**United States Court of Appeals for the Federal Circuit**

03-1336, -1337

ELI LILLY AND COMPANY,

> Plaintiff-Appellant,

v\.

ARADIGM CORPORATION,

> Defendant-Cross Appellant.

[Donald E. Knebel]{.underline}, Barnes & Thornburg, of Indianapolis,
Indiana, argued for plaintiff-appellant. With him on the brief were
[Todd G. Vare]{.underline} and [Erin Roth Bohannon]{.underline}.

[Gregory A. Castanias]{.underline}, Jones Day, of Washington, DC, argued
for defendant-cross appellant. With him on the brief were [Tharan
Gregory Lanier]{.underline} of Menlo Park, California, and [Todd
Geremia]{.underline} of New York, New York.

Appealed from: United States District Court for the Southern District of
Indiana

Judge Richard L. Young

**United States Court of Appeals for the Federal Circuit**

03-1336, -1337

ELI LILLY AND COMPANY,

Plaintiff-Appellant,

v\.

ARADIGM CORPORATION,

Defendant-Cross Appellant.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

DECIDED: July 20, 2004

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Before LOURIE, CLEVENGER, and GAJARSA, [Circuit Judges]{.underline}.

Opinion for the court filed by [Circuit Judge]{.underline} CLEVENGER.
Concurring opinion filed by [Circuit Judge]{.underline} LOURIE.

CLEVENGER, [Circuit Judge]{.underline}.

Eli Lilly and Company (\"Lilly\") sued Aradigm Corporation (\"Aradigm\")
seeking, [inter alia]{.underline}, to have two of its scientists
recognized as joint inventors on Aradigm\'s U.S. Patent No. 5,888,477
(\"the \'477 patent\"). Based on a jury verdict, the United States
District Court for the Southern District of Indiana entered final
judgment in favor of Lilly insofar as it ordered the Patent and
Trademark Office to add one of Lilly\'s scientists, Dr. DiMarchi, as an
inventor. [Eli Lilly & Co. v. Aradigm Corp.]{.underline}, No. IP
98-828-C-Y/F (S.D. Ind. Mar. 5, 2003). On the inventorship issue,
Aradigm cross appeals and we reverse.

In the same district court proceedings, Lilly also sought to recover
damages based on contract and unjust enrichment causes of action. The
district court entered final judgment in favor of Aradigm on the unjust
enrichment claim and in favor of Lilly on the contract claim, but it
awarded only nominal contract damages to Lilly. [Id.]{.underline} Lilly
appeals the district court\'s judgment on these state law claims, and we
affirm.

I

Lilly is a pharmaceutical company. In May 1996, U.S. Patent No.
5,514,646 (\"the \'646 patent\") issued to Lilly. It claims among other
inventions the insulin analog \"lispro\" (now commercially marketed by
Lilly as Humalog^®^), and it lists Dr. DiMarchi as an inventor.
Traditionally, regular, or natural, insulin is administered by
subcutaneous injection, [i.e.]{.underline}, via a needle that deposits
the insulin under the skin, to help diabetics regulate their blood
glucose levels. When regular insulin molecules are in aqueous solution
in the syringe, they self-associate into a stable hexamer, or
six-molecule cluster. It is believed that the approximately
thirty-minute delay between the insulin\'s injection and the onset of
its therapeutic effect can be traced to the time required for the
hexamer delivered under the skin to disassociate into unclustered
monomers and to diffuse away from the injection site and into the blood
stream.

Lispro is a modified version of regular insulin. Like all proteins,
insulin is a molecule made up of linear sequences of amino acids strung
together in chains. Lispro is comprised of chains of amino acids
identical to those in regular insulin except that two amino acids at one
point in one of the chains are reversed in order. According to the \'646
patent, this slight structural alteration makes lispro \"less prone to
. . . self-association\" than regular insulin and endows lispro with \"a
comparatively more rapid onset of activity,\" while at the same time
enabling lispro to \"retain\[\] the biological activity of \[regular\]
insulin.\" \'646 patent, col. 1, ll. 17-20. In other words,
\"\[a\]lthough \[lispro\] exists in solution as a hexamer, it very
rapidly disassociates into a virtually entirely monomeric form following
subcutaneous administration . . . \[permitting it to be\] absorbed
quantitatively faster than \[regular\] insulin after subcutaneous
administration.\" \'477 patent, col. 12, ll. 14-19.

Aradigm\'s business focuses on drug delivery through the inhalation of
aerosols. In January 1997, a number of Aradigm scientists filed a patent
application that, in March 1999, issued as the \'477 patent. Titled
\"Use of Monomeric Insulin as a Means for Improving the Bioavailability
of Inhaled Insulin,\" Aradigm\'s \'477 patent claims methods of
aerosolized administration of lispro, among other monomeric insulin
analogs, in which the lispro \"quickly enters the circulatory system
after being inhaled into the lung.\" [Id.]{.underline} at col. 3, ll.
9-10. One difficulty with administering regular insulin in aerosolized
form is believed to be that inhaled insulin \"is sequestered in the lung
to a significant degree\" and therefore does not rapidly or predictably
enter the bloodstream where insulin must be located to have its
therapeutic effect. [Id.]{.underline} at col. 13, l. 8. When filing the
\'477 patent, Aradigm believed that inhalation of lispro instead of
regular insulin would reduce the tendency of insulin to remain in the
lungs because, \"as with subcutaneous delivery, the disassociation of
insulin from hexameric to monomeric form is an important first step
prior to the absorption of insulin into the blood stream,\" and because
lispro dissociates more rapidly than regular insulin does.
[Id.]{.underline} at col. 13, ll. 15‑18.

> As relevant to this appeal, the \'477 patent contains the following
> method claims:
>
> 5\. A method of improving the bioavailability of insulin delivered via
> the lung, comprising:
>
> aerosolizing a formulation of an insulin analog which analog rapidly
> disassociates into monomeric form;
>
> inhaling the aerosolized formulation of the insulin analog into the
> lungs in a manner which allows the particles of the insulin analog to
> deposit on the lung tissue.
>
> 6\. The method of claim 5, wherein the inhaled insulin analog is
> insulin lispro which rapidly disassociates in a monomeric form
> producing a relative bioavailablity greater than twice that seen after
> the inhalation of a similar amount of recombinant human insulin.
>
> 15\. A method of reproducibly effecting a serum glucose level,
> comprising:
>
> aerosolizing a formulation comprising monomeric insulin;
>
> administering the aerosolized formulation.
>
> 17\. The method of claim 15, wherein the monomeric insulin is insulin
> lispro.

[Id.]{.underline} at col. 49, l. 65 to col. 50, l. 10; col. 50, ll.
38-42, 48-49.

II

All of Lilly\'s allegations reduce to a single alleged wrong: that
Aradigm improperly appropriated information about the advantages of
pulmonary delivery of lispro from Lilly and incorrectly claimed the
invention in the \'477 patent as exclusively its own. In 1995 and 1996,
Lilly and Aradigm held four meetings to discuss a possible collaboration
that would take advantage of Lilly\'s expertise in insulin compounds and
Aradigm\'s expertise in aerosolized drug delivery. Several scientists
from Lilly were involved in the four meetings with Aradigm scientists:
In June and November of 1995, Dr. Harrison from Lilly attended; in June
1996, Dr. Roeder from Lilly attended; and in July 1996, Drs. DiMarchi
and Wolff from Lilly, among others, attended. Lilly insists that its
scientists conveyed to Aradigm during these meetings the specific
advantages to be expected from using lispro instead of regular insulin
in an aerosol delivery device.

In the district court, Lilly brought a claim under 35 U.S.C. § 256 to
address the alleged omission of Drs. Harrison and DiMarchi from the list
of inventors on the \'477 patent,[^1] arguing to the jury that both were
joint inventors of the inventions in dependent claims 6 and 17. The
verdict form instructed the jury to answer whether or not Lilly had
proved by clear and convincing evidence that either Dr. Harrison or Dr.
DiMarchi had contributed to either of the two following inventions:
\"inhaling an aerosolized formulation of insulin lispro into the lungs,
which produces a relative bioavailability greater than twice that seen
after the inhalation of a similar amount of \[regular\] insulin,\" or
\"a method for aerosolizing a formulation of insulin lispro and
administering that aerosolized formulation.\" The former states the
invention of claim 6, and the latter states the invention of claim 17.
The jury found that Dr. DiMarchi only---not Dr. Harrison---was a
co-inventor of the former invention claimed in claim 6, but that neither
Lilly scientist was a co-inventor of the latter invention of a method
for aerosolizing and administering lispro claimed in claim 17.

In its cross-appeal, which we address first, Aradigm argues that the
jury verdict finding Dr. DiMarchi to be a co-inventor of claim 6 cannot
stand. Aradigm argues that the district court\'s instructions to the
jury on the inventorship issue were legally erroneous, and that, even if
the instructions were not erroneous, Lilly did not introduce substantial
evidence to demonstrate by clear and convincing evidence that Dr.
DiMarchi was a co-inventor of the invention in claim 6. We hold that the
instructions were not erroneous, but that the record does not contain
substantial evidence to support the jury\'s finding that Dr. DiMarchi
was a co-inventor given Lilly\'s clear and convincing burden of proof on
the issue. Lilly argues that, if we reverse the jury verdict due to
insufficient evidence, a new trial is required because Lilly should only
have been required to satisfy a preponderance of the evidence burden of
proof to demonstrate co-inventorship.[^2] We reject this argument.[^3]

Lilly also tried two contract claims and an unjust enrichment claim to
the jury. These claims resulted in only two dollars of nominal damages
against Aradigm. In its post-judgment briefing, Lilly did not argue that
the jury\'s findings on these claims were incorrect. Instead, Lilly
argued that the jury\'s findings demonstrated that Lilly was entitled to
an injunction prohibiting Aradigm from continuing to file and prosecute
patent applications containing information in which Lilly retains
contractual or equitable rights. The district court denied Lilly\'s
requests for injunctive relief, and Lilly appeals this denial to us. We
affirm.

We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(1).

III

Section 256 creates a cause of action in the district courts for
correction of non-joinder of an inventor on a patent provided the
non-joinder error occurred without deceptive intent. [See]{.underline}
35 U.S.C. § 256 (2000) (permitting correction of inventorship
\"\[w\]henever . . . through error an inventor is not named in an issued
patent and such error arose without any deceptive intention on his
part\"); [MCV, Inc. v. King-Seeley Thermos Co.]{.underline}, 870 F.2d
1568, 1571 (Fed. Cir. 1988) (holding that deceptive intent in failing to
join an inventor would not permit correction of inventorship under
section 256 and could invalidate the patent).[^4]

In a section 256 proceeding, \"\[t\]he inventors as named in an issued
patent are presumed to be correct.\" [Hess v. Advanced Cardiovascular
Sys., Inc.]{.underline}, 106 F.3d 976, 980 (Fed. Cir. 1997). The general
rule is that a party alleging misjoinder or non-joinder of inventors
must meet the heavy burden of proving its case by clear and convincing
evidence, [see]{.underline} [id.]{.underline} (citing [Garret Corp. v.
United States]{.underline}, 422 F.2d 874, 880 (Ct. Cl. 1970)),[^5] and
must provide evidence to corroborate the alleged joint inventor\'s
conception, [see]{.underline} [Ethicon, Inc. v. United States Surgical
Corp.]{.underline}, 135 F.3d 1456, 1461 (Fed. Cir. 1998) (holding that
\"an alleged co-inventor must supply evidence to corroborate his
testimony\" of conception).

Section 116 of Title 35 is the statutory locus of joint inventorship
doctrine. It provides that a person not listed on a patent need not
demonstrate that he made a contribution equal in importance to the
contribution made by the listed inventors to claim his right to joint
inventor status. [See]{.underline} 35 U.S.C. § 116 (2000) (\"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.\"). In fact, section
116 \"sets 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]{.underline}, 123 F.3d 1466,
1473 (Fed. Cir. 1997). However, a long line of decisions in this court
holds that a person is a joint inventor only if he contributes to the
conception of the claimed invention. [See, e.g.]{.underline}, [C.R.
Bard, Inc. v. M3 Sys., Inc.]{.underline}, 157 F.3d 1340, 1352 (Fed. Cir.
1998); [Fina Oil]{.underline}, 123 F.3d at 1473 (\"The case law thus
indicates that to be a joint inventor, an individual must 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.\"); [Sewall v. Walters]{.underline}, 21
F.3d 411, 415 (Fed. Cir. 1994); [see also]{.underline} [Burroughs
Wellcome Co. v. Barr Labs., Inc.]{.underline}, 40 F.3d 1223, 1227-28
(Fed. Cir. 1994) (\"Conception is the touchstone of inventorship, the
completion of the mental part of invention.\"). The line between actual
contributions to conception and the remaining, more prosaic
contributions to the inventive process that do not render the
contributor a co-inventor is sometimes a difficult one to draw.
Contributions to realizing an invention may not amount to a contribution
to conception if they merely explain what was \"then state of the art,\"
[Hess]{.underline}, 106 F.3d at 981, if they are too far removed from
the real-world realization of an invention, [see, e.g.]{.underline},
[Garret Corp.]{.underline}, 422 F.2d at 881 (\"One who merely suggests
an idea of a result to be accomplished, rather than means of
accomplishing it, is not a joint inventor.\"), or if they are focused
solely on such realization, [see, e.g.]{.underline},
[Ethicon]{.underline}, 135 F.3d at 1460 (\"\[O\]ne does not qualify as a
joint inventor by merely assisting the actual inventor after conception
of the claimed invention.\").

It is however uncontroversial that the alleged joint inventor seeking to
be listed on a patent must demonstrate that his labors were conjoined
with the efforts of the named inventors. Joint inventorship under
section 116 can only arise when collaboration or concerted effort
occurs---that is, when the inventors have some open line of
communication during or in temporal proximity to their inventive
efforts:

> What is clear is that the statutory word \"jointly\" is not mere
> surplusage. 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 suggestion at a
> meeting. . . .
>
> \[J\]oint inventorship under Section 116 requires at least some
> quantum of collaboration or connection.

[Kimberly-Clark Corp. v. Procter & Gamble Distrib. Co.]{.underline}, 973
F.2d 911, 917 (Fed. Cir. 1992).

A

First, we review Aradigm\'s suggestion that the jury instructions are
erroneous. We apply the law of the regional circuit in which the
district court sits, here the Seventh Circuit, to this issue. \"The
standard of review for jury instructions is prejudicial legal error.\"
[Tex. Digital Sys., Inc. v. Telegenix, Inc.]{.underline}, 308 F.3d 1193,
1201 (Fed. Cir. 2002); [see also]{.underline} [Hasham v. Cal. State Bd.
of Equalization]{.underline}, 200 F.3d 1035, 1051 (7th Cir. 2000)
(\"\[T\]he first question to be answered is whether the instructions
misstate or insufficiently state the law. If they do, \[the next\]
question \[is\] whether the flawed instruction \'confused or misled the
jury causing prejudice to a litigant.\'\" (quoting [Doe v.
Burnham]{.underline}, 6 F.3d 476, 479 (7th Cir. 1993) (citation
omitted))). \"In reviewing the correctness of jury instructions, the
United States Court of Appeals for the Seventh Circuit \'look\[s\] to
the instructions as a whole, in a common sense manner, avoiding
fastidiousness, inquiring whether the correct message was conveyed to
the jury reasonably well.\'\" [C&F Packing Co. v. IBP,
Inc.]{.underline}, 224 F.3d 1296, 1303 (Fed Cir. 2000) (quoting [Wilk v.
Am. Med. Ass\'n]{.underline}, 719 F.2d 207, 218 (7th Cir. 1983)). \"A
party seeking to alter a judgment based on erroneous jury instructions
must establish that (1) it made a proper and timely objection to the
jury instructions, (2) those instructions were legally erroneous, (3)
the errors had prejudicial effect, and (4) it requested alternative
instructions that would have remedied the error.\" [Advanced Display
Sys., Inc. v. Kent State Univ.]{.underline}, 212 F.3d 1272, 1281 (Fed.
Cir. 2000) (citations omitted). If the challenging party prevails, then
it is entitled to a new trial. [Ecolab Inc. v. Paraclipse,
Inc.]{.underline}, 285 F.3d 1362, 1373 (Fed. Cir. 2002). \"Whether a
jury instruction is legally erroneous is a question of law,\" and thus
is reviewed without deference to a trial court. [Id.]{.underline}

Aradigm initially argues that the district court erred by not construing
claim 6 before sending the inventorship issue to the jury. It is true
that the legal scope of a claim must be known before the contributions
of an alleged co-inventor can be compared to that claim to determine
whether the correct inventors were named. [See]{.underline} [Trovan,
Ltd. v. Sokymat SA, Irori]{.underline}, 299 F.3d 1292, 1302 (Fed. Cir.
2002) (\"\[A\]n inventorship analysis, like an infringement or
invalidity analysis, begins as a first step with a construction of each
asserted claim to determine the subject matter encompassed thereby. The
second step is then to compare the alleged contributions of each
asserted co-inventor with the subject matter of the properly construed
claim to then determine whether the correct inventors were named.\"
(citation omitted)). Aradigm, however, never requested that the district
court construe any terms in claim 6 and never offered a construction of
claim 6. Only after the presentation of all of the evidence to the jury
did Aradigm even suggest that claim construction might be helpful to
determine the proper scope of the claimed invention. We hold that
Aradigm has waived its right to request a construction of claim 6 and
that Aradigm has thereby implicitly conceded that the meanings of the
terms in claim 6 are clear and not in need of construction.
[See]{.underline} [United States Surgical Corp. v. Ethicon,
Inc.]{.underline}, 103 F.3d 1554, 1568 (Fed. Cir. 1997) (holding that
claim construction is required only \"when the meaning or scope of
technical terms and words of art is unclear and in dispute and requires
resolution to determine\" the issue before the court).

Likely realizing the difficulties of requesting a claim construction at
such an advanced stage of the proceedings, Aradigm next falls back to
argue that the jury instructions on inventorship of claim 6 are error
because the description in the instructions of the invention to which
Dr. DiMarchi was alleged to have contributed prejudicially paraphrased
the actual language of claim 6. The jury was presented with descriptions
of the invention of claim 6 in two places. First, in final instruction
number 20, the jury was told that: \"The \'inventions\' at issue in this
case include: . . . that aerosolized lispro produces a relative
bioavailability greater than twice that seen after the inhalation of a
similar amount of \[regular\] human insulin.\" Second, as earlier
described, the jury\'s verdict form described the invention in claim 6
as \"inhaling an aerosolized formulation of insulin lispro into the
lungs, which produces a relative bioavailability greater than twice that
seen after the inhalation of a similar amount of \[regular\] insulin.\"
At trial, Aradigm objected to the paraphrasing in jury instruction 20
and the special verdict question, noting that \"the jury should be
directed to the specific claims to which Lilly claims to have made a
contribution rather than these characterizations of the claims,\" that
\"a characterization of the claims will confuse the jury,\" and \"that a
characterization of the claims simply by pulling words out of them is
not a complete description of what is claimed.\"

We hold that Aradigm cannot demonstrate error in the paraphrasing that
merits a new trial for two reasons. First, Aradigm\'s objection was not
sufficiently specific to preserve its prejudicial paraphrasing argument
on appeal. It is black letter law that objections must state
\"distinctly the matter objected to and the grounds of the objection.\"
Fed. R. Civ. P. 51 (2002); [see also]{.underline} [Avern Trust v.
Clarke]{.underline}, 415 F.2d 1238, 1241 (7th Cir. 1969) (\"Rule 51 of
the Federal Rules of Civil Procedure precludes the assignment of error
when no specific objection to an instruction is made.\"). As the Supreme
Court has stated, the purpose of this rule is to ensure that objections
point out to a district court its alleged error so that the district
court has the first opportunity to correct the error. [See]{.underline}
[Palmer v. Hoffman]{.underline}, 318 U.S. 109, 119 (1943) (\"In fairness
to the trial court and to the parties, objections to a charge must be
sufficiently specific to bring into focus the precise nature of the
alleged error.\"). Aradigm alleged that the jury would be confused by
the paraphrase, but Aradigm\'s objection neither communicated to the
district court why the paraphrase was prejudicial nor \"br\[ought\] into
focus the precise nature of the alleged error.\" [Id.]{.underline}
Aradigm never indicated what aspect of the claim the paraphrase left
out. Generically alleging that the wording of a jury instruction is
confusing, without suggesting the logical error the jury might make,
does not give the district court the information that it requires to see
the alleged error of its ways and to have a meaningful first opportunity
to consider changing course.

Second, addressing Aradigm\'s argument on the merits, we conclude that
the jury instructions were not erroneous as a whole. Read in conjunction
with independent claim 5, dependent claim 6 claims a method comprising
the two steps of \"aerosolizing\" lispro and \"inhaling the aerosolized
formulation of \[lispro\] . . . into the lungs\" in a manner in which
the lispro \"rapidly disassociates in a monomeric form producing a
relative bioavailability greater than twice that seen after the
inhalation of a similar amount of \[regular\] insulin.\" \'477 patent,
col. 50, ll. 1, 3-4, 7-9. Although it does not recite the aerosolizing
of lispro as a distinct first step, the description of the invention on
the verdict form does contain the requirement that the invention include
\"inhaling an aerosolized formulation\" of lispro, necessarily
encompassing the step of aerosolizing. Thus we see little
difference---and certainly not a prejudicial difference---between the
language of the claim and the language of the verdict form. In fact, on
appeal, Aradigm does not allege error in the statement of the invention
on the verdict form.

The statement of the invention in instruction 20, however, recites only
one limitation on the method of aerosolizing lispro claimed in claim 6:
that aerosolized lispro satisfy the double-bioavailability limitation.
We conclude that this is not error prejudicial to Aradigm. The Seventh
Circuit \"\'look\[s\] to the instructions as a whole, in a common sense
manner, avoiding fastidiousness, inquiring whether the correct message
was conveyed to the jury reasonably well.\'\" [C&F Packing]{.underline},
224 F.3d at 1303 (quoting [Wilk]{.underline}, 719 F.2d at 218). In light
of the verdict form, any alleged error in instruction 20 did not prevent
the jury from reasonably discerning the correct message. Additionally,
the law of inventorship does not hinge co-inventor status on whether a
person contributed to the conception of all the limitations in any one
claim of the patent. Rather, the law requires only that a co-inventor
make a contribution to the conception of the subject matter of a claim.
[See]{.underline} 35 U.S.C. § 116 (\"Inventors may apply for a patent
jointly even though . . . each did not make a contribution to the
subject matter of every claim of the patent.\"); [Ethicon]{.underline},
135 F.3d at 1461-63 (granting co-inventorship status provided the person
\"contributed to the invention defined by\" a claim or \"if \[the
person\'s\] contribution found its way into the defined invention\" in a
claim). If Dr. DiMarchi had in fact conceived of the
double-bioavailability limitation on the method of inhaling lispro and
communicated this conception to Aradigm, then Dr. DiMarchi would on the
record before us be a co-inventor of claim 6 as the invention in claim 6
is nothing more than using lispro in the aerosolizing/inhaling method of
claim 5 in a manner that meets the double-bioavailability limitation.

Finally, Aradigm argues that the district court\'s paraphrase of claim 6
permitted the jury to find that Dr. DiMarchi was a co-inventor when Dr.
DiMarchi contributed only \"a mere realization about the chemical
properties of lispro\" that were in the public domain. A contribution of
information in the prior art cannot give rise to joint inventorship
because it is not a contribution to conception. [See]{.underline}
[Hess]{.underline}, 106 F.3d at 981. Aradigm\'s argument, however,
presumes that the limitation of aerosolized lispro \"producing a
relative bioavailability greater than twice that seen after the
inhalation of a similar amount of recombinant human insulin\" in claim 6
merely recites a fact of nature. Aradigm argues that the double
bioavailability of aerosolized lispro vis-á-vis aerosolized natural
insulin is inherent in all uses of aerosolized lispro, and that the
double-bioavailability language is therefore not a limitation on the
scope of claim 6 at all. Regardless of their veracity, we refuse to
accept these presumptions as proven fact for the first time at this
point in the proceedings. Furthermore, Aradigm\'s argument is not an
argument that the district court improperly paraphrased claim 6 in the
jury instructions, but is rather an argument that claim 6 requires
construction because it does not convey its scope through the plain and
clear meaning of its language. If a litigant seeks to raise such an
argument, it must press the district court to engage in claim
construction early in the proceedings. As previously discussed, Aradigm
failed to make such a timely request.

B

Next, we turn to Aradigm\'s argument that there is insufficient evidence
in the record to support the jury verdict, that is, to satisfy Lilly\'s
burden to demonstrate by clear and convincing evidence that Dr. DiMarchi
was a joint inventor of claim 6 of the \'477 patent.

Inventorship is a mixed question of law and fact: The overall
inventorship determination is a question of law, but it is premised on
underlying questions of fact. [See]{.underline} [Univ. of Colo. Found.,
Inc. v. Am. Cyanamid Co.]{.underline}, 342 F.3d 1298, 1304 (Fed. Cir.
2003); [Ethicon]{.underline}, 135 F.3d at 1460. When we review the
denial of a post-verdict motion for judgment as a matter of law on a
mixed question of law and fact given to a jury without a special verdict
form detailing the underlying questions of fact, we must sustain the
jury\'s conclusion unless the jury was not presented with substantial
evidence to support any set of implicit findings sufficient under the
law to arrive at its conclusion. [See]{.underline} [Applied Med. Res.
Corp. v. United States Surgical Corp.]{.underline}, 147 F.3d 1374, 1376
(Fed. Cir. 1998) (stating that for the appellant to prevail it must
demonstrate that \"the facts were not sufficient to support the
conclusions necessarily drawn by the jury on the way to its verdict\").

\"Substantial evidence is more than a mere scintilla. It means such
relevant evidence as a reasonable mind might accept as adequate to
support a conclusion.\" [Consol. Edison Co. v. NLRB]{.underline}, 305
U.S. 197, 229 (1938). Substantial evidence is not a fixed quantum of
evidence: What is or is not substantial may only be determined with
respect to the burden of proof that the litigant bore in the trial
court. \"For example, in reviewing whether the evidence supports a
finding of fact . . . the decision might be affirmed if the standard of
proof below were \'weight of evidence\' and might be reversed on the
same record if the standard of proof were \'clear and convincing\'
evidence.\" [SSIH Equip. S.A. v. U.S. Int\'l Trade Comm\'n]{.underline},
718 F.2d 365, 383 (Fed. Cir. 1983) (Nies, J., additional comments); [see
also, e.g.]{.underline}, [Juicy Whip, Inc. v. Orange Bang,
Inc.]{.underline}, 292 F.3d 728, 738 (Fed. Cir. 2002) (reviewing a jury
verdict for \"substantial evidence satisfying \[defendant\'s\] clear and
convincing burden of proof\" on an invalidity defense).

Dr. DiMarchi\'s claim to co-inventorship depends on the subject matter
communicated during the 1995 and 1996 meetings between Aradigm and
Lilly, and Lilly cannot demonstrate by clear and convincing evidence
that Dr. DiMarchi communicated to Aradigm\'s scientists that aerosolized
lispro might be used to produce \"a relative bioavailability greater
than twice that seen after the inhalation of a similar amount of human
insulin.\" Dr. DiMarchi did not state that he communicated this
conception to Aradigm\'s scientists. He only testified that he
remembered talking about insulin at a meeting in July of 1996, and that
he never talks about insulin without discussing lispro and its
properties:

> Q: Did you ever have occasion to discuss with Aradigm directly your
> views on the characteristics of the lispro molecule and how it would
> be effective in an aerosolized delivery system?
>
> A: \[I\]f you mention human natural insulin, I\'m thinking lispro. So
> if someone comes to me under a confidentiality agreement and starts to
> discuss insulin delivery by the pulmonary route, it is just
> inconceivable that I\'m not going to think about lispro and begin to
> talk about its virtues. (Trial Tr. 343.)
>
> Q: Do you remember discussing lispro during that meeting?
>
> A: I remember discussing insulin, and, as I have shared with you
> \[insulin and lispro\] are one -- they are synonymous. We talk about
> insulin, we are going to talk about lispro. (Trial Tr. 344.)

Dr. Wolff, another Lilly scientist testified that at this meeting
\"there was a question from Aradigm as to whether there were . . . other
molecules that Lilly might be interested in pursuing besides regular
insulin, and then Richard DiMarchi said that lispro would be one that
would be a candidate.\" (Trial Tr. 805.) Lilly also argues that an email
written by Ms. Hakes, a product development manager for Lilly,
demonstrates that Dr. DiMarchi communicated his conception of the
relevant invention. The email, however, only summarized a \"follow-up\"
on the July meeting, not the July meeting itself, in which Ms. Hakes
stated \"that different molecules \[other than natural insulin\] may
offer better treatment of diabetes than natural insulin and that lispro
was just one such example.\" None of this testimony directly states that
Dr. DiMarchi communicated to Aradigm that the bioavailability of
aerosolized insulin could be increased twofold by using lispro rather
than natural insulin. Evidence that Dr. DiMarchi merely suggested that
Aradigm try lispro in its aerosol delivery devices is insufficient to
support the jury\'s verdict on claim 6 by clear and convincing evidence.

The testimony of Lilly\'s Dr. Roeder, who met with Aradigm scientists in
June of 1996, is no more helpful to Lilly. At most, Dr. Roeder\'s
testimony shows that he too viewed lispro as a candidate for
aerosolization, but damning to Lilly, Dr. Roeder explicitly testified
that he did not mention that aerosolized lispro should be used to
produce a relative bioavailability greater than twice that seen after
inhalation of human insulin.

Without any direct evidence of communication of conception, Lilly relies
largely on circumstantial evidence. Lilly argues that there is no
evidence in the record that Aradigm was considering using lispro in an
aerosol device prior to the July 1996 meeting, that emails and notes
demonstrate Aradigm\'s post-meeting interest, and that the January 1997
application for the \'477 patent proves Aradigm\'s firm grasp of the
concept shortly thereafter. Lilly argues that the jury\'s inference that
Dr. DiMarchi communicated the idea at the July 1996 meeting of
aerosolizing lispro rather than insulin to increase bioavailability
twofold is therefore a permissible inference. We disagree. While
circumstantial evidence may in some cases be sufficient to surmount the
clear and convincing evidence burden of proof, we conclude that the
circumstantial evidence presented here is insufficient and that the
jury\'s verdict cannot stand.

C

Assuming we were to find, as we have, that there is insufficient
evidence in the record to support the jury\'s finding of clear and
convincing evidence to demonstrate Dr. DiMarchi\'s inventive
contribution to claim 6, Lilly, too, argues that the jury instructions
contain prejudicial error. Lilly argues that it need only demonstrate
that Dr. DiMarchi contributed to the conception of claim 6 by a
preponderance of the evidence. Under this less demanding trial court
burden of proof, Lilly proposes that the circumstantial evidence in the
record is sufficient to support a jury verdict in its favor and that we
must therefore remand for a new trial. [See]{.underline} [Price v.
Symsek]{.underline}, 988 F.2d 1187, 1194 (Fed. Cir. 1993) (\"\[T\]he
erroneous burden of proof utilized by the \[the tribunal below\] worked
against \[appellant\'s\] interest, [i.e.]{.underline}, it was more
difficult to overcome than the proper burden of proof. Such a situation
cannot ordinarily be classified as \'harmless.\'\"). We reject Lilly\'s
argument that a preponderance of the evidence burden is the correct
burden in this case.

Lilly does not contend that, as a general rule, the clear and convincing
evidence burden of proof announced in [Hess]{.underline},
[see]{.underline} 106 F.3d at 980, is incorrect. Rather, Lilly argues
that its non-joinder inventorship claim falls into an exception to the
[Hess]{.underline} rule to which the preponderance of the evidence
burden of proof applies. As a legal proposition, Lilly proposes that the
[Hess]{.underline} rule does not apply \"when there are two co-pending
patent applications claiming the same subject matter\" in front of the
Patent and Trademark Office (\"PTO\"), one of which issues as the patent
allegedly omitting the inventor, and the other of which was filed by the
allegedly omitted inventor. As a factual proposition, Lilly points to a
patent application that it filed prior to the issuance of Aradigm\'s
\'477 patent and alleges that its application claims the same subject
matter as the claims of the \'477 patent at issue in this inventorship
dispute.

Doctrinally, Lilly\'s argument borrows from the burden of proof used in
interference proceedings in which multiple parties claim that they
deserve exclusive rights to an invention because they were the first to
invent it. [See]{.underline} 37 C.F.R. § 1.601(i) (2003) (\"An
interference is a proceeding . . . to determine any question of
patentability and priority of invention between two or more parties
claiming the same patentable invention.\" (emphasis omitted)). To
succeed in an interference proceeding, regardless of whether it is
conducted in the PTO or a district court under 35 U.S.C. § 291, a party
that does not have the earliest effective filing date needs only to
demonstrate by a preponderance of the evidence that it was the first to
invent if the two patents or applications at issue were co-pending
before the PTO. [See]{.underline} [Slip Track Sys., Inc. v. Metal-Lite,
Inc.]{.underline}, 304 F.3d 1256, 1262 (Fed. Cir. 2002). The general
presumption of patent validity does not pertain to patent applications
before they issue, so there is no presumption that the inventors on a
patent application are correct when two claims in co-pending patent
applications assert inherently conflicting rights to the same invention.
[See]{.underline} [Apotex USA, Inc. v. Merck & Co., Inc.]{.underline},
254 F.3d 1031, 1037 n.1 (Fed. Cir. 2001). Provided the applications were
co-pending, the timing of the interference proceeding is immaterial: the
presumption of validity is nonexistent and the preponderance of the
evidence burden is appropriate even if both of the patents have issued
by the time a section 291 interference proceeding is initiated in a
district court. \"However, the presumption \[of validity\] may
effectively be implicated in the case of a priority contest between an
issued patent and an application that was filed after the issuance of
the patent. In such a situation, the junior party must establish
priority of invention by clear and convincing evidence.\"
[Id.]{.underline}

To make its burden of proof argument, Lilly does not ask us to make an
unprecedented analogical leap directly from a priority claim in an
interference proceeding to a joint inventorship claim under section 256.
Lilly argues that our decision in [Environ Products, Inc. v. Furon
Co.]{.underline}, 215 F.3d 1261 (Fed. Cir. 2000), has already taken that
step, or at least that it strongly counsels us to take that step now. We
disagree on both counts. We conclude that [Environ Products]{.underline}
has not established a preponderance of the evidence burden of proof in
section 256 joint inventorship disputes when the person allegedly
omitted from an issued patent had a co-pending patent application
claiming the same subject matter as the issued patent. Furthermore, we
decline to extend the holding of [Environ Products]{.underline} to
create such a rule.

Our [Environ Products]{.underline} opinion addressed a complicated,
multi-party infringement action. Environ accused Advanced Polymer and
Furon of infringing its patent. Both Advanced Polymer and Furon raised
invalidity defenses based on prior invention. Advanced Polymer relied on
a pending patent application to establish priority, and Furon based its
defense on its issued patent. In addition, Furon raised a defense of
invalidity alleging incorrect inventorship on Environ\'s patent and
filed a separate infringement action against Environ that was
consolidated with Enivron\'s infringement action against Furon. Thus, at
the end of the day, [Environ Products]{.underline} 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.
The parties stipulated that Environ\'s patent, Furon\'s patent, and
Advanced Polymer\'s application all claimed the same subject matter, and
they \"agreed on the description of the common subject matter that would
serve as the basis for determining who was the original inventor.\"
[Id.]{.underline} at 1263.

The district court put the inventorship issue to a jury in the form of a
special verdict form. Because Environ\'s patent had the earliest filing
date, [id.]{.underline} at 1262, the special verdict form required
Advanced Polymer and Furon to provide clear and convincing evidence of
priority of invention to prevail but only required Environ to provide
preponderant evidence of priority to prevail, [id.]{.underline} at 1264.
The jury found Environ to be the original inventor of the common subject
matter. [Id.]{.underline} at 1262.

On appeal, the Federal Circuit held that all parties in the priority
contest should only have had to prove their claim to original
inventorship by a preponderance of the evidence. The court held that the
priority contest was essentially the functional equivalent of the
priority phase of an interference proceeding involving patents whose
applications had been co-pending before the PTO:

> The challenge to inventorship was raised as an invalidity defense to
> Environ\'s charge of infringement . . . . On this basis the district
> court accorded \[Environ\'s\] patent the statutory presumption of
> validity . . . which requires that invalidity be established by clear
> and convincing evidence. . . .
>
> The case at bar differs from those in which the presumption of
> validity accorded a higher burden of proof to the challenged patent,
> however, in that the three competing claimants all had patent
> applications that were co-pending. . . . \[H\]ad these applications
> been the subject of an interference proceeding in the PTO or a § 291
> proceeding in the district court, the burden of proof of prior
> invention would be with the junior applicants, but the standard of
> proof would be the preponderance of the evidence. The formality of
> invoking § 291 does not affect the standard of proof of priority of
> invention between co-pending interfering patents, whether the issue
> arises as a defense in an infringement suit or in an action designated
> as under § 291. The correct standard of proof of priority of
> invention, as between co-pending interfering patents, is the
> preponderance of the evidence, the junior patentee bearing the burden
> of pleading and proving priority.

[Id.]{.underline} at 1265-66.

[Environ Products]{.underline} does not bind us here: It did not involve
a section 256 claim for non-joinder, and it expressly limited its
holding to priority contests. [See]{.underline} [id.]{.underline} at
1266 n.4 (noting that the holding \"relates solely to that of priority
of invention of common claimed subject matter in issued patents\" and
that it \"does not affect the standard of proof as to any other question
that may be in dispute\").

Nor should [Environ Products]{.underline} be extended on policy grounds
to apply in actions seeking to establish joint inventorship. There are
differences between using a co-pending application to prove
[prior]{.underline} invention and using it to prove [joint]{.underline}
invention, and these differences counsel against permitting a co-pending
application to reduce the burden of proof in an action seeking to
correct non-joinder of an inventor. As discussed above, a claim to joint
inventorship requires proof of \"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 suggestion at
a meeting.\" [Kimberly-Clark]{.underline}, 973 F.2d at 917. The
existence of co-pending applications does throw into question the
presumption of validity for the first-filed patent insofar as the
presumption involves an issue of timing or priority, namely that the
patentee was the first to invent. [Apotex]{.underline}, 254 F.3d at 1037
n.1. The existence of co-pending applications, however, does not
undermine to the same degree the presumption that each of the groups of
inventors listed on the patent applications acted independently. The
clear and convincing burden of proof is applied to joint inventorship
disputes because of a \"strong temptation for persons who consulted with
the inventor and provided him with materials and advice, to reconstruct,
so as to further their own position, the extent of their contribution to
the conception of the invention.\" [Hess]{.underline}, 106 F.3d at 980.
Proof of contribution to conception cannot rely entirely on the timing
of conception: The burden of demonstrating the required \"element of
joint behavior,\" [Kimberly-Clark]{.underline}, 973 F.2d at 917, should
remain unaffected by an alleged joint inventor\'s co-pending patent
application.

Furthermore, a party seeking to correct non-joinder is not required to
risk any rights to any invention of its own, and it should not receive
the benefit of a lower standard of proof without the accompanying risk.
In an interference proceeding, or in a priority contest that is its
functional equivalent as in [Environ Products]{.underline}, the junior
party places its own patent claims on the line and may lose its rights
to those claims if it does not successfully demonstrate priority. In a
section 256 action alleging non-joinder, however, the plaintiff does not
have to put its patent assets at risk.

Lilly\'s argument that [Environ Products]{.underline} should have
controlled in the district court proceedings below is also tenuous
because in [Environ Products]{.underline} all the parties contesting
priority agreed that their patents claimed the same subject matter. The
first step of an interference proceeding is to determine whether two
patents can and do claim the same subject matter; priority can be
adjudicated only after the common subject matter has been identified.
[See]{.underline} 37 C.F.R. § 1.601(i) (\"An interference may be
declared . . . when . . . the applications contain claims for the same
patentable invention.\"); [see also]{.underline} [Fujikawa v.
Wattanasin]{.underline}, 93 F.3d 1559, 1569-71 (Fed. Cir. 1996)
(affirming the PTO\'s denial of a motion to declare an interference or
to consider priority concerning a particular invention because one of
the patent applications at issue did not describe, and therefore could
not claim, the invention).

Thus, even in a case seeking to determine priority rather than joint
inventorship, there can be no functional equivalent of the priority
phase of an interference proceeding as there was in [Environ
Products]{.underline} unless the parties agree to bypass judicial
delineation of the conflicting subject matter. If no such agreement
exists, a junior party with an issued patent that was co-pending at the
PTO must either bring a formal claim under section 291 to determine if
there is conflicting subject matter prior to the priority determination,
or it must surmount the clear and convincing burden of proof to
demonstrate priority. Lilly and Aradigm never agreed to the fact that
Lilly\'s patent application claimed some of the same subject matter as
is claimed in the \'477 patent, let alone to the definition of the
invention claimed by both. We cannot, therefore, treat Lilly\'s
inventorship claim as the functional equivalent of the priority
determination in an interference proceeding.[^6]

There was another forum in which Lilly could have tried a priority claim
with a preponderance of the evidence burden of proof. Lilly knew of the
\'477 patent while its application was pending. Lilly could have sought
to provoke an interference proceeding in the PTO based on the \'477
patent---either by relying on the existing claim language in its
application or by copying the claims of the \'477 patent provided those
claims were supported by the specification---but it chose not to do so.
As Lilly elected not to provoke an interference proceeding in the PTO,
it hardly seems unfair to Lilly to deny it the advantages that it would
have enjoyed in such a PTO proceeding.

[Environ Products]{.underline} prevents form from triumphing over
substance in priority contests embedded in infringement proceedings,
provided that the parties have stipulated to a definition of the
interfering subject matter. The preponderance of the evidence burden of
proof that [Environ Products]{.underline} establishes, however, is not
applicable to Lilly\'s joint inventorship claim under section 256
because that claim involves neither priority per se nor subject matter
that has been determined to be interfering.

IV

Finally, we turn to that part of Lilly\'s appeal addressing the district
court\'s state-law judgments. Lilly\'s first argument addresses the
district court judgment entered on a contract claim. In 1996, Lilly and
Aradigm entered into an Insulin Supply Agreement. Under this agreement,
Lilly supplied regular insulin for Aradigm\'s use in studies
investigating the pulmonary delivery of regular insulin. In return,
Aradigm agreed, [inter alia]{.underline}, that \"\[a\]ll information
provided to Aradigm . . . by Lilly will be kept in confidence for at
least ten (10) years after execution of this Agreement, unless Lilly
gives \[Aradigm\] written permission to disclose it sooner,\" that
\"\[d\]ata emanating from the . . . studies . . . will not be released
by Aradigm . . . without Lilly\'s review and comment,\" and that \"Lilly
will be furnished with a copy of any proposed publication or
presentation for review and comment thirty (30) days prior to such
presentation or submission for publication.\" In 1997, Lilly and Aradigm
also entered into a Lispro Supply Agreement with similar terms
restricting Aradigm\'s use of lispro-related information.

At trial, Lilly argued that Aradigm breached both of these agreements by
filing patent applications, including the \'477 patent application,
containing information encompassed within the supply agreements without
obtaining Lilly\'s permission and without granting Lilly the opportunity
to review the applications. The jury agreed, finding Aradigm in breach
of both agreements. The jury awarded nominal damages---the only damages
sought by Lilly. In its post-judgment briefing, Lilly requested an
injunction prohibiting Aradigm from continuing to breach the supply
agreements and, in particular, from filing further patent applications
containing information encompassed within the supply agreements without
complying with the terms of the contracts. The district court denied
Lilly\'s post-judgment request for injunctive relief on the contract
claim, [see]{.underline} [Eli Lilly & Co. v. Aradigm Corp.]{.underline},
No. IP 98-828-C-Y/F, slip op. at 5-6 (S.D. Ind. Mar. 5, 2003) (\"[Entry
on Post-Judgment Motions]{.underline}\"), and Lilly appeals this denial
to us.

The district court emphasized that Lilly had not requested injunctive
relief as a remedy for its contract claim at any point prior to the
entry of the judgment. [Id.]{.underline}, slip op. at 3 (\"\[A\]s of the
time of the jury verdict, Lilly had not requested any equitable relief
from the court, which, if requested and granted, could have been
reflected in the Original Judgment.\"). Lilly\'s complaint requested
other forms of injunctive relief based on other causes of action, but it
did not request equitable relief based on the contract claim. The
district court therefore permissibly treated Lilly\'s post-judgment
request for injunctive relief as a motion to amend the judgment under
Federal Rule of Civil Procedure 59(e). Under Seventh Circuit law, a
district court \"may grant a Rule 59(e) motion to alter or amend the
judgment if the movant presents newly discovered evidence that was not
available at the time of trial or if the movant points to evidence in
the record that clearly establishes a manifest error of law or fact.\"
[In re Prince]{.underline}, 85 F.3d 314, 324 (7th Cir. 1996). We review
an order denying a motion to amend a judgment for abuse of discretion,
[id.]{.underline}, and we conclude that the district court did not abuse
its discretion in denying Lilly\'s belated request for a new form of
relief based on breach of contract when Lilly could have made a timely
request.

Lilly\'s second argument addresses the district court judgment entered
on an unjust enrichment claim. On the special verdict form presenting
the elements of this claim, the jury made two actual findings in favor
or Lilly---that \"Lilly provided valuable services or benefits to
Aradigm,\" presumably in the form of information about insulin or
lispro, and that \"the services or benefits provided were at the express
or implied request of Aradigm.\" However, the jury also made a factual
finding against Lilly that \"the services or benefits were \[not\]
provided under circumstances such that it is only fair that Lilly be
compensated.\" Based on these factual findings, the district court
entered judgment in favor of Aradigm on the unjust enrichment claim. In
Lilly\'s post-judgment briefing, Lilly argued that the district court\'s
judgment is erroneous because the jury\'s factual findings in Lilly\'s
favor should ineluctably lead to a verdict in Lilly\'s favor on the
unjust enrichment claim. As a corollary, Lilly argues that the jury\'s
finding against Lilly on the fairness of compensation is merely a
finding of no compensable monetary damages. Lilly presses this argument
because if the judgment was in its favor Lilly believes it would be
entitled to the same injunctive relief it sought under the contract
claim---namely an injunction prohibiting Aradigm from further use of Dr.
DiMarchi\'s contribution to the \'477 patent and from further
prosecuting patents based on the lispro study data. The district court
denied Lilly\'s request, concluding that the findings in Lilly\'s favor
were insufficient to support an unjust enrichment claim under Indiana
law. [Entry on Post-Judgment Motions]{.underline}, slip op. at 1-4.

As in Lilly\'s contract claim, under Seventh Circuit law, a district
court \"may grant a Rule 59(e) motion to alter or amend the judgment if
the movant presents newly discovered evidence that was not available at
the time of trial or if the movant points to evidence in the record that
clearly establishes a manifest error of law or fact,\" and we review an
order denying a motion to amend a judgment for abuse of discretion. [In
re Prince]{.underline}, 85 F.3d at 324. We affirm the district court\'s
denial of Lilly\'s motion because the district court\'s interpretation
of Indiana law under which a claim of unjust enrichment can be made out
only \"under circumstances in which equity demands compensation to
prevent unjust enrichment,\" [Briggs v. Clinton County Bank & Trust
Co.]{.underline}, 452 N.E.2d 989, 1004 (Ind. Ct. App. 1983) (internal
quotation marks omitted), is neither manifest error nor an abuse of
discretion.

V

In conclusion, we affirm the district court\'s denial of Lilly\'s
requests for post-judgment relief on the state law claims, but we
reverse the district court\'s denial of Aradigm\'s motion for judgment
as a matter of law on the section 256 joint inventorship claim. There is
not sufficient evidence in the record to support the jury\'s conclusion
that Lilly demonstrated by clear and convincing evidence that Dr.
DiMarchi collaborated with Aradigm\'s scientists in a manner that could
render him a joint inventor of claim 6 in the \'477 patent.

COSTS

No costs.

[AFFIRMED-IN-PART AND REVERSED-IN-PART]{.underline}

**United States Court of Appeals for the Federal Circuit**

03-1336,-1337

ELI LILLY AND COMPANY,

Plaintiff-Appellant,

v\.

ARADIGM CORPORATION,

Defendant-Cross Appellant.

LOURIE, [Circuit Judge]{.underline}, concurring.

I concur in the result reached by the majority and in its opinion,
except for the analysis in Section III.C relating to the burden of proof
and its purported basis for distinguishing the [Environ]{.underline}
case. The majority imposes a "clear and convincing" test for Lilly to
show joint inventorship, asserting that a joint inventorship question is
different from the priority dispute dealt with in [Environ]{.underline}.
I disagree; there is of course a difference, but one that should not
affect the burden of proof.

First, it is important to note, as the majority does, that a
preponderance of the evidence burden of proof applies when the
contesting patents are, or were, copending in the Patent and Trademark
Office. That is the holding of [Environ]{.underline}. The two parties
here had copending applications at one time, and thus the
[Environ]{.underline} burden should apply absent a meaningful
distinction. The majority decides that [Environ]{.underline} is
distinguishable because it deals with priority whereas this case
involves joint invention. However, in my view, that is not a meaningful
distinction.

While joint inventorship is indeed a different issue from priority, I
fail to see how the issues require a different standard. In each case,
one party is trying to establish that his activities with respect to the
invention claimed in another party\'s patent occurred at a time and/or
in a relationship with that other party either to antedate the other
party\'s effective date of invention or to establish a joint inventor
relationship. An identical invention (or at least lack of separate
patentability) and either a timeliness or jointness fact need to be
shown. Thus, a preponderance of the evidence burden of proof should
apply to both. Because of the copendency of the applications, the
concern that a second applicant may simply have copied an invention
already patented by another does not arise. But we do not need to decide
that issue.

The majority holds, and I agree, that Lilly failed to provide
substantial evidence to the jury that Dr. DiMarchi conveyed to Aradigm
scientists that lispro should be administered by aerosol to achieve a
doubling of bioavailability. That being the case, we need not decide
that a joint inventorship situation requires a different, and more
severe, burden of proof than a priority situation. Lilly loses simply
because it cannot show communication of the same invention as Aradigm
claimed. For that reason, I would not make what I believe is a false
distinction between [Hess]{.underline} and [Environ]{.underline} in
order to decide an issue that is readily resolvable on a ground already
dealt with by the panel. That decision is not necessary to the
resolution of this case.

[^1]: A person who alleges that he is a co-inventor of the invention
    claimed in an issued patent who was not listed as an inventor on the
    patent may bring a cause of action to correct inventorship in a
    district court under 35 U.S.C. § 256. [See]{.underline} [MCV,
    Inc. v. King-Seeley Thermos Co.]{.underline}, 870 F.2d 1568, 1570
    (Fed. Cir. 1988) (holding that \"section 256 . . . explicitly
    authorizes judicial resolution of co-inventorship contests over
    issued patents\"). At the time Lilly filed its complaint, the \'477
    patent had not yet issued. Lilly filed its complaint on June 19,
    1998, and the \'477 patent did not issue until March 30, 1999.
    Because section 256 creates a cause of action in the district courts
    only to modify inventorship on issued patents, Lilly initially
    styled its count seeking a declaratory judgment establishing
    Lilly\'s scientists as inventors on Aradigm\'s patent applications
    as an action under 35 U.S.C. § 116. The text of section 116,
    however, only grants the Director of the Patent and Trademark Office
    the authority to take certain actions and plainly does not create a
    cause of action in the district courts to modify inventorship on
    pending patent applications. At the time it filed its complaint,
    Lilly did not have a cause of action to challenge inventorship on
    the \'477 patent application, and Lilly never moved to amend the
    complaint.

    However, in its ruling on Aradigm\'s motion for summary judgment on
    March 31, 2000, after the issue date of the \'477 patent, the
    district court held in a footnote that Lilly\'s claim seeking to
    correct an inventor\'s name could at that time be sustained under
    section 256. Because neither party objected, we conclude that the
    district court effected a constructive amendment of the complaint,
    supplementing the pleadings with a count properly based on section
    256.

[^2]: In its briefs, Lilly styled its burden-of-proof argument as a
    direct appeal. However, a party lacks standing to appeal a judgment
    if that judgment grants the party all of the relief requested.
    [See]{.underline} [California v. Rooney]{.underline}, 483 U.S. 307,
    311 (1987) (\"The \[lower court\'s\] use of analysis that may have
    been adverse to the \[appellant\'s\] long-term interests does not
    allow the \[appellant\] to claim status as a losing party for
    purposes of this Court\'s review.\"); [Mueller v.
    Reich]{.underline}, 54 F.3d 438, 441 (7th Cir. 1995), [vacated on
    other grounds by]{.underline} 519 U.S. 1144 (1997), (\"\[A\] party
    is not permitted to appeal [or]{.underline} cross-appeal unless it
    wants the judgment of the lower court modified in some way.\").
    Lilly conceded at oral argument that it had no standing to appeal
    directly on the inventorship issue because it received all of the
    relief it requested under section 256. The district court correctly
    held that Dr. DiMarchi\'s status as a co-inventor of the invention
    in claim 6 entitled Lilly, as the assignee of Dr. DiMarchi\'s
    interest, to the rights of a co-owner of the entire \'477 patent.
    [Eli Lilly & Co. v. Aradigm Corp.]{.underline}, No. IP 98-828-C-Y/F,
    slip op. at 5-6 (S.D. Ind. Mar. 5, 2003) (relying on [Ethicon, Inc.
    v. United States Surgical Corp.]{.underline}, 135 F.3d 1456, 1465
    (Fed. Cir. 1998) (\"\[I\]n the context of joint inventorship, each
    co-inventor presumptively owns a pro rata undivided interest in the
    entire patent, no matter what their respective contributions.\")).
    We therefore reach Lilly\'s burden-of-proof argument on inventorship
    only because we conclude, as Aradigm maintains in its cross-appeal,
    that there is insufficient evidence to support the jury verdict
    under the more demanding clear and convincing burden of proof.

[^3]: Lilly does not seek to defend its co-inventorship judgment by
    contesting the adverse aspects of the jury\'s fact finding
    concerning Dr. DiMarchi\'s lack of a contribution to the invention
    in claim 17 or Dr. Harrison\'s lack of a contribution to the
    invention in either claim. We therefore do not review those aspects
    of the verdict.

[^4]: Despite the allegations of misappropriation of proprietary
    information, neither party has alleged deceptive intent.

[^5]: As noted above, Lilly argues that, on the facts of this case, the
    correct burden of proof is the more lenient preponderance of the
    evidence burden. We address and dismiss that contention below in
    Section III.C.

[^6]: Lilly argues that, although the existence of the same subject
    matter in its application and the \'477 patent was not stipulated to
    by the parties, the examiner\'s remarks during the course of
    prosecuting Lilly\'s patent application prove the existence of
    mutually claimed subject matter. In a final office action, the
    examiner rejected all of the claims in Lilly\'s patent application
    because they were anticipated by, under section 102(e), or in the
    alternative obvious over, under section 103(a), the \'477 patent.
    (From the record on appeal, this office action appears to be the
    last one, as it ends with the statement that \"\[a\]pplicants
    apparently intend to abandon this application in favor of a related
    pending application.\") To explain the rejection, the examiner
    further stated that \"\[t\]he instant method claims and the claims
    of \'477 are drawn to essentially the same subject matte\[r\].\" We
    cannot, however, take this as a determination binding on Aradigm
    that there is common subject matter. The examiner also explained
    that the anticipation rejection was based on the disclosure in the
    specification of the \'477 patent, so claims 6 and 17 of the \'477
    patent---the only ones at issue here---need not have claimed the
    same subject matter as the claims of Lilly\'s application for
    Lilly\'s application to have been anticipated. Furthermore, the
    examiner\'s rejection was not appealed to or reviewed by the Board
    of Patent Appeals and Interferences.