IN RE CYCLOBENZAPRINE HYDROCHLORIDE, 09-2118.

Decision Date12 March 2010
Docket NumberNo. 09-2118.,09-2118.
PartiesIn re CYCLOBENZAPRINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULE PATENT LITIGATION.
CourtU.S. District Court — District of Delaware

William J. Marsden, Jr., Esquire, Susan Morrison Coletti, Esquire and Jennifer Lynn Hall, Esquire of Fish & Richardson P.C., Wilmington, DE, for Plaintiffs. Of Counsel: Duane-David Hough, Esquire, John D. Garretson, Esquire and John S. Goetz, Esquire of Fish & Richardson P.C., New York, NY, Jonathan E. Singer, Esquire of Fish & Richardson P.C., Minneapolis, MN. Of Counsel for Plaintiff Eurand, Inc.: Jessica Wolff, Esquire of Cooley Godward Kronish LLP, San Diego, CA, Richard S. Sanders, Esquire of Cooley Godward Kronish LLP, Boston, MA, Tryn T. Stimart, Esquire of Cooley Godward Kronish LLP, Washington, D.C.

Richard L. Horwitz, Esquire, David E. Moore, Esquire and D. Fon Muttamara-Walker, Esquire of Potter Anderson & Corroon, LLP, Wilmington, DE, for Defendants Mylan Inc. and Mylan Pharmaceuticals Inc. Of Counsel: James H. Wallace, Jr., Esquire, Mark A. Pacella, Esquire and Brian H. Pandya, Esquire of Wiley Rein LLP, Washington, D.C.

Brian E. Farnan, Esquire and John C. Phillips, Jr., Esquire of Phillips, Goldman & Spence, PA, Wilmington, DE, for Defendant Barr Laboratories Inc. Of Counsel: George C. Lombardi, Esquire, Julia M. Johnson, Esquire and Maureen L. Rurka, Esquire of Winston & Strawn LLP, Chicago, IL.

Joseph Scott Shannon, Esquire and Artemio C. Aranilla, Esquire of Marshall Dennehey Warner Coleman & Goggin, Wilmington, DE, for Defendants Anchen Pharmaceuticals, Inc. and Anchen, Inc. Of Counsel: Don J, Mizerk, Esquire and Julie A. Katz, Esquire of Husch Blackwell Sanders Welsh & Katz, Chicago, IL.

MEMORANDUM OPINION

SUE L. ROBINSON, District Judge.

I. INTRODUCTION

The dispute at bar in this consolidated patent infringement action concerns the submission of an Abbreviated New Drug Application ("the ANDA"),1 and amendment thereto, by Anchen Pharmaceuticals, Inc. ("Anchen Pharmaceuticals") to manufacture and sell generic versions of AMRIX® (cyclobenzaprine hydrochloride extended-release capsules) ("the ANDA products"), a skeletal muscle relaxant proprietary to plaintiffs Eurand, Inc. ("Eurand") and Anesta AG ("Anesta") (collectively, "plaintiffs").2 In response to the ANDA, plaintiffs filed a suit against defendants Anchen Pharmaceuticals and Anchen, Inc. ("Anchen Holding") (collectively, "defendants") on July 7, 2009 for infringement of U.S. Patent No. 7,387,793 ("the `793 patent"). (D.I. 1)3 Anchen Pharmaceuticals subsequently amended the ANDA, resulting in plaintiffs' second complaint against defendants, filed on September 9, 2009 and alleging the infringement of U.S. Patent No. 7,544,372 ("the `372 patent"). (Civ. No. 09-715-SLR, D.I. 1)

Pending before the court are defendants' motions to dismiss. Anchen Holding moves to dismiss this action for lack of subject matter jurisdiction pursuant to Fed.R.Civ.P. 12(b)(1) and for failure to state a claim pursuant to Fed.R.Civ.P. 12(b)(6). (D.I. 10; Civ. No. 09-715-SLR, D.I. 11) Anchen Pharmaceuticals likewise moves to dismiss for lack of subject matter jurisdiction and for failure to state a claim, as well as for lack of personal jurisdiction under Fed.R.Civ.P. 12(b)(2) and improper venue under Fed.R.Civ.P. 12(b)(3). (D.I. 12; Civ. No. 09-715-SLR, D.I. 11) The court has jurisdiction pursuant to 28 U.S.C. § 1338(a). For the reasons that follow, the court grants in part and denies in part the motions.

II. BACKGROUND
A. The Parties and Patents-in-Suit

Eurand, a Nevada corporation with a principal place of business located in Ohio, owns all title and interest in the 793 patent and the `372 patent (collectively, "the Eurand patents"). (Civ. No. 09-715-SLR, D.I. 1 at ¶¶ 16, 19) Eurand is engaged in the development, manufacture and commercialization of pharmaceutical and biopharmaceutical products. Anesta, a Swiss corporation having a principal place of business in Switzerland, is a wholly owned subsidiary of Cephalon.4 Anesta obtained exclusive licenses to the Eurand patents pursuant to an Asset Purchase Agreement ("APA"). (Id. at ¶¶ 17, 20) The APA also transferred to Anesta all title and interest in approved New Drug Application ("NDA") No. 21-777 for cyclobenzaprine hydrochloride extended-release capsules in 15 mg and 30 mg doses, both sold under the tradename AMRIX ®. (Id. at ¶ 17) The Orange Book of the Food and Drug Administration ("FDA") lists, inter alia, the Eurand patents as the unexpired patents associated with AMRIX ®. (Id. at 22) AMRIX® is a muscle relaxant whose dosage form allows for the treatment of muscle spasms with a single daily dose. (D.I. 22, ex. 2)

Anchen Pharmaceuticals is a California corporation with a principal place of business in Irvine, California. (D.I. 1 at ¶ 5) The business of Anchen Pharmaceuticals is focused on the development and commercialization of extended release and niche generic products. Anchen Pharmaceuticals distributes these products throughout the United States, including the State of Delaware. Anchen Holding is a corporation organized and existing under the laws of the State of Delaware, with a principal place of business in Irvine, California. (Id. at ¶ 6) It is alleged that Anchen Holding has sold millions of dollars worth of pharmaceutical products within the United States generally, and the State of Delaware specifically, under its stylized "Anchen" trademark (serial no. 77037779). (Id., exs. B, C)

While the pleadings do not specify the exact business relationship between Anchen Pharmaceuticals and Anchen Holding, the two entities share senior corporate officers, including Margaret Choy ("Ms. Choy"), Senior Vice President of Regulatory Affairs. (Id. at ¶ 7) Plaintiffs allege that defendants closely coordinate commercial activities and hold themselves out to the marketplace as one company. (Id.) For example, during prosecution of Anchen Pharmaceuticals' trademark application for the work mark ANCHEN (serial no. 77051871), representatives for Anchen Pharmaceuticals stated that "Anchen Pharmaceuticals, Inc. and Anchen Holding, through separate legal entities, constitute a single source to the relevant public, and there is unity of control with respect to the nature and quality of the goods." (Id.)

B. The ANDA and the Instant Suit

On May 29, 2009, Anesta (through Cephalon) received a letter dated May 28, 2009 from Anchen Pharmaceuticals regarding the ANDA. (Id. at ¶ 23) Eurand received the same notification letter on or about June 3, 2009 ("the first notification letters"). (Id. at ¶ 22) In the first notification letters, Anchen Pharmaceuticals stated its intent to engage in the commercial manufacture, use or sale of a generic equivalent of AMRIX® prior to the expiration of the 793 patent. (D.I. 22, ex. 3) Anchen Pharmaceuticals further alleged that the 793 patent was invalid, unenforceable, or would not be infringed by the ANDA products, and that it had certified as such to the FDA ("Paragraph IV Certification").5 (Id.) Ms. Choy is designated by the first notification letters as the contact person in connection with the Paragraph IV Certification. (D.I. 1 at ¶ 7) Plaintiffs have acknowledged Anchen Pharmaceuticals' offer of access to the confidential information contained in the ANDA ("the offer of access"), but have declined to accept in light of allegedly unreasonable terms and conditions Anchen Pharmaceuticals has placed upon the receipt of this information.6 (Id. at ¶ 26)

On July 7, 2009, after negotiations in connection with the offer of access faltered, and within the requisite 45-day period, plaintiffs filed Civ. No. 09-492-SLR pursuant to 35 U.S.C. § 271(e)(2)(A). This suit triggered a 30-month stay on the FDA's approval of the ANDA. See 21 U.S.C. 355(j)(5)(B)(iii).

Plaintiffs subsequently received a second set of notification letters from Anchen Pharmaceuticals on August 13, 2009, which provided notification of an amendment to the ANDA ("the second notification letters"). (Civ. No. 09-715-SLR, D.I. 17, ex. 3) In the second notification letters, Anchen Pharmaceuticals alleged that the claims of the '372 patent are invalid, unenforceable and/or will not be infringed by the ANDA products. (Id.) On September 23, 2009, plaintiffs instituted Civ. No. 09-715-SLR against defendants, alleging that defendants infringed the '372 patent by submitting the amended ANDA to the FDA, and that defendants will continue to infringe the '372 through the manufacture, marketing and/or sale of the ANDA products. (Civ. No. 09-715-SLR, D.I. 1)

III. STANDARD OF REVIEW

In reviewing a motion filed under Rule 12(b)(1), the court must first identify whether the motion presents a facial or factual challenge to the court's subject matter jurisdiction. See Samsung Elecs. Co., Ltd. v. ON Semiconductor Corp., 541 F.Supp.2d 645, 648 (D.Del.2008). Where the movant presents a facial challenge, the court must accept all factual allegations in the complaint as true and may only consider the complaint and documents referenced therein or attached thereto. Id. (citing Gould Elecs., Inc. v. United States, 220 F.3d 169, 176 (3d Cir.2000)). Where the movant presents a factual challenge, the court need not confine its consideration to the allegations of the complaint nor accept those allegations as true. Mortensen v. First Fed. Sav. & Loan, 549 F.2d 884, 891 (3d Cir.1977). Rather, the court may consider evidence outside the pleadings, including affidavits, depositions, and testimony, "to resolve any factual issues bearing on jurisdiction."7Samsung, 541 F.Supp.2d at 648 (citing Gotha v. United States, 115 F.3d 176, 179 (3d Cir.1997)). "Plaintiff bears the burden of proving that subject matter jurisdiction exists." Id.

In reviewing a motion filed under Rule 12(b)(2), the court must accept all of a plaintiffs allegations as true and construe disputed facts in the plaintiffs favor. Pinker v. Roche Holdings Ltd., 292 F.3d 361, 368 (3d Cir.2002) (quoting ...

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