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In a major win for the Initiative for Medicines, Access & Knowledge (I-MAK) and its partners, Brazil and Europe took steps forward to address the global hepatitis C and HIV crises by rejecting key unmerited patents held by Gilead Sciences. At the same time, the US Patent Trial and Appeal Board (PTAB) blocked two initial patent challenges brought by I-MAK against one of the company’s unmerited patents on hepatitis C medicine sofosbuvir, representing a step backwards for millions of US patients in need of affordable drugs.
Filed last October by the US-based nonprofit, the challenges argue that one of Gilead’s core patents on sofosbuvir—the backbone of the drugs Sovaldi, Harvoni, and Epclusa—failed to meet legal standards for novelty and non-obviousness under US patent law. While the PTAB blocked the two patent challenges, an additional eight patent challenges filed by I-MAK against other Gilead patents, including one on the base compound for Sovaldi, are still pending with the board and will be announced later this spring and summer.
“Too many families are suffering without the medicines they need because unmerited drug patents are keeping prices artificially high,” said Priti Krishtel, I-MAK co-founder and co-executive director. “If we are ever going to fix the root cause of the drug pricing crisis, we have to address the rampant manipulation of the patent system. As Gilead’s shareholders gather next week, they should take note of the mounting scrutiny of its patenting practices—and the effect that unmerited patents are having on millions of suffering Americans.”
The patent challenges come at a time of high demand for hepatitis C treatments. Exacerbated by the opioid epidemic, the hepatitis C infection rate is at an all-time high with an estimated 3.5 million people with chronic hepatitis C in the US, and more than 85 per cent of Americans diagnosed with the disease will not receive treatment this year. Baby boomers, Medicaid recipients, veterans and people in prison are among those hit the hardest by the disease.
On last Friday, in response to a patent challenge by the Brazilian coalition Grupo de Tralbalho sobre Propriedade Intelectual (GTPI/ABIA), with I-MAK’s legal support, Brazil’s National Institute of Industrial Property rejected one of Gilead’s many patents for sofosbuvir. While there have been three patent rejections on sofosbuvir in Brazil, there are still many more patent applications that, if granted, could block access to affordable hepatitis C treatment for patients and the fight is far from over. More than an estimated 1.5 million people in Brazil have hepatitis C, and worldwide only seven percent of the 71 million people living with the disease have received treatment.
Days before the Brazil decision, the European Court of Justice invalidated Gilead’s efforts to seek an extension of it patents protection for the HIV drug Truvada, adding to the mounting global movement to reject unmerited patents that are blocking millions from getting the treatment they need.
The PTAB’s institution decisions concern challenges specifically to a patent on sofosbuvir’s prodrug—a compound which helps humans metabolize an inactive drug base compound once it enters the body. Because sofosbuvir is a nucleoside, and the prodrug in sofosbuvir has accompanied nucleoside treatments for decades, I-MAK argueds that the use of the prodrug was an obvious choice, rather than a “novel and non-obvious” one. Gilead’s three main prodrug patents on Sovaldi extend its monopoly on the drug by four years, to 2029.
In its decisions, the PTAB declined to institute a review on one of Gilead’s prodrug patents, citing the timing of Gilead’s initial applications was before certain evidence that had been submitted by I-MAK, and that Gilead’s prodrug was not specifically described in other evidence prior art submitted by I-MAK. Eight additional patent challenges to other Gilead patents, including on the Sovaldi base compound and crystalline structures, remain before the PTAB with decisions expected in the coming weeks.
“At a time when rampant abuse by pharmaceutical companies of the drug patent system is harming millions of American families, we strongly disagree with the US board’s rulings today,” said Tahir Amin, co-founder and co-executive director at I-MAK. “Our review found that sofosbuvir was developed through obvious tweaks to existing compounds and common formulations—thereby disqualifying it from meeting the requirements of standards of novelty under US patent law. While countries around the world reject Gilead’s unmerited patents, including a partial rejection on the same patent in Europe which has similar legal standards, the US decision raises questions about the where the balance of power lies in the American patent system and its ability to get life-saving drugs into the hands of people who need them.”
If Gilead’s challenged patents are overturned, I-MAK estimates that US taxpayers could save up to more than $10 billion on Sovaldi and more affordable generics could come to market 14 years earlier. A recent I-MAK report illustrates how unmerited patents are reducing market competition and artificially raising drug prices, while millions in the US go without vital treatment.
Since 2006, I-MAK has been working to increase access to medicines around the world. The organization’s legal work and research reaches across 49 countries and 20 treatments for eight diseases, including hepatitis C, HIV, leukemia, tuberculosis, diabetes, cancer, and blood-related disorders.
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