Remdesivir And Federal March-In Rights

The recent Government Accountability Office (GAO) report, Information on Federal Contributions to Remdesivir, examined whether federal patent rights were appropriate given the federal government’s contributions to the drug’s research and development. The report concluded: Gilead’s collaboration with government scientists on remdesivir did not result in any intellectual property rights for government-funded researchers or government agencies.

This was not what those calling for the GAO report wanted to hear or expected to hear. It’s important to note that one of the loudest voices calling for this study was former California Attorney General who is now Secretary for Health and Human Services, Xavier Becerra.

The GAO report was asked by Congress to do an independent review of the federal government’s role in researching the use of remdesivir to treat COVID-19. The drug now known as Veklury was the first COVID-19 treatment to receive an Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) to treat anyone at risk of serious manifestations of the virus consists.

The GAO report stood in the face of strong political headwinds. In August 2020, citing concerns about remdesivir pricing and availability, 34 attorneys general urged federal officials to exercise the government’s rights of entry over COVID-19 treatment. The attorney general said Gilead was “unable to provide” sufficient supplies of remdesivir to meet the health and safety needs of the country “during the COVID-19 pandemic. To politicians and experts who Regularly referring to the innovative biopharmaceutical industry as a free run of government research grants, the GAO report should serve as a wake-up call: When the healthcare ecosystem works together, we can achieve remarkable results at warp speed.

Who “invents” new drugs? The roles of industry and the NIH

A study by Bhaven N. Sampat and Frank R. Lichtenberg entitled “What are the respective roles of the public and private sectors in pharmaceutical innovation?” provides data-driven analysis that justifies the National Institutes of Health (NIH) – but in the right frame of reference. Sampat and Lichtenberg examined 478 drugs that were linked to prescription drug sales of $ 132.7 billion in 2006. Less than 10 percent of these drugs had a public patent. Pharmaceuticals with public sector patents accounted for only 2.5 percent of sales, although the indirect effects were higher for drugs that were prioritized by the FDA. (Drugs that offer significant advances in treatment or offer treatment for which there is no adequate therapy are prioritized.) Drugs whose uses cited federally funded research and development or government publications accounted for 27 percent of sales.

While the NIH plays an important role in basic research and early discovery, does it rob the prolific Peter of paying the best price to the Paul government for promoting public health through the ill-considered use of invasion rights? The answer is a resounding “no,” and GAO’s new report on Remdesivir confirms that conclusion.

A look at the record

Between 2009 and 2013, Gilead Sciences, Inc. (Gilead) synthesized the remdesivir compound, conducted and funded preclinical research that first identified and confirmed the antiviral activity of remdesivir and its parent compound against coronavirus and other viruses, and patented the compounds began .

Between 2013 and 2020, the Centers for Disease Control and Prevention (CDC), the Department of Defense (DOD), and the NIH led and funded preclinical research collaborations that helped demonstrate remdesivir’s antiviral properties against multiple viruses, and the three from the NIH Funded clinical trials complement, but not replace, Gilead’s ongoing research. (Examples of federal support can be found in Appendix 1.)

As of December 2020, federal funding for preclinical and clinical trials with remdesivir was approximately $ 162 million: $ 109.2 million for NIH-funded clinical trials; $ 39.7 million for DOD preclinical research; US $ 11.9 million for preclinical research from the NIH and NIH-funded universities; and; $ 0.7 million for preclinical research for the CDC.

Figure 1: Examples of federal participation in the development of remdesivir, 2013–20

Source: Analysis of Government Accountability Office information from the Centers for Disease Control and Prevention, Department of Defense, Gilead Sciences, and the National Institutes of Health, Report No. GAO-21-272, March 2021.

The straightforward, straightforward, and politically inconvenient conclusion of the GAO independent report found that “The CDC, DOD, NIH, and NIH-funded university-funded remdesivir research did not result in state patent rights because, according to government and university officials, the contributions of the Federal research has not produced any new inventions. “The NIH lead investigators working on coronavirus research projects told GAO that they were not considering filing invention disclosures because their work did not involve any modification of remdesivir or its parent compound.

In addition, Gilead entered into research collaborations with federal agencies and universities on a portfolio of existing patents and patent applications, including the remdesivir compound, which would have left little room for federal agencies to generate their own patents. For example, the GAO report cites that DOD officials told them that when DOD scientists performed antiviral testing of remdesivir for the Ebola virus, they used standard tests and screening methods and did not develop new tests or new methods.

GAO found that NIH scientists had not filed invention disclosures from their remdesivir research, and that invention disclosures were unlikely to be filed because Gilead had already determined that remdesivir was useful in treating coronavirus before the NIH began its research started. NIH officials informed GAO that the NIH did not conduct an inventory analysis in these circumstances.

Most of the federally funded research supported a clinical trial of remdesivir for the treatment of COVID-19 following the onset of SARS-CoV-2 (nearly a decade after Gilead invented remdesivir) that ran parallel to the Gilead-sponsored clinical trial Studies with COVID-19 was carried out.

The urgency of collaborative science

The GAO report is clear and will make many people unhappy. However, this does not mean that public-private partnerships are of no use. On the contrary, they are more important today than ever before.

It was President Franklin Roosevelt who recognized the vital role of the federal government, working with “good old American know-how” to win World War II and advance the American century. Decades before Operation Warp Speed, a partnership was formed to defeat a natural enemy. A previous public-private partnership between industry, academia, and government, the Manhattan Project, demonstrated the value of working together in the face of a deadly human enemy.

On November 17, 1944, President Roosevelt wrote to Vannevar Bush, director of the three-year scientific research and development office: “New frontiers of spirit are before us and if they pioneer with the same vision, audacity and drive with which we wage this war we can create fuller and more fruitful occupations and fuller and more fruitful lives. “Bush replied to the President in his 1945 report:” Science: The Endless Frontier “:” Science can only be effective in the national good as a member of a team, regardless of whether it is peace or war. But without scientific progress, no success in other directions can ensure our health, prosperity and security as a nation in the modern world. “

When it comes to regulated health technologies and the anti-COVID-19 armaments in particular, cooperation is an indispensable prerequisite. Politics is a distraction. Science has to be collegial, intramural and transnational.

The remarkable speed with which we have developed diagnostics, therapeutics and vaccines to fight COVID-19 shows that more, not less, collaboration is needed. Just because those calling on the federal government to exercise invasion rights on remdesivir didn’t get their way doesn’t mean they should pick up their marbles and go home. One of the most important lessons from the pandemic is that we can achieve amazing things when the healthcare ecosystem works together. We’re all in the same boat. The two-dimensional “good guys / bad guys” approach is simple and harmful to public health promotion. There are seldom simple answers to complex questions. HL Mencken reminds us, “For every complex problem there is a clear, simple, and wrong answer.” Remdesivir invasion rights fall into this category.

The devil is in the details

The government report shows that Gilead’s significant investment in the drug, which exceeded $ 1 billion in 2020 alone, far outweighs federal funding for research related to remdesivir, as identified by GAO.

Footnote 35 on page 15 describes Gilead’s investment of more than $ 930 million in research and development related to remdesivir, including $ 786 million in Gilead-funded research and development and $ 147 million in remdesivir free shipping for use in clinical and research environments. For those who are demanding that invasion rights “follow the money”, it is important to understand what this means and where it is leading. Oscar Wilde quipped, “The truth is seldom pure and never easy.” When “science is back,” we all follow science.

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