[Ip-health] Midissia Therapeutics license of NIH owned breast and prostate cancer vaccine patents

Jamie Love james.love at keionline.org
Mon Apr 11 10:26:33 PDT 2016


http://www.keionline.org/node/2459

2016: Midissia Therapeutics license of NIH owned breast and prostate cancer
vaccine patents

Sabarni K. Chatterjee, Ph.D., M.B.A.
Senior Licensing and Patenting Manager,
NCI Technology Transfer Center,
9609 Medical Center Drive, RM 1E530 MSC 9702,
Bethesda, MD 20892-9702 (for business mail),
Rockville, MD 20850-9702
Telephone: (240)-276-5530; Facsimile: (240)-276-5504
April 8, 2016

Via E-mail: chatterjeesa at mail.nih.gov

Dear Dr. Chatterjee:

I am writing to express our opposition to the grant of an exclusive license
to Midissia Therapeutics ("MIDISSIA") located in San Francisco, California,
USA, as described in this federal register notice:

Document Citation: 81 FR 15313
Page: 15313 -15314 (2 pages)-
Document Number: 2016-06374
Shorter URL: https://federalregister.gov/a/2016-06374

I have also copied description of the relevant patents from the Federal
Register notice in Annex 1 to this letter. Apparently the patents are for a
field of use that includes vaccines for prostate and her2 breast cancer.

KEI wrote earlier, on March 22 and March 24, asking for a call to discuss
this proposed exclusive license, noting that we wanted to know more about
the license and the technology, before commenting. Due largely to your busy
schedule, it was only possible to arrange a call today, two days after the
close of the comment period.

We object to the granting of an exclusive license to Midissia Therapeutics,
but more generally, we are writing to express our continued amazement and
concern about the lack of transparency at the NIH over these exclusive
licenses.

We were unable to find any information about Midissia Therapeutics, and
your office refused to provide the names of the principles, the address or
the phone number of the business. We asked how mature was the technology,
and you would not tell us. We asked whether the NIH had funded clinical
trials for the vaccines, and you would not tell us.

We asked whether the NIH had undertaken the required analysis under 37 CFR
404.7(a)(1)(ii)(A-D), to determine if:

(A) The interests of the Federal Government and the public will best be
served by the proposed license, in view of the applicant’s intentions,
plans, and ability to bring the invention to practical application or
otherwise promote the invention’s utilization by the public;

(B) The desired practical application has not been achieved, or is not
likely expeditiously to be achieved, under any nonexclusive license which
has been granted, or which may be granted, on the invention;

(C) Exclusive or partially exclusive licensing is a reasonable and
necessary incentive to call forth the investment of risk capital and
expenditures to bring the invention to practical application or otherwise
promote the invention’s utilization by the public; and

(D) The proposed terms and scope of exclusivity are not greater than
reasonably necessary to provide the incentive for bringing the invention to
practical application or otherwise promote the invention’s utilization by
the public;

We were assured that such analysis had been done, because of course, the
regulations require it, but you would not indicate if such an analysis
actually existed in terms of any form of documentation or written format.
You would not discuss any aspect of this determination that might be
relevant to evaluating the reasonableness of the decision to license on an
exclusive basis.

We find it appalling and insulting to taxpayers and patient groups that the
NIH has allowed the public comment phase of the license to become a sham. I
doubt this is your fault, but I encourage you to share our concerns with
your senior managers.

With regard to this licensing proposal, I request under the Freedom of
Information Act all documents related to this licensing application,
including any documents, if any exist, which were relevant to the
evaluation of:

37 CFR 404.7(a)(1)(ii)(A-D), or
37 CFR 404.7(a)(1)(iii)

As well as any due diligence or conflict of interest analysis related to
the company getting the licenses, and any economic analysis of the
appropriate royalty rate or term of the license.

Sincerely,

James Love
Knowledge Ecology International
1621 Connecticut Avenue, Suite 500
Washington, DC 20009
James.Love at keionline.org
+1.202.332.2670

http://keionline.org

Annex 1

https://federalregister.gov/a/2016-06374

Intellectual Property

United States Provisional Patent Application No. 60/476,467, filed June 5,
2003, entitled "Immunogenic Peptides and Peptide Derivatives For The
Treatment of Prostate And Breast Cancer Treatment" [HHS Reference No.
E-116-2003/0-US-01]; International Patent Application No. PCT/US2004/17574
filed June 2, 2004 entitled "Immunogenic Peptides and Peptide Derivatives
or The Treatment of Prostate And Breast Cancer Treatment" [HHS Reference
No. E-116-2003/0-PCT-02]; United States Patent No.7,541,035, issued June 2,
2009, entitled "Immunogenic Peptides and Peptide Derivatives For The
Treatment of Prostate And Breast Cancer Treatment" [HHS Reference No.
E-116-2003/0-US-03]; United States Patent No. 8,043,623, issued 25 Oct
2011, entitled "Immunogenic Peptides and Peptide Derivatives For The
Treatment of Prostate And Breast Cancer Treatment" [HHS Reference No.
E-116-2003/0-US-04]; United States Provisional Patent Application No.
61/915,948, filed December 13, 2013, entitled "Multi-Epitope TARP Peptide
Vaccine and Uses Thereof" [HHS Reference No. E-047-2014/0-US-01];
International Patent Application No. PCT/US2014/070144 filed December 12,
2014 entitled "Multi-Epitope TARP Peptide Vaccine and Uses Thereof" [HHS
Reference No. E-047-2014/0-PCT-02]; and all continuation applications,
divisional applications and foreign counterpart applications claiming
priority to the US provisional application no. 61/915, 948 and U.S.
Provisional Application No. 62/248,964 filed October 30, 2015 titled
"Compositions and Methods for the Treatment of HER2-Expressing Solid
Tumors" [HHS Reference No. E-187-2015/0-US-01] and continuation
applications, divisional applications and foreign counterpart applications
claiming priority to the US provisional application no. 62/248,964.
The patent rights in these inventions have been assigned to the government
of the United States of America.

The prospective exclusive license territory may be worldwide and the field
of use may be limited to the use of Licensed Patent Rights for the
following:

(1) Development and commercialization of a therapeutic cancer vaccine
specifically in combination with Licensee's proprietary or exclusively
in-licensed vectors/adjuvants and ME-TARP;

(2) Development and commercialization of a combination product using
Licensee's proprietary or exclusively in-licensed check point inhibitor
with Ad-Her2 and ME-TARP vaccine within the Licensed Patent Rights.

-- 
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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