A case has been filed against the pharmaceutical companies Pfizer and Teva Pharma (generics) in the US Courts for ‘maintaining monopoly power’ and ‘for delaying entry of cheaper generic versions of anti-depressant drug Venlafaxine Hydrochloride from the US market. Venlafaxine Hydrochloride, is a drug prescribed for major mental illnesses like depression and anxiety disorders. The case Walgreen Co et al v. Wyeth Inc et al was filed on 30th November 2011 in the U.S. District Court, District of New Jersey, No. 11-06958.
The compound venlafaxine hydrochloride was patented in 1985 and Wyeth had already enjoyed more than 20 years of patent monopoly and exclusivity, slated to expire in 2008.
Wyeth (now taken over by Pfizer) used fraudulently obtained patents to block more affordable generic versions of Venlafaxine Hydrochloride XR (extended release) from the market by listing these patents in the U.S. Orange Book even though it knew that the extended release venlafaxine formulation was a routine development and in no way a new invention. It then promptly filing baseless patent infringement litigation against each and every generic manufacturer that tried to bring a generic extended release venlafaxine product to market, thereby triggering the automatic two-and-a-half year stays of FDA approval of generic versions.
Wyeth asserted that generic manufacturers were infringing its method of use patents – patents Wyeth knew to be invalid and/or unenforceable – in seventeen sham lawsuits. Wyeth was aware that in the 1990’s, methods for achieving sustained or extended release of the active ingredient in pharmaceuticals were well known in the industry.
The complaint highlights that Wyeth indulged in an anticompetitive scheme – obtaining fraudulent patents, engaging in sham litigation, and entering a price-fixing agreement with Teva to delay cheaper generic equivalents from reaching the market.
The complaint consisting of 78 pages can be viewed here.
Reuters reported the case on 1 Dec 2011. See newsreport here .
