Gilead Blockbuster Hepatitis C Drug Patent Infringement Ruling Overturned

Federal judge finds that sofosbuvir (Sovaldi) and ledipasvir/sofosbuvir (Harvoni) do not infringe on Merck patents.

A federal judge recently overturned a jury verdict that required Gilead Sciences to pay $2.54 billion over charges that its blockbuster hepatitis C virus (HCV) drugs sofosbuvir (Sovaldi) and ledipasvir/sofosbuvir (Harvoni) infringed on patents held by Merck & Co, according to Reuters.

The previous verdict was the largest patent case ever brought before a court, according to the report.

However, US District Judge Leonard Stark from Delaware ruled that Merck’s patent was invalid and did not meet the requirements for disclosing how to make the drug without unnecessary experimentation.

Gilead said in a statement that it believed the patent was invalid from the start and felt positively about the new ruling.

On the other side, Merck said in a statement that it plans to appeal and feels that the ruling was not representative of the facts, according to Reuters.

“We believe the judge’s ruling does not reflect the facts of the case,” a Merck spokesperson told STAT. “The patent at issue in this case facilitated significant advances in the treatment of patients with HCV infection, and achieving these advancements required many years of research and significant investment by our subsidiary and its partners.”

The tension between the companies started 1 year before Merck’s acquisition of Idenix Pharmaceuticals to improve its HCV portfolio. In 2013, Idenix filed a patent infringement lawsuit against Gilead, in which they argued the patents for sofosbuvir were too similar to patents for its previously developed HCV drug, according to STAT.

To further complicate the issue, sofosbuvir was developed by Pharmasset, which was bought by Gilead in 2011. Gilead owned and launched sofosbuvir when the original lawsuit was filed in 2013, according to the article.

Idenix argued that the founder of Pharmasset—who was also a consultant for Idenix—disclosed confidential information about its research efforts to his own scientists, which lead to the development of sofosbuvir, according to STAT.

This is the second victory Gilead has won against Merck, according to STAT. The first came when a federal judge ruled that Gilead did not have to pay $200 million in damages related to another patent infringement lawsuit over sofosbuvir. The judge ruled that Merck’s lawyer gave false testimony about his involvement in negotiations with Pharmasset and displayed a “pattern of misconduct,” STAT reported.