(Reuters) – Merck & Co on Thursday was awarded $2.54 billion in royalties by a federal jury in a patent lawsuit against Gilead Sciences Inc over Gilead’s blockbuster hepatitis C drugs Sovaldi and Harvoni.
The jury in Delaware reached the verdict following a nearly two-week trial, finding that a patent acquired by Merck in 2014 on hepatitis C treatments was valid.
“The jury’s verdict upholds patent protections that are essential to the development of new medical treatments,” Merck said in a statement Thursday.
Currently, an individual’s condition must reach a critical level before Missouri will cover some of the most effective treatments available.
On October 18, the state of Missouri was sued for denying “medically necessary treatment” to two individuals “and numerous other Medicaid benificiaries” infected with the Hepatitis C virus (HCV). The Missouri Department of Social Services estimates that 13,000 Missouri Medicaid beneficiaries have chronic HCV, a transmissible virus that attacks the liver and can lead to liver scarring, liver cancer, and death.
Since 2014, several new drugs that can cure patients with high rates of success, without the severe side effects of previous treatment, have become available. But they have a steep price tag. Harvoni is one of the new HCV drugs. According to NPR, it cures 93 percent of patients but costs $1,125 per pill; the full course of the drug ranges from $63,000 to $95,000.
Colorado’s Medicaid agency was hit with a federal lawsuit last week claiming it illegally restricted treatments for thousands of low-income hepatitis C sufferers.
The American Civil Liberties Union filed the class-action lawsuit in federal district court despite a pivot earlier this month by the health agency to expand access to new life-saving drugs. The new drug rules, which the ACLU says do not go far enough, take effect Saturday.
The lawsuit was filed on behalf of a low-income Denver resident, Robert Cunningham, who was diagnosed with the communicable disease more than a decade ago but has recently been denied access to direct-acting antivirals, a new class of drugs used to treat hepatitis C.
Nothing about a Washington state lawsuit called B.E. v. Teeter is as simple as it seems.
It was filed this year by two hepatitis C patients against the state’s Medicaid program to help the poor gain access to drugs such as Gilead Sciences Inc.’s $1,000-a-pill cure.
But behind the team bringing the case is Gilead itself. While the drug giant isn’t involved in the lawsuit, the company and its foundation have donated hundreds of thousands of dollars to the researchers, lawyers, patient advocates and medical expert who have helped build the case.
The University of Minnesota is suing Gilead Sciences Inc., alleging the pharmaceuticals company’s lucrative Hepatitis C drugs infringe on a university patent.
In a lawsuit filed in Minnesota’s U.S. District Court Monday, the university claimed its intellectual property covers Gilead products that contain the drug sofosbuvir, including those sold under the brand names Sovaldi and Harvoni. Those Hepatitis C treatments have generated more than $20 billion in revenue for Foster City, Calif.-based Gilead.
The state university system said it brought its patent concerns to Gilead (Nasdaq: GILD) in August 2015, but the company continued its alleged infringement.
Tennessee inmates infected with hepatitis C on Monday filed a federal lawsuit against state prison officials, asking the court to force the state to start treating all inmates who have the potentially deadly disease.
The lawsuit, filed by attorneys with the ACLU and other advocates in U.S. District Court in Nashville, says the Tennessee Department of Correction officials knowingly denying inmates care for their hepatitis C, also known as HCV, constitutes cruel and unusual punishment. It alleges the department is denying care because the best available medication is too expensive.
“In reality, (department officials) ignore the medical needs of (inmates) and class members in order to save costs. (The department’s) written politics for HCV diagnosis, assessment and treatment utilize outdated standards of care and normalize the practice of refusing treatment for unjust and medically unsound reasons,” the lawsuit states.
The following opinion is written by Sonia Canzater, an associate with the O’Neill Institute for National and Global Health Law at Georgetown University.
Last week, a federal judge in Washington state ruled that the state Medicaid authority cannot place undue limitations on access to hepatitis C (HCV) drugs for patients, as Medicaid has the duty to provide “medically necessary” treatment to the patients it covers. Until this ruling, many states, including Washington, citing the high cost of the latest direct acting antiviral (DAA) drugs to treat HCV and justification to restricted Medicaid recipients’ access to these drugs only to patients whose liver has already sustained serious damage because of the illness.
On June 3, 2016, under the looming threat of litigation and in acknowledgment of the Washington state holding, the Delaware Division of Medicaid and Medical Assistance changed their policy of rationing Hepatitis C drugs to no longer restrict treatment only to those with significant liver damage or cirrhosis.