A
federal jury in California has ruled in favor of drugmaker Merck &
Co. in a high-stakes lawsuit against rival Gilead Sciences Inc. over
patents for lucrative new drugs that rapidly cure hepatitis C.
Merck accused Gilead of infringing on patents
it filed over a decade ago, claiming Gilead's sofosbuvir infringes on
those patents. Merck, which is based in Kenilworth, New Jersey, is
seeking billions in damages and royalties on sales of Gilead's two
hepatitis drugs.
Sofosbuvir is the active ingredient in Gilead's
Sovaldi and a component of its Harvoni. They were launched in 2013 and
2014, respectively, and became blockbusters overnight. Together, the two
drugs brought in $19.1 billion last year — nearly two-thirds of total
revenue for Gilead, a biologic drugmaker based in Foster City,
California.
On Tuesday, a jury in San Jose, California,
ruled Merck's patents are valid. That came a month after a federal judge
ruled that Harvoni and Sovaldi infringe on Merck's patents. Now the
jury's ruling sends the case to a new phase to decide damages.
"The jury's verdict accurately reflects the evidence in this case," Merck said in a statement.
Merck won U.S. approval on Jan. 28 for its own
hepatitis C drug, Zepatier, and priced it well under Harvoni's list
price of $94,000 per treatment course. That set up a battle between the
companies to win favorable formulary positions, and thus more sales,
from insurers and prescription benefit managers.
Meanwhile, the courtroom battle concerned
whether Pharmasset, a company Gilead bought for $11 billion in 2011 to
get the rights to then-experimental drug Sovaldi, used Merck's 2002
patents to develop that drug.
Merck argued that Gilead infringed two patents
for compounds and methods to develop treatments for the liver-destroying
virus. Merck said it, a company called Ionis Pharmaceuticals of
Carlsbad, California, and their partners spent years and significant
money working on the patents.
Gilead denied any patent infringement, saying Pharmasset began working on sofosbuvir's development a year earlier.
In a statement Tuesday, Gilead said, "Although
we are disappointed by the jury's verdict today, there are a number of
remaining issues to be decided by the jury and the judge. Therefore, it
is premature to comment any further."
According to Merck, Gilead initially filed the
lawsuit, seeking a declaratory judgment that the Merck and Ionis
Pharmaceuticals patents were invalid.
Merck had been a dominant maker of hepatitis C
treatments until Gilead's drugs were approved. Those drugs, as well as
Merck's and new ones from a couple other rivals, have revolutionized
treatment for hepatitis C, which roughly 3 million Americans have.
Older drugs required a year of treatment, with
awful side effects, yet barely cured half of the patients. The new drugs
cure about 95 percent of patients in eight to 12 weeks.
In after-hours trading, Merck shares rose 2.2
percent to $54.19, and Ionis Pharmaceuticals rose nearly 8 percent to
$45. Shares of Gilead dipped 2.7 percent to $91.30.
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