[Ip-health] KEI Comments: ERYTHRYx Therapeutics: Prospective Grant of an Exclusive Patent License on Methods of Modulating Erythropoiesis With Arginine Vasopressin Receptor 1B Molecules | Knowledge Ecology International

James Love james.love at keionline.org
Mon Jul 9 14:16:19 PDT 2018


This is an odd exclusive license.  The NIH wants to grant exclusive rights
on patents for new uses of a very old drug.

Apparently the license will cover "“Use of arginine vasopressin receptor 1B
agonists to treat anemia caused by (i) chronic renal failure on dialysis,
(ii) receiving myelosuppressive chemotherapy, or (iii) lacking antidiuretic
hormone.”

ERYTHRYx Therapeutics,, the company getting the license did not exist until
January of 2018, has no web page, and lists its type of business as "patent
holding."

Our full comments on on the KEI web page here.

https://www.keionline.org/28353

We conclude with these comments.

For the NIH to enable citizens to comment usefully on these proposed
exclusive licenses, the NIH needs to provide more context to justify the
exclusive nature of the license, and the terms of the license themselves.
For example, the NIH should explain in lay terms, how much money the
government has spent on the inventions so far, and how much additional
investment is estimated to be necessary to further commercialize the
products.

. . .

In this case, for a patent on a repurposed drug to a shell company with no
visible operations, a shorter term of license would be more appropriate
than a life-of-patent license. The HHS policy in the early 1980s was to
permit an initial exclusive term of 5 years, subject to the possibility of
an extension upon a showing that the extended term was justified.

. .

Finally, during the period of exclusivity the price should bear some
relationship to the risks and costs of obtaining FDA approval for a new
indication. The NIH could include in the license a provision that the price
should be sufficiently reasonable that for most private insurance plans,
the drug is considered a Tier 1 or Tier 2 medication, and also that the
company selling the drug as a monopoly for the patented repurposed use have
a sufficiently robust patient assistance program to ensure the drug is
accessible to persons without insurance or with inadequate insurance, a
possible situation that seems quite relevant looking forward.
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