[Ip-health] KEI asks the Department of Health and Human Services to adopt a policy on licensing CRISPR patents

Jamie Love james.love at keionline.org
Tue Jun 6 04:43:00 PDT 2017


http://keionline.org/node/2801

KEI asks the Department of Health and Human Services to adopt a policy on
licensing CRISPR patents
6. June 2017 - 5:21

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).

http://keionline.org/sites/default/files/CRISPR-SecPrice-6Jan2017.pdf

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/sites/default/files/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

-- 
James Love.  Knowledge Ecology International
http://www.keionline.org/donate.html
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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