Your tax dollars at work: Licencing of patents on US government owned inventions: concerns about transparency, protection of public interest

On February 23, I provided a few notes on our work monitoring the NIH licensing of four inventions, (1) patents on a new class of drugs to treat the HCV virus (to a company without a web page, address or known principals), (2) a new drug for HER2+ breast cancer (a license apparently never issued), (3) patents on a diagnostic testing technology to a small Irish firm, and (4) licenses to a large portfolio of patents for attenuated respiratory syncytial virus (RSV) vaccines, to the French firm Sanofi.

We ended up filing 10 pages of comments on the RSV vaccine patents, with MSF, in response to a notice in the Federal Register.

The RSV comments were signed by myself, Diane Singhroy, the KEI Scientific and Technical Advisor, and Judit Rius, the U.S. Manager and Legal Policy Adviser for the Access Campaign at Medecins Sans Frontieres/ Doctors Without Borders (MSF).

The NIH apparently does not make the comments on licenses public, but a copy of our March 8, 2016 filing is available here: http://keionline.org/node/2445

In preparing the RSV comments, we were met with even more secrecy from the NIH, which prompted our colleague Claire Cassedy to write to the White House Office of Science and Technology Policy (OSTP) to register a complaint.

The licensing contact at the NIH, whose name was listed on the Federal Register notice as the person to contact for information, told us he was not allowed to talk to KEI, and we would have to direct our questions to the Office of Communications and Government Relations (OCGR). We reached out to the OCGR, which asked us to contact someone else, and in the end, the NIH would not answer any questions about the vaccine license, or even share the patent applications, which, according to the Federal Register Notice, are supposed to be available.

The NIH has spent more than 25 years developing a vaccine for RSV, and has taken the vaccine into trials with humans. KEI and MSF want the NIH to address pricing and affordability issues, before we give the vaccine away to Sanofi, and we also want the NIH to consider doing the remaining trials itself, so that the vaccine technology would be available to any manufacturer, and could be made available to the public at the cost of production, instead of whatever monopoly price Sanofi will end up charging.

Our comments on the RSV vaccine also pushed the NIH to address the obligations in federal regulations for such licenses, including in particular 37 C.F.R. § 404.7(a)(1)(ii)(B-C), which requires the agency to limit the use of exclusive rights, so that the rights granted are “not greater than reasonably necessary to provide the incentive for bringing the invention to practical application.”

While we were working on the RSV vaccine patents, KEI also asked the U.S. Army about a notice of intent for an exclusive license to patents on the Digital Optical Method (DOMTM), or United States Patent No. 7,495,767. In the DOMTM case, we asked the Army the following question:

Did the Army do any analysis to determine if the public is better off with an exclusive or non-exclusive license for this technology? As you know, the point of an exclusive license is to create a monopoly on the technology. Did the Army determine that the public benefits from creating a monopoly in this case, and if so, will the Army share that analysis with Knowledge Ecology International (KEI) so we can publish that analysis and provide commentary?

All of these cases involve government owned patents — inventions involving government employees. We are also looking at the related issue of how other government funded inventions are managed, when the inventors are not government employees, but the patented inventions or non-patented research benefited from federal research grants, contracts or other subsidies (of which there are many), such as the issues surrounding Xtandi, (http://keionlinelorg/xtandi), a drug invented at UCLA on grants from the Army and the NIH. These broader issues will be addressed in another comment.