Pfizer Inc. v. Johnson & Johnson & Janssen Biotech, Inc.
Opinion
Joyner, District Judge
Before the Court are Defendants' Motion to Dismiss (Doc. No. 27) and Corrected Memorandum in Support thereof (Doc. No. 31), Plaintiff's Response in Opposition thereto (Doc. No. 42), Defendants' Reply in Support thereof (Doc. No. 48), and Plaintiff's Notice of Supplemental Authority (Doc. No. 54). We deny Defendants' Motion for the following reasons.
I. BACKGROUND
This case arises from an antitrust action brought by Pfizer, Inc. ("Pfizer") against Johnson & Johnson, along with its wholly *497owned subsidiary, Janssen Biotech, Inc. (collectively, "J & J"), for allegedly anticompetitive practices in the pharmaceutical market for infliximab products. The practices at issue are embodied by exclusive agreements and bundled rebates. Pfizer's principal claim is that J & J violated federal antitrust laws by engaging in anticompetitive behavior to shield Remicade from competition posed by Pfizer's biosimilar, Inflectra.
Under consideration is J & J's Motion to Dismiss Pfizer's Complaint for failure to state a claim under Fed. R. Civ. P. 12(b)(6). 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 FACTS1
The subject medications in this litigation are J & J's Remicade and Pfizer's Inflectra. Both are branded forms of infliximab, which is a biologic drug used to treat a range of immune-mediated diseases. Compl. ¶ 35. Biologics are relatively new medications to the pharmaceutical market, and their unique qualities are relevant to our decision.
Biologic medications, such as infliximab, are complex mixtures derived from living systems. Id. ¶ 28. Biologics stand in contrast to more common drugs that are chemically synthesized and whose structure is known. Id. Therefore, the composition of biologics are not easily identified or characterized. Id. This makes biologic medications difficult to replicate and produce in generic form. Id.
The emergence of biologics prompted Congress to enact the Biologic Price Competition and Innovation Act ("BPCIA"). Id. ¶ 31. The BPCIA provides an abbreviated regulatory approval pathway for the introduction of drugs that are biosimilar to a biologic, similar to the abbreviated approval process for generic drugs under the Hatch-Waxman Act. Id. ¶ 33. To prove that an applicant drug is biosimilar to an originator product, the applicant must show that it is "highly similar to the [originator] notwithstanding minor differences in clinically inactive components" and that "there are no clinically meaningful differences between the [proposed biosimilar] and the [originator] in terms of safety, purity, and potency." Id. (quoting
One important difference between biosimilars approved under the BPCIA and generic medications approved under the Hatch-Waxman Act is that biosimilars are not automatically substitutable with the originator biologic.
With this in mind, we turn to the competing products in this case. J & J introduced the first infliximab product under the brand name Remicade in the United States in 1999.
Pfizer brought Inflectra to market in 2016 after it received FDA approval as the first biosimilar to Remicade.
Remicade and Inflectra are administered intravenously at an institutional setting, such as a clinic or hospital.
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Joyner, District Judge
Before the Court are Defendants' Motion to Dismiss (Doc. No. 27) and Corrected Memorandum in Support thereof (Doc. No. 31), Plaintiff's Response in Opposition thereto (Doc. No. 42), Defendants' Reply in Support thereof (Doc. No. 48), and Plaintiff's Notice of Supplemental Authority (Doc. No. 54). We deny Defendants' Motion for the following reasons.
I. BACKGROUND
This case arises from an antitrust action brought by Pfizer, Inc. ("Pfizer") against Johnson & Johnson, along with its wholly *497owned subsidiary, Janssen Biotech, Inc. (collectively, "J & J"), for allegedly anticompetitive practices in the pharmaceutical market for infliximab products. The practices at issue are embodied by exclusive agreements and bundled rebates. Pfizer's principal claim is that J & J violated federal antitrust laws by engaging in anticompetitive behavior to shield Remicade from competition posed by Pfizer's biosimilar, Inflectra.
Under consideration is J & J's Motion to Dismiss Pfizer's Complaint for failure to state a claim under Fed. R. Civ. P. 12(b)(6). 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 FACTS1
The subject medications in this litigation are J & J's Remicade and Pfizer's Inflectra. Both are branded forms of infliximab, which is a biologic drug used to treat a range of immune-mediated diseases. Compl. ¶ 35. Biologics are relatively new medications to the pharmaceutical market, and their unique qualities are relevant to our decision.
Biologic medications, such as infliximab, are complex mixtures derived from living systems. Id. ¶ 28. Biologics stand in contrast to more common drugs that are chemically synthesized and whose structure is known. Id. Therefore, the composition of biologics are not easily identified or characterized. Id. This makes biologic medications difficult to replicate and produce in generic form. Id.
The emergence of biologics prompted Congress to enact the Biologic Price Competition and Innovation Act ("BPCIA"). Id. ¶ 31. The BPCIA provides an abbreviated regulatory approval pathway for the introduction of drugs that are biosimilar to a biologic, similar to the abbreviated approval process for generic drugs under the Hatch-Waxman Act. Id. ¶ 33. To prove that an applicant drug is biosimilar to an originator product, the applicant must show that it is "highly similar to the [originator] notwithstanding minor differences in clinically inactive components" and that "there are no clinically meaningful differences between the [proposed biosimilar] and the [originator] in terms of safety, purity, and potency." Id. (quoting
One important difference between biosimilars approved under the BPCIA and generic medications approved under the Hatch-Waxman Act is that biosimilars are not automatically substitutable with the originator biologic.
With this in mind, we turn to the competing products in this case. J & J introduced the first infliximab product under the brand name Remicade in the United States in 1999.
Pfizer brought Inflectra to market in 2016 after it received FDA approval as the first biosimilar to Remicade.
Remicade and Inflectra are administered intravenously at an institutional setting, such as a clinic or hospital.
Within weeks of Inflectra's launch in 2016, J & J began to deploy its "Biosimilar Readiness Plan."
Exclusive Contracts. A key component of J & J's scheme was to secure contractual commitments from commercial insurance companies to exclude biosimilars from coverage under their plans, thereby making Remicade the exclusive infliximab available to patients covered under those plans.
Bundled Rebates and Multi-Product Bundling. Pfizer also alleges that J & J has forced insurers into accepting exclusive contracts by introducing a rebate program that would provide savings off Remicade's increasing list price for all existing Remicade patients.
Pfizer posits that the force of J & J's "all-or-nothing" rebate program is effective *499because it bundles the base of existing Remicade patients with new patients entering the infliximab market.
Beyond bundling contestable and incontestable patients, J & J has also bundled rebates across multiple products.
Pfizer claims that Inflectra's exclusion from coverage by most insurers results in an even greater foreclosure than just the patients covered by those insurers.
Pfizer claims that J & J's multi-faceted approach to control the infliximab market has foreclosed it from competing. Pfizer alleges that it continues to offer "a significantly lower price for Inflectra unit-for-unit."
As a result of J & J's exclusionary contracting scheme, and despite Pfizer's efforts to compete, Remicade's price continues to rise.
As a result of J & J's anticompetitive conduct, Pfizer claims that it has been foreclosed from competing for at least 70 percent of all commercially insured patients in the United States. Compl. ¶ 8. The spillover effect that J & J's scheme *500causes on providers' purchasing decisions has led 90 percent of provider account stocking no Inflectra at all.
Pfizer points out that it is not the only one harmed as a result of J & J's exclusionary conduct.
III. LEGAL STANDARD
Fed. R. Civ. P. 8(a)(2) requires that a complaint contain "a short and plain statement of the claim showing that the pleader is entitled to relief." Plaintiffs are not required to provide detailed factual allegations in their complaint, though they must do more than merely state legal conclusions and formulaic recitations of the elements of the cause of action. Ashcroft v. Iqbal,
A party may move to dismiss a complaint for failure to state a claim upon which relief can be granted. Fed. R. Civ. P. 12(b)(6). When considering a motion to dismiss under Rule 12(b)(6), a district court must "accept as true the factual allegations in the complaint and all reasonable inferences that can be drawn therefrom." Krantz v. Prudential Invs. Fund Mgmt. LLC,
"To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to 'state a claim to relief that is plausible on its face.' " Ashcroft v. Iqbal,
The Court's analysis, below, applies this governing standard to J & J's Rule 12(b)(6) arguments for dismissal.
IV. DISCUSSION
Pfizer has asserted claims under Section 1 and Section 2 of the Sherman Act and Section 3 of the Clayton Act. Compl. ¶¶ 110, 117, 125, 136. The law applicable to each claim is effectively the same as it applies to J & J's Motion to Dismiss. Eisai, Inc. v. Sanofi Aventis U.S., LLC,
*501J & J raises three lines of attack against J & J's Complaint. First, J & J generally targets Pfizer's alleged pleadings, arguing that Pfizer has failed to plead facts that constitute an antitrust injury. Second, J & J argues that Pfizer has failed to plead specific allegations establishing antitrust injury with respect to the particular conduct that is the subject of Pfizer's Complaint. Lastly, J & J argues that the facts that Pfizer did plead lack sufficient basis to support its antitrust injury. We address each below.
A. General Antitrust Injury
"Competition is at the heart of the antitrust laws." Philadelphia Taxi Ass'n, Inc. v. Uber Techs., Inc.,
The law therefore establishes antitrust injury as a common pleading requirement for antitrust plaintiffs. Brunswick Corp. v. Pueblo Bowl-O-Mat, Inc.,
Under this requirement, Pfizer "must allege harm to competition, not just harm to its own business" to adequately plead antitrust injury. In re EpePen (Epinephrine Injection, USP) Mktg., Sales Practices and Antitrust Litig., ,
While an antitrust plaintiff must present plausible allegations establishing antitrust injury, "the adequacy of a [plaintiff's] contentions regarding the effect on competition is typically resolved after discovery, either on summary judgment or after trial." Brader,
For example, in Brader, the Third Circuit reversed the district court's dismissal of antitrust claims based on the antitrust injury pleading requirement.
Pfizer's Complaint sufficiently alleges that it has suffered an antitrust injury as the result of J & J's anticompetitive conduct. J & J's efforts to foreclose Pfizer from the market, as Pfizer has alleged, have led to increased prices for consumers and limited competitive options for end payors, providers, and patients. Pfizer provides detailed allegations regarding J & J's exclusionary terms with many of the nation's largest insurers, the incentive structure that forces end payors and providers into accepting those terms, Pfizer's efforts to compete, including its guarantees that Inflectra would cost less than Remicade, and showed how market participants on many levels are injured from J & J's ability to sell Remicade without having to compete with Inflectra and other biosimilars.
Along a similar line of attack, J & J also takes aim at Pfizer's alleged antitrust injury by arguing that Pfizer's inability to gain market share is caused by reasons other than J & J's alleged anticompetitive conduct. For example, J & J argues that Inflectra's lack of competition is the result of providers' lack of comfort and awareness of biosimilars, Inflectra's lack of "interchangeability" status with Remicade, and Remicade's substantial rebates. J & J Corrected Mem. at 1, 14-15 (Doc. No. 31).
While these arguments may prove true after discovery, they are not grounds for dismissing Pfizer's Complaint. The existence of possible alternative causes of an antitrust injury is not a valid ground for dismissal. In re EpePen, ,
This reasoning is illustrated in In re EpePen, in which Sanofi asserted antitrust claims against Mylan on the basis that Mylan prevented Sanofi's pharmaceutical from competing.
While J & J may ultimately be correct that Inflectra's lack of success is the result of something other than J & J's conduct, its argument is misplaced at this stage in the litigation. In considering the sufficiency of Pfizer's alleged antitrust injury, "dispositive weight should not be given to lists of possible alternatives, which virtually any defendant can generate." Phillip E. Areeda & Herbert Hovenkamp, Antitrust Law: An Analysis of Antitrust Principles and Their Application ¶ 338 (4th Ed., 2018 Cum. Supp. 2010-2017). We therefore reject J & J's invitation to dismiss Pfizer's Complaint on the basis that Pfizer's own *503actions caused Inflectra's lack of success to date.
B. Conduct Specific Antitrust Injury
J & J next asks us to dismiss Pfizer's Complaint on the basis that Pfizer has failed to allege facts establishing antitrust injury resulting from J & J's particular conduct that is the subject to Pfizer's Complaint.
As noted above, Pfizer claims that J & J has engaged in a multifaceted scheme to prevent Inflectra and other biosimilars from competing with Remicade. Pfz. Resp. at 19. This scheme includes "secur[ing] contractual commitments from commercial insurance companies to exclude biosimilars from coverage under their plans." Compl. ¶ 58. Such commitments, as Pfizer alleges, cause Remicade to be the exclusive infliximab available to new and current infliximab patients.
Exclusive dealing arrangements arise when a buyer agrees to purchase certain goods or services only from a particular seller for a certain period of time. These agreements can be in the form of express or de facto terms -- terms that naturally result in the buyer purchasing exclusively from the seller. ZF Meritor, LLC v. Easton Corp.,
On one hand, such agreements may benefit consumers because they can assure supply and price stability. On the other hand, such agreements can also deprive competitors access to a certain market. We therefore consider exclusive dealing arrangements under a rule of reason framework, in which we analyze "the likely or actual anticompetitive effects of the exclusive dealing arrangement, including whether there was reduced output, increased price, or reduced quality in goods or services." Eisai, Inc. v. Sanofi Aventis U.S., LLC,
Another form of potentially anticompetitive conduct is bundled rebates. Bundled rebates pose antitrust concern when a defendant forecloses competition from its product in a competitive market by linking it to a product on which it faces no competition. LePage's Inc. v. 3M,
Focusing on Pfizer's alleged antitrust injury, J & J makes several arguments specific to each aspect of its alleged anticompetitive conduct.
First, J & J argues that Pfizer's alleged antitrust injury based on J & J's multi-product bundling should be dismissed because Pfizer failed to allege that it offered its own multi-product bundles. According to J & J, Pfizer was either required to plead facts establishing that it offered its own competing bundle or that it *504was incapable of doing so. J & J Resp. at 13.
J & J relies heavily on Eisai, where the Third Circuit stated it previously "limited the reasoning in LePage's to cases in which a single-product producer is excluded through a bundled rebate program offered by a producer of multiple products, which conditions the rebates on purchases across multiple different product lines."
Pfizer, of course, is not a single-product producer. It admits as much in its Complaint. Compl. ¶ 18. Moreover, Pfizer has not alleged any facts suggesting that J & J is hindering its ability to compete with J & J's multi-product bundles by offering their own multi-product bundles. J & J's multi-product bundles, on their own, therefore do not present antitrust concern.
Second, J & J cites Eisai for the proposition that bundling contestable and incontestable demand, for the same product, cannot constitute an antitrust violation. However, the Third Circuit did not completely shut the door on such a theory, as J & J argues.
Bundling Remicade's incontestable demand could create anticompetitive consequences by foreclosing competition for new infliximab patients -- thereby posing antitrust concern that was lacking in Eisai. Taking Pfizer's allegations as true, new infliximab patients are contestable because they have not yet been anchored to a specific infliximab product. If incontestable demand is truly inelastic, then this could fall into a traditional bundling case where J & J has bundled its power over existing Remicade patients to break the competitive mechanism and deprive new infliximab patients (and their insurers) of the ability to make a meaningful choice between Remicade and its biosimilars. See Eisai,
C. Allegations Supporting Pfizer's Efforts to Compete
Lastly, J & J argues that Pfizer's alleged antitrust injury based on J & J's exclusive contracts should be dismissed because Pfizer failed to plead adequate facts establishing that it attempted to compete. J & J supports this argument by claiming Pfizer's allegations regarding the price of Inflectra and Remicade lack sufficient accuracy to make plausible Pfizer's efforts to compete.
J & J mainly takes issue with Pfizer's reliance on Average Sales Price ("ASP") and Wholesale Acquisition Cost ("WAC"). According to J & J, Pfizer cannot rely on ASP and WAC to support its efforts to compete with J & J by offering lower prices because both metrics lack sufficient specificity. J & J Corrected Mem. at 17.
As noted above, WAC is essentially a metric reflecting list price, whereas ASP is based on an annual average that does account for rebates and discounts off list price. J & J argues that because WAC does not reflect the net price after discounts and rebates, it provides no indication about the price competition between Remicade and Inflectra. The problem with ASP, according to J & J, is that because Remicade's current ASP reflects a yearly net average, and because Inflectra has been on the market for less than a year at *505the time Pfizer filed its Complaint, Remicade's ASP reflects pricing data from months where Inflectra was not yet on the market. J & J Corrected Mem. at 3-4, 16-18.
At this stage, we find that Pfizer's allegations containing ASP data do support the plausibility of its claims. According to Pfizer, it has priced Inflectra lower than J & J's Remicade even accounting for incentives such as bundled discounts and rebates. Pfizer also alleges that Remicade's ASP continues to increase despite Inflectra's entrance to the market at a 24 percent lower per unit cost. Supp. Auth. at 2. These allegations lend plausibility to Pfizer's theory that J & J is engaging in anticompetitive behavior, which is foreclosing biosimilars from competing.
We agree with J & J that the WAC provides minimal support for the proposition that Inflectra costs less on a unit-for-unit basis than Remicade. Nevertheless, Pfizer's allegations regarding Remicade's increasing WAC does support Pfizer's theory that J & J's bundled rebate force purchasers into excluding Remicade's biosimilars from the market. Increasing Remicade's WAC in turn increases the penalties for not excluding Inflectra and other biosimilars in the form of lost incentives. Accepting as true Pfizer's allegations that existing Remicade patients will not switch to a biosimilar despite price competition, the increasing penalties that payors may face for exiting patients may effectively force payors into accepting J & J's exclusionary terms for all patients.
J & J's arguments against Pfizer's support for its pricing allegations are misplaced -- or rather, mistimed. Discovery will reveal whether Pfizer has offered more competitive pricing for Inflectra, as alleged in its Complaint. If Pfizer's claims about pricing prove true, then the pricing data may indicate that J & J's conduct has prevented Pfizer from competing in violation of the antitrust laws. Ultimately, the legality of J & J's conduct will depend on whether it foreclosed a substantial share of the market such that competition has been harmed. ZF Meritor,
V. CONCLUSION
For the foregoing reasons, J & J's Motion to Dismiss is denied. An appropriate Order will follow.
333 F. Supp. 3d 494 (Pfizer Inc. v. Johnson & Johnson & Janssen Biotech, Inc.) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.