# 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 PHARMACEUTI CALS INC., USA ( now known as Glenmark Generics., Inc., USA ) AND GLENMARK PHARMACEUTI CALS 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

______________________

J OHN A LLCOCK

, DLA Piper LLP, (US) of San Diego, California, argued for all plaintiffs -appellees. With him
on the brief were S TUART E. P OLLACK and S TANLEY J.SANOFI

- AVENTIS DEUTSCHLAN D v. GLENMARK

PHARMACEUTICALS 2

P ANIKOWSKI

, for Ab b ott GmbH & Co. Kg, et al. and

B ENJAMIN C. H SING and S APNA W. P ALLA

, Kaye Scholer, LLP, of New York, New York , for Sanofi

- aventis Deutsc hland GmbH, et al.

J AMES G ALBRAITH , Kenyon & Kenyon LLP, of New York, New York, argued for defendants

- appellants. With
him on the brief were H UIYA WU

, L EE B. S HELTON and

M ICHAEL S. C HANG

.

______________________

Before N EWMAN

, L INN

, and W ALLACH

, Circuit Judges.

N EWMAN

, Circuit Judge

.
This patent infringement suit concerns the antihype rtension drug having the brand name Tarka ®

. Tarka ® is a combination of two active ingredients into a single dosage product: the angiotensin converting enzyme (ACE) inhib itor 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 owne d by or excl usively licensed to S anofi -A ventis 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) (collectiv ely “ Plaintiffs”).

The New Drug Application (NDA) for the Tarka ® product was approved by the Food and Drug Administr ation in 1996 and acquired by Abbott Laboratories in 2001.
In 2007 the defendants Glenmark Pharmaceuticals Inc.
and Glenmark Pharmaceutical s Ltd. ( collectively “Gle nmark”) 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
“P aragraph IV C ertification ,” leading to the filing by

Plai ntiffs of this infringement suit

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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 gene ric 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 ju ry 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 judgme nt 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 aw arded 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 jud gment was not final.

We conclude that jurisdiction is proper

, and affirm the district court’s judgment and related rulings. 1

1 S anofi -A ventis 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.”).SANOFI

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I

J URISDICTION

Within 30 days after t he district court deni ed Gle nmark’s post

- verdict motion s, Glenmark filed a notice of appeal. Plaintiffs state that this appeal is premature

because the district court did not issue a document ent itled “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 th e 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. Glenma rk appealed within 30 days of that

denial.

Glenmark points out that 28 U.S.C. §1292(c)(2) reco gnizes finality for purposes of appeal although the accoun ting 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 ot herwise be appealable to the United States Court of Appeals for the Federal Circuit and is final except
for an ac counting.

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 da m ages.S ANOFI

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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 B hd . 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

P ATENT V ALIDITY

Glenmark’s principal challenge to validity is on the ground of obviousness.

The Tarka ® product is a combination of two hyperte nsion medications, trandolapril and verapamil hydrochl oride. 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). Th e 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 objectiveSANOFI

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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. T he 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; wher ein said ACE inhibitor and said calcium antagonist are present in said composition in amounts effe ctive for treating hypertension;

. . . 3. A composition according to claim 1, wher ein said ACE inhibitor is trandolapril [formula omitted] or a physiologically accepta ble salt ther eof, or quinapril [formula omitted] or a physiolog ically acceptable salt thereof.

The jury was instructed on the presumption of validity, and that invalidity must be proved by clear and convin cing 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 comp onents 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 beS ANOFI

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attributed to one of the prior art components of the co mbination.

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” co mpound, whereas the prior art had studied primarily “si ngle

- ring” compounds. At the time the ’244 patent application was filed in 1986, the single

- ring ACE inhib itors enalapril and captopril were the only ACE inhibitor s 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 u nchanged in prior art studies involving combinations with

calcium channel blockers.

Glenmark argued at trial, and repeats on this appeal,
that the T arka ® product simply subst ituted one known
ACE inhibitor for another . The Plaintiffs responded that there were hundreds if not thousands of potential comb inations of ACE inhibitors and calcium antagonists in 1986, and that none of the available informatio n pointed directly at the combinations claimed. The Plaintiffs pointed out that nothing in the art suggested the comb ination of the double

- ring trandolapril with verapamil hydrochloride, or suggested that this combination would provide the previously unavailable extended and i mproved 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 ch annel blocker in any prior art reference. He opined that the number of rings on the ACE inhibitor was not an i mportant consideration for his analysis. T his view was challenged by the testimony of Plaintiffs’ expert, whoSANOFI

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testified that persons skilled in this field at the time of the patent generally believed that double

- ring ACE inhi bitors 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 inhib it 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 ph ysicians 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 perce ptions 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 cha nnel blockers required more than once daily dosing, and that the longer

- lasting effectiveness of the Tarka ® comb ination, alo ng 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 co ntrolling 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

an tagonists, 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 cha nnel blockers as a matter of law, patentability is not avai l-S ANOFI

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able even if the combination is later found to possess unexpected or advantageous properties. Glenmark states that the jur y 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 so lutions” 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 iden tified 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 , 85 3 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 dire ction as to which of many possible choices is likely t o be
successful.”

Glenmark argues that the in ventors’ 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.

Technolo gic 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

.SANOFI

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Glenmark als o 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 consid er all of the characteristics possessed by the claimed invention, whe never 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 i nvention’s properties and a dvantages 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 liti g ation 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 combin ation w as 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 s hown or predicted

in the prior art , the combination may be obvious to try.

In Merck v. Biocraft the claimed combination of am iloride and hydrochlorothiazide was specifically named in the prior art, and had no “ unexpected ly 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 pa tent claimed theS ANOFI

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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 147 7 , 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 comb ination of the known compounds naproxen and sumatri ptan 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 testim ony 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 substanti al evidence to support findings that in turn support the verdict that obviousness had not been proved by clear and convincing evidence. The di strict court’s review of the evidence and confirmation of the jury verdict manifests no error of law. The judgme nt that invalidity had not been proved is affirmed.SANOFI

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III

S POLIATION

The district court concluded that Glenmark had vi olated its duty to preserve relevant evidence when litig ation 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 poli cy whereby all emails and related electronic documents were retained for only one month, and that this policy continued as Glenmark was procee ding with production of the generic product and prepar ation of the ANDA in 2006. In response to Plaintiffs’

disco very 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 prepar ation for litigation.

The district court appl ied 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

e vidence 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 “re asonably 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 litig a-S ANOFI

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tion.’” Id. (quoting H olm e s 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 d ete r mined that Glenmark systematically overwrote the emails on its email server between February 23, 2006 and mi d- 2007 and that some of these

documents were r elevant to the claims in suit.

An adverse inference permits you, the jury, to

in fer that the destroyed emails and attached do cu ments 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 dec ision.

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 t he statement that prej udice 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 circumstant ial evidence to suggest the contents of destroyed evidence.” Beaven v. U.S. Dep’ t of Justice , 622 F.3d 540, 555 (6th Cir. 2010).SANOFI

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Glenmark’s witnes ses 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

mark eting) 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 develo p a generic version of Tarka ® , and acknowledged that Glenmark used email to comm unicate with the team in India during the deve lopment. I t was pointed out to the district court that attorney work pro duct claims were made relative to this period, before
Glenmark’s later institution of a litigation hold. It was
reasonable for the distr ict court to infer that some d estroyed 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) (“T he unexplained failure or refusal of a party to judicial proceedings to pr oduce evidence that would tend to throw light on the issues authorizes, under certain circumstances, an inference or

presump tion unfavorable to such party.” ).

The destroyed records were from the period that was acknowledged to include discussion of the gen eric 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 genera lly may receive the fact of the document’s nonproduction or destruction as evidence that the party that has pre vented production did so out of the well

- founded fear th at 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 clearlyS ANOFI

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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 determin ations 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

S TANDING

Glenmark challenges the standing of Abbott Labor atories 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 entitl ement 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

exclu sive 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 productSANOFI

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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 distrib utor for Abbott Laboratories.

The Plaintiffs state that Abbott Laboratories and ALI have exclusive rights to market this prod uct 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 Ag reement” 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 La boratories’ 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

s ufficient 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 rel ying on Abbott Laboratori es’ 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

argue s that the 2010 Confirmatory Agreement could notS ANOFI

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cure these defects, and also is “void for lack of consider ation.” Glenmark Br. at 55

– 56.

The district court penetrated these complexities. The court’s finding that any necessary licenses existed, e xpressly 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 th at they are clearly erroneous.”); Aspex Eyewear, Inc. v. Miracle Optics, Inc ., 434 F.3d 1336, 1344 (Fed. Cir. 2006) (“ Determining whethe r 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 Laborator ies 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 conv inces the trier of fact
of mutual inte nt 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.”).SANOFI

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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 bea ring on patent exclusivity, the issue before the distr ict court was whether the Plaintiffs intended to grant excl usive 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 r ights 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

d istrict court did not clearly err in finding that the Plai ntiffs intended that the Abbott United States companies have exclusive rights in the United States under the ’244
patent.

We affirm that Abbott Lab oratories 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 Gle nmark’s infringement. Glenmark does not appeal the amount of damages.S ANOFI

- AVENTIS DEUTSCHLAND v. GLENMARK 19

PHARMACEUTICALS

C ONCLUSION

The rulings and judgment of the district court are a ffirmed. We remand to the district court for the reserved accounting of any p ost

- verdict damages.

AFFIRMED AND REMANDED