ, agreeing with Sunovion that the clinical trial constituted a prior public use. Dey appealed.

On appeal, the Federal Circuit disagreed with the district court, holding that Sunovion's clinical trial did not constitute clear and convincing evidence of a prior public use, and that a reasonable jury could return a verdict for Dey. The Court stated it viewed the record differently than the district court on two fact-bound issues. First, the Court did not agree that the use of Batch 3501A by the study participants was "indisputably open and free." Slip op. at 8-9. The Court explained that the loss of a tiny fraction of the thousands of Batch 3501A vials without penalty and the self-administration of the medication at home did not preclude a reasonable jury from concluding that the use of Batch 3501A was sufficiently controlled and restricted, rather than unfettered and public.

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