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Wellbutrin PAL Member Lawsuit Summary
While the active ingredient of Wellbutrin and Zyban has been off patent for nearly ten years, in 1995 Glaxo received a patent for the extended release formula of Wellbutrin SR. In 1999, generic drug manufacturer Andrx filed two ANDAs with the FDA seeking to sell generic versions of extended release Wellbutrin and Zyban. Andrx argued that because its generic used a different method of extended release, that it did not infringe on Glaxo's patent. Four other generic manufacturers followed Andrx's lead, and several have received tentative approval to manufacture and market their generic versions. In spite of this, these generics have not come to market because of Glaxo's anti-competitive actions.
In September of 1999, Glaxo filed a patent infringement case against Andrx, triggering automatically a 30 month stay on production and marketing of Andrx's generic versions of Wellbutrin and Zyban. In spite of a decision against Glaxo in April, 2001, by the PTO the company continued to pursue the patent infringement suit, delaying the entry of generics into the market and thereby earning it millions in monopoly-priced profits from sales of Wellbutrin and Zyban. This is, therefore, another case of consumers paying more for a patented drug because the brand name manufacturer has manipulated the patent system to keep a generic off the market.
The PAL case was voluntarily dismissed in 2003 following an adverse appeals court decision in the Andrx patent litigatin. However, the case was refiled in December 2004 after subsequent positive appeals court decisions in patent cases involving two other generic competitors. The defendants filed a motion to dismiss on March 23, 2005. The Defendants' motion to dismiss has been denied.
Update October 2008: A motion to certify an end-payor class was filed on June 29, 2006, and briefing and argument on the motion were concluded on July 31, 2008. A decision is pending.
In the meantime, defendant GlaxoSmithKline submitted a motion for summary judgment on their patents on October 20, 2008.