US government, drugmaker Gilead come to a head over patents for HIV antiviral Truvada

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The US Department of Health and Human Services (HHS), and pharmaceutical company Gilead Sciences Inc. continue to wage war over government-owned patents for HIV pre-exposure prophylaxis (PrEP), or drugs to help prevent uninfected patients from contracting the virus. 

In this case, the US Patent Trial and Appeal Board on Feb. 5, 2020, denied Gilead’s request to review the validity of two patents held by HHS for Truvada, a PrEP intended to prevent HIV infection.

Gilead had petitioned the board for a review on Aug. 23 of four patents protecting PrEP, claiming the Centers for Disease Control and Prevention was not the first to discover that using PrEP could successfully prevent HIV infection.

The request to review the remaining two patents is still under consideration.

Gilead takes aim at patents, calling them invalid

The two drugs prescribed in PrEP treatment are Truvada and the recently approved Descovy, both of which Gilead manufactures and sells. In a statement released on the day of the rulings, Gilead says it has compelling evidence that the patents are invalid and will continue to fight to overturn them.

“An invention cannot be patented if it has been publicly used or otherwise available to the public for more than a year before another seeks to patent it,” the statement reads. “Well before HHS claims to have invented the concept of PrEP, others have conceived of using and had used antiretroviral, including Truvada, … for PrEP.”

The board in both the first and second rulings on Feb. 5 say the review would not be granted due to Gilead’s failing to provide enough evidence that would establish “a reasonable likelihood that the petitioner would prevail with respect to at least one of the claims challenged in the petition.”

If the patents were to be deemed invalid, Gilead would not be required to apply to the government for licensure or pay royalties for the manufacture and sale of the drugs.

Department of Health and Human Services strikes back

HHS, in response to Gilead’s August request for review, filed a patent infringement lawsuit against the company on Nov. 6. According to an HHS news release issued that day, the patents allow HHS to license the PrEP programs and receive a reasonable royalty from the drugmakers. 

Two drug companies outside of the US making a generic version of Truvada have agreed to license. Gilead, however, has refused to apply to the CDC for licensing, denying the agency the royalty payments, the release states.

“Gilead has willfully and deliberately induced infringement of the HHS patents,” the HHS claims. It says that as a result, Gilead has profited from research funded by “hundreds of millions of taxpayer dollars and reaped billions from PrEP through the sale of Truvada and Descovy.”

Truvada was first approved by the FDA in 2004 as a post-diagnosis treatment for HIV. According to the HHS release, Truvada was only used in post-diagnosis therapy until the mid-2000s, when CDC researchers had succeeded where others had not in discovering the drug was also effective as a preventative therapy. Trials, costing hundreds of millions of taxpayer dollars, found PrEP to be 99% effective in preventing HIV in high-risk individuals when combined with safer-sex practices.

HHS recognizes Gilead’s role in selling Truvada and Descovy to patients for prevention of HIV. Communities have put these drugs to use in saving lives and reducing the spread of HIV. However, Gilead must respect the US patent system, the groundbreaking work of CDC researchers, and the substantial taxpayer contributions to the development of these groundbreaking drugs. The complaint filed today seeks to ensure that they do.”

— HHS Secretary Alex M. Azar II

The patentability of claims in question

Gilead, in its Feb. 5 statement, refuted the HHS’s claims, saying company officials were not allowed to present key evidence for the inter partes review, in which the patentability of claims in a patent was reviewed. The evidence Gilead points to included guidelines published in 2004 that recommended using Truvada and other antiretrovirals as a treatment before HIV exposure. Gilead plans to use this in the company’s defense in the lawsuit.

“Gilead has additional defenses to the Government’s lawsuit, beyond those contained in the IPRs, and will vigorously defend itself in that litigation,” the statement reads. “Gilead also believes the Government breached its contractual obligations to inform Gilead of any attempt to secure patents on work derived from the use of materials and information Gilead provided to the government.”

HHS, however, says Gilead only received FDA approval to sell Truvada as a PrEP after the CDC’s findings were published.

Patients caught in the crossfire: President Trump’s goal to stop HIV spread by 2030

President Trump, in his 2019 State of the Union Address, called to end the transmission of HIV in America by 2030. According to a February 2019 HHS blog post, the president’s plan calls for providing the most at-risk groups, including gay and bisexual men, transgender women, minorities and people who use intervenous drugs and share needles, with both PrEP drugs and HIV medicine antiretroviral therapy (ART). Patients who take ART as prescribed and “maintain an undetectable viral load can live long, healthy lives and have effectively no risk of sexually transmitting HIV to a partner,” according to the HHS.

“HIV has cost America too much for too long,” HIV.gov says, with the government spending $20 billion annually in direct health expenditures for HIV prevention and care. More than 1.1 million Americans are living with HIV, and over 700,000 have died from the virus since 1981. Despite the development of effective treatment, 40,000 are still being diagnosed annually and another 400,000 are expected to be diagnosed during the next 10 years without intervention.

Trump’s plan, “Ending the HIV Epidemic: A Plan for America,” includes the use of new geographical data to pinpoint US locations that are considered HIV “hotspots.” The plan “acts boldly on this unprecedented opportunity by providing the hardest-hit communities with the additional expertise, technology, and resources required to address the HIV epidemic in their communities,” the HHS blog post states.

According to the post, the plan will ensure individuals are diagnosed as quickly as possible and treated to stop them from spreading the virus to others. The plan is also intended to protect those vulnerable of infection with the use of PrEP, and to respond quickly to areas where HIV is spreading, providing the necessary medications and educational programming.

The high cost of treatment: Gilead gets on board with Trump’s plan

The high cost of PrEP medications, selling for about $24,000 per year in the US, stands as a roadblock to the plan’s success, according to a news release from Harvard Pilgrim Health Care Institute (HPHCI). To negate this, HHS has developed “Ready, Set, PrEP,” which offers free PrEP medication to patients who qualify. The Trump administration met with Gilead officials in the months following his State of the Union address to work out a deal to help provide access to the drug. A May 2019 HHS news release reports that Gilead agreed in the meetings to donate PrEP medication for up to 200,000 individuals for up to 11 years.

The agreement stipulated that Gilead would provide Truvada until the FDA approved its newer PrEP drug Descovy, which was approved in October 2019. Gilead then agreed to donate Descovy until 2030 or until a generic form of Descovy becomes commercially available.

Gilead has been promoting Descovy since its release as the superior of the two drugs, according to a news release. The January 2020 HPHCI study in the Annals of Internal Medicine, however, concluded these claims are “overstated.”

These drugs are equally effective when used for PrEP in gay and bisexual men and transgender women, and the potential safety benefits of [Descovy] over [Truvada] have not yet been shown to be clinically significant.”

Douglas Krakower, MD, Beth Israel Deaconess Medical Center and assistant professor of medicine Harvard Medical School.

Gilead claims its new drug is better than Truvada

Truvada likely will be available in generic form this year, driving down the cost and making it more available to patients. Gilead, however, will have exclusive rights to Descovy until 2022 at the earliest and possibly until 2025, according to the HPHCI. The authors of the HPHCI study say Gilead’s promotion of Descovy as the safer drug choice could lead more doctors to prescribe it and in turn lead to “cost ramifications” for patients.

With the exorbitant cost of these drugs, there are huge public health and economic implications if most PrEP users begin to use the newer [Descovy] pill rather than [Truvada] for PrEP. Gilead is asking us to ‘update’ our PrEP to [Descovy], but that’s not a clinically necessary or cost-effective choice for the vast majority of PrEP users.”

 Julia Marcus, Ph.D., assistant professor in the department of population medicine at Harvard Medical School and HPHCI

The researchers found Truvada has extensive data showing its effectiveness in all high-risk populations, while Descovy, having only been on the market for a few months, has limited data on only gay and bisexual men and a small group of transgender women.

During the study, “small changes” in kidney and bone biomarkers were found in those taking Truvada, and weight gain and cholesterol changes were side effects with Descovy. Researchers said these are small changes that may not be clinically important.

Regardless, Krakower says Truvada should remain the drug of choice for most PrEP users.

Given the available clinical evidence and public health context, [Truvada] should remain the first choice for the vast majority of PrEP users.”

Dr. Krakower

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