Antitrust Class Action Filed Over Acne Drug Solodyne
The International Union of Operating Engineers Local 132 has sued Medicis Pharmaceuticals and a number of generic drug manufacturers, alleging a conspiracy to monopolize the market for the minocycline hydrochloride-based acne drug Solodyn by illegally preventing an artificial version from going to market. The putative antitrust class action was filed in the U.S. District Court for the Northern District of California on Thursday August 1, 2013.
Girard Gibbs has brought this class action lawsuit on behalf of “any person, business, union or other entity who purchased (by paying some or all of the purchase price) Solodyn or its AB-rated generic equivalent in the United States, District of Columbia or Puerto Rico from December 2008 to present.”
The case is International Union of Operating Engineers Local 132 et al. v. Medicis Pharmaceutical Corp. et al., case number 2:13-cv-3583, in the U.S. District Court for the Northern District of California.
Abbreviated New Drug Applications for Generic Solodyn
According to the complaint, Medicis claimed that it was entitled to have the U.S. Food and Drug Administration (FDA) delay approval of certain abbreviated new drug applications for generic versions of Solodyn. The complaint also stated that Medicis had executed unlawful deals with competitors to prevent alternate versions of the drug from hitting the shelves.
Medicis allegedly engaged in a scheme to improperly launch infringement suits against competitors in an attempt to automatically stay FDA approval of generic version of the drug by improperly listing a patent it held on Solodyn in the FDA’s Orange Book, said the complaint. The suit claims that U.S. U.S. Patent Number 5,902,838 did not belong in the Orange Book and was invalid because it was based on substantial prior art that the company did not disclose to examiners.
The complaint also alleges that Medicis allegedly tried to undermine pending ANDAs through the introduction of new versions of Solodyn in 2011 with slightly altered doses in an attempt to prevent pharmacists from being able to prescribe less costly generic versions of the drug in the future. The complaint further alleged that Medicis entered deals in which it agreed to pay competitors to keep them from filing ANDAs seeking approval of generic forms of the drug.
The complaint further alleges that Medicis agreed to allow Teva Pharmaceuticals USA Inc., Mylan Inc., and Sandoz Inc. to each sell six-month supplies of generic Solodyn during an exclusive window of time without competition from the others. The deal came under the guise of an agreement to settle suits in which Medicis alleged that the pharmaceutical companies were infringing the '838 patent. These three pharmaceutical companies are also named as defendants in the case. Plaintiffs in the case claim that consumers were paying artificially higher prices for drugs while the companies raked in profits.