By Dani Kass

Law360 (May 27, 2020, 10:17 PM EDT) -- Activists working to expand access to COVID-19 medications are making the case that the federal government is the rightful co-owner of patents covering Gilead Science Inc.'s antiviral drug remdesivir, and that the feds should harness that ownership to make the medication accessible and affordable.

Remdesivir, an experimental drug that the U.S. Food and Drug Administration has authorized for emergency use, was developed with the help of researchers from the United States Army Medical Research Institute of Infectious Diseases and the Centers for Disease Control and Prevention, and in a May 20 report, activists said those agencies' scientists should be given credit.

As co-owner, the government would be able to make, import, use and sell the drug without Gilead's permission and license it to generic manufacturers, according to the report from the PrEP4All Collaboration and the Technology Law and Policy Clinic of the New York University School of Law.

The report asks: "If the U.S. government co-invented remdesivir, with substantial investment by the American public in its development, why should Gilead alone profit and control who can manufacture it?" 

PrEP4All has been fighting Gilead since before the novel coronavirus outbreak to expand access to its notoriously expensive but highly effective HIV medication, and likely was part of the successful push to get the government to sue for ownership rights of Gilead's HIV prevention patents.

The report acknowledges that Gilead has already donated its stock of remdesivir, but said there's concern of "widespread shortages" and how the company will eventually price the medication given its "unfortunate history of charging remarkably high prices for life-saving antiviral drugs."

PrEP4All also admitted that it's working only with public information and doesn't know what agreements, if any, have been reached behind the scenes between the government and Gilead, or if government scientists directly contributed to the chemical synthesis of the drug.

But the report points to press releases and other disclosures that show the joint effort to develop remdesivir and how it ties to U.S. Patent Nos. 9,724,360 and 9,949,994 and a pending patent application. It claims that even if Gilead synthesized the drug on its own, the government still may have "contributed significantly to the legal 'conception' of the compound" which would still lend to ownership rights.

The closest precedent in federal courts to determine such ownership would be Brigham Young University v. Pfizer in Utah. That case settled before the inventorship question was finalized, but allowed for a scientist to be considered a co-inventor if he or she conceived of a method that's outside the exercise of ordinary skill, which was then used to create the patented compound, PrEP4All said.

The organization said even if the government doesn't claim ownership of the patents, it still has the right to authorize generic companies to start making the drug if Gilead overcharges or can't supply enough, so long as Gilead is properly compensated. PrEP4All encouraged it to use that right.

"'[Invoking those rights] would not and should not preclude Gilead from being financially rewarded, and celebrated, for its genuine contributions to the inventorship and development of remdesivir," the report states.

PrEP4All admitted that the best-case scenario would be for Gilead to make the drug cheap — citing Public Citizen's price of $1 per patient per day, which would still turn the company a profit — and accessible globally without a fight or government intervention. It noted that Gilead has already licensed patents for remdesivir to generic companies in over 100 countries.

"We hope that Gilead learns from its past mistakes and commits this time to global fair pricing," the report states.

In a statement Wednesday, Gilead defended its sole ownership of the patents.

"Gilead scientists discovered remdesivir, identified its broad-spectrum antiviral activity, optimized the formulation of the product and scaled up the manufacturing process," the company said. "Although government funding was used to further characterize remdesivir's profile after its initial discovery, this did not result in the creation of the underlying intellectual property invented by Gilead."

The drugmaker noted the supply it has already donated and said that it's ramping up production to keep its supply available for the long term.

"Gilead's ownership of intellectual property is not a barrier to access," the company said. "Gilead has demonstrated responsible use of intellectual property and has helped address many unmet medical needs throughout the world, and this will continue in the case of remdesivir."

Representatives for the United States Army Medical Research Institute of Infectious Diseases and the CDC didn't immediately respond to requests for comment Wednesday.

--Editing by Bruce Goldman.

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