Published On: Wed, Apr 5th, 2017

GlaxoSmithKline Urges Third Circuit to Ignore Ruling in Fosamax Case

GlaxoSmithKline PLC has asked the Third Circuit Appeals Court to ignore the ruling in a product liability case involving the drug Fosamax when deciding whether to revive a suit brought on by buyers of Wellbutrin. The company argues that the Fosamax case is irrelevant in many ways.

GSK filed a letter in response to the buyers’ request earlier in the week asking to consider the March 22 decision that reversed the dismissal of a product liability suit involving Fosamax.

The drugmaker says the ruling in the Fosamax case rejected an argument from Merck that the U.S. FDA’s (Food and Drug Administration) behavior was an issue of law and should be decided by the court. GSK argues that in the current case, a lower court already determined that Wellbutrin buyers presented speculation, not facts, as evidence of delay. The burden is on the buyers, GSK says.

Buyers of Wellbutrin filed suit after GSK made a reverse payment settlement in 2007 with Biovail Corp., the drug’s patent owner. Biovail later merged with Valeant Pharmaceuticals International and other generic drug makers, including Teva Pharmaceuticals.

gavel court scales justice ruling

photo via Pixabay user Succo

As part of the deal, Teva agreed to delay the production of a generic version of the antidepressant until 2008 if generic makers, including Anchen Pharmaceuticals, prevailed in the patent disputes against GSK.

GSK agreed not to sell a generic version of Wellbutrin for six months after Teva began selling generic versions of the drug.

A court concluded in 2015 that the buyers of Wellbutrin lacked the evidence to prove the deal had anti-competitive effects. Even if the plaintiffs did have proof, the court ruled, a reasonable jury would be unable to decide whether the effects outweighed the benefits of the settlement for the competition. The buyers appealed the decision.

The buyers filed a letter last week that cited the court’s reversal in the Fosamax case. The reversal ruled the that the jury should make the decision on a hypothetical question of whether the FDA would have rejected safety warnings. The buyers argue that their case is similar in that it questions when competing generic drugs would have entered the market if GSK hadn’t come to a settlement.

In its response, GSK said Fosamax was held to a higher standard than it should be. Merck’s defense, they say, required proof that its warnings would have been rejected by the FDA.

GSK’s letter filing comes just days after the FDA rejected Mylan’s application to market a generic version of Advair, the company’s lung disease drug. The news sent GSK’s stock higher last week. Shares of GSK gained 0.7% on the news.

Hikma Pharmaceuticals is awaiting a decision from the FDA on marketing its generic version of Advair. The decision is expected by May 10.

The case involving Wellbutrin and the threat of competition to Advair is pressuring GSK. If generic versions of Advair are allowed to hit the market by mid-2017, the company expects sales of the drug to fall to 1 billion pounds from 1.83 billion pounds the previous year.

Author: Jacob Maslow

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