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Sanofi-Aventis v. Apotex Inc.
659 F.3d 1171
Fed. Cir.
2011
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Docket

*1 Conclusion III arise I and Count Count

Because facts, operative

from the same Trusted In- previously asserted

claims court, CFC in federal district

tegration are these claims barred

properly held however, by erred,

by § 1500. The CFC II because does

dismissing Count operative substantially the same

arise claims. Accord- district court

facts as the II to Count apply does not

ingly, jurisdic- subject has matter the CFC claim.

tion over that

AFFIRMED-IN-PART, REVERSED-

IN-PART, AND REMANDED

Costs party shall bear own costs.

Each Sanofi-Synthelabo,

SANOFI-AVENTIS, Bristol-Myers Squibb Holding Partner-

Pharmaceuticals Plaintiffs-Appellees,

ship, Apotex Corp., INC. and

APOTEX

Defendants-Appellants.

No. 2011-1048. Appeals,

United States Court

Federal Circuit. 18, 2011.

Oct. *3 Cravath, Chesler, &

Evan R. Swaine NY, LLP, York, Moore, argued for of New him on the brief plaintiffs-appellees. With J. Stark and David Green- were Richard Robert counsel on the brief were wald. Of Baechtold, Murnane and L. John D. Wil- Celia, Solander, Fitzpatrick, liam E. Scinto, York, Harper of New NY. & Breisblatt, Fatten Muchin & Robert B. LLP, Rosenman, IL, Chicago, argued him on defendants-appellants. With Eric was Cohen. Of counsel brief C. P. Stephen was Benson. SCHALL, NEWMAN,

Before MOORE, Judges. Circuit filed Opinion for Circuit Judge Judge MOORE. Circuit dissents-in-part. NEWMAN MOORE, Judge. Drug Circuit an Abbreviated Application New (ANDA) with the United States Food and (collec- Apotex Corp. Inc. and (FDA) Drug seeking ap- Administration Apotex) appeal tively, the United States proval generic the sale of clopidogrel District Court for the District of Southern prior bisulfate to the expiration tablets New York’s award (the 4,847,265 U.S. Patent No. '265 pat- Sanofi-Synthelabo, ent). I, 470 Plavix 1372-73. The Bristol-Myers Squibb Sanofi Pharma- submission included a paragraph IV certi- Holding Partnership (collectively, ceuticals pursuant fication 21 U.S.C. Sanofi) holding and its Inc. is *4 355(j)(2)(A)(vü)(IV) asserting that jointly severally damages. and liable for patent '265 is invalid. Id. at 1373. In Inc., v. Apotex 748 Sanofi-Aventis response submission, to the Sanofi filed (S.D.N.Y.2010). F.Supp.2d Apotex 293 21, 2002, on suit March alleging that the appeals also the district court’s denial of filing of the ANDA act constituted an motion supplemental its to a leave file 271(e)(2). infringement under 35 U.S.C. answer, defenses, affirmative and counter- Although Apotex Id. pro- admitted that its patent pleading claims misuse and breach posed generic product infringe claim of contract. J.A. 2.1-2.22. Because the 3 of the patent, Apotex '265 counter- district court by awarding erred prejudg- seeking claimed a declaration that the '265 ment interest in addition to Sanofi’s “actu- is invalid and unenforceable. Id. al specified parties’ in the settle- filing Sanofi’s forty-five the suit within agreement, ment we reverse-in-part. We days receiving of Apotex’s para- notice affirm the district holding court’s graph IV certification triggered thirty- a Apotex Inc. jointly severally and liable stay approval month of FDA for the for all and its of Apotex’s denial ANDA pursuant 21 U.S.C. motion for supplemental leave file a § 355(j)(5)(B)(iii). Id. answer, defenses, affirmative and counter- claims. 17, The stay expired May 2005, on 20, 2006, January on gave Apotex the FDA

Background approval generic final to sell product. its appeal This is the third Prior we have in Id. to the approval, par- heard FDA’s nearly this decade old ties negotiations Hatch-Waxman dis- initiated settlement pute regarding clopidogrel bisulfate tab- culminated in tentative agreement on lets, (the by sold Sanofi under the brand name March 2006 agree- March 2006 ment). Plavix®. In appeal, the first we Id. In the agreement, affirmed March 2006 the district grant granted Apotex court’s preliminary a future license un- injunction. Sanofi-Synthelabo patent, der the v. '265 Apotex, which would allow Inc., (Fed.Cir.2006) (Plavix Apotex F.3d 1368 to begin generic sale of its product I). In the appeal, second we several months patent expired. affirmed before the judgment district court’s J.A. 683. patent- expressly agreed, Sanofi also invalid, alia, in-suit is infringed, not during not inter the pendency of the unenforceable. Sanofi-Synthelabo Apo- license would not launch an authorized tex, Inc., (Fed.Cir.2008) generic. F.3d 1075 Id. (Plavix II). The facts most relevant to generic An authorized is a generic drug

this appeal are set forth as follows. sold company who markets the

On (or November drug brand name a third party licen- through agent, see). Pharm., U.S. Apotex Corp., filed See Mylan Inc. v. U.S. Food, Admin., agree- in the expressly agree Drug & Cir.2006). (4th generics, generic like launch an authorized Authorized ment price at a reduced during are sold license. generics, pendency other drug. name Under compared to the brand negotiating the settle- The BMS executive Act Hatch-Waxman provisions Sanofi, of the however, orally on behalf Apotex filed its time in effect that Sanofi would not promised Apotex ANDA, 180-day Apotex was entitled generic during this launch an authorized during which the exclusivity period 30, 2006, period. pre- BMS time On generic clo- other approve FDA would not to the sented the once products bisulfate pidogrel but failed to disclose the approval, FTC the FDA. approval from received agreement regarding oral existence of the However, 355(j)(5)(B)(iv). U.S.C. 5, 2006, On generic. an authorized June au- may still market an company branded the oral to the Apotex disclosed 180-day this exclu- generic during thorized disclosure, light FTC. Pharm., Inc., 454 sivity period. Mylan requested a written FTC certification *5 an sale of authorized at 273. The to that BMS made no BMS confirm had (through lower patients benefits generic promise to launch an authorized oral not company, but and the branded prices) pendency the of generic during by generic introduc- harms the first-to-file executive the license. The BMS submitted Id. ing generic competition. requested without disclos- certification as Compa- Bristol-Myers Squibb Although 28, 2006, ing July the On promise. oral (BMS) this it litigation, a to ny party attorneys general the informed the state Bristol-Myers plaintiff owner of is an parties they approve would not the Holding Pharmaceuticals Squibb Sanofi promised but to re- May agreement, 2006 of orders Partnership. a result entered As investigation an into the consider pending BMS, involving litigation previous in a agreement between existence of the oral subject ap- was to agreement 2006 March parties. Trade Commission by the Federal proval 2006, Apotex July On declared (FTC) attorneys state and a of consortium pursuant rights to its regulatory to denial objected multiple The FTC general. pro- agreement, May agreement, 2006 under 2006 which of the March provisions preventing including provision Regulatory Sanofi Review has not vided that “[i]f generic dur- launching 31, 2006, an authorized by July either completed been license. In view period Apotex’s of ing that there party right declare has withdrew the objections, these Sanofi ... Denial Regulatory [and] has been a resumed____” and review agreement from administrative J.A. litigations will be negotia- settlement parties reinstituted 8, 2006, Apotex launched August 693. On tions. generic product. bisulfate clopidogrel its preliminary injunction, moved for Sanofi 26, 2006, May executed

On granted August on court which the district terms settlement second —the 31, 2006, Apotex Sanofi-Synthelabo v. in ap- issue this are at partially of which (S.D.N.Y.2006), Inc., F.Supp.2d 317 (the 488 agreement). 2006 Unlike peal I.1 In Plavix and which we affirmed Sanofi did not agreement, the March 2006 arising purposes action paragraph 1. In 9 of product by Apotex generic its jurisdiction and out a sale Apotex personal consented to date of its license. prior to the effective of New York in the District venue Southern answer, gener- plemental its Apotex alleged few weeks marketed that the $884,418,724 ic it product had in net sales. patent '265 was unenforceable for misuse due to BMS’s failure to disclose the district held a The court bench trial oral agreement to the FTC and its later regarding liability January 22 between and false certification to the FTC. also February and on June added a counterclaim for breach con- an opinion holding issued the '265 tract, alleging duty that BMS its breached patent was both not invalid and not unen- regula- use reasonable efforts to secure Sanofi-Synthelabo v. Apotex forceable. tory (S.D.N.Y.2007). approval F.Supp.2d Infringement not an was issue at the trial: The court district denied mo- Apotex previously admitted that infring- tion September on 2009. J.A. 2.1-2.23. 271(e)(2) ed generic under because its claim, Regarding patent misuse product infringe would claim 3 the '265 district court determined that the claim patent. Additionally, Sanofi never amend- ‘unnecessary was “an inappropriate pleadings ed specifically allege its in- action,” 2.8, diversion’ from J.A. [the] 271(a)-(b) fringement under after Apo- “expand, complicate prolong began selling generic tex product. its discovery in prolong [the] action and court district bifurcated the issue dam- ultimate resolution.” Id. at 2.10. The dis- ages, which was scheduled for pro- future trict also determined that given our 271(e)(4)(C). pursuant ceedings Id. recent Corp. en banc decision Princo 12, 2008, On December we af- Commission, International Trade *6 the firmed district court’s in decision Pla- (Fed.Cir.2010) (en banc), F.3d 1318 BMS’s vix II. likely actions did not patent constitute mis- During the pendency liability of the trial use. Id. at 2.9. The district court similar- appeal, government and pursued the ly denied the motion to add the breach of charges against in BMS relation to its so, counterclaim. contract In doing the failure to agreement disclose the oral and district court Apotex determined that its later false certification to the FTC. On could file the breach sepa- of contract suit 30, 2007, May after the trial liability had rately and that granting motion “would ended, but before the district court en- both delay disposition litigation of this and decision, tered its pleaded guilty BMS to ... prejudice by requiring Sanofi it to making false statements to the FTC address an additional discovery.” area of § violation of 18 U.S.C. 1001. J.A. 1826- Id. at 2.11. 2009, 26, 41. On March brought FTC against BMS, a civil action resulting in a May 2006 set Sanofi’s consent judgment wherein BMS admitted “actual “50% of net it was in of obligations violation to 18, sales.” 2009, J.A. 693. On December truthfully all provisions disclose of the Sanofi for summary moved judgment on May 2006 agreed pay BMS to 9, 2010, damages. issue of On October penalty $2,100,000. a civil granted district court Sanofi’s motion 22, May summary for judgment

On and during damages Apo- ordered (50% stage $442,209,362 the litigation, Apotex tex to sought pay damages leave sales) supplemental answer, file a affirmative net and an additional defenses, and $107,930,857 counterclaims. In sup- in prejudgment interest.2 2. prejudgment The district court compounded calculated quarterly August 2006 rate, average at the prime interest annual until October 2010. J.A. 17.

1177 in a litigation judgment If the results inter awarding prejudgment 17. J.A. not the '265 invalid or est, rejected Apotex’s court the district unenforceable, agrees that its ac- arguments Sanofi infringement damages past tual Sanofi-Aventis, an such award. precluded Apotex, date on up which at The district F.Supp.2d 296-97. 50% enjoined, Apo- will be rejected Apotex’s arguments court also clopidogrel prod- sales tex’s net was not avail interest agrees .... further that it ucts Sanofi U.S.C. remedy pursuant able as a damages under 271(e)(4)(C). will seek increased fur § Id. The district court § 35 U.S.C. 284. Apotex Inc. and ther held that severally liable Corp. jointly were and added). (emphasis J.A. Apotex appeals Id. damages. at paragraph court The district held jurisdiction pursuant have and we 14(h) prejudg- did not bar award 1295(a)(1). § U.S.C. interest. 296-97. The district court F.Supp.2d at Discussion infringement for acts un- reasoned that the dis- Apotex argues that appeal, On 271(e)(2) may der 35 U.S.C. courts 1) by: granting

trict court erred monetary “damages or other relief’ award in addition to interest 271(e)(4)(C) after pursuant to 35 U.S.C. agree- in the damages specified importation has there been commercial 2) ment; awarding interest drug. Id. The dis- generic or sale 3) rate; jointly holding Apotex Inc. prime damages that such trict determined damages; severally for Sanofi’s and liable by 35 under are defined U.S.C. 4) Apotex’s motion for leave denying and are “[djamages which distinct answer, affirmative supplemental to file a recovery.” at 297. Be- categories of Id. defenses, pleading pat- and counterclaims agreement only cause the “ex- ” of contract. ent misuse breach the district court plicitly limits *7 prevent that it did not an addi- determined Prejudgment Interest of “interest on those dam- tional award grant court’s We review a district at 297. The pursuant to 284. Id. ages” of for an abuse of interest “[i]n court concluded that the ab- district v. Indus. Electro discretion. contrary, the agreement Scientific of sence Inc., 1341, 1349 Scanning 247 F.3d Gen. interest on dam- general awarding the rule (Fed.Cir.2001). “A district court abuses in actions re- ages infringement on decision is based its discretion when its mains unaltered.” Id. at 297. fact, clearly findings of is based erroneous that the district court Apotex contends law, of or the interpretations on erroneous by awarding prejudg- abused discretion unreasonable, fanci arbitrary or clearly is in the of ment interest addition to amount Techs., 138 Corp. FAS Cybor ful.” May damages” specified the “actual banc). (Fed.Cir.1998) (en 1448, 1460 Apotex argues that the agreement. 2006 a May agreement, 2006 when read as para parties dispute whether The whole, contractually lim- 14(h) that Sanofi 2006 shows May agreement of graph the recovery full to 50% of Para ited its recovery damages. of limits Sanofi’s par- when contends the Apotex denial net sales. regulatory that if graph 14 states pay- separate a interest contemplated ties parties litigation between occurs May agreement expressly 2006 ment and: will resume 1178

provided Apotex points para- terpretation agreement it. a for of settlement de which graph agreement, 10 of the defines novo. v. Spellings, Hatalmud 505 F.3d Apotex (2d Cir.2007). the amount Sanofi will reimburse 139, 145 inventory: for investment in parties appear agree The Apotex Apo- Sanofi reimburse for will governs New York law contract the inter clopidogrel tex’s of bisulfate stock bulk pretation May 2006 See goods price ... and finished for not to Appellants’ Br. 50-51 New York (citing million, Apotex which repre- exceed $40 law); 22 Appellees’ contract Br. (citing actual, fully sents and warrants is its law). New York contract Under New inventory, for loaded cost as evi- York may law a court interpret contract by denced documents will pro- as a resorting matter law without vide. sum will payable That be within extrinsic if evidence contract is days 30 Regulatory after Clearance ... straightforward unambiguous. Postle with interest the date execution McGraw-Hill, Inc., waite v. this at an annual interest (2d Cir.2005). Even where contractu 6.5%, rate compounded monthly. al ambiguous, term is if the intention of added). J.A. 691 (emphasis parties clear from four is corners argues the district court did agreement, interpretation of the abuse its discretion awarding pre- law, contract is a matter of and the court judgment interest. Sanofi contends that may appropriately summary rule on judg because the is silent regarding ment. See id. interest, the district court parties’ dispute on hinges whether correctly applied the general rule that 14(h) paragraph agree- “prejudgment ordinarily interest should be ment imposition allows of prejudg- Corp. awarded.” Gen. Motors v. Devex interest addition to “actual dam- Corp., S.Ct. U.S. ages,” or (1983). damages” whether the “actual L.Ed.2d 211 award is the full measure of Sanofi’s dam- Sanofi argues that it inconsequential ages. reviewing After expressly para- included in agreement, we conclude that graph agreement, but phrase intended that “actual not in paragraph 14. Sanofi contends that include all necessary to compen- absent language, the contractual sate Sanofi Apotex’s infringement. Be- no statutory right have to the inter- *8 cause prejudgment a interest is form of est in connection with reimbursements for compensatory damages, the district court inventory specified paragraph 10. by awarding erred additional prejudgment contrast, Sanofi contends that under 284 interest pursuant to 35 U.S.C. it statutory has a right prejudgment to interest preserve that did not to need long Courts have that pre held the agreement. settlement judgment is a compensato interest form of ry relief. “No matter of interpretation

Because the what area law of a is considered, agreement interest, settlement prejudgment is not an issue when unique law, awarded, patent to of apply part plaintiffs we the law is a of successful the appropriate regional complete compensation.” Transmatic, circuit. Novame dix, Indus., Ltd. v. NDM Acquisition Corp., Inc. v. 166 Gulton 180 F.3d 1347- (Fed.Cir.1999). F.3d (Fed.Cir.1999); 1180 The Sec see also Oiness Wal (Fed.Cir. ond Co., Circuit reviews the green district court’s in- 1996) patentee’s no puni- alty profits, interest has or the lost but also (“Prejudgment tive, only In- compensatory, purposes. prejudgment but interest. compensates patent the owner for

terest Moreover, in separate section of the of money of its between the date the use agreement, paragraph the parties ex- judgment.”). of The injury and the date stated pressly prejudgment that interest explained policy be- Supreme Court the be and the spe- should awarded under awarding hind cifically set forth how to calculate such the laws: (“That pay- interest. J.A. 691 sum bewill time that An award of interest the ... able with interest from the date of royalty have been payments the of execution this at an annual merely pat- serves to make the received 6.5%, compounded interest rate of month- whole, damages owner since his con- ent ly.”). We conclude royalty only of the value of the sist whole, agreement, taken as indicates forgone but use payments also parties agreed upon amount when infringe- money time of between damages” they “actual to intended this judgment. the date compensatory damages necessary be 655-56,103 compensate in- Sanofi 461 U.S. at Corp., Motors Gen. added). fringement. interpret words “ac- We (emphasis S.Ct. damages” tual in this to be the contract agreement supports damages full measure of all compensatory damages.” interpretation of “actual this interest). (including prejudgment damages” “actual but By allowing Sanofí Indeed, damages un expressly excluding increased construe “actual 14(ii) Act, already indi not to include paragraph der the Patent inter- to account would lead a result parties cates that the intended est counter to purpose potential damages general for all issue: Post- (“Contracts lewaite, 411 F.3d at 67 must agrees damages that its actual Sanofi whole, possible, read as a and if be courts by up to any past infringement Apotex, interpret general must them to effect the enjoined, the date on which contract.”). By agreeing purpose will be 50% of net sales.... simple quantify to a formula to Sanofi’s it will not agrees Sanofi further 14(ii), damages” in paragraph “actual damages seek increased under 35 U.S.C. litigating potentially avoided § 284. complex issue. is benefi- certainty Such damages 693. Increased under J.A. parties. cial to both benefited compensatory puni are not in nature but knowing potential exact amount See, Sensonics, e.g., v. Aeroson tive. Inc. liability. Sanofi benefited because it could (Fed.Cir.1996). 1566, 1574 Corp., ic having fix without to resort Thus, reading paragraph natural litigation, including further complex 14(ii) was entitled to collect discovery. These ben- potentially lengthy *9 “actual 50% of net sales as its however, if disappear, prejudgment efits (i.e. damages), damages” compensatory in interest not included “actual dam- any but could not collect “increased dam ages” here —the since—as demonstrated (i.e. ages” punitive damages). the Su As engage litigation must in parties further in Motors preme Court’s decision General large an liability. over additional clear, patentee’s damages makes Corp. argues the district court cor- only consist not of traditional valuations Sanofi roy- to rectly as a concluded that it did not need patent damages such reasonable preserve right prejudgment strongly to inter- The law favors the settle est, ment of all statutory litigation, including patent right because there is to dis See, e.g., Hemstreet v. Spiegel, putes. § par- interest under 35 U.S.C. 284. Both (Fed.Cir.1988). By 851 F.2d arguments ties also make numerous re- agreeing to a formula to calculate Sanofi’s garding prejudg- whether the award of damages” May “actual in the agree appropriate ment in interest ment, up any gave right Sanofi to supple 271(e)(2) § infringement action based on recovery ment its additional prejudg with their interpretation “damages” term ment interest. Because the district court 271(e)(4)(C) in §§ 35 U.S.C. and 284. in erred its interpretation arguments While interesting, these neither agreement, we reverse the district court’s illuminate nor resolve issue before award of interest pursuant to 35 U.S.C. meaning us—the “actual damages” in § 284.4 agreement. agreed upon damages” “actual are a creature of Liability Inc.’s contract and not of the Patent By Act. Apotex engaged After in the com entering agreement, into the mercial generic product, sale of its parties agreement decided that the itself— complaint never amended allege ei 271(e)(4)(C) § § govern or 284—would ther direct infringement under 35 U.S.C. appropriate of damages measure 271(a) § or infringement induced under 35 Apotex’s infringement. 271(b). Instead, § U.S.C. Sanofi only al noted, As the district correctly leged that Apotex infringed pursuant to 35 “[i]n absence of to the 271(e)(2) § U.S.C. infringement pro —the contrary, general rule awarding inter vision of the Hatch-Waxman Act. Infringe est on in damages patent infringement ac 271(e)(2) ment under hypothetical “is a tions remains unaltered.” case that asks the factfinder to determine 748 F.Supp.2d at Such an agreement 297. whether the drug that will be upon sold exists here. parties To the extent approval of the ANDA will infringe the intended damages” “actual only mean In re Brimonidine Pat patent.” asserted they Litig., ent royalty (Fed.Cir. reasonable have ex 643 F.3d 2011). pressly 271(e)(4) language chosen such they Section only did sets out “the regard remedies which damages.” may granted by be “increased J.A. a court (“Sanofi infringement an act agrees further [under that it will not 271(e)(2).]” here, seek increased Relevant damages under 35 statute U.S.C. 284.”). sets forth only are so, available By do failing in specific instances, namely: manifested a clear intent to have the set tlement agreement scope define the full [D]amages or monetary other relief may potential recovery.3 Sanofi’s be awarded an against infringer if only argues 3. The dissent that Bank New York v. interest in "actual is clear Co., (2d Cir.1994), Amoco Oil 35 F.3d 643 from the four corners of the contract. Cf. requires us to award Postlewaite, at 411 F.3d 67. York, however, this case. In Bank New ambiguous settlement issue was awarding Because the district court erred in and the court found clear no indication of the interest, we need not address parties' intent within the Bank of Apotex’s arguments that the district court also York, contrast, New *10 at 662. in this by awarding prime erred interest at the rate. parties’ case the prejudg- intention to include manufacture, fringement. May agreement been commercial there has use, sell, broadly “Apo- sale within the to include “Apotex” offer to or defines importation Corp., collectively into the tex Inc. Apotex States or and and United approved drug.... including entity an individually, any States of and now United by or hereafter owned or controlled of 271(e)(4)(C). § Barry Sherman, them.” J.A. 690. Dr. argue Apo not that Apotex does Apotex signed Chairman and CEO infringer” “an under Inc. tex agreement behalf of Apotex on both 271(e)(2). However, during the dam Inc. and Apotex Corp. J.A. 694. Addition- lawsuit, Apotex phase argued of the ages ally, parties’ Stipulated in the Statement of Apotex that Inc. is not for the first time Order, in Apotex Facts Pre-Trial Joint it for never en damages, liable because Apotex Corp. admitted that- “the acts of manufacture, in the “commercial gaged subject respect with to the matter of this use, sell, sale within the offer or United of, action were at the direction with done into the importation or United States the authorization of and with coopera- drug,” required an as approved States tion, participation Apotex and assistance of 271(e)(4)(C). Instead, Apotex by argued Thus, only Inc.” J.A. 2498. logical read- imported drug Apotex Corp. that alone ing of the commercial in made all sales the Unit and Apotex Apotex both Inc. and Corp. agreed Inc. Although Apotex conceded ed States. jointly severally to be and liable for Sano- Canada, in drug that it manufactured Therefore, fi’s damages.” “actual we af- argues that Apotex nevertheless firm the court’s district determination showing present any failed to evidence jointly Apotex severally Inc. is and liable place took in the Apotex Inc.’s actions damages. for Sanofi’s result, Apotex Inc. United States. As held claims that cannot be liable for Apotex’s Supplemental Answer 271(e)(4)(C).

infringement under determined that the The district court Although “court should free agreement governed the dam- ly give justice amend] leave when so [to issue, Apotex that both Inc. ages at 15(a), requires,” Sec Fed.R.Civ.P. parties to the Apotex Corp. were ond Circuit “it is within sound discre grant deny tion of court to or the district F.Supp.2d The district court also v. Mattingly, leave to amend.” Green until Apotex waited the dam- noted Cir.2009). (2d The Second trial, after the on ages phase trial Circuit reviews the denial a motion concluded, already “to liability draw dis- an amend the for abuse of dis pleadings purposes Apo- tinction for between these cretion. Id. A district court abuses its Corp., and to tex Inc. and assert ruling discretion if it an erro bases on the first time a defense to Inc.’s a clearly neous view of the law or errone at n. 2. liability damages.” Id. ous of the evidence. Id. A assessment grant district to amend agree with the district court that the court should leave We any apparent or de agreement governs liability “[i]n absence delay, clared bad ease and not address reason —such undue this need above, on dilatory part faith or motive statutory arguments. As discussed 14(ii) movant, failure cure deficien purpose paragraph repeated the clear allowed, by previously to define cies amendments May 2006 was Sanofi’s prejudice opposing party in- undue to the damages from compensatory *11 amendment, grant ent has done in a virtue of allowance of the so manner [or] futility of amendment....” See Foman v. anticompetitive that has effects.” BMS’s Davis, 178, 227, 182, 83 371 U.S. S.Ct. 9 failure to disclose the oral deal with side (1962); McCarthy L.Ed.2d see also v. Apotex, and its false certification to the 184, Corp., Dun Bradstreet 482 F.3d & same, regarding way FTC in no broad- (2d Cir.2007) (“A court district has discre grant. ened the of the scope patent '265 reason, deny good tion to leave for includ Although perhaps plausible it is faith, ing futility, delay, bad or undue un scope patent '265 could grant have to prejudice opposing party.”). due To been if broadened the FTC failed to dis- the extent district court bases the de conduct, cover nefarious such BMS’s a legal nial to a upon of leave amend inter hypothetical is irrelevant here —the FTC pretation, the Second Circuit reviews the quickly of the discovered existence oral Schulmann, novo. Spiegel denial de v. 604 agreement and BMS’s false certification (2d Cir.2010). F.3d prior to either the FTC or state attor- neys general giving approval to the Apotex argues district agreement. by denying court abused its discretion Apotex’s leave to add an amend to affirma Apotex contends that our decision patent

tive defense of misuse and coun Qualcomm Corp., terclaim for breach of contract. Inc. v. We dis Broadcom agree. (Fed.Cir.2008), 1021-22 n. 8 supports argument patent may its that a

Apotex’s allegations regarding patent be held unenforceable for the failure to entirely misuse arise from BMS’s conduct comply statutory with a obligation to dis surrounding its failure to disclose the exis- close relating patent information li to tence of the oral regarding an Qual cense and settlement generic authorized to the FTC and the not, however, comm is regarding case attorneys consortium of general. state patent misuse, but instead concerns wheth contends under both Federal patentee er a waived rights law its prior judgments, and the FTC’s enforce BMS duty patents had a to inform its to its the FTC its oral due failure disclose promise not to gener- launch an authorized their existence to a standard-setting or argues ic. Apotex that BMS’s Qualcomm, failure to ganization. Id. at 1008. oral agreement, despite disclose the this therefore, provides no basis for distin disclose, duty affirmative rises to the guishing later our en banc decision in patent level of misuse that rendered the Brinco, expressly Brinco. As we held '265 patent during unenforceable the en- patent “the defense of misuse is not avail tire period Apotex generic product. sold its presumptive able to a infringer simply be patentee engages cause a in some kind of

The district properly rejected wrongful conduct, commercial even con Apotex’s patent misuse defense as futile. may duct anticompetitive have ef See Acito IMCERA Grp., (2d Cir.1995) (“One reprehensi fects.” 616 F.3d at 1329. good As reason to be, ble deny may they as BMS’s actions leave amend is such do not when leave futile.”). Brinco, patent pat would be constitute misuse: 616 F.3d at “Where key held inquiry leveraged beyond we “that the entee has not patent under scope rights grant misuse doctrine whether ... the Patent Act, patentee impermissibly has broadened misuse has not been found.” Id. at physical temporal scope or pat- of the *12 A. No. Apotex court’s deci- Inc. v. Civ. turn to the district Next we (Fla. County Broward to add a CACE11001243 Apotex’s motion deny sion Ct.2011). Apo- of contract. for breach counterclaim alleges that Sanofi counterclaim

tex’s Conclusion fail- agreement by breached reverse the forgoing For the reasons we the oral side ing to disclose grant prejudgment in- contends district court’s Apotex Specifically, the FTC. terest, holding affirm its that the oral we to disclose that BMS’s failure severally liable for all jointly of the Inc. is paragraph 18 agreement breached damages, Apotex’s that and affirm its denial requirement agreement’s an- supplemental to motion for leave to file efforts” “use reasonable both defenses, swer, affirmative and counter- The district court approval. FTC obtain claims. to add the counter- motion denied both de-

claim, determining that “it would REVERSED-IN-PART, AFFIRMED- ... litigation of this lay disposition IN-PART by requiring it to address prejudice discovery.” J.A. 2.11.

an area of additional Costs court the district Apotex contends No Costs. judge discretion because abused its discovery into the reopened have NEWMAN, could in Judge, dissenting Circuit that seven- *13 See, Ecolab, Corp., Inc. v. FMC 569 e.g., awarding damages rule interest on in pat (Fed.Cir.2009) (“When 1335, F.3d 1353 ent infringement actions remains unal patentee patent asserts a claim that is held tered.” F.Supp.2d 748 at infringed, prejudgment to be valid and in- 284; Motors, (citing § 297 35 U.S.C. Gen. awarded.”); generally Crystal terest is 2058). 657, 103 461 U.S. at S.Ct. Corp. Semiconductor v. TriTech Micro- panel majority proposes that the Int’l, (Fed. 1336, 246 F.3d electronics 1346 prejudgment contract’s silence on interest Cir.2001) (“the discretion of the district parties means that intended and denying prejudgment court in interest is agreed, silence, by forgo their in- such circumstances”); specific limited to Lum- terest. But as Court confirmed in Indus., Inc. v. D.M. E. Corp., mus & 862 Motors, background General rule is (“It (Fed.Cir.1988) 267, F.2d 275 is clear interest is awarded on withholding from General Motors that the damages for infringement, as re- delay interest based on is quired by statute. 6See Corbin on Con- ”); exception, Gyro- not the rule.... (“The tracts 26.1 critical concept is that Co., Corp. Champion Spark Plug mat v. parties apply background if rule their (Fed.Cir.1984) 549, (“the 735 F.2d 555 Assuming contract is silent. that the rule repeated Court’s statements that prejudg- defeasible, may is and be changed ment interest ordinarily ‘should be award- agreement, parties have the choice of ed’ indicates that is the governing saying it, nothing keeping and or affirma- enunciated”); principle the Court Paper it.”). tively modifying displacing or Converting Mach. Co. v. Magnar-Graphics (Fed.Cir.1984) Corp., 11, 745 F.2d 23 If the parties had intended to prevent (“Prejudgment ordinarily interest should the award of they interest would have justification be awarded absent some explicitly, done so for the award of interest award, withholding such an v. Leinoff rule, is the statutory exception. Sons, Inc., 734, Louis Milona & Motors, Gen. 461 U.S. at 103 S.Ct. (Fed.Cir.1984); 743 to compensate is 2058 (“[PJrejudgment interest should be delay patentee experiences in obtain awarded justifi- under 284 absent some ing money he would have received sooner award.”). cation for withholding such an occurred, if infringement no had Central requires Section 284 “damages adequate to Soya Co., Co. v. A. Geo. Hormel & 723 compensate infringement for the ... to- 1573, 1578(Fed.Cir.1983).”). F.2d ” gether with interest and costs.... 35 “[wjhile The district court observed that U.S.C. 284. Agreement explicitly Settlement limits The panel majority incorrectly states damages, it in any way does not an restrict interest is included in award of the “actual damages.” interest on those Sa- damages” percentage measured as F.Supp.2d 748 nofi-Aventis (S.D.N.Y.2010). sales. “Actual and Paragraph “prejudg- 14 of Agreement way separate categories, Settlement interest” are states the damages measured, correctly shall be and district court does not observed. Sa- (“Dam- nofi-Aventis, mention that damages such shall F.Supp.2d be free of the routine award of ages interest. The district categories interest are distinct correctly contract, interpreted recovery.”). Prejudgment interest applying New York contract prec- law and awarded on actual in order to real- expectations are ties’ reasonable fairly. In Beatrice party injured treat “[wjhere ized.”). law, Printing & New York England Under v. New Co. Foods Co., another, F.2d than interpretation one is broader Lithographing (Fed.Cir.1991), explained the court the broader inter- apply courts should not only applied can be interest manifestation of absent a clear “prejudgment pretation damage portion or actual primary Bank New York v. Amoco Oil intent.” por- enhanced punitive (2nd Cir.1994). or not to the Co., tion,” “prejudgment and that agreed York the had Bank Newof *14 delay a for the compensate ‘to designed recovery to no “any to limit obtaining money experiences patentee $550,000 not discuss than and did more in- if no sooner have received he would agreement, interest in the prejudgment occurred,’ ‘on the other while fringement upheld the award and the Second Circuit punish- as hand, are trebled damages interest such that the total prejudgment ” 745 F.2d ment,’ Paper Converting, citing $550,000,explaining that: amount exceeded Motors, 461 U.S. also Gen. at 23. See people business could not [Reasonable (“An inter- 655-56, award of 103 S.Ct. 2058 precision how the inclusion of know with royalty pay- the time that est from interest should affect the prejudgment merely been received ments would have all, damages. After cap level of the on whole, owner to make the serves party precision neither could know with only not of the damages consist since his judgment final be ren- when would also of royalty payments but of the value in- ... Absent a clear intent to dered. money between use of the forgone interest within the prejudgment clude the date of the infringement and time of we think that meaning “damages,” Barrier, v. Stan- Inc. judgment.”); Roton faced with businesspeople reasonable (Fed.Cir. Works, 1112, 1128 ley uncertainty prejudgment over how much 1996) damages plus pre- (awarding actual would be would exclude interest there damages). on the actual interest judgment meaning interest from the prejudgment punitive dam- parties’ agreement The “damages.” not an sought not was be ages The Circuit’s rea- 35 F.3d at 662. Second award of forgo the agreement to standard here; York the New soning applicable is damages. actual interest on the York correctly applied New district court interpret must Settlement This court contrast, this court’s decision is law. the intent in accordance with Agreement law, panel for the contrary to New York law of required by the as parties, Agree- majority interprets the Settlement See, v. Philles e.g., New York. Greenfield interest, ment, concerning as by its silence Inc., Records, 750 N.Y.S.2d 98 N.Y.2d general rule that interest opting out of the (2002) (“The fun- 780 N.E.2d lack of “clear despite awarded is in- damental, of contract precept neutral inter- of intent” to withhold manifestation con- agreements are terpretation est. intent.”); parties’ in accord with strued interest is not “a Awarding prejudgment v. Never Venture Snug Square Harbor purpose of general to the result counter 520, 675 Laundry, 252 A.D.2d Home majority ar- panel (“In agreement,” as (1998) construing N.Y.S.2d purpose The gues. Maj. Op. at 1179. read as a contract, must be the document the measure Agreement is to state purpose parties’ to determine the whole of sales. specified percentage as a intent, interpretation giving practical section of in a different parties, That the par- so that the language employed to the Agreement dealing purchase with inventory, provided payment expressly purchases,

of interest on those does majority’s theory,

support panel inventory interest on sale of rule, prejudg-

is not the established on infringement damages. correctly district ruled “the

fact that parties agreed on an interest (see obligation

rate for one Settlement ¶ 10),

Agreement damages, but not for statutory right

does not vitiate Sanofi’s

pursuant to section 284 to

interest.” F.Supp.2d

at 297.

My colleagues reading err in con-

tract’s silence on interest infringement meaning that the intended and

agreed forgo the interest to which the

patentee prece- is entitled statute and must,

dent. I respectfully, dissent.

STRECK, INC., Plaintiff-Appellee, &

RESEARCH DIAGNOSTIC

SYSTEMS, INC., Defendant-

Appellant.

No. 2011-1045.

United States Appeals, Court of

Federal Circuit.

Oct. claim. notes contract part. Apo- the time passed teen months between I I respectfully dissent from Part of the to amend and tex moved leave opinion, court’s which reverses district summary judgment granted court district prejudgment court’s award of interest on damages. on the issue of agreed damages. conditional The Agreement general did not alter the may deny a motion to A court rule that interest is awarded “significantly delay amend where it would patent infringement. damages on Block v. dispute.” the resolution of the depend not on general rule does whether (2d Assocs., First Blood damages are measured the amount of Cir.1993). court denied the district When profits, royalty infringing lost or as a on motion, litigation spanned had sales, or, here, agreed percentage an fact, full trial and nearly eight years. Thus, injured party sales. to make liability for the on the issue of appeal whole, monetary on the paid already occurred. See patent claims had correctly recog- so loss. The district Realty Corp., Xerox Co. v. Gussack court, applying nized. The district Su- Cir.2000) (2d (“Generally, in preme prece- Court and Federal Circuit liability on the troducing new claims for dent, not to have erred. has been shown defen day prejudice last of trial will dant.”). Therefore, Motors say explained cannot that the The Court General we 648, 654, Corp., 461 U.S. Corp. its discretion when Devex district court abused (1983), 2058, 76 L.Ed.2d 211 adding the counterclaim 103 S.Ct. determined ordinarily underly “prejudgment interest should be delay the resolution of the Furthermore, necessary to afford the the de awarded where ing patent dispute. infringe- for the plaintiff compensation has full way prejudiced Apotex nial in no who has precedent ment.” Federal Circuit against a claim Sanofi for breach brought rule, recognizing faithful to this court. See been of contract Florida state edent, pat- the award of interest on and held that “[i]n the absence of rule, exception. ent is the contrary, general to the

Case Details

Case Name: Sanofi-Aventis v. Apotex Inc.
Court Name: Court of Appeals for the Federal Circuit
Date Published: Oct 18, 2011
Citation: 659 F.3d 1171
Docket Number: 2011-1048
Court Abbreviation: Fed. Cir.
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