BIG PHARMA WATCH: BRAND NAME DRUG MAKER TOUTS PATENT ABUSE PLAYBOOK THAT DELAYED ACCESS TO SAFER AND MORE EFFECTIVE TREATMENTS

Gilead CEO Touts Success of Company’s Patent Playbook on HIV Portfolio That Extended Monopolies Until At Least 2033

On a recent earnings call with investors, Gilead Sciences’ Chairman and Chief Executive Officer touted the company’s patent strategy around its portfolio of HIV drugs. Gilead’s anti-competitive tactics have extended monopolies for the Big Pharma giant and featured a particularly egregious product-hopping strategy that blocked patients from accessing a treatment that would have supported better health outcomes.

“Again, just to remind you, of course, the totality of our HIV business is such that we really don’t have any significant patent expiry until Biktarvy in 2033,” the drug company’s CEO touted to investors.

Gilead has a demonstrated track record of blocking competition around its HIV portfolio, which includes several of the company’s blockbuster drugs. Gilead is also notorious for having purchased government-funded research breakthroughs for pennies on the dollar, only to charge tens of thousands of dollars for these products while gaming the system to extend monopoly pricing.

Gilead Employs “Product Hopping” Scheme to Block Access to Safer HIV Treatments

Last July, The New York Times published an article exposing how brand name drug maker Gilead employed a greedy patent strategy around a pair of blockbuster HIV treatments to maximize profits while blocking access to newer versions of those treatments proven to be safer for patients.

The Gilead scheme offers a particularly egregious case study in the Big Pharma practice of “product hopping,” one of the pharmaceutical industry’s commonly employed tactics to game the patent system. Product-hopping involves a drug manufacturer making changes to an existing product — then patenting those changes before an original product expires to extend exclusively, delay competition and keep prices high.

According to coverage from The Times, internal documents from Gilead showed executives and researchers at the company were aware that a newer version of one of their HIV drugs, Truvada, “had the potential to be less toxic to patients’ kidneys and bones than the earlier iteration.” However, the company purposefully delayed the development of this “less toxic” treatment so that its eventual release would coincide with the loss of patent protection around Gilead’s existing HIV treatments that were already on the market. This meant Gilead delayed the development of a safer, less harmful treatment for HIV for over ten years.

Gilead Profits From Taxpayer-funded R&D

Gilead has also repeatedly acquired government-funded research breakthroughs for pennies on the dollar and turned them into blockbuster drugs.

• Gilead Sciences Did Not Invent Its Blockbuster Hepatitis C Treatment Sovaldi, Rather It Acquired The Product From A Small Company, Much Of Whose Work Was Federally Funded. “Gilead Sciences did not invent its blockbuster treatment for hepatitis C, sofosbuvir (Sovaldi), which it priced at $1,000 per pill. Rather, it acquired the product from a small company founded by the drug’s inventor, a faculty member at Emory University, much of whose work on the usefulness of nucleoside viral inhibitors was federally funded. Gilead paid $11 billion in late 2011 for the rights to market Sovaldi, an amount it totally recouped in its first year of sales after approval of the drug in late 2013.” (“The $2.6 Billion Pill – Methodological And Policy Considerations,” New England Journal of Medicine, May 14, 2015)

• Gilead Recouped Its Investment In Sovaldi In Its First Year On Market. “Gilead paid $11 billion in late 2011 for the rights to market Sovaldi, an amount it totally recouped in its first year of sales after approval of the drug in late 2013.” (“The $2.6 Billion Pill – Methodological And Policy Considerations,” New England Journal of Medicine, May 14, 2015)

• $84,000: The cost of a single course of treatment for Gilead’s blockbuster Hepatitis C Drug Sovaldi. (“Wyden-Grassley Sovaldi Investigation Finds Revenue-Driven Pricing Strategy Behind $84,000 Hepatitis Drug,” U.S. Senate Committee on Finance Report, December 1, 2015)

• Taxpayer Funded Research Also Contributed To Gilead’s Blockbuster HIV Prevention Treatment Truvada. “Thomas Folks spent years in his U.S. Centers for Disease Control and Prevention lab developing a treatment to block deadly HIV in monkeys. Then San Francisco AIDS researcher Robert Grant, using $50 million in federal grants, proved the treatment worked in people who engaged in risky sex. Their work — almost fully funded by U.S. taxpayers — created a new use for an older prescription drug called Truvada: preventing HIV infection. But the U.S. government, which patented the treatment in 2015, is not receiving a penny for that use of the drug from Gilead Sciences, ­Truvada’s maker, which earned $3 billion in Truvada sales last year.” (“An HIV Treatment Cost Taxpayers Millions. The Government Patented It. But A Pharma Giant Is Making Billions,” The Washington Post, March 26, 2019)

• Taxpayer Dollars Funded “Much Of The Preclinical And Clinical Research” Behind Gilead’s COVID-19 Treatment, Remdesivir. “The research outlined below demonstrates how the U.S. Army, the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH)/National Institute Allergies and Infectious Diseases (NIAID) either conducted or funded much of the preclinical and clinical development of remdesivir. (“Role of the Federal Government in the Development of Remdesivir,” Knowledge Ecology International, March 20, 2020)

The comments from Gilead’s CEO are the latest reminder of the extent of Big Pharma’s patent playbook – and underscore the urgency for Congress to hold the pharmaceutical industry accountable and crack down on egregious anti-competitive tactics, like product-hopping and patent thicketing.

Read more about Gilead’s product-hopping scheme on its HIV portfolio HERE.

Read more about Big Pharma’s patent abuse HERE.

Learn more about market-based solutions to hold Big Pharma accountable and lower prescription drug prices HERE.

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