Non-Inventors Sloppy Lab Notebook Cannot Corroborate Reduction to Practice

Medichem v. Rolabo (Fed. Cir. 2006).

The parties here are sparing over rights to a novel process for making loratadine, the active ingredient of Claratin®. Rolabo filed its patent application first, but Medichem reduced to practice prior to that filing. 

Interference-in-fact: In order to proceed with an interference, the case must satisfy a two-way test — i.e., each disclosure, when considered as prior art, must at least render the other’s claims obvious.  Here some prior art taught away from adding a particular compound, while others suggested the addition.  The CAFC determined that in such a case, obviousness could be found because “the prior art, viewed as a whole, [teaches] that the addition of a tertiary amine sometimes works to improve the yield.” 

Priority: The later-filed case has the burden of establishing priority by a preponderance of the evidence. Here, the late-filer, Medichem, asserted an actual reduction to practice that occurred prior to Rolabo’s patent filing.  Proof of reduction to practice requires (1) an actual embodiment meeting all the claimed limitations; (2) showing that the invention would work; and (3) corroboration evidence to show (1) and (2).

On appeal, the CAFC found that Medichem failed to provide the necessary corroboration evidence under part (3) above — reversing the lower court’s decision. In its decision, the appellate panel found, as a matter of law, that a non-inventor’s lab notebook was insufficient corroboration evidence where the non-inventor did not testify at trial or otherwise attest to the notebook’s authenticity and where the notebook had not been signed and dated in accordance with good lab practices.

Given the facts of this case, [the noninventor's] notebook should therefore not be accorded much corroborative value. In view of the minimal corroborative value of the inventors’ 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 Medichem’s reduction to practice.

Notes:

• Interestingly, a parallel interference was also conducted by the BPAI — resolving the issue in favor of Rolabo. Stampa v. Jackson, 65 U.S.P.Q.2d 1942 (B.P.A.I. 2002).
• Read the decision.