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Lilly Scientist Not an Inventor of Aradigm Patent

July 20, 2004

Decision icon Decision

Last Month at the Federal Circuit - August 2004

Judges: Clevenger (author), Gajarsa, and Lourie (concurring)

In Eli Lilly & Co. v. Aradigm Corp., No. 03-1336 (Fed. Cir. July 20, 2004), the Federal Circuit reversed a district court’s holding— based on a jury verdict—that a scientist from Eli Lilly and Company (“Lilly”) was a coinventor on a patent owned by Aradigm Corporation (“Aradigm”).

Aradigm’s U.S. Patent No. 5,888,477 (“the ‘477 patent”) is directed to a methodof using Lilly’s insulin analog, “lispro,” to increase the bioavailability of inhaled insulin. Lilly sued to have two of its scientists recognized as joint inventors. The district court ordered that one of the scientists, Dr. DiMarchi, be added as an inventor after a jury determined that Lilly demonstrated by clear and convincing evidence that Dr. DiMarchi collaborated with Aradigm’s scientists.

On appeal, Aradigm argued that the jury instructions were in error because the district court did not construe the claims before sending the inventorship issue to the jury. Although the Federal Circuit recognized that the legal scope of a claim must be known before the contributions of an alleged coinventor can be compared to that claim, the Court rejected Aradigm’s argument because it failed to press the district court to engage in claim construction.

As to the burden of proof, Lilly argued that its nonjoinder inventorship claim should be an exception to the requirement for clear and convincing evidence, and that a preponderance of the evidence standard should apply. Specifically, Lilly pointed to a patent application that it filed prior to the issuance of Aradigm’s ’477 patent and proposed that a preponderance of the evidence standard should apply when there are two copending patent applications claiming the same subject matter, one of which issued as the patent allegedly omitting the inventor, and the other of which was filed by the allegedly omitted inventor.

As support for this proposition, Lilly cited the Federal Circuit’s decision in Environ Products, Inc. v. Furon Co., 215 F.3d 1261 (Fed. Cir. 2000). Environ Products involved a three-way priority contest between two issued patents and a patent application—all of which were pending before the PTO at the same time. Moreover, the parties agreed that the same subject matter was claimed.

The Federal Circuit distinguished Environ Products because it did not involve a § 256 claim for nonjoinder and was expressly limited to priority contests. Therefore, the Court held that a preponderance of the evidence burden of proof is inappropriate in § 256 joint-inventorship disputes when the person allegedly omitted from an issued patent had a copending patent application claiming the same subject matter as the issued patent.

In support of its decision, the Federal Circuit noted that a party seeking to correct nonjoinder is not required to risk any rights to its own invention as would be required in an interference. Therefore, such a party should not receive the benefit of a lower standard of proof without the accompanying risk. Moreover, the Court refused to treat Lilly’s inventorship claim as the functional equivalent of the priority determination in an interference proceeding because (1) Lilly and Aradigm never agreed that Lilly’s patent application claimed the same invention as the ’477 patent, and (2) Lilly could have sought to provoke an interference proceeding in the PTO based on the ’477 patent but chose not to.

In his concurring opinion, Judge Lourie agreed with the result reached by the majority, except for the analysis relating to the burden of proof for inventorship. Because Judge Lourie found no meaningful distinction between inventorship and priority in such a context, he saw no need for different burdens of proof. Moreover, Judge Lourie noted that because the Court found that Lilly had failed to provide substantial evidence to the jury, it was not necessary for the Court to decide this question.