[Ip-health] NIH's proposed license for patents ​for the Treatment, Prevention, and Diagnosis of Hematological Cancers.

James Love james.love at keionline.org
Wed May 23 10:08:56 PDT 2018


Attached is a draft for comments to the NIH on a proposed exclusive patent
license involving CD47 Phosphorodiamidate Morpholino Oligomers
​​
for the Treatment, Prevention, and Diagnosis of Hematological Cancers.

​
If anyone (or any group) wants to co-sign this set of comments (which are
due early next week) or has some suggestions, send me a note at
james.love at keionline.org.


​---------​
The comments set out three areas of concern, (1) the pricing, affordability
and access issues, (2) freedom for researchers to use the inventions, and
(3) requirements for transparency of the development and commercialization
of the medicine.
​

Most exclusive NIH patent licenses do not result in successful treatments,
but some do.  The comments for this license can also be seen as advocacy
for new norms, setting out conditions that could also be considered as more
general requirements on government or charity funding R&D, or even as
models for excessive pricing or transparency, regardless of who funded by
the R&D.

In the
​ draft​
comments, the pricing suggestions begin with a
​n​
ask that US residents not pay more than residents of the seven largest
economies that have at least 50 percent of US per capita income.  This is
followed by proposals to subject prices to health technology assessments,
limiting
​the term of the ​
exclusivity to seven years, or an alternative formula where exclusivity is
reduced for every $.5 billion earned over $1 billion in global cumulative
sales.  The NIH is also asked to limit exclusivity to countries that have a
per capita income of at least 30 percent of the U.S., or alternatively, to
rep
​​
ort
​ annually​
on the reasonable and feasible measures that will be taken to ensure
access. There is a proposal for an annual transparency report on prices,
revenues, R&D outlays, etc, as well.

The deadline to file comments with the NIH is May 30.  I would like to
close out the letter by the close of day on May 29, which is the Tuesday
after Memorial day in the United States.
​

Jam
​es.love at keionline.org
​



==========================draft letter=============

Jaime M. Greene
Senior Licensing and Patenting Manager
NCI Technology Transfer Center
Email: greenejaime at mail.nih.gov.


Date: May XX, 2018

Re: Prospective Grant of an Exclusive Patent License: Use of the CD47
Phosphorodiamidate Morpholino Oligomers for the Treatment, Prevention, and
Diagnosis of Hematological Cancers. Notice for comment published in 83 FR
22501.

Dear Jaime Greene:

Knowledge Ecology International (KEI) and ___________________ individuals
and organizations concerned about drug pricing and access to patented
medicines, oppose the grant of an exclusive license of the National
Institutes of Health (NIH) patents noticed in 83 FR 22501, to Morphiex
Biotherapeutics (“Morphiex”) located in Boston, MA. The above entities
oppose the issuing of the license unless:


​A. ​
The NIH has determined that an exclusive license is “a reasonable and
necessary incentive” to induce investments for the development and
practical application of the invention, as is required by 35 USC § 209, and
shares its analysis with the public; and

​B.  ​
The NIH limits the scope of rights for the exclusivity to only those rights
reasonably necessary to induce investments for the development and
practical application of the invention, and in particular, that the field
of use is sufficiently narrow, that the term of the exclusivity is
sufficiently limited, and that the license contains sufficient safeguards
to ensure that the invention is “available to the public on reasonable
terms,” as is required by 35 USC § 209 and 35 USC § 201(f).


Morphiex Biotherapeutics does not appear to have a web page, and there is
almost no information available about the company, other than a February
27, 2018 registration of the company in Delaware.  As of May 23, 2018, the
company Facebook page had only one entry, which was just a logo and no
text. One imagines that such a company may also have few assets, yet the
NIH is proposing an exclusive license of inventions that have a potential
for the treatment, prevention, and diagnosis of hematological cancers.

Our comments address three areas of concern, (1) the pricing, affordability
and access issues, (2) freedom for researchers to use the inventions, and
(3) requirements for transparency of the development and commercialization
of the medicine.

We propose the following safeguards regarding the pricing of and access to
products that use the inventions:

​1. ​
Products are priced no higher in the United States than the median price
charged in the seven largest economies as measured by nominal GNI that have
a nominal GNI per capita of at least 50 percent of the United States. To
fully appreciate our concerns about the discriminatory pricing that makes
US residents pay more than everyone else, please review the cross country
price comparisons here: http://drugdatabase.info/drug-prices/

​2. ​
Prices for products in the United States do not exceed the estimated value
of the treatment, as determined by independent health technology
assessments selected by Department of Health and Human Services (HHS).

​3. ​
Patient co-payments under third party Medicare and private reimbursement
programs are affordable.

​4. ​
The geographic area for the exclusivity excludes countries with a per
capita income less than 30 percent that of the United States, and, if there
is no such exclusion, the company be required to report annually on the
reasonable and feasible measures that will be taken to ensure access to
patients living in such countries. Here, please note the data from
http://drugdatabase.info/drug-prices/, which shows that in many developing
countries, prices are frequently higher than the prices for high income
countries in Europe, despite the much lower per capita income in developing
countries (including for taxpayer funded cancer drugs), illustrating the
need for a policy to be included in NIH licenses.

​5. ​
The initial period of exclusivity is set at seven years, subject to
extensions if the company can demonstrate it has not recovered sufficient
profits given the risk-adjusted value of the clinical trials used to
register similar drugs for the lead indication.

​6.  ​
Absent satisfaction of the requirements of proposed safeguard number 5, the
exclusivity of the product be reduced when cumulative global revenues for
the product exceed $1 billion, by one year for every $0.5 billion in
cumulative sales that exceed $1 billion in cumulative sales.


​
Note that the licensing of inventions to the company significantly reduces
the company’s costs of preclinical research, which various studies have
estimated to be 40 to 55 percent of drug development costs on a risk- and
capital cost-adjusted basis.

To address research by third parties on the patented invention, we propose
the NIH explicitly permit researchers worldwide to use the inventions for
research purposes, regardless of whether or not research has a grant or
contract from a U.S. government agency, and for both profit or non-profit
organizations.

To address transparency, we proposes the following requirements.

​1. ​
The company will be required to provide an annual report for the public
providing disclosures of the following items:

​2. ​
The amount of money R&D to obtain FDA and foreign government approvals of
the inventions, including in particular, the amount of money spent each
year on each trial, and the relevant tax credits, grants and other
subsidies received from any government or charity relating to those R&D
outlays,

​3. ​
The prices and revenue for the products, by country,

​4. ​
The number of units sold, in each country,

​5. ​
The product-relevant patents obtained in each country, and

​6. ​
The regulatory approval obtained in each country.



Sincerely,




--
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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