Federal Judge Reopens Gilead Case Amid Allegations Former Merck & Co. Scientist Lied

May 2, 2016
By Alex Keown, BioSpace.com Breaking News Staff

FOSTER CITY, Calif. – A $200 million award to Merck may be in jeopardy after reports a former Merck scientist lied to a jury about claims that he was responsible for the development of hepatitis drugs patented by Merck that Gilead Sciences had been accused of infringing upon.

However, Bloomberg reported this morning that Gilead claims there is evidence the scientist, Phil Durette, may have relied upon work previously done by Pharmasset Inc. , a company that was later acquired by Gilead. There is apparently enough evidence to support Gilead’s claims that U.S. District Judge Beth Labson Freeman told Bloomberg she was “outraged” over what she said could be “untruthful testimony.”

Gilead argued its scientists were working on the hepatitis C compounds before Merck secured its own patents. The company argued that the compound has its roots at Pharmasset Inc., which Gilead acquired in 2011 for $11 billion.

In its argument over Durette, Gilead said that in 2004, when Merck was considering its own acquisition of Pharmasset, Durette participated in a conference call where that company’s hepatitis drugs were discussed. Initially he told the jury he wasn’t on that call, but then later recanted, saying he “forgot” he was on the call, Bloomberg reported. Merck claims Durette’s changing testimony was not intentional, saying that the scientist acknowledged that “he’d been on the call once his personal notes confirmed it,” Bloomberg reported.

The two sides are expected to be in court today to file additional charges over the testimony of Durette. If the patent trial is reopened, it could conceivably swing even more in Gilead’s favor and have the $200 million award lowered even more, or perhaps dismissed altogether.

In March, a jury ordered Gilead to pay Merck $200 million in damages for patent infringement for two lucrative hepatitis C drugs, Harvoni and Sovaldi, both of which are highly effective treatments for hepatitis. The award was far less than the almost $3 billion Merck was initially seeking. Merck sought 10 percent of revenue generated from the two drugs, which was nearly $20 billion in 2015, alone.

Merck has its own recently approved hepatitis C drug, Zepatier.

Zepatier was granted breakthrough therapy designation for the treatment of chronic HCV genotype 1 infection in patients with end stage renal disease on hemodialysis and for the treatment of chronic HCV genotype 4 infection. Breakthrough therapy designation is a program designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.

Although Gilead took a hit from damages award, the company is not through developing additional treatments for hepatitis, even though Harvoni and Sovaldi provide near cures for the patients who used the drugs. In January, Gilead submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for tenofovir alafenamide, an investigational, once-daily treatment for adults with chronic hepatitis B virus infection. The company is also continuing to use Sovaldi in combination with other drugs, including a triplet drug comprised of Sovaldi, velpatasvir, and a protease inhibitor for the treatment of genotype 3 HCV patients. Also, in the waning days of 2015, Harvoni was approved for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus (HCV) infection and in patients co-infected with HIV by the U.S. FDA.