[Ip-health] HHS is urged to investigate a Gilead hepatitis C patent for failing to disclose federal funding

Kim Treanor kim.treanor at keionline.org
Thu Mar 15 10:18:58 PDT 2018


HHS is urged to investigate a Gilead hepatitis C patent for failing to
disclose federal funding
Ed Silverman in Stat News on 15 March 2018

An advocacy group asked the Department of Health and Human Services to
investigate whether a key hepatitis C patent held by Gilead Sciences (GILD)
failed to disclose federal funding for grants that were used to develop the
blockbuster Sovaldi treatment.


Such a failure could have far-reaching implications for the drug maker and
hepatitis C patients, because federal law would permit the government to
take title to the patent. In its March 14 letter, the advocacy group
suggested such a move might allow the government to reach a marketing
agreement with the company that could, ultimately, lead to lower prices for
public and private payers.

“Gilead would have to get a license from the government to continue
providing the product and the government could make money off a royalty and
also solve some other problems, such as affordability and access,” said
Jamie Love of Knowledge Ecology International, the advocacy group. “The
government would have enormous leverage over the price of the drug.”


Under a federal law known as the Bayh-Dole Act, as well as federal
regulations, a grant recipient is required to disclose federal funding that
contributed to an invention, and include language in patent applications
and any patent describing the role the funding played.


The move to push the HHS to investigate the patent is part of a broader
effort to widen access to high-priced medicines, notably hepatitis C
treatments, which have strained payer budgets over the last several years
and created dilemmas for some patients. When Sovaldi first became available
four years ago, the drug cost $1,000 a pill, or $84,000 for a regimen,
before rebates or discounts.


Kim Treanor
Knowledge Ecology International
kim.treanor at keionline.org
tel.: +1.202.332.2670 <(202)%20332-2670>

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