$235 Million Pharma Infringement Award Could Turn on Single Screenshot
Time is of the essence as GlaxoSmithKline and Teva dispute whether a generic version of cardiovascular drug Coreg infringed GSK's method of using it to treat congestive heart failure.
September 05, 2019 at 05:17 PM
5 minute read
Juanita Brooks was hunting for a $235 million citation.
Time was winding down on an hour-long argument in which the Fish & Richardson partner was trying to revive a $235 million jury award that Brooks had won for GlaxoSmithKline LLC, but that Chief U.S. District Judge Leonard Stark of the District of Delaware had thrown out on posttrial motions.
The U.S. Court of Appeals for the Federal Circuit sounded divided as arguments in GlaxoSmithKline v. Teva unspooled Wednesday morning. Chief Judge Sharon Prost of the U.S. Court of Appeals for the Federal Circuit had ticked off a number reasons for agreeing with Stark that Teva Pharmaceuticals Inc. had not induced infringement of GSK's method of treating congestive heart failure with the drug Coreg. Judge Kimberly Moore of the U.S. Court of Appeals for the Federal Circuit, on the other hand, said she "can't imagine a stronger case for induced infringement," given that Teva had touted the equivalence of its generic version of Coreg in press releases and marketing materials. Judge Pauline Newman was the third judge on the panel.
Teva's lawyer, Goodwin Procter partner William Jay, argued that Teva issued the press releases in 2004 and 2007, before GSK patented a method of using carvedilol, the active ingredient in Coreg, to treat congestive heart failure. "The patent issued in 2008," he told the court. "There is not a shred of evidence that anyone saw these press releases during the time period when the patent was in force. None. None at all."
Brooks said Teva has been displaying the press releases for all the world to see over the last 12 years. Jurors were shown a screenshot of one taken in 2015, she said. "They put those press releases up on their website, and they're still there today," Brooks said.
The focus of Wednesday's arguments was expected to be the label accompanying Teva's generic product. Teva explicitly "carved out" congestive heart failure from its drug's indicated uses in 2007 so as not to infringe GSK's patent. Then in 2011 it amended the label to include congestive heart failure. GSK had argued that that the labels combined with Teva's press releases and marketing materials touting its generic as "AB rated," or therapeutically equivalent to Coreg, induced doctors to infringe its method of treating congestive heart failure.
"We know the labels are important. You said to Judge Stark, no label, no inducement. So we can all agree with that," Prost told Brooks. But, she said, GSK had stressed the importance of press releases at trial to recover damages regardless of which label was in effect. And the only doctors called to testify said they weren't influenced by press releases. "I think what the district court was concluding was the circumstantial evidence and the inferences largely went against you," Prost said.
Moore appeared to have a 180-degree opposite take. She said inducement is a factual issue for a jury, and if any evidence supports its verdict, it must be respected. "I'll tell you what," she said to Teva lawyer Jay. "One thing Chief Judge Prost said earlier is the labels are important, we can all agree on that." She then added in a stage whisper, "I don't agree."
"I think the releases are enough," Moore said. "I think the releases present enough evidence when presented to a jury, that could have sufficed, even if the label had never said heart failure. Never, at any point."
The 2015 screenshot is evidence that doctors could have seen the press releases during the patent period, she told Jay.
"That's not correct, your honor," Jay said. "The screenshot is not of the press release. It's a screenshot of another thing from Teva's website, a different exhibit."
Moore sounded temporarily stumped. "Are you saying the jury was never made aware that Teva put press releases on its website?"
"I am saying that," Jay replied.
"The jury was never told Teva puts press releases on its website?" Moore asked.
"Never," Jay said. "Not once. Never."
When Brooks returned for rebuttal, the discussion quickly turned to the disputed screenshot. It was pretty clear that, at least for Moore's vote, the display of the press release would be critical.
"Were you mistaken? Did I misunderstand you?" Moore asked Brooks.
"I'm not mistaken," Brooks said, but her colleagues were still sifting through the trial record in an effort to locate the precise citation.
"Because he said you were unequivocally misspeaking or wrong when you said that," Moore said.
"I know that I'm not because we, in our brief, showed the court … that those press releases are still on the website," Brooks said.
"Showed the court or showed the jury?" Moore pressed.
"Both," Brooks said. "We'll find it before I finish, and I have very little time."
Just as her final seconds expired, the Fish team located the document. "Here we go," Brooks said. "It's Appendix 6353."
"This is the actual document that was presented to the jury, and it shows that it was pulled from the Teva website on April 14, 2015?" Moore said.
"Yes, your honor," Brooks said.
"So the jury had in front of it very clearly the idea that as of 2015, this release was still accessible on the Teva website?" Moore said.
"Correct, your honor," Brooks said.
"Got it," Moore said.
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