2017: KEI asks the Department of Health and Human Services to adopt a policy on licensing CRISPR patents

Posted on by KEI Staff

On June 6, 2017, Knowledge Ecology International wrote to the U.S. Department of Health and Human Services (DHHS) asking the Department to adopt a policy on the licensing of federally-funded CRISPR patented inventions. (Copy here).

In part 1, the 17 page letter reviews the importance of the CRISPR technology. Part 2 discusses the public interest in non-discriminatory licensing of CRISPR patent. In part 3, makes suggestions regarding the policies that would advance the public interest, and ensure that those inventions are “available to the public on reasonable terms” and that the licenses are designed to achieve the purposes and objectives of the Bayh-Dole Act and to maximize the benefits to taxpayers and patients.

The table of contents of the letter is as follows:

Table of contents

  • Part 1. The CRISPR technology has important research and medical applications.
    • Figure 1: Pipeline of CRISPR–Cas- assisted drug discovery (From Fellmann C et al.)
  • Part 2. There is a public interest in open, non-discriminatory licensing of CRISPR patents on reasonable terms.
    • 1. The CRISPR patent landscape and licensing arrangements
    • Table 1: CRISPR patent landscape
    • Figure 2: CRISPR-CAS9 licensing agreements
    • 2. Exclusive licenses on CRISPR are contrary to federal guidance
    • 3. Exclusive licenses are an unnecessary and inappropriate means to incentivize research using the CRISPR platform.
    • 4. Exclusive licenses on CRISPR patents will limit patient access.
  • Part 3. DHHS policy on the licensing of CRISPR patents.
  • Conclusion
  • Annex 1: NIH Sharing Policies and Related Guidance

The suggestions on licensing are as follows:

Part 3. DHHS policy on the licensing of CRISPR patents.

As noted in Annex 1, DHHS has adopted at least 20 statements on sharing policies and related guidance for NIH-funded research resources.

There is a pressing need for a U.S. government policy statement regarding the licensing of government-funded CRISPR inventions.

The following comments are offered to assist the DHHS in developing such a policy statement:

  1. In 2001 and in subsequent agreements with the WiCell Research Institute, Inc., the NIH intervened to ensure access to non-commercial research institutions to patented inventions involving stem cells.[fn [48]] The WiCell/NIH agreement can be seen as implementing a 1999 NIH policy statement on “Sharing Biomedical Research Resources,”[fn [49]] and focused primarily on ensuring non-profit entities would be able to use stem cells for research purposes.[fn [50]]
  2. The policy statement for CRISPR patents should ensure non-exclusive licensing in all fields of technology. The CRISPR technology is not a product, but a tool that can be used to create products and advance our understanding of human diseases. It is in the public interest to ensure non-discriminatory freedom to use the technology, in some cases royalty-free, and in other cases with fair and reasonable remuneration.
  3. A related area concerns patents that are essential to implement standards. For many technologies, including but not limited to those involving networked information technologies or green energy technologies, so-called standards essential patents (SEPs) can impose costs on society and limit innovation, if licensed on unreasonable or discriminatory terms. Often these disputes are resolved through contracts between patent holders and Standards Developing Organizations (SDOs), with a commitment that the patent holders agree to license patents on fair, reasonable, and non-discriminatory terms, referred to as FRAND terms. The US Patent and Trademark Office (USPTO) and the U.S. Department of Justice (USDOJ) have addressed this issue in a nuanced January 8, 2013 policy statement.[fn [51]]
  4. In the case of the CRISPR patents, the policy should be to ensure open and non-discriminatory licensing of the patents to both nonprofit and for-profit entities.
  5. The licensing of CRISPR patents to non-commercial entities for research purposes should be royalty-free, a condition met by earlier CRISPR patent holders.
  6. The licensing of CRISPR patents to commercial entities may require payment of royalties, but only on FRAND terms.
  7. The licensing of CRISPR patents to any entity should not have reach-through rights to subsequent patents, unless the reach-through clause is designed to benefit an entity that is creating a research commons.
  8. The funding agency should require the patent holders to disclose license agreements and royalty payments, as well as the rationale for royalties charged.
  9. The NIH should reserve the right to require that royalty payments be based upon only the use as a research tool, or only on final products.

Notes

[48] WiCell Agreement No. 02-W012B, 09042012 NIH, Amended and Restated Memorandum of Understanding between WiCell Research Institute, Inc. and Public Health Service U.S. Department of Health and Human Services. November 2012. https://www.ott.nih.gov/wp-content/uploads/documents/pdfs/wicell-rev.pdf

[49] National Institutes of Health. Sharing Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Research Grants and Contracts. Federal Register Vol. 64, No. 246, page 72090-6. December 23, 1999.

[50] Debra Roberton, NIH sacrifices commercial rights in WiCell deal, Nature Biotechnology 19, 1001 (1 November 2001), doi:10.1038/nbt1101-1001.

[51] United States Department Of Justice And United States Patent & Trademark Office Policy Statement On Remedies For Standards-essential Patents Subject To Voluntary F/rand Commitments January 8, 2013