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

Other KEI comments on NIH licenses are found here: http://keionline.org/nih-licenses


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@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@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.