There Is Only One Sure Way to Fix the Hepatitis C Epidemic

Media Article 13 Nov 2017


BY TAHIR AMIN ON 11/13/17 AT 6:30 AM






The opioid crisis has triggered immense tragedy, touching almost every community in America and creating complex healthcare problems, including a rise in chronic infections transmitted through injection drug use.

New hepatitis C infections are at a 15-year high, impacting some of our most vulnerable communities and flaring up in areas with high rates of opioid addiction— like rural West Virginia, Kentucky, and Tennessee—while still remaining prevalent in urban areas.


Roughly 3.5 million Americans live with hepatitis C, currently the most common blood-borne infection in America. Misuse of prescription opioids has triggered the recent surge of infections, which total around 30,000 new cases per year, and if untreated, can lead to liver failure or liver cancer.


And While Millions Of Americans Live With This Progressive And Communicable Disease, 85 Percent Of People Diagnosed With Chronic Hepatitis C Will Not Receive Treatment This Year.

Why? A single course of treatment can cost as much as $94,000.

In 2013, Gilead Sciences brought sofosbuvir, the backbone of its fleet of hepatitis C drugs, to market. While the medical community viewed these new treatments with great excitement, high costs have severely limited access. This year, just 160,000 people with hepatitis C are expected to be able to receive treatment—while Gilead will make a projected $9 billion in revenue from global sales.

The consequences of the exorbitant price of hepatitis C medication are dire. Many Americans cannot afford to pay for treatment out-of-pocket, and payers and state Medicaid programs are forced to ration treatment to the very sickest.

Louisiana, for example, estimates that the cost of providing treatment to everyone in-state infected with hepatitis C would be nearly $1 billion. This means that many patients must wait years—sometimes until they are on the brink of liver failure—to receive medicine that can cure them.

And some aren’t so lucky: hepatitis C is the deadliest infectious disease in the U.S. In 2015, deaths tallied around 20,000, cutting across age, race and gender demographics.

Gregg Alton, Gilead’s executive vice president, corporate and medical affairs, in New Delhi September 15, 2014. U.S. drugmaker Gilead Sciences Inc has agreed to license its hepatitis C drug Sovaldi to seven India-based drugmakers to sell cheaper versions of the $1,000-a-pill medicine in 91 developing nations including India.ANINDITO MUKHERJEE/REUTERS


In countries with access to generic versions of hepatitis C drugs, the cost of a single course of treatment is less than $1,000, roughly one percent of the price in the U.S. But Americans cannot access generic treatment, because Gilead Sciences has locked down for decades, the exclusive rights to sell brand-name hepatitis C treatment.

To keep prices high, Gilead has constructed an elaborate thicket of patents around its treatment portfolio—and the soonest a generic competitor will be able to enter the market at this time is 2034.

The patent system in the U.S. was created in order to reward “novel and non-obvious” inventions. But drug companies like Gilead, much like patent trolls, game our legal system, securing unmerited patents on science that does not meet the legal standards for exclusivity. And Gilead’s patents on sofosbuvir do not meet the legal standard for novelty and non-obviousness.

For example, there are multiple patents on the crystalline forms used in Sovaldi, despite the fact that these structures are inherent and obvious in the parent molecule. Gilead secured a patent on naturally occurring structures to the tune of billions in profits and decades of market exclusivity.

That’s why lawyers, scientists and health experts at my organization filed the first-ever U.S. patent challenges against sofosbuvir, the backbone of Sovaldi, Epclusa and Harvoni. We have identified six unmerited patents which, if removed, would save Americans an estimated $10 billion and allow generics to get to market 14 years earlier.

The only way to fix the hepatitis C epidemic—and the drug pricing problem writ large—is to curb the abuses that allow drug companies to set such prohibitively high prices in the first place.

Gilead’s tactics are nothing new. Brand-name pharmaceutical companies have developed a toolbox of tricks to block generic competition, including what the pharmaceutical industry calls “product lifecycle management.”While pharmaceutical companies argue they need generational exclusivity to fund research and development, the simple truth is that they spend far more on marketing and lobbying than innovating.

Meanwhile, their legal gymnastics have severe consequences for the public: a recent white paper authored by my organization found unmerited patents and anti-competitive strategies on Revlimid and Gleevec—two high-cost cancer drugs—as well as Sovaldi will cost Americans over $55 billion in excess costs in the next 15 years.


Until we put an end to the cascade of unmerited patents fueling exorbitant drug prices, companies like Gilead will continue to abuse the system and claim monopolies on vital medication. It is time we re-evaluate the broken patent system that is holding back the country from addressing our most pressing public health crises—paving the way for affordable drug prices, a more competitive marketplace and a healthier America.

Tahir Aminis an intellectual property lawyer and co-founder of the Initiative for Medicines, Access and Knowledge (I-MAK).

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