[Ip-health] ​KEI and MSF comments to the NIH on the licensing of patents on Attenuated Respiratory Syncytial Virus Vaccines

Jamie Love james.love at keionline.org
Thu Mar 10 01:57:51 PST 2016

​KEI and MSF comments to the NIH on the licensing of patents on Attenuated
Respiratory Syncytial Virus Vaccines

9 March 2016

KEI and MSF comments regarding the Notice published in the Federal Register
on February 22, 2016, [81 F.R. 8728], entitled ‘Prospective Grant of
Exclusive License: Production of Attenuated Respiratory Syncytial Virus
Vaccines’ (available here: https://federalregister.gov/a/2016-03486; KEI
comments here:

A KEI press release follows:

Diane Singhroy
KEI Scientific and Technical Advisor
+1 (202) 332-2670
diane.singhroy at keionline.org

KEI and Doctors Without Borders/MSF Ask NIH to Ensure Fair Price for New
RSV Vaccine

Washington, DC, March 9, 2016 — Yesterday evening, Tuesday, March 8, 2016,
Knowledge Ecology International (KEI) and Doctors Without Borders/Médecins
Sans Frontières (MSF) raised concerns with the National Institutes of
Health over the lack of transparency, and the potential for excessive
pricing, in the grant of an exclusive license on patents for a new
government-developed childhood and senior vaccine.

KEI and MSF submitted comments to the National Institute of Allergy and
Infectious Diseases (NIAID) on the prospective grant of an exclusive
license to the French company Sanofi on the patents for attenuated strains
of respiratory syncytial virus (RSV) — a virus that affects almost every
infant — developed over the course of 25 years of research at the National
Institutes of Health, primarily in the lab of NIAID scientist Dr. Peter

A exclusive license would allow Sanofi to set an unreasonable or
discriminatory price in the United States, and unaffordable prices in
developing countries, KEI and MSF argued. "We are concerned," the comments
said, "that the National Institute of Allergy and Infectious Diseases
(NIAID), National Institutes of Health (NIH), and Department of Health and
Human Services (HHS) exclusive licensing of patent rights of this promising
vaccine candidate to Sanofi will result in:

1. Sanofi pricing an important vaccine out of the reach of routine use in
pediatric and/or adult populations;

2. Sanofi abusing the granted monopoly to charge excessive prices,
something the NIH has been loath to address after previous licenses have
been issued;

3.  Sanofi requiring U.S. residents to pay more than other countries for a
vaccine developed at public expense (see http://keionline.org/xtandi for a
petition to the NIH relating to a prostate cancer drug invented at UCLA on
federal grants, and priced far higher in the United States than in any
other country); and

4.  Delays in the entry of competitive suppliers for the manufacturing and
distribution of the vaccine that will increase affordability and reduce
supply shortages,

5.  Barriers to innovation, including enhancements that make the vaccines
more effective in low resource settings."

KEI and MSF noted the NIAID's lack of transparency in providing information
on the above concerns, after KEI made multiple requests for information.
(An additional letter, explaining the NIH's overall lack of transparency on
the grant of licenses, to Nancy Weiss, a senior intellectual property
advisor at the White House Office of Science and Technology Policy, is
available here:

RSV is one of the most common childhood diseases. In the United States
alone, RSV infects over two million children younger than five annually,
causing over 57,000 hospitalizations. Worldwide, RSV is associated with the
death of about 200,000 children under the age of five every year.

The submission asked the NIH to obtain an agreement from Sanofi that the
taxpayer-funded RSV vaccine is sold in the United States at reasonable
prices, and not a prices higher than in other high income countries, and
that it is affordable in developing countries.

A concluding comment also suggested an alternative method to fund the
continued development and commercialization of this vaccine, which would
involve either the NIH or third-party payers funding the final stages of
trials and registration of the vaccine, and receiving benefits for doing so.

"Even better would be for the NIH to reject the use of exclusive licenses,
and to conclude the development of the vaccine either with its own funding,
or by approaching third-party payers (in the public and private sectors) to
share the costs of the final development of the vaccine. Those providing
funding to conclude the vaccine development could be offered access at
concessionary prices and possibly share in the eventual licensing income
from non-exclusive licensing of the patents."


James Love.  Knowledge Ecology International
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love

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