The US government's patent lawsuit against Gilead Sciences indicates it is tired of being milked by pharma companies
Something momentous happened towards the end of 2019. In November, the US Department of Health and Human Services (HHS) filed a patent infringement case against Gilead Sciences “seeking damages for Gilead’s infringement of HHS patents related to pre-exposure prophylaxis (or PrEP)” a medication for HIV prevention. There has been shock and awe over this historic step since the US government is not known to file lawsuits to enforce its patents.
This is significant for more reasons: PrEP is a simple way of preventing HIV infection through a pill-a-day regime. Although ignorance is one factor why people don’t take the medication, the major issue is the cost of the drug. Gilead charges more than $2,000 for a year’s supply for PrEP which is sold for less than $100 by generic drug firms elsewhere. Reports say Gilead has earned $3 billion in 2018 from the drug (marketed as Truvada and Descovy) although it does not own the patents and has been jacking up the price.
Why has the US government finally taken such a bold step given that the industry is one of the biggest and most powerful lobbyists on Capitol Hill and funds the elections of Congressional representatives?
In 2016, non-profit Centre for Responsive Politics reported the pharma industry had donated $589,344 to Hillary Clinton’s campaign. One reason is that the steep cost of new medications is something that even the US healthcare system is finding unaffordable with drug majors charging as much as $1,000 per pill for treating cancer.
The other is that public health groups have been mounting tremendous pressure on the government to act against the price gouging. Current policies force Americans to pay twice for their medicines: First through their taxes to fund research into new therapies and again for those very medicines.
Last year, healthcare providers, patient groups and civil society groups launched a targeted campaign urging HHS and its agency, the Centers for Disease Control and Prevention (CDC) to act. Among the 42 who pushed a petition in spring 2019, led by the PrEP4All Collaboration, are the influential Global Health Justice Partnership at Yale Law School and Public Citizen.
Their petition underlines one of the strangest ironies of the US healthcare system. Funding of billions of dollars for public research into disease treatment by CDC goes to fill the coffers of private drug firms while financially exhausting patients by their predatory pricing. In the case of Truvada and Descovy, the irony goes deeper: The patents are held by CDC!
Health groups say that since 2015 Gilead has been infringing a portfolio of patents owned by the government which protect the use of Truvada and Descovy — the generic drugs are tenofovir disoproxil fumarate/emtricitabine — as a preventive, too, meaning PrEP is also covered.
That the government is listening becomes clear from the case filed by HHS. The petition says Gilead has “wilfully and deliberatively” infringed its patents after refusing attempts by HHS to license these. As a result, “Gilead has profited from research funded by hundreds of millions of taxpayer dollars and reaped billions from PrEP”. How the case pans out is vital not just for the US but the world, too.
This was first published in Down To Earth's print edition (dated 1-15 February, 2020)
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