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Teva Wins New Hearing in Glaxo ‘Skinny Label’ Drug Patent Case

Feb. 9, 2021, 4:53 PM

A U.S. appeals court agreed to reconsider a controversial October ruling that generic-drug maker Teva Pharmaceutical Industries Ltd. said would enable brand companies to block low-cost competition.

A split three-judge panel of the U.S. Court of Appeals for the Federal Circuit had revived a $235 million patent-infringement verdict won by GlaxoSmithKline Plc over Teva’s sales of a generic version of the heart drug Coreg. The panel will rehear arguments in the case on Feb. 23 in Washington.

The dispute is over so-called “skinny labels,” used by generic-drug makers when they are selling a copycat of a branded medicine but only for limited uses. The practice is encouraged to allow low-cost medicines on the market even when a drugmaker has discovered new treatments for a branded medicine.

The jury had found that, notwithstanding a Teva label that excluded Glaxo’s patented treatment for congestive heart failure, Teva was responsible for inducing doctors to prescribe the drug for that purpose. Jurors said Teva should compensate Glaxo for the $234 million in profits it lost to the competition plus $1.4 million in royalties on the $75 million in Teva sales.

Consumer groups and other generic-drug makers urged the Federal Circuit, the nation’s top patent court, to reconsider the decision, saying it would undermine efforts to lower drug costs.

Read More: A Skinny Label Is Worth a Few Hundred Million Dollars to Amarin

They point to a lawsuit filed by Amarin Corp., which is trying to get a generic version of its heart medicine, Vascepa, pulled off the market. Amarin’s main patents were canceled last year but it claims Hikma Pharmaceuticals Plc’s skinny label induces doctors to prescribe the drug for a newly-approved cardiovascular indication.

Glaxo said its case was very fact-specific because of “Teva’s actions, as a whole,” including old press releases Teva kept on its website. The carve-out options “continue to remain viable if properly done,” Glaxo said.

The February hearing will focus only on the period from Jan. 8, 2008, when the Glaxo patent was reissued, through April 30, 2011, when the Food and Drug Administration ordered Teva to amend its label. All other issues are “sufficiently briefed,” the court order said.

The case is GlaxoSmithKline LLC v. Teva Pharmaceuticals USA LLC, 18-1976, U.S. Court of Appeals for the Federal Circuit (Washington).

To contact the reporters on this story:
Susan Decker in Washington at sdecker1@bloomberg.net;
Christopher Yasiejko in Wilmington, Delaware, at cyasiejko1@bloomberg.net

To contact the editors responsible for this story:
Jon Morgan at jmorgan97@bloomberg.net

Elizabeth Wasserman

© 2021 Bloomberg L.P. All rights reserved. Used with permission.