Non-profit asks US government to take Gilead hepatitis C patent

A non-profit organisation has requested that the US government take the title of a patent covering Gilead’s sofosbuvir-based hepatitis C medicine.

Non-profit Knowledge Ecology International (KEI) has requested an investigation into US patent number 7,964,580 for failure to report National Institutes of Health (NIH) funding associated with the invention.

In a letter sent to the Department of Health and Human Services on Wednesday, March 14, KEI said that a failure to disclose is a violation of federal law and regulations, as well as NIH guidelines and contractual agreements with the grant recipient.

The non-profit has asked the government to investigate the non-disclosure and to undertake measures to remedy the failures to disclose. Specifically, KEI has asked that the government take title to the patent, which is possible under the Bayh-Dole Act.

Patent ‘580 identifies three inventors, all employed by Pharmasset (which was acquired by Gilead in 2011) at the time the patent was filed.

KEI claimed that Pharmasset received a series of NIH grants and that the principle investigator for these grants was Jinfa Du, one of the three inventors listed on the patent.

In a statement, KEI alleged that a review of the patent shows that the invention is upon the work funded by the NIH in three grants.

“The patent in question may be worth billions of dollars,” said the letter.

It added: “In addition to whatever liability for royalties Gilead could be responsible for stemming from its use of a government-owned patented invention (if the government takes possession), there would be opportunities to use the Bayh-Dole royalty-free right to exercise considerable leverage over the prices of all sofosbuvir-based hepatitis C treatments.”

A spokesperson for Gilead said it was the company's policy to fully disclose appropriate grants/contributions.

"We are reviewing KEI’s letter and cannot comment beyond that," they said.

In December last year, LSIPR reported that non-profit group the Initiative for Medicines, Access & Knowledge (I-MAK) had brought another two patent challenges against Gilead over sofosbuvir.

Two months earlier, I-MAK had accused Gilead of obtaining “unmerited patents” for its medicine and filed the “first-ever” US challenges against six patents covering sofosbuvir at the Patent Trial and Appeal Board.

Médecins Sans Frontières also challenged a patent application filed by Gilead in China in December 2017, claiming that the rejection of the patent would “pave the way towards the availability of affordable generic versions”.

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