[Ip-health] ​ Senit Bio license, “Prospective Grant of an Exclusive/Co-Exclusive Patent License: Development and Commercialization of Next Generation Chimeric Antigen Receptor (CAR) Therapies for the Treatment of FMS-Like tyrosine kinase 3 (FLT3) Expressing Cancers”

James Love james.love at keionline.org
Fri Apr 19 11:17:43 PDT 2019


This is a draft of a comment on a new NIH exclusive license on a cancer
technology.  We have to file today.   Let me know if anyone wants to join.
Right now, KEI, UACT and Social Security Works are signing.

Jamie

-----------

Jim Knabb,

Senior Technology Transfer Manager,

NCI Technology Transfer Center,

Email: jim.knabb at nih.gov.

RE:

Dear Jim Knabb,

We are writing regarding the proposed exclusive/co-exclusive patent license
of several patent applications to Senti Bio, as set out in the Federal
Register notice dated April 4, 2019 [84 FR 13305]
https://www.federalregister.gov/documents/2019/04/04/2019-06575/prospective-grant-of-an-exclusiveco-exclusive-patent-license-development-and-commercialization-of
for:

“the development of a universal/split chimeric antigen receptor (CAR)-based
immunotherapy using autologous or allogeneic human lymphocytes (T cells or
NK cells) transduced with lentiviral vectors, for the prophylaxis or
treatment of cancers expressing FMS-like tyrosine kinase 3 (FLT3; also
known as CD135), wherein the CAR construct binds to the FLT3-binding domain
referenced as NC7 in the invention, but NC7 is not included in the CAR
construct. “

Conditions on License

It is our understanding, from your email on April 3, 2019, that the
technology is in the pre-clinical stage, and that according to your email
on April 5, 2019, that National stage patent applications were only filed
in the United States, Europe, Canada, Japan, and Australia.

No price discrimination against U.S. residents.
We ask that an exclusive license including a requirement that any treatment
that uses the inventions, be available to the public on reasonable terms,
 and that those terms include a requirement that prices in the United
States are not higher than the median price charged in the seven largest
economies, with at least 50 percent of U.S. per capita income, as measured
by the World Bank GNI per capita Atlas method.

Years of exclusivity.
We propose the license reduce the years of exclusivity when revenues are
large. The NIH has many options, including by providing an option for
non-exclusive licensing, such as was done in the ddI case. We propose that
the exclusivity of the license be reduced when the global cumulative sales
from products or services using the inventions exceed certain benchmarks.
For example, the period of exclusivity in the license could be reduced by
one year for every $500 million in global cumulative revenue after the
first one billion in global sales.

Transparency of R&D outlays.
The licensee should be required to file an annual report to the NIH,
available to the public, on the research and development (R&D) costs
associated with the development of any product or service that uses the
inventions, including reporting separately and individually the outlays on
each clinical trial. We will note that this is not a request to see a
company business plan or license application. We are asking that going
forward the company be required to report on actual R&D outlays to develop
the subject inventions. Reporting on actual R&D outlays is important for
determining if the NIH is meeting the requirements of 35 U.S.C. § 209, that
“the proposed scope of exclusivity is not greater than reasonably necessary
to provide the incentive for bringing the invention to practical
application.” Specifically, having data on actual R&D outlays on each
clinical trial used to obtain FDA approval provides evidence that is highly
relevant to estimating the risk adjusted costs of bringing NIH licensed
inventions to practical application.

Standards

As you know, when the federal government owns a patent, the decision to
grant an exclusive license is subject to restrictions and standards set out
in 35 USC 209.

https://www.govinfo.gov/content/pkg/USCODE-2011-title35/html/USCODE-2011-title35-partII-chap18-sec209.htm

These requirements include an obligation for the NIH to determine if an
exclusive license is “a reasonable and necessary incentive to . . . call
forth the investment capital and expenditures needed to bring the invention
to practical application,” and when the agency finds that “finds that the
public will be served by the granting of the license” to ensure that:

“the proposed scope of exclusivity is not greater than reasonably necessary
to provide the incentive for bringing the invention to practical
application, as proposed by the applicant, or otherwise to promote the
invention's utilization by the public;”  [35 USC 209(a)(2)]

As you know, the term ‘practical application’ is defined in the Bayh-Dole
Act to include the obligation to

“to establish that the invention is being utilized and that its benefits
are to the extent permitted b law or Government regulations available to
the public on reasonable terms.”  [35 USC 201(f)]

Advice of the Attorney General

Prior the granting an exclusive license, we ask the NIH to seek the advice
of the Attorney General with respect to antitrust law, as is required by 40
USC 559 for a patent or invention.

United States Code, 2015 Edition
40 U.S.C.  §559. Advice of Attorney General with respect to antitrust law
(b) Advice Required.—
(1) In general.—An executive agency shall not dispose of property to a
private interest until the agency has received the advice of the Attorney
General on whether the disposal to a private interest would tend to create
or maintain a situation inconsistent with antitrust law.
(2) Exception.—This section does not apply to disposal of—
(A) real property, if the estimated fair market value is less than
$3,000,000; or
(B) personal property (other than a patent, process, technique, or
invention), if the estimated fair market value is less than $3,000,000.

We understand that in the past the NIH has take the position that the
Bayh-Dole Act somehow provides an exception to 40 USC 559, but that seems
to have been a mistake.  There are two provisions in the Bayh-Dole Act that
are relevant.

In 35 U.S. Code  § 211, “Relationship to antitrust laws,” the Act states
“Nothing in this chapter shall be deemed to convey to any person immunity
from civil or criminal liability, or to create any defenses to actions,
under any antitrust law.”

In 35 U.S. Code § 210,  “Precedence of chapter,” mentions 21 separate acts
that the Bayh-Dole Act takes precedence over, but does not mention 40 USC
559. The NIH would have to argue that 40 USC 599  is “inconsistent with the
Bayh-Dole Act, despite the plain language in 40 U.S.C. §559 regarding
government owned patents.

Sincerely,





--
James Love.  Knowledge Ecology International
U.S. Mobile +1.202.361.3040
U.S. office phone +1.202.332.2670
http://www.keionline.org
twitter.com/jamie_love


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