Sanofi-Aventis Deutschland GMBH v. Glenmark Pharmaceuticals Inc. , 748 F.3d 1354 ( 2014 )

United States Court of Appeals
for the Federal Circuit
______________________
SANOFI-AVENTIS DEUTSCHLAND GMBH AND
AVENTIS PHARMA S.A.,
Plaintiffs-Appellees,
AND
ABBOTT GMBH & CO. KG, AND
ABBOTT LABORATORIES,
Plaintiffs-Appellees,
v.
GLENMARK PHARMACEUTICALS INC., USA
(now known as Glenmark Generics., Inc., USA) AND
GLENMARK PHARMACEUTICALS LTD.,
Defendants-Appellants.
______________________
2012-1489
______________________
Appeal from the United States District Court for the
District of New Jersey in No. 07-CV-5855, Judge Dennis
M. Cavanaugh.
______________________
Decided: April 21, 2014
______________________
JOHN ALLCOCK, DLA Piper LLP, (US) of San Diego,
California, argued for all plaintiffs-appellees. With him
on the brief were STUART E. POLLACK and STANLEY J.
2 SANOFI-AVENTIS DEUTSCHLAND v. GLENMARK
PHARMACEUTICALS
PANIKOWSKI, for Abbott GmbH & Co. Kg, et al. and
BENJAMIN C. HSING and SAPNA W. PALLA, Kaye Scholer,
LLP, of New York, New York, for Sanofi-aventis Deutsch-
land GmbH, et al.
JAMES GALBRAITH, Kenyon & Kenyon LLP, of New
York, New York, argued for defendants-appellants. With
him on the brief were HUIYA WU, LEE B. SHELTON and
MICHAEL S. CHANG.
______________________
Before NEWMAN, LINN, and WALLACH, Circuit Judges.
NEWMAN, Circuit Judge.
This patent infringement suit concerns the antihyper-
tension drug having the brand name Tarka®. Tarka® is a
combination of two active ingredients into a single dosage
product: the angiotensin converting enzyme (ACE) inhibi-
tor trandolapril, and the calcium channel blocker (also
called “calcium antagonist”) verapamil hydrochloride.
The combination drug is covered by United States Patent
No. 5,721,244 (the ’244 patent) and is owned by or exclu-
sively licensed to Sanofi-Aventis Deutschland GmbH (a
company of Germany), Aventis Pharma S.A. (a company
of France); Abbott GmbH (a company of Germany), and
Abbott Laboratories and Abbott Laboratories Inc. (United
States companies) (collectively “Plaintiffs”).
The New Drug Application (NDA) for the Tarka®
product was approved by the Food and Drug Administra-
tion in 1996 and acquired by Abbott Laboratories in 2001.
In 2007 the defendants Glenmark Pharmaceuticals Inc.
and Glenmark Pharmaceuticals Ltd. (collectively “Glen-
mark”) filed an abbreviated new drug application (ANDA)
for the generic counterpart of this product. Since the ’244
patent had not expired, Glenmark filed a Hatch-Waxman
“Paragraph IV Certification,” leading to the filing by
Plaintiffs of this infringement suit.
SANOFI-AVENTIS DEUTSCHLAND v. GLENMARK 3
PHARMACEUTICALS
Launch of Glenmark’s generic product was stayed for
30 months, as the statute provides. 21 U.S.C.
§355(j)(5(B)(iii). After the stay expired in 2010, Plaintiffs
moved for a preliminary injunction, which the district
court denied. In June 2010 Glenmark launched its gener-
ic product “at-risk,” while this litigation proceeded in the
district court.
Trial was to a jury. Glenmark admitted infringement,
and the jury held that the ’244 patent had not been
proved invalid. The jury awarded $15,200,000 in lost
profits and $803,514 in price erosion damages. Post-trial
motions were denied, and judgment was entered on the
verdict. The district court retained authority to assess
post-verdict damages if this court sustained the judgment
on appeal.
Glenmark does not appeal the quantum of damages,
but argues (1) that the ’244 patent is invalid, (2) that
Glenmark is entitled to a new trial based on a prejudicial
jury instruction on evidence spoliation, and (3) that no
damages should be awarded due to lack of standing of the
Abbott United States companies. Plaintiffs defend the
judgment, and also state that this court lacks jurisdiction
to entertain this appeal because the district court’s judg-
ment was not final.
We conclude that jurisdiction is proper, and affirm the
district court’s judgment and related rulings. 1
1 Sanofi-Aventis Deutschland Gmbh v. Glenmark
Pharms. Inc., USA, 821 F. Supp. 2d 681 (D.N.J., 2011)
(“Final Op.”); 2010 U.S. Dist. LEXIS 65323 (D.N.J. July 1,
2010) (“Spoliation Op.”); 2011 U.S. Dist. LEXIS 70692,
DMC-JAD, 2011 WL 2609855 (D.N.J. June 30, 2011)
(“Standing Op.”).
4 SANOFI-AVENTIS DEUTSCHLAND v. GLENMARK
PHARMACEUTICALS
I
JURISDICTION
Within 30 days after the district court denied Glen-
mark’s post-verdict motions, Glenmark filed a notice of
appeal. Plaintiffs state that this appeal is premature
because the district court did not issue a document enti-
tled “final judgment” and retained authority to award
post-judgment damages; thus Plaintiffs argue that there
is no appellate jurisdiction.
Glenmark responds that on September 30, 2011 the
district court entered an Order that disposed of every
pending claim and defense except the final calculation of
damages. The Order (1) denied Glenmark’s pre-verdict
Rule 50(a) motion, (2) denied Glenmark’s motions for
post-verdict judgment as a matter of law on the issues of
standing and double patenting, and (3) granted Plaintiffs’
request for an injunction. ECF No. 379. Glenmark timely
filed a renewed motion for judgment as a matter of law
under Rule 50(b), which the district court denied. ECF
No. 410. Glenmark appealed within 30 days of that
denial.
Glenmark points out that 28 U.S.C. §1292(c)(2) recog-
nizes finality for purposes of appeal although the account-
ing of damages may not be complete. The statute assigns
the Federal Circuit jurisdiction of:
§1292(c)(2)-- an appeal from a judgment in a civil
action for patent infringement which would oth-
erwise be appealable to the United States Court of
Appeals for the Federal Circuit and is final except
for an accounting.
In Robert Bosch, LLC v. Pylon Mfg. Corp., 719 F.3d 1305,
1317 (Fed. Cir. 2013) (en banc), this court reiterated that
“an accounting” includes the determination of damages.
SANOFI-AVENTIS DEUTSCHLAND v. GLENMARK 5
PHARMACEUTICALS
The jury found the damages for the period covered by
the evidence at trial. The district court’s issuance of an
Order closing the case, with provision for an accounting of
any additional damages that may accrue if the decision is
affirmed on appeal, does not negate finality of a judgment
that meets the terms of §1292(c)(2). No “magic words” are
needed to confer final judgment. See Local Union No.
1992 of Int’l Bhd. of Elec. Workers v. Okonite Co., 358 F.3d
278, 285 (3d Cir. 2004) (“The order’s denomination as an
‘order,’ rather than a ‘judgment,’ does not mean that it
fails to satisfy the separate document requirement” of the
final judgment rule.); Hill v. Potter, 352 F.3d 1142, 1144
(7th Cir. 2003) (“The test for finality is . . . whether the
district court has finished with the case.”). Glenmark is
correct that the judgment was final and ripe for appeal,
and that this court is properly exercising jurisdiction.
II
PATENT VALIDITY
Glenmark’s principal challenge to validity is on the
ground of obviousness.
The Tarka® product is a combination of two hyperten-
sion medications, trandolapril and verapamil hydrochlo-
ride. The combination is stated to provide longer-lasting
control than previously known treatments. The product is
stated to have significant advantages including improved
kidney function and improved blood vessel structure
without the need for multiple daily doses. There was
evidence that these benefits were not known for prior art
hypertension treatments.
Patent validity on the ground of obviousness is a
question of law based on underlying facts. Graham v.
John Deere Co., 383 U.S. 1, 17–18 (1966). The factual
components include the scope and content of the prior art,
the differences between the prior art and the claimed
invention, the level of skill in the art, and any objective
6 SANOFI-AVENTIS DEUTSCHLAND v. GLENMARK
PHARMACEUTICALS
evidence of nonobviousness. Id. at 17. When the question
of obviousness is tried to a jury, on appeal we ascertain
whether the jury was correctly instructed on the law,
whether there was substantial evidence in support of
factual findings necessary to the verdict, and whether the
verdict was correct on the supported facts. The court
must “accept implicit factual findings upon which the
legal conclusion is based when they are supported by
substantial evidence.” Kinetic Concepts, Inc. v. Smith &
Nephew, Inc., 688 F.3d 1342, 1359 (Fed. Cir. 2012).
In suit is claim 3 of the ’244 patent, shown with claim
1 from which it depends:
1. A pharmaceutical composition comprising:
(a) an angiotensin-converting enzyme inhibitor
(ACE inhibitor) . . . , and (b) a calcium antagonist
or a physiologically acceptable salt thereof; where-
in said ACE inhibitor and said calcium antagonist
are present in said composition in amounts effec-
tive for treating hypertension; . . .
3. A composition according to claim 1, where-
in said ACE inhibitor is trandolapril [formula
omitted] or a physiologically acceptable salt there-
of, or quinapril [formula omitted] or a physiologi-
cally acceptable salt thereof.
The jury was instructed on the presumption of validity,
and that invalidity must be proved by clear and convinc-
ing evidence. The jury found that claim 3 had not been
proved invalid on the ground of obviousness. Glenmark
argues that the verdict cannot stand, as a matter of law,
on the premise that if a combination of classes of compo-
nents is already known, all selections within such classes
are obvious to try, as a matter of law. Glenmark argues
that it is irrelevant that the combination is ultimately
found to have unpredicted or superior properties if those
properties, though unknown in the prior art, could be
SANOFI-AVENTIS DEUTSCHLAND v. GLENMARK 7
PHARMACEUTICALS
attributed to one of the prior art components of the com-
bination.
A
The trandolapril ACE inhibitor in the Tarka® product
is distinguished from the class of previously known ACE
inhibitors in that trandolapril is a “double-ring” com-
pound, whereas the prior art had studied primarily “sin-
gle-ring” compounds. At the time the ’244 patent
application was filed in 1986, the single-ring ACE inhibi-
tors enalapril and captopril were the only ACE inhibitors
approved by the FDA, and both of these drugs had a short
duration of action. Captopril was typically dosed three or
more times per day and enalapril was dosed twice per
day. The dosage requirements of these drugs were un-
changed in prior art studies involving combinations with
calcium channel blockers.
Glenmark argued at trial, and repeats on this appeal,
that the Tarka® product simply substituted one known
ACE inhibitor for another. The Plaintiffs responded that
there were hundreds if not thousands of potential combi-
nations of ACE inhibitors and calcium antagonists in
1986, and that none of the available information pointed
directly at the combinations claimed. The Plaintiffs
pointed out that nothing in the art suggested the combi-
nation of the double-ring trandolapril with verapamil
hydrochloride, or suggested that this combination would
provide the previously unavailable extended and im-
proved efficacy.
At trial Glenmark’s expert agreed that quinapril and
trandolapril are of the class of double-ring ACE inhibitors,
and that neither of these double-ring compounds was
suggested for use in combination with a calcium channel
blocker in any prior art reference. He opined that the
number of rings on the ACE inhibitor was not an im-
portant consideration for his analysis. This view was
challenged by the testimony of Plaintiffs’ expert, who
8 SANOFI-AVENTIS DEUTSCHLAND v. GLENMARK
PHARMACEUTICALS
testified that persons skilled in this field at the time of
the patent generally believed that double-ring ACE inhib-
itors were not more effective than single-ring inhibitors to
control hypertension because single-ring structures were
believed to fill the “pocket” of the ACE enzyme to inhibit
the enzyme’s activity, and that the double-ring inhibitors
would not fit in the pocket as effectively. Plaintiffs’ expert
also explained that as a mode of treatment, combination
therapy was not favored in 1986 as compared to “stepped
care,” in which physicians were instructed to use one drug
at a time.
Glenmark’s expert disagreed as to whether persons of
ordinary skill in 1986 would have had different percep-
tions of the single-ring and double-ring ACE inhibitors,
and different expectations as to combination products.
However, there was not disagreement that the previously
tested combinations of ACE inhibitors and calcium chan-
nel blockers required more than once daily dosing, and
that the longer-lasting effectiveness of the Tarka® combi-
nation, along with its improved kidney and blood vessel
function, were not provided by, or predicted or suggested
by, the prior art.
Glenmark argues that claim 3 is nonetheless invalid
as a matter of law. Glenmark argues that it is not con-
trolling whether any double-ring product had previously
been evaluated or suggested for combination with calcium
antagonists, for all combinations were obvious as a matter
of law. Glenmark argues that because the single-ring
inhibitors had been tested in combination with calcium
antagonists, it was “obvious to try” every combination of
effective ACE inhibitor and calcium channel blocker.
Glenmark Br. at 35 (“It is not invention merely to select
something from a list of items in the prior art.”).
Glenmark argues that since it was “obvious to try” the
double-ring inhibitors in combination with calcium chan-
nel blockers as a matter of law, patentability is not avail-
SANOFI-AVENTIS DEUTSCHLAND v. GLENMARK 9
PHARMACEUTICALS
able even if the combination is later found to possess
unexpected or advantageous properties. Glenmark states
that the jury verdict was based on incorrect law, and that
the ’244 patent is invalid.
In KSR International Co. v. Teleflex Inc., 550 U.S.
398, 421 (2007) the Court explained that “obvious to try”
may apply when “there are a finite number of identified,
predictable solutions” to a known problem. The Court
explained that when the path has been identified and
“leads to the anticipated success, it is likely the product
not of innovation but of ordinary skill and common sense.”
Id. This court has elaborated that the identified path
must “present a finite (and small in the context of the art)
number of options easily traversed to show obviousness.”
Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d
1358, 1364 (Fed. Cir. 2008). As illustrated in In re
O’Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988), it would not
be “obvious to try” when “the prior art gave either no
indication of which parameters were critical or no direc-
tion as to which of many possible choices is likely to be
successful.”
Glenmark argues that the inventors’ selection of the
double-ring ACE inhibitors for testing in combination
with calcium antagonists is of itself evidence that it was
obvious to try this combination. Patentable invention
does not require that inventors work from ignorance.
Technologic advance flows from knowledge, experience,
insight—perhaps hunch or curiosity. Patentability does
not turn on how the invention was made, but on whether
it would have been obvious to a person of ordinary skill in
the field. In Eisai Co. v. Dr. Reddy’s Laboratories, Ltd.,
533 F.3d 1353 (Fed. Cir. 2008), the court observed that in
the medical arts “potential solutions are less likely to be
genuinely predictable,” id. at 1359, as compared with
other arts such as the mechanical devices in KSR.
10 SANOFI-AVENTIS DEUTSCHLAND v. GLENMARK
PHARMACEUTICALS
Glenmark also argues that later-discovered benefits
cannot be considered in an obviousness analysis, here
referring to the improved kidney and blood vessel function
that were observed after the patent application was filed.
That is incorrect; patentability may consider all of the
characteristics possessed by the claimed invention, when-
ever those characteristics become manifest. See, e.g.,
Knoll Pharm. Co. v. Teva Pharm. USA, Inc., 367 F.3d
1381, 1385 (Fed. Cir. 2004) (holding that “[t]here is no
requirement that an invention’s properties and ad-
vantages were fully known before the patent application
was filed, or that the patent application contains all of the
work done in studying the invention, in order for that
work to be introduced into evidence in response to litiga-
tion attack.”); Genetics Inst. LLC v. Novartis Vaccines &
Diagnostics, Inc., 655 F.3d 1291, 1307 (Fed. Cir. 2011)
(holding that inventors may rely on advantages appearing
after the patent application was filed). See also In re
Khelghatian, 364 F.2d 870, 876 (CCPA 1966) (reliance on
an unexpected property not disclosed in the application
may be entitled to weight if “directed to that which would
inherently flow from what was originally disclosed”).
Glenmark states that its position that this combina-
tion was obvious to try is supported by this court’s rulings
in Merck & Co. v. Biocraft Laboratories, Inc., 874 F.2d 804
(Fed. Cir. 1989) and Richardson-Vicks Inc. v. Upjohn Co.,
122 F.3d 1476 (Fed. Cir. 1997). The Plaintiffs respond
that those cases conform to the criteria in KSR, 550 U.S.
at 417, that when the components provide only their
known properties, to produce results shown or predicted
in the prior art, the combination may be obvious to try.
In Merck v. Biocraft the claimed combination of ami-
loride and hydrochlorothiazide was specifically named in
the prior art, and had no “unexpectedly good” properties
compared with the separate components, 874 F.2d at 808–
09; thus the court held that it was obvious to try this
combination. In Richardson-Vicks the patent claimed the
SANOFI-AVENTIS DEUTSCHLAND v. GLENMARK 11
PHARMACEUTICALS
combination of pseudoephedrine and ibuprofen in a single
pill; no unexpected properties were asserted for this
combination of known products, and the court held that
the combination was “clearly suggested by the prior art.”
122 F.3d at 1477, 1484. In both of these cases the drug
combinations were deemed obvious to try, for reasons in
conformity with the Court’s explication in KSR.
The Plaintiffs contrast those cases with the court’s
ruling in Pozen Inc. v. Par Pharmaceutical, Inc., 696 F.3d
1151, 1165 (Fed. Cir. 2012), where on facts analogous to
the case at bar, the court sustained a patent on a combi-
nation of the known compounds naproxen and sumatrip-
tan for treatment of migraine headaches, for this
combination was not previously known or suggested, and
was found to have longer-lasting efficacy than either
component separately. The Plaintiffs stress that there
was no prior knowledge that the combination of a double-
ring ACE inhibitor with calcium antagonists would be
longer lasting than the hypertension treatments at the
time.
The jury could reasonably have relied on the testimo-
ny of the Plaintiffs’ expert, that persons skilled in the art
in 1986 would not have predicted the longer-lasting
hypertension control demonstrated by the double-ring
structures of quinapril and trandolapril in combination
with calcium antagonists, because of the widespread
belief that double-ring inhibitors would not fit the pocket
structure of the ACE. Although Glenmark disputed every
aspect, there was substantial evidence to support findings
that in turn support the verdict that obviousness had not
been proved by clear and convincing evidence. The dis-
trict court’s review of the evidence and confirmation of the
jury verdict manifests no error of law. The judgment that
invalidity had not been proved is affirmed.
12 SANOFI-AVENTIS DEUTSCHLAND v. GLENMARK
PHARMACEUTICALS
III
SPOLIATION
The district court concluded that Glenmark had vio-
lated its duty to preserve relevant evidence when litiga-
tion is planned or reasonably foreseen. The court denied
the Plaintiffs’ motion for default, but instructed the jury
that it was permitted to draw an adverse inference that
the electronic documents that Glenmark deleted in 2005
and 2006 would have been unfavorable.
Glenmark does not dispute that in 2005 and 2006 it
had in place a policy whereby all emails and related
electronic documents were retained for only one month,
and that this policy continued as Glenmark was proceed-
ing with production of the generic product and prepara-
tion of the ANDA in 2006. In response to Plaintiffs’
discovery requests on filing of this Hatch-Waxman suit,
Glenmark produced three emails from 2005 and twenty-
two email chains from 2006, although other evidence,
such as the work product log, showed activity in prepara-
tion for litigation.
The district court applied Third Circuit law, under
which spoliation occurs when “the evidence was in the
party’s control; the evidence is relevant to the claims or
defenses in the case; there has been actual suppression or
withholding of evidence; and the duty to preserve the
evidence was reasonably foreseeable to the party.” Bull v.
United Parcel Serv., Inc., 665 F.3d 68, 73 (3d Cir. 2012).
The district court found that litigation became “rea-
sonably foreseeable” to Glenmark no later than the date
asserted for “work product” in its privilege log. Spoliation
Op. at 9. The privilege log contained entries for “work
product” as early as February 2006. The court observed
that “[a] party claiming work-product immunity bears the
burden of showing that the materials in question ·were
‘prepared in the course of preparation for possible litiga-
SANOFI-AVENTIS DEUTSCHLAND v. GLENMARK 13
PHARMACEUTICALS
tion.’” Id. (quoting Holmes v. Pension Plan of Bethlehem
Steel Corp., 213 F.3d 124, 138 (3d Cir. 2000)).
The district court exercised its discretion, and gave
the jury a permissive instruction, as follows:
You may make an adverse inference in this
case against Glenmark. In this case, I have de-
termined that Glenmark systematically overwrote
the emails on its email server between February
23, 2006 and mid-2007 and that some of these
documents were relevant to the claims in suit.
An adverse inference permits you, the jury, to
infer that the destroyed emails and attached doc-
uments might or would have been unfavorable to
the position of Glenmark. However, you are not
required to draw such an inference, and the
weight to be given such an inference is your deci-
sion.
Jury Instructions, ECF No. 366 at 16, ll.1-13.
Glenmark argues that the district court’s instruction
was improper and prejudicial, citing Hill v. Laeisz, 435
F.3d 404, 420 (3d Cir. 2006) for the statement that preju-
dice occurs when “there is a reasonable possibility” that
the error affected the result. Glenmark argues that the
Plaintiffs did not show that any deleted emails contained
relevant evidence. The Plaintiffs respond that the content
of the emails is unknown because they were destroyed,
and point to Glenmark’s decision to produce and follow
the ANDA procedure for a generic version of Tarka® in
2005, and Glenmark’s claim of litigation work product
protection starting in February 2006, as indirect evidence
of relevance of the destroyed documents. A spoliation
sanction “may rely on circumstantial evidence to suggest
the contents of destroyed evidence.” Beaven v. U.S. Dep’t
of Justice, 622 F.3d 540, 555 (6th Cir. 2010).
14 SANOFI-AVENTIS DEUTSCHLAND v. GLENMARK
PHARMACEUTICALS
Glenmark’s witnesses stated that email was a mode of
communication used during the relevant time frame.
Terrance Coughlin, Glenmark’s President and CEO,
stated that he communicated by email with Dr. Soni (Vice
President of Intellectual Property) and Mr. Dutra (head of
marketing) when they were unable to meet in person. Dr.
Soni testified that he communicated with the research
and development department in India concerning the
decision to develop a generic version of Tarka®, and
acknowledged that Glenmark used email to communicate
with the team in India during the development. It was
pointed out to the district court that attorney work prod-
uct claims were made relative to this period, before
Glenmark’s later institution of a litigation hold. It was
reasonable for the district court to infer that some de-
stroyed emails related to issues for which litigation was
expected by Glenmark. See Gumbs v. Int’l Harvester, Inc.,
718 F.2d 88, 96 (3d Cir. 1983) (“The unexplained failure
or refusal of a party to judicial proceedings to produce
evidence that would tend to throw light on the issues
authorizes, under certain circumstances, an inference or
presumption unfavorable to such party.”).
The destroyed records were from the period that was
acknowledged to include discussion of the generic drug,
marketing in the United States, preparation of the
ANDA, and the Paragraph IV Certification challenging
the patent. Glenmark did not negate the reasonable
inference that the destroyed emails related to relevant
issues. See Brewer v. Quaker State Oil Ref. Corp., 72 F.3d
326, 334 (3d Cir. 1995) (“When the contents of a document
are relevant to an issue in a case, the trier of fact general-
ly may receive the fact of the document’s nonproduction or
destruction as evidence that the party that has prevented
production did so out of the well-founded fear that the
contents would harm him.”). Absent any reasonable
negation of this inference, the district court’s finding that
the documents were likely to be relevant was not clearly
SANOFI-AVENTIS DEUTSCHLAND v. GLENMARK 15
PHARMACEUTICALS
erroneous, and informing the jury of the destruction
program was not an abuse of discretion. See Fujifilm
Corp. v. Benun, 605 F.3d 1366, 1370 (Fed. Cir. 2010) (The
district court abuses its discretion only “if its determina-
tions are based on an erroneous view of the law or on a
clearly erroneous assessment of the evidence.”).
Although the district court declined to impose the
sanction of forfeiture as requested by Plaintiffs, the court
was well within its discretion in informing the jury that it
may draw an inference that the destroyed documents may
have been unfavorable to Glenmark. The courts are not
required to tolerate acts in derogation of the integrity of
judicial process. Chambers v. NASCO, Inc., 501 U.S. 32,
45 (1991) (“A primary aspect of that discretion is the
ability to fashion an appropriate sanction for conduct
which abuses the judicial process.”). The destruction of
documents in the course of preparation for litigation has
no entitlement to judicial protection, and need not be
concealed from the jury. A new trial on this ground is not
warranted.
IV
STANDING
Glenmark challenges the standing of Abbott Labora-
tories and Abbott Laboratories, Inc. (ALI) as co-plaintiffs
in the instant suit. Glenmark argues that these United
States companies do not have exclusive licenses to the
’244 patent, as Glenmark states is required for entitle-
ment to damages for their lost profits and price erosion
due to infringement.
It is not disputed that Sanofi-Aventis as the owner by
assignment of the ’244 patent, and Aventis Pharma as
exclusive licensee of the ’244 patent, have standing in this
action. Aventis Pharma in turn granted the “irrevocable,
sole and exclusive right” to Abbott GmbH to make, use,
and sell the trandolapril-verapamil combination product
16 SANOFI-AVENTIS DEUTSCHLAND v. GLENMARK
PHARMACEUTICALS
under the ’244 patent. Abbott Laboratories has since
2001 been the owner of the FDA-approved NDA for this
product, and ALI is the exclusive United States distribu-
tor for Abbott Laboratories.
The Plaintiffs state that Abbott Laboratories and ALI
have exclusive rights to market this product under the
’244 patent through express and implied licenses. The
Plaintiffs provided the district court with evidence of the
agreements and understandings related to the exclusive
rights in the United States. The Plaintiffs provided a
“Confirmatory Agreement” executed in 2010, describing
the various transfers of rights.
The district court found that the Abbott arrangements
constituted express and implied exclusive rights and
licenses to the United States plaintiffs. The court also
found that Abbott Laboratories’ 2001 acquisition of the
NDA, and ALI’s exclusive distributor agreement “indicate
intent of the parties to provide Abbott Laboratories and
ALI with an exclusive license.” Standing Op. at 8. As
held in Kalman v. Berlyn Corp., 914 F.2d 1473, 1481 (Fed.
Cir. 1990), “an exclusive vendor of a product under a
patent could be a co-plaintiff in an action for patent
infringement.” See also Weinar v. Rollform Inc., 744 F.2d
797, 807 (Fed. Cir. 1984) (holding that an oral contract is
sufficient to confer co-plaintiff standing when the acts of
infringement injured all of the plaintiffs and when
“[m]ultiple recoveries are neither recoverable nor here
involved”).
Glenmark argues that the district court erred in rely-
ing on Abbott Laboratories’ ownership of the NDA since
2001, because Abbott Germany’s exclusive license is dated
2004. Glenmark states that Abbott Laboratories could
not make ALI the exclusive distributor under a patent in
which Abbott Laboratories had no rights. Glenmark
argues that the 2010 Confirmatory Agreement could not
SANOFI-AVENTIS DEUTSCHLAND v. GLENMARK 17
PHARMACEUTICALS
cure these defects, and also is “void for lack of considera-
tion.” Glenmark Br. at 55–56.
The district court penetrated these complexities. The
court’s finding that any necessary licenses existed, ex-
pressly or impliedly, has not been shown to be incorrect in
law or clearly erroneous in fact. See ATACS Corp. v.
Trans World Commc’ns, Inc., 155 F.3d 659, 665 (3d Cir.
1998) (“This issue of contract formation invokes a mixed
standard of appellate review. The district court’s factual
findings, especially with respect to the parties’ intentions,
will not be reversed unless the record demonstrates that
they are clearly erroneous.”); Aspex Eyewear, Inc. v.
Miracle Optics, Inc., 434 F.3d 1336, 1344 (Fed. Cir. 2006)
(“Determining whether there was an implied license . . .
prior to the filing of the complaint may involve a factual
determination.”).
The district court found that Abbott Laboratories and
ALI had exclusive rights to the patented product in the
United States, based on Abbott Laboratories’ ownership of
the NDA and the relationships and agreements among
the Plaintiffs. Glenmark argues that this reasoning is
flawed because the agreements and the NDA were not
consonant in time, pointing out that Abbott Laboratories
owned the NDA before Abbott Germany obtained the
exclusive rights to the ’244 patent in the United States.
The district court held that in determining patent and
license rights in complex transfers, the standard is
whether the evidence as a whole convinces the trier of fact
of mutual intent to transfer and vest exclusive rights. See
Weinar, 744 F.2d at 807 (oral contract sufficient to confer
co-plaintiff standing when “all of the evidence presented
at trial, taken together supports the inference of an
exclusive right”). Here all entities in the license chain
joined in the suit, such that there is no danger of multiple
suits for infringement. Id. (“Multiple recoveries are
neither recoverable nor here involved.”).
18 SANOFI-AVENTIS DEUTSCHLAND v. GLENMARK
PHARMACEUTICALS
Glenmark relies on Rite-Hite, which held that non-
exclusive independent sales organizations who served as
distributers for Rite-Hite do not have standing as co-
plaintiffs in a patent suit when they do not have “any
right to exclude others under the patent.” Rite-Hite Corp.
v. Kelley Co., 56 F.3d 1538, 1553 (Fed. Cir. 1995). Here,
Abbott Laboratories and ALI have fully exclusive rights in
the United States. Although Glenmark argues that
Abbott Laboratories’ ownership of the NDA has no bear-
ing on patent exclusivity, the issue before the district
court was whether the Plaintiffs intended to grant exclu-
sive rights to Abbott’s United States companies, and did
so grant. Abbott Laboratories’ exclusive ownership of the
NDA conforms to that intent, and is reflected in the
entirety of the commercial relationships, as the district
court recognized.
Abbott Laboratories’ acquisition of the Tarka® NDA
comports with the license to Abbott Germany and the
confirmation of the exclusive license to Abbott’s United
States companies for the United States patent rights
applicable to the Tarka® NDA. See 21 U.S.C. §355(a) (“No
person shall introduce or deliver for introduction into
interstate commerce any new drug, unless an approval of
an application filed pursuant to subsection (b) or (j) of this
section is effective with respect to such drug.”). The
district court did not clearly err in finding that the Plain-
tiffs intended that the Abbott United States companies
have exclusive rights in the United States under the ’244
patent.
We affirm that Abbott Laboratories and ALI have the
exclusive rights to the Tarka® product in the United
States. As established in Kalman, 914 F.2d at 1481, these
United States entities have standing to participate in this
suit and to recover damages for their injury due to Glen-
mark’s infringement. Glenmark does not appeal the
amount of damages.
SANOFI-AVENTIS DEUTSCHLAND v. GLENMARK 19
PHARMACEUTICALS
CONCLUSION
The rulings and judgment of the district court are af-
firmed. We remand to the district court for the reserved
accounting of any post-verdict damages.
AFFIRMED AND REMANDED