Gilead Relinquishes Its PrEP Patent—But Did It Mislead Investors?

On May 8, pharmaceutical company Gilead quietly announced that it will relinquish its exclusive patent on Truvada for HIV pre-exposure prophylaxis (PrEP), the only drug approved to prevent HIV-negative people from becoming infected with the virus. Gilead has recently come under fire for infringing on the Center for Disease Control and Prevention’s own patent on the drug—a situation on which Filter recently reported. The news is a major step forward for activists involved in the #BreakThePatent campaign.

Buried in its quarterly report, Gilead stated that Teva Pharmaceuticals will be permitted to launch a generic version of what has been sold as Truvada, after a settlement agreement was reached in 2014. Teva will be able to launch its “generic fixed-dose combinations of emtricitabine and TDF and generic fixed-dose combinations of emtricitabine, TDF and efavirenz” in the United States on September 30, 2020.

Now activists are calling on the company to clarify its intentions to make the drug available as a generic. They suggest this could show that Gilead, all along, has had the power to expedite the process of making PrEP available to more people.

But did Gilead mislead investors about its planned patent relinquishment of the medications?

On May 8, Douglas M. Brooks, Gilead’s executive director of Community Engagement, told investors that the anticipated relinquishment of its exclusive patent on Truvada for pre-exposure prophylaxis (PrEP), the only drug approved to prevent HIV-negative people from becoming infected with the virus, was set for September 3, 2020, a year earlier than expected. He emphasized, according to an email reviewed by Filter, that this change is not in response “to current discussions with the US government to broaden access to Truvada for PrEP for vulnerable populations and support the federal plan to end the HIV epidemic.”

Instead, Brooks said that the agreement with Teva to hold an early launch of its generic version—in 2020, instead of 2021—was reached in 2014. “This agreement is not related to current discussions with the US government to broaden access to Truvada for PrEP for vulnerable populations and support the federal plan to end the HIV epidemic,” he said.

But according to shareholder call minutes from July 2017 that were recently removed from the Gilead’s website, then-CEO of Gilead John Milligan had told investors that “With regard to generic Truvada, we don’t expect generic Truvada in the United States until 2021.” This was in response to investment bank Leerink Partners representative Geoffery Porges’s question, “At least, can we anticipate that it won’t be in the next 18 months?”—signaling that the patent break would require important planning for investors.

Gilead settled a lawsuit with Teva Pharmaceuticals in 2014, agreeing to permit them to launch “generic fixed-dose combinations of emtricitabine and TDF and generic fixed-dose combinations of emtricitabine, TDF and efavirenz” in the US, though the exact details of the agreement had been kept under wraps.

In a statement issued by activist group PrEP4ALL, Dr. Aaron S. Lord asks, “If this agreement was made in 2014, why did he lie to shareholders?

Gilead did not respond to Filter‘s request for comment at time of publication.

Gilead’s questionable monopoly on hugely profitable Truvada rocketed to national attention in the final days of March after the Washington Post revealed that the CDC, for years, has held the patent to Truvada—which was developed with the help of taxpayer dollars—for PrEP.

A few days later, PrEP4All activists staged an action at the AIDSWatch 2019 gathering in Washington as part of their broader #BreakThePatent movement, interrupting CDC director Robert Redfield’s speech to bring attention to the ongoing issue of Truvada’s disappointingly-low rates of uptake by gay and bisexual men, which can in part be attributed to its steep cost. Gilead charges more than $2,000 a month for a drug that carries a production cost of around $6 for a month’s supply.

In April, Democratic presidential candidate Bernie Sanders and six other senators joined the #BreakThePatent movement, demanding  that Health and Human Services (HHS) and the CDC investigate Gilead’s alleged patent infringement on, and price-gouging of, a medication that has the potential to drastically reduce new HIV infections. The Department of Justice then launched an investigation into “the facts about the strength of the government patent.”

Relinquishing the drug could hit the company’s revenue stream hard. In the first quarter of 2019, the company’s HIV drugs were the primary driver of revenue, racking up a $3.6 billion—with $606 million coming specifically from Truvada—out of its total $5.2 billion in product sales.

PrEP4All continues to stress that Gilead can do more than just #BreakThePatent—though it is a critical first step.

“Even their announcement today leaves Gilead with exclusive rights to Truvada as PrEP for another 15 months and Teva as the only generic manufacturer on the US market,” wrote Lord. “This will do little to reduce price in a way that will increase access and PrEP4All remains suspicious of the terms and lack of transparency surrounding the Teva settlement. I have to ask, what’s to stop them—other from a desire for profit margins—from releasing the rights now?”


Photograph: Wikimedia Commons

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