[Ip-health] KEI and UACT comments on the prospective grant of an exclusive license to Midissia Therapeutics for HER2 positive cancer

James Love james.love at keionline.org
Thu Aug 16 07:42:46 PDT 2018


Below are the comments filed by Knowledge Ecology International (KEI) and
the Union for Affordable Cancer Treatment (UACT) regarding a prospective
grant of an exclusive license of NIH-owned patents to the California-based
company Midissia Therapeutics. The prospective exclusive license is for the
development and commercialization of cancer immunotherapy. The original
Federal Register notice is here.

The NIH describes the geographic area as “worldwide” and the field of use

“development and commercialization of Ad-HER2 vaccines as a therapeutic
against HER2-positive cancers as covered within the scope of the Licensed
Patent Rights, excluding uses in combination with vectors/adjuvants,
checkpoint inhibitors or other immune modulators.”

According to the NIH notice:

This technology describes a recombinant adenoviral vector that expresses
the extracellular (EC) and transmembrane (TM) domains of the human HER2
protein and is designed to induce a polyclonal anti-tumor response. HER2 is
a member of the epidermal growth factor family and is overexpressed in
subsets of breast, ovarian, gastric, colorectal, pancreatic and endometrial
cancers. This vaccine encodes for the entire EC and TM domains of human
HER2neu and is specifically contained within a recombinant adenoviral
vector that has the knob of Adenovirus 5 and substituted fiber of
Adenovirus 35. The substitution of the knob of Adenovirus 35 whose receptor
is CD46 allows for efficient and maximal transduction of human dendritic
and hematopoietic cells.

These are the second set of comments KEI files on a prospective license of
NIH-owned inventions to the same company, Midissia Therapeutics. The first
set of comments, filed on April 8, 2016, are available here:

Below are the comments that KEI and UACT filed on the 13th.

August 13, 2018

Ricquita Pollard, Technology Transfer Manager,
NCI Technology Transfer Center,
Via Email: pollardrd at mail.nih.gov.

Re: Prospective Grant of an Exclusive Patent License to Midissia
Therapeutics for the Development and Commercialization of Cancer
Immunotherapy, per 83 FR 35665

Dear Ricquita Pollard:

The following are comments from Knowledge Ecology International (KEI) and
the Union for Affordable Cancer Treatment (UACT), on the proposed exclusive
license for patents noticed in the Federal Register for a license to
Midissia Therapeutics located in San Francisco, California.

1. No discrimination against US residents in pricing

We ask that the NIH include language in the proposed exclusive license to
ensure that the prices in the U.S. for any drug, vaccine, medical device or
other health technology using the inventions are not higher than the median
price charged in the seven countries with the largest gross domestic
product (GDP), that also have a per capita income of at least 50 percent of
the United States, as measured by the World Bank Atlas Method.

We consider this a modest request to protect U.S. residents, who paid for
the R&D that created the licensed inventions.

2. Reduce term of exclusivity when revenues are large

In addition to an external reference pricing test, we propose that the
exclusivity of the license in the U.S. should be reduced when the global
cumulative sales from products or services using the inventions exceed
certain benchmarks.

Given the modest cost of acquiring an NIH patented invention, the amount of
money the developer needs in sales to justify additional investments in R&D
is reduced, as compared to cases where a company developes or acquires the
technology from non government sources.

This request is consistent with the statutory requirements of 35 USC 209,
which requires that “the proposed scope of exclusivity is not greater than
reasonably necessary to provide the incentive for bringing the invention to
practical application.”

One possible implementation of revenue benchmarks is as follows:
exclusivity will be reduced by one year for every $500 million in revenue
equivalents, earned after the first $1 billion, where revenue equivalent is
defined as global cumulative sales plus market entry rewards as well as
government grants or tax credits, for the product or products using the
invention. However, the NIH could choose different benchmarks, so long as
the limits on exclusivity address the requirements of 35 USC 209, that the
incentive is “not greater than reasonably necessary.”

3. Developing countries

We are concerned that several NIH funded inventions are not accessible in
developing countries, due to prices that are high and not affordable in
markets where per capita incomes are significantly lower than the United
States. For this reason, we ask the NIH to limit the exclusivity in the
license to countries that have per capita incomes that are at least 30
percent of the United States.

We also ask the NIH to reach out to the Medicines Patent Pool (MPP), in
order to enter into an agreement that gives the MPP an option to negotiate
non-exclusive open licenses for the inventions in developing countries.

4. Transparency

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 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 USC 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


James Love
Knowledge Ecology International

Manon Anne Ress
Union for Affordable Cancer Treatment

James Love.  Knowledge Ecology International
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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