Bloomberg: MSD требует от Gilead выплаты лицензионного вознаграждения от продаж софосбувира

Gilead Sciences Inc., which pioneered a cure for hepatitis C, is trying to fend off a demand by Merck & Co. for more than $3 billion in a patent dispute over the liver disease treatment.

A compound in Gilead’s blockbuster drugs Sovaldi and Harvoni was found by a judge last month to have infringed Merck’s patents. Now, a jury must decide whether those patents are still valid, and if so, how much Gilead owes Merck in royalties.

Gilead plans to show jurors that scientists were working on the foundation for its medicine at least as early as 2001, a year before Merck got the patent rights that it’s seeking to enforce in the case, Juanita Brooks, a lawyer for the world’s largest biotechnology firm, said Monday during opening arguments at a trial in federal court in San Jose, California. She said Gilead owes the success of its drug not to Merck but to laboratory research done 15 years ago by Pharmasset Inc., which Gilead acquired in 2011 for $11 billion.

“It’s clear whose invention this is,” Brooks told the jury. “It’s clear this is Pharmasset’s invention and Gilead’s acquisition. So why are we here?”

Merck’s lawyer countered that the key invention at issue derived from work by his Kenilworth, New Jersey-based client “before it was ever even a figment of the imagination at Pharmasset.” Merck alleges that immediately after the company published its patent in 2002, Pharmasset used it to develop what would later become the compound sofosbuvir.

‘Not True’

“Gilead wants you to think Merck’s patents are based on Pharmasset’s inventions, but that’s just not true,” attorney Bruce Genderson said in his opening statement. “They were based on Merck’s own work over years.”

Sofosbuvir generated about $19 billion revenue in 2015 for Gilead, which dominates the market with its cure for hepatitis C, with list prices in the U.S. from $84,000 for a 12-week course to $94,500 before discounts.

While Gilead’s profit has risen almost sevenfold in the last three years, the Foster City, California-based company expects a flattening of its hepatitis C drug sales in the U.S. this year as competition intensifies among drugmakers.

In the trial, Gilead is fighting a royalty demand for 10 percent of the $31.7 billion it’s made from sofosbuvir. Even if it loses, Bloomberg Intelligence analyst Asthika Goonewardene said, the company should be able to weather a penalty of that size.

“Sure, investors won’t be thrilled, but that’s assuming Gilead rolls over and plays and dead and gives Merck 10 percent -- that’s highly unlikely,” he said. “A $3 billion charge will be uncomfortable, but no one is worried they can’t keep the lights on at night.”

Merck is not seeking a court-ordered ban on sales of Gilead products that allegedly infringe its patents, Genderson said in court.

‘Prohibitive’ Royalty

The fight in federal court in San Jose started in 2013 when Gilead sued its rival after being being asked to pay what it called a “prohibitive” royalty on sofosbuvir. Gilead said in its complaint that it saw the request, coming on the eve of regulatory approval for sofosbuvir, as a “threat” by Merck to bring infringement claims over two of its patents registered in 2002.

Merck’s own liver disease treatments Victrelis and PegIntron last year generated $200 million in global sales, tumbling almost 63 percent in a year. The company said the fall was a contributor to Merck’s 6.5 percent drop in sales in 2015. In 2012, the year before sofosbuvir hit the market, Merck’s two hepatitis C drugs combined to generate about $1.2 billion in sales, according to data compiled by Bloomberg.

In 2015, activist groups raised concerns that patents covering expensive hepatitis C treatments have restricted access to more affordable generic drugs in countries including China and India. The Indian patent office began hearings in February to determine whether the sofosbuvir patent will be valid in a market where millions of people suffer from liver disease while some 700 million live on less than $2 a day. Gilead has licensed 11 manufacturers in India to make generic forms of the pill, which are going for as little as $4.29 a pill.