Free Opening Brief in Support - District Court of Delaware - Delaware

Case 1:07-cv-00138-JJF

Document 15

Filed 05/03/2007

Page 1 of 21

Case 1:07-cv-00138-JJF

Document 15

Filed 05/03/2007

Page 2 of 21

Case 1:07-cv-00138-JJF

Document 15

Filed 05/03/2007

Page 3 of 21

Case 1:07-cv-00138-JJF

Document 15

Filed 05/03/2007

Page 4 of 21

Case 1:07-cv-00138-JJF

Document 15

Filed 05/03/2007

Page 5 of 21

Case 1:07-cv-00138-JJF

Document 15

Filed 05/03/2007

Page 6 of 21

Case 1:07-cv-00138-JJF

Document 15

Filed 05/03/2007

Page 7 of 21

Case 1:07-cv-00138-JJF

Document 15

Filed 05/03/2007

Page 8 of 21

Case 1:07-cv-00138-JJF

Document 15

Filed 05/03/2007

Page 9 of 21

Case 1:07-cv-00138-JJF

Document 15

Filed 05/03/2007

Page 10 of 21

Case 1:07-cv-00138-JJF

Document 15

Filed 05/03/2007

Page 11 of 21

Case 1:07-cv-00138-JJF

Document 15

Filed 05/03/2007

Page 12 of 21

Case 1:07-cv-00138-JJF

Document 15

Filed 05/03/2007

Page 13 of 21

Case 1:07-cv-00138-JJF

Document 15

Filed 05/03/2007

Page 14 of 21

Case 1:07-cv-00138-JJF

Document 15

Filed 05/03/2007

Page 15 of 21

Case 1:07-cv-00138-JJF

Document 15

Filed 05/03/2007

Page 16 of 21

Case 1:07-cv-00138-JJF

Document 15

Filed 05/03/2007

Page 17 of 21

Case 1:07-cv-00138-JJF

Document 15

Filed 05/03/2007

Page 18 of 21

Case 1:07-cv-00138-JJF

Document 15

Filed 05/03/2007

Page 19 of 21

Case 1:07-cv-00138-JJF

Document 15

Filed 05/03/2007

Page 20 of 21

Case 1:07-cv-00138-JJF

Document 15

Filed 05/03/2007

Page 21 of 21

Case 1:07-cv-00138-JJF

Document 15-2

Filed 05/03/2007

Page 1 of 6

Case 1:07-cv-00138-JJF

Document 15-2

Filed 05/03/2007

Page 2 of 6

Case 1:07-cv-00138-JJF

Document 15-2

Filed 05/03/2007

Page 3 of 6

Case 1:07-cv-00138-JJF

Document 15-2

Filed 05/03/2007

Page 4 of 6

Case 1:07-cv-00138-JJF

Document 15-2

Filed 05/03/2007

Page 5 of 6

Case 1:07-cv-00138-JJF

Document 15-2

Filed 05/03/2007

Page 6 of 6

Case 1:07-cv-00138-JJF

Document 15-3

Filed 05/03/2007

Page 1 of 4

Case 1:07-cv-00138-JJF

Document 15-3

Filed 05/03/2007

Page 2 of 4

Not Reported in F.Supp.2d Not Reported in F.Supp.2d, 2005 WL 2415959 (D.Del.) (Cite as: Not Reported in F.Supp.2d)

Page 1

Benitec Australia Ltd. v. Nucleonics, Inc. D.Del.,2005. Only the Westlaw citation is currently available. United States District Court,D. Delaware. BENITEC AUSTRALIA LTD., Plaintiff, v. NUCLEONICS, INC., Defendant. No. Civ.A. 04-0174 JJF. Sept. 29, 2005. John W. Shaw, Glenn C. Mandalas, of Young Conaway Stargatt & Taylor, LLP, Wilmington, Delaware, Marc R. Labgold, Kevin M. Bell, and Scott A.M. Changers, of Patton Boggs LLP, McLean, Virginia; Richard J. Oparil, of Patton Boggs LLP, Washington, District of Columbia, for Plaintiff, of counsel. Paul E. Crawford, of Connolly, Bove, Lodge & Hutz, Wilmington, Delaware, Dennis J. Mondolino, and Jason A. Lief, of Morgan Lewis & Bockius LLP, New York, New York, for Defendant, of counsel. MEMORANDUM OPINION FARNAN, J. *1 Pending before the Court is the Motion For Voluntary Dismissal Without Prejudice (D.I.108) filed by Plaintiff, Benitec Australia, Ltd. ("Benitec"). FN1 For the reasons discussed, the Court will grant Benitec's motion. FN1. Defendant Nucleonics, Inc. filed an Unopposed Motion And Supporting Memorandum To File A Surreply In Opposition To Plaintiff's Motion For Voluntary Dismissal Without Prejudice (D.I.117). The Court will grant the Motion, and the Surreply will be deemed filed. BACKGROUND The parties are engaged in conducting research and developing technologies to create therapeutics to treat disease using gene silencing technologies. On March 22, 2004, Benitec filed its Complaint (D.I.1), alleging that Defendant, Nucleonics, Inc. ("Nucleonics"), infringes U.S. Patent No. 6,573,099 ("the '099 patent").

On February 16, 2005, Nucleonics files a Motion To Amend Its Answer to add seven declaratory judgment counterclaims of non-infringement, patent invalidity under 35 U.S.C. § 102, patent invalidity under 35 U.S.C. § 103, patent invalidity under 35 U.S.C. § 112(1), patent invalidity under 35 U.S.C. § 112(2), patent invalidity under 35 U.S.C. § 116, and patent unenforceability. (D.I.91). On September 14, 2005, the Court issued an Order granting Nucleonics' Motion To Amend Its Answer (D.I.119). The parties have not yet completed discovery. PARTIES' CONTENTIONS By its motion, Benitec contends that this case should be dismissed without prejudice pursuant to Federal Rule of Civil Procedure 41(a) because of a substantive change in the law with regard to the scope of the exemption set forth in 35 U.S.C. § 271(e)(1). Specifically, Benitec contends that the recent decision of the United States Supreme Court in Merck KGAA v. Integra Lifesciences I, Ltd., 125 S.Ct. 2372 (2005), had the effect of negating the case or controversy before the Court with regard to infringement of Benitec's patents and, therefore, dismissal is warranted. In response, Nucleonics contends that the Court retains jurisdiction to decide its counterclaims for invalidity, unenforceability, and non-infringement because Nucleonics has a reasonable apprehension of being sued by Benitec in the future. Nucleonics argues that, because Benitec filed a lawsuit for patent infringement against Nucleonics and Benitec has not provided Nucleonics with a covenant not to sue for past, present, and future acts, jurisdiction over the declaratory judgment counterclaims exists. LEGAL STANDARD When a plaintiff moves for a dismissal without prejudice under Rule 41(a)(2), the decision to dismiss with prejudice or without is left to the discretion of the court. Buse v. Vanguard Group of Inv. Co., No. 91-3560, 1994 WL 111359, at *2 (E.D. Pa Apr. 1 1994). Specifically, Rule 41(a)(2) provides: "[A]n action shall not be dismissed at the plaintiff's instance

© 2007 Thomson/West. No Claim to Orig. U.S. Govt. Works.

Case 1:07-cv-00138-JJF

Document 15-3

Filed 05/03/2007

Page 3 of 4
Page 2

Not Reported in F.Supp.2d Not Reported in F.Supp.2d, 2005 WL 2415959 (D.Del.) (Cite as: Not Reported in F.Supp.2d) save upon order of the court and upon such terms and conditions as the court deems proper. If a counterclaim has been pleaded by a defendant ... the action shall not be dismissed against the defendant's objection unless the counterclaim can remain pending for independent adjudication by the court. Unless otherwise specified in the order, a dismissal under this paragraph is without prejudice." Fed.R.Civ.P. 41(a)(2) (2004). A Rule 41(a)(2) motion "will be determined after attempting to secure substantial justice to both parties." DuToit v. Strategic Minerals Corp., 136 F.R.D. 82 (D.Del.1991) citing Lunn v. United Aircraft Corp., 26 F.R.D. 12, 14 (D.Del.1960). Moreover, while considering the legitimate interests of both parties, the Court must bear in mind that a plaintiff's motion should be granted absent substantial prejudice to the defendant. Id. at 10. DISCUSSION *2 The Court concludes that dismissing Benitec's action would not cause substantial prejudice to Nucleonics because no actual controversy supports jurisdiction under the Declaratory Judgment Act for Nucleonic's declaratory judgment claims against Benitec. Nucleonics objects to dismissing Benitec's action without prejudice because Nucleonics contends that Benitec's action "brought a public cloud of uncertainty" over Nucleonics. (D.I. 110 at 2.) Thus, Nucleonics contends that Benitec should not now be allowed to leave the playing field, keeping its patent safe from scrutiny with regard to invalidity or unenforceability, while continuing to taint Nucleonic's current and future business and technology with the threat of another lawsuit. Nucleonics argues that the Declaratory Judgment Act, 28 U.S.C. § 2201, permits the Court to independently adjudicate Nucleonics' counterclaims. The Declaratory Judgment Act "requires an actual controversy between the parties before a federal court may exercise jurisdiction over an action for a declaratory judgment." EMC Corp. v. Norand Corp., 89 F.3d 807, 810 (Fed.Cir.1996). Nucleonics has the burden of establishing the existence of an actual case or controversy. See Cardinal Chemical Co. v. Morton Intern., Inc., 508 U.S. 83, 95 (1993). When a party has actually been charged with infringement of a patent, there is, necessarily, a case or controversy adequate to support jurisdiction of a counterclaim pursuant to the Declaratory Judgment Act. Id. at 96.

Furthermore, a counterclaim questioning the validity or enforceability of a patent raises issues beyond the initial claim for infringement. Id. The issue before the Court, then, is whether an actual controversy sufficient to support the Court's jurisdiction over Nucleonics' declaratory judgment counterclaims continues to exist if Benitec's patent infringement claim is dismissed. Benitec contends that dismissing its infringement claim divests the Court of jurisdiction to hear the counterclaims. However, a number of courts have held that withdrawing a charge of infringement will not necessarily preclude the existence of an actual controversy, especially if, as here, the withdrawal occurs after the filing of the declaratory judgment action. See, e.g., C.R. Bard, Inc. v. Schwartz, 716 F.2d 874, 881 (Fed.Cir.1983); Societe de Conditionnement v. Hunter Eng'g, 655 F.2d 938 (9th Cir.1981). In turn, Nucleonics contends that, because Benitec has refused to enter into a covenant not to sue for enforcement of the '099 patent against Nuceonics at a later time, an actual controversy necessarily exists. However, a patentee's refusal to promise not to enforce the patent, while "relevant to the [actual controversy] determination," is "not dispositive." BP Chems. Ltd. v. Union Carbide Corp., 4 F.3d 975, 980 (Fed.Cir.1993). In the alternative, Nucleonics contends that it has a reasonable apprehension of suit because Benitec has already sued Nucleonics and others for patent infringement, Benitec has not promised not to assert the '099 patent against Nucleonics in the future, and Benitec has requested a voluntary dismissal of its action without prejudice. In reply, Benitec contends that Nucleonics has nothing to fear because Nucleonics' research activities are exempt from infringement liability pursuant to § 271(e)(1) and the Supreme Court's decision in Integra. *3 The test for determining whether an actual case or controversy exists in a declaratory judgment action involving patents is two-pronged. First, the defendant's conduct must have created on the part of the plaintiff a reasonable apprehension that the defendant will initiate suit if the plaintiff continues the allegedly infringing activity. Second, the plaintiff must actually have either produced the product or have prepared to produce that product. Indium Corp. v. Semi-Alloys, Inc., 781 F.2d 879 (Fed.Cir.1985) With regard to the first prong, the Court concludes that Nucleonics has demonstrated a reasonable apprehension of suit. The factual background in this

© 2007 Thomson/West. No Claim to Orig. U.S. Govt. Works.

Case 1:07-cv-00138-JJF

Document 15-3

Filed 05/03/2007

Page 4 of 4
Page 3

Not Reported in F.Supp.2d Not Reported in F.Supp.2d, 2005 WL 2415959 (D.Del.) (Cite as: Not Reported in F.Supp.2d) case is such that Nucleonics could be concerned that Benitec would, at some time, file a patent infringement suit against it. By suing Nucleonics and alleging that Nucleonics' technology is now covered by the Benitec's patent, Benitec has engaged in a course of conduct that shows a willingness to protect that technology. See, e.g., C.R. Bard v. Schwartz, 716 F.2d 874, 880-81 (Fed.Cir.1983); Int'l Medical Prosthetics Research Assocs., Inc. v. Gore Enter. Holdings, Inc., 787 F.2d 572, 575, 229 U.S.P.Q. 278, 281 (Fed.Cir.1986) With regard to the second prong, production or preparation of a product, Nucleonics contends that its entire research effort is devoted to the RNAi area of technology and its activities will ultimately leave the safe harbor created by Integra. Nucleonics further alleges that it anticipates beginning research on livestock diseases, which are unprotected by the safe harbor. In response, Benitec argues that future infringement is not ripe for adjudication because Benitec's product may never be approved by the FDA or may be approved in a form that does not implicate the claims of the '099 patent. (D.I. 115 at 18.) The declaratory judgment plaintiff carries the burden of proving the existence of facts underlying its allegations of the existence of an actual controversy. Jervis B. Webb Co., 742 F.2d 1388, 1399 (Fed.Cir.1984). On the record before it, the Court concludes that Nucleonics has not demonstrated that it has produced or has prepared to produce a product that would be the target of an infringement lawsuit by Benitec. At the time this lawsuit was filed, Nucleonics was several years away from obtaining FDA approval. Further, as argued by Benitec, there is no certainty that any product approved by the FDA would be the same product that was in clinical trials at the time this lawsuit was filed. And finally, Nucleonics has adduced no evidence that it has undertaken sales or marketing activity with regard to any product. For these reasons, he Court concludes that any threat of litigation that may have existed now lacks sufficient immediacy and reality to support declaratory judgment jurisdiction. CONCLUSION In the circumstances presented here, the Court concludes that no actual controversy supports jurisdiction under the Declaratory Judgment Act for Nucleonic's declaratory judgement claims against Benitec with regard to the '099 patent. Accordingly, the Court will grant Benitec's Motion For Voluntary © 2007 Thomson/West. No Claim to Orig. U.S. Govt. Works. Dismissal Without Prejudice (D.I.108). *4 An appropriate Order will be issued. ORDER

At Wilmington, this 29th day of September 2005, for the reasons set forth in the Memorandum Opinion issued this date, IT IS HEREBY ORDERED that: 1. The Motion For Voluntary Dismissal Without Prejudice (D.I.108) filed by Plaintiff, Benitec Australia, Ltd. is GRANTED. 2. Defendant Nucleonics, Inc.'s Unopposed Motion And Supporting Memorandum To File A Surreply In Opposition To Plaintiff's Motion For Voluntary Dismissal Without Prejudice (D.I.117) is GRANTED. 3. The Surreply attached as Exhibit 1 to the Unopposed Motion And Supporting Memorandum To File A Surreply In Opposition To Plaintiff's Motion For Voluntary Dismissal Without Prejudice (D.I.117) is deemed filed. D.Del.,2005. Benitec Australia Ltd. v. Nucleonics, Inc. Not Reported in F.Supp.2d, 2005 WL 2415959 (D.Del.) END OF DOCUMENT

Case 1:07-cv-00138-JJF

Document 15-4

Filed 05/03/2007

Page 1 of 2

Case 1:07-cv-00138-JJF

Document 15-4

Filed 05/03/2007

Page 2 of 2

Slip Copy Slip Copy, 2007 WL 930720 (C.A.Fed.) (Cite as: Slip Copy)

Page 1

Medimmune, Inc. v. Genentech, Inc. C.A.Fed.,2007. Only the Westlaw citation is currently available.This case was not selected for publication in the Federal Reporter.NOTE: This disposition is nonprecedential. United States Court of Appeals,Federal Circuit. MEDIMMUNE, INC., Plaintiff-Appellant, v. GENENTECH, INC., Defendant-Appellee, andCity of Hope, Defendant-Appellee, andCelltech R & D, Ltd., Defendant-Appellee. No. 04-1300, 04-1384. March 7, 2007. Before NEWMAN and MAYER, Circuit Judges, and CLEVENGER, Senior Circuit Judge. PER CURIAM. ON MOTION ORDER *1 In Medimmune, Inc. V. Genentech, Inc., 127 S.Ct. 764 (2007), the Supreme Court reversed this court's decision, reported at 427 F.3d 958 (Fed.Cir.2005), and remanded with instructions that the lower court consider the issues flowing from the Court's decision that Medimmune "was not required, insofar as Article III is concerned, to break or terminate its 1997 license agreement before seeking a declaratory judgment in federal court that the underlying patent is invalid, unenforceable, or not infringed." The Court "express[ed] no opinion on ... the applicability of licensee estoppel under [the] circumstances" of the case at bar, id. at 769-70, and declined to affirm the dismissal of the declaratory judgment claims on discretionary grounds, the Court "leav[ing] the equitable, prudential, and policy arguments in favor of such a discretionary dismissal for the lower courts' consideration on remand." Id. at 777. The Court similarly left for consideration on remand any meritsbased arguments for denial of declaratory relief in this case. Genentech now moves for briefing and argument before this court, pointing to the potentially farreaching impact of the Court's decision and the advantages of expeditious elaboration of the law and

policy of patent licensing. We agree that the Court recognized that various issues may require further development. However, as Genentech recognizes in its motion, the Court's remand order is not amenable to determination upon the available record. The issues of law, equity, and policy, and their application to these parties, also require development of the relevant facts, and are not appropriately resolved in the first instance by an appellate tribunal. The Court so recognized, stating that "facts bearing on the usefulness of the declaratory judgment remedy, and the fitness of the case for resolution, are peculiarily within the [district courts'] grasp." 127 S.Ct. at 776, quoting Wilton v. Seven Falls Co., 515 U.S. 277, 289 (1995). Accordingly, IT IS ORDERED THAT: (1) The mandate issued on November 8, 2005, is hereby recalled and these appeals are reinstated. (2) The motion is denied. (3) We remand to the district court for further proceedings consistent with the Court's opinion. C.A.Fed.,2007. Medimmune, Inc. v. Genentech, Inc. Slip Copy, 2007 WL 930720 (C.A.Fed.) END OF DOCUMENT

© 2007 Thomson/West. No Claim to Orig. U.S. Govt. Works.

Case 1:07-cv-00138-JJF

Document 15-5

Filed 05/03/2007

Page 1 of 17

Case 1:07-cv-00138-JJF

Document 15-5

Filed 05/03/2007

Page 2 of 17

--- F.3d ------ F.3d ----, 2007 WL 942201 (C.A.Fed. (N.J.)), 82 U.S.P.Q.2d 1225 (Cite as: --- F.3d ----)

Page 1

Teva Pharmaceuticals USA, Inc. v. Novartis Pharmaceuticals Corp. C.A.Fed. (N.J.),2007. United States Court of Appeals,Federal Circuit. TEVA PHARMACEUTICALS USA, INC., PlaintiffAppellant, v. NOVARTIS PHARMACEUTICALS CORPORATION, Novartis Pharma AG and Novartis International Pharmaceutical Ltd., DefendantsAppellees. No. 06-1181. March 30, 2007. Background: Competitor that had filed abbreviated new drug application (ANDA) for generic drug brought action against patent holder for declaratory judgment on validity or infringement of method patents not challenged in holder's suit alleging infringement of drug patent. The United States District Court for the District of New Jersey, Jose L. Linares, J., 2005 WL 3619389, dismissed suit for lack of jurisdiction. Competitor appealed. Holdings: The Court of Appeals, Gajarsa, Circuit Judge, held that: (1) actual controversy is the sole requirement for federal court jurisdiction under the Declaratory Judgment Act (DJA) and statute conferring subject matter jurisdiction over declaratory judgment action on infringement or validity of drug patent, and (2) the competitor had an injury-in-fact and justiciable Article III controversy with holder.

118A Declaratory Judgment 118AIII Proceedings 118AIII(H) Appeal and Error 118Ak392 Appeal and Error 118Ak393 k. Scope and Extent of Review in General. Most Cited Cases Federal Courts 170B 755

170B Federal Courts 170BVIII Courts of Appeals 170BVIII(K) Scope, Standards, and Extent 170BVIII(K)1 In General 170Bk754 Review Dependent on Whether Questions Are of Law or of Fact 170Bk755 k. Particular Cases. Most Cited Cases Dismissal of declaratory judgment action for lack of jurisdiction presents a question of law reviewed without deference. Dismissal of declaratory judgment action for lack of jurisdiction presents a question of law reviewed without deference. [2] Declaratory Judgment 118A 393

118A Declaratory Judgment 118AIII Proceedings 118AIII(H) Appeal and Error 118Ak392 Appeal and Error 118Ak393 k. Scope and Extent of Review in General. Most Cited Cases Federal Courts 170B 776

Reversed.

Friedman, Senior Circuit Judge, concurred in the judgment and filed opinion. [1] Declaratory Judgment 118A 393

170B Federal Courts 170BVIII Courts of Appeals 170BVIII(K) Scope, Standards, and Extent 170BVIII(K)1 In General 170Bk776 k. Trial De Novo. Most Cited Cases The determination of whether an actual controversy exists under the Declaratory Judgment Act (DJA) in a patent case is a question of law reviewed de novo. 28 U.S.C.A. § 2201. The determination of whether an actual controversy exists under the Declaratory Judgment Act (DJA) in a patent case is a question of law reviewed de novo. 28

© 2007 Thomson/West. No Claim to Orig. U.S. Govt. Works.

Case 1:07-cv-00138-JJF

Document 15-5

Filed 05/03/2007

Page 3 of 17
Page 2

--- F.3d ------ F.3d ----, 2007 WL 942201 (C.A.Fed. (N.J.)), 82 U.S.P.Q.2d 1225 (Cite as: --- F.3d ----) U.S.C.A. § 2201. [3] Declaratory Judgment 118A 393 3, § 2, cl. 1.

118A Declaratory Judgment 118AIII Proceedings 118AIII(H) Appeal and Error 118Ak392 Appeal and Error 118Ak393 k. Scope and Extent of Review in General. Most Cited Cases Federal Courts 170B 870.1

A justiciable Article III controversy requires the party instituting the action to have standing and the issue presented to the court to be ripe. U.S.C.A. Const. Art. 3, § 2, cl. 1. [5] Federal Civil Procedure 170A 103.3

170B Federal Courts 170BVIII Courts of Appeals 170BVIII(K) Scope, Standards, and Extent 170BVIII(K)5 Questions of Fact, Verdicts and Findings 170Bk870 Particular Issues and Questions 170Bk870.1 k. In General. Most Cited Cases District court's factual findings supporting its determination on questions of actual controversy and jurisdiction under the Declaratory Judgment Act (DJA) are reviewed for clear error. 28 U.S.C.A. § 2201. District court's factual findings supporting its determination on questions of actual controversy and jurisdiction under the Declaratory Judgment Act (DJA) are reviewed for clear error. 28 U.S.C.A. § 2201. [4] Federal Civil Procedure 170A 103.2

170A Federal Civil Procedure 170AII Parties 170AII(A) In General 170Ak103.1 Standing 170Ak103.3 k. Causation; Redressability. Most Cited Cases Article III standing requires a plaintiff to allege personal injury fairly traceable to the defendant's allegedly unlawful conduct and likely to be redressed by the requested relief. U.S.C.A. Const. Art. 3, § 2, cl. 1. [6] Federal Civil Procedure 170A 103.2

170A Federal Civil Procedure 170AII Parties 170AII(A) In General 170Ak103.1 Standing 170Ak103.2 k. In General; Interest. Most Cited Cases Federal Courts 170B 12.1

Injury or

170A Federal Civil Procedure 170AII Parties 170AII(A) In General 170Ak103.1 Standing 170Ak103.2 k. In General; Interest. Most Cited Cases Federal Courts 170B 12.1

Injury or

170B Federal Courts 170BI Jurisdiction and Powers in General 170BI(A) In General 170Bk12 Case or Controversy Requirement 170Bk12.1 k. In General. Most Cited Cases Of the three Article III standing requirements, injuryin-fact is the most determinative; whatever else the case or controversy requirement embodies, its essence is a requirement of injury in fact. U.S.C.A. Const. Art. 3, § 2, cl. 1. Of the three Article III standing requirements, injuryin-fact is the most determinative; whatever else the case or controversy requirement embodies, its essence is a requirement of injury in fact. U.S.C.A. Const. Art. 3, § 2, cl. 1. [7] Federal Civil Procedure 170A 170A Federal Civil Procedure 170AII Parties 103.2

170B Federal Courts 170BI Jurisdiction and Powers in General 170BI(A) In General 170Bk12 Case or Controversy Requirement 170Bk12.1 k. In General. Most Cited Cases A justiciable Article III controversy requires the party instituting the action to have standing and the issue presented to the court to be ripe. U.S.C.A. Const. Art.

© 2007 Thomson/West. No Claim to Orig. U.S. Govt. Works.

Case 1:07-cv-00138-JJF

Document 15-5

Filed 05/03/2007

Page 4 of 17
Page 3

--- F.3d ------ F.3d ----, 2007 WL 942201 (C.A.Fed. (N.J.)), 82 U.S.P.Q.2d 1225 (Cite as: --- F.3d ----) 170AII(A) In General 170Ak103.1 Standing 170Ak103.2 k. In General; Injury or Interest. Most Cited Cases An injury-in-fact necessary for Article III standing must be personal, concrete, and particularized and actual or imminent. U.S.C.A. Const. Art. 3, § 2, cl. 1. [8] Declaratory Judgment 118A 62

Cases Under the prohibition against advisory opinions, federal courts are to decide only actual controversies by judgment which can be carried into effect, and not to give opinions upon moot questions or abstract propositions, or to declare principles or rules of law which cannot affect the matter in the case before it. U.S.C.A. Const. Art. 3, § 2, cl. 1. [12] Federal Civil Procedure 170A 103.2

92III(B) Judicial Powers and Functions 92k69 k. Advisory Opinions. Most Cited

118A Declaratory Judgment 118AI Nature and Grounds in General 118AI(D) Actual or Justiciable Controversy 118Ak62 k. Nature and Elements in General. Most Cited Cases Under the declaratory judgment standard of an actual controversy, all the circumstances must demonstrate the Article III justiciability requirement that the case be ripe for judicial review. U.S.C.A. Const. Art. 3, § 2, cl. 1; 28 U.S.C.A. § 2201(a). [9] Federal Courts 170B 12.1

170B Federal Courts 170BI Jurisdiction and Powers in General 170BI(A) In General 170Bk12 Case or Controversy Requirement 170Bk12.1 k. In General. Most Cited Cases The doctrine of ripeness focuses on the conduct of the defendant to determine whether the defendants actions have harmed, are harming, or are about to harm the plaintiff. [10] Federal Courts 170B 12.1

170A Federal Civil Procedure 170AII Parties 170AII(A) In General 170Ak103.1 Standing 170Ak103.2 k. In General; Injury or Interest. Most Cited Cases Congress by legislation may expand standing to the full extent permitted by Article III, thus permitting litigation by one who otherwise would be barred; Congress, however, cannot expand standing beyond the Article III jurisdiction of federal courts. U.S.C.A. Const. Art. 3, § 2, cl. 1. [13] Federal Civil Procedure 170A 103.2

170B Federal Courts 170BI Jurisdiction and Powers in General 170BI(A) In General 170Bk12 Case or Controversy Requirement 170Bk12.1 k. In General. Most Cited Cases A controversy is "ripe" if the question presented is fit for judicial review, meaning it is entirely or substantially a question of law and postponing a decision would work a substantial hardship on the challenging party. [11] Constitutional Law 92 69

170A Federal Civil Procedure 170AII Parties 170AII(A) In General 170Ak103.1 Standing 170Ak103.2 k. In General; Injury or Interest. Most Cited Cases As long as Congress remains within constitutional limits, it may enact statutes creating legal rights, the invasion of which creates standing, even though no injury would exist without the statute. U.S.C.A. Const. Art. 3, § 2, cl. 1. [14] Declaratory Judgment 118A 232

118A Declaratory Judgment 118AII Subjects of Declaratory Relief 118AII(L) Patents 118Ak231 Patents 118Ak232 k. Validity of Patents. Most Cited Cases Declaratory Judgment 118A 233

92 Constitutional Law 92III Distribution of Governmental Powers and Functions

118A Declaratory Judgment 118AII Subjects of Declaratory Relief 118AII(L) Patents

© 2007 Thomson/West. No Claim to Orig. U.S. Govt. Works.

Case 1:07-cv-00138-JJF

Document 15-5

Filed 05/03/2007

Page 5 of 17
Page 4

--- F.3d ------ F.3d ----, 2007 WL 942201 (C.A.Fed. (N.J.)), 82 U.S.P.Q.2d 1225 (Cite as: --- F.3d ----) 118Ak231 Patents 118Ak233 k. Infringement of Patents. Most Cited Cases Declaratory Judgment 118A 300

Article III case or controversy. U.S.C.A. Const. Art. 3, § 2, cl. 1; 28 U.S.C.A. § 2201(a). [17] Declaratory Judgment 118A 232

118A Declaratory Judgment 118AIII Proceedings 118AIII(C) Parties 118Ak299 Proper Parties 118Ak300 k. Subjects of Relief in General. Most Cited Cases The Declaratory Judgment Act (DJA) and statute conferring subject matter jurisdiction over declaratory judgment action on infringement or validity of drug patent expand standing to constitutional limits and provide a way for plaintiffs to bring actions in federal court when they might otherwise be barred. 28 U.S.C.A. § 2201; 35 U.S.C.A. § 271(e)(5). [15] Declaratory Judgment 118A 232

118A Declaratory Judgment 118AII Subjects of Declaratory Relief 118AII(L) Patents 118Ak231 Patents 118Ak232 k. Validity of Patents. Most Cited Cases Declaratory Judgment 118A 233

118A Declaratory Judgment 118AII Subjects of Declaratory Relief 118AII(L) Patents 118Ak231 Patents 118Ak233 k. Infringement of Patents. Most Cited Cases Declaratory Judgment 118A 300

118A Declaratory Judgment 118AII Subjects of Declaratory Relief 118AII(L) Patents 118Ak231 Patents 118Ak232 k. Validity of Patents. Most Cited Cases Declaratory Judgment 118A 233

118A Declaratory Judgment 118AII Subjects of Declaratory Relief 118AII(L) Patents 118Ak231 Patents 118Ak233 k. Infringement of Patents. Most Cited Cases An actual controversy is the sole requirement for federal court jurisdiction under the Declaratory Judgment Act (DJA) and statute conferring subject matter jurisdiction over declaratory judgment action on infringement or validity of drug patent. 28U.S.C.A. § 2201; 35 U.S.C.A. § 271(e)(5). [16] Declaratory Judgment 118A 62

118A Declaratory Judgment 118AIII Proceedings 118AIII(C) Parties 118Ak299 Proper Parties 118Ak300 k. Subjects of Relief in General. Most Cited Cases Under the Declaratory Judgment Act (DJA) and statute conferring subject matter jurisdiction over declaratory judgment action on infringement or validity of drug patent, a plaintiff is only required to satisfy Article III, which includes standing and ripeness, by showing under all the circumstances an actual or imminent injury caused by the defendant that can be redressed by judicial relief and that is of sufficient immediacy and reality to warrant the issuance of a declaratory judgment. U.S.C.A. Const. Art. 3, § 2, cl. 1; 28 U.S.C.A. § 2201(a); 35 U.S.C.A. § 271(e)(5). [18] Declaratory Judgment 118A 5.1

118A Declaratory Judgment 118AI Nature and Grounds in General 118AI(D) Actual or Justiciable Controversy 118Ak62 k. Nature and Elements in General. Most Cited Cases An "actual controversy" within the meaning of the Declaratory Judgment Act (DJA) is the same as an

118A Declaratory Judgment 118AI Nature and Grounds in General 118AI(A) In General 118Ak5 Discretion of Court 118Ak5.1 k. In General. Most Cited Cases Unlike non-declaratory judgment actions, even if there is an actual controversy, the district court is not required to exercise jurisdiction to address the merits of a declaratory judgment action, as it retains

© 2007 Thomson/West. No Claim to Orig. U.S. Govt. Works.

Case 1:07-cv-00138-JJF

Document 15-5

Filed 05/03/2007

Page 6 of 17
Page 5

--- F.3d ------ F.3d ----, 2007 WL 942201 (C.A.Fed. (N.J.)), 82 U.S.P.Q.2d 1225 (Cite as: --- F.3d ----) discretion under the Declaratory Judgment Act (DJA) to decline declaratory judgment jurisdiction. 28 U.S.C.A. § 2201. [19] Courts 106 90(1) Federal Civil Procedure 170A 103.3

106 Courts 106II Establishment, Organization, and Procedure 106II(G) Rules of Decision 106k88 Previous Decisions as Controlling or as Precedents 106k90 Decisions of Same Court or CoOrdinate Court 106k90(1) k. In General. Most Cited Cases Courts 106 90(2)

170A Federal Civil Procedure 170AII Parties 170AII(A) In General 170Ak103.1 Standing 170Ak103.3 k. Causation; Redressability. Most Cited Cases An Article III controversy is found where a plaintiff has demonstrated an injury-in-fact caused by the defendant that can be redressed by the court. U.S.C.A. Const. Art. 3, § 2, cl. 1. [22] Declaratory Judgment 118A 234

106 Courts 106II Establishment, Organization, and Procedure 106II(G) Rules of Decision 106k88 Previous Decisions as Controlling or as Precedents 106k90 Decisions of Same Court or CoOrdinate Court 106k90(2) k. Number of Judges Concurring in Opinion, and Opinion by Divided Court. Most Cited Cases The Court of Appeals respects the principle of stare decisis and follows its own precedential decisions unless the decisions are overruled by the court en banc or by other controlling authority such as an intervening Supreme Court decision. [20] Declaratory Judgment 118A 61

118A Declaratory Judgment 118AI Nature and Grounds in General 118AI(D) Actual or Justiciable Controversy 118Ak61 k. Necessity. Most Cited Cases A justiciable controversy within Article III is the only limitation on jurisdiction under the Declaratory Judgment Act (DJA). U.S.C.A. Const. Art. 3, § 2, cl. 1; 8 U.S.C.A. § 2201. [21] Federal Civil Procedure 170A 170A Federal Civil Procedure 170AII Parties 170AII(A) In General 170Ak103.1 Standing 170Ak103.2 k. In General; Interest. Most Cited Cases 103.2

118A Declaratory Judgment 118AII Subjects of Declaratory Relief 118AII(L) Patents 118Ak231 Patents 118Ak234 k. Claim of Infringement as Condition Precedent. Most Cited Cases Patent holder's competitor that had filed abbreviated new drug application (ANDA) for generic drug had an injury-in-fact and justiciable Article III controversy with holder and, therefore, could file action for declaratory judgment on validity or infringement of method patents listed in Orange Book, even though holder had not sued or threatened to sue competitor over those patents after its paragraph IV certification; the holder had sued competitor for infringement of the drug patent, that suit, although a different case, created a present and actual controversy, and the declaratory judgment arose from the same controversy. U.S.C.A. Const. Art. 3, § 2, cl. 1; Federal Food, Drug, and Cosmetic Act, § 505(j)(2)(A)(vii), (j)(5)(C), 21 U.S.C.A. § 355(j)(2)(A)(vii), (j)(5)(C); 28 U.S.C.A. § 2201(a); 35 U.S.C.A. § 271(a), (e)(2)(A), (e)(5). [23] Health 198H 319

Injury or

198H Health 198HI Regulation in General 198HI(E) Drugs; Medical Devices and Instruments 198Hk315 Applications and Approvals 198Hk319 k. Generic and Orphan Drugs; Market Exclusivity. Most Cited Cases Patent holder's failure to sue for infringement of method patents when it sued for infringement of drug patent did not block holder from suing on the method patents, and the holder's suit on the patent expiring first invoked automatic thirty-month stay of competitor's abbreviated new drug application

© 2007 Thomson/West. No Claim to Orig. U.S. Govt. Works.

Case 1:07-cv-00138-JJF

Document 15-5

Filed 05/03/2007

Page 7 of 17
Page 6

--- F.3d ------ F.3d ----, 2007 WL 942201 (C.A.Fed. (N.J.)), 82 U.S.P.Q.2d 1225 (Cite as: --- F.3d ----) (ANDA) for generic drug, reserved option of future litigation on the method patents, and prevented the generic drug from entering the market until the expiration of the last patent. Federal Food, Drug, and Cosmetic Act, § 505(j)(5)(B)(iii), 21 U.S.C.A. § 355(j)(5)(B)(iii). [24] Federal Courts 170B 12.1

170Bk12.1 k. In General. Most Cited Cases Congress has authority to give standing and create justiciable injuries through legislation for parties that might otherwise have no recourse as long as Congress does not exceed the limitations of Article III. U.S.C.A. Const. Art. 3, § 2, cl. 1. Congress has authority to give standing and create justiciable injuries through legislation for parties that might otherwise have no recourse as long as Congress does not exceed the limitations of Article III. U.S.C.A. Const. Art. 3, § 2, cl. 1. Patents 291 328(2)

170B Federal Courts 170BI Jurisdiction and Powers in General 170BI(A) In General 170Bk12 Case or Controversy Requirement 170Bk12.1 k. In General. Most Cited Cases A justiciable controversy under Article III can arise from either an actual or an imminent injury. U.S.C.A. Const. Art. 3, § 2, cl. 1. [25] Declaratory Judgment 118A 231.1

118A Declaratory Judgment 118AII Subjects of Declaratory Relief 118AII(L) Patents 118Ak231 Patents 118Ak231.1 k. In General. Most Cited Cases A justiciable declaratory judgment controversy arises for the filer of an abbreviated new drug application (ANDA) when a patentee lists patents in the Orange Book, the ANDA applicant files its ANDA certifying the listed patents under paragraph IV, and the patentee brings an action against the submitted ANDA on one or more of the patents. U.S.C.A. Const. Art. 3, § 2, cl. 1; Federal Food, Drug, and Cosmetic Act, § 505(j)(2)(A)(vii), (j)(5)(C), 21 U.S.C.A. § 355(j)(2)(A)(vii), (j)(5)(C); 28 U.S.C.A. § 2201(a); 35 U.S.C.A. § 271(a), (e)(2)(A), (e)(5). [26] Federal Civil Procedure 170A 170A Federal Civil Procedure 170AII Parties 170AII(A) In General 170Ak103.1 Standing 170Ak103.2 k. In General; Interest. Most Cited Cases Federal Courts 170B 12.1 103.2

291 Patents 291XIII Decisions on the Validity, Construction, and Infringement of Particular Patents 291k328 Patents Enumerated 291k328(2) k. Original Utility. Most Cited Cases 5,246,937, 5,840,763, 5,866,581, 5,916,893, 6,124,304. Cited. Henry C. Dinger, Goodwin Procter LLP, of Boston, Massachusetts, argued for plaintiff-appellant. With him on the brief were Shepard M. Remis and Roland H. Schwillinski. Of counsel on the brief were Allyn Z. Lite and Michael E. Patunas, of Lite Depalma Greenberg & Rivas, LLC, of Newark, New Jersey. Hugh C. Barrett, Fitzpatrick, Cella, Harper & Scinto, of New York, New York, argued for defendantsappellees. With him on the brief were Robert L. Baechtold, Nicholas N. Kallas, and Simon D. Roberts. Before MAYER, Circuit Judge, FRIEDMAN, Senior Circuit Judge, and GAJARSA, Circuit Judge. GAJARSA, Circuit Judge. *1 Teva Pharmaceuticals ("Teva") appeals from the dismissal of its declaratory judgment action by the United States District Court for the District of New Jersey. The district court, relying on our two-part declaratory judgment test for patent non-infringement as modified by our recent decision in Teva Pharmaceuticals USA, Inc., v. Pfizer, Inc., 395 F.3d 1324 (2005) ( "Pfizer"), found that Teva failed to establish a reasonable apprehension of imminent suit and that it therefore lacked jurisdiction over the declaratory judgment action. In light of the Supreme Court's recent decision in MedImmune, Inc. v. Genentech, Inc., --- U.S. ----, 127 S.Ct. 764, 166 L.Ed.2d 604 (2007), which finds that our declaratory

Injury or

170B Federal Courts 170BI Jurisdiction and Powers in General 170BI(A) In General 170Bk12 Case or Controversy Requirement

© 2007 Thomson/West. No Claim to Orig. U.S. Govt. Works.

Case 1:07-cv-00138-JJF

Document 15-5

Filed 05/03/2007

Page 8 of 17
Page 7

--- F.3d ------ F.3d ----, 2007 WL 942201 (C.A.Fed. (N.J.)), 82 U.S.P.Q.2d 1225 (Cite as: --- F.3d ----) judgment test for non-infringement or invalidity "conflicts" with its precedent, we reverse. I. BACKGROUND Novartis holds a New Drug Application ("NDA") for three strengths of the drug Famvir® . Upon filing its Famvir® NDA, Novartis listed five patents in the Food and Drug Administration's ("FDA") Orange Book, each of which covers and is directed to various aspects of Famvir® , including U.S Patent Nos: 5,246,937 (" 937 patent"); 5,840,763 (" 763 patent"); 5,866,581 (" 581 patent"); 5,916,893 (" 893 patent"); and 6,124,304 (" 304 patent"). The 937 patent is directed to the active ingredient in Famvir® , famciclovir, while the remaining Orange Book patents are directed to methods of therapeutic use ("method patents") of Famvir® . The 937 patent expires in 2010, but the related therapeutic use patents do not expire until 2014-15. In 2004, Teva filed an Abbreviated New Drug Application ("ANDA") with the FDA for generic famciclovir tablets in which Teva certified under paragraph IV of 21 U.S.C. § 355(j)(2)(A)(vii) that its drug did not infringe any of the five Novartis Famvir® Orange Book patents or that the patents were invalid. Teva's paragraph IV certifications constitute technical infringement under 35 U.S.C. § 271(e)(1). Accordingly, Novartis had 45 days to sue on these patents in order to invoke a statutorily mandated 30-month stay to delay immediate FDA approval of Teva's famciclovir ANDA. See 21 U.S.C. § 355(j)(5)(B)(iii). Novartis brought an infringement suit against Teva on the 937 patent alone and did not include in the action the related therapeutic use patents. The infringement suit is pending in the United States District Court for the District of New Jersey. Novartis Pharm. Corp. v. Teva Pharm. USA, Inc., No. 051887, 2005 WL 3664014 (D.N.J.2005). After Novartis filed suit, Teva brought this declaratory judgment action on the four remaining method patents under 21 U.S.C. § 355(j)(5)(C) and 35 U.S.C. § 271(e)(5) to establish "patent certainty." Title 21 U.S.C. § 355(j)(5)(C) is a 2003 amendment to the ANDA statute entitled "civil action to obtain patent certainty." Under this provision, if the patentee or NDA holder does not bring an infringement suit within 45 days after receiving notice of a paragraph IV certification, the ANDA applicant may bring a civil action for a declaratory judgment that the patent

at issue is invalid or will not be infringed by the drug for which the ANDA was submitted. Id. Title 35 U.S.C. § 271(e)(5) is a 2003 amendment to the patent statute that works in conjunction with the 2003 amendment to the ANDA statute to provide that in a civil action to obtain patent certainty, federal courts "shall, to the extent consistent with the Constitution, have subject matter jurisdiction in any action brought ... under § 2201 of title 28 for a declaratory judgment that such patent is invalid or not infringed." Teva argues that by bringing suit on the 937 patent alone in the first instance, "Novartis has sought to put Teva to the hard choice of either launching at risk of massive liability for patent infringement when the 937 patent expires or Teva prevails in the pending infringement action, or foregoing that opportunity and thereby effectively extending the term of the 937 patent." Appellant Br. 9 (footnotes omitted). *2 Novartis moved to dismiss for lack of subject matter jurisdiction, arguing that Teva had no reasonable apprehension that it would be sued by Novartis for infringing the four method patents. In response, Teva argued that: (1) Novartis had already sued Teva on the underlying composition patent; (2) listing patents in the Orange Book established infringement as a matter of law; (3) Novartis had a history of aggressively suing generic drug companies; and (4) Novartis had declined to give Teva a covenant not to sue. The district court dismissed Teva's declaratory judgment action requesting "patent certainty" on the four method patents. Teva Pharm., USA, Inc., v. Novartis Pharm. Corp., No. 05-2881, slip op. at 10, 2005 WL 3619389 (D.N.J. Dec. 12, 2005). In so doing, the district court applied our two prong "reasonable-apprehension-of-imminent-suit" test from Pfizer.FN1 395 F.3d at 1332. After comparing the facts of this case to those in Pfizer, the district court found that Teva had failed to establish a reasonable apprehension of imminent suit and that the district court therefore lacked jurisdiction over the declaratory judgment action. Teva, slip op. at 10. Teva timely appealed to this court. We have jurisdiction under 28 U.S.C. § 1295(a)(1). [1][2][3] The district court's dismissal of Teva's declaratory judgment action for lack of jurisdiction presents a question of law that we review without deference. See Pfizer, 395 F.3d at 1332 (citing GenProbe Inc. v. Vysis, Inc., 359 F.3d 1376, 1379 (Fed.Cir.2004)). The determination of whether an actual controversy exists under the Declaratory Judgment Act in a patent case is a question of law

© 2007 Thomson/West. No Claim to Orig. U.S. Govt. Works.

Case 1:07-cv-00138-JJF

Document 15-5

Filed 05/03/2007

Page 9 of 17
Page 8

--- F.3d ------ F.3d ----, 2007 WL 942201 (C.A.Fed. (N.J.)), 82 U.S.P.Q.2d 1225 (Cite as: --- F.3d ----) that we review de novo. BP Chems. Ltd. v. Union Carbide Corp., 4 F.3d 975, 978 (Fed.Cir.1993). The district court's factual findings supporting its determination are reviewed for clear error. Id. II. ANALYSIS A. Our starting point in analyzing Teva's appeal is the Declaratory Judgment Act, 28 U.S.C. § 2201(a) under which Teva filed this suit. The relevant text of the Act reads: In a case of actual controversy within its jurisdiction ... any court of the United States, upon the filing of an appropriate pleading, may declare the rights and other legal relations of any interested party seeking such declaration, whether or not further relief is or could be sought. 28 U.S.C. § 2201(a). In the ANDA context, Congress explicitly extended federal court declaratory judgment jurisdiction under 28 U.S.C. § 2201 to ANDA paragraph IV disputes such as Teva's and did so "to the extent consistent with the Constitution." 35 U.S.C. § 271(e)(5).FN2 The Supreme Court recently re-affirmed that the Act's "actual controversy" requirement "refers to the type of `Cases' and `Controversies' that are justiciable under Article III." MedImmune, 127 S.Ct. at 771 ("[T]he phrase `case of actual controversy' in the Act refers to the type of `Cases' and `Controversies' that are justiciable under Article III.") (citing Aetna Life Ins. Co. v. Haworth, 300 U.S. 227, 240, 57 S.Ct. 461, 81 L.Ed. 617 (1937)). *3 In MedImmune, the Court found that its precedent "did not draw the brightest of lines between those declaratory-judgment actions that satisfy the case-orcontroversy requirement and those that do not." Id. Instead of applying a bright line, the Court stated that its decisions required: that the dispute be "definite and concrete, touching the legal relations of the parties having adverse legal interests"; and that it be "real and substantial" and "admi[t] of specific relief through a decree of a conclusive character, as distinguished from an opinion advising what the law would be upon a hypothetical state of facts." Id. (citing Aetna Life Ins. Co., 300 U.S. at 240-41, 57 S.Ct. 461).

Previously, the Court held that "the difference between an abstract question and a `controversy' contemplated by the Declaratory Judgment Act is necessarily one of degree, and it would be difficult, if it would be possible, to fashion a precise test for determining in every case whether there is such a controversy." Md. Cas. Co. v. Pac. Coal & Oil Co., 312 U.S. 270, 273, 61 S.Ct. 510, 85 L.Ed. 826 (1941). In MedImmune, the Court re-affirmed the correct standard for determining a justiciable declaratory judgment action: "Basically, the question in each case is whether the facts alleged, under all the circumstances, show that there is a substantial controversy, between the parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment." Id. (citing Md. Cas. Co., 312 U.S. at 273, 61 S.Ct. 510). [4] Thus, MedImmune teaches that in a declaratory judgment action, "all the circumstances" must demonstrate that a justiciable Article III "controversy" exists. A justiciable Article III controversy requires the party instituting the action to have standing and the issue presented to the court to be ripe. Lujan v. Defenders of Wildlife, 504 U.S. 555, 560, 112 S.Ct. 2130, 119 L.Ed.2d 351 (1992). [5][6][7] Article III standing requires "[a] plaintiff [to] allege personal injury fairly traceable to the defendant's allegedly unlawful conduct and likely to be redressed by the requested relief." Allen v. Wright, 468 U.S. 737, 751, 104 S.Ct. 3315, 82 L.Ed.2d 556 (1984). Of the three standing requirements, injury-infact is the most determinative: "[W]hatever else the `case or controversy' requirement embodie[s], its essence is a requirement of `injury in fact.' " Schlesinger v. Reservists Comm. to Stop the War, 418 U.S. 208, 218, 94 S.Ct. 2925, 41 L.Ed.2d 706 (1974) (citing Ass'n of Data Processing Serv. Org., Inc. v. Camp, 397 U.S. 150, 152, 90 S.Ct. 827, 25 L.Ed.2d 184 (1970)). An injury-in-fact must be "personal," "concrete and particularized," and "actual or imminent." Lujan, 504 U.S. at 560, 112 S.Ct. 2130; Warth v. Seldin, 422 U.S. 490, 501, 95 S.Ct. 2197, 45 L.Ed.2d 343 (1975). [8][9][10] Under the declaratory judgment standard, "all the circumstances" must demonstrate the Article III justiciability requirement that the case be ripe for judicial review. Abbott Labs. v. Gardner, 387 U.S. 136, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967). The doctrine of ripeness focuses on the conduct of the defendant to determine whether the defendants

© 2007 Thomson/West. No Claim to Orig. U.S. Govt. Works.

Case 1:07-cv-00138-JJF

Document 15-5

Filed 05/03/2007

Page 10 of 17
Page 9

--- F.3d ------ F.3d ----, 2007 WL 942201 (C.A.Fed. (N.J.)), 82 U.S.P.Q.2d 1225 (Cite as: --- F.3d ----) actions have harmed, are harming, or are about to harm the plaintiff. Ripeness can be an issue in obtaining anticipatory relief like declaratory judgments. Id. at 149, 87 S.Ct. 1507. A "controversy" is "ripe" if the question presented is "fit for judicial review," meaning it is entirely or substantially a question of law and postponing a decision would work a substantial hardship on the challenging party. Id. at 149-50, 87 S.Ct. 1507 (applying the test and holding that a regulation requiring drug manufacturers to change labeling was ripe for review before it was enforced because the regulation had an immediate and expensive impact on the plaintiffs' operations and plaintiffs risked a substantial sanction for non-compliance). *4 [11] Similar to the ripeness doctrine and based on the same constitutional "controversy" requirement is the Court's prohibition against advisory opinions. Under this doctrine, federal courts are to decide only "actual controversies by judgment which can be carried into effect, and not to give opinions upon moot questions or abstract propositions, or to declare principles or rules of law which cannot affect the matter in the case before it." Local No. 8-6, Oil, Chem. & Atomic Workers Int'l Union v. Missouri, 361 U.S. 363, 367, 80 S.Ct. 391, 4 L.Ed.2d 373 (1960). Although there can be a fine line between declaratory judgments and advisory opinions, the Supreme Court maintains the necessity of avoiding issuing advisory opinions based upon hypothetical facts. Elec. Bond & Share Co. v. Sec. & Exch. Comm'n, 303 U.S. 419, 58 S.Ct. 678, 82 L.Ed. 936 (1938). [12][13] Notwithstanding the Court's justiciability precedent, it is well established that Congress by legislation "may expand standing to the full extent permitted by [A]rticle [III] of [the] Constitution, thus permitting litigation by one who otherwise would be barred." Gladstone Realtors v. Vill. of Bellwood, 441 U.S. 91, 100, 99 S.Ct. 1601, 60 L.Ed.2d 66 (1979). Congress, however, cannot expand standing beyond the Article III jurisdiction of federal courts. Id. Thus, as long as Congress remains within constitutional limits, it may "enact statutes creating legal rights, the invasion of which creates standing, even though no injury would exist without the statute." Linda R.S. v. Richard D., 410 U.S. 614, 617 n. 4, 93 S.Ct. 1146, 35 L.Ed.2d 536 (1973) (citing Trafficante v. Metro. Life Ins. Co., 409 U.S. 205, 212, 93 S.Ct. 364, 34 L.Ed.2d 415 (1972) (White, J., concurring)). [14][15][16][17][18] The Declaratory Judgment Act and 35 U.S.C. § 271(e)(5) are examples of

legislation that expand standing to constitutional limits and provide a way for plaintiffs to bring actions in federal court when they might otherwise be barred. The sole requirement for federal court jurisdiction under both provisions is an "actual controversy," 28 U.S.C. § 2201(a), which is the same as an Article III case or controversy. See Aetna Life Ins., 300 U.S. at 239-41, 57 S.Ct. 461. This means that under both provisions, a declaratory judgment plaintiff is only required to satisfy Article III, which includes standing and ripeness, by showing under "all the circumstances" an actual or imminent injury caused by the defendant that can be redressed by judicial relief and that is of "sufficient immediacy and reality to warrant the issuance of a declaratory judgment." MedImmune, 127 S.Ct. at 771 (internal citations omitted). FN3 [19] In the instant case, we follow the Court's analysis in MedImmune in determining whether Teva has a justiciable controversy within the meaning of Article III. Id. By following MedImmune, we recognize that we are not relying on our two-part reasonable-apprehension-of-suit test. See, e.g., Pfizer, 395 F.3d at 1332-33. This court respects the principle of stare decisis and follows its own precedential decisions unless the decisions are "overruled by the court en banc, or by other controlling authority such as an intervening ... Supreme Court decision." Tex. Am. Oil Co. v. U.S. Dep't of Energy, 44 F.3d 1557, 1561 (Fed.Cir.1995) (en banc). *5 Under our patent jurisprudence, we developed a two-part test to determine if an "actual controversy" exists in a general declaratory judgment action for patent non-infringement or invalidity. See, e.g., Pfizer, 395 F.3d at 1332-33. This test requires both (1) an explicit threat or other action by the patentee, which creates a reasonable apprehension on the part of the declaratory plaintiff that it will face an infringement suit and (2) present activity which could constitute infringement or concrete steps taken with the intent to conduct such an activity. See, e.g., id. In MedImmune, the Supreme Court in a detailed footnote stated that our two-prong "reasonable apprehension of suit" test "conflicts" and would "contradict" several cases in which the Supreme Court found that a declaratory judgment plaintiff had a justiciable controversy.FN4 127 S.Ct. at 774 n. 11. In MedImmune, the Court disagreed with our "reasonable apprehension of imminent suit" test and re-affirmed that the "actual controversy" requirement in the Declaratory Judgment Act is the same as the "Cases" and "Controversies" requirement in Article

© 2007 Thomson/West. No Claim to Orig. U.S. Govt. Works.

Case 1:07-cv-00138-JJF

Document 15-5

Filed 05/03/2007

Page 11 of 17
Page 10

--- F.3d ------ F.3d ----, 2007 WL 942201 (C.A.Fed. (N.J.)), 82 U.S.P.Q.2d 1225 (Cite as: --- F.3d ----) III. Id. at 771. The Court further re-affirmed that an "actual controversy" requires only that a dispute be " `definite and concrete, touching the legal relations of parties having adverse legal interests'; and that it be `real and substantial' and `admi[t] of specific relief through a decree of a conclusive character, as distinguished from an opinion advising what the law would be upon a hypothetical set of facts.' " Id. (quoting Aetna Life Ins. Co., 300 U.S. at 240-41, 57 S.Ct. 461). The Court summarized the declaratory judgment "actual controversy" requirement by quoting the "all the circumstances" test from Maryland Casualty. Id. Thus, because the Supreme Court in MedImmune cautioned that our declaratory judgment "reasonableapprehension-of-suit" test "contradict[s]" and "conflicts" with its precedent, these Federal Circuit tests have been "overruled by ... an intervening ... Supreme Court decision." Tex. Am. Oil Co., 44 F.3d at 1561; see also, Sandisk v. STMicroelectronics, 480 F.3d 1372 (Fed.Cir.2007). Therefore, we follow MedImmune's teaching to look at "all the circumstances" under Maryland Casualty to determine whether Teva has a justiciable Article III controversy. B. The district court was bound by our precedent in Pfizer to apply the "reasonable-apprehension-ofimminent-suit" test to Teva's declaratory judgment action. Teva, slip op. at 9, 2005 WL 3619389. In applying this test, the district court considered Teva's standing and concluded that Teva had failed to establish the type of injury-in-fact that we required in Pfizer because Teva could not show a reasonable apprehension of imminent suit. Teva, slip op. at 9, 2005 WL 3619389; see Pfizer, 395 F.3d at 1333 (requiring a showing of "imminent suit"). The district court found that because Teva could not establish an Article III controversy under our precedent, it did not have jurisdiction and dismissed Teva's declaratory judgment action. *6 [20][21] We hold that MedImmune applies to Teva's declaratory judgment action and takes precedence over the district court's application of Pfizer, which required Teva to show a single type of Article III injury-in-fact, "a reasonable apprehension of imminent suit." 395 F.3d at 1333. The question in this case is whether Teva has a justiciable controversy within Article III, which is the only limitation on our jurisdiction under the Declaratory Judgment Act. See 28 U.S.C § 2201. An Article III controversy is found where a plaintiff has

demonstrated an injury-in-fact caused by the defendant that can be redressed by the court. See Steel Co., 523 U.S. at 83, 118 S.Ct. 1003. In the present case, only the concrete injury-in-fact requirement under Article III is in dispute. [22][23] We hold that under "all the circumstances" as found in this case, Teva has an injury-in-fact and therefore has a justiciable Article III controversy. Here, Novartis argues that there is no actual controversy between it and Teva on the four method patents in spite of Teva's paragraph IV certifications of the four method patents because Novartis has not filed suit nor threatened to sue Teva on the method patents. Moreover, Novartis contends that the suit on the 937 patent is an entirely different controversy. Novartis is incorrect. There is no question that Novartis has already filed suit based on Teva's act of infringement in submitting the ANDA. Under 35 U.S.C. § 271(e)(2)(A), submitting an ANDA, regardless of how many paragraph IV certifications it may contain, is a single act of infringement: "It shall be an act of infringement to submit-an [ANDA] application ... for a drug claimed in a patent or for the use of which is claimed in a patent." (Emphasis added). While it is true that the suit on the 937 patent is a different "case" than Teva's declaratory judgment action, Novartis created a present and actual "controversy" by choosing to sue under 35 U.S.C. § 271(e)(2)(A) on Teva's single act of infringement, thereby placing into actual dispute the soundness of Teva's ANDA and Teva's ability to secure approval of the ANDA. Thus, while Teva's declaratory judgment action and the pending 937 suit are different "cases," they arise from the same controversy created when Novartis listed its Famvir® patents in the Orange Book, Teva submitted its ANDA certifying all five Famvir® patents under paragraph IV, and Novartis sued Teva challenging the submission of Teva's ANDA.FN5 Novartis' conduct raises the questions of if and how 35 U.S.C. § 271(e)(2) applies to multiple suits between the same parties on the submission of a single ANDA with more than one paragraph IV certification. It is clear from the statutory language that recovering damages for a 35 U.S.C. § 271(e)(2)(A) infringement action is only time barred by the statutory six-year statute of limitations. See 35 U.S.C. § 286 ("[N]o recovery shall be had for any infringement committed more than six years prior to the filing of the complaint or counterclaim for infringement in the action."); see also, A.C. Aukerman Co. v. R.L. Chaides Const. Co., 960 F.2d 1020, 1030 (Fed.Cir.1992) (explaining that § 286 is

© 2007 Thomson/West. No Claim to Orig. U.S. Govt. Works.

Case 1:07-cv-00138-JJF

Document 15-5

Filed 05/03/2007

Page 12 of 17
Page 11

--- F.3d ------ F.3d ----, 2007 WL 942201 (C.A.Fed. (N.J.)), 82 U.S.P.Q.2d 1225 (Cite as: --- F.3d ----) "not a statute of limitations in the sense of barring a suit for infringement" ... but rather a "limit to recovery to damages for infringing acts committed within six years of the date of the filing of the infringement action."). Thus, Novartis has the right of an immediate action against Teva under 35 U.S.C. § 271(e)(2)(A) on any or all of the remaining Famvir® Orange Book patents.FN6 These actions could be brought at any time until the patents expire and damages would be limited only by the six-year limitations period. While it is unclear whether Novartis would be prohibited from suing under the doctrine of claim preclusion, Teva remains under the threat of an infringement suit because the 45-day statutory window does not preclude Novartis from pursuing additional infringement suits under 35 U.S.C. § 271(e)(2)(A). In light of Novartis' pending suit on the same ANDA, this threat of litigation is a present injury creating a justiciable controversy. Moreover, Novartis retains the right to sue Teva under the Famvir® patents pursuant to 35 U.S.C. § 271(a). Therefore, Novartis has numerous opportunities to bring an action at any time for patent infringement and is not precluded by the 45-day window. *7 [24] The district court erred in finding that Teva did not demonstrate an Article III controversy. Teva, slip op. at 6-10, 2005 WL 3619389. A justiciable controversy can arise from either an actual or an imminent injury. While it is true that several of Teva's grounds alleging an "actual controversy" when standing alone might not be sufficient, if taken as a whole these circumstances establish a justiciable controversy with Novartis that can be resolved by allowing Teva to bring a declaratory judgment. First, Novartis listed its Famvir® patents in the Orange Book. By so doing, Novartis represents that "a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use or sale" of generic famciclovir covered by the claims of its listed Famvir® patents. 21 U.S.C. § 355(b)(1); see Pfizer, 395 F.3d at 1341 (Mayer, J., dissenting). While this conduct on its own may not be sufficient to establish an Article III controversy, it is a circumstance to be considered in determining whether a justiciable controversy exists under the totality of the circumstances. A second circumstance that supports Teva's claim of a justiciable controversy is Teva's submission of its ANDA certifying that it did not infringe Novartis' Famvir® Orange Book patents or that the patents

were invalid. The very act of submitting an ANDA is an act of infringement. 35 U.S.C. § 271(e)(2); see Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 678, 110 S.Ct. 2683, 110 L.Ed.2d 605 (1990) (holding that the statute creates an "act of infringement that consists of submitting an ANDA ... containing the fourth type of certification"). There is no question that under 35 U.S.C. § 271(e)(2), Novartis would have an immediate justiciable controversy against Teva as soon as Teva submitted the ANDA; indeed, that is exactly what occurred in this case. It logically follows that if such an action creates a justiciable controversy for one party, the same action should create a justiciable declaratory judgment controversy for the opposing party. In fact, the Supreme Court has stated: "It is immaterial that frequently, in the declaratory judgment suit, the positions of the parties in the conventional suit are reversed; the inquiry is the same in either case." Md. Cas. Co., 312 U.S. at 273, 61 S.Ct. 510. This conclusion is supported in the legislative history of the 2003 "civil action to obtain patent certainty" amendment to the Hatch-Waxman Act: [T]he Hatch-Waxman Act has always provided that patent owners and brand drug companies can bring patent infringement suits against a generic applicant immediately upon receiving notice that the generic applicant is challenging a patent [by filing an ANDA]. The [ANDA] declaratory judgment provisions ... simply level the playing field by making it clear that the generic applicant can also seek a prompt resolution of these patent issues by bringing a declaratory judgment action if [it is not sued] ... within 45 days. *8 149 Cong. Rec. S15885 (Nov. 25, 2003) (remarks of Sen. Kennedy, ranking member of the Senate HELP committee). A third circumstance we find relevant in determining whether Teva has established an actual controversy is the combination of three statutory provisions: 1) the "civil action to obtain patent certainty" under 21 U.S.C. § 355(j)(5)(C); 2) the ANDA declaratory judgment provision under 35 U.S.C § 271(e)(5); and 3) the purpose of the Hatch-Waxman Act. The "civil action to obtain patent certainty," which was enacted in 2003 is designed to prevent patentees from "gaming" the Hatch-Waxman Act.FN7 See 21 U.S.C. § 355(j)(5)(C). This amendment specifically permits an ANDA applicant to file a declaratory judgment action under 28 U.S.C. § 2201 against the patent owner or the brand-name drug company "for a declaratory judgment that the patent [listed in the Orange Book] is invalid or will not be infringed by

© 2007 Thomson/West. No Claim to Orig. U.S. Govt. Works.

Case 1:07-cv-00138-JJF

Document 15-5

Filed 05/03/2007

Page 13 of 17
Page 12

--- F.3d ------ F.3d ----, 2007 WL 942201 (C.A.Fed. (N.J.)), 82 U.S.P.Q.2d 1225 (Cite as: --- F.3d ----) the drug" covered by the ANDA if the patentee has not brought an infringement action within 45 days. Id. By virtue of 35 U.S.C § 271(e)(5), Congress extended federal court jurisdiction over these ANDA declaratory judgment actions "to the extent consistent with the Constitution." 35 U.S.C. § 271(e)(5). By filing a lawsuit on only one its five patents certified under paragraph IV in Teva's ANDA, Novartis has tried to simultaneously leverage the benefits provided to a patentee under the HatchWaxman Act and avoid the p