# Petition for Writ of Certiorari — Implax Laboratories, Inc. v. Astrazeneca AB (No. 05-1583) > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386016_1029%3A1 ## Record - **Collection:** Supreme Court brief - **Document type:** Petition for Writ of Certiorari - **Published:** January 1, 2006 ## Text INS VOU, U.S. one oe Bins TILED (\\ 051583 JUN 2 - 2006 No. OFFICE OF THE CLERK In the Supreme Court of the Anited States IMPAX LABORATORIES, INC:, Petitioner, Ws ASTRAZENECA AB, AKTIEBOLAGET HASSLE, KBI-E INC., KBI INC. and ASTRAZENECA LP, Respondent. On Petition for a Writ of Certiorari to the United States Court of Appeals for the Federal Circuit PETITION FOR WRIT GF CERTIORARI JEFFREY J. TONEY Counsel of Record Joun L. Nortu WILLIAM F. LonGc SUTHERLAND ASBILL & BRENNAN LLP 999 PEACHTREE STREET ATLANTA, GA 30309 (404) 853-8000 Counsel for Petitioner Impax Laboratories, Inc. Becker Gallagher Legal Publishing, Inc. 800.890.5001 ¢ ‘ j QUESTION PRESENTED In a patent infringement action, does the Seventh Amendment of the United States Constitution guarantee a jury trial on factual issues relating to a counterclaim seeking to have the patent declared invalid? ii LIST OF PARTIES TO THE PROCEEDING PURSUANT TO RULES 14.1(b) AND 29.6 Petitioner Impax Laboratories, Inc. certifies that the names of all parties to this proceeding appear in the caption of this Petition for Writ of Certiorari. Petitioner has no parent corporation, and no publicly held company owns 10% or more of its stock. ili TABLE OF CONTENTS TE ad os en oho hy igo pee he oes 1 STATEMENT OF JURISDICTION ............. J CONSTITUTIONAL PROVISION .... : Saat asa 2 DEAS EEEITE SIO BIO A oe a ke oe ee 2 Pics RU so ee ee aa ws ss Okara ys BD, PROCES AI on ee bs ere in wo 5 SUMMARY OF ARGUMENT ........:-.-.20+¢. 7 REASONS FOR GRANTING THE WRIT ........ -, 1 A. THE FEDERAL CIRCUIT HAS FAILED TO ADHERE TO THIS COURT’S SEVENTH AMENDMENT PRECEDENT ........2.64:. 10 1. The Federal Circuit failed to consider whether a counterclaim seeking a declaratory judgment of invalidity raises a legal (rather than equitable) issue as an independent claim, apart from other issues that may exist including whether the patentee seeks damages .... . 10 2. Acounterclaim seeking a declaratory judgment of invalidity must be evaluated under this Court’s historical test to ascertain whether the Seventh Amendment guarantees a jury trial . 13 iV 3. The 18th century common law writ of scire facias is the best historical analog to the modern declaratory judgment claim to invalidate a patent and, pursuant to this analog, the Seventh Amendment guarantees evies a: WY el ke 6 be B. THE FEDERAL CIRCUIT’S SEVENTH AMENDMENT JURISPRUDENCE IS INCONSISTENT AND FLAWED, WILL CONTINUE TO CONFUSE THE DISTRICT COURTS, AND HAS PUT THE FEDERAL CIRCUIT IN A POSITION OF CONFLICT WITH THE OTHER CIRCUITS .......... 5s PEPE es 6 eee Fe SS 2. In re SGS-Thomson Microelectronics, Inc. . . STOO Ga Oe EG 4. Inconsistent application of the Lockwood opinion has caused district court confusion . 5. In re Technology Licensing’s interpretation of Lockwood puts the Federal Circuit in direct conflict with the law of other circuits and will cause further confusion in the district courts * s- 2.0.8 & 6 4 2 Oe 6-8. 6 OO. pO GE: O28 28: 4 Se BSR ee a ey a, ee et ee ee eee ee a i ee te a A ey ee ee ee ee ae oe he ee eo a ee Se a oe ae oe ee et a Oe ee Pe Oe eS a Vv C. THE CASE PRESENTS AN ISSUE OF EXTRAORDINARY NATIONAL IMPORTANCE THAT THE LOWER COURTS WILL NOT ek es ee ea eee ae 27 COPIA x kon 0 bide a hg a ele a oa ne tee 29 APPENDIX Appendix A Appendix B Appendix C Appendix D Appendix E vi TABLE OF AUTHORITIES Cases American Airlines, Inc. v. Lockwood, SED tis SEAR SIO oN 6 ok he 3, 8, 20 American Airlines, Inc. v. Lockwood, DED las SEA es ek aes 3, 8, 20 Arkwright v. Nightingale, ce, Wes a Se ee Bee os eA eee 20 Armco, Inc. v. Armco Burglar Alarm Co., Inc., O75 Fae Tis CGM. FO) es eek eee eo 25 Attorney General ex rel. Hecker v. Rumford Chemical Works, We hs OE ces PE he eee eee ee GS 17 Baltimore & Carolina Line v. Redman, DP As EE Le eG ee ee eee ee 19 Beacon Theatres, Inc. v. Westover, SP ie ee 5b ee Ek eee 10 Blonder-Tongue Labs., Inc. v. University of Illinois Found.., is REL R21. Lc} Se ee goer nreny uracrane- 27 Cardinal Chemical Co. v. Morton International, Te Ge, ee ok a ee eee 11, 27, 28 Curtis v. Loether, WES UD OP ot od ccs abepewneees Dairy Queen, *. . v. Wood, ny Aw RR 6 bib do oes kk 8 10, 12 Dimick v. Schiedt, ee re ee ee ov oka ee chase ee PA Ex parte Wood & Brundage, Se Ths Oe Os hb ee been a eA eee 14 Glaxo Group Lid. v. Apotex, Inc., No. 00 C 5791, 2001 WL 1246628 (N.D. Ill. Oct. 16,2001) ..... 23 Glaxo, Inc. v. Novopharm, Ltd. , L1G P30 1562 Gee, CO Ts os oe Sa ROW 5 5 Hildebrand v. Board of Trustees, OG? F208 70s CO Oe. LIS a ok a 25 Hoechst Marion Roussel, Inc. v. Par Pharmaceutical, Inc., Civ. No. 95-3673 (DRD), 1996 WL 468593 (D.N.J. March 14, 1996) ...... 22 In re Apotex, 49 Fed. Appx. 902 (Fed. Cir. 2002) ..... 21, 23, 26 In re Evangelist, FOF 2G 2? CAGE Te 2 eee ee 25 In re Lockwood, SO F.3d 966 (Fed: Cir. 1995) ............ passim In re SGS-Thomson Microelectronics, Inc., 1995 WL 258370 (Fed. Cir. April 25, 1995) . . passim Vill In re Technology Licensing Corp. ., 423 F.3d 1286 (Fed. Cir. 2005) ........... passim Jacob v. City of New York, BE SOD ooo ce a 6 vib pve ewe ve Vee bos 27 King v. Arkwright, WE BiNis ORR, POOP ec cee ete eee 15, 18 King v. Else, 1 Carp. P.C. 103, cue, eee. Gee: 96 CB. 76D)... oe ee 15, 18 Maldonado v. Flynn, ee ee Fa tee Gls BOOED osc 6 wee oe eee Se 7 Markman v. Westview Instruments, Inc. ., es POO ck cic weap ee 13, 14, 15 Mowry v. Whitney, ee a kee wees 18 Parsons v. Bedford, Breedlove & Robeson, Oe Re By 8 ot |) es 1] Pernell v. Southall Realty, I kd org wee wie wba 13 Pfizer Inc. v. Novopharm Ltd.., No. 00 C 1475, 2001 WL 477163 (N.D. Til. May 3, 2001) ....... 23 Ross v. Bernhard, De CE EPO 6 iw Soe Biclc de ew aeses 11, 12 ix ibe i Sanofi-Synthelabo v. Apotex Inc., No. 02- Civ. 2255 RWS, 2002 WL 1917871 (S.D.N.Y. Aug. 20, 2002) ....22 Shubin v. United States Dist. Court, SAF Fae ee. SPD kad dees 540 SS Tull v. United States, EN Si. WEE CRE i 0.6 xe a Ae ee ce passim Warner-Lambert Co. v. Purepac Pharmaceutical Co. , No. Civ. A. 98-2749 (JCL), 2001 WL 883232 (D.N.J. March 30, 2001) ...... 22 Statutes Pe is 8 IR 8 eo 5 REA DERE RCE ] BE Stas 6 AAO Vike obese ce tae eee es 28 De ec BASE 8 ee eis kee REE Ke I Be atthe BR ied ork wie a eee 1 BO Wi OME 6S re eee es beens l Pe TE: Pees eeu Cae Meese 5, 6, 22, 23 Other Authorities 1 J. Oldham, The Mansfield Manuscripts and the Growth of English Law in the 18th century CRO iw as Mk WERE Lee 15, 18 3 William Blackstone, Commentaries on the Laws of England ...... 14, 17 D.S. Davies, The Early History of the Patent Specification, ae ho eas NOTE 5 5. 6x 09 ES Gin we ee 17 E. W. Hulme, Privy Council Law and Practice of Letters Patent For Invention From the Restoration to 1794, 33 Law.Q.Rev 180 (1917) ........... 18 C. MacLeod, Inventing the Industrial Revolution-The English Patent System, 1660-1800 (1988) ....... 18 Wendy H. Schacht & John R. Thomas, The Hatch- Waxman Act: Legislative Changes In The 108th Congress Affecting Pharmaceutical Patents, See OE TL Dene CO bi ks Se ee es 27 ] Petitioner Impax Laboratories, Inc. (“Impax”) respectfully petitions this Court for writ of certiorari to review the order of the Court of Appeals for the Federal Circuit denying Impax’s petition for a writ of mandamus to reinstate Impax’s wrongfully stricken demand for a jury trial on Impax’s counterclaim seeking a declaration that two patents are invalid. OPINIONS BELOW The opinion of the Federal Circuit is reported at 2006 U.S. App. LEXIS 6931 and reproduced in Petitioner’s Appendix (“App”) at 5a. The order denying panel rehearing was not reported but is reproduced in App. at 3a. The order denying rehearing en banc is reported at 2006 U.S. App. LEXIS 10771 and is reproduced in App. at La. STATEMENT OF JURISDICTION Impax seeks review of an order of the Court of Appeals for the Federal Circuit issued on March 2, 2006 denying Impax’s Petition for a Writ of Mandamus to reinstate Impax’s demand for a jury trial in the District Court. App. at 5a. The Court of Appeals issued orders denying a panel rehearing and a rehearing en banc on March 16 and April 13, 2006, respectively. App. at 3a, la. This Court has jurisdiction under 28 U.S.C. § 1254(1) to review the Court of Appeals’ decision by writ of certiorari. The Court of Appeals had jurisdiction to consider Impax’s petition for a writ of mandamus under 28 U.S.C. § 1651. The District Court has jurisdiction over this case under 28 U.S.C. § 1338 and-28 U.S.C. § 1407(a). 2 CONSTITUTIONAL PROVISION The Seventh Amendment of the Constitution provides: In Suits at common law, where the value in controversy shall exceed twenty dollars, the right to trial by jury shall be preserved, and no fact tried by a jury, shall be otherwise re-examined in any Court of the United States, than according to the rules of the common law. STATEMENT OF THE CASE A. INTRODUCTION This case presents the question whether the Seventh Amendment guarantees a jury trial on disputed issues raised in an independent declaratory judgment counterclaim seeking to invalidate a patent. The Federal Circuit held that the issue is governed by Technology Licensing Corp., 423 F.3d 1286 (Fed. Cir. 2005), in which it previously held, erroneously, that the right to a jury trial on such a counterclaim against the patentee depends entirely upon whether the patentee is seeking to recover damages from the accused infringer at the time of trial. Jd. at 1290-91. Technology Licensing Corporation has petitioned this Court for a writ of certiorari to review the Federal Circuit’s Technology Licensing opinion. See Technology Licensing Corp. v. United States Dist. Court, Misc. Docket No. 765, docketed March 30, 2006. Technology Licensing Corporation’s petition presents the same question as the present case. Impax respectfully submits that the Court should consolidate Technology Licensing Corporation’s petition with the present one and consider them together. 3 The Supreme Court previously recognized the importance of the issue presented in this Petition and agreed to decide it in American Airlines, Inc. v. Lockwood, 515 U.S. 1121 (1995). The jury demand was withdrawn, however, before the Court issued a decision, thereby mooting the issue. American Airlines, Inc. v. Lockwood, 515 U.S. 1182 (1995). In the present case, Petitioner Impax, the accused infringer below, timely demanded a jury trial on its counterclaims seeking a declaratory judgment of noninfringement, invalidity and unenforceability, and antitrust counterclaims. In a remarkable strategic ploy on the eve of trial, the patentee offered to dismiss its damages claim against Impax (but not its damages claim against Impax’s distributor, Teva Pharmaceuticals USA, Inc. (“Teva”)) if the district court would sever Impax’s antitrust counterclaims and strike Impax’s jury demand on its remaining counterclaims of non- infringement, invalidity, and unenforceability. The district court accepted the patentee’s offer, severed Impax’s antitrust counterclaims and struck Impax’s jury demand. The patentee then voluntarily dismissed its claim for damages. Impax seeks review of the order of the Federal Circuit Court of Appeals denying Impax’s petition for a writ of mandamus to compel the district court to reinstate the Impax’s jury demand. As previously noted, the Federal Circuit ruled that this case is governed by /n re Technology Licensing Corp., 423 F.3d 1286 (Fed. Cir. 2005). The Technology Licensing court improperly decided that there was no right to a jury trial on an accused infringer’s declaratory judgment counterclaim seeking to invalidate a patent unless the patentee was seeking to recover damages. The Federal] Circuit opinion failed to take into account the critical fact that a counterclaim seeking a declaratory judgment of invalidity raises a legal (as opposed 4 to equitable) issue and demands independent legal relief: a judgment against the patentee that the patent is invalid. The modern counterclaim seeking a declaration of invalidity is closely analogous to the 18" century English writ of scire facias, a common law action asserted against the patentee to invalidate his patent, a proceeding that was tried before a jury. The Federal Circuit’s ruling therefore conflicts with this Court’s numerous decisions holding that the Seventh Amendment preserves the right to a jury in cases analogous to an 18" century common law proceeding. See, e.g., Tull v. United States, 481 U.S. 412 (1987). Because the invalidity issue asserted in an independent action against the patentee would have been tried to a jury in a common law court at the time the Seventh Amendment was adopted in 1791, the issue must be tried to a jury today, without regard to whether other legal issues have been raised in the case (including whether or not the patent holder is seeking damages). See Tull, 481 U.S. at 425-426. The Technology Licensing opinion also directly conflicts with two of the Federal Circuit’s prior opinions: In re Lockwood, 50 F.3d 966 (Fed. Cir. 1995), cert. granted, 515 U.S. 1121, vacated, 515 U.S. 1182, and Jn re SGS-Thomson Microelectronics, Inc. , 1995 WL 258370 (Fed. Cir. April25, _ _ 1995), cert. denied, sub nom., Int’l Rectifier Corp. v. SGS- Thomson Microelectronics, Inc., 516 U.S. 931 (1995) (nonprecedential). The Lockwood court held that a counterclaim of invalidity gave rise to a right of trial by jury even though the patentee’s damages claim had been dismissed pursuant to summary judgment. Lockwood, 50 F.3d at 969, 981. The SGS-Thomson court held that a right to a jury trial existed on a counterclaim seeking a declaratory judgment of invalidity notwithstanding that the patentee was seeking only injunctive relief and had never sought to recover damages. 5 SGS-Thomson, 1995 WL 258370, at *2. The Federal Circuit’s attempt to harmonize its Technology Licensing opinion with its Lockwood opinion also has put the Federal Circuit’s Seventh Amendment jurisprudence in direct conflict with other circuits. Moreover, the Federal Circuit’s opinion in Technology Licensing unfairly placed the right to a jury trial in a patent case entirely within the strategic control of the patentee. Impax therefore requests this Court to review the Federal Circuit’s decision. B. PROCEEDINGS BELOW Petioner Impax is a generic pharmaceutical company. Plaintiff AstraZeneca and three related companies (collectively, “Astra”) sued Impax in May 2000, initially asserting “artificial” infringement under 35 U.S.C. - § 271(e)(2)(A) by virtue of Impax’s Abbreviated New Drug Application (“ANDA”) to the Food and Drug Administration (“FDA”). See Appendix in Support of Impax’s Petition for a Writ of Mandamus (“PMApp.”) at A46; see Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1569 (Fed. Cir. 1997). Impax had not yet received FDA approval to manufacture or market the accused pharmaceutical products, so Astra could not sue under 35 U.S.C. § 271(a)-(c) and could not seek to recover damages. See 35 U.S.C. §§ 271(a) and (e)(4)(C). After the action was underway, Impax received FDA approval and began to manufacture and market the accused products in September 2004. PMApp. at A160. Astra responded by filing a Second Amended Complaint that added allegations of actual infringement under 35 U.S.C. § 271(a)- (c) and sought recovery of damages. App. at 39a. Astra contemporaneously filed a separate. infringement action 6 seeking to recover damages from Impax’s distributor, Teva. PMApp. at A354. In response to Astra’s Second Amended Complaint, Impax timely asserted counterclaims seeking declarations of invalidity, noninfringement under 35 U.S.C. §§ 271(a)-(c) and (e) and unenforceability and seeking to recover damages based on antitrust counterclaims under Walker Process and “sham litigation” theories. PMApp. at A166. Impax timely demanded a jury. App. at 6a. Astra did not raise any issue concerning Impax’s right to a jury until after the close of discovery. In December 2005, without filing any motion and without any explanation about why it delayed so long before raising the issue, Astra expressed during an evidentiary hearing a desire to include Impax as part of a planned consolidated multi-month bench trial involving several other non-related defendants. PMApp. at A461. The bench trial was then scheduled to start only a few weeks later. /d. Astra “proposed” to the District Court that it would dismiss its damages claim against Impax (but indicating an intent to recover the “full measure” of its damages instead from Impax’s distributor, Teva) if the District Court would sever Impax’s antitrust counterclaims and strike Impax’s jury demand. PMApp. at A476-A477. Astra’s unusual proposal was accepted by the District Court, which entered an order severing Impax’s antitrust counterclaims and conditionally striking Impax’s jury demand subject to Astra’s dismissal of its damages claims against Impax. App. at 44a-45a. Astra then filed a dismissal of its damages claim with prejudice, which the District Court immediately signed. PMApp. at All. The District Court denied Impax’s motion for reconsideration. App. at 9a, 37a. Impax petitioned the Court of Appeals for the Federal Circuit for a writ of mandamus to compel the district court to 7 reinstate Impax’s jury demand. Withom? orai argument, a panel of the Federal Circuit issued an order on March 2, 2006, denying Impax’s petition. App. at Sa. On March 16 and April 13, 2006, respectively, the Court of Appeals issued orders denying Impax’s petition for a panel rehearing and a rehearing en banc. App. at 3a, la. Meanwhile, the consolidated bench trial commenced on April 3, 2006, and is continuing into June 2006, with post- trial submissions thereafter. The commencement of the trial has not mooted the issue raised herein and this Court now should review the question presented. Were Impax to fail to pursue its petition with this Court, Astra may argue that Impax’s petition for mandamus provided Impax’s only opportunity to challenge the improperly stricken jury demand. See Maldonado v. Flynn, 671 F.2d 729 (2d Cir. 1982). If Astra’s argument prevails, then Impax may be denied further opportunity to raise the issue after final judgment and the Federal Circuit’s decision in this case forever would escape this Court’s review. SUMMARY OF ARGUMENT The Federal Circuit erred by holding that the right to a jury trial on an accused infringer’s independent counterclaim of invalidity depends entirely upon whether the patentee asserts a claim for damages in the same suit. See App. at 6a- 7a (following Jn re Technology Licersirg Corp., 423 F.3d 1286 (Fed. Cir. 2005)). The Feu. ! Circuit failed to evaluate whether the independent relief requested by the accused infringer’s counterclaim - namely, to invalidate the patent - asserts legal relief rather than equitable relief. See Tull v. United States, 481 U.S. 412 (1987). 8 The Federal Circuit’s flawed holding resulted from improper application of this Court’s “historical test” to determine whether the relief sought by a counterclaim of invalidity - namely, an affirmative judgment against the patentee that the patent is invalid - would have been tried in an 18" century common law court. The 18" century writ of scire facias to mvalidate a patent, an action filed against the patentee and requesting a judgment of invalidity, is closely analogous to and serves as the best historical analog to the modern declaratory judgment counterclaim to invalidate a patent. The writ of scire facias was a common law action tried to a jury. The Seventh Amendment’s guarantee of a jury trial therefore extends to a counterclaim seeking a declaratory judgment of invalidity, without regard to whether the patentee has asserted a damages claim. A decade ago, the Federal Circuit wrongly decided that the writ of scire facias was not the best 18" century analog. Lockwood, 50 F.3d at 974 n.9.' Nevertheless, the Lockwood court determined that a declaratory judgment counterclaim of invalidity “is not purely an equitable issue” and therefore is guaranteed a right to a jury trial under the Seventh Amendment. /d. at 980. The patentee in Lockwood had sought to recover damages, but his claims had been dismissed as a result of an adverse summary judgment ruling. /d. at 969. The Lockwood court emphasized that the right to a jury trial could not depend upon the patentee’s claims that had been dismissed. /d. ' As previously noted, this Court agreed to review this opinion but the issue was mooted before the Court issued a decision. American Airlines v. Lockwood, 515 U.S. 1121 (1995); American Airlines v. Lockwood, 515 U.S. 1182 (1995). 9 In a subsequent opinion, the Federal Circuit again held that a counterclaim to invalidate a patent was guaranteed a right of trial by jury, notwithstanding that that patentee was seeking only equitable relief. In re SGS-Thomson Microelectronics, Inc. , 1995 WL 258370 (Fed. Cir. April 25, 1995), cert. denied, sub nom., Int’l Rectifier Corp. v. SGS- Thomson Microelectronics, Inc., 516 U.S. 931 (1995) (nonprecedential). The SGS-Thomson court relied upon Lockwood’s holding that a claim seeking a declaratory judgment of invalidity was a legal claim, and therefore, that either party was entitled to a jury trial on demand. /d. at *2. In the recent Technology Licensing opinion, the Federal Circuit expressed that Lockwood was still binding law, but reached a decision that is incompatible with the reasoning and holdings of Lockwood and SGS-Thomson. Technology Licensing conducted no further analysis of whether a counterclaim seeking a declaratory judgment of invalidity constituted legal relief. See Technology Licensing, 423 F.3d at 1289-91. Yet, it concluded that the right to a jury depended solely upon whether the plaintiff was seeking damages at the time of trial. Jd. at 1290-91. This case presents the convergence of two issues of great importance: the right to a jury trial, and the issue of patent validity. The issue will arise frequently in pharmaceutical cases filed under the Hatch-Waxman Act, which are initially filed with no damages claim but which often provide the patentee an opportunity to amend with a claim for damages. This Court previously agreed to resolve the issue, the Federal Circuit repeatedly has refused to consider the question en banc despite vigorous dissents, and it appears unlikely that the lower courts will evaluate this issue further. Impax respectfully submits that this Court should decide the issue now. 10 REASONS FOR GRANTING THE WRIT A. THE FEDERAL CIRCUIT HAS FAILED TO ADHERE TO THIS COURT’S SEVENTH AMENDMENT PRECEDENT 1. The Federal Circuit failed to consider whether a counterclaim seeking a declaratory judgment of invalidity raises a legal (rather than equitable) issue as ah independent claim, apart from other issues that may exist including whether the patentee seeks damages. In evaluating the right to a jury trial on a counterclaim of invalidity, the Federal Circuit erred by disregarding as irrelevant the legal (as opposed to equitable) nature of the counterclaim. The Federal Circuit mistakenly held (by following Technology Licensing) that “the accused infringer or declaratory judgment counterclaimant is entitled to a jury trial only if the infringement claim, as asserted by the patentee, would give rise to a jury trial.” See App. at 7a; In re Technology Licensing Corp., 423 F.3d 1286, 1290 (Fed. Cir. 2005). Contrary to the Federal Circuit’s reasoning, an invalidity counterclaim raises a legal issue and seeks legal relief. The Seventh Amendment therefore guarantees a right to have that issue tried to a jury, without regard to whether other equitable claims or issues have been joined in the action. See Tull v. United States, 481 U.S. 412, 425 (1987) (“if a legal claim is joined with an equitable claim, the right to a jury trial on the legal claim, including all issues common to both claims, remains intact”); accord Dairy Queen, Inc. v. Wood, 369 U.S. 469, 479 (1962); Beacon Theatres, Inc. v. Westover, 359 U.S. 500, 504 (1959). The Seventh Amendment’s 1] guarantee of a right to a jury trial on a legal claim does not depend upon the procedural posture in which the claim is asserted. See Ross v. Bernhard, 396 U.S. 531, 533 (1970) (the Seventh Amendment preserves the right to a jury trial in any suits in which legal rights were determined “in contradistinction to those where equitable rights alone were recognized, and equitable remedies were administered ... [and] may well be construed to embrace all suits, which are not of equity and admiralty jurisdiction, *“hatever may be the peculiar form which they may assume to settle legal rights” (quoting Parsons v. Bedford, Breedlove & Robeson, 3 Pet. 433, 447, 7 L.Ed. 732 (1830))); see also Tull, 481 U.S. at 417. The Federal Circuit erroneously reasoned that whether a counterclaim of invalidity is legal or equitable in nature is dependent upon the plaintiff patentee’s requested relief. The Federal Circuit failed to recognize that a declaratory judgment claim seeking to invalidate a patent “presents a claim independent of the patentee’s charge of infringement,” even when it is asserted as a counterclaim to a patentee’s claim of infringement. See Cardinal Chemical Co. v. Morton International, 508 U.S. 83, 96 (1993) (emphasis supplied). In Cardinal Chemical, this Court noted the “criticalf{]” difference between the mere affirmative defense of invalidity and a claim seeking a declaratory judgment of invalidity; the former may be mooted by a finding of noninfringement, while the latter is not. /d. at 93. The Federal Circuit’s Technology Licensing opinion improperly reasoned that no difference existed between the affirmative defense of invalidity and a claim seeking a declaratory judgment of invalidity. Technology Licensing, 423 F.3d at 1289. Rather than analyzing the independent remedy sought by the counterclaim, the Federal Circuit erroneously looked upon it as constituting 12 a claim purely dependent on the patentee’s election of remedies. Whether the patentee seeks damages or only an injunction is entirely irrelevant to whether the independent relief requested by the accused infringer constitutes a legal remedy. This Court repeatedly has held that the Seventh Amendment guarantees a right to a jury trial on a legal claim even when it is asserted as part of an otherwise equitable proceeding. Ross, 396 U.S. at 538 (“legal claims are not magically converted into equitabie issues by their presentation to a court of equity”); Dairy Queen, 396 at473 n.8 (“It would make no difference if the equitable cause clearly outweighed the legal cause so that the basic issue of the case taken as a whole is equitable. As long as any legal cause is involved the jury rights it creates control.”). The Federal Circuit therefore failed to conduct the appropriate analysis. Whether the patentee is seeking to recover damages might be relevant to whether a right to a jury existed on the patentee’s claims, but it should not impact whether a right to a jury exists on the accused infringer’s independent counterclaim. The correct analysis requires a determination of whether a declaratory judgment claim to invalidate a patent itself constitutes a legal action rather than a purely equitable one. If the counterclaim to invalidate a patent constitutes a legal action, then the Seventh Amendment guarantees a right to a jury without regard to the patentee’s claim for relief. 13 2. A counterclaim seeking a declaratory judgment of invalidity must be evaluated under this Court’s historical test to ascertain whether the Seventh Amendment guarantees a jury trial. When not otherwise required by statute, the common law as it existed at ratification of the Seventh Amendment in 1791 determines whether an action presents a legal issue giving rise to a right of trial by jury. See Markman v. Westview Instruments, Inc., 517 U.S. 370, 377 (1996). Under this “historical test,” either party is entitled to a jury trial in those actions that are analogous to late 18" century “suits at common law.” Tull v. United States, 481 U.S. 412, 417-18 (1987). When applying this test, the court must compare the claim asserted to the single, closest 18" century analog. See id. at 417 n.6. More importantly, the court must examine the remedy sought to determine whether it is legal or equitable in nature. See id. The remedy need not match precisely the remedy provided under the historical analog. See Tull, 481 U.S. at 420 (the Seventh Amendment requires jury trials “in actions unheard of at common law”); see also Pernell v. Southall Realty, 416 U.S. 363, 376 (1974) (statutory action at issue included right to a jury trial because it could fairly be characterized as a “substitute” for an 18" century common law ejectment action); see Curtis v. Loether, 415 U.S. 189, 195 (1974) (right to a jury existed because statutory cause of action was “analogous to a number of tort actions recognized at common law”). If the “nature of the relief authorized by {the modern action] was traditionally available only in a court of law, petitioner in this present action is entitled to a jury trial on demand.” Tull, 481 U.S. at 423. 14 3. The 18" century common law writ of scire facias is the best historical analog to the modern declaratory judgment claim to invalidate a patent and, pursuant to this analog, the Seventh Amendment guarantees the right to a jury trial. The writ of scire facias, an 18" century common law proceeding to repeal a patent, provides the best historical analog to the modern declaratory judgment claim to invalidate a patent. Like the modern declaratory judgment counterclaim to invalidate a patent, the writ of scire facias was an independent action brought against the patentee, not by the patentee. See Lockwood, 50 F.3d at 974 n.9. More significantly, the remedy provided under the writ - which this Court has emphasized is the more important part of the historical analysis — was exactly the same as in a counterclaim of invalidity: an affirmative judgment against the patentee that the patent is invalid. See Tull, 481 U.S. at 421. The writ of scire facias was a legal proceeding in a common law court tried before a jury. 3 William Blackstone, Commentaries on the Laws of England, 48 (14" Ed.); see also In re Technology Licensing Corp., 423 F.3d 1286, 1292-93 (Fed. Cir. 2005) (Newman, J., dissenting) and authorities cited therein; see ex parte Wood & Brundage, 22 U.S. 603, 613-615 (1824) (under the Patent Act of 1793, a scire facias common law proceeding before a jury was the proper way to challenge the validity a patent).?_ This Court’s Markman ? The 18" century writ of scire facias sometimes was conducted in English chancery courts, which exercised both equitable jurisdiction and common law jurisdiction. When proceeding under a writ of scire facias to adjudicate the validity of patent, the chancery court was exercising its common law jurisdiction, and the issue of validity would be tried to a jury. 3 William Blackstone, Commentaries on the Law of England 47-48. 15 opinion cited an example of a writ of scire facias invalidating a patent solely because “there was no new invention described in the specification.” King v. Else, 1 Carp. P.C. 103, Dav. Pat. Cas. 144 (K.B. 1785) (cited by Markman, 517 U.S. at 1391). The court in Else directed a jury verdict: “the jury must find for the crown.” Jd. Even when the issue of novelty was combined with an issue of fraud - which is precisely the situation in the present case - the issues were tried to a jury under 18" century English procedure. See e.g., King v. Arkwright, 1 Carp. P.C. 53 (K.B. 1785) (the issues submitted to the jury included “1. Whether the invention is new? 2. If it be new, whether it was invented by the defendant? And 3. Whether the invention is sufficiently described by his specification?”). Another example of an 18" century Scire facias proceeding tried before a jury is King v. Jacob described in 1 J. Oldham, The Mansfield Manuscripts and the Growth of English Law in the 18" century, 767-68 (1992). A declaratory judgment counterclaim to invalidate a patent presents a legal issue because the writ of scire facias proceeding is the best analog to Impax’s declaratory judgment counterclaim for invalidity and because it was a common law proceeding that tried the issue of validity to a jury. Impax therefore is entitled to a jury on its counterclaim of invalidity. 16 B. THE FEDERAL CIRCUIT’S SEVENTH AMENDMENT JURISPRUDENCE IS INCONSISTENT AND FLAWED, WILL CONTINUE TO CONFUSE THE DISTRICT COURTS, AND HAS PUT THE FEDERAL CIRCUIT IN A POSITION OF CONFLICT WITH THE OTHER CIRCUITS. The Federal Circuit opinions addressing the right to a jury trial with respect to an accused infringer’s declaratory judgment counterclaim of invalidity have been inconsistent and analytically flawed, will continue to confuse the district courts, and has put the Federal Circuit in a position of conflict with the other circuits. The earliest opinion, /n re Lockwood, 50 F.3d 966 (Fed. Cir. 1995), cert. granted, 515 U.S. 1121, vacated, 515 U.S. 1182,° held that a right to a jury exists on a declaratory judgment counterclaim of invalidity, but it did so under a flawed historical analysis in an opinion that has caused confusion in the district courts. The recent Technology Licensing opinion has added even more confusion because it superficially approved the reasoning of Lockwood but in reality cannot be reconciled with Lockwood. The Federal Circuit’s attempt to harmonize its Technology Licensing opinion with Lockwood has resulted in a view directly contrary to the law of numerous other circuits. 1. In re Lockwood The seminal Lockwood opinion held that the Seventh Amendment guarantees a right to a jury trial on a counterclaim of invalidity, but it reached that conclusion by > The issue became moot after the petition for certiorari was granted but before the Court decided the issue, because the patentee withdrew its jury demand. 17 misapplication of the historical test. The Lockwood court acknowledged the compelling similarity between the 18" century writ of scire facias and the modern declaratory judgment claim to invalidate a patent. Lockwood, 50 F.3d at 974 n.9. Nevertheless, the Lockwood court expressed two concerns that made it reluctant to identify the writ of scire facias as the best historical analog to a counterclaim seeking to invalidate a patent. First, the Lockwood court noted that a scire facias action was filed in the name of the king rather than an aggrieved person. /d. at 975 n.9. The court’s concern was unfounded because, although the action nominally was asserted in the name of the king, the action was intended to benefit a specific person or company. Eighteenth century procedure enabled an aggrieved subject to petition the king to initiate the proceeding, and, if so petitioned, the king was required to file a writ of scire facias. Attorney General v. Rumford Chem. Works, 32 F. 608, 618 (C.C.D.R.I. 1876) (“The action of _Scire facias not only was a remedy provided by law for the crown in behalf of the public, but also for any subject of the crown who could show that a void or illegal patent operated to his prejudice”); see also 3 William Blackstone, Commentaries on the Law of England, 260-61. Second, the Lockwood court wrongly concluded that the writ of scire facias could invalidate a patent only for fraud and not for mere invalidity (e.g., lack of novelty). Lockwood, 50 F.3d at 975 n.9. In fact, 18 century English patents included “revocation” clauses that entitled the king to revoke the patent if it became “generally inconvenient.” D.S. Davies, The Early History of the Patent Specification, 50 L.Q.R. 86, 100-106 (1934). One of the most frequent reasons to invalidate a patent under this clause was lack of novelty. /d. at 104. If the suggestion of novelty made in the ed 18 application later proved to be false, even if no fraud was alleged, the patent could be repealed for such “false suggestion” through a writ of scire facias. Id. at 106; see, e.g., Else, 1 Carp. P.C. 103; see Arkwright, 1 Carp. P.C. 53; see Mowry v. Whitney, 81 U.S. 434, 439-440 (187:); see also E. W. Hulme, Privy Council Law and Practice of Letters Patent For Invention From the Restoration to 1794, 33 Law.Q.Rev 180 (1917);* see also Lockwood, 50 F.3d at 985 (a scire facias could issue for either fraud (inequitable conduct) or an unlawful grant (invalidity)) (Nies, J., dissenting); see also Technology Licensing, 423 F.3d at 1292- 93 (Newman, J., dissenting) and authorities cited therein. The Lockwood court was concerned overly about finding a perfect historical analog, contrary to the doctrine of this Court. Tull, 481 U.S. at 421 (“characterizing the relief sought is ‘{mJore important’ than finding a precisely analogous common-law cause of action in determining whether the _Seventh Amendment guarantees a jury trial”; quoting Curtis v. Loether, 415 U.S. 189, 196 (1974)). Yet, the Lockwood court tacitly acknowledged that the writ of scire facias provides the only historical action against the patentee with the remedy of an affirmative judgment invalidating his patent. The identical nature of the remedy is far more significant thay’ whether some difference existed in the basis for invalidating . Up until about 1750, the jurisdiction to repeal a patent rested solely with the Privy Counsel. In about 1750, the Privy Counsel divested its jurisdiction to repeal patents to the common law courts. See 1 J. Oldham, The Mansfield Manuscripts and the Growth of English law in the Eighteenth Century, 730-31 (1992); C. MacLeod, Inventing the Industrial Revolution-The English Patent System, 1660-1800, 59 (1988); E.W. Hulme, Privy Council Law and Practice of Letters Patent For Invention From the Restoration to 1794, 33 Law.Q.Rev. 180, at 189-91, 193-4 (1917). 19 a patent under scire facias — the identified difference did not in fact exist - or whether the king was nominally required to initiate such an action. See Tull, 481 U.S. at 421 (characterizing the remedy is the more important part of the analysis). The purpose of the Seventh Amendment “is to preserve the substance of the common-law right of trial by jury, as distinguished from mere matters of form or procedure, and particularly to retain the common-law distinction between the province of the court and that of the jury....” Baltimore & Carolina Line v. Redman, 295 U.S. 654, 657 (1935). The 18" century writ of scire facias makes clear that a claim requesting an affirmative judgment of patent invalidity against the patentee firmly was within the province of the jury. Nevertheless, the Lockwood court erroneously concluded that the best historical analog was the traditional 18" century patent suit in which the patentee sued the accused infringer and the accused infringer asserted invalidity as a defense. Lockwood, 50 F.3d at 974-75. The court observed that whether invalidity was tried to a jury in the 18” century depended upon whether the patentee sought damages. /d. at 976. The patentee, unable to obtain both damages and an injunction, would have to choose common law damages or an equitable injunction, which would determine whether the patentee’s invalidity defense would be tried to a jury. Jd. Because the patentee had the option of whether his claim was tried to a jury in an 18" century patent suit, the Lockwood court decided that it should not deny the patentee that same option today. /d. Lockwood failed to realize that in an 18" century patent infringement suit, a finding that the patent was invalid provided an accused infringer a defense only for that 20 particular case. It did not prevent the patentee from suing in subsequent suits on the same patent. See, e.g., Arkwright v. Nightingale, Dav. Pat. Cas. 37 (C.P. 1785) (an example of a successful suit on a patent that had been adjudicated invalid in a prior trial four years earlier). The patentee could sue again on the patent, and the next defendant would be required to prove again that the patent was invalid. /d. The remedy provided by a writ of scire facias — to repeal the patent - was more similar to the modern counterclaim of invalidity because it prevented the patentee from ever suing again on the same patent. Although Lockwood misapplied the historical test, it still reached the correct result, holding that “patent validity is not purely an equitable issue,” and therefore, that a right to a jury trial exists on an accused infringer’s counterclaim of invalidity. Lockwood, 50 F.3d at 980. Lockwood focused not on whether damages were actually asserted, but rather whether damages “could” have been asserted. Jd. at 977. Whether damages were actually asserted, much less whether they were asserted and later dismissed, was not relevant: “the particulars of the [patentee’s claim] can play no part in our determination whether he enjoys a Seventh Amendment right to a jury trial as to validity in [the accused] infringer’s action for a declaratory judgment.” /d. at 969. The Federal Circuit refused to consider the issue en banc. Id. at 980. This Court recognized the importance of the issue and granted the defendant’s petition for a writ of certiorari, American Airlines, Inc. v. Lockwood, 515 U.S. 1121 (1995), but the jury demand was withdrawn and the issue mooted before this Court issued a decision. American Airlines, Inc. v. Lockwood, 515 U.S. 1182 (1995). 21 2. In re SGS-Thomson Microelectronics, Inc. In a subsequent opinion, the Federal Circuit again held that the Seventh Amendment guarantees a right to a jury trial on an accused infringer’s counterclaim of invalidity. Jn re SGS-Thomson Microelectronics, Inc. , 1995 WL 258370 (Fed. Cir. April 25, 1995), cert. denied, sub nom., Int’l Rectifier Corp. v. SGS-Thomson Microelectronics, Inc., 516 U.S. 931 (1995) (nonprecedential). The SGS-Thomson court construed Lockwood as entitling either party to a jury trial on a counterclaim seeking a declaratory judgment of invalidity, notwithstanding that the patentee was seeking only injunctive relief and had never asserted a claim for damages. /d. at *2. The court reiterated that whether the patentee actually seeks to recover damages is irrelevant. /d. The SGS-Thomson court noted that Lockwood had based its decision on “the legal nature of the declaratory judgment action, not the nature of the patentee’s claim.” Jd. The Federal Circuit again refused to consider the issue en banc. In re SGS-Thomson Microelectronics, Inc. , 1995 WL 258370 (Fed. Cir. 1995). 3. In re Apotex In a later opinion, the Federal Circuit distinguished the situation in which damages could not be alleged because no actual infringement had occurred, as in a case filed under the Hatch-Waxman Act. Jn re Apotex, 49 Fed. Appx. 902, 903 (Fed. Cir. 2002) (nonprecedential) (“We agree with the district court that under the unusual circumstances of this case, involving only possible future infringement, and in which there can be no damages because no infringing products have been marketed, the only relief that is before the district court is equitable in nature.”). The Apotex court was 22 apparently persuaded by Lockwood ’s distinguishing Shubin v. United States Dist. Court, 313 F.2d 250 (9" Cir. 1963), cert. denied, 373 U.S. 936 (1963), which held that the patentee did not have a right to a jury trial on the accused infringer’s counterclaim seeking a declaratory judgment of invalidity. The Lockwood court noted that the patentee in Shubin sought only an injunction against threatened infringement, not actual infringement. Lockwood indicated that the proper focus was on the remedy that the “patentee could have brought” rather than whether a damages claim was actually filed. Lockwood, 50 F3d at 977 (emphasis supplied).° 4. Inconsistent application of the Lockwood opinion has caused district court confusion. Although Lockwood reached the right result, the opinion confused the lower courts, resulting in inconsistent application. Some courts interpreted Lockwood and SGS- Thompson to hold that a right to a jury trial existed on a counterclaim seeking a declaratory judgment of invalidity, without regard to whether the patentee could or did file a claim for damages in the same action. See, e.g., Sanofi- Synthelabo v. Apotex Inc., No. 02- Civ. 2255 RWS, 2002 WL 1917871 (S.D.N.Y. Aug. 20, 2002); Warner-Lambert Co. v. Purepac Pharmaceutical Co., No. Civ. A. 98-2749 (JCL), 2001 WL 883232 (D.N.J. March 30, 2001); Hoechst Marion Roussel, Inc. v. Par Pharmaceutical, Inc., Civ. No. 95-3673 (DRD), 1996 WL 468593 (D.N.J. March 14, 1996). > The supposed distinction relied upon in Apotex is not relevant in the present case because Astra has alleged actual infringement under 35 U.S.C. §271(a). 23 Other district courts distinguished the situation in which no damages could have been asserted by the patentee, such as was initially asserted in the present case,° when only “artificial” infringement is asserted under 35 U.S.C. § 271(e) based on the accused infringer’s filing of an ANDA. See, e.g. Pfizer Inc. v. Novopharm Ltd., No. 00 C 1475, 2001 WL 477163 (N.D. Ill. May 3, 2001); Glaxo Group Lid. v. Apotex, Inc., No. 00 C 5791, 2001 WL 1246628 (N.D. Ill. Oct. 16, 2001). As noted above, this was the apparent reasoning of the Federal Circuit’s Apotex opinion. 5. In re Technology Licensing’s interpretation of Lockwood puts the Federal Circuit in direct conflict with the law of other circuits and will cause further confusion in the district courts. In the recent Technology Licensing opinion, the Federal Circuit issued a per curiam opinion that cannot be reconciled with Lockwood, SGS-Thomson, or Apotex. As _ noted, Lockwood and SGS-Thomson held that a declaratory judgment counterclaim seeking to invalidate a patent was legal in nature and therefore entitled the counterclaimant to a right to trial by jury under the Seventh Amendment. Apotex held that a counterclaim + invalidity was a legal claim if there was actual infringement giving rise to a claim for damages (whether or not the patentee sought to recover damages). The Technology Licensing court disagreed with the reasoning of all of these opinions, holding that whether a counterclaim to invalidate a patent gives rise to a right of jury trial depends entirely upon whether patentee is seeking to recover damages ® Astra initially sued Impax only for artificial infringement under 35 U.S.C. § 271(e), but later added a claim for damages and injunctive relief under 35 U.S.C. § 271(a)-(c). 24 at the time of trial. Technology Licensing, 423 F.3d at 1290- 91. The Technology Licensing court did not conduct its own historical analysis, but merely accepted at face value the Lockwood court’s prior (and faulty) dicta that a writ of scire facias was not the appropriate historical analog. Technology Licensing, 423 F.3d at 1290 n.2. Superficially approving Lockwood, id. at 1288 n.1 (“the court’s analysis in Lockwood has been neither supplanted nor questioned and we find its reasoning pertinent”), the Technology Licensing court attempted to distinguish Lockwood. The Technology Licensing patentee had voluntarily withdrawn its damages claim, whereas the Lockwood patentee’s damages claim was dismissed because of an adverse summary judgment ruling on infringement. Technology Licensing, 423 F.3d at 1289-90. The Technology Licensing court attempted to use this distinction to harmonize its opinion with Lockwood by suggesting that the voluntary withdrawal of patentee’s damages claim was a waiver of the right to a jury on the accused infringer’s counterclaim. /d. Despite the Technology Licensing court’s efforts to harmonize its opinion with Lockwood, the two opinions are in direct conflict. Lockwood held that whether the plaintiff had sought to recover damages was not relevant to whether a right to a jury trial exists in a declaratory judgment counterclaim of invalidity. Under Lockwood, the patentee should have been free to dismiss voluntarily its damages claim without risking loss of its right to a jury trial on the accused infringer’s declaratory judgment counterclaim of invalidity. Technology Licensing’s interpretation of Lockwood puts the Federal Circuit jurisprudence in direct conflict with the law of other circuits. Technology Licensing holds that a patentee’s damages claim provides entitlement to a jury trial 25 if the damages claim is dismissed because of an adverse summary judgment, but not if the patentee voluntarily dismisses the damages claim. Appellate courts in other circuits have uniformly held that a claim dismissed - whether by summary judgment or voluntarily - bears no relevance in determining whether the remaining claims are entitled to a jury trial. See, e.g., In re Evangelist, 760 F.2d 27, 32 (1* Cir. 1985) (claim for damages dismissed on summary judgment not relevant when determining party’s asserted Seventh Amendment right to a trial by jury on remaining claims even though the claim might be reinstated); Hildebrand v. Board of Trustees, 607 F.2d 705, 710 (6" Cir. 1979) (accord); Armco, Inc. v. Armco Burglar Alarm Co., Inc., 693 F.2d 1155, 1158 (5 Cir. 1982) (voluntarily dismissed claims cannot support a right to a jury trial). Technology Licensing reflects the same discredited reasoning in an initial nonprecedential opinion that the Lockwood court withdrew and replaced with the reported, precedential opinion. Compare In re Lockwood, 30 U.S.P.Q.2d 1292, 1295 (Fed. Cir. March 10, 1994) (withdrawn) with Lockwood, 50 F.3d at 969. The Lockwood court’s withdrawn opinion held that the patentee was entitled to a jury trial because he had initially claimed damages. Jn re Lockwood, 30 U.S.P.Q.2d at 1295 (“The claim for infringement damages and any asserted defenses still exist in the case even though the district court granted a partial summary judgment on the ground that there was no infringement”). But the Lockwood court realized the fundamental error of that reasoning and replaced the nonprecedential opinion with a precedential opinion: “the [patentee’s dismissed] damages claim exists no more ... [and] the particulars of [the patentee’s] dismissed claim can play no part in our determination whether he enjoys a Seventh Amendment right to a jury trial as to validity in [the accused 26 infringer’s] action for a declaratory judgment.” Lockwood, 50 F.3d at 969. The conflicting Technology Licensing and Lockwood decisions places the Federal Circuit in conflict with other Circuits and will continue to confuse the district courts. Although the Technology Licensing opinion included a vigorous dissent, the Federal Circuit again refused to consider the issue en banc. In re Technology Licensing Corp., 2005 U.S. App. LEXIS 26690 (Fed. Cir., Nov. 18, 2005). 6. The present case In the present case, the Federal Circuit panel issued a one sentence statement, with no analysis, that the issue was governed by Jechnology Licensing. App. at 7a. The Panel did not refer to the Lockwood, SGS-Thomson or Apotex opinions. The Federal Circuit once again refused to consider the issue en banc. App. at la. 7. Summary The Federal Circuit never has properly performed the historical analysis mandated by this Court. The two precedential opinions that have been issued by the Federal Circuit cannot be reconciled with each other or with the precedent of this Court, have put the Federal Circuit in conflict with other circuits, and will cause further confusion in the district courts. The Federal Circuit repeatedly has refused to consider the issue en banc. This Court previously granted certiorari on this issue but it was later mooted by the parties. Impax respectfully submits that this Court should consider this important issue now. 27 C. THE CASE PRESENTS AN _ ISSUE OF EXTRAORDINARY NATIONAL IMPORTANCE THAT THE LOWER COURTS WILL NOT FURTHER ANALYZE This case concerns the overlap of two issues of extraordinary importance: the right to a jury trial and patent invalidity. The fundamental importance of the right to a jury trial cannot be overstated. It is a “sacred” right that must be “jealously guarded by the courts.” Jacob v. City of New York, 315 U.S. 752, 752-753 (1942). “[A]ny seeming curtailment of the right to a jury trial should be scrutinized with the utmost care.” Dimick v. Schiedt, 293 U.S. 474, 486 (1935). And this Court has repeatedly recognized the national importance of resolving questions of patent invalidity. Cardinal Chemical Co. v. Morton Int’l, Inc., 508 U.S. 83, 100 (1993) (citing Blonder-Tongue Labs., Inc. v. University of Illinois Found. , 402 U.S. 313, 336 (1971)). The Federal Circuit’s unconstitutional restriction on the right to a jury will greatly impact pharmaceutical cases filed under the Hatch-Waxman Act, such as the present case. The Hatch-Waxman Act is of immense importance to the well- being of the United States. By carefully balancing the rights among patentees, generic drug companies, and the public, the Act has enhanced the ability of generic pharmaceutical companies to get their competing drugs to the marketplace, and dramatically lowered the price of life-saving prescription drugs. Wendy H. Schacht & John R. Thomas, The Hatch- Waxman Act: Legislative Changes In The 108th Congress Affecting Pharmaceutical Patents, CRS Report RL 32377, at 1 (2004). The Federal Circuit’s Seventh Amendment jurisprudence unfairly favors patentees in all patent actions, 28 but especially in Hatch-Waxman litigation. Such actions do not include a claim for damages when they are filed but can be amended to assert a damages claim if the accused generic drug company receives FDA approval and begins marketing its generic product before resolution of the case. According to the Federal Circuit precedent, the patentee can amend its initial complaint with a damages claim, then dismiss the damages claim immediately before trial should a jury trial become strategically less desirable. After obtaining injunctive relief against the generic drug company, the patentee can file damages suits against the generic drug company’s distributors (which is Astra’s precise strategy in the present case). The Federal Circuit’s simplistic Seventh Amendment “damages” reasoning holds as irrelevant that the generic drug company potentially is still being subjected to damages liability from the generic drug company’s distributors’ claims of indemnity. The Seventh Amendment should not be construed to permit such remarkable gamesmanship. Unless corrected by this Court, the gamesmanship exhibited by Astra in the present case undoubtedly will be implemented by patentees not only in Hatch-Waxman cases, but in many other patent cases. The issue therefore will continue to arise with frequency. Because the Federal Circuit has near-exclusive jurisdiction over patent appeals from all districts, 28 U.S.C. § 1295(a)(1), this case presents “a matter of special importance to the entire Nation.” Cardinal Chemical, 508 U.S. at 89. The Federal Circuit’s repeated refusal to address the issue en banc makes clear that it is not likely to analyze the issue further. Other circuits also are unlikely to consider the issue because the vast majority of patent cases will be appealed to the Federal Circuit. In the unlikely event that the issue is presented to some other circuit, that circuit is likely to defer 29 to the Federal Circuit’s faulty Technology Licensing opinion. Awaiting further consideration of the issue in the lower courts therefore will not further crystallize the issue. This Court should resolve this issue now. CONCLUSION Impax respectfully submits that the Court should grant Impax’s petition for a writ of certiorari. DATED: June 2, 2006 Respectfully submitted, Jeffrey J. Toney Counsel of Record John L. North William F. Long Sutherland Asbill & Brennan LLP 999 Peachtree Street Atlanta, Georgia 30309 (404) 853-8000 Attorneys for Petitioner Impax Laboratories, Inc. la APPENDIX A UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT MISCELLANEOUS DOCKET NO. 815 [Filed April 13, 2006] IN RE ) IMPAX LABORATORIES, INC., ) Petitioner. ) ) ORDER A combined petition for panel rehearing’ and for rehearing en banc having been filed by the Petitioner, and a response thereto having been invited by the court and filed by the Respondent, and the petition for rehearing and response, having been referred to the panel that heard the appeal, and thereafter the petition for rehearing en banc and response having been referred to the circuit judges who are in regular active service, UPON CONSIDERATION THEREOF, it is " The petition for panel rehearing was denied in the order issued on March 16, 2006. 2a ORDERED that the petition for rehearing en banc be, and the same hereby is, DENIED. FOR THE COURT, /s/ Jan Horbaly Clerk Dated: 04/13/2006 3a APPENDIX B UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT MISCELLANEOUS DOCKET NO. 815 [Filed March 16, 2006] IN RE IMPAX LABORATORIES, INC., Petitioner. Nee ee Nee Nee” Before MICHEL, Chief Judge, LOURIE and GAJARSA, Circuit Judges. ON PETITION FOR WRIT OF MANDAMUS LOURIE, Circuit Judge. ORDER Impax Laboratories, Inc. petitions for rehearing of this court’s order denying its petition for a writ of mandamus to direct the United States District Court for the Southern District of New York to vacate its order that struck Impax’s jury trial demand, Impax also moves to stay trial court proceedings. 4a Upon consideration thereof, IT IS ORDERED THAT: The petition for rehearing and the motion to stay trial court proceedings are denied by the panel. The petition for rehearing en banc and the motion shall be circulated to the court. FOR THE COURT Date: Mar 16 2006 /s/ Alan D. Lourie Circuit Judge 5a APPENDIX C UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT MISCELLANEOUS DOCKET NO. 815 [Filed March 2, 2006] IN RE ) IMPAX LABORATORIES, INC., ) Petitioner. ) ) ON PETITION FOR WRIT OF MANDAMUS Before MICHEL, Chief Judge, LOURIE and GAJARSA, Circuit Judges. LOURIE, Circuit Judge. ORDER Impax Laboratories, Inc. petitions for a writ of mandamus to direct the United States District Court for the Southern District of New York to vacate its order that struck Impax's jury trial demand. AstraZeneca AB, Aktiebolaget Hassle, KBI-E, Inc., KBI Inc. and AstraZeneca, LP (AstraZeneca) oppose. AstraZeneca sued Impax for infringement of its patents. Impax's counterclaims sought declaratory judgments of 6a noninfringement, invalidity, and unenforceability and alleged antitrust violations. Impax timely asserted a demand for a jury trial. By agreement of the parties, the patent issues were to be tried first. After the pre-trial proceedings in the patent case were completed, AstraZeneca indicated that it would withdraw its request for damages. The district court ruled that Impax thus had no right to a jury trial for the patent issues. Impax moved for reconsideration, which the district court denied. The remedy of mandamus is available only in extraordinary situations to correct a clear abuse of discretion or usurpation of judicial power. In re Calmar, Inc., 854 F.2d 461, 464 (Fed. Cir. 1988). A party seeking a writ bears the burden of proving that it has no other means of attaining the relief desired, Mallard v. United States Dist. Court for Southern Dist., 490 U.S. 296, 309, 109 S. Ct. 1814, 104 L. Ed. 2d 318 (1989), and that the right to issuance of the writ is “clear and indisputable,” Allied Chemical Corp. v. Daiflon, Inc., 449 U.S. 33, 35, 101 S. Ct. 188, 66 L. Ed. 2d 193 (1980). Impax argues that it is entitled to a jury trial, notwithstanding the withdrawal of AstraZeneca's request for damages, based on our case law. Impax also argues that it is entitled to a jury trial because its antitrust counterclaims and patent counterclaims may share factual issues common to both. The district court, relying on our decision in Jn re Technology Licensing Corp. , 423 F.3d 1286 (Fed. Cir. 2005) (no right to jury trial on declaratory judgment counterclaims if the patentee is not seeking damages), held that Impax was not entitled to a jury trial on the patent issues because the only 7a requested relief was equitable in nature. Regarding the argument that there were issues common to both the antitrust and patent counterclaims, the district court stated that “Impax has failed to cite or allege a single question of fact common to both its severed antitrust counterclaims and the remainder of its claims.” The district court further stated that in its opinion, there were no questions of fact common to both proceedings and that any claim construction issues that might arise in both the patent case and the antitrust counterclaims were not issues that would be decided by the jury. We agree that our decision in /n re Technology Licensing Corp. supports the district court's determination that Impax was not entitled to a jury trial on its counterclaims regarding the patents. Regarding issues that might be common to the antitrust counterclaims and the patent case, Impax for the first time in this mandamus petition asserts one issue that might be common to both cases. However, because Impax failed to timely raise that issue before the district court, we decline to consider it here. Thus, Impax had not met its burden of showing that its right to issuance of mandamus is clear and indisputable. Accordingly, IT IS ORDERED THAT: The petition for a writ of mandamus is denied. FOR THE COURT Mar 2, 2006 /s/ Date Alan D. Lourie Circuit Judge 8a APPENDIX D UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK 00 Civ. 7597 (BSJ) 01 Civ. 2998 (BSJ) M-21-81 (BSJ) MDL Docket No. 1291 [Filed February 24, 2006] ASTRAZENECA AB, et al., Plaintiffs, V. IMPAX LABORATORIES, INC., Defendant. ee ee ee ee ee a Se Te i a ee a ee ~~ In re OMEPRAZOLE PATENT LITIGATION ee a BARBARA S. JONES UNITED STATES DISTRICT JUDGE 9a Order Before the Court is a motion by Defendant Impax Laboratories, Inc. (“Impax”) for reconsideration of the Court’s Order of January 13, 2006 striking Impax’s jury demand or, in the alternative, for certification for interlocutory appeal (“Pl. Reconsideration Mem.”). In response to a request for guidance due to the timing of Impax’s motion and the schedule for the trial of this case, the Court directed Plaintiffs Astrazeneca AB, Aktiebolaget Hassle, KBI-E, Inc., KBI Inc., and Astrazeneca, LP (collectively “Plaintiffs”) not to respond to Impax’s motion until further notice from the Court. (See February 17 Order). After careful consideration of Impax’s motion, and for the reasons stated below, the Court confirms the findings of its January 13 Order and denies Impax’s request for certification of this issue for interlocutory appeal pursuant to 28 U.S.C. § 1292 (b). BACKGROUND Plaintiffs filed their initial complaint against Impax in the District of Delaware on May 15, 2000. The action was transferred to the Southern District of New York by the Multidistrict Litigation (“MDL”) Panel on September 28, 2000 for pre-trial proceedings. On February 1, 2005, the Court granted Plaintiffs leave to file a Second Amended Complaint against Impax, in which Plaintiffs added allegations of direct, contributory, and inducing infringement under § 271(a)-(c) and demanded damages. (Second Amend. Compl., Mar. 1, 2005 at 4¢ 19a-20, 31a-32). On February 14, 2005, Impax filed its Answer and Counterclaims to Plaintiffs’ Second Amended Complaint, wherein Impax demanded a jury trial on Plaintiffs’ infringement claims and 10a all of its counterclaims. (Impax’s Answer & Counterclaims at ¢ 235). In their counterclaims, Impax sought declarations of noninfringement, invalidity, and unenforceability of the ‘S05 and ‘230 patents and also alleged Walker Process fraud and sham litigation in violation of the Sherman Act 15 U.S.C. § 1 and 2 (the “antitrust counterclaims”). (/d. at {4 172-234). At the same time, Plaintiffs’ claims for damages and willful infringement were severed and stayed pending resolution of the patent liability issues. Plaintiffs and Impax also agreed to sever and stay the antitrust counterclaims in 2003, and in conformity with that agreement, the parties have not, to date, taken any discovery on any antitrust issues. (See Oct. 29, 2003 Letter from Ohly to Taylor; Nov. 6, 2003 Letter from Ohly to Taylor; and Mar. 2, 2004 Letter from Ohly to Carlin). On January 18, 2005, Plaintiffs brought a patent infringement action against Impax’s distributor, Teva Pharmaceuticals, seeking an injunction and damages, and Teva raised counterclaims under the Sherman Act and Declaratory Judgment Act. On June 28, 2005, following a request from Plaintiffs, the Court directed that the case against Teva be stayed pending the outcome of the Impax case. (June 28, 2005 Order; see also June 23, 2005 Letter to the Court from Errol Taylor) At a hearing held on December 1, 2005, Plaintiffs suggested that the Court bifurcate the 35 U.S.C. § 271(a)-(c) claims of infringement from the solely equitable claims arising under § 271(e) in order to allow the Court to rule, as the trier of fact, on the “representativeness” of Impax’s expired samples and to consolidate this case for a bench trial. Because the issue was raised at that hearing, the Court requested simultaneous briefing on the issue of whether Impax ila is entitled to a jury trial. The parties’ briefing was submitted to the Court in December 2005. In Plaintiffs’ submissions, Plaintiffs stated that they were “prepared to dismiss with prejudice its request for damages against Impax if it will permit the Impax case to be tried without a jury at the same time as the in-district Second Wave cases (Lek, Mylan and Esteve).” (Pl. Dec. 2005 Mem. at 2). Upon consideration of all submissions, including supplemental briefing filed by Impax, the Court denied Impax’s demand for a jury trial by an Order dated January 13, 2006. Impax moved for reconsideration on February 14, 2006. By letter to the Court dated February 15, 2006, Plaintiffs “request{ed] that the Court rule without further briefing that Impax’s untimely request for reconsideration or certification be denied,” or alternatively, if the Court required a substantive response, “that the Court postpone the start of trial for two weeks.” (See February 15, 2006 Letter to the Court from Errol B. Taylor, at 2). Impax responded to Plaintiffs’ letter the following day, stating that Impax does not oppose delaying the trial and requesting expedited consideration of its motion. (See February 15, 2006 Letter to the Court from William F. Long and February 15, 2006 Letter to the Court from Michael A. Siem). By Order dated February 17, 2006, Plaintiffs wre directed that they need not respond to Impax’s motion wntil further notice from the Court. 12a DISCUSSION I. Standard For Reconsideration Under Local Rule 6.3 Or Federal Rule Of Civil Procedure 54(b) Local Rule 6.3 provides that: [a] notice of motion for reconsideration or re- argument of a court order determining a motion shall be served within ten (10) days after the entry of the court’s determination of the original motion, or, in the case of a court order resulting in a judgment, within ten (10) days after the entry of the judgment. There shall be served with the notice of motion a memorandum setting forth concisely the matters or controlling decisions which counsel believes the court has overlooked. Accordingly, any motion for reconsideration pursuant to Local Rule 6.3 was due on January 27, 2006, ten business days after the January 13, 2006 Order. At the latest, if the time for reconsideration is measured from the Court’s entry of the Dismissal With Prejudice of Plaintiffs’ Damages Claims, the deadline under Local Rule 6.3 was January 31, 2006. Under Local Rule 6.3, Impax’s motion is long overdue. Nevertheless, Impax correctly points out that “a district court always has discretion to reconsider one of its prior orders to correct clear error or to prevent manifest injustice.” (February 15, 2006 Letter to the Court form William F. Long, citing FED. R. Civ. P. 54(b); In re Crysten/Montenay Energy Co. , 226 F.3d 160, 165 n.5 (2d Cir. 2000); Official Comm. of the Unsecured Creditors of Color Tile, Inc. v. Coopers & Lybrand, 322 F.3d 147, 167 (2d Cir. 2003)). Federal Rule of Civil Procedure 54 (b) states: i3a When more than one claim for relief is presented in an action, whether as a claim, counterclaim, cross-claim, or third-party claim, or when multiple parties are involved, the court may direct the entry of a final judgment as to one or more but fewer than all of the claims or parties only upon an express determination that there is no just reason for delay and upon an express direction for the entry of judgment. In the absence of such determination and direction, any order or other form of decision, however designated, which adjudicates fewer than all the claims or the rights and liabilities of fewer than all the parties shall not terminate the action as to any of the claims or parties, and the order or other form of decision is subject to revision at any time before the entry of judgment adjudicating all the claims and the rights and liabilities of all the parties. The Court recognizes that the “[m]aintenance of the jury as a fact-finding body is of such importance and occupies so firm a place in our history and jurisprudence that any seeming curtailment of the right to a jury trial should be scrutinized with the utmost care.” Dimick v. Schiedt, 293 U.S. 474, 486 (1935); see also Jacob v. City of New York, 315 U.S. 752, 752-53 (1942) (“The right of jury trial in civil cases at common law is a basic and fundamental feature of our system of federal jurisprudence which is protected by the Seventh Amendment.”). Therefore, the Court - in its discretion - has considered Impax’s motion pursuant to FED. R. Civ. P. 54(b). Il. Standard For The Seventh Amendment Right To A Jury Trial The Seventh Amendment preserves the right to a jury trial “in suits at common law” and guarantees that “no fact tried l4a by a jury, shall be otherwise re-examined in any Court of the United States, than according to the rules of common law.” U.S. CONST. AMEND. VII. As the Court stated in its January 13, 2006 Order, a party’s right to a jury is safeguarded only so far as that right would have existed in 1791, i.e., in courts of law and not in courts of equity. Dimick v. Schiedt, 293 U.S. 474, 476 (1935); Tegal Corp. v. Tokyo Electron Am. , Inc., 257 F.3d 1331, 1339 (Fed. Cir. 2001). With the merger of courts of law and equity, courts now consider both the nature of the action involved and the remedy sought to determine whether a case is “more similar to cases that were tried in courts of law than the suits tried in courts of equity or admiralty.” Tull v. U.S., 481 U.S. 412, 417-18 (1987); Chauffeurs, Teamsters & Helpers, Local No. 391 v. Terry, 494 U.S. 558, 565 (1990). “The Supreme Court has repeatedly taught that courts must examine both the nature of the action involved and the remedy sought, and that the nature of the remedy is more important than that of the action.” Tegal Corp. v. Tokyo Electron Am., Inc., 257 F.3d 1331, 1339 (Fed. Cir. 2001) (citing Terry, 494 U.S. at 565; Tull, 481 U.S. at 417, 421). Generally, the right to a jury trial on patent liability issues depends on the plaintiff's decision to seek damages. See, e.g., Bioavail Laboratories, Inc. v. Torpharm, Inc., 01 Civ. 9008, 2002 WL 1732372 (N.D. Ill. July 25, 2002) (right to a jury trial arises when damages may be awarded under § 271(e)(4)(C)); Kos Pharmaceuticals, Inc. v. Barr Laboratories, Inc., 218 F.R.D. 387, 390 (S.D.N.Y. 2003). Nevertheless, because the right to a jury trial is determined for each issue, as opposed to the action as a whole, a court must examine each claim to ascertain whether equitable or legal relief is sought. Ross v. Bernhard, 396 U.S. 531, 537-38 (1970). 15a Ill. Impax’s Asserted Right To A Jury Trial Based On The 18th Century Writ Of Scire Facias Impax first claims that “[t]he 18th century writ of scire facias provides a precise analog to a declaratory judgment action brought by a person accused of infringement” and, “[bJecause the issue of validity in a writ of scire facias was tried in a court of law before a jury, the historical test demonstrates that Impax is entitled to a jury trial on its invalidity counterclaim under the Seventh Amendment.” (Impax Reconsideration Mem. at 8). Impax’s argument attempts to obscure clear precedent that was cited in this Court’s January 13 Order. The Federal Circuit has held that declaratory judgment actions for invalidity or non-infringement do not warrant a Seventh Amendment right to a jury trial unless “the infringement claim, as asserted by the patentee, would give rise to a jury trial.” In re Technology Licensing Corp., 423 F.3d 1286, 1290 (Fed. Cir. Sept. 12, 2005). Because declaratory judgment actions themselves are said to be “neither legal nor equitable,” Gulfstream Aerospace Corp. v. Mayacama Corp., 485 U.S. 271, 284 (1988), “declaratory judgment actions are, for Seventh Amendment purposes, only as legal or equitable in nature as the controversies on which they are founded.” Jn re Lockwood, 50 F.3d 966, 973 (Fed. Cir. 1995); see also Beacon Theatres, Inc. v. Westover, 359 U.S. 500 (1959); Petition of Rosenman & Colin, 850 F.2d 57, 60 (2d Cir. 1988); (American) Lumbermens Mutual Casualty Co. v. Timms & Howard, Inc., 108 F.2d 497, 499 (2d Cir. 1939): Owens-Illinois, Inc. v. Lake Shore Land Co., Inc., 610 F.2d 1185, 1189 (3d Cir. 1979); 5 Moore’s Federal Practice { 38.29 at 38-230 (2d ed. 1987). 16a Furthermore, Impax’s attempt to argue that it is entitled to a jury trial on its invalidity counterclaim is based upon its blatantly incorrect assertion that “[a]lthough the writ could be based upon a claim that the patent was obtained fraudulently, it is clear that the writ could also be based upon, or combined with, a claim that the patent was invalid for lack of novelty, independent of any claim of fraud.” (Pl. Reconsideration Mem. at 7). In fact, in a footnote to its argument, Impax itself cites to opinions of the Federal Circuit that clearly state just the opposite - i.e., that the scire facias proceeding was not analogous to a counterclaim of invalidity. (See Impax Reconsideration Mem. at 8 n.5). The Federal Circuit stated in In re Lockwood, 50 F.3d at 975 n.9, that: {a] scire facias issued at common law to repeal patents which have been obtained surreptitiously, or upon false suggestion. The contemporary analog of the writ is thus an action for a declaration of unenforceability due to inequitable conduct, not due to invalidity. (citations and internal quotations omitted).' Just last year, in In re Technology Licensing Corp., 423 F.3d at 1290 n.2, the Federal Circuit reiterated its opinion that the writ of scire facias was not analogous to a counterclaim to invalidate a patent, citing “Lockwood’s clear ruling that the writ of scire ' The Supreme Court accepted certiorari in Lockwood but vacated the Federal Circuit’s opinion without comment when the Petitioner withdrew its jury demand, thereby mooting the issue in that case. Nevertheless, subsequent Federal Circuit and district courts have cited Lockwood, many of which this Court relied upon in its January 13 Order. See, e.g., In re Technology Licensing Corp., 423 F.3d 1286 (Fed. Cir. 2005); Tegal Corp. v. Tokyo Electron America Inc., 257 F.3d 1331, 1340-41 (Fed. Cir. 2001). ‘7a facias (an action by the sovereign to cancel a patent obtained by fraud) is not analogous to the modern-day ‘action to invalidate a patent.” Impax’s attempt to have this Court rely on the dissents to Lockwood and Technology Licensing are hardly worth addressing in a motion for reconsideration, which generally requires that the movant point to “controlling decisions or factual matters that were put before {the Court] on the underlying motion and which, had they been considered, might have reasonably altered the result before the court.” Cielo Creations, Inc. v. Gao Da Trading Co., 04 Civ. 1952 (BSJ), 2004 WL 1857556, *1 (S.D.N.Y. August 18, 2004) (emphasis added and citations omitted); see also American Civil Liberties Union v. Dept. of Defense, 396 F. Supp. 2d 459, 460 (S.D.N.Y. 2005) (reconsideration appropriate when controlling authority had been overlooked by the court and should be granted to correct for clear error or to prevent manifest injustice). As such, this Court simply directs Impax to the words of the Technology Licensing Court, where it stated that: [aJll of the nineteenth century cases cited by the dissent were infringement actions for damages in which the defense of patent invalidity was raised. Because they were actions at least in part for damages, the parties were entitled to a jury trial on the issue of patent invalidity, just as they would be today. Those cases do not address, and certainly do not decide, the very different issue presented in this case, in which only equitable relief is sought. Tech. Licensing, 423 F.3d at 1290 n.2. 18a Accordingly, this Court finds that the writ of scire facias does not, by historical analogy, entitle Impax to a jury trial under the Seventh Amendment on its counterclaim for a declaratory judgment of invalidity. The Court confirms its January 13 Order, which found that because Astra’s request for damages has been dismissed with prejudice, only equitable relief now is sought, and Impax is not entitled to a jury trial based on its non-infringement and invalidity declaratory judgment counterclaims.” IV. Impax’s Asserted Right To A Jury Trial Under Jn re Lockwood Impax also asserts that “Lockwood clearly shows that Impax is entitled to a jury trial, notwithstanding that Astra dismissed its damages claims with prejudice.” (Impax Reconsideration Mem. at 9). Later cases from the Federal Circuit explicitly state that “Lockwood does not stand for the proposition that a counterclaim for invalidity always gives rise ? Impax’s counterclaim for a declaration of unenforceability is based in an allegation that Plaintiffs engaged in “inequitable conduct.” (See Impax’ Answer & Counterclaims at | 192). The Federal Circuit has also clearly held that actions based on inequitable conduct are equitable and do not provide the grounds for a Seventh Amendment right to a jury trial. Paragon Podiatry Lab., Inc. v. KLM Labs, Inc., 984 F.2d 1182, 1190 (Fed. Cir. 1993) (holding that a party “has no right to a jury trial respecting the factual element of culpable intent as part of the defense of inequitable conduct”); Gardco Mfg., Inc. v. Herst Lighting Co., 820 F.2d 1209, 1212 (Fed. Cir. 1987) (agreeing with district court that “the defense of inequitable conduct is equitable in nature and thus does not give rise to the right of trial by jury”). Therefore, Impax’s counterclaim of patent unenforceability also does not give rise to a right to a jury trial. 19a to a right to a jury trial (for either party).” Tech. Licensing, 423 F.3d at 1290. Rather, [a]fter analyzing the nature of a declaratory judgment action for patent invalidity and the pertinent historical background, the court in Lockwood noted that an action for invalidity could not be brought at common law, and it held that a patent infringement action with a counterclaim of invalidity ‘resembles nothing so much as a suit for patent infringement in which the affirmative defense of invalidity has been pled.’ The court noted that in such common law actions, the patentee could elect whether to proceed at law or in equity, based on the remedy sought, and the right to a jury would depend on the patentee’s choice: ‘If the patentee sought only damages, the patentee brought an action at law; in such a case, the defense of invalidity was tried to the jury, assuming that a jury had been demanded. . . . However, if the patentee facing past acts of infringement nevertheless sought only to enjoin future acts of infringement, the patentee could only bring a suit in equity, and the defense of invalidity ordinarily would be tried to the bench.’ Technology Licensing, 423 F.3d at 1289 (quoting Lockwood, 50 F.3d at 974, 976) (emphasis in original). The Technology Licensing Court stated that: the more accurate reading of Lockwood is that (1) it preserves to the patentee the right to elect a jury by seeking damages in an infringement action or counterclaim, and (2) the accused infringer or declaratory judgment counterclaimant is entitled to a jury trial only if the infringement claim, as asserted by 20a the patentee, would give rise to a jury trial. Thus, if the patentee seeks only equitable relief, the accused infringer has no right to a jury trial, regardless of whether the accused infringer asserts invalidity as a defense (as in the Tegal case) or as a separate claim (as in this case). Tech. Licensing, 423 F.3d at 1290 (citing Tegal Corp. v. Tokyo Electron America, Inc., 257 F.3d 1331, 1341 (Fed. Cir. 2001)) (“A defendant, asserting only affirmative defenses and no counterclaims, does not have a right to a jury trial in a patent infringement suit if the only remedy sought by the plaintiff-patentee is an injunction.”)). Furthermore, in distinguishing the procedural posture of Lockwood, the Federal Circuit further clarified the reasoning underlying Lockwood: In Lockwood, the patentee had not elected to limit himself to an equitable remedy. Although the issue of infringement had been removed from the case by summary judgment, the Lockwood court nonetheless considered whether the patentee had forfeited his right to a jury trial by taking any steps that would have required him, historically, to file his case in equity. The Lockwood court looked at the declaratory judgment counterclaim as an inverted action for infringement in which the patentee had not surrendered his right to a jury. Therefore, the patentee retained his right to a jury trial on the counterclaim. In this case, by contrast, the patentee has voluntarily abandoned its claim for damages and is proceeding only on a request for equitable relief. Thus, the declaratory judgment action in this case is an inverted form of an infringement action in which the patentee 2la has sought only an injunction. In the historically analogous setting of a patent infringement suit with an invalidity defense, the case would therefore have been tried in an equity court, where neither party would be entitled to a jury. Tech. Licensing, 423 F.3d at 1289. In sum, Lockwood “is not as broad” as Impax’s characterization suggests. Tech. Licensing, 423 F.3d at 1289. Despite Impax’s arguments to the contrary, the procedural posture of this case clearly more closely resembles that of Technology Licensing, where “the patentee has voluntarily abandoned its claim for damages and is proceeding only on a request for equitable relief.” /d. Accordingly, the Court confirms its January 13 Order, finding that Impax is not entitled to a jury trial on its affirmative defenses or declaratory judgment counterclaims. (January 13 Order at 6- 7). V. Impax’s Asserted Right To A Jury Trial Based On Counterclaims That Were Asserted In Response To Plaintiffs’ Damages Claims Impax argues that its counterclaims were asserted in response to Plaintiffs’ claims for actual damages and, therefore, “Impax is entitled to a jury trial notwithstanding that Astra dismissed its damages claims.” (PI. Reconsideration Mem. at 16). Here, as in Anti-Monopoly, Inc. v. General Mills Fun Group, 611 F.2d 296, 307 (9th Cir. 1979), Impax “has not cited any authority for the proposition that, having once asserted a claim for damages, a party may not withdraw such a Claim, or that upon such withdrawal a jury trial remains 22a appropriate although only equitable issues remain in the case.” Likewise, Impax’s “allegation that pre-trial maneuvering by [Plaintiffs] in an effort to deprive it of a jury trial somehow vitiates the equitable.nature of the case is not persuasive.” Anti-Monopoly, 611 F.2d at 307. See also Tech. Licensing, 423 F.3d at 1291 (holding “that the patentee’s decision to seek only equitable relief resulted in the entire case . . . being triable to the court without a jury.” In addition, “the Supreme Court has repeatedly taught that courts must examine both the nature of the action involved and the remedy sought, and that the nature of the remedy is more important than that of the action.” Tegal, 257 F.3d at 1339 (citing Terry, 494 U.S. at 565; Tull, 481 U.S. at 417, 421) (emphasis added). Here, the nature of the remedy sought in Impax’s counterclaims for declaratory judgment of invalidity and non-infringement is exclusively equitable, not legal. Accordingly, the Court’s January 13 Order is confirmed. VI. Impax’s Asserted Right To A Jury Trial Because Plaintiffs’ Damages Claim Against Teva Is Still Pending Impax also asserts that it “is entitled to a jury trial on it [sic] counterclaims because Astra’s damages claim against Teva is still pending.” (Pl. Reconsideration Mem. at 17). Impax claims that because its declaratory judgment counterclaims under § 271(a) “arose out of damages claims against Impax’s distributor, [Teva,] which in turn gives right to an indemnity claim by Teva against Impax, Impax’s counterclaims raise legal issues” - thereby entitling Impax to a jury trial. (Pl. Reconsideration Mem. at 17). 23a Impax cites no controlling authority for this proposition. Impax refers to only one district court case, Nippo Electric Glass Co. Lid. y. Sheldon, 489 F. Supp. 119, 122 (S.D.N_Y. 1980), which held that when a patentee accused a manufacturer’s customers of direct infringement due to their use of the manufacturer’s product, the manufacturer had reason to fear that it could be sued as contributory infringer and therefore met the “actual controversy” requirement within the meaning of the Declaratory Judgment Act, 28 U.S.C. § 2201. In addition to the fact that the holding in Nippo speaks to standing and not the right to a jury trial, the Nippo court relied extensively on the fact that the manufacturer in that case had “entered into an agreement with [the distributors] to indemnify them for any liability for infringement of the subject patents.” Nippo, 489 F.Supp. at 121. Impax does not claim that such an indemnification agreement exists between Impax and Teva, and alludes only to its fear of “a potential indemnity claim from Teva.” (PI. Reconsideration Mem. at 15) (emphasis added). This Court finds that Impax has failed to provide sufficient support for its broad and novel theory that a plaintiff's dam2ges claims against a customer/distributor entitle the manufacturer to a jury trial in its own, distinct case. Thus, Impax’s arguments have not persuaded the Court that a revision of its January 13 Order is necessary. Vil. Impax’s Asserted Right To A Jury Trial Based On Its Antitrust Counterclaims Impax asserts that denying Impax a jury trial conflicts with the Supreme Court’s holding in Beacon Theatres v. Westover, 359 U.S. 500 (1959) and the Federal Circuit’s holding in Cabinet Vision v. Cabinetware, 129 F.3d 595 (Fed. Cir. 1997). This Court disagrees. Beacon Theatres and 24a Cabinet Vision are easily distinguished on their facts and procedural posture, and more recent case law shows that those distinguishing facts are outcome determinative. See, e.g., Anti-Monopoly, 611 F.2d at 307-308. First, in Beacon Theatres a competitor theater had brought an action against petitioner alleging duress and coercion for making threats of litigation and treble damage suits. 359 U.S. at 502. The competitor plaintiff sought (1) a declaratory judgment to settle some of the key issues that such an antitrust suit would raise and (2) an injunction of any antitrust suit by petitioner pending the outcome of the declaratory judgment litigation. /d. In response, the petitioner filed an answer which denied the threats and asserted antitrust counterclaims with treble damages, as well as a cross-claim against an exhibitor who had intervened. The petitioner also demanded a jury trial. /d. The district court viewed the issues raised by the Complaint for Declaratory Relief as essentially equitable. Beacon Theatres, 359 U.S. at 503. Acting under Rules 42(b) and 57 of the Federal Rules of Civil Procedure, the court determined that it would decide issues common to both proceedings before trying petitioner’s counterclaim before a jury. Jd. A common issue of the Complaint for Declaratory Relief, the counterclaim, and the cross-claim was the existence of competition between the two theatres. Beacon Theatres, 359 U.S. at 503-504. The Court of Appeals for the Ninth Circuit found that the district court had acted within the proper scope of its discretion and denied petitioner’s application for a writ of mandamus requiring the district court to set aside its ruling. Beacon Theatres, 359 U.S. at 501. The Supreme Court reversed, reasoning that the district court’s order “would compel [the petitioner] to split his antitrust case, 25a trying part to a judge and part to a jury.”* Beacon Theatres, 359 U.S. at 508. That problem does not exist here. The initial complaint and procedural posture of this case are quite different. Here, Plaintiffs’ initial complaint was based on patent infringement not an anticipated antitrust action, which also became the counterclaims. More significantly, the parties themselves agreed to sever and stay Impax’s antitrust counterclaims - the Court did not attempt to “try[{] part to a judge and part to a jury.” Id. This Court maintains that the procedural history, reasoning, and holding of Anti-Monopoly, Inc. v. General Mills Fun Group, 611 F.2d 296, 307 (9th Cir. 1979), a case decided more recently than Beacon Theatres, best inform the jury trial issue in the present action. In Anti-Monopoly, the plaintiff's original complaint contained two counts for > The Supreme Court also stated that: {t]he District Court’s finding that the Complaint for Declaratory Relief presented basically equitable issues draws no support from the Declaratory Judgment Act. . . . That statute, while allowing prospective defendants to sue to establish their nonliability, specifically preserves the right to jury trial for both parties. It follows that if [the petitioner} would have been entitled to a jury trial in a treble damage suit against [the competitor theater], it cannot be deprived of that right merely because [the competitor theater] took advantage of the availability of declaratory relief to sue [the petitioner] first. Since the right to trial by jury applies to treble damage suits under the antitrust laws the Sherman and Clayton Act issues on which [the competitor theater] sought a declaration were essentially jury questions. Beacon Theatres, 359 U.S. at 504. 26a damages and a count seeking equitable relief, and the defendant counterclaimed for an accounting and damages. Anti-Monopoly, 611 F.2d at 307. The defendant later withdrew this counterclaim, and moved for severance of the plaintiff's two legal claims. /d. After the legal claims were severed, the district judge who ultimately heard the case determined that a jury trial would be inappropriate since only equitable claims remained to be tried. Jd. The Ninth Circuit upheld the order denying a jury trial, because “[no} legal issues remained to be tried in the district court in the matter now before us.” Anti-Monopoly, 611 F.2d at 308. As in Anti-Monopoly, Impax “cannot complain about the severance of its legal claims, for it acquiesced in that action.” Anti-Monopoly, 611 F.2d at 307. Long before the court issued its order severing and staying Impax’s antitrust counterclaims pursuant to FED. R. Civ. P. 42(b), the parties had made such an agreement among themselves and had not engaged in any discovery on the antitrust issues. (See Oct. 29, 2003 Letter from Ohly to Taylor; Nov. 6, 2003 Letter from Ohly to Taylor; and Mar. 2, 2004 Letter from Ohly to Carlin). With respect to the second case that Impax relies upon, Cabinet Vision, the holding of the Federal Circuit is not as broad as Impax represents. In Cabinet Vision, the appellee had asserted the affirmative defense of inequitable conduct and a Walker Process antitrust counterclaim in response to the appellants’ claim of patent infringement. Cabinet Vision, 129 F.3d at 597. The Federal Circuit vacated the judgment of the district court and remanded the matter for further action consistent with its opinion that the district court erred in holding that the jury’s factual findings on inequitable conduct were advisory. The court stated that: By conceptually separating the fact finding common to 27a both causes of action, the district court misled itself into believing that the jury’s fact findings could be merely advisory as to the inequitable conduct, and that the counterclaim could be dismissed because the verdict was not binding on the counterclaim and the jury did not address the antitrust issue. But given the design of these jury instructions, the jury did not fail to address questions 8 through 13 related to the Walker Process counterclaim. It resolved the factual dispute by way of its answer to question 7, [which resolved in the negative at least one of the questions of fact necessary to both the Walker Process counterclaim and the defense of inequitable conduct]. These errors cannot be excused, even if [the appellee] failed to ‘advise the court on how to separate and manage those issues that were for the court and those that were for the jury.’ Interpretation of the law is the responsibility of the court. Cabinet Vision, 129 F.3d at 600-601. Impax argues that “‘conceptual separating’ is precisely the result of the January 13 Order” and asserts that “{t}he court is not entitled conceptually to separate the factual issues common to both the antitrust counterclaim and Impax’s other defenses.” (Pl. Reconsideration Mem. at 19). Yet, Impax has failed to cite or allege a single question of fact common to both its severed antitrust counterclaims and the remainder of its case scheduled for trial. To the contrary, Impax’s argument is entirely speculative. (See Pl. Reconsideration Mem. at 19 (stating that “[t]o the extent that factual issues remain in the case that overlap with the antitrust counterclaims, Impax remains entitled to a jury trial.”)). In the Court’s opinion, the only potential “material issue 28a of fact common to both the equitable claim[s] and the {antitrust} counterclaim{s]” are issues regarding claim construction. Beacon Theatres, 359 U.S. at 514 n.4 (Stewart, J., dissenting). It is well-established that the interpretation of patent claims through claim construction is a determination made as a matter of law - by the court. Markman v. Westview Instruments, Inc. , 52 F.3d 967, 976 (Fed. Cir. 1995); Graco, Inc. v. Binks Mfg. Co., 60 F.3d 785, 791 (Fed. Cir. 1995); see also Astra Aktiebolag v. Andrx Pharmaceuticals, Inc. , 222 F. Supp. 2d 423 (S.D.N.Y. 2002) (the “First Wave Litigation”). Because Impax’s counterclaims depend on issues of claim construction that have been or will be decided by the court under Markman, 52 F.3d at 976, it is this Court’s conclusion that no questions of fact common to both its severed antitrust counterclaims and the remainder of its case that would be decided by a jury remain. More specifically, the first antitrust counterclaim asserted by Impax is based on an allegation of Walker Process fraud. (See Impax’s Answer and Counterclaims to Plaintiffs’ Amended Complaint, 44 202-220). Under Walker Process Equipment, Inc. v. Food Machinery & Chemical Corp. , 382 U.S. 172 (1965), the enforcement of a patent procured by fraud on the Patent and Trademark Office (“PTO”) may violate the Sherman Act provision concerning monopolization, provided that the other elements necessary for a violation are present. Common law or Walker Process fraud: is generally held not to exist unless the following indispensable elements are found to be present: (1) a representation of a material fact, (2) the falsity of that representation, (3) the intent to deceive or, at least, a state of mind so reckless as to the consequences that it is held to be the equivalent of intent (scienter), (4) 29a a justifiable reliance upon the misrepresentation by the party deceived which induces him to act thereon, and (5S) injury to the party deceived as a result of his reliance on the misrepresentation. In re Spalding Sports Worldwide, Inc., 203 F.3d 800, 807 (Fed. Cir. 2000) (citing Nobelpharma AB v. Implant Innovations, Inc., 141 F.3d 1059, 1069-70 (Fed. Cir. 1998)). Impax’s Walker Process counterclaim fundamentally depends on issues of claim construction to show that Plaintiffs engaged in a misrepresentation of a material fact - the first element required in a claim of Walker Process fraud. With respect to the ‘505 patent, Impax alleges that: [t]he claims of the ‘S05 patent require that each core of the claimed formulation contain an ‘effective amount’ of omeprazole, a requirement not met by Plaintiffs’ PRILOSEC® product. (Impax’s Answer and Counterclaims, ¢ 211) (emphasis added). However, this Court has already ruled that it “intend[s] to adhere . . . to [its] prior claim construction in the first wave as to ‘effective amount,’ as to ‘alkaline reacting compound,’ as to ‘inert subcoating,’ as to ‘disposed on,’ as to ‘acid labile compound,’ as to “except omeprazole,’ and as to ‘alkaline core.’” (Transcript of November 22, 2005 Conference before Judge Jones at 5, lines 9-15, referencing Astra v. Andrx, 222 F. Supp. 2d at 447-85 (S.D.N.Y. 2002) (construing the above claim terms); see also January 12, 2006 Order (denying the Second Wave Defendants’ summary judgment motions based, in part, on adherence to prior claim construction)). In the First Wave Litigation, the Court specifically construed the 30a claim term “effective amount” in a manner such that Plaintiffs’ PRILOSEC® product meets the patent’s requirement. Astra v. Andrx, 222 F. Supp. 2d at 462-64. The Court reiterated that construction in its January 12 Order resolving the Second Wave Defendants’ summary judgment motions, stating that: {aJs the Court held in the First Wave Litigation, *““effective amount” . . . requires an amount of each substance such that the combination of omeprazole plus the ARC meets the stated goal of stabilizing the omeprazole.’ (January 12, 2006 Order at 9, citing Astra v. Andrx, 222 F. Supp. 2d at 463).* Moreover, Impax makes no argument that term “effective amount,” as already construed by this Court, would not include Plaintiffs’ PRILOSEC® product. With regard to the ‘230 patent, Impax alleges that: [t]he ‘230 patent expressly excludes omeprazole from the patent: ‘The object of the present invention is thus an enteric coated dosage form of acid labile compounds with the general formula I defined above except the compound omeprazole . . . .” (‘230 patent, * Furthermore, the Court found that: the addition of the term ‘effective amount’ ‘did nothing more than make express what had been implicit in the claim as Originally worded,” . . . which the Federal Circuit declared does not constitute an amendment ‘made for “a substantial reason related to patentability” and thus does not create prosecution history estoppel.’ (Id. at 12, citing Interactive Pictures v. Infinite Pictures, 274 F.3d 1371, 1377 (Fed. Cir. 2001)). 3la Col. 7, lines 51-54). As a result, Plaintiffs’ PRILOSEC® product is expressly excluded from the ‘230 patent. (Impax’s Answer and Counterclaims, 4211). To the contrary, this Court already has held, as a matter of claim construction, that the ‘230 patent does not exclude omeprazole. Astra v. Andrx, 222 F. Supp. 2d at 483-85. As the Court stated in its January 12 Order: The Court previously held that the term ‘acid labile pharmaceutically active substance’ (or ‘acid labile compound’) includes substances that ‘are transformed into biologically active compounds by a rapid degeneration or transformation in acid media’ - including omeprazole. The Court found that the statement ‘except omeprazole’ ‘is discussing compounds of the general formula I, clearly relates to claim 2 and does not limit the scope of claim 1.’ . ... The Court has not been persuaded of a need to deviate from its previous finding that an ‘acid labile pharmaceutically active substance’ or ‘acid labile compound’ includes omeprazole. (January 12, 2006 Order at 16-17, citing Astra v. Andrx, 222 F. Supp. 2d at 483-85) (emphasis added). Thus, because (1) Impax’s Walker Process counterclaim depends on claim construction to show that Plaintiffs misrepresented a material fact to the PTO (the first required element), and (2) the Court has already construed those terms in a manner that does not support Impax’s claims of misrepresentation and will construe any additional disputed claim terms, as it must under Markman, 52 F.3d at 976, there are simply no questions of fact common to Impax’s Walker 32a Process counterclaim and the rest of the case that would be decided by a jury. Impax’s second antitrust counterclaim is based on an allegation of “Sham Litigation.” In Professional Real Estate Investors, Inc. v. Columbia Pictures Industries, Inc., 508 U.S. 49, 60-61 (1993), the Supreme Court outlined the following two-part definition of “sham” litigation: First, the lawsuit must be objectively baseless in the sense that no reasonable litigant could realistically expect success on the merits. If an objective litigant could conclude that the suit is reasonably calculated to elicit a favorable outcome, an antitrust claim premised on the sham exception must fail. Only if challenged litigation is objectively baseless may a court examine the litigant’s subjective motivation. Under this second part of the test, a court focuses on whether the baseless lawsuit conceals “an attempt to interfere directly with the business relationships of a competitor,” E. R.R. Presidents Conference v. Noerr Motor Freight, Inc., 365 U.S. 127, 144 (1961), through the “use [of] the governmental process - as opposed to the outcome of that process - as an anticompetitive weapon,” City of Columbia v. Omni Outdoor Advertising, Inc., 499 U.S. 365, 380 (1991) (emphasis in original). See alse Q-Pharma, Inc. v. Andrew Jergens Co.., 360 F.3d 1295, 1305 (Fed. Cir. 2004). Impax’s Sham Litigation counterclaim also depends on issues of clair construction, which must be decided by the court, to show that Plaintiffs’ lawsuit is “objectively baseless.” Specifically, Impax alleges that: although plaintiffs knew that the ‘505 and ‘230 patents were unenforceable and otherwise invalid, that they [sic] ‘SOS and ‘230 patents were improperly listed in the Orange Book and that Plaintiffs were estopped 33a from asserting the ‘505 and ‘230 patents against a formulation having a subcoating in situ and that this action was baseless, the plaintiffs commenced and continued to prosecute the present action in an attempt to enforce the ‘50S and ‘230 patents against Impax... . (Id. at { 225). Whether the claims of the Plaintiffs’ patents are construed to include or exclude subcoatings formed in situ is a matter for the Court to decide, as it did in the First Wave Litigation. See Astra v. Andrx, 222 F. Supp. 2d at 464-70 (finding that the “subcoating” called for in Plaintiffs’ patent was a layer that was physically on and conformed to the contours of the core and was underneath another layer or coating, but did not include gelatine capsules, could be made of one or more materials, and could contain imperfections). As the Court stated in its January 12 Order: In construing the term ‘subcoating,’ this Court determined in the First Wave Litigation that a subcoating is ‘disposed on’ the core region by virtue of its position relative to the core but that “does not require that the subcoating be applied using any particular process’ and ‘the subcoatiag need not necessarily be ‘physically applied to’ the core in a separate processing step.”... . The Court is not persuaded that deviation from that construction or finding is merited here, which leaves disputed issues of fact as to whether Apotex’ ANDA Product infringes by use of an in situ subcoating. (January 12, 2006 Order at 27-28, citing Astra v. Andrx, 222 34a F. Supp. 2d at 470). Thus again, because (1) Impax’s Sham Litigation counterclaim depends on claim construction to show that Plaintiffs’ suit against Impax is “objectively baseless” (the first required element), and (2) the Court has already construed those claim terms in a manner that does not support Impax’s allegation that the suit is “objectively baseless” and will construe any additional disputed claim terms, as it must under Markman, 52 F.3d at 976, there are simply no questions of fact common to Impax’s Sham Litigation counterclaim and the rest of the case that would be decided by a jury. Accordingly, for the reasons stated above, the January 13 Order is confirmed. VIII. Impax’s Asserted Right To A Jury Trial Based On The Court’s Lack Of Discretion To Strike Impax’s Jury Demand Impax next argues that “this court does not have discretion to advance equitable issues to a bench trial to the detriment of Impax’s right to a jury trial.” (PI. Reconsideration Mem. at 21). For the reasons stated above and in its January 13 Order, it is the Court’s considered judgment that Impax does not have a right to a jury trial based on the claims am: defenses remaining in the action. Therefore, the Court is not acting to the detriment of any right by seeking to hold a consolidated trial of the Second Wave Defendants, including Impax, in this Multi-district Litigation. 35a The Court did properly exercise its discretion - in the interest of judicial economy and in a manner consistent with the parties’ prior agreement and actions to date - when it ordered that Impax’s “antitrust counterclaims be severed and stayed pending resolution of the remainder of the patent infringement action.” (January 13 Order at 7-8). “Under Rule 42(b), a district court has broad discretion in separating issues and claims for trial as part of its wide discretion in trial management.” Gardco Mfg., Inc. v. Herst Lighting Co. , 820 F.2d 1209, 1212 (Fed. Cir. 1987); Fep R. Civ. P. 42(b). Although Impax does not dispute the Court’s authority under Rule 42(b), to the extent that Impax’s motion for reconsideration confuses or misrepresents the Court’s exercise of discretion, the motion is denied and the January 13 Order is confirmed. IX. Impax’s Request For Certification For Interlocutory Appeal In the alternative, “Impax has requested the Court certify this issue for an immediate appeal under 28 U.S.C. § 1292(b).” (Pl. Reconsideration Mem. at 23). 28 U.S.C. § 1292(b) states, in pertinent part, that: {wjhen a district judge, in making in a civil action an order not otherwise appealable under this section, shall be of the opinion that such order involves a controlling question of law as to which there is substantial ground for difference of opinion and that an immediate appeal from the order may materially advance the ultimate termination of the litigation, he shall so state in writing in such order. The Court of Appeals which would have jurisdiction of an appeal of such action may thereupon, in its discretion, permit an appeal to be taken from such order, if application is 36a made to it within ten days after the entry of the order... . An interlocutory appeal under § 1292(b) is to be used, or applied, only in exceptional cases, where an intermediate appeal may avoid protracted or expensive litigation. See, e.g., Campbell v. DiGuglielmo, 115 F. Supp. 2d 452, 454 (S.D.N.Y. 2000) (stating that the court of appeals determines whether exceptional circumstances justify a departure from the basic policy of postponing appellate review until after entry of final judgment); /n re Buspirone Patent Litigation, 210 F.R.D. 43, 49 (S.D.N.Y. 2002); Gulino v. Board of Educ. of City School Dist. of City of New York, 234 F. Supp. 2d 324 (S.D.N.Y. 2002). The provision, therefore, is used sparingly and construed strictly by the court of appeals. See Wausau Business Ins. Co. v. Turner Const. Co., 151 F. Supp. 2d 488 (S.D.N.Y. 2001); Campbell, 115 F. Supp. 2d at 454. The fact that a case involves an important legal question, without more, is generally insufficient to justify the application of the provision. Bobolakis v. Compania Panamena Maritima San Gerassimo, S.A., 168 F.Supp. 236, 239-40 (S.D.N.Y. 1958). In this Court’s considered judgment, the issue of Impax’s entitlement to a jury does not present “a controlling question of law as to which there is substantial ground for differences of opinion.” 28 U.S.C. § 1292(b). Moreover, Impax has not shown any reason why this is an “exceptional case” that warrants abandoning “the policy in the ordinary case of discouraging piecemeal appeals.” /n re Heddendorf, 263 F.2d 887, 889 (Ist Cir. 1959); 36 C.J.S. Federal Courts § 428. In addition, the form of alternative relief sought by Impax is not procedurally correct. To the extent a party disputes a district court’s denial of its jury demand in a patent litigation, 37a the common procedural mechanism is to petition the Federal Circuit for a writ of mandamus, under 28 U.S.C. § 1651, to compel the district court to grant its request for a jury trial. See, e.g., Beacon Theatres, 359 U.S. at 511; Lockwood, 50 F.3d at 970; Tech. Licensing, 423 F.3d at 1288. As the Supreme Court noted in Dairy Queen, Inc. v. Wood, 269 U.S. 469, 472 (1962), it is “the responsibility of the Federal Courts of Appeals to grant mandamus where necessary to protect the constitutional right to trial by jury.” Therefore, Impax’s request for certification for interlocutory appeal is denied. CONCLUSION Accordingly, the Court’s January 13 Order is confirmed and Impax’s request for certification for interlocutory appeal is denied. SO ORDERED. /s/ BARBARA S. JONES UNITED STATES DISTRICT JUDGE Dated: New York, New York February 24, 2006 38a APPENDIX E UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK M-21-81 (BSJ) MDL Docket No. 1291 [Filed January 13, 2006] In re ) OMEPRAZOLE PATENT LITIGATION ) ) BARBARA 5S. JONES UNITED STATES DISTRICT JUDGE ORDER At the request of the Court at a hearing on December 1, 2005, Plaintiffs Astrazeneca AB, Aktiebolaget Hassle, KBI-E, Inc., KBI Inc., and Astrazeneca, LP (collectively “Plaintiffs” ) and Defendant Impax Laboratories, Inc. (“Impax”) have submitted briefing on the issue of whether Impax is entitled to a jury trial. For the reasons below, the Court finds that, under the circumstances of the case and in the interest of judicial economy, Impax does not have a right to a jury trial. 39a BACKGROUND Plaintiffs Astrazeneca AB, Aktiebolaget Hassle, KBI-E, Inc., KBI Inc., and Astrazeneca, LP (collectively “Plaintiffs” ) filed their initial complaint against Impax in the District of Delaware on May 15, 2000. The action was transferred to the Southern District of New York by MDL Panel on September 28, 2000 for pre-trial proceedings. On February 1, 2005, the Court granted Plaintiffs leave to file a Second Amended Complaint against Impax, in which Plaintiffs added allegations of direct, contributory and inducing infringement under § 271(a)-(c) and demanded damages. (Second Amend. Compl., Mar. 1, 2005 at 44 19a-20, 31a-32 (Declaration of Emily Jane Kunz in Support of Astra’s Memorandum of Law Concerning Impax’ Right to a Jury Trial (“Kunz Decl.”), Ex. C)). On February 14, 2005, Impax filed its Answer and Counterclaims to Plaintiffs’ Second Amended Complaint, wherein Impax demanded a jury trial on Plaintiffs’ infringement claims and all its counterclaims. (Impax’ Answer & Counterclaims at 4 235). In their counterclaims, Impax sought declarations of noninfringement, invalidity, and unenforceability of the ‘SOS and ‘230 patents and made Walker-Process and sham litigation antitrust counterclaims. (Id. at ¢4 172-234). At the same time, Plaintiffs’ claims for damages and willful infringement were severed and stayed pending resolution of the patent liability issues. (Order Granting Leave to File Second Amended Complaint and Severing and Staying Discovery and Trial on Willful Infringement and Damages (Kunz Decl., Ex. B)). Plaintiffs and Impax also agreed to sever and stay the antitrust counterclaims in 2003, and in conformity with that agreement, the parties have taken no discovery to date on any antitrust issues. (See Oct. 29, 2003 Letter from Ohly to Taylor; Nov. 6, 2003 Letter from Ohly 40a to Taylor; and Mar. 2, 2004 Letter from Ohly to Carlin (Kunz Decl. Exs. E, F, & G, respectively)). At the December | , 2005 hearing, Plaintiffs suggested that the Court bifurcate the 35 U.S.C. § 271(a)-(c) claims of infringement from the solely equitable claims arising under § 271(e) in order to allow the Court to rule, as the trier of fact, on the “representativeness” of Impax’ expired samples and to consolidate this case for a bench trial. DISCUSSION I. The Seventh Amendment Right to a Jury Trial The Seventh Amendment preserves the right to a jury trial “in suits at common law” and guarantees that “no fact tried by a jury shall be otherwise re-examined in any Court of the United States” other than according to the rules of common law.” U.S. Const. Amend. VII. A party’s right to a jury is a safeguarded only so far as that right would have existed in 1791, i.e., in courts of law and not in courts of equity. Dimick v. Schiedt, 293 U.S. 474, 476 (1935); Tegal Corp. v. Tokyo Electron Am., Inc., 257 F.3d 1331, 1339 (Fed. Cir. 2001). With the merger of courts of law and equity, courts now consider both the nature of the action involved and the remedy sought to determine whether a case is “more similar to cases that were tried in courts of law than the suit tried in courts of equity or admiralty.” Tull v. U.S., 481 U.S. 412, 417-18 (1987); Chauffeurs, Teamsters & Helpers, Local No. 391 v. Terry, 494 U.S. 558, 565 (1990). Generally, the right to a jury trial on patent liability issues depends on the plaintiff's decision to seek damages. See, e.g., Bioavail Laboratories, Inc. v. Torpharm, Inc., 2002 WL 1732372 (July 25, 2002, No. 01C 9008) (right to a jury trial 4la arises when damages may be awarded under § 271(e)(4)(C)). Here, after Impax began commercial sales, Plaintiffs amended their complaint to seek both equitable and legal relief under § 271(a)-(c) and 271(e). Considering the efficiency of a consolidated trial of all Second Wave defendants, Plaintiffs now are “prepared to dismiss with prejudice its request for damages against Impax if it will permit the Impax case to be tried without a jury at the same time as the in-district Second Wave cases (Lek, Mylan and Esteve).” (Pl. Mem. at 2). Nevertheless, because the right to a jury trial is determined for each issue, as opposed to the action as a whole, the Court examines each claim to ascertain whether equitable or legal relief is sought. Ross v. Bernhard, 396 U.S. 221 (1970). Il. Plaintiffs’ Claims Plaintiffs’ claims of infringement under § 271(a)-(c) are a legal action but are considered purely equitable if damages are not sought. Tegal, 257 F.3d at 1338-1340 (holding that even though the plaintiff initially sued for both damages and injunctive relief, when the damages were dropped, the nature of the action was no longer legal). As the court in Tegal explained, where a plaintiff is seeking only “an injunction, it is clear that [the plaintiff] would have need[ed] . . . to bring its case in a court of equity.” /d. at 1331. Therefore, because Plaintiffs have agreed to dismiss with prejudice their claims for damages, the claims of infringement and relief sought under § 271(a)-(c) are equitable in nature. As to Plaintiffs’ claims of infringement under § 271(e)(2), they are purely equitable and do not give rise to a jury trial right. See Sanofi-Synthelabo v. Apotex, No. 02 Civ, 2255, 2002 WL 1917871, at2 (S.D.N.Y. Aug. 20, 2002)(“There is no question that Sanofi has no right to a jury trial on its claims pursuant to § 271(e)(2).”); Glaxo Group Ltd. v. 42a Apotex, Inc., 2001 WL 1256628, at *15 (N.D. Ill. Oct. 16, 2001), aff'd, Jn re Apotex, No 690, 2002 WL 31388364 (Fed. Cir. Oct. 9, 2002). Likewise, requests for attorney’s fees and costs cannot alter the fundamental nature of an equitable action and are therefore themselves equitable, not legal, claims. Emmpresa Cubana Del Tobacco v. Culbro Corp., 123 F. Supp. 2d 203, 211 (S.D.N.Y. 2000); Northgate Homes, Inc. v. City of Dayton, 126 F.3d 1095, 1099 (8th Cir. 1997). As set forth above, the Court finds that upon dismissal of Plaintiffs’ claims for damages, the balance of Plaintiffs’ claims are purely equitable and, therefore, do not support a right to a jury trial under the Seventh Amendment. Ill. Impax’ Affirmative Defenses and Counterclaims A. Impax’ Affirmative Defenses Historically “legal” affirmative defenses do not create a right to a jury trial because the Seventh Amendment has been “understood to protect claims, and not defenses which assert no claim for relief.” Burlington N. R.R. Co. v. Neb. Pub. Power Dist. , 931 F. Supp. 1470, 1481 (D. Neb. 1996). As the Federal Circuit explained, “a defendant, asserting only affirmative defenses and no counterclaims, does not have a right to a jury trial in a patent infringement suit if the only remedy sought by the plaintiff-patentee is an injunction.” Tegal, 257 F.3d at 1341. Thus, Impax’ affirmative defenses alone do not alter the Seventh Amendment analysis of Impax’ right to a jury trial because they do not alter the equitable nature of the claims at issue. 43a B. Impax’ Non-infringement and _ Invalidity Declaratory Judgment Counterclaims The Federal Circuit recently held that declaratory judgment actious for invalidity or non-infringement do not warrant a Seventh Amendment right to a jury trial unless “the infringement claim, as asserted by the patentee, would give rise to a jury trial.” Jn re Tech. Licensing Corp., 423 F.3d 1286, 1290 (Fed. Cir. Sept. 12, 2005). Declaratory judgment themselves are “neither legal nor equitable.” Gulfstream Aerospace Corp. v. Mayacama Corp., 485 U.S. 271, 284 (1988). Rather, “the nature of the underlying dispute determines whether a jury trial is available.” Petition of Rosenman & Colin, 850 F.2d 57, 60 (2d Cir. 1988). Here, once Astra dismisses with prejudice its request for damages, Impax is not entitled to a jury trial based on its non- infringement and invalidity declaratory judgment counterclaims. C. Impax’ Unenforceability Counterclaim Impax’ counterclaim for a declaration of unenforceability is based in an allegation that Plaintiffs engaged in “inequitable conduct.” (See Impax’ Answer & Counterclaims at 4 192). The Federal Circuit has held that inequitable conduct defenses are equitable and no not provide the grounds for a Seventh Amendment right to a jury trial. Paragon Podiatry Lab., Inc. v. KLM Labs, Inc., 984 F.2d 1182, 1190 (Fed. Cir. 1993); Gardco Mfg., Inc. v. Herst Lighting Co., 820 F.2d 1209, 1212 (Fed. Cir. 1987)(agreeing with district court that “the defense of inequitable conduct is equitable in nature and thus does not give rise to the right of trial by jury”). Therefore, Impax’ counterclaim of patent unenforceability also does not give rise to a right to a jury trial. 44a D. Impax’ Antitrust Counterclaims Plaintiffs and Impax agreed to sever and stay Impax’ antitrust counterclaims in 2003, and in conformity with that agreement, the parties have taken no discovery to date on any antitrust issues. (See Oct. 29, 2003 Letter from Ohly to Tayl [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386016_1029%3A1. Public record. Not legal advice.