HHS commits to IP transparency following watchdog’s criticism
The US Department of Health and Human Services (HHS) will reveal more information regarding its licensing of IP to private companies for drug development, it has confirmed in a letter to a congressional watchdog.
HHS issued the letter, after the Government Accountability Office (GAO), criticised the department’s failure to publicly disclose the information in a report titled, “NIH should publicly report more Information about the licensing of Its Intellectual Property”, released publicly on Friday, November 20. The letter was then attached to the published report.
“NIH provides limited information to the public about its licensing activities. For example, the agency does not report which of its patents are licensed or release metrics that would enable the public to evaluate how licensing affects patient access to resulting drugs,” said the report.
Increasing the transparency of its licensing activities could improve the public’s and policymakers’ understanding of NIH’s management of its IP, it argued.
The report pointed out that since 1980, HHS’s research has generated over 4,000 US patents owned by the government and 32 licences that contributed to the development of 34 drugs approved by the US Food and Drug Administration.
While these represent a small portion of drugs approved by FDA, they include new treatments for life-threatening diseases, such as cancer and HIV-caused immunodeficiency syndrome, and have generated substantial revenues for the drug industry, noted the report.
“NIH must demonstrate to the public that it uses the statutory tools available for managing its IP to benefit the American people,” it stated.
“While NIH considers competition before granting exclusive licences, it has not incorporated a statutory provision related to federal antitrust laws into its standard license agreements.”
After viewing the report ahead of publication, HHS pledged in its letter to be more transparent when allowing private companies to license government-owned drug and vaccine patents.
HHS said it would add patent information to its list of FDA approved products on the US Office of Technology Transfer Office’s website and that it would be developing a plan early next year outlining the process for providing more information about patents and licences on a website.
“The plans would take into account IT and database capabilities, the scope of the patent and licence information, the timing of updates, any concerns by commercial stakeholders, and the public’s need for greater transparency of technology transfer activities,” the letter added.
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