Vanderbilt Univ. v. ICOS Corp. (Fed. Cir. 2010)

    By Donald Zuhn --

Last month, in Vanderbilt Univ v. ICOS Corp., the Federal Circuit affirmed a decision of the District Court for the District of Delaware finding that Plaintiff-Appellant Vanderbilt University had failed to prove that Vanderbilt scientists Drs. Jackie Corbin, Sharron Francis, and Sekhar Konjeti were joint inventors of U.S. Patent Nos. 5,859,006 and 6,140,329.  The '006 and '329 patents are directed to compounds and methods for treating erectile dysfunction, including the compound tadalafil, a PDE5 inhibitor and the active ingredient in the drug Cialis®.

Drs. Corbin and Francis were among the first to discover PDE5, which is a phosphodiesterase enzyme that binds to and hydrolyzes cGMP.  In 1989, Glaxo Inc. entered into an agreement with Dr. Corbin to underwrite his research of cGMP analogs.  In 1990, Dr. Corbin sent an abstract to Glaxo Group Ltd. (a U.K.-based subsidiary of Glaxo Inc.) disclosing his discovery that the potency of cGMP analogs is enhanced by adding a phenyl ring at the 8-position.  Building upon their research on cGMP analogs, the Vanderbilt scientists modified a PDE inhibitor in 1991 by attaching a phenyl ring to the 8-position of the compound and an electron-donating hydroxyl group at the 4 position of the phenyl ring, thus creating a PDE inhibitor that was 160 times more potent at inhibiting PDE5 than the original compound.  In a letter to Vanderbilt's general counsel, Dr. Corbin disclosed possible therapeutic uses for the new PDE inhibitor, including the treatment of male impotence.

At the end of 1991, Dr. Corbin mentioned his work on PDE5 inhibitors to Dr. Barry Ross, a scientist at Glaxo Group Ltd., and in January of 1992, he sent a research proposal to Glaxo Group Ltd. outlining his test results.  In February, Drs. Corbin and Francis discussed the proposal with Dr. Ross, and later that month, Dr. Corbin sent a more detailed research proposal to Dr. Ross.  In March, Glaxo's research facility in France tested 26 compounds for PDE5 inhibition, and in early April, Dr. Ross forwarded copies of Dr. Corbin's detailed research proposal to certain Glaxo scientists at the French facility.  In late April, Glaxo scientists at the French facility tested another 29 compounds for PDE inhibition.  That testing led to the identification of a lead compound.  Dr. Alain Claude-Marie Daugan, the named inventor on the '006 and '329 patents, discovered tadalafil (at left) after modifying that lead compound.  Prior to the discovery of tadalafil, Glaxo assigned its interest in the compounds to Defendant-Appellee ICOS Corp.

In 2005, Vanderbilt brought suit against ICOS, seeking to correct inventorship of the '006 and '329 patents under 35 U.S.C. § 256 by adding Drs. Corbin, Francis, and Konjeti as joint inventors.  According to Vanderbilt, the identification of the lead compound by Glaxo scientists at the French facility could not have been accomplished without the use of Dr. Corbin's detailed research proposal, and tadalafil could not have been identified from that lead compound without relying on the Vanderbilt scientists' work.  The District Court, however, found for ICOS, determining that the Vanderbilt Scientists could not be co-inventors because they never "conceived the specific chemical structure of the compound claimed [i.e., tadalafil] or the compound with all of its components."  In support of its decision, the District Court cited Bd. of Educ. ex rel. Bd. of Trustees of Fla. State Univ. v. Am. BioScience Inc., 333 F.3d 1330 (Fed. Cir. 2003), which the Court said "precludes the result plaintiff seeks:  namely, that the contribution of a molecular scaffold in the context of one molecule . . . renders the disclosing party or parties inventors of a different family of molecules containing the same scaffold."  Notwithstanding this finding, the District Court noted that "[t]his is not to say that Corbin, Francis, and Konjeti did not make contributions to Daugan's inventive process; only that, under the applicable law, these contributions fall more into the category of 'prosaic' contributions because they did not conceive the invention as claimed."

On appeal, Vanderbilt argued that Dr Corbin's disclosure of his detailed research proposal to Glaxo Group Ltd. led to the identification by Glaxo scientists at the French facility of a lead compound incorporating the same molecular scaffold as Vanderbilt's PDE5 inhibitors.  At trial, ICOS initially argued that Glaxo scientists at the French facility independently discovered the compounds that were tested for PDE5 inhibition through their knowledge of the vasorelaxation effect of beta-carbolines, which was allegedly gleaned in part from a May 1992 paper.  However, Glaxo's internal records indicated that the compounds were first tested in April 1992, before that paper was published.  ICOS then "backed away" from this story and instead argued that the lead compound was identified in the April 1992 search by looking to the structure of a compound identified in Glaxo's earlier March 1992 search.  This second story was supported by the testimony of Glaxo's scientists at the French facility, who testified that they did not have any knowledge about the Vanderbilt scientists' research until June 1993, long after the April 1992 search had been performed.  In response, Vanderbilt argued that in view of its changing story, Glaxo lacked credibility, and Vanderbilt suggested that Glaxo's scientists used the detailed research proposal to guide their structure searches in April 1992.  In addition, Vanderbilt argued that the key modification to the lead compound that yielded tadalafil was the addition of an electron-donating substituent on the phenyl ring based upon the work of the Vanderbilt scientists.

Noting that "Vanderbilt admits that no direct evidence supports its claims to joint inventorship," and further, that ICOS countered Vanderbilt's arguments with direct evidence supporting its claim of sole identification of the lead compound and independent discovery of tadalafil, the Federal Circuit agreed with the District Court that Vanderbilt had failed to meet its burden of showing joint inventorship by clear and convincing evidence.  The Federal Circuit did agree with Vanderbilt that "the district court opinion contains some erroneous statements regarding the law of joint inventorship and a misunderstanding of the relevance of American BioScience to the facts of this case," but concluded that "[t]hese errors, however, do not affect the outcome of this appeal and are therefore harmless in context."  With regard to the District Court's "misunderstanding," the Federal Circuit noted that while "[t]he district court understood our decision in American BioScience to require that each co-inventor have an independent conception of the final compound for a chemical invention, . . . [s]uch an interpretation is clearly wrong under our established precedent.  Instead, a group of co-inventors must collaborate and work together to collectively have a definite and permanent idea of the complete invention."  The Federal Circuit also noted that "the district court's statement that 'the contribution of a molecular scaffold in the context of one molecule' could never rise to the level of joint inventorship for 'a different family of molecules containing the same scaffold' is in error."  Nevertheless, the Federal Circuit determined that:

[T]he district court, however, did not rest its opinion solely on this interpretation of our case law.  The district court correctly noted that conception requires identification of the specific chemical structure of the compound.  The parties agree that Dr. Daugan was the first to conceive of tadalafil.  After a careful review of the evidence, the district court concluded that the parties' respective stories about whether the Vanderbilt Scientists contributed to the identification of [Glaxo's lead compound] were "equally plausible" and that Vanderbilt failed to produce any evidence of joint invention of tadalafil.  For Vanderbilt to succeed in its inventorship claim, it must carry its burden of proof of demonstrating that the Vanderbilt Scientists contributed to the claimed invention with clear and convincing evidence.  See Hess v. Advanced Cardiovascular Sys., Inc., 106 F.3d 976, 980 (Fed. Cir. 1997).  The district court's findings demonstrate that under the correct legal test, Vanderbilt did not carry its burden.  Thus, any erroneous interpretations of our case law were harmless error.

In his opinion concurring in part and dissenting in part, Judge Dyk "respectfully dissent[ed] from the majority's conclusion that the district court's legal error was harmless," stating that the District Court's findings were "either contradictory or infected by the court's legal error."  Judge Dyk's disagreement lay not with Vanderbilt's argument concerning tadalafil, but rather with Vanderbilt's argument concerning Glaxo's identification of the lead compound.  Here, he notes that "[t]he district court found that the Vanderbilt scientists did in fact make contributions to Glaxo's work, a point the majority ignores."  Judge Dyk also pointed to ICOS' changing story regarding the identification of the lead compound at trial.  He concludes that:

There are two possible ways to interpret the district court's findings, either of which requires a remand.  The first is that the district court's findings are directly contradictory.  The court could not have properly found that the Vanderbilt scientists made a contribution to the identification of [Glaxo's lead compound] if it were "equally plausible" that they did not make a contribution.  . . .  The alternative is that the district court found that Vanderbilt did not establish by clear and convincing evidence that the Vanderbilt scientists' contributions were sufficient to make them joint inventors.  The problem with this interpretation of the finding is that it is obviously tainted by the district court's view that in order to be joint inventors, the Vanderbilt scientists must have "conceived the 'specific chemical structure of the compound' claimed or 'the compound with all of its components,' or communicated that compound to Glaxo."

Stating that "the district court found that the Vanderbilt scientists made some contribution, [but] has not told us exactly what that contribution was or why that contribution was not enough to make the Vanderbilt scientists joint inventors under the correct standard," Judge Dyk believed that the District Court's decision should have been vacated and remanded.

Vanderbilt Univ. v. ICOS Corp. (Fed. Cir. 2010)
Panel: Chief Judge Michel and Circuit Judges Clevenger and Dyk
Opinion by Circuit Judge Clevenger; concurring in part and dissenting in part opinion by Circuit Judge Dyk