Antitrust Law Daily Wrap Up, ANTITRUST—E.D. Pa.: Mucinex patent holder doesn’t have to supply generic tablets, (Apr 21, 2016)

By Greg Hammond, J.D.

In an action in which a consumer goods company was accused of violating the antitrust laws by withholding supply of its authorized generic drug, the company could not be forced to produce generic versions of Mucinex within 30 days. The federal district court in Philadelphia denied pharmaceutical companies’ motion for preliminary injunction, finding that the plaintiffs failed to sustain their burden of proving that they suffered immediate irreparable harm, that the balance of the harms tips in their favor, and that granting the injunction would serve the public’s interest (URL Pharma, Inc. v. Reckitt Benckiser Inc., April 20, 2016, Tucker, P.).

In 2007, multinational consumer goods company Reckitt Benckiser, Inc. held the patent for the only Food and Drug Administration-approved form of extended-release guaifenesin (ERG), an over-the-counter expectorant sold under the brand name Mucinex. Reckitt sued generic drug manufacturer Mutual Pharmaceuticals for patent infringement after Mutual planned to sell a generic version of ERG, and Mutual subsequently brought an antitrust action against Reckitt. The parties reached a settlement agreement wherein Mutual agreed to refrain from entering the ERG market until another generic manufacturer began offering generic ERG to the public. Mutual claims, however, that Reckitt refused to supply ERG after Perrigo Co. began legally selling a generic version of 600 mg ERG, bringing claims for monopolization and attempted monopolization, as well as breach of contract claims.

On a motion for preliminary injunction, Mutual, URL Pharma, Inc., and United Research Laboratories, Inc. asked the court to: (1) compel Reckitt to commence supply of Mutual’s requirements of 600 mg ERG tablets within 30 days and/or (2) prohibit Reckitt from continuing to prioritize its own requirements of 600 mg ERG over those of Mutual.

The court denied the plaintiffs’ motion for preliminary injunction, finding that the plaintiffs failed to sustain their burden of proving that they suffered immediate irreparable harm, that the balance of the harms tips in their favor, and that granting the injunction would serve the public’s interest.

First, the court found that the plaintiffs failed to demonstrate a clear showing of immediate irreparable injury, because of the plaintiffs’ delay in bringing the motion for preliminary injunction—seven months after filing the suit and nearly two years after Perrigo began selling the generic Mucinex ERG—combined with the speculative nature of the irreparable harm.

Second, the harm Reckitt would incur if required to comply with a preliminary injunction exceeds the harm the plaintiffs would incur absent the entry of the injunction, the court concluded. In particular, if Reckitt was required to hastily complete the production of the tablets in 30 days, it would jeopardize its reputation as a reputable provider of over-the-counter drugs, as well as its financial security.

Lastly, it is not in the public’s interest to grant the injunction, the court determined, because requiring the production of the pills on a shorter timeframe, without the required tests, reports, validation studies, or quality agreements, would violate the FDA regulations and the court would effectively usurp the FDA of its role as the administrative body tasked with ensuring generic drug safety.

The case is No. 2:15-cv-00505-PBT.

Attorneys: Daniel P. Shapiro (Katten Muchin Rosenman LLP) for URL Pharma, Inc., Mutual Pharmaceutical Co., Inc. and United Research Laboratories, Inc. Richard L. Bazelon (Bazelon, Less & Feldman, PC) for Reckitt Benckiser Inc.

Companies: URL Pharma, Inc.; Mutual Pharmaceutical Co., Inc.; United Research Laboratories, Inc.; Reckitt Benckiser Inc.

Cases: Antitrust PennsylvaniaNews