On appeal following remand to establish whether an interference-in-fact existed between interfering patents, the U.S. Court of Appeals for the Federal Circuit affirmed the district court’s finding of an interference-in-fact but reversed its award of priority based on lack of corroboration for the inventor’s testimony. Medichem, S.A. v. Rolabo, S.L., Case No. 05-1179 (Fed. Cir. Feb. 3, 2006) (Gajarsa, J.).

Medichem and Rolabo are manufacturers of loratadine, the active antihistamine ingredient in Claritin. Medichem’s U.S. Patent No. 6,084,100 (the `100 patent) and Rolabo’s 6,093,827 (the `827 patent) both claim a process for preparing loratadine. The claims in the `100 patent require the presence of a tertiary amine and are a species of the claims in the `827 patent. In an earlier appeal, the Federal Circuit determined the district court lacked jurisdiction because it failed to establish as a precondition for determining priority the existence of an interference-in-fact (see IP Update Vol. 7, No. 1, January 2004). On remand and to decide the second prong of the two-way interference-in-fact test, the district court found Medichem’s invention was obvious in view of Rolabo’s genus in part because Rolabo’s invention did not exclude the use of tertiary amines. Priority was awarded to Medichem. Rolabo, the party having the earlier priority date, appealed and argued Medichem’s invention was unobvious and the district court erred in awarding priority based on uncorroborated oral testimony of the inventors.

The Federal Circuit affirmed the existence of an interference-in-fact, finding the species to be obvious in view of the genus. The Court reasoned the use of a tertiary amine in the claimed Rolabo process was obvious because there was clear guidance in the prior art that the addition of a tertiary amine can optimize the type of chemical reaction employed.

Turning to the priority issue, the Court commenced its analysis with a detailed review of the law and policy underlying the requirement for independent corroboration of an inventor’s oral testimony. The Court noted that corroboration is fundamental to the credibility of an inventor’s testimony, and the independent nature of the evidence is key to establishing its sufficiency. The Court found documentary evidence of the inventors lacked corroborative value because it failed to provide an independent source of authority. The inventors notebooks were unwitnessed, and a spectral analysis of loratadine was found, at most, to corroborate the existence of the compound rather than to reduce to practice of the claimed process. A laboratory notebook of a non-inventor also was found to be insufficient because it similarly lacked independence from the inventor. The non-inventor’s notebook was neither signed nor witnessed. It contained entries by the inventor, but the non-inventor failed to testify at trial as to the notebook’s genuineness. The Court concluded the evidence was insufficient as a matter of law to independently corroborate Medichem’s reduction to practice.

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