Posts Tagged: "hepatitis C"

Merck Hepatitis C Virus Treatment Patents Unenforceable due to Unclean Hands

On Wednesday, April 25th, the Court of Appeals for the Federal Circuit issued a precedential decision in Gilead Sciences v. Merck & Co. et. al., which affirmed a lower court’s ruling that Merck could not assert claims from two patents against Gilead because Merck had unclean hands regarding the patents. The case, coming out of the Northern District of California, involves patents covering methods for effectively treating the hepatitis C virus (HCV)… Reviewing the facts of the case, the Federal Circuit panel found sufficient evidence supporting the district court’s findings of serious business misconduct by Merck, that Merck’s misconduct was related to the litigation and that litigation misconduct had occurred based on false testimony provided by Merck’s non-firewalled patent lawyer, who had originally testified that he was not a party to the March 2004 phone call with Pharmasset.

Undermining Innovation Is Not A Victory: Hepatitis C Drug Center Stage in Global Patent Battle

Thanks to a number of new Hepatitis C drugs (Sofosbuvir Ledipasvir, Ladispavir) the disease is curable for many patients. While this is an undeniable victory for patients and payers, the innovators who made this possible have been villainized and undermined. At a time when the public health community should celebrate the tremendous health benefits these breakthrough drugs have brought to patients around the world, they are instead organizing to ensure the destruction of the incentives that made these drugs a reality. A recent study from the Centers for Disease Control and Prevention estimates that 2% – 3% of the world’s population is living with hepatitis C. The World Health Organization states that globally an estimated 71 million people have chronic hepatitis C infection and approximately 399,000 people die each year from the disease.

Idenix Loses Patent on HCV Treatment that Supported $2.54 Billion Infringement Verdict

In invalidating the Idenix patent, the Delaware district court effectively overturns what had been the largest award for royalty damages in a U.S. patent infringement case ever handed out. After a two-week trial in December 2016, the jury had awarded Index $2.64 billion in damages, which was based on finding Gilead infringed the Idenix patent – U.S. Patent No. 7,608,597 — by selling the hepatitis C virus (HCV) treatments Harvoni and Sovaldi.

A look at treatments for hepatitis C, America’s top infectious disease killer

The FDA has been pretty active this year in approving new tests and treatments designed to help identify and eliminate the hepatitis C virus in patients. Swiss healthcare developer Roche (VTX:ROG) received FDA approval this March for a new quantitative RNA test which can help physicians see exactly what level of HCV exists in a patient’s blood instead of simply confirming an active infection. Earlier this year, in late January, the FDA granted approval to Merck & Co. (NYSE:MRK) for a once-daily single tablet treatment branded as Zepatier. Zepatier is another combination drug therapy which incorporates elbasvir and grazoprevir, both HCV RNA inhibitors, and is designed to treat patients having one of two strains of HCV, including the most common strain. A 12-week regimen of the treatment costs $54,600.

Gilead Sciences continues to produce new pharmaceuticals to treat hepatitis C, HIV

Although not a prolific filer of U.S. patent applications, Gilead does currently holds 2,131 active patent grants according to data collected by Innography… Despite all of the recent focus on Gilead’s anti-viral medications, we noted a trio of patents issued to the company recently by the USPTO to address issues in patient cardiac health. U.S. Patent No. 9056108, issued under the title Method of Treating Atrial Fibrillation, claims a kit containing a first composition which includes dronedarone or a pharmaceutically acceptable salt thereof, and then a second composition which includes ranolazine. This innovation was found to improve the anti-arrhythmic efficacy of dronedarone, which can be used to treat atrial fibrillation but is poorly tolerated by patients in higher doses.