In re Remicade Antitrust Litig.

345 F. Supp. 3d 566
CourtDistrict Court, E.D. Pennsylvania
DecidedDecember 4, 2018
DocketCIVIL ACTION No. 17-cv-04326; No. 18-cv-00303
StatusPublished
Cited by11 cases

This text of 345 F. Supp. 3d 566 (In re Remicade Antitrust Litig.) is published on Counsel Stack Legal Research, covering District Court, E.D. Pennsylvania primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In re Remicade Antitrust Litig., 345 F. Supp. 3d 566 (E.D. Pa. 2018).

Opinion

Joyner, District Judge

Before the Court are Defendants' Johnson & Johnson and Janssen Biotech, Inc. (collectively "Janssen") ("J & J") Motion to Dismiss for failure to state a claim under Fed. R. Civ. P. 12(b)(6) (Doc. No. 67-1), Indirect and Direct Purchaser Plaintiffs' Joint Opposition thereto (Doc. No. 73), and Defendants' Reply in Support thereof (Doc. No. 75).

I. Background

This case arises from an antitrust action brought by Direct and Indirect Purchasers of Defendants' drug Remicade, against Johnson & Johnson, along with its wholly owned subsidiary, Janssen Biotech, Inc. (collectively, "J & J"), alleging artificially inflated prices and monopolization of the pharmaceutical market for biologic infliximab drugs. The Direct and Indirect Purchasers' principle claim is that J & J undertook an anticompetitive scheme, consisting of exclusive agreements and coercive bundled rebates, to foreclose competition posed by biosimilar versions of Remicade, specifically Pfizer's Inflectra and Merck's Renflexis. The scheme allegedly caused providers and insurers to pay overcharges for infliximab products that they would not have paid absent J & J's anticompetitive conduct.

Under consideration is J & J's Motion to Dismiss the Indirect Purchasers' Consolidated Amended Complaint and to Dismiss *574the Amended Direct Purchaser Class Action Complaint for failure to state a claim under Fed. R. Civ. P. 12(b)(6) (Doc. No. 67-1). This Motion is fully briefed and ripe for the Court's adjudication. The Court has considered the parties' submissions and decides this matter without oral argument. Fed. R. Civ. P. 78 ; Loc. R. Civ. P. 7.1(f).

II. Alleged Facts

This case arises from essentially the same facts that have been described in detail in this Court's related decision denying Defendants J & J's motion to dismiss Pfizer's complaint alleging federal antitrust violations. Pfizer Inc. v. Johnson & Johnson, 333 F.Supp.3d 494 (E.D. Pa. 2018) ; Doc. No. 58). For the purposes of considering Defendants' motion, we will summarize facts relevant to Indirect and Direct Purchaser Plaintiffs' claims.1

The medications at the center of this litigation are biologic infliximab products, used as treatment for maintaining chronic auto-immune inflammatory conditions. Dir. AC ¶ 2, ¶ 41. Infliximab products cannot be taken orally and are only administered intravenously, generally by an in-office health care provider. Id. at ¶ 5. J & J's drug Remicade was the first biologic infliximab to enter the market in 1998. Ind. CAC ¶ 21. In 2009, Congress enacted the Biologic Price Competition and Innovation Act (BPCIA), an analog to the shortcut for FDA approval that the Hatch-Waxman amendments provide for chemically synthesized medications. Dir. AC ¶ 8-9. To attain approval as a "biosimilar" under the BPCIA, a manufacturer must demonstrate that "there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity and potency." Ind. CAC ¶ 38. Once J & J's patent on Remicade expired in 2016, the FDA approved three other medications including Pfizer's Inflectra and Merck's Renflexis. Dir. AC ¶ 16-19, Ind. CAC ¶ 4. Competition from the introduction of biosimilars into the infliximab market was expected to lower prices for potentially lifesaving biologic medications that otherwise might have been unaffordable for some patients.2 Dir. AC ¶ 14, ¶ 20.

The Direct and Indirect Purchaser Plaintiffs argue that insurance coverage is key to biologic infusion products like infliximab because treatment is so expensive that most patients will not be able to pay out of pocket. Id. at ¶ 54. Therefore, infliximab products are either reimbursed by insurance companies, or they are paid for by health care providers who administer the drug through a "buy and bill" system where they pay upfront for the drug then bill an insurer or third-party payor for reimbursement. Id. at ¶ 57. Plaintiffs argue that this system incentivizes providers to choose a biologic that is "widely covered by insurance" to avoid the risk that their reimbursement claim could be denied. Id. at ¶ 58, ¶ 60.

Defendants' Biosimilar Readiness Plan

1. Exclusive agreements

Plaintiffs allege that Defendants' exclusive contracts with insurers block biosimilar *575competition in more than one way. Ind. CAC ¶ 47, 48. Some contracts require insurers to deny coverage for biosimilars altogether. Other contractual preconditions effectively preclude biosimilar competition. For example, the "fail first" exception, under which providers cannot choose a biosimilar unless a patient has first failed to respond to treatment with Remicade. Dir. AC ¶ 23.

2. Bundled rebates

J & J allegedly uses bundled rebates as leverage over insurers by threatening a rebate penalty in "many millions of dollar[s] annually" if insurers do not enter contracts that foreclose them from reimbursing competitor biosimilars. Dir. AC ¶ 76. First, J & J engages in multi-product bundling, linking rebates for Remicade to other J & J drugs and medical devices that their competitors do not offer. Through this "portfolio approach," "insurers and providers that refuse to grant exclusivity to Remicade would be forced to pay higher prices or forego enhanced rebates on multiple J & J products." Id. at ¶ 84.

Second, J & J also bundles demand from "contestable" patients (new users of infliximab or those who have switched to a biosimilar product) and "incontestable" patients (those "already controlling their chronic conditions with Remicade are less likely to switch to a lower-priced biosimilar."). Id. at ¶ 77. J & J's contracts threaten to deny rebates "on allRemicade prescriptions if anyinfliximab biosimilar prescriptions are reimbursed." Id. at ¶ 79. Plaintiffs call this the "rebate trap." Id. at ¶ 80, ¶ 139.

3. Anticompetitive Effects

Pricing data, insurance coverage, and overpayment are among the anticompetitive effects of Defendants' plan. Although Pfizer's Inflectra and Merck's Renflexis entered the market with WAC's (Wholesale Acquisition Cost or list price) at up to a 35% discount to Remicade, Remicade's WAC has increased since Pfizer and Renflexis entered the market in 2016 and 2017. Notably, J & J "still has over a 90% market share." Id. at ¶ 102.

Additionally, Plaintiffs show evidence that "between 2007 and 2017, Remicade's Average Sales Price ("ASP") increased more than 62 percent. Despite Remicade's price hikes, unit sales of Remicade have actually grown 15 percent...from 2012 to 2016." Ind. CAC. ¶ 109. Providers, seeking to avoid rebate penalties, allegedly choose not to stock Inflectra even when it is covered by Medicare and other government programs,

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345 F. Supp. 3d 566, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-remicade-antitrust-litig-paed-2018.