Dive Brief:
- A trial in a California federal court between Gilead and Merck began this week over patents to ingredients in Gilead's blockbuster hepatitis C treatments, the Wall Street Journal reports.
- Although Gilead launched Sovaldi (sofosbuvir) in 2013, Merck claims it patented key nucleosides related to sofosbuvir in 2002. Merck had demanded a 10% royalty of sales of Gilead's Harvoni and Sovaldi, leading to a 2013 counter-suit by Gilead.
- Gilead bought the patents to sofosbuvir in 2011 when it acquired Pharmasset for $11 billion.
Dive Insight:
Within a year of its launch in December 2013, Sovaldi became the second-best selling drug in the world after AbbVie's Humira (adalimumab). Gilead followed up on that success with Harvoni, which combines sofosbuvir with ledaspavir. In 2015, Harvoni generated nearly $14 billion in global sales.
Opening statements were held earlier this week, as the opposing lawyers lay out the competing arguments. Merck's claim to the nucleosides includes its 2002 patent, which covers 150 different compounds and gives it a broad basis for claiming patent rights to different compounds.
However, Gilead's attorney told the court, "In this world, the smallest change can make the biggest difference," according to the Recorder. In this case, it is a difference potentially worth billions of dollars.
Gilead is arguing it owes Merck nothing because the 2002 patents aren't specific enough to cover Gilead's patent for sofosbuvir.