Dec 2, 2022

To embed, copy and paste the code into your website or blog: <iframe frameborder="1" height="620" scrolling="auto" src="//www.jdsupra.com/post/contentViewerEmbed.aspx?fid=83ab5196-6cb7-4e1e-974d-04d287d0e98a" style="border: 2px solid #ccc; overflow-x:hidden !important; overflow:hidden;" width="100%"></iframe> On October 19, 2022, U.S. District Judge Mitchell Goldberg in the Eastern District of Pennsylvania granted Aquestive Therapeutics Inc.’s (f/k/a MonoSol Rx LLC) motion for summary judgment in the long-running Suboxone MDL, finding Aquestive was not liable for its role in an alleged anticompetitive “product hopping” scheme.1 Facts and Allegations Indivior, Inc. (f/k/a Reckitt Benckiser Pharmaceuticals, Inc.) manufactures opioid-addiction treatment, Suboxone (buprenorphine), which was originally provided as a tablet. As the tablet’s exclusivity was coming to an end, Indivior investigated whether it could change the drug in a way that could extend its exclusivity. Indivior consulted with Aquestive, which had developed a patented sublingual or under-the-tongue dissolvable film. Aquestive touted the benefits of its film for patients, including that it was quick dissolving with rapid onset that bypasses the GI, has no need for water and is easy to administer (particularly to children and elderly) with no difficulty swallowing and no chance of error in dosing, is portable, easy to find if dropped, and discrete, among other benefits. Aquestive also promoted its film product as allowing brand drug manufacturers to extend product life cycles and to protect against generic encroachment. In 2010, Indivior removed the tablet version from the market and replaced it with the film version, just as generic competitors were readying to launch their own versions of the tablets. In 2016, a group of States’ Attorneys General (“States”) brought an antitrust suit against Indivior and Aquestive based on the product switch. The States alleged that Aquestive partnered with Indivior to develop the Suboxone film beginning in 2006 and agreed in 2008 to manufacture it. They further claimed that Aquestive first suggested the strategy of pulling the pill from the market, which Aquestive denied. Indivior engaged in a public campaign to allegedly disparage the tablet product, raised the price on the tablets, and filed a citizen petition with the FDA, seeking to persuade the agency to approve the film by raising safety concerns that the tablet could accidentally be taken by children. Indivior also requested that the tablet be subject to a risk evaluation and mitigation strategy (REMS) to which it did not partake in. The FDA decided to allow the generic pills in 2013, but many patients had already switched to the film version. As a result, the States alleged that their health insurance programs overpaid for the drug. Summary Judgment Decision In a 33-page opinion, Judge Goldberg recently granted summary judgment and dismissed Aquestive from the case, finding that the States failed to adduce evidence that Aquestive joined a conspiracy. First, Judge Goldberg rejected the States’ argument that Aquestive’s own promotion of its film product as “protection against generic encroachment” and “not AB-rated” to other versions of a product proved Aquestive’s agreement to join a conspiracy in violation of the antitrust laws.2 Judge Goldberg found such promotion to be in line with harm to a competitor, not to the competitive process. “To hold otherwise would suggest that a company such as MonoSol, whose sole purpose is the development and marketing of film, could not pursue its business goals without violating antitrust laws.”3 Second, Judge Goldberg rejected the States’ argument that Aquestive conspired with Indivior by merely suggesting a “hard switch” strategy.4 While there was a factual dispute over whether Aquestive actually suggested the strategy, Judge Goldberg found the dispute to be immaterial as “[e]ven assuming MonoSol originally suggested the introduction of film and the withdrawal of the tablet” the evidence did not “create a reasonable inference that [the parties] reached an agreement[. ]”5 “[O]ther than the ‘suggestion’ . . . MonoSol took no action to help Reckitt . . . . MonoSol had no ability to cause the withdrawal . . . could not have prevented Reckitt from withdrawing . . . and was not even aware of the final withdrawal decision[. ]”6 Thus, Judge Goldberg held that “mere suggestion or awareness of that strategy is insufficient to establish an antitrust conspiracy.”7 Third, Judge Goldberg found that the States failed to adduce evidence that Aquestive agreed to “any other portion of the alleged antitrust conspiracy,” such as Indivior’s choice to raise the price of Suboxone tablets, engage in an allegedly false safety marketing campaign, file a citizen petition with the FDA, and allegedly delay a shared REMS process.8 While Aquestive was generally aware and supportive of Indivior’s conduct, “[m]ere awareness of and private support for actions by an alleged monopolist do not establish that there had been a meeting of the minds[. ]”9 Fourth, Judge Goldberg rejected the argument that a conspiracy could be inferred by virtue of economic incentives alone found in the supply agreements between Aquestive and Indivior. The States had argued that Aquestive was “not paid strictly on a per-strip basis but also received royalties to share in Reckitt’s profits” such that “the more film Reckitt sold, the more profits for MonoSol.”10 Judge Goldberg found that the agreements were “lawful and procompetitive” and that “[d]eveloping a new product and getting paid for it, including a royalty, is fully consistent with legitimate conduct and does not create an inference of anticompetitive behavior.”11 Fifth, Judge Goldberg rejected the use by the States of certain language used by the parties to draw broad conclusions of conspiracy. Specifically, the States pointed out that Aquestive referred to itself as a “strategic partner” and not “just a contract manufacturer[. ]”12 Judge Goldberg refused to draw any such broad inferences, finding that “[c]ompanies often choose to present themselves as existing for more than just a mere profit-making purpose.”13 Takeaways In summary, Judge Goldberg held that: The States have presented no evidence that MonoSol and Reckitt ever reached any agreement, meeting of the minds, or conscious commitment to a common scheme as to the actual withdrawal of tablets, the pricing of tablets or film, the safety marketing campaign, the Citizen Petition, or the REMS process. At best, MonoSol worked diligently to do precisely what it contractually agreed to do: produce Suboxone film sufficient to meet Reckitt’s needs in exchange for a per-strip charge and a royalty share of the profits. Antitrust laws do not prohibit agreement to engage in such a lawful endeavor.14 Judge Goldberg’s decision stands as a reminder that alleged anticompetitive conduct coupled with an otherwise pro-competitive agreement does not render the agreement anticompetitive or join all parties to the agreement to an antitrust conspiracy. Judge Goldberg’s decision further confirms that “‘knowledge alone is not sufficient to prove that any particular defendant intended to join a conspiracy.’”15 1 In re Suboxone (Buprenorphine Hydrochloride & Naloxone) Antitrust Litig., No. 2445 13-MD-2445, 2022 WL 11804048 (E.D. Pa. Oct. 19, 2022). 2 Id. at *2, 12. 3 Id. at *13. 4 Id. 5 Id. (emphasis in original). In dicta, Judge Goldberg stated that even if Aquestive reached an agreement with Indivior regarding the tablet withdrawal strategy, “it is not clear that mere introduction of a new product combined with withdrawal of the prior product, standing alone, could be the basis of an unlawful antitrust conspiracy.” Id. at *15 n.10. In so stating, Judge Goldberg distinguished the Second Circuit’s 2015 Namenda decision, noting that other courts had since required “some conduct beyond the hard switch . . . to prove unlawful, anticompetitive conduct.” Id. (discussing New York ex rel. Schneiderman v. Actavis PLC, 787 F.3d 638, 653-54 (2d Cir. 2015), In re Loestrin 24 Fe Antitrust Litigation, 433 F. Supp. 3d 274, 330-31 (D.R.I. 2019), and Mylan Pharms Inc. v. Warner Chilcott Public Ltd., 838 F.3d 421, 440 (3d Cir. 2016)).