Jon Campisi Aug. 29, 2013, 12:27pm


In what seems to be a fast-growing antitrust docket, another plaintiff has

filed suit against a handful of drug companies accused of scheming to delay market entry of the generic version of the acne medication Solodyn.

Lawyers representing the Fraternal Order of Police, Fort Lauderdale Lodge 31, Insurance Trust Fund filed a class action complaint Aug. 27 at the federal courthouse in Philadelphia against a number of pharmaceutical manufacturers over allegations that the defendants engaged in an overarching anticompetitive scheme to exclude competition from the market for minocycline hydrochloride extended release tablets, a prescription medication used to treat the skin condition acne.

The lead defendant, Medicis Pharmaceutical Corp., stands accused of orchestrating what the lawsuit calls a multi-faceted scheme with the generic drug companies named as additional defendants to improperly restrain trade, and maintain, extend and abuse Medicis’s monopoly power in the market for the acne medication, which goes by the brand name Solodyn.

The defendants did so at the detriment of the plaintiff and the class of end-payor purchasers it seeks to represent, causing them to overpay for the medication, the suit states.

Like other antitrust suits filed over the issue, the latest complaint asserts that Medicis and the generic drug manufacturers named as defendants conspired to exclude market competition for Solodyn, which gained FDA approval back in 2006, and is referred to as Medicis’s “flagship” pharmaceutical.

Medicis knew that Solodyn, which apparently generated about half of the defendant’s sales by 2007, was vulnerable to a “rapid, near-complete loss of sales upon entry into the market of less expensive, generic versions of Solodyn,” the complaint states.

The suit points out that Solodyn contains the old antibiotic ingredient minocycline, meaning Solodyn would not qualify for a period of regulatory exclusivity that would have prevented the FDA from approving a generic version of the product.

“Recognizing the fire threat that generic competition posed to its Solodyn sales in the near-term, Medicis formulated a multi-step plan … to protect Solodyn from generic competition using any means necessary, whether lawful or unlawful,” the complaint reads.

The lawsuit goes on to claim that while a declaratory judgment action was pending on behalf of Impax Laboratories seeking a declaration that the Solodyn patent was invalid because Medicis withheld information from the patent examiner, Medicis filed a baseless “sham” citizen petition with the FDA to delay FDA approval of Impax’s generic version of Solodyn.

Impax is named as a defendant in the current lawsuit, as are Lupin Pharmaceuticals, Sandoz Inc., Mylan Inc., Matrix Laboratories LDT, Teva Pharmaceuticals, Barr Laboratories, Ranbaxy Pharmaceuticals, and Valeant Pharmaceuticals International.

Medicis had no basis to file the citizen petition, the suit claims, although it did so with the knowledge that the mere filing of the petition would delay FDA approval of Impax’s version of Solodyn.

The complaint also says that Medicis bought itself more time to maintain its monopoly over Solodyn by engaging in an anticompetitive switch strategy known in the drug industry as “product hopping,” in which Medicis introduced certain versions of Solodyn in various strengths that did not face imminent generic competition.

The new dose strengths offered no benefits to consumers, the suit states, with the only “benefit” going toward Medicis.

The defendant, the suit alleges, aggressively destroyed demand for Solodyn legacy strengths and then converted that demand to the new strengths using what the plaintiff calls Medicis’s “army of sales force detailers.”

If not for the anticompetitive scheme and agreements with the generic drug company codefendants, the lawsuit states, generic Solodyn in legacy strengths would have entered the market as early as December 2008, after Impax received FDA approval to launch its generic version of the medication.

The plaintiff brings the case on behalf of all consumers and third-party payors in the U.S. and Puerto Rico who bought or paid for branded and/or generic Solodyn since December 2008.

The lawsuit accuses the defendants of violating federal antitrust laws, which have to do with marketplace competition.

The complaint was filed by lawyers Jayne A. Goldstein and Adam Giffords Kurtz, of the firm Pomerantz Gossman Hufford Dahlstrom & Gross, and Robert Klausner and Stuart A. Kaufman, attorneys practicing with Klausner Kaufman Jensen & Levinson.

The plaintiff seeks declaratory judgment along with unspecified monetary damages.

 

The federal case number is 2:13-cv-05021-JCJ. 

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