Stark Wipes Out $235M Infringement Verdict Against Teva for Hypertension Drug
A Delaware federal judge on Wednesday wiped out a $235 million verdict against Teva Pharmaceuticals for supposedly infringing a GlaxoSmithKline plc patent for the hypertension drug Coreg.
March 29, 2018 at 06:06 PM
3 minute read
A Delaware federal judge on Wednesday wiped out a $235 million verdict against Teva Pharmaceuticals for supposedly infringing a GlaxoSmithKline plc patent for the hypertension drug Coreg.
U.S. District Chief Judge Leonard P. Stark of the District of Delaware ruled in a post-trial opinion that the evidence in the case did not support a jury's finding in June that Teva's ”skinny label” for a generic version of the drug had caused doctors to infringe GSK's patent.
The Wilmington panel had awarded a total of $235.4 million to GSK—$234.1 million for lost profits and an added $1.4 million in royalties—after a six-day trial last summer.
Teva had asked Stark to reverse the jury verdict last August, arguing that a host of other factors had led doctors to prescribe its generic for uses other than the narrow indication listed on its label. In court documents, Teva said physicians had been influenced by industry publications, research studies and GSK's own marketing activity, and not Teva's skinny label alone.
“In order to uphold the verdict, the court must find in the record substantial evidence to render it reasonable for the jury to have inferred that at least one doctor was so induced,” Stark wrote in a 26-page memorandum opinion.
“The court's determination, however, is that—given the dearth of evidence that doctors read and understand and are affected by labels, and given the vast amount of evidence that doctors' decisions to prescribe carvedilol during the relevant periods were influenced by multiple non-Teva factors—such an inference was an unreasonable one for the jury to have drawn.”
Stark did not overturn a jury's decision to uphold the validity of GSK's patent.
Neither GSK nor Teva responded to calls Thursday requesting comment on Stark's ruling.
The jury handed down its verdict June 20, just one day after trial wrapped up in the case accusing Teva of improperly marketing its generic as a substitute for Coreg. GSK had charged that Teva's label for the beta-blocker carvedilol had encouraged patients and doctors to use its generic to treat congestive heart failure, or CHF, even though it had a specific “carve out” that excluded the chronic disease.
In its post-trial briefing, GSK said there was “ample evidence” to support to jury's finding, including the company's own expert, who said he himself had been induced to infringe the patent.
However, Stark poked holes in GSK's reading of the testimony of Peter McCullough, saying the transcript “does not show Dr. McCullough stating what GSK seems to think he said.” Instead, Stark said that McCullough merely indicated that he did not read Teva's label prior to administering generic carvedilol.
The drugmaker, he said, had provided no other direct evidence at trial showing that any doctor had ever been induced to infringe the patent.
“Without proof of causation, which is an essential element of GSK's action, a finding of inducement cannot stand,” Stark wrote.
Attorneys for both sides were not immediately available to comment.
GSK was represented by W. Chad Shear, Martina Tyreus Hufnal, Craig Countryman, Douglas E. McCann, Elizabeth M. Flanagan, Jeremy D. Anderson, Limin Zheng, Michael A. Amon, Robert M. Yeh and William R. Woodford of Fish & Richardson.
Teva is represented by Christopher T. Holding, Daryl L. Wiesen, Alexandra Lu, Andrew E. Riley, Corrine L. Lusic, Ira J. Levy, J. Anthony Downs and Jennifer L. Ford of Goodwin Procter.
The case is captioned GlaxoSmithKline v. Teva Pharmaceuticals USA.
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