[Ip-health] Questions and response from the NIH on the Prospective Grant of an Exclusive Patent License to ElevateBio for the Development and Commercialization of 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 Nov 30 10:51:24 PST 2018


The NIH has a Federal Register notice for public comments on an exclusive
license to patents on a new CAR T treatment for cancer.  We believe the
technology may be important.

The company seeking the license, ElevateBio, does not even appear to have a
web page.  We asked the NIH 11 questions about the license.  Today the NIH
replied, with a straight answer to 1 of the 11 questions, and about 10
non-answers.

I am attaching our reply to the NIH reply.

Jamie

---------- Forwarded message ---------
From: James Love <james.love at keionline.org>
Date: Fri, Nov 30, 2018 at 7:36 PM
Subject: Re: ElevateBio license for Prospective Grant of an Exclusive
Patent License: Development and Commercialization of Chimeric Antigen
Receptor (CAR) Therapies for the Treatment of FMS-Like Tyrosine Kinase 3
(FLT3) Expressing Cancers
To: <jim.knabb at nih.gov>

1. Does ElevateBio have a web page?
- Generally, the existence of web pages is publicly available and
information that can be ascertained by the commenting party using any
number of internet search engines.

This is not an "answer."  It is you refusing to answer.  I would not have
asked if I had been able to find the company web page using the Google
search engine.

2. Does ElevateBio have any SEC filings?
- Similar to Question 1 above, a search for SEC filings can be performed by
the commenting party via the SEC website.

This is also not an "answer."  But again, I found nothing on the SEC web
site.


3. Are any of the key staff, board members or investors current or former
NIH employees?
- NIH ethics regulations would generally prohibit current employees or
recently departed employees from participating in such roles.

Good to know.  What ethics regulations are you referring to, exactly?

I note that lots of other licenses are made to former NIH employees,
including previous cases where we have filed comments.   For example,
the miRecule
license.


4. Who are the key staff, board members of investors?
- This information is generally publicly available. Any information
provided to us that is not publicly available regarding personnel for
ElevateBio is considered business confidential information

This is not an answer.  There is a federal Register Notice asking for
public comments on an exclusive license to a company with almost not public
record of anything.  If you refuse to provide basic information about the
company, it is hard to evaluate the proposal for the exclusive license.


5. Is there any public evidence to evaluate the capacity of ElevateBio to
financing the development of this technology?
- As required by 37 CFR 404, the evidence necessary to evaluate the
capacity of ElevateBio to develop this invention was contained within the
license application, which is considered business confidential information.

Are you trying to say, "no"?


6. What is the status of or intentions for national filings for the
following countries listed on the WIPO PCT page?
- The status of the intellectual property associated with the technology
for which a license is proposed is accurately provided in the Notice of
Intent to Grant.

Actually, the Federal Register Notice does not say which countries will
progress to the national filings.  The notice only says that "The
prospective exclusive license territory may be worldwide," and the PCT page
for the national phase is blank.  I'm assuming you have actually looked at
the PCT page, and we did provide a link.


7. According to the United States Public Health Service Technology Transfer
Policy Manual, Chapter No. 300,
PHS Licensing Policy: “PHS seeks to promote commercial development of
inventions in a way that provides broad accessibility for
developing countries.” What concrete measures will the NIH include to
implement this objective?
- We do not anticipate filing patent applications in developing countries,
which will permit the invention to be exploited in those jurisdictions. We
anticipate that the exclusive grant of rights to ElevateBio will make
possible the commercial development of a product that can be used by
patients throughout the world.

There is a conflict between designing so many countries in the PCT
application, then granting worldwide rights, and then telling us "We do not
anticipate filing patent applications in developing countries."

Do you consider India a developing country?
More generally, how do you define developing countries?
Will the license limit the exercise of exclusives rights to developed
countries, with a definition of developed countries?

Right now most countries is sub-Saharan Africa, and most countries in South
America and Asia, are designated countries for the PC application.


8. What is the status of the development of this technology? Specifically,
what trials if any has the NIH funded or
undertaken relating to this technology/treatment?
- The technology is at an early stage of preclinical development, and
requires partnering with industry to ensure that clinical trials can be
conducted on a scale necessary to support FDA approval.

Thank you for answering question 8.


9. How much money has the NIH spent on research directly related to the
technology to be licensed?
- NCI’s Technology Transfer Center does not have access to the budgets and
costs of individual labs/projects as it is not our purview to monitor
research expenses.

Does the leadership of the NIH find this information unimportant?


10. Will the license be life of patent or less than life of patent?
- The terms of the agreement have not yet been negotiated.

We know the license has not been concluded.  Do you ever negotiate terms
for exclusive licenses that are shorter than the term of the patent?  If
the answer is no, then this will be help us understand what is likely for
this license.


11. What concrete measures will the NIH include in the license to ensure
that the inventions are "available to the public on reasonable terms",
which is a requirement of the Bayh-Dole Act?
- Such measures are yet to be negotiated. Our licenses typically include
benchmarks designed to perfect and develop the invention, clinically test
it, and make it as widely available as possible to advance public health.

In the past two decades what has been "typically" done  is for the NIH to
play no role in moderating the prices of products.  That is what we are
asking the NIH change. The outcomes of past practices are prices that
create financial toxicity and unequal access.


-  If I can be of any further assistance, please let me know.

Next time provide more information and more context to explain and justify
the decision to offer an exclusive license to a company.  Don't treat the
public with contempt when they ask basic questions about a monopoly on a
technology that could end up costing hundreds of thousands of dollars, have
huge co-payments, and be unaffordable to patients who will die without
access.


We ask that you extend the deadline for public comment so the NIH can
provide more answers to the questions we asked.

Jamie





 Sincerely,
 Jim Knabb, Ph.D.
 Senior Technology Transfer Manager
 National Cancer Institute, TTC
 Jim.Knabb at nih.gov

On Fri, Nov 30, 2018 at 6:37 PM Knabb, Jim (NIH/NCI) [E] <jim.knabb at nih.gov>
wrote:

> Dear Mr. Love,
>
>
>
> Thank you for your submitted questions below. Please find the answers to
> these questions attached.
>
>
>
> Many thanks,
>
> Jim
>
>
>
> Jim Knabb, Ph.D.
>
> Senior Technology Transfer Manager
>
> NCI Technology Transfer Center
>
> 9609 Medical Center Drive, RM 1E530 MSC 9702
>
> Bethesda, MD 20892-9702 (for USPS mail)
>
> Rockville, MD 20850-9702 (for courier service/visitors)
>
> knabbjr at mail.nih.gov
>
>
>
>
>
>
>
>
>
> *From:* James Love <james.love at keionline.org>
> *Sent:* Sunday, November 25, 2018 11:29 AM
> *To:* Knabb, Jim (NIH/NCI) [E] <jim.knabb at nih.gov>
> *Cc:* Manon Ress <MANON.RESS at cancerunion.org>; Luis Gil Abinader <
> luis.gil.abinader at keionline.org>; Braberg, Hannes <hbraberg at gmail.com>
> *Subject:* ElevateBio license for Prospective Grant of an Exclusive
> Patent License: Development and Commercialization of Chimeric Antigen
> Receptor (CAR) Therapies for the Treatment of FMS-Like Tyrosine Kinase 3
> (FLT3) Expressing Cancers
>
>
>
>
> Jim Knabb
>
> Senior Technology Transfer Manager,
>
> NCI Technology Transfer Center,
>
> Telephone: (240)-276-7856;
>
> Email: jim.knabb at nih.gov.
>
>
>
> Dear Jim Knabb,
>
>
>
> We have some questions about the National Cancer Institute prospective
> grant of an Exclusive Patent License ElevateBio. (“Elevate”), located in
> Cambridge, MA.*
>
>
>
> 1. Does ElevateBio have a web page?
>
> 2. Does ElevateBio have any SEC filings?
>
> 3. Are any of the key staff, board members or investors current or former
> NIH employees?
>
> 4. Who are the key staff, board members of investors?
>
> 5. Is there any public evidence to evaluate the capacity of ElevateBio to
> financing the development of this technology?
>
> 6. What is the status of or intentions for national filings for the
> following countries listed on the WIPO PCT page?
>
>
>
> https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2017205747
>
>
>
> Designated States:     AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN,
> BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC,
> EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JP,
> KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG,
> MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA,
> RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN,
> TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW
>
> African Regional Intellectual Property Organization (ARIPO) (BW, GH, GM,
> KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW)
>
> Eurasian Patent Office (AM, AZ, BY, KG, KZ, RU, TJ, TM)
>
> European Patent Office (EPO) (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES,
> FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT,
> RO, RS, SE, SI, SK, SM, TR)
>
> African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA,
> GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG)
>
>
>
> 7. According to the United States Public Health Service Technology
> Transfer Policy Manual, Chapter No. 300, PHS Licensing Policy:
>
>
>
> “PHS seeks to promote commercial development of inventions in a way that
> provides broad accessibility for developing countries.”
>
>
>
> What concrete measures will the NIH include to implement this objective?
>
>
>
> 8. What is the status of the development of this technology?
> Specifically, what trials if any has the NIH funded or undertaken relating
> to this technology/treatment?
>
>
>
> 9. How much money has the NIH spent on research directly related to the
> technology to be licensed?
>
>
>
> 10. Will the license be life of patent or less than life of patent?
>
>
>
> 11.  What concrete measures will the NIH include in the license to ensure
> that the inventions are "available to the public on reasonable terms",
> which is a requirement of the Bayh-Dole Act?
>
>
>
> Jamie
>
>
>
>
>
> ---------------------------------------------------------
>
> * Notes
>
>
>
>
> https://www.federalregister.gov/documents/2018/11/19/2018-25197/prospective-grant-of-an-exclusive-patent-license-development-and-commercialization-of-chimeric
>
>
>
> E-133-2016: FLT3-Specific Chimeric Antigen Receptors and Methods Using Same
>
>
>
> 1. US Provisional Patent Application 62/342,394, filed May 27, 2016
> (E-133-2016-0-US-01);
>
>
>
> 2. International Patent Application PCT/US2017/034,691, filed May 26, 2017
> (E-133-2016-0-PCT-02)
>
>
>
> “The development of a mono- or multi-specific FMS-like tyrosine kinase 3
> (FLT3; also known as CD135) chimeric antigen receptor (CAR)-based
> immunotherapy using autologous or allogenic human lymphocytes (T cells or
> NK cells) transduced with lentiviral vectors, wherein the viral
> transduction leads to the expression of a CAR that targets FLT3 (comprised
> of the FLT3-binding domain referenced as NC7 in the invention as well as an
> intracellular signaling domain), for the prophylaxis or treatment of
> FLT3-expressing cancers.”
>
>
>
> This technology discloses a CAR vector that targets FLT3 comprised of an
> anti-FLT3 antibody known as NC7, and an intracellular signaling domain.
> FLT3 (CD135) is a cytokine receptor expressed on hematopoietic progenitor
> cells, and is one of the most frequently mutated genes in acute myeloid
> leukemia (AML) and infant acute lymphoblastic leukemia (ALL). FLT3 mutation
> leads to increased cell surface expression and therefore on leukemic cells,
> which makes it an attractive candidate for cellular therapies such as CAR-T.
>
>
>
> --
>
> James Love.  Knowledge Ecology International
> http://www.keionline.org <http://www.keionline.org/donate.html>
>
> twitter.com/jamie_love
>


-- 
James Love.  Knowledge Ecology International
http://www.keionline.org <http://www.keionline.org/donate.html>
twitter.com/jamie_love


-- 
James Love.  Knowledge Ecology International
http://www.keionline.org <http://www.keionline.org/donate.html>
twitter.com/jamie_love


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