Court awards Merck $200 million in patent infringement case

A jury of the U.S. District Court awarded $200 million to Merck and Ionis Pharmaceuticals in a suit against Gilead Sciences for patent infringement for hepatitis C treatments. Gilead disputes the ruling and plans to appeal.

Merck and Ionis filed the suit with claims that Gilead infringed upon jointly patented compounds and methods when developing sofosbuvir, which is utilized in Sovaldi (sofosbuvir, Gilead Sciences) and Harvoni (ledipasvir/sofosbuvir, Gilead Sciences). The lawsuit specifically called into question patents 7,105,499 and 8,481,712, comprising two methods and eight composition of matter claims, and demanded 10% royalty on sales of sofosbuvir-based drugs.

To reach the $200 million final number, the jury determined Gilead’s sales from 2013 through 2015 to be $5 billion after expenses and assessed a 4% royalty. There will be an additional ruling on royalties from January 1, 2016, going forward. Ionis announced it will receive 20% of the award once legal fees are extracted.

“We used our expertise in a 1998 collaboration with Merck to discover and develop modified nucleosides that benefit patients with HCV,” Stanley T. Crooke, chairman and CEO at Ionis said in a press release. “The verdict today confirms the validity and value of the intellectual property covering the nucleoside analogs and methods we and Merck invented to treat HCV.”

A Merck press release echoed that sentiment: “The jury’s verdict upholds patent protections that are essential to the development of new medical treatments. Given that it guarantees a firm a period of return on investment, patent protection provides the research-based pharmaceutical and biotechnology industries with an incentive to invest in research and development.”

Gilead, however, plans to appeal the verdict if it is upheld by a judge, according to Michele Rest, spokesperson for the company.

“Since Merck made no contribution and assumed none of the risk in the discovery and development of sofosbuvir, we do not believe Merck is entitled to any amount of damages,” Rest told Healio.com/Hepatology in an email statement. “We continue to believe the Merck patents are invalid. In the event the judge maintains the jury’s verdict, we will appeal.” – by Katrina Altersitz

Disclosure: Crooke is an employee of Ionis Pharmaceuticals. Rest is an employee of Gilead Sciences.