In re Suboxone (Buprenorphine Hydrochloride & Naloxone) Antitrust Litigation

64 F. Supp. 3d 665, 2014 WL 6792663
CourtDistrict Court, E.D. Pennsylvania
DecidedDecember 3, 2014
DocketMDL No. 2445, 13-MD-2445
StatusPublished
Cited by33 cases

This text of 64 F. Supp. 3d 665 (In re Suboxone (Buprenorphine Hydrochloride & Naloxone) Antitrust Litigation) 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 Suboxone (Buprenorphine Hydrochloride & Naloxone) Antitrust Litigation, 64 F. Supp. 3d 665, 2014 WL 6792663 (E.D. Pa. 2014).

Opinion

[672]*672 MEMORANDUM OPINION

GOLDBERG, District Judge.

This multidistrict litigation raises the following question: can a pharmaceutical' company marketing brand-name prescription drugs be subject to antitrust liability for engaging in what has been referred to as a “product hopping” scheme? Plaintiffs urge that the answer to this question is “yes,” and allege that as the period of exclusivity on the brand-name drug, Su-boxone, expired and generic versions of that drug were to become available, Reck-itt Benekiser, Inc. effectuated inconsequential changes to the Suboxone dosage form to prevent competition from generic formulations. More specifically, Plaintiffs, the Direct Purchasers of Suboxone (“Direct Purchasers”) and the End Payors of Suboxone (“End Payors”) claim that Reck-itt and its affiliates (“Reckitt”) switched from sublingual Suboxone tablets to a sub-lingual Suboxone film for the purpose of stymying generic competition. This switch was allegedly accompanied by Reckitt falsely disparaging the tablet through fabricated safety concerns and ultimately removing Suboxone tablets from the market just as generic Suboxone tablets were able to begin competing. Reckitt is also alleged to have manipulated FDA regulations to delay the entry of generic Subox-one’ onto the market, thereby unlawfully maintaining a monopoly in violation of § 2 of the Sherman Act and state law. According to Plaintiffs, Reekitt’s conduct negatively affected competition and resulted in ongoing overpayments by consumers.

Before me is Reekitt’s motion to dismiss which essentially argues that Plaintiffs’ complaint describes nothing more than new product development and marketing. Reckitt is correct that thé development and marketing of new products is typically viewed as procompetitive. However, due to market characteristics unique to the' pharmaceutical industry, I conclude that some of Plaintiffs’ claims do plausibly allege antitrust violations and should survive Defendants’ motions to dismiss. This opinion explains the bases for my ruling.

I. FACTUAL AND PROCEDURAL BACKGROUND

The facts alleged by Plaintiffs are as follows:1 Suboxone (Buprenorphine Na-[673]*673loxone or “BPN/NLX”) is a prescription drug used for the maintenance treatment of opioid dependence. It is the only pharmaceutical on the market that provides maintenance treatment for patients suffering from opioid addiction that can also be prescribed in an office setting for the patient’s home use. All other opioid addiction maintenance treatments, such as methadone, can only be dispensed at a clinic. Suboxone has been approved for home use because it is co-formulated to help prevent abuse, containing both: (1) buprenorphine, an opioid which treats the withdrawal symptoms; and (2) naloxone, an opioid antagonist, which causes the immediate onset of withdrawal symptoms if the product is inappropriately melted and injected. Today, Suboxone has annual sales of over one billion dollars and accounts for 20% of Reckitt’s profits. (DP Compl. ¶¶ 5, 74-77.)

Under the Federal Food, Drug and Cosmetic Act (“FDCA”), 21 U.S.C. §§ 301 et seq., a manufacturer that creates a new drug must obtain the approval of the Food and Drug Administration (“FDA”) to sell the drug by filing a New Drug Application (“NDA”). Under the Drug Price Competition and Patent Term Restoration Act, Pub.L. No. 98-417 (1984), commonly known as the Hatch-Waxman Act, certain pioneer drugs can gain periods of exclusivity. However, Hatch-Waxman also simplified the process by which generic manufacturers can compete with brand-name drugs on the market through the filing of an Abbreviated New Drug Application (“ANDA”). For example, Hatch-Waxman eliminated the need for generic manufacturers seeking ANDA approval to duplicate clinical studies that had already been performed by a bioequivalent brand-name drug manufacturer. (Id. at ¶¶ 38-42.)

In order for a drug to be deemed bioe-quivalent, the generic product must be shown to deliver the same amount of active ingredient into a patient’s blood stream for the same amount of time as the brand-name drug. ANDA filers demonstrating bioequivalence generally seek to have their product deemed “AB-rated” to the brand-name drug. This rating means that in addition to being bioequiyalent, the two drugs are also pharmaceutically equivalent — which includes such considerations as having the same active ingredient, the same strength, the same route of administration and the same dosage form. A pharmacy may not substitute a generic drug for a brand-name drug unless the generic is AB-rated. (Id. at ¶¶ 42-44.)

Competition from low cost AB-rated generic drugs saves consumers billions of dollars a year. When an AB-rated generic drug enters the market, the brand-name company often suffers a rapid, steep decline in sales — on average 80% within the first year. AB-rated generic competition enables direct and indirect purchasers to obtain both the generic drugs and the brand-name drugs at substantially lower prices. (Id. at ¶¶ 9, 51, 55.)

The FDA approved Reckitt’s NDA for Suboxone tablets in 2002. Although Reck-itt did not have a patent for Suboxone tablets, it was able to obtain a seven-year period of exclusivity from the FDA because Suboxone was found to be an orphan drug.2 Reckitt’s period of exclusivity for [674]*674Suboxone tablets was scheduled to expire on October 8, 2009. (Id. at ¶¶ 78-80.) Plaintiffs allege that Reckitt, knowing its period of exclusivity would soon be over, began developing Suboxone film and obtaining patent protection for this new product. Reckitt’s actions while developing and marketing its new product are described as a “product-hopping scheme” and are alleged to be anticompetitive with the aim of maintaining Reckitt’s monopoly in the Suboxone market.

A. Description of Alleged Conduct

1. Product-Hopping: Development of Suboxone Film and the Alleged Destruction of the Tablet Market

The NDA for Suboxone film was submitted on October 20, 2008 and was approved August 30, 2010. The patent for Suboxone film — patent 8,017,150 (“the '150 patent”) — expires September 2023. Generic Suboxone tablets cannot be AB-rated to branded Suboxone film due to the differences in,dosage form — that is, sublingual tablet versus sublingual film. Therefore, a pharmacist cannot provide a patient with generic Suboxone tablets when a patient has a prescription for Suboxone film. (Id. at ¶¶ 81, 88.)

Plaintiffs allege that there are few differences between Suboxone film and Su-boxone tablets, and that the film is not superior to the tablets. In support of this assertion, Plaintiffs claim that the two products are so similar that Reckitt submitted safety and efficacy studies performed on Suboxone tablets when seeking approval of the Suboxone film NDA. The two products are alleged to have equivalent bioavailability, meaning that the products release the same amount of active ingredients into a patient’s bloodstream. Although Reckitt indicated in its NDA that the film’s individual packaging reduced the risk for accidental pediatric exposure to the drug, Plaintiffs assert that the evidence provided by Reckitt on this issue was flawed.

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Cite This Page — Counsel Stack

Bluebook (online)
64 F. Supp. 3d 665, 2014 WL 6792663, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-suboxone-buprenorphine-hydrochloride-naloxone-antitrust-paed-2014.