Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Teva Pharmaceutical Industries Ltd. v. AstraZeneca Pharmaceuticals

August 24, 2009

TEVA PHARMACEUTICAL INDUSTRIES LTD., PLAINTIFF,
v.
ASTRAZENECA PHARMACEUTICALS LP AND IPR PHARMACEUTICALS, INC., DEFENDANTS.



The opinion of the court was delivered by: Yohn, J.

Memorandum

Plaintiff Teva Pharmaceutical Industries Ltd. ("Teva") brings this patent infringement action against defendants AstraZeneca Pharmaceuticals, LP ("AZLP") and IPR Pharmaceuticals, Inc. ("IPR").*fn1 Presently before the court is defendants' motion to transfer venue, pursuant to 28 U.S.C. § 1404(a), to the District of Delaware. For the reasons discussed below, the court will deny the motion.

I. Facts and Procedural History

Teva is an Israeli corporation with its principal place of business in Israel. (Compl. ¶ 4.) Teva has an American subsidiary, Teva Pharmaceuticals USA, Inc. ("Teva USA"), which is a Delaware corporation with its principal place of business in this judicial district. (Defs.' Mem. Law Supp. Mot. Transfer Venue ("Defs.' Venue Mem.") at 8.) Teva USA is not a party to this lawsuit. Teva owns United States Patent No. RE 39,502 (the "'502 Patent"), entitled "Stable Pharmaceutical Compositions containing 7-Substituted-3,5-Dihydroxyheptanoic Acids or 7-Substituted-3,5-Dihydroxyheptenoic Acids," which was reissued by the United States Patent and Trademark Office on March 6, 2007. U.S. Patent No. RE 39,502 (filed Mar. 17, 2005). The '502 Patent contains 55 claims and covers certain compositions of statins*fn2 that are stabilized to prevent degradation over time.*fn3 (Compl. ¶¶ 11-12, Ex. A.) Plaintiff claims the invention disclosed in the '502 Patent comprises pharmaceutical formulations of statins combined with "a stabilizing effective amount of at least one amido-group containing polymeric compound or at least one amino-group containing polymeric compound, or combination thereof." '502 Patent col.16 ll.28-31. The claimed formulations do not contain a stabilizing amount of other stabilizers, id. col.16 ll.31-34, but may contain "at least one pharmaceutically acceptable excipient*fn4 selected from the group consisting of a lubricant, a glidant, a binder, a filler, a disintegrant, a diluent, a carrier, a colorant, a coating material, and a preservative," id. col.18 ll.60-64. Thus, while not claiming any particular active drug compound, the '502 Patent claims certain stabilized formulations of statins.

Defendant AZLP is a Delaware Corporation with its principal place of business in Delaware. (Comp. ¶ 5; Defs.' Venue Mem. at 8.) AZLP maintains a "business center" in this judicial district. (Id. ¶ 10; Answers of AZLP and IPR ¶ 10; see also Pl.'s Opp'n Defs.' Mot. Transfer Venue ("Pl.'s Venue Resp.") at 4.) Defendant IPR is a Puerto Rican corporation with its principal place of business in Puerto Rico. (Compl. ¶ 8; Defs.' Venue Mem. at 8.) AZLP and IPR are sister corporations, sharing a common parent, AstraZeneca PLC, a British corporation. (Id. ¶ 9.) IPR manufactures-and holds the approved New Drug Application*fn5 ("NDA") No. 21-366 for-Crestor in 5, 10, 20, and 40 mg dosages. (Compl. ¶¶ 13-15.) Crestor (the active ingredient of which has the generic name rosuvastatin calcium) is a statin, (id. ¶ 14; Defs.'s Venue Mem. at 9), and AZLP markets, distributes, and sells Crestor in the United States, (Compl. ¶ 15; Answers of AZLP and IPR ¶ 15; Defs.' Venue Mem. at 8). Plaintiff alleges that Crestor, as currently formulated and sold, infringes the '502 Patent. (Compl. ¶¶ 15-16.) Accordingly, plaintiff brings the present infringement suit.

On December 11, 2007, AZLP, IPR, AstraZeneca UK Ltd., and Shionogi Seiyaku Kabushiki Kaisha*fn6 (collectively, "ANDA plaintiffs") filed suit (the "ANDA action") against several generic drug manufacturers ("ANDA defendants"), alleging that the ANDA defendants infringed upon U.S. Patent No. RE 37,314 (the "'314 Patent"). (Defs.' Venue Mem. at 9.) The ANDA plaintiffs added Teva USA as a defendant to the ANDA action in July 2008. (Id.) The ANDA action is a multi-district litigation consolidated in the District of Delaware now involving at least eight defendants, captioned In re: Rosuvastatin Calcium Patent Litigation, 08-1949 (D. Del.). (See Defs.' Venue Mem. Ex. 10.)*fn7 The '314 Patent, entitled "Pyrimidine Derivatives," covers rosuvastatin calcium, the active ingredient in Crestor. (Id. at 9; see also id. Ex. 9.) In the ANDA action, ANDA plaintiffs allege that ANDA defendants infringed the '314 Patent when they filed Abbreviated New Drug Applications*fn8 ("ANDAs") to market generic rosuvastatin calcium. (Id. at 9.) When filing their ANDAs, ANDA defendants certified that at least one of ANDA plaintiffs' patents was invalid or would not be infringed by the generic rosuvastatin calcium that ANDA defendants seek to market. (See Defs.' Venue Mem. Ex. 1.) Congress has defined such an application, if erroneous, as an act of infringement, enabling patent holders to file suit against would-be generic manufacturers; however, only limited remedies are available to patent holders in such suits. 35 U.S.C. § 271(e). This type of infringement, consisting "of submitting an ANDA containing a certification . . . that a listed patent is invalid or that the manufacture, sale, or use of the proposed product would not infringe that patent" has come to be known as an "artificial act of infringement." Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1358 (Fed. Cir. 2003); see Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 675-78 (1990) (explaining the relevant statutory regime and discussing "the creation of a highly artificial act of infringement that consists of submitting an ANDA . . . that is in error as to whether commercial manufacture, use, or sale of the new drug (none of which, of course, has actually occurred) violates the relevant patent").*fn9

II. Discussion

Under 28 U.S.C. § 1404(a), "[f]or the convenience of parties and witnesses, in the interest of justice, a district court may transfer any civil action to any other district or division where it might have been brought." The decision to grant a motion for a transfer of venue lies within the discretion of the district court, but "the plaintiff's choice of venue should not be lightly disturbed." Jumara v. State Farm Ins. Co., 55 F.3d 873, 879 (3d Cir. 1995); see also Shutte v. ARMCO Steel Corp., 431 F.2d 22, 25 (3d Cir. 1970) (reminding that "plaintiff's choice of a proper forum is a paramount consideration in any determination of a transfer request"). The defendant bears the burden of proving that venue is proper in the transferee district and that convenience and justice would be served by transferring the action to another district. Jumara, 55 F.3d at 879. "There is nothing . . . in the language or policy of § 1404(a) to justify its use by defendants to defeat the advantages accruing to plaintiffs who have chosen a forum which, although it was inconvenient, was a proper venue." Van Dusen v. Barrack, 376 U.S. 612, 633-34 (1964); see also Shutte, 431 F.2d at 25 (reasoning that "unless the balance of convenience of the parties is strongly in favor of defendant, the plaintiff's choice of forum should prevail." (emphasis in Shutte; internal quotation omitted)).

The Third Circuit*fn10 has enumerated several public and private factors for district courts to consider when determining whether to grant a motion for a transfer of venue. Jumara, 55 F.3d at 879. The private interests include: (1) plaintiff's choice of forum; (2) defendant's choice of forum; (3) where the claim arose; (4) "the convenience of the parties as indicated by their relative physical and financial condition"; (5) "the convenience of the witnesses-but only to the extent that the witnesses may actually be unavailable for trial in one of the fora"; and (6) "the location of the books and records (similarly limited to the extent that the files could not be produced in the alternative forum)." Id. The public interests include: (1) "the enforceability of the judgment"; (2) "practical considerations that could make the trial easy, expeditious, or inexpensive"; (3) "the relative administrative difficulty in the two fora resulting from court congestion"; (4) "the local interest in deciding local controversies at home"; (5) "the public policies of the fora"; and (6) judicial familiarity "with the applicable state law in diversity cases."

Id. at 879-80. While examining these factors, courts must be mindful that the plaintiff's choice of forum deserves great weight. Id.

The court must first consider whether venue is proper in the District of Delaware, where defendants seek to have this case transferred-that is, whether the action "might have been brought" in the District of Delaware. Pursuant to 28 U.S.C. § 1400(b), "[a]ny civil action for patent infringement may be brought in the judicial district where the defendant resides, or where the defendant has committed acts of infringement and has a regular and established place of business." Crestor products with formulations allegedly infringing the '502 Patent are sold nationwide, and AZLP is a Delaware corporation with its principal place of business in Delaware. Undisputedly, the District of Delaware is a proper venue for this action as to AZLP.

As to IPR, however, the record does not include sufficient information from which the court could conclude whether venue would be proper in the District of Delaware. Section 1400(b) provides two tests under which, if either is satisfied, venue is proper in patent infringement cases. Under those tests, venue is proper (1) "in the judicial district where the defendant resides" or (2) "where the defendant has committed acts of infringement and has a regular and established place of business." (emphasis added). IPR has failed to show Delaware would be a proper venue under either§ 1400(b) test. First, the record does not establish that IPR passes the § 1400(b) residency test. Regarding the residency of corporations, 28 U.S.C. § 1391(c) states, in relevant part:

For purposes of venue under this chapter, a defendant that is a corporation shall be deemed to reside in any judicial district in which it is subject to personal jurisdiction at the time the action is commenced.

In arguing for transfer to the District of Delaware, defendants made no attempt to establish that IPR is subject to personal jurisdiction in Delaware.*fn11 Thus, the court cannot determine whether venue would be proper in Delaware under the first § 1400(b) test.*fn12 For the reasons discussed below, however, even assuming IPR ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.