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Monopoly Claims Survive in Wellbutrin Antitrust Lawsuit
The Legal Intelligencer
March 18, 2009
A federal judge has refused to dismiss monopoly claims against pharmaceutical giant GlaxoSmithKline, maker of the wildly popular antidepressant drug Wellbutrin, for allegedly using sham patent suits to delay generic versions of the drug from making their way to the market.
In the suit, a group of drug wholesalers claim that GSK conspired with Biovail, the Canadian company it partnered with to market Wellbutrin XL, an extended release version of the drug.
Lawyers for GSK and Biovail moved for dismissal of the suit, arguing that the plaintiffs failed to show any illegal conspiracy because all of the conduct by GSK and Biovail could also be viewed as "merely parallel" conduct that could just as easily have been done independently.
But U.S. District Judge Mary A. McLaughlin disagreed, saying the plaintiffs had specifically alleged "joint action" by GSK and Biovail in pursuing the alleged sham lawsuits.
"The plaintiffs have adequately alleged a conspiracy between GSK and Biovail to maintain GSK’s monopoly over the American market for Wellbutrin XL," McLaughlin wrote in her 22-page opinion in In re Wellbutrin XL Antitrust Litigation.
"The plaintiffs have not simply alleged a series of parallel actions by competitors, but have alleged joint action by GSK and Biovail in the form of the first two infringement suits and a coordinated use of FDA regulations in order to delay generic competitors," McLaughlin wrote.
McLaughlin found that the allegations "do not relate to two competing enterprises who engaged in apparently coordinated business tactics." Instead, McLaughlin said, "the allegation is that GSK and Biovail performed a single, joint action in order to frustrate the marketing of generic competitors."
The ruling is a victory for a team of plaintiffs lawyers led by Thomas M. Sobol and David S. Nalven of Hagens Berman Sobol Shapiro in Boston, who argued that GSK and Biovail set out to protect GSK’s monopoly by concocting plans to delay generic manufacturers from marketing competing versions of Wellbutrin XL.
Joining them on the briefs are attorneys Jeffrey Kodroff and John Macoretta of Spector Roseman & Kodroff in Philadelphia; Daniel Berger, David F. Sorensen, Eric L. Cramer and Peter Kohn of Berger & Montague in Philadelphia; Dianne M. Nast of Roda Nast in Lancaster, Pa.; Linda P. Nussbaum and John D. Radice of Kaplan Fox & Kilsheimer in New York; Joseph M. Vanek and David P. Germaine of Vanek Vickers & Masini in Chicago; and Paul E. Slater of Sperling & Slater in Chicago.
The original patent on Wellbutrin expired long ago and generic versions have been available since the late 1980s. GSK recaptured some of the market when it introduced Wellbutrin SR, a "sustained release" version of the drug that was to be taken just twice daily instead of three times.
In 2003 the FDA approved another sustained-release formulation called Wellbutrin XL, intended to be taken just once a day.
But plaintiffs lawyers claim that GSK and Biovail knew they would soon be facing generic competition because the only patent protecting the XL version of the drug was a patent for an extended release agent that was "stabilizer free."
When generic manufacturers created versions of the drug that used stabilizers, the suit alleges that GSK and Biovail conspired to wage a series of lawsuits that they were sure to lose in court but would nonetheless delay the generic versions from getting to market.
"The lawsuits had no likelihood of ever succeeding, but nevertheless they served GSK’s and Biovail’s immediate purpose of triggering U.S. laws that would long delay the FDA’s approval of generic extended release bupropion," lead plaintiffs attorneys Sobol and Nalven wrote in their brief.
GSK and Biovial, they wrote, "knew that even though the courts would eventually rule against them in the infringement actions, in the meantime the GSK/Biovial venture would reap many hundreds of millions, perhaps billions, in revenues that it otherwise would have lost had it not abused the U.S. laws for generic entry."
By 2006, the suit says, the rulings came down. Three federal judges, in three separate districts, rejected GSK and Biovail’s position and found that the use of stabilizer by the generic manufacturers was decisive.
The patent infringement suits were later settled without any appeals, clearing the way for the FDA to approve entry for generic Wellbutrin XL.
But new court battles soon erupted when direct and indirect purchasers of Wellbutrin XL filed a series of antitrust suits alleging that the sham patent lawsuits were designed to illegally extend GSK’s monopoly.
"By filing sham lawsuits and sham regulatory filings with the FDA to delay generic entry, GSK and Biovail unlawfully acquired and maintained monopoly power," Sobol and Nalven wrote.
GSK’s lead lawyer, Arthur Makadon of Ballard Spahr Andrews & Ingersoll, declined to comment on the ruling.
