Court bars Merck from prosecuting Gilead in patent infringement case

A jury of the U.S. District Court barred Merck from further asserting the patent suit for hepatitis C treatments against Gilead Sciences after they found Merck to be guilty of “unclean hands” and their patent attorney’s actions to be “dishonest and duplicitous,” according to court documents.

“In this case, Gilead is guilty of patent infringement. It admitted so much in response to Merck’s motion for summary judgment,” according to the court order. “By contrast, Merck has engaged in business misconduct and litigation misconduct that the Court has found to be egregious.”

The court documents state Merck’s patent attorney Philippe Durette, MD, PhD, — the person responsible for filing claims for prosecution of patents 7,105,499 and 8,481,712— was dishonest with the Court, Pharmasset and Gilead Sciences. They further state Merck allowed and supported its own attorney to violate the principles of the legal system and Merck now “shares the consequences of those actions.”

According to the court order, Durette knowingly misled Pharmasset in regards to his status as being within the firewall during the patent process. Merck approved the misconduct by assigning the HCV patent attorney to handle the Pharmasset due diligence work and thereafter, when Durette ceased his due diligence work on Pharmasset’s compound, directed him to remain active in prosecuting Merck’s overlapping HCV packet docket through which he obtained confidential Pharmasset PSI-61330 disclosure.

The Court further concluded that Durette intentionally “fabricated” testimony during the trial and Merck condoned that as well.

Merck plans to appeal the verdict, according to Lainie Keller, spokesperson for the company.

“The judge’s ruling does not reflect the facts of the case and we will be filing the appropriate motions to begin the appeals process,” Keller told Healio.com/Hepatology via email. “In its decision, the jury recognized that patent protections are essential to the development of new medical treatments. The compounds and methods 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 Merck and its partners.”

Merck and Ionis first filed the patent 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 questions the two patents, comprising two methods and eight composition of matter claims, and demanded 10% royalty on sales of sofosbuvir-based drugs.

Gilead argued that Merck’s claims were invalid and Merck had waived their rights to the two patents, but the court denied Gilead’s motion of invalidity and granted Merck’s judgment of infringement.

In March, a jury determined Gilead was guilty of patent infringement and awarded $200 million in damages for sales of sofosbuvir and ledipasvir/sofosbuvir through December 31, 2015 to Merck and Ionis Pharmaceuticals. Gilead appealed this decision.

In the appeal, the Court said Gilead did not show Merck waived its right to the two patents. “The record, however, reflects a pervasive pattern of misconduct by Merck and its agents constituting unclean hands, which renders Merck’s ’499 and ’712 Patents unenforceable against Gilead,” the latest document states,

Gilead said in a statement: “We are pleased the court has ruled in Gilead’s favor and determined that Merck’s patents are unenforceable against Gilead, and therefore, Merck is not entitled to recover any damages,” Michele Rest, spokesperson for Gilead, told Healio.com/hepatology via email. “Gilead has always believed Merck’s patents are invalid and unenforceable, and we feel vindicated by [the] decision.” – by Melinda Stevens

Disclosure: Keller is an employee of Merck. Rest is an employee of Gilead.