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