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.
SANOFI-AVENTIS DEUTSCHLAND v. GLENMARK

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2

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 Deutschland 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 antihypertension drug having the brand name Tarka®. Tarka® is a 

combination of two active ingredients into a single dosage 

product: the angiotensin converting enzyme (ACE) inhibitor 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 exclusively 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 Administration in 1996 and acquired by Abbott Laboratories in 2001. 

In 2007 the defendants Glenmark Pharmaceuticals Inc. 

and Glenmark Pharmaceuticals Ltd. (collectively “Glenmark”) 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. 
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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 generic 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 judgment 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.”).

 
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4

I 

JURISDICTION

Within 30 days after the district court denied Glenmark’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 entitled “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) recognizes finality for purposes of appeal although the accounting 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 otherwise 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.
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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 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 hypertension medications, trandolapril and verapamil hydrochloride. 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 
SANOFI-AVENTIS DEUTSCHLAND v. GLENMARK

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6

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; wherein said ACE inhibitor and said calcium antagonist 

are present in said composition in amounts effective for treating hypertension; . . . 

3. A composition according to claim 1, wherein said ACE inhibitor is trandolapril [formula 

omitted] or a physiologically acceptable salt thereof, or quinapril [formula omitted] or a physiologically acceptable salt thereof.

The jury was instructed on the presumption of validity, 

and that invalidity must be proved by clear and convincing 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 components 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

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attributed to one of the prior art components of the combination.

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” compound, whereas the prior art had studied primarily “single-ring” compounds. At the time the ’244 patent 

application was filed in 1986, the single-ring ACE inhibitors 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 unchanged 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 combinations 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 combination of the double-ring trandolapril with verapamil 

hydrochloride, or suggested that this combination would 

provide the previously unavailable extended and improved 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 important consideration for his analysis. This view was 

challenged by the testimony of Plaintiffs’ expert, who 
SANOFI-AVENTIS DEUTSCHLAND v. GLENMARK

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8

testified that persons skilled in this field at the time of 

the patent generally believed that double-ring ACE inhibitors 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 perceptions 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 channel blockers required more than once daily dosing, and 

that the longer-lasting effectiveness of the Tarka® combination, 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 controlling 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 channel blockers as a matter of law, patentability is not avail-
SANOFI-AVENTIS DEUTSCHLAND v. GLENMARK 9

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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 direction 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. 
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10

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, whenever 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 advantages 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 litigation 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 combination 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 amiloride 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

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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 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 combination of the known compounds naproxen and sumatriptan 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 doublering ACE inhibitor with calcium antagonists would be 

longer lasting than the hypertension treatments at the 

time.

The jury could reasonably have relied on the testimony 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 district 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.
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12

III

SPOLIATION

The district court concluded that Glenmark had violated its duty to preserve relevant evidence when litigation 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 proceeding with production of the generic product and preparation 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 twentytwo email chains from 2006, although other evidence, 

such as the work product log, showed activity in preparation 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 “reasonably 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-
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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 determined 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 documents 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 decision.

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 prejudice 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).
SANOFI-AVENTIS DEUTSCHLAND v. GLENMARK

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14

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 product 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 destroyed 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 generally 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 
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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 determinations 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 Laboratories 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 entitlement 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 
SANOFI-AVENTIS DEUTSCHLAND v. GLENMARK

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16

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 distributor 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 relying 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

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cure these defects, and also is “void for lack of consideration.” Glenmark Br. at 55–56.

The district court penetrated these complexities. The 

court’s finding that any necessary licenses existed, expressly 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.”).
SANOFI-AVENTIS DEUTSCHLAND v. GLENMARK

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18

Glenmark relies on Rite-Hite, which held that nonexclusive independent sales organizations who served as 

distributers for Rite-Hite do not have standing as coplaintiffs 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 bearing on patent exclusivity, the issue before the district 

court was whether the Plaintiffs intended to grant exclusive 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 Plaintiffs 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 Glenmark’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 affirmed. We remand to the district court for the reserved 

accounting of any post-verdict damages.

AFFIRMED AND REMANDED