January 27, 2023

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-standing Suboxone MDL, finding that Aquestive not liable for its role in an alleged anti-competitive “product hopping” scheme.1

facts and claims

Indivior, Inc. (f/k/a Reckitt Benckiser Pharmaceuticals, Inc.) manufactures Suboxone (buprenorphine), originally provided as a tablet, for the treatment of opioid addiction. As the tablet’s exclusivity came to an end, Indivior investigated whether it could modify the drug in a way that would extend its exclusivity. Indivior consulted Aquestive, which had developed a patented sublingual, or under the tongue, dissolvable film. Aquestive praised his film’s benefits for patients, including that it dissolves quickly, has a quick onset, bypasses the gastrointestinal tract, requires no water, and is easy to administer (especially to children and the elderly), with no difficulty swallowing and no Risk of error in dosing, is portable, easy to find if dropped, and discreet, among other benefits. Aquestive also promoted its foil product as allowing branded drug manufacturers to extend product lifecycles and guard against generic drug intrusion. In 2010, Indivior removed the tablet version from the market and replaced it with the film version, just as generic competitors were poised to launch their own versions of the tablets.

In 2016, a group of attorneys general (“states”) filed an antitrust lawsuit against Indivior and Aquestive over the product switch. States claimed that beginning in 2006, Aquestive partnered with Indivior to develop the Suboxone film and agreed to manufacture it in 2008. They further claimed that Aquestive first proposed the strategy to take the pill off the market, which Aquestive denied. Indivior engaged in a public campaign to allegedly disparage the pill product, increased the price of the pills, and filed a citizen petition with the FDA to persuade the agency to approve the film, citing safety concerns that the pill was accidental children could be taken along. Indivior also requested that the tablet undergo a risk assessment and mitigation strategy (REMS), which it did not participate in. The FDA decided to approve the generic pills in 2013, but many patients had already switched to the film version. As a result, states claimed that their health insurance programs overpaid for the drug.

decision in summary judgment

In a 33-page opinion, Judge Goldberg recently returned summary judgment and dismissed Aquestive from the case, noting that states had failed to present evidence that Aquestive had joined a conspiracy.

First, Judge Goldberg dismissed the states’ argument that Aquestive’s own advertising of its film product as “protection from generic interference” and “non-AB rated” for other versions of a product evidenced Aquestive’s consent to join a conspiracy in violation of antitrust laws to join .2 Judge Goldberg found that such promotion harmed a competitor, not the competitive process. “To claim otherwise would mean that a company like MonoSol, whose sole purpose is the development and marketing of films, could not pursue its business goals without violating antitrust laws.”3

Second, Judge Goldberg dismissed the states’ argument that Aquestive conspired with Indivior by simply proposing a “hard switch” strategy.4 While there was a factual dispute as to whether Aquestive actually proposed the strategy, Judge Goldberg considered the dispute immaterial because “[e]Even assuming that MonoSol originally proposed introducing film and withdrawing the tablet, the evidence “does not allow a reasonable conclusion that [the parties] reached a approval[.]”5 “[O]different than the “suggestion”. . . MonoSol did nothing to help Reckitt. . . . MonoSol was unable to initiate the revocation. . . could not have prevented Reckitt from retiring. . . and was not even aware of the final decision to withdraw[.]”6 Thus, Judge Goldberg ruled that “the mere suggestion or knowledge of this strategy is not sufficient to constitute an antitrust conspiracy.”7

Third, Judge Goldberg found that states had failed to present evidence that Aquestive consented to “another part of the alleged antitrust conspiracy,” such as a citizen filing with the FDA and allegedly delaying a joint REMS trial.8th Aquestive was aware of Indivior’s behavior in general and supported it: “[m]Knowledge of and private support for actions of an alleged monopolist does not prove that a disagreement took place[.]”9

Fourth, Judge Goldberg rejected the argument that conspiracy could be inferred solely from economic incentives in the supply contracts between Aquestive and Indivior. States had argued that Aquestive was “unpaid.” strict per strip, but also received royalties to share Reckitt’s profits”, so that “the more films Reckitt sold, the more profits for MonoSol”.10 Judge Goldberg found that the agreements were “lawful and pro-competitive” and that “[d]Developing a new product and being paid for it, including a license fee, is fully consistent with lawful conduct and does not constitute anti-competitive conduct.”11

Fifth, Judge Goldberg objected to the states’ use of certain terms used by the parties to draw general conclusions of conspiracy. Specifically, the states pointed out that Aquestive describes itself as a “strategic partner” and not “just as a contract manufacturer”.[.]”12 Justice Goldberg declined to draw such sweeping conclusions, noting that “[c]companies often choose to present themselves as existing in order to achieve more than just pure profit.”13

snack

In summary, Judge Goldberg noted the following:

States have presented no evidence that MonoSol and Reckitt ever reached an agreement, disagreement, or conscious commitment to a common plan regarding the actual pill withdrawal, pill or film pricing, safety marketing campaign, or citizen petition, or the REMS method. At best, MonoSol worked diligently to do exactly what it was contracted to do: produce enough Suboxone film to meet Reckitt’s needs, in exchange for a per-strip fee and a royalty on profits. Antitrust laws do not prohibit agreements to participate in such a lawful endeavor.14

Judge Goldberg’s decision recalls that alleged anticompetitive conduct in conjunction with an otherwise pro-competitive agreement does not make the agreement anticompetitive or bind all parties to the agreement in an antitrust conspiracy. Judge Goldberg’s decision further confirms that “knowledge alone is insufficient to prove that a particular defendant intended to join a conspiracy.”fifteen

1 Regarding Suboxone (Buprenorphine Hydrochloride & Naloxone) Antitrust Litig.No. 2445 13-MD-2445, 2022 WL 11804048
(ED Pa. 19 Oct 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 had reached an agreement with Indivior
Regarding the tablet withdrawal strategy, “it is not clear that the mere launch of a new product is involved
The withdrawal of the predecessor product alone could be the basis of an unlawful antitrust conspiracy.” ID. at *15 n.10. With that statement, Judge Goldberg honored the 2015 of the Second Circuit Nameda decision and found that other courts had done so
because required “a certain behavior beyond the hard switch. . . to prove illegal, anti-competitive behavior.” ID. (to discuss
New York exrel. Schneiderman v Actavis PLC787 F.3d 638, 653-54 (2nd circle 2015), Regarding Loestrin 24 Fe Antitrust
litigation
, 433 F. Supp. 3d 274, 330-31 (DRI 2019) and Mylan Pharms Inc. v Warner Chilcott Public Ltd.838 F.3d 421,
440 (3. Cir. 2016)).
6 ID. at 15.
7 ID. (quote Speaking of baby food166 F.3d 112, 133 (3d Cir. 1999)).
8th ID. at *16.
9 ID.
10 ID. (emphasis added).
11 ID.
12 ID. at *17.
13 ID.
14 ID. at *18.
fifteen ID. at *17 (quote Regarding vitamins Antitrust Litig., 320 F. Supp. 2d 1, 16 (DDC 2004)).

Leave a Reply

Your email address will not be published. Required fields are marked *