Here at Patent Baristas, we love the mystery and intrigue that comes with litigation to establish priority of invention. These matters often bring out juicy details worthy of a good Dynasty episode.

In a particularly protracted example, the U.S. Court of Appeals for the Federal Circuit, in Medichem, S.A., v. Rolabo, S.L. (05-1179, 05-1248), reversed the priority rights between U.S. Patent No. 6,084,100 (the 100 patent), assigned to Medichem, S.A. (Medichem), and U.S. Patent No. 6,093,827 (the 827 patent), assigned to Rolabo, S.L. (Rolabo).

The District Court found the existence of an interference-in-fact and awarded priority of invention to Medichem but the CAFC reversed the courts award of priority to Medichem, based on the insufficiency of the evidence that Medichem introduced at trial to corroborate the testimony of its inventors regarding reduction to practice of the invention.

Rolabos 827 patent and Medichems 100 patent both claim a process for making loratadine, the active ingredient in the allergy medication Claritin. The only significant difference between the processes claimed by Medichem and Rolabo is that Medichems process, which requires a tertiary amine, is a species within the genus of the Rolabo invention.

The first step in an interference analysis is for the court to determine whether an interference exists under 35 U.S.C. §291 by asking whether the patents . . . have the same or substantially the same subject matter in similar form as that required by the PTO pursuant to 35 U.S.C. § 135. In order to make this determination, the court uses the two-way test which states that two patents interfere only if (1) invention A either anticipates or renders obvious invention B, where Party A‘s claimed invention is presumed to be prior art vis-à-vis Party B and (2) vice versa.

The Federal Circuit looked at whether the district court erred in awarding priority of invention to Medichem based on the oral testimony of Medichem co-inventors, testimony that Rolabo claims was not corroborated by independent evidence, and thus should not have been credited in the final determination of whether reduction to practice was established before the critical date.

Priority of invention goes to the first party to reduce an invention to practice unless the other party can show that it was the first to conceive of the invention and that it exercised reasonable diligence in later reducing that invention to practice. The key issue on appeal was whether Medichem provided adequate corroboration of the inventor’s testimony regarding the alleged actual reduction to practice.

In a case involving reduction to practice, an unwitnessed notebook is insufficient on its own to support a claim of reduction to practice. In addition, the court stated that when an inventor claims a process for making a chemical compound rather than the compound itself, it is the successful reduction to practice of the process that must be corroborated, and not merely the successful production of the compound per se.

Medichem produced a documented request for the analysis of a loratadine sample, purported to have been produced via the claimed synthetic route, which was sent by one co-inventor to another. It also included the original laboratory notebook of co-inventor Dr. Rodriguez as well as the original laboratory notebook of former Medichem employee, and noninventor, Lola Casas.

In its review, the CAFC stated that:

This court now turns to consider the corroborative value of the three principal pieces of potentially corroborative evidence: the NMR spectra, the notebooks of Medichems inventors, and the notebook of non-inventor Casas. We note at the outset that the problem with the dated NMR data is that at most they corroborate that the inventors were in possession of the chemical loratadine as of that date; they do not, in themselves, adequately corroborate the claimed process, as they do not establish whether the sample that was analyzed was actually produced by that process.

Not helping their cause was Medichem admitting to fraudulently backdating certain documents relating to a purported 1995 reduction to practice.

In the end, the CAFC held that:

Where a laboratory notebook authored by a non-inventor is offered into evidence pursuant to authentication by an inventor, where the author of the notebook has not testified at trial or otherwise attested to its authenticity, and where the notebook has not been signed or witnessed and has not been maintained in reasonable accordance with good laboratory practices sufficient to reasonably ensure its genuineness under the circumstances, then the corroborative value of the notebook is minimal. Given the facts of this case, Casas notebook should therefore not be accorded much corroborative value. In view of the minimal corroborative value of the inventor’s notebooks and the limited value of the NMR spectrum, we conclude that the evidence, evaluated as a whole under the rule of reason, is insufficient as a matter of law to corroborate Medichems reduction to practice.

See the entire opinion here.

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