KPH HEALTHCARE SERVICES, INC. v. JANSSEN BIOTECH, INC.

CourtDistrict Court, D. New Jersey
DecidedOctober 8, 2021
Docket2:20-cv-05901
StatusUnknown

This text of KPH HEALTHCARE SERVICES, INC. v. JANSSEN BIOTECH, INC. (KPH HEALTHCARE SERVICES, INC. v. JANSSEN BIOTECH, INC.) is published on Counsel Stack Legal Research, covering District Court, D. New Jersey primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
KPH HEALTHCARE SERVICES, INC. v. JANSSEN BIOTECH, INC., (D.N.J. 2021).

Opinion

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY

KPH HEALTHCARE SERVICES, INC., A/K/A KINNEY DRUGS, INC., HEALTH DIRECT PHARMACY SERVICES, AND NOBLE HEALTH SERVICES, INDIVIDUALLY AND ON BEHALF OF ALL OTHERS SIMILARLY SITUATED, Civ. No. 20-cv-05901 (KM) (ESK) Plaintiff, OPINION v. JANSSEN BIOTECH, INC., JANSSEN ONCOLOGY, INC., JANSSEN RESEARCH & DEVELOPMENT, LLC, and BTG INTERNATIONAL LIMITED,

Defendants.

KEVIN MCNULTY, U.S.D.J.: To extend its time as the sole seller of profitable prostate cancer drug brand-named Zytiga, Janssen Biotech (“Janssen”), along with BTG International Limited (“BTG”), obtained a follow-on patent that was later invalidated. Now, KPH Healthcare Services (“KPH”), alleging that Janssen’s actions violated antitrust laws, seeks to represent a class of direct purchasers of Zytiga who allegedly overpaid for the drug during the period in which Janssen’s actions delayed the entrance of generic versions of Zytiga into the market. Defendants move to compel arbitration and stay this district court case. (DE 51.)1 For the following reasons, the motion to compel arbitration (DE

1 Certain citations to the record are abbreviated as follows: DE = docket entry in this case FAC = First Amended Complaint (DE 44) Mot. = Janssen’s brief in support of its motion to compel arbitration (DE 55) 51) is GRANTED, a second motion to dismiss the complaint (DE 56) is DENIED as moot, and the case is STAYED. I. BACKGROUND In 1997, BTG obtained a patent on a compound called “abiraterone acetate.” (FAC ¶ 91.) BTG licensed this patent to Cougar Biotechnology in 2004, and Cougar was purchased by Janssen in 2009. (Id. ¶ 92.) The compound is the key ingredient in Janssen’s drug Zytiga, which was approved by the FDA in 2011. (Id. ¶ 104.) Zytiga proved useful in the treatment of prostate cancer, and it earned Janssen billions of dollars in sales revenue. (Id. ¶ 7–8.) This first patent, however, was set to expire in 2016. (Id. ¶ 7.) The likely result would be generic competition and decreased profits for Janssen, so Janssen tried for years to find a way to delay that competition. Its initial attempts to obtain a new patent on the combined use of abiraterone and a steroid, prednisone, were repeatedly rejected by the United States Patent and Trademark Office (“PTO”) as obvious. (Id. ¶ 93–102, 105–110.) In 2013, Janssen was finally successful in obtaining a new patent, asserting arguments based, inter alia, on the commercial success of Zytiga. (Id. at ¶ 127–28.) Janssen, however, never disclosed to the PTO that Zytiga’s commercial success could be attributable to the blocking effect of a patent that forbade any other company from manufacturing and selling a drug that contained abiraterone acetate. (Id. at ¶ 126.) In 2015, a number of generic manufacturers filed Abbreviated New Drug Applications (“ANDAs”) with the FDA, claiming that Janssen’s new patent was invalid and that they should be able to sell generic versions of Zytiga when the first patent expired in 2016. (Id. ¶ 139–40.) Janssen, exercising its rights under the Hatch-Waxman Act, filed an infringement action against the generic manufacturers, triggering a 30-month stay of the approval of the ANDAs. (Id. ¶

Opp. = KPH’s brief in opposition to Janssen’s motion to compel arbitration (DE 63) 35, 141.)2 After extended litigation, both the Patent Trial and Appeal Board (“PTAB”) and this court determined that Janssen’s second patent was invalid for obviousness. (Id. ¶ 175–212.)3 That determination was upheld by the Federal Circuit (Id. ¶ 222–23).4 As a result of this extended litigation, KPH argues, Janssen invalidly and excessively delayed the entrance of generics into the market. (Id. ¶ 224–27.) As a result of the delay, direct purchasers paid much more for Zytiga than they would have paid for a generic substitute if generics had been available, as they should have been. (Id. ¶ 270, 277.) KPH alleges that Janssen’s actions violate the Sherman Act, 15 U.S.C. §§ 1–2, and seeks to represent a class of direct purchasers. KPH is not itself a direct purchaser of Zytiga but brings this case as the assignee of a direct purchaser, McKesson Corporation. (Id. ¶ 19; Mot. at 8–9.) As such, KPH “stands in the shoes” of McKesson in all relevant respects: it can only bring claims that McKesson could have brought and is bound by any restrictions that limited McKesson’s ability to sue. James Talcott, Inc. v. H. Corenzwit & Co., 76 N.J. 305, 309–10 (1978).5 Here, the relevant restriction is the dispute resolution clause included in McKesson’s Distribution Agreement with Janssen to distribute Zytiga and other Janssen drugs. (DE 54.) That clause reads in pertinent part as follows: In the event of a dispute arising between the parties regarding this Agreement and prior to commencement of escalated action set forth below, the parties shall attempt in good faith to amicably resolve such dispute by good faith settlement discussions…. In the event the above settlement discussions are ineffective, any controversy or claim arising out of or relating to this Agreement between the parties (including without limitation any controversy

2 The suit was BTG Int’l Ltd., et al., v. Amneal Pharmaceuticals LLC, et al., 15-cv- 5909 (D.N.J.). 3 BTG Int’l Ltd. v. Amneal Pharms. LLC, 352 F. Supp. 3d 352 (D.N.J. 2018). 4 BTG Int’l Ltd. v. Amneal Pharms. LLC, 923 F.3d 1063 (Fed. Cir. 2019). 5 The assignment agreement between McKesson and KPH specifically states that the assignment exists “only to the extent the cause of action arises from McKesson's purchase of Zytiga that were subsequently resold to Customer.” (DE 52 ¶ 1.) or claim relating to this Agreement involving the parent company, subsidiaries, or affiliates under common control of the Company or the Distributor (a “Dispute”)), shall first be submitted to mediation. … Any Dispute that cannot be resolved by mediation… shall be resolved by arbitration. (Id. §§ 4.16(a)-(b).)6 Defendants are currently litigating several related cases involving Zytiga. By order entered July 1, 2020, the briefing schedule in this case was tied to the appointment of class counsel and creation of a leadership structure in two related cases. (DE 23.)7 Class counsel was appointed and a leadership structure created on February 10, 2021. See Louisiana Health Serv. & Indem. Co. v. Janssen Biotech Inc., 2021 WL 486895 (D.N.J. Feb. 10, 2021). Thereafter, on February 22, 2021, KPH filed an amended complaint. (DE 44) On April 6, 2021, the defendants filed a joint motion to compel arbitration (DE 51) and a joint motion to dismiss the complaint (DE 56). KPH filed briefs in opposition to both motions on May 6, 2021 (DE 63, 64), and defendants filed replies on June 7, 2021 (DE 70, 71). II. STANDARD OF REVIEW AND GOVERNING LAW The threshold motion is the one to compel arbitration. “[W]hen it is clear on the face of the complaint that a validly formed and enforceable arbitration agreement exists and a party’s claim is subject to that agreement, a district court must compel arbitration under a Rule 12(b)(6) pleading standard . . . .” MZM Constr. Co. v. N.J. Bldg. Laborers Statewide Benefit Funds, 974 F.3d 386,

6 The Janssen Agreement requires that actual arbitration be preceded by an attempt to mediate the issues. Both parties, however, present the issue to the Court as one of arbitration simpliciter, and neither asks the Court to compel, or deny compulsion of, mediation, which at this point may be futile. As KPH, by bringing suit, jumped the gun on both mediation and arbitration, and neither side refers to mediation in its briefs, I treat the issue as waived. I take no position as to whether the arbitrator may or should require mediation. 7 Those cases are Louisiana Health Service & Indemnity Co., et al. v. Janssen Biotech, Inc., et al., No.

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