[Ip-health] 2016: Great Lakes Neuroscience and NIH exclusive license on MS/ALS patent | Knowledge Ecology International

Jamie Love james.love at keionline.org
Mon Apr 11 07:53:18 PDT 2016


2016: Great Lakes Neuroscience and NIH exclusive license on MS/ALS patent

The following is the KEI comment to the NIH proposed exclusive license to
Great Lakes Neuroscience for a patent on Multiple Sclerosis, Amyotrophic
Lateral Sclerosis and certain other CNS Disorders. (PDF version here [1]).
KEI asks the NIH for certain information about the proposed license, and
also asks the NIH to include provisions in the license that protect
consumers in both the United States and developing countries.

For the United States, KEI asks that prices be:

*   no higher than the median price changed in the seven countries with the
largest GDP,
    that have per capita incomes of at least half that of the United States

If the geographic area includes worldwide rights, KEI asks that "the
products should be made available at affordable prices in developing
countries," and

     The NIH should also have the option of providing a non-exclusive
license to the Medicines
     Patent Pool (MPP) to permit competitive supply by generic drug
manufacturers, for use in
     developing countries.

KEI notes GSK has recently announced it has begun negotiations with the MPP
to license the patents for its oncology products, and certainly the NIH can
be at least as sensitive to the health needs of patients living in
developing countries as is the big pharma company GSK.

KEI also asked the NIH to meet its statutory responsibly under 35 USC
209(a) to ensure that the “scope of exclusivity is not greater than
reasonably necessary” to develop the product, and proposed the following
clause in the license:

            The exclusive rights will extend to five years from the first
sale of a product
            receiving approval by the U.S. FDA, or until the license holder
recovers at
            least $1 billion in global sales from the product, whichever is
shorter, and
            thereafter, the license will become non-exclusive. After the
first five years of
            exclusivity, the NIH can extend the exclusivity by another 3
years, upon a
            showing that such extension is reasonable in light on the risk
adjusted R&D
            costs to bring the product market, and the net revenues from

KEI is also asking for more transparency regarding the costs of developing
new products, and the pricing, sales and royalty payments on products.

Below is the text of the comment to the NIH.

   [ snip]

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