Comments on a prospective exclusive license of NIH-owned inventions to Beoro Therapeutics

Today Knowledge Ecology International (KEI), the Union for Affordable Cancer Treatment (UACT), Health GAP, Social Security Works (SSW), People of Faith for Access to Medicines (PFAM), Universities Allied for Essential Medicines (UAEM) and Dean Baker filed comments to the National Institutes of Health (NIH) regarding the grant of an exclusive license to Germany-based firm Beoro Therapeutics, GmbH. According to this Federal Register notice, the prospective license concerns “the development of an anti-BCMA immunotoxin for the treatment of human cancer,” primarily multiple myeloma.

A PDF of the comments are available here.

The Federal Register notice published by the NIH provides no information about Beoro Therapeutics other than the fact it is located in Germany.

On June 7, 2018 KEI asked the NIH six questions about Beoro, the terms of the license, and process for determining if an exclusive license was needed or if the rights were sufficiently narrow.

Questions from KEI to the NIH

1. What is the proposed consideration for the exclusive license?
2. Are there any former NIH employees involved with the company?
3. Does this company have a track record of developing new drugs or treatments?
4. Will the company manufacture or conduct research in the United States.
5. Did the NIH do any analysis to see if a term that is less than the life of a patent would be appropriate and sufficient?
6. Did the NIH ask DOJ for a review, under 40 USC 559?

On June 13, 2018, the NIH replied refusing to answer any of these questions, claiming that they are related either to “business confidential information for the applicant or an ongoing lawsuit you have filed.” The lawsuit the NIH is referring to concerns a different technology licensed to a different company, see here.

The joint comments filed today on the prospective exclusive license to Beoro Therapeutics address three areas of concern: (1) the pricing, affordability and access issues, (2) freedom for researchers to use the patented inventions, and (3) requirements for transparency of the development and commercialization of the medicine.

We oppose the grant of this license unless the following issues are addressed:

  • the pricing, affordability and access to the developed medical technology;
    • Prices in the US should not be higher than in other large economies;
    • Prices in the US should not exceed the value of the treatment;
    • The geographical area of the license should exclude poor countries;
    • In compliance with 35 USC 209, the initial period of exclusivity should be limited to that which is “reasonably necessary” to provide the incentive to investment in the needed R&D. One suggestion was to have revenue benchmarks, so that the period of exclusivity would be reduced by one year for every $500 million in global sales, after the first $1 billion in sales. An alternative was to set the exclusivity at 7 years, subject to extensions if the company can demonstrate it has not recovered sufficient profits given the risk-adjusted value of the clinical trials used to register similar drugs for the lead indication.
  • the freedom for researchers to use the patented inventions, and
  • the transparency on the development and commercialization of the drug.

A list of previous comments on exclusive licenses over NIH-owned patents is available here.