Vanderbilt Univ. v. Icos Corp.

United States Court of Appeals for the Federal Circuit
*Revised April 9, 2010
2009-1258
VANDERBILT UNIVERSITY,
Plaintiff-Appellant,
v.
ICOS CORPORATION,
Defendant-Appellee.
Robert S. Brennen, Miles & Stockbridge P.C., of Baltimore, Maryland, argued for
plaintiff-appellant. With him on the brief were Donald E. English, Jr.; Kurt C. Rommel and
James T. Carmichael, of McLean, Virginia. Of counsel were Leona Marx and David
Williams, II, Vanderbilt University, of Nashville, Tennessee.
Kevin M. Flowers, Marshall, Gerstein & Borun LLP, of Chicago, Illinois, argued for
defendant-appellee. With him on the brief were Thomas I. Ross and Matthew C. Nielsen.
Of counsel on the brief were Paul R. Cantrell, Donald L. Corneglio and Dan L. Wood, Eli
Lilly and Company, of Indianapolis, Indiana.
Appealed from: United States District Court for the District of Delaware
Judge Sue L. Robinson
* Revised to correct name of attorney Robert S. Brennen
United States Court of Appeals for the Federal Circuit
2009-1258
VANDERBILT UNIVERSITY,
Plaintiff-Appellant,
v.
ICOS CORPORATION,
Defendant-Appellee.
Appeal from the United States District Court for the District of Delaware
in case no. 05-CV-506, Judge Sue L. Robinson.
__________________________
DECIDED: April 7, 2010
__________________________
Before MICHEL, Chief Judge, CLEVENGER and DYK, Circuit Judges.
Opinion for the court filed by Circuit Judge CLEVENGER. Opinion concurring in part
and dissenting in part filed by Circuit Judge DYK.
CLEVENGER, Circuit Judge.
This is an appeal from the United States District Court for the District of Delaware
in a patent action that Vanderbilt University ("Vanderbilt") brought against ICOS
Corporation ("ICOS") on July 20, 2005. Vanderbilt filed suit under 35 U.S.C. § 256alleging that Vanderbilt scientists Jackie D. Corbin ("Dr. Corbin"), Sharron H. Francis
("Dr. Francis"), and Sekhar R. Konjeti ("Dr. Konjeti") (collectively the "Vanderbilt
Scientists") should be added as joint inventors on U.S. Patent Nos. 5,859,006 ("the '006
patent") and 6,140,329 ("the '329 patent"). The district court rendered its findings of fact
and conclusions of law in a January 27, 2009 opinion. Vanderbilt Univ. v. ICOS Corp.,
594 F. Supp. 2d 482 (D. Del. 2009). The district court entered final judgment on
January 29, 2009, concluding that Vanderbilt failed to prove that the Vanderbilt
Scientists are joint inventors of the '006 and '329 patents. Vanderbilt appeals the district
court's final judgment. For the reasons stated below, we affirm.
I
This case involves compounds and methods for treating erectile dysfunction,
including the compound known as tadalafil, a PDE5 inhibitor and the active ingredient in
the drug Cialis®. PDE5 is a phosphodiesterase enzyme found in smooth muscle cells
that binds to and hydrolyzes or breaks down cGMP, a cyclic nucleotide found in smooth
muscle tissues. In normal function, cGMP binds with and activates a cGMP-dependent
protein kinase which results in relaxation and dilation of the smooth muscle cell. PDE5
inhibitors bind to PDE5 and prevent it from binding with and breaking down cGMP.
Drs. Corbin and Francis are employed by Vanderbilt University and were among
the first to discover PDE5 in the late 1970s. Since that time, Drs. Corbin and Francis
have worked on both the development of cGMP analogs and PDE5 related research.
In December 1988, Dr. Corbin submitted a research proposal to Glaxo Inc.
("Glaxo") 1 requesting it sponsor his research to develop cGMP analogs. The proposal
1
Glaxo Inc., later renamed Glaxo Wellcome Inc., was a North Carolina
corporation that merged with SmithKline Beecham to form Glaxo SmithKline in 2001.
Glaxo Group Limited ("Glaxo U.K.") was a U.K.-based subsidiary of Glaxo. At all times
relevant to this litigation, Glaxo maintained a research facility in Les Ulis, France ("Glaxo
France"). The patents in suit list a Glaxo France scientist as the sole inventor and are
assigned to ICOS.
2009-1258 2
listed new cGMP analogs that Dr. Corbin hoped would activate cGMP-dependent
protein kinase.
In June 1989, Glaxo entered into an agreement with Dr. Corbin through Glaxo's
"Cardiovascular Discovery Grant" program to underwrite the Vanderbilt Scientists'
research of cGMP analogs. Under the agreement, the University retained ownership of
intellectual property, but Glaxo was granted a license agreement to any discoveries.
During the three years of the program, Drs. Corbin, Francis, and Konjeti submitted
numerous presentations and progress reports to Glaxo.
In November 1990, Dr. Corbin sent an abstract to Glaxo U.K. disclosing his
discovery that the potency of cGMP analogs is enhanced by adding a phenyl ring at the
8-position. Meanwhile, the Vanderbilt Scientists continued to work on improving
potency with new cGMP analogs. In May 1991, however, Glaxo indicated to Dr. Corbin
its concern that cGMP analogs do not work well as orally-administered drugs and
encouraged the Vanderbilt Scientists to shift their future focus to PDE5 inhibitors.
Outside of the Glaxo program, the Vanderbilt Scientists continued to work on
other research interests. In November 1991, the Vanderbilt Scientists applied the
results of their cGMP analog research to synthesize a new PDE5 inhibitor. The
Vanderbilt Scientists used a 3-isobutyl-1-methylxanthine ("IBMX") compound because it
was a cheap and readily available PDE5 inhibitor that is easily substituted at the 8-
position. Building upon their earlier research, the Vanderbilt Scientists attached a
phenyl ring to the 8-position of the compound and attached an electron-donating
hydroxyl group at the 4 position of the phenyl ring. By applying the results of their
cGMP research to IBMX, the Vanderbilt Scientists created a PDE5 inhibitor they thought
2009-1258 3
was 160 times more potent in inhibiting PDE5 than the original IBMX molecule.
Dr. Corbin drafted a letter to Vanderbilt's general counsel disclosing possible
therapeutic uses for the new IBMX analogs, including the treatment of male impotence.
In December 1991, during discussions regarding a new research agreement,
Dr. Corbin mentioned Vanderbilt's work on PDE5 inhibitors to Dr. Barry Ross, a scientist
at Glaxo U.K. On January 3, 1992, Dr. Corbin sent a research proposal to Glaxo U.K.
detailing the test results of the cGMP analogs developed under the first research
agreement. In the proposal, Dr. Corbin also described the Vanderbilt Scientists' IBMX
analog that was 160-fold more potent as a PDE5 inhibitor than the original IBMX
molecule. Dr. Corbin explained the Vanderbilt Scientists' overall strategy that "the
potencies of existing inhibitors . . . could be enhanced by appending groups that would
allow the inhibitors to more closely resemble the entire cyclic GMP molecule."
Dr. Corbin proposed that Glaxo fund the Vanderbilt Scientists' work on PDE5 inhibitors
going forward. Dr. Corbin also noted in the January letter that "the cG kinase has
important disease-related functions other than the induction of vascular smooth muscle
relaxation." Male impotence was listed as an area of interest, though Glaxo was not
researching male impotence at the time.
On February 3, 1992, Drs. Corbin and Francis met with Dr. Ross regarding the
January proposal. Later that month, on February 24, Dr. Corbin sent a more detailed
research proposal to Dr. Ross which disclosed the exact design of the Vanderbilt IBMX
analog. The detailed research proposal also identified a table of IBMX and zaprinast 2
2
Zaprinast was the most powerful known PDE5 inhibitor at the time of the
research proposal.
2009-1258 4
analogs that Vanderbilt proposed for further testing. Many of the listed compounds
contain what Vanderbilt now refers to as the "Vanderbilt Structural Features" of
Vanderbilt's IBMX analog.
On March 11 and 12, 1992, Glaxo France tested 26 compounds for PDE5
inhibition, including a compound it designated GR35273x.
On April 8, 1992, Dr. Ross forwarded copies of Vanderbilt's February 24, 1992
proposal to six Glaxo scientists, including Dr. Richard Labaudiniere, the head of
chemistry and leader of the PDE5 project at Glaxo France.
On April 23, 1992, Glaxo France tested 29 compounds for PDE5 inhibition,
including a beta-carboline compound designated GR30040x. Vanderbilt claims all of
the tested compounds make some use of the Vanderbilt Structural Features with 11 of
the 29 compounds containing nearly all of the Vanderbilt Structural Features. Based on
the PDE5 inhibition test results, Dr. Labaudiniere identified GR30040x as a lead
compound for further research on PDE5 inhibition. Dr. Labaudiniere assigned the
further GR30040x research to Dr. Alain Claude-Marie Daugan, the named inventor on
the patents at issue, as a separate study. In the course of testing various modifications
to the GR30040x compound between June 1992 and January 1994, Dr. Daugan
discovered tadalafil, the claimed compound at issue in this case.
II
In 1991, Glaxo assigned to ICOS the rights, title, and interest in the compounds
covered by the patents at issue. Vanderbilt brought this suit under 35 U.S.C. § 256against ICOS to correct inventorship of the '006 and '329 patents. Vanderbilt asserts
that the Vanderbilt Scientists should be added as joint inventors. According to
2009-1258 5
Vanderbilt, the GR30040x compound could not have been identified by
Dr. Labaudiniere as the lead compound without his use of the Vanderbilt Structural
Features. Nor could tadalafil have been identified by Dr. Daugan without his reliance on
Vanderbilt's work. The district court held a bench trial and found in favor of ICOS.
In its analysis, the district court noted that 35 U.S.C. § 116, the applicable section
for joint inventorship, sets "no explicit lower limit on the quantum or quality of inventive
contribution required for a person to qualify as a joint inventor." Vanderbilt Univ. v.
ICOS Corp., 594 F. Supp. 2d 482, 504 (D. Del. 2009) (quoting Fina Oil & Chem. Co. v.
Ewen, 123 F.3d 1466, 1473 (Fed. Cir. 1997)). The district court further noted that "a
person is a joint inventor 'only if he contributes to the conception of the claimed
invention.'" Id. (quoting Eli Lilly & Co. v. Aradigm Corp., 376 F.3d 1352, 1458-59 (Fed.
Cir. 2004)). After a summary of the law regarding conception of chemical compounds,
the district court concluded that "conception of a chemical substance includes
knowledge of both the specific chemical structure of the compound and an operative
method of making it" and "does not occur unless one has a mental picture of the
structure of the chemical." Id. (quoting Burroughs Wellcome Co. v. Barr Labs., Inc.,
40 F.3d 1223, 1230 (Fed. Cir. 1994) and Amgen, Inc. v. Chugai Pharm. Co., Ltd.,
927 F.2d 1200, 1206 (Fed. Cir. 1991)). The district court determined that the Vanderbilt
Scientists could not be co-inventors because they never "conceived the specific
chemical structure of the compound claimed or the compound with all of its
components." Id. at 505 (citations omitted).
To guide its analysis, the district court reviewed our decision in American
BioScience and concluded the case contained similar facts and thus controlled its
2009-1258 6
decision. Id. at 504-05. The district court recognized that in American BioScience we
declined to add inventors who provided the "starting materials" for a chemical
compound. See Bd. Of Educ. ex rel. Bd. of Trustees of Fla. State Univ. v. Am.
BioScience Inc., 333 F.3d 1330 (Fed. Cir. 2003) ("American BioScience"). The district
court found that "[t]he 'Vanderbilt Structural Features' constitute no more than a 'specific
portion[] of a claimed compound' in the language of American BioScience." Vanderbilt
Univ., 594 F. Supp. 2d at 505.
The district court concluded that "[b]ecause there is no evidence that [the
Vanderbilt Scientists] ever conceived the 'specific chemical structure of the compound'
claimed, Burroughs Wellcome, 40 F.3d at 1230, or 'the compound with all of its
components,' American BioScience, 333 F.3d at 1340, or communicated that compound
to Glaxo, plaintiff has failed to demonstrate by clear and convincing evidence, that
Corbin, Francis and Konjeti are coinventors of the patents at issue." Id. The district
court noted that "even if the court were to find that plaintiff's disclosure of [the Vanderbilt
Structural Features] led to the identification of GR30040x and the subsequent discovery
of tadalafil, American BioScience 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." Id. at 506-07.
Even after reaching the conclusion that its decision was bound by American
BioScience, the district court provided a detailed analysis of the remaining facts of the
case. First, the 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
2009-1258 7
law, these contributions fall more into the category of 'prosaic' contributions because
they did not conceive the invention as claimed." Id. at 505. After again reviewing the
conflicting stories of the parties, the district court alternatively noted that "the court views
plaintiff's theory . . . and defendant's story . . . equally plausible with respect to the
identification of GR30040x." Id. at 506. Also, in the absence of any evidence of
collaboration between the Vanderbilt Scientists and Dr. Daugan, the district court
rejected Vanderbilt's claim to have contributed to Dr. Daugan's identification of tadalafil.
Id. at 505-06.
III
We begin by reviewing our case law on joint inventorship. The statutory
requirements for joint inventorship are found in 35 U.S.C. § 116 which states, in
pertinent part:
When an invention is made by two or more persons jointly, they shall
apply for patent jointly and each make the required oath, except as
otherwise provided in this title. Inventors may apply for a patent jointly
even though (1) they did not physically work together or at the same time,
(2) each did not make the same type or amount of contribution, or (3) each
did not make a contribution to the subject matter of every claim of the
patent.
35 U.S.C. § 116 (1988).
Section 116 was amended, in relevant part, in 1984 to clarify the law of joint
inventorship by codifying the principles set forth in Monsanto Co. v. Kamp,
269 F. Supp. 818 (D.D.C. 1967). See Kimberly-Clark Corp. v. Proctor & Gamble Distrib.
Co., Inc., 973 F.2d 911, 916 (Fed. Cir. 1992). The court in Monsanto stated:
A joint invention is the product of collaboration of the inventive endeavors
of two or more persons working toward the same end and producing an
invention by their aggregate efforts. To constitute a joint invention, it is
necessary that each of the inventors work on the same subject matter and
2009-1258 8
make some contribution to the inventive thought and to the final result.
Each needs to perform but a part of the task if an invention emerges from
all of the steps taken together. It is not necessary that the entire invention
concept should occur to each of the joint inventors, or that the two should
physically work on the project together. One may take a step at one time,
the other an approach at different times.
Monsanto, 269 F. Supp. at 824.
In Kimberly-Clark, we applied section 116 to a situation where Proctor & Gamble
wished to attribute inventor status to one of its employees who did not collaborate with
the named inventor. 973 F.2d at 912-13. While both employees worked on the same
subject matter, the court noted that the named inventor "worked alone and was
completely unaware of earlier work done by other [] employees." Id. at 913. The court
reviewed the amendments and Monsanto and stated that:
For persons to be joint inventors under Section 116, there must be some
element of joint behavior, such as collaboration or working under common
direction, one inventor seeing a relevant report and building upon it or
hearing another's suggestions at a meeting. Here there was nothing of
that nature. Individuals cannot be joint inventors if they are completely
ignorant of what each other has done until years after their individual
efforts. They cannot be totally independent of each other and be joint
inventors.
Kimberly-Clark, 973 F.2d at 917.
A primary focus of section 116 has thus always been on collaboration and joint
behavior. A person must contribute to the conception of the claimed invention to qualify
as a joint inventor. Eli Lilly & Co. v. Aradigm Corp., 376 F.3d 1352, 1359 (Fed. Cir.
2004). Yet, each contributor need not have their own contemporaneous picture of the
final claimed invention in order to qualify as joint inventors. See Fina Oil & Chem. Co. v.
Ewen, 123 F.3d 1466, 1473 (Fed. Cir. 1997) ("One need not alone conceive of the
entire invention, for this would obviate the concept of joint invention."). Rather, "the
2009-1258 9
qualitative contribution of each collaborator is the key – each inventor must contribute to
the joint arrival at a definite and permanent idea of the invention as it will be used in
practice." Burroughs Wellcome Co. v. Barr Labs. Inc., 40 F.3d 1223, 1229 (Fed. Cir.
1994). The interplay between conception and collaboration requires that each co-
inventor engage with the other co-inventors to contribute to a joint conception.
Inventorship is a question of law that we review without deference. Ethicon,
Inc. v. U.S. Surgical Corp., 135 F.3d 1456, 1460 (Fed. Cir. 1998). We review the
underlying findings of fact for clear error. See Hess v. Advanced Cardiovascular Sys.,
Inc., 106 F.3d 976, 980 (Fed. Cir. 1997).
IV
Vanderbilt raises two arguments on appeal. First, Vanderbilt argues that its
disclosure of the Vanderbilt Structural Features led to Glaxo France's identification of
the GR30040x molecule incorporating the same molecular scaffold. In this regard, the
gist of Vanderbilt's case is that Dr. Labaudiniere could only have identified GR30040x
by using the Vanderbilt Structural Features. Second, Vanderbilt alleges that the key
modification to GR30040x that yielded tadalafil was the addition of an electron-donating
substituent on the phenyl ring based upon the work of the Vanderbilt Scientists.
There is no dispute raised between the parties regarding the district court's
finding that Dr. Labaudiniere at Glaxo France identified GR30040x as a lead compound
for research regarding PDE5 inhibition. Thus, as all relevant contact between the
Vanderbilt Scientists and Glaxo occurred at Glaxo U.K., Vanderbilt attempts to piece
together sufficient facts to demonstrate that the Vanderbilt Structural Features must
have been used by Dr. Labaudiniere to identify GR30040x. As Vanderbilt's argument is
2009-1258 10
based largely upon criticizing ICOS's evidence regarding how GR30040x was
recognized, we first review Glaxo's version of the story.
ICOS contends that Dr. Labaudiniere independently discovered the compounds
to be tested for PDE5 inhibition through his knowledge of beta-carbolines and their
vasorelaxation effect. This theory can be found in a paper received by the Journal of
Medicinal Chemistry on February 5, 2003, entitled "The Discovery of Tadalafil: A Novel
and Highly Selective PDE5 Inhibitor." According to Glaxo, Dr. Labaudiniere became
aware of the vasorelaxation effect of beta-carbolines from his review of two references:
a 1983 article in the European Journal of Pharmacology ("the Koe article") and a May
1992 article in the Journal of Pharmacology and Experimental Therapeutics ("the
Elgoyhen article"). Glaxo claims that Dr. Labaudiniere identified two beta-carboline
compounds, β-CEE and GR35273x, in March 1992 as potential PDE-5 inhibitors.
Dr. Labaudiniere then searched an internal database in April 1992 with the beta-
carboline core structure of these two molecules and his search yielded GR30040x.
Glaxo's internal "PDE V Inhibitors Project Annual Report for the Year Ending 30/4/93"
confirms this story.
Vanderbilt takes issue with Glaxo's story because Glaxo's internal testing records
indicate that GR30040x was first tested by Glaxo on April 23, 1992. The Elgoyhen
article was not published until May 8, 1992. As the district court found, GR30040x could
not have been identified based upon the Elgoyhen reference.
At trial, ICOS backed away from the Elgoyhen story and instead argued that
Dr. Labaudiniere took GR35273x from another Glaxo program and tested it on
March 11 and 12, 1992 for PDE5 inhibition. According to ICOS, Dr. Labaudiniere
2009-1258 11
undertook substructure searches using the tetrahydro beta-carboline scaffold of
GR35273x, based upon the "impressive" PDE5 inhibition results and his knowledge
from the Koe article, and identified GR30040x, among other compounds. ICOS points
to the large number of tetrahydro beta-carbolines tested between March and July 1992
to support its theory.
ICOS also points to Glaxo documents to corroborate various details of its story.
For example, the minutes of a Glaxo Cardiovascular Research Management Committee
meeting in April 1992 describe GR35273x as a compound used in a different study. In
the June 1992 minutes, the same committee noted that GR35273x displayed a high
PDE5 inhibition activity and noted that Glaxo was starting a program testing GR35273x
analogs. At the same meeting, GR30040x was identified as a new PDE5 inhibitor.
ICOS also points to testimony of Dr. Labaudiniere and Dr. Daugan to corroborate
its theory on the identification of GR30040x. Dr. Labaudiniere testified that he did not
have any knowledge about the Vanderbilt Scientists' research until June 1993, he did
not consider IBMX as a starting point for his work on PDE5 inhibitors, and he was not
aware of anyone at Glaxo France using data relating to IBMX analogs or trying to
develop PDE5 inhibitors that would resemble cGMP. Dr. Daugan confirmed his
recollection matches that of Dr. Labaudiniere. In sum, ICOS argues that Vanderbilt's
case fails for lack of evidence of any joint collaboration on the invention since neither of
the Glaxo France scientists had any knowledge of the work of the Vanderbilt Scientists
when they did their work relating to the discovery of tadalafil.
Vanderbilt argues a different view of the same facts. First, Vanderbilt points out
that GR30040x is never identified in any Glaxo documents as a GR35273x analog.
2009-1258 12
Vanderbilt also argues that a GR35273x substructure search would not yield GR30040x
because no documents demonstrate that Glaxo identified the beta-carboline structure in
GR35273x as significant until October 1992. Finally, Vanderbilt argues that Glaxo lacks
credibility as it had previously claimed GR30040x was identified from a β-CEE search
until that was proven false. In sum, Vanderbilt attacks Glaxo's story based upon
missing documentary evidence.
Vanderbilt instead proposes that Dr. Labaudiniere reviewed the February 1992
research proposal and conducted a substructure search based upon the Vanderbilt
IBMX analog. Vanderbilt points out that in April, just weeks after receiving the February
proposal, Glaxo France tested 29 compounds for PDE5 inhibition. Vanderbilt points out
a number of structural similarities between the tested compounds and its February
research proposal.
Vanderbilt's second argument is that after the GR30040x project was assigned to
Dr. Daugan, he added to tadalafil an additional element of the Vanderbilt Structural
Features by replacing the pyridine ring in GR30040x with a combination of a phenyl ring
and an electron-donating methoxy substituent. Vanderbilt argues that this modification
directly uses the results of the Vanderbilt Scientists' research. ICOS responds that the
modifications were all part of a standard trial and error procedure that would be tried
with any molecules of interest.
The only evidence of record regarding Glaxo's modifications to GR30040x is the
testimony of Dr. Daugan and Dr. Labaudieniere. Dr. Daugan testified that "[t]he first
thing [he] did in this series was explore the replacement of the pyridinyl[] moiety with
other heterocyclic or aromatic moieties." Dr. Labaudiniere testified that there are a
2009-1258 13
standard group of substitutions or additions that would be tried with any molecules of
interest. Dr. Labaudiniere characterizes the modifications leading to tadalafil as
"obvious" and conducted in a "trial-and-error" fashion. There is no testimony or
documentary evidence demonstrating a link between the Vanderbilt Scientists and
Dr. Daugan prior to the identification of tadalafil. Indeed, Vanderbilt admitted in the
district court that it had no direct evidence to support its view of the facts; instead
Vanderbilt argued that it "need not prove specifically how that occurred, but simply how
it logically could have occurred."
V
Vanderbilt's challenge to the stated inventorship of the '006 and '329 patents
turns on competing claims to inventorship of GR30040x and to tadalafil. As explained
above, Vanderbilt admits that no direct evidence supports its claims to joint
inventorship. Nonetheless, Vanderbilt argues that Dr. Labaudiniere could not have
identified GR30040x as a lead compound independently; nor could Dr. Daugan have
identified tadalafil on his own. ICOS counters Vanderbilt's arguments with direct
evidence supporting Dr. Labaudiniere's claim to sole identification of GR30040x and
with similar direct evidence pointing to Dr. Daugan's independent discovery of tadalafil.
To succeed on its claim to joint inventorship, Vanderbilt must prevail by clear and
convincing evidence. Our precedent has long required proof of misjoinder or nonjoinder
of co-inventors by clear and convincing evidence. 3 See Eli Lilly & Co. v. Aradigm
3
Vanderbilt recognizes that the clear and convincing evidence test for
correction of inventorship is settled law which binds the court. It suggests that the law
should be changed to a lower standard of proof, namely preponderance of the
evidence, and that under the lower test it should prevail in this case. We express no
view on whether Vanderbilt would prevail under a preponderance of the evidence test.
2009-1258 14
Corp.,376 F.3d 1352, 1364 (Fed. Cir. 2004); Ethicon v. U.S. Surgical Corp., 135 F.3d
1456, 1460-61 (Fed. Cir. 1998); Hess v. Advanced Cardiovascular Sys., Inc., 106 F.3d
976, 980 (Fed. Cir. 1997). The district court correctly concluded that Vanderbilt failed to
meet its burden.
We find no clear error in the district court's factual findings underpinning its
determination regarding Glaxo's identification of GR30040x. The district court noted
that "there is a close proximity in time of the relevant events which renders plausible
plaintiff's theory that Glaxo did take note of [the Vanderbilt IBMX compound] and
incorporated the 'Vanderbilt Structural Features' into the beta-carboline research it was
conducting." Vanderbilt Univ. v. ICOS Corp., 594 F. Supp. 2d 482, 506 (D. Del. 2009).
However, after a thorough review of all of the evidence, the district court concluded "the
court views plaintiff's theory (which is devoid of evidence regarding the alleged
substructure searches based on [the Vanderbilt IBMX compound]) and defendant's
story (which is devoid of the aforementioned foundation) equally plausible with respect
to the identification of GR30040x." Id. We agree that Vanderbilt fails to present clear
and convincing evidence to support its argument that the work of the Vanderbilt
Scientists was appropriated by Dr. Labaudiniere for his substructure search.
As for Vanderbilt's argument that Dr. Daugan made use of the Vanderbilt
Scientists' research for the modifications to GR30040x, the district court noted that
"plaintiff admitted that Corbin, Francis and Konjeti never had any direct communication
with Daugan regarding this subject matter." Id. at 505 n.50. The district court also
Vanderbilt is of course free to seek en banc reconsideration of our settled law on this
issue.
2009-1258 15
noted "a lack of evidence" supporting Vanderbilt's request for an inference that
Dr. Labaudiniere communicated the Vanderbilt Structural Features to Dr. Daugan. Id.There is nothing in the record to suggest that these factual findings are erroneous.
Thus, Vanderbilt also fails to present clear and convincing evidence to support its
argument that the modifications to GR30040x by Dr. Daugan made use of the
Vanderbilt Scientists' research.
VI
Vanderbilt makes much of what it perceives to be an error of law committed by
the district court. We agree 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. These errors, however, do
not affect the outcome of this appeal and are therefore harmless in context. When
tested by the correct law, the facts of the case still require affirmance.
The 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. The district court ruled that because the Vanderbilt Structural Features
constitute no more than a portion of a claimed compound, the Vanderbilt Scientists
cannot, as a matter of law, be joint inventors. Vanderbilt Univ., 594 F. Supp. 2d at 505.
The district court hinged this portion of its opinion on the following language from
American Bioscience:
Having in mind specific portions of a claimed compound is not the same
as conceiving the compound with all of its components. One must have a
conception of the specific compounds being claimed, with all of their
component substituents . . . .
2009-1258 16
333 F.3d at 1340. Yet, when this language from American BioScience is reviewed in
context, the district court's error is clear.
The portion of the opinion quoted by the district court phrased the question under
review as "whether the district court erred in determining that the FSU scientists were
true inventors of the claimed compounds." Id. (emphasis added). In American
BioScience the court was faced with choosing between two competing groups of
inventors.
Prior to the invention of the compounds at issue in American BioScience,
Dr. Tao, a scientist at Florida State University ("FSU"), left FSU to join a group of
scientists at American BioScience that were working on similar subject matter. Id. at
1333-35. Shortly after Dr. Tao joined American BioScience, the company filed a patent
application that led to the patent in suit, which claimed three taxol analog compounds.
The patent named Dr. Tao and three American BioScience scientists as joint inventors.
In the district court, FSU claimed that the patent named the wrong inventors. FSU
asserted that three of its scientists, along with Dr. Tao, were the correct team of joint
inventors. The district court reviewed the evidence on behalf of both competing teams
of joint inventors, and concluded that the FSU team was the true group of joint
inventors. Accordingly, the district court ordered that the three American BioScience
scientists be removed from the patent and the patent be corrected to add the three FSU
scientists as inventors. Bd. of Educ. v. Am. BioScience, Inc., No. 4:99cv131/RV, 2001
WL 34104924, at *11 (N.D. Fla. 2001).
American BioScience appealed to this court, arguing clear error in the fact
findings made by the district court to support its correction of inventorship. Because the
2009-1258 17
record provided no evidence of conception by any of the FSU scientists, acting
individually or together, this court found clear error in awarding inventorship to the FSU
joint inventor team. Properly understood, American BioScience correctly states the law
governing joint inventorship. Absent conception within an inventorship team, there can
be no invention.
This court began its inquiry with the statement that "[i]nvention requires
conception, and 'conception does not occur unless one has a mental picture of the
structure of the chemical . . . or whatever characteristics sufficiently distinguish it. It is
not sufficient to define it solely by its principal biological property.'" American
BioScience, 333 F.3d at 1340 (quoting Amgen Inc. v. Chugai Pharm. Co., 927 F.2d
1200, 1206 (Fed. Cir. 1991)). This court held that the FSU group could not have been
the true inventors unless the group had a complete mental picture of the structure of the
chemical compounds at issue, and continued its analysis with the language relied upon
by the district court. See id. at 1340 ("One must have a conception of the specific
compounds being claimed, with all of their component substituents, and the record does
not support a finding that [anyone in the FSU group] conceived the three claimed
compounds . . . .").
While it is true that the court used the term "one" in reference to conception, it is
apparent from context that the court was referring to "the inventor" or, in the case of
joint inventors, "the group of inventors." Thus, in American BioScience, the court found
that the FSU inventors were not part of any group or collaboration that together
envisioned the final claimed compounds. This is because "[w]hile Holton may have
invented many of the compounds synthesized in his laboratory . . . there is nonetheless
2009-1258 18
no evidence of conception by Holton or anyone else at FSU of analogs having the
[required combination of molecules]." Id. at 1341. The court's finding in American
BioScience was premised on the fact that the FSU and American BioScience scientists
were not working together, but rather competing for the patent rights in the compounds
at issue. There was no evidence of conception within the FSU group, and this court
found sufficient evidence of conception within the American BioScience group.
Vanderbilt is correct that the district court erred in reading American BioScience
to find that each co-inventor must have an independent mental picture of the complete
compound claimed. Such 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. Similarly, 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. Vanderbilt Univ., 594 F. Supp. 2d at
506-07. "The determination of whether a person is a joint inventor is fact specific, and
no bright-line standard will suffice in every case." Fina Oil & Chem. Co. v. Ewen,
123 F.3d 1466, 1473 (Fed. Cir. 1997). Our case law was not intended to create such a
bright line rule as was used by the district court.
As previously stated, the 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
2009-1258 19
the Vanderbilt Scientists contributed to the identification of GR30040x 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.
COSTS
No costs.
AFFIRMED
2009-1258 20
United States Court of Appeals for the Federal Circuit
2009-1258
VANDERBILT UNIVERSITY,
Plaintiff-Appellant,
v.
ICOS CORPORATION,
Defendant-Appellee.
Appeal from the United States District Court for the District of Delaware
in case no. 05-CV-506, Judge Sue L. Robinson.
DYK, Circuit Judge, concurring in part and dissenting in part.
There is no question that the district court applied the wrong standard for joint
inventorship. The majority agrees, and I agree. However, I respectfully dissent from
the majority’s conclusion that the district court’s legal error was harmless, because in
my view, the findings are either contradictory or infected by the court’s legal error. I
would vacate the judgment and remand, requiring the district court to make findings of
fact in light of the correct law.
I
Vanderbilt University (“Vanderbilt”) argues that its scientists—Drs. Jackie D.
Corbin, Sharron H. Francis, and Sekhar R. Konjeti (“the Vanderbilt scientists”)—should
be added as joint inventors to the patents in suit under two theories: (1) Dr. Richard
Labaudiniere (“Labaudiniere”) at Glaxo, Inc. (“Glaxo”) used the Vanderbilt scientists’
disclosure of 8-(4-hydroxy phenylthio)-IBMX to identify the compound GR30040x, which
was in turn used by Dr. Alain Daugan (“Daugan”), the sole inventor listed on the patents
in suit, and (2) Daugan used the Vanderbilt scientists’ disclosure of 8-(4-hydroxy
phenylthio)-IBMX to modify GR30040x and create the patented compounds. ICOS
Corporation (“ICOS”) 1 responds that the Vanderbilt scientists’ disclosure played no role
in Glaxo’s identification of GR30040x or the patented compounds. I agree with the
majority that the district court’s findings with respect to the second theory are not clearly
erroneous. The court found that Daugan did not himself directly utilize the Vanderbilt
scientists’ contributions; this finding was supported by Daugan’s testimony that he was
not aware of the contributions and Labaudiniere’s testimony that he did not forward the
Vanderbilt scientists’ work to Daugan.
However, the findings with respect to the first theory were either tainted by the
district court’s legal error or are contradictory on their face. The district court found that
the Vanderbilt scientists did in fact make contributions to Glaxo’s work, a point the
majority ignores. After incorrectly explaining that the Vanderbilt scientists could not be
joint inventors because there was no evidence that they had ever conceived the
complete patented compound, the district court went on to state:
This 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.
Vanderbilt Univ. v. ICOS Corp., 594 F. Supp. 2d 482, 505 (D. Del. 2009) (quoting Eli
Lilly & Co. v. Aradigm Corp., 376 F.3d 1352, 1358–59 (Fed. Cir. 2004)) (emphases
added). The district court also found that ICOS’s position that Glaxo made no use of
1
In 1991, Glaxo and ICOS entered into a collaboration agreement wherein
all rights, title, and interest in the compounds ultimately covered by the patents in suit
were assigned to ICOS.
2009-1258 2
the Vanderbilt scientists’ disclosures was “untenable.” Id. at 505–06. It further stated
that ICOS “loses credibility in the court’s view for failing to acknowledge that Glaxo
made any use of plaintiff’s disclosure.” Id. at 506. The court even cited a number of
factors supporting its finding that Glaxo relied on the Vanderbilt scientists’ work in
Glaxo’s research: the disclosed potency of 8-(4-hydroxy phenylthio)-IBMX, the common
structure of the compounds, and the short time between the Vanderbilt disclosure and
Glaxo’s identification of GR30040x. Id. at 505–06.
At the same time, the district court found that ICOS’s theory as to how
Labaudiniere identified GR30040x was unsupported. Prior to trial, ICOS asserted that
Labaudiniere identified GR30040x by following up on research reported in two journal
articles. Id. at 496. But after it was shown that one of those articles was not published
until after GR30040x had been tested, ICOS offered a different story at trial. ICOS
claimed that Labaudiniere arrived at GR30040x by performing substructure searches
based on the tetrahydro beta-carboline fragment of GR35273, a compound discovered
in a separate Glaxo program. See id. at 497–98. However, the district court noted that
“nowhere in its papers did [ICOS] articulate why Labaudiniere selected tetrahydro beta-
carbolines (more specifically, the tetrahydro beta-carboline fragment of GR35273) for
his substructure searches.” Id. at 506.
Thus the district court found that the Vanderbilt scientists did make a contribution
to the identification of GR30040x. The district court then went on to find that
“[Vanderbilt]’s theory (which is devoid of evidence regarding the alleged substructure
searches based on 8-(4-OH-PT)-IMBX [sic]) and [ICOS]’s story (which is devoid of the
aforementioned foundation) [are] equally plausible with respect to the identification of
2009-1258 3
GR30040x.” Id. at 506 (emphasis added). As a footnote to this finding, the district court
added: “Notably, even if GR30040x were the invention, the balance would not so tip in
favor of plaintiff such as to constitute clear and convincing evidence.” Id. at 506 n.53.
II
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 GR30040x if it were “equally plausible” that
they did not make a contribution. In this situation, we must send the case back to the
district court so that it can reconsider its findings. Both this circuit and other circuits
have uniformly found that judgments based on contradictory findings cannot stand.
See, e.g., Essex Electro Eng’rs, Inc. v. Danzig, 224 F.3d 1283, 1295 (Fed. Cir. 2000);
Mattson v. Dep’t of Treasury, 86 F.3d 211, 215 (Fed. Cir. 1996); Lyles v. United States,
759 F.2d 941, 944 (D.C. Cir. 1985); Grano v. Dep’t of Dev. of City of Columbus, 637
F.2d 1073, 1081–82 (6th Cir. 1980); Legate v. Maloney, 334 F.2d 704, 708 (1st Cir.
1964).
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.” Vanderbilt, 594 F. Supp. 2d at 505 (citations
2009-1258 4
omitted). In particular, the district court misinterpreted our decision in American
Bioscience when it stated that the Vanderbilt scientists could not be joint inventors
“even if the court were to find that [their] disclosure of 8-(4-OH-PT)-IMBX [sic] led to the
identification of GR30040x and the subsequent discovery of [the patented compounds]”
because “the contribution of a molecular scaffold in the context of one molecule . . .
[could not] render[] the disclosing party or parties [joint] inventors of a different family of
molecules containing the same scaffold.” Id. at 506–07; see Bd. of Educ. ex rel. Bd. of
Trustees of Fla. State Univ. v. Am. BioScience, Inc., 333 F.3d 1330 (Fed. Cir. 2003).
The majority correctly rejected this legal error. See Majority Op. at 19.
An alleged joint inventor does not have to conceive of the entire claimed
invention, as the district court mistakenly required. He merely must contribute to the
conception of the claimed invention. Eli Lilly, 376 F.3d at 1359. There is “no explicit
lower limit on the quantum or quality of inventive contribution required for a person to
qualify as a joint inventor.” Fina Oil & Chem. Co. v. Ewen, 123 F.3d 1466, 1473 (Fed.
Cir. 1997). The law does not require that the joint inventors physically work together or
at the same time, or each make the same level of contribution. 35 U.S.C. § 116; see
also Kimberly-Clark Corp. v. Procter & Gamble Distrib. Co., 973 F.2d 911, 917 (Fed.
Cir. 1992) (providing “one inventor seeing a relevant report and building upon it” as an
example of joint inventive effort). A joint inventor need only “make a contribution to the
conception of the claimed invention that is not insignificant in quality, when that
contribution is measured against the dimension of the full invention.” Fina Oil, 123 F.3d
at 1473. While the district court found that the Vanderbilt scientists made some
contribution, it has not told us exactly what that contribution was or why that contribution
2009-1258 5
was not enough to make the Vanderbilt scientists joint inventors under the correct
standard. If the Vanderbilt scientists made contributions, as the district court found, the
fact that those contributions may not have been “appropriated by Dr. Labaudiniere for
his substructure search,” Majority Op. at 15, does not foreclose the possibility that the
Vanderbilt scientists’ contribution was sufficient to make them joint inventors.
Because the district court’s findings were either contradictory or tainted by legal
error, I think we must vacate the judgment of the district court and remand in order that
the court may make factual findings under the proper law. I dissent from the majority’s
decision to affirm what I view as an untenable district court decision.
2009-1258 6