United States District Court, D. New Jersey
SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC. and BAUSCH & LOMB PHARMA HOLDINGS CORP., Plaintiffs,
METRICS, INC., COASTAL PHARMACEUTICALS, INC., MAYNE PHARMA GROUP LIMITED, and MAYNE PHARMA (USA), INC., Defendants
[Copyrighted Material Omitted]
For Plaintiffs: John F. Brenner, Esq., Melissa Anne Chuderewicz, Esq., PEPPER HAMILTON, LLP, PRINCETON, NJ; Bryan C. Diner, Esq., FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, Washington, DC.
For Defendants: Sandra A. Jeskie, Esq., DUANE MORRIS, LLP, Philadelphia, PA.
JEROME B. SIMANDLE, Chief United States District Judge.
This is a patent infringement action brought by Plaintiffs Senju Pharmaceutical Company, Bausch & Lomb, Inc., and its subsidiary, Bauch & Lomb Pharma Holdings Corp. Plaintiffs hold the rights to three patents for novel formulations of bromfenac, an active ingredient in Prolensa®, a drug that is used to treat patients who have undergone cataract surgery. Plaintiffs filed this case on June 20, 2014, alleging that Defendants infringed upon their patents by submitting Abbreviated New Drug Applications (" ANDAs" ) seeking FDA approval for the manufacture and sale of a bromfenac ophthalmic solution intended to be a generic of Prolensa®, in violation of 35 U.S.C. § 271(e)(2). The case was initially brought against four defendants: Metrics, Inc. (" Metrics" ), Coastal Pharmaceuticals, Inc. (" Coastal" ), Mayne Pharma Group Limited, and Mayne Pharma (USA), Inc. Only Metrics and Mayne Pharma Group Limited remain in this action.
Six days after plaintiffs filed their Complaint, Defendants filed for inter partes review of two of Plaintiff's patents before the Patent Trial and Appeal Board (" PTAB" ).
Presently before the Court is Defendants' motion to dismiss the Complaint for lack of personal jurisdiction, and Plaintiffs' motion to enjoin Defendants from proceeding in the parallel inter partes review process before the PTAB. The Court heard
oral argument on both claims and accepted supplemental briefing.
For the reasons that follow, the Court finds that it lacks general jurisdiction over Mayne Pharma Group Limited but will permit limited discovery as to specific jurisdiction. The Court finds that it has jurisdiction over Metrics and will deny Defendants' motion to dismiss with respect to Metrics. The Court will also deny Plaintiffs' motion to enjoin inter partes review before the PTAB.
A. Plaintiffs' patents and Defendants' ANDA application
Plaintiffs hold all substantial rights to three patents for novel formulations of bromfenac, an active ingredient in the ophthalmic drug Prolensa®, which is approved by the FDA for treatment of post-operative inflammation and reduction of pain in patients who have undergone cataract surgery. The patents are issued by the United States Patent and Trademark Office (" USTPO" ) under United States Patent Nos. 8,129,431 (" the '431 patent" ), 8,669,290 (" the '290 patent" ), and 8,754,131 (" the '131 patent" ).
On March 13, 2014, Defendant Metrics sent a letter to Plaintiffs stating that it had submitted an Abbreviated New Drug Application (" ANDA" ) with the Food and Drug Administration (" FDA" ) pursuant to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.A. § 355(j), for the manufacture and sale of a bromfenac ophthalmic solution intended to be a generic of Prolensa® . (Compl. [Docket Item 1] ¶ 20; Pls.' Mot. to Enjoin, Ex. 9.) The ANDA included a certification under § 355(j)(2)(A)(vii)(IV), known as a Paragraph IV Certification, claiming that Plaintiffs' '431 and '290 patents were " invalid or will not be infringed by the manufacture, use, or sale" of the new drug being submitted for FDA approval.
Plaintiffs then commenced this action for infringement on June 20, 2014, seeking an injunction to prevent the manufacture, use, import, and sale of defendants' generic, a judgment of infringement on the three patents, and declaratory relief. (Compl. at 10-11.)
B. Defendants' motion to dismiss for lack of personal jurisdiction
Defendant Mayne Pharma Group Limited is a corporation based in Australia; while Metrics, Coastal, and Mayne Pharma (USA), Inc. are subsidiaries of Mayne Pharma Group Limited (Compl. ¶ ¶ 4-7.)
Defendants moved to dismiss this case for lack of personal jurisdiction, arguing that the Court lacked jurisdiction over all Defendants. [Docket Item 30.] Following oral argument and upon agreement by both parties, the Court entered an Order dismissing Coastal from this action. Mayne Pharma (USA), Inc. was later also dismissed as a defendant in this case.
The remaining Defendants are Metrics, Inc. and Mayne Pharma Group Limited, the parent company.
Metrics, a wholly-owned subsidiary of Mayne Pharma Group Limited, is a corporation organized under the laws of North Carolina. (Compl. ¶ 4.) Metrics directly manufactures, markets, and sells generic drug products throughout the United States, including New Jersey. (Compl. ¶ 10.) According to Defendants, direct sales of products to New Jersey represented 4% of Metrics' overall U.S. product and service sales for the latest fiscal year. (First Cross Decl. [Docket Item 30-1] ¶ 15.) Although Metrics has no offices, facilities, or other real property in New Jersey, the company is registered to do business in New Jersey and employs one individual in the state who is solely associated with the business division of the company. (First Cross Decl. ¶ 8-14.)
Plaintiffs served Metrics with the Complaint pursuant to New Jersey Court Rule 4:4-4(a)(6), which provides for in personam jurisdiction over a corporate defendant by personal service within the state upon an authorized agent of the corporation. N.J. Ct. R. 4:4-4(a)(6). Defendant's registered agent in New Jersey, Corporation Trust Company, accepted service in West Trenton, New Jersey. (See Executed Summons [Docket Item 8].)
Plaintiffs argue that service upon a registered agent in the state established this Court's personal jurisdiction over Metrics. Defendants argue that service upon a registered agent did not automatically establish jurisdiction, and that Metrics' contacts as a whole are insufficient for either general or specific jurisdiction.
Defendant Mayne Pharma Group Limited, the parent company of Metrics, is an Australian corporation that manufactures, markets, and sells generic drug products around the world. (Compl. ¶ 6.) Defendant has no physical presence in New Jersey, nor does it have any employees in the state. Plaintiffs allege that Defendant's two corporate predecessors, Mayne Pharma Limited and Mayne Pharma Pty Ltd, have previously used a New Jersey address for professional licensure as a pharmaceutical manufacturer in 2006 and 2007. Plaintiffs attached business certificates to their opposition brief which showed that Mayne Pharma Limited and Mayne Pharma Pty Ltd previously had licenses associated with a Paramus, New Jersey address from approximately 2002 to 2007. (Pls.' Opp. Exs. 23, 24.)
In addition, Plaintiffs allege that three other corporate predecessors and subsidiaries of Defendant, namely Mayne Pharma Limited, F.H. Faulding & Co., and Mayne Pharma International Pty Ltd, filed 11 patent infringement actions in New Jersey over the course of 14 years. (Pls.' Opp. [Docket Item 50] 4, 7, 9; Pls.' Opp. Exs. 11-21.) Specifically, Plaintiffs allege that corporate predecessor F.H. Faulding & Co. previously filed two lawsuits in the District of New Jersey in 2000 and 2001 (Pls.' Opp. 7; id. Ex. 11, 12); subsidiary Mayne Pharma International Pty Ltd previously filed seven lawsuits in this district in the years 2008-2010 (Pls.' Opp. Exs. 13-19); and Mayne Pharma Limited, whose connection to Defendant is disputed, filed two counterclaims in this district in 2007. (Pls.' Opp. Exs. 20, 21.) None of the suits involve the patents at issue in this case.
Finally, Plaintiffs note that Defendants' active pharmaceutical ingredient supplier, Johnson-Matthey, is based out of West
Deptford, New Jersey. Defendants acknowledge that Johnson-Matthey supplies the active ingredient in the product that is the subject of this suit, but argue that the ingredients in this case were actually manufactured and shipped from Massachusetts. (Def. Supp. Letter of Oct. 17, 2014 [Docket Item 68]; Pls.' Supp. Letter of Oct. 15, 2014 [Docket Item 66], at *3; Pls.' Opp. 11; Def. Reply 12.)
C. Plaintiffs' motion to enjoin Defendants from participating in inter partes review
On March 13, 2014, Defendant Metrics sent a letter to Plaintiff Bausch & Lomb Inc. advising Plaintiff that Metrics had recently submitted an ANDA with the FDA with a Paragraph IV certification to Plaintiffs' '431 patent. Metrics stated that it expected ANDA filing acceptance shortly. (Pl. Mot. to Enjoin, Ex. 9 [Docket Item 10].)
Plaintiffs filed this patent infringement action on June 20, 2014. [Docket Item 1.] On June 26th, Defendants filed two petitions for inter partes review (" IPR" ) before the Patent Trial and Appeal Board (" PTAB" ) seeking a ruling on the validity of Plaintiff's '290 and '431 patents. One day later, on June 27th, Defendant Metrics provided a Notice Letter to Plaintiffs advising Plaintiffs that it had filed an ANDA for Prolensa® . The letter informed Plaintiffs that the ANDA included Paragraph IV Certifications to two of Plaintiffs' patents: the '431 patent and the '290 patent.
While Defendants' IPR petitions were pending, Plaintiffs moved for an injunction in this Court to prevent Defendants from participating in the inter partes review process. Plaintiffs argued that the " first-filed" rule requires this Court to decide the issue of infringement. Plaintiffs also argue that when defendants filed their ANDA, they " filed a civil action," under § 35 U.S.C. § 315(a)(1), which therefore prohibits them from filing a subsequent petition for inter partes review.
Defendants opposed Plaintiffs' motion, arguing that Plaintiffs' reading of § 315(a)(1) was not supported by the language of the statute; and that the Court lacks authority to entertain ...