Print PDF

Inventors’ Priority Testimony Must Be Independently Corroborated

February 03, 2006
Totten, Jeffrey C.

Decision icon Decision

Last Month at the Federal Circuit - March 2006

Judges: Schall, Gajarsa (author), Dyk

In Medichem, S.A. v. Rolabo, S.L., Nos. 05-1179, -1248 (Fed. Cir. Feb. 3, 2006), the Federal Circuit affirmed the judgment of the district court on the proper establishment of interfering subject matter and on the finding of the existence of an interference-in-fact, but reversed the award of priority to Medichem, S.A. (“Medichem”) due to insufficient corroboratory evidence.

Medichem and Rolabo, S.L. (“Rolabo”) are assignees of patents claiming a process for making loratadine, the active ingredient in the allergy medication Claritin®, from two precursor chemicals by a chemical reaction known as the McMurry reaction. Medichem’s patent, U.S. Patent No. 6,084,100 (“the ’100 patent”), requires the claimed process to be carried out in the presence of a chemical known as a tertiary amine. Rolabo’s patent, U.S. Patent No. 6,093,827 (“the ’827 patent”), on the other hand, permits, but does not require, a tertiary amine in the claimed process.

Medichem brought an action in the district court under 35 U.S.C. § 291, alleging an interference-in-fact between the ’100 and ’827 patents, claiming priority of invention, and seeking to invalidate Rolabo’s ’827 patent under 35 U.S.C. § 102(g). Following a bench trial, the district court found no interferencein- fact but nonetheless awarded priority to Medichem. In an earlier appeal, Medichem, S.A. v. Rolabo, S.L., 353 F.3d 928 (Fed. Cir. 2003), theFederal Circuit vacated the award of priority and remanded the case to the district court to complete the determination of whether an interference-in-fact existed. The Federal Circuit instructed the district court that both prongs of the “two-way” test must be satisfied to create an interference-in-fact. Under this test, the two patents would interfere only if Medichem’s invention anticipates or renders obvious Rolabo’s invention, assuming for the purposes of the test that Medichem’s invention qualified as prior art to Rolabo’s process, and vice versa. The Federal Circuit noted that Medichem’s species claims anticipate the genus claims of the ’827 patent, but asked the district court to determine whether the patents meet the second prong of the two-way test. Only after finding an interference-in-fact may the district court consider priority.

On remand, the district court held that, pursuant to the two-way test, an interferencein- fact exists because the claims of the ’827 patent would anticipate and render obvious the claims of the ’100 patent. The district courtthus awarded priority to Medichem after finding that Medichem reduced the invention to practice prior to Rolabo’s constructive reduction to practice date. Rolabo appealed.

On appeal, the Federal Circuit affirmed the district court’s finding that an interference-infact exists. The Federal Circuit agreed that the prior art, combined with the teachings of the ’100 patent, would render the ’827 patent obvious. The prior art disclosed potential advantages and disadvantages to using a tertiary amine in a McMurry reaction. Despite this conflict, when viewed as a whole, the art taught that adding a tertiary amine sometimes improves the yield of McMurry reactions. Thus, the art provides the requisite motivation to combine references and the reasonable expectation of success to render the ’827 patent obvious.

The Federal Circuit also held that the district court did not err in failing to formally define a count corresponding to the interfering subject matter. The district court clearly identified the interfering subject matter by identifying the interfering claims, and need not refer to the subject matter as a “count.”

Finally, the Federal Circuit reversed the award of priority of invention to Medichem. To establish priority, Medichem argued that its inventors reduced the claimed process to practice prior to Rolabo’s effective filing date. Showing actual reduction to practice requires, inter alia, evidence sufficient to corroborate the purported reduction to practice. Credibility concerns underlie the corroboration requirement, which requires knowledge independent of the inventors.

The Federal Circuit considered three pieces of potentially corroborative evidence. The first piece of evidence, spectral data, showed the presence of loratadine, but failed to establish the process by which the inventors created the compound. As the disputed invention covered the process of making loratadine, the Court held that this evidence failed to establish reduction to practice. The second piece of evidence, the inventors’ laboratory notebooks, were not witnessed and do not provide independent authority. Therefore, the Court held that they have minimal corroborative value.

Finally, the Federal Circuit found the third piece of evidence, a noninventor’s laboratory notebook, insufficient to corroborate reduction to practice as well. The inventor and the noninventor frequently made notes in each other’s notebooks, and the noninventor did not testify at trial. Instead, the district court relied on the inventor’s testimony to authenticate pertinent passages in the notebook. Because the district court lacked noninventor testimony regarding the notebook’s contents and the notebook was unsigned and undated, the Federal Circuit held that the notebook was of minimal corroborative value. The Court noted that Medichem’s fraudulent backdating of other documents relating to the case further diminished the value of the evidence. Absent corroboration, the district court erred in awarding priority to Medichem.