Clinical drug trials operating under standard confidentiality procedures do not constitute a third-party public use under pre-America Invents Act Section 35 U.S.C. § 102(b) as a matter of law.

Dey, L.P. et al. v. Sunovion Pharm., Inc., No. 2012-1428 (Fed. Cir. May 20, 2013).

The alleged infringer claimed the plaintiff’s patents were invalid as anticipated by the alleged infringer’s public use, which occurred prior to the filing of the plaintiff’s patents. 35 U.S.C. § 102(b) as it existed prior to the America Invents Act Section required that a prior use must either be 1) accessible to the public; or 2) commercially exploited. The district court granted partial summary judgment for the alleged infringer, holding that the alleged infringer’s clinical drug trial was a publically accessible prior use. In finding disputed issues of fact, the Federal Circuit reversed, holding that under third-party public use jurisprudence the invention was not publically available if the circumstances surrounding the prior use indicated that the third party had a reasonable expectation it would remain secret.

The Federal Circuit rejected the district court’s determination that standard clinical trial procedures failed to establish a reasonable expectation of secrecy. Specifically, the court disagreed with the district court’s conclusion that the invention was publically available because the protocol—which allowed participants to take the drug at home and failed to account for a small amount of the unused drug despite the requirement it be returned—did not sufficiently restrict use, citing the restrictions contained in agreements between the clinical trial administrators and the participants. The court also dismissed the idea that a showing of non-public use required a formal confidentiality agreement, finding that the study participants’ necessary ability to discuss their treatment with family members and other healthcare providers did not render the invention publically available because the participants’ level of skill and knowledge limited their ability to understand and disclose the pertinent details of the inventive formulation.

Citing procedural rules, the Federal Circuit remanded to allow the district court to determine if any factual dispute surrounding the clinical trial remained. Judge Newman dissented on the basis that summary judgment should have been entered for the patentee. She concluded that the standard, undisputed confidentiality procedures employed in the clinical trial not only negated a finding of public availability but created a reasonable expectation of secrecy that established the absence of public use as a matter of law.

A copy of the opinion can be found here.