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From Health Law Daily, September 12, 2017

Suboxone® market manipulation action survives dismissal

By Sara Cracau, J.D.

An antitrust action against several pharmaceutical manufacturers of the Suboxone® tablet was successfully pleaded to support claims of a scheme of market monopolization and attempted monopolization. A Pennsylvania district court found that sufficient facts were also pleaded to support both an inference of concerted action and that the conspiracy was likely to have hampered competition (State of Wisconsin v. Indivior Inc., September 8, 2017, Goldberg, M.).

Allegations. A group of states brought an antitrust action regarding Suboxone, a prescription drug, against a number of pharmaceutical manufacturers, including Indivior Inc. and MonoSol Rx, LLC, alleging that the manufacturers in a concerted scheme designed to prevent or delay less expensive generic versions of the Suboxone tablet from entering the market in order to preserve their profits from the sale of Suboxone. The complaint detailed various antitrust allegations, including monopolization, attempted monopolization, conspiracy to monopolize, as well as individual state law claims. Indivior moved to dismiss.

As the orphan drug exclusivity period for Suboxone tablets neared expiration, Indivior allegedly formulated a "Buprenorphine Generic Offensive Strategy" together with MonoSol by developing a new sublingual version of Suboxone, which could be used to secure patent protection. Individor also allegedly converted the market for co-formulated buprenorphine/naloxone from Suboxone tablets to the newly developed version of the drug. Indivior’s multi-front offensive included aggressively promoting the alleged superiority of the film to doctors, payors, and pharmacists, encouraging use of the film, and pricing film at prices less than the tablets. It issued a press release raising health concerns about the tablets and ultimately withdrew them from the market entirely.

Monopolization. The court denied the manufacturers’ motion to dismiss the states’ product-hopping and delay claims underlying their anti-competitive conduct. The court concluded that there was a reasonable inference that once generic tablets entered the market, the price disconnect between the prescribing physician and the ultimate consumer would have impeded competition by generic manufacturers preventing them from pricing their tablets lower than Suboxone film. The manufacturers’ product-hopping actions constituted a combination of product withdrawal with other conduct, having an overall effect of coercing consumers instead of persuading them on the merits, and impeding competition. The court found that the complaint pleaded a plausible claim of anticompetitive delay based on a description of multiple actions comprising an overarching scheme. Despite an FDA order for Indivior to cooperate with potential generic competitors to the Suboxone tablet in the risk evaluation and mitigation strategies (REMS) process, Indivior feigned cooperation and ultimately refused to participate in any part of the shared REMS process. Furthermore, Indivior allegedly filed a sham citizen petition with the FDA raising concerns about the safety of the tablet form of Suboxone and requesting the FA to withhold approval of the abbreviated new drug applications (ANDAs) for a generic substitute unless certain conditions relating to safety were met.

The court rejected the manufacturers’ arguments that the states failed to include allegations of "actual foreclosure" and allegations of a price disconnect. The court noted that allegations of total foreclosure are not required for a product hopping claim to survive a motion to dismiss and here sufficient facts were pleaded to allow a plausible inference that the "product hop substantially foreclosed competition." Similarly, allegations of a price disconnect in the pharmaceutical industry are not vital to plausibly pleading an antitrust violation even though they certainly could be helpful to explain why a product hop may be anticompetitive.

Conspiracy claims. The court denied the manufacturers’ motion to dismiss the conspiracy claims, finding that the complaint sufficiently pleaded facts to support claims of monopolization and attempted monopolization. In addition, the court found that there were sufficient facts to support an inference of concerted action and that the conspiracy was likely to hamper competition. There was a reasonable inference that the agreement between Indivior and MonoSol created economic incentives for the parties to exert their best efforts in carrying out a joint venture related to Suboxone film. The relationship between the parties was "one of competitive reality" lacking "complete unity of interest," and was not "characteristic of independent action."

The case is MDL No. 2445/No. 13-MD-2445.

Attorneys: Gwendolyn J. Cooley, Attorney General of Wisconsin, for the State of Wisconsin. Jonathan Berman (Jones Day) for Indivior Inc. f/k/a Reckitt Benckiser Pharmaceuticals, Inc. and Indivior PLC f/k/a Reckitt Benckiser Group PLC. Benjamin Ernst (Wilmer Cutler Pickering Hale and Dorr LLP) for Reckitt Benckiser Health Care UK Ltd. Andrew J. Lee (Steptoe & Johnson LLP) for MonoSol Rx, LLC.

Companies: Indivior Inc. f/k/a Reckitt Benckiser Pharmaceuticals, Inc.; Indivior PLC f/k/a Reckitt Benckiser Group PLC; Reckitt Benckiser Health Care UK Ltd.; MonoSol Rx, LLC

MainStory: TopStory CaseDecisions FDCActNews AntitrustNews DrugBiologicNews GenericDrugNews PrescriptionDrugNews PennsylvaniaNews

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