Cohen Placitella & Roth PC Combats Improper Extensions of Patent Monopolization of Brand-Name Drugs

By: Chris Placitella @ Jan 16, 2014

Cohen Placitella & Roth, PC has filed class actions on behalf of union health and welfare benefit plan clients, alleging violations of federal and state antitrust and unfair competition laws. The complaints allege that Teva Pharmaceuticals, USA, Inc. and Boehringer Ingelheim Pharmaceuticals, Inc. engaged in an illegal “pay-for-delay” scheme that delayed the entry onto the market of a generic version of Boehringer Ingelheim’s anti-stroke medication Aggrenox(tm).

As a result of this illegal scheme, the complaints allege, “Plaintiff and the members of the class have paid far more for Aggrenox than they would have had Boehringer allowed [Teva] to manufacture and market a generic [Aggrenox ] equivalent.” Defendants’ anti-competitive practices enabled Boehringer to extend its patent monopoly improperly, in turn, inflating its Aggrenox profits, which it shared with Teva.

Boehringer first offered the brand name Aggrenox in December 1999 under the protection of a patent it had secured. By 2008, Aggrenox sales yielded $366 million for Boehringer. That year, Teva’s predecessor sought approval from the federal Food and Drug Administration to manufacture and market a generic Aggrenox equivalent. After Boehringer had sued Teva for patent infringement, the parties agreed to a reverse payment settlement whereby Boehringer paid Teva as much as $120 million over through 2015 in exchange for Teva’s agreement not to bring a generic Aggrenox equivalent to market.

“Pay-for-delay” agreements, such as Boehringer’s with Teva, enable pharmaceutical companies to preserve the monopoly’s they have over the brand name drugs they develop beyond the time when those monopolies should expire. Payments to would-be generic competitors are a small price to pay to preserve monopoly profits the brand name manufacturers will certainly lose absent the agreement.

Of course, as pay-for-delay cases have evolved, so too has the sophistication and elaboration of the reverse payment arrangements brand name and generic manufactures concoct. In the Aggrenox case, for example, Teva offered to promote Aggrenox through a subsidiary now known as Teva Women’s Health to obstetricians, gynecologists and women’s health care professionals starting in March 2009. Boehringer’s payments to Teva, however, “far exceed[ed] the value of the services [that have been] provided,” clearly representing compensation to Teva to delay manufacturing and marketing a generic equivalent.

The Aggrenox cases are but one group of a pay-for-delay litigation in which Cohen Placitella & Roth is involved on behalf of its clients. Earlier in 2013, Cohen Placitella & Roth filed cases against Medicis Pharmaceutical Corporation and Impax Laboratories, Inc., relating to the acne drug, Solodyn, and, more recently, against Endo Pharmaceuticals, Inc. and Actavis, Inc., relating to the topical pain patch, Lidoderm.

If you wish to discuss these cases with Cohen Placitella & Roth, please contact Jacob A. Goldberg or Michael Coren at 1.888.375.760 or through our online form.

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