[Ip-health] KEI comments to FDA on Prospective Grant of an Exclusive Patent License: Field-Deployable Mass Spectrometer Diagnostic for SARS, SARS-CoV-2 and Other Viruses, Bacteria and Bacterial Serovar, and Drug Impurities to Advion, Inc

Claire Cassedy claire.cassedy at keionline.org
Mon Nov 30 11:51:35 PST 2020


https://www.keionline.org/34750

KEI comments to FDA on Prospective Grant of an Exclusive Patent License:
Field-Deployable Mass Spectrometer Diagnostic for SARS, SARS-CoV-2 and
Other Viruses, Bacteria and Bacterial Serovar, and Drug Impurities to
Advion, Inc. located in Ithaca, New York, as noticed in 85 FR 72672

Posted on November 30, 2020 by KEI Staff

To: Ken Millburne
Technology Transfer Program
Food and Drug Administration
Via email: Kenneth.millburne at fda.hhs.gov

From: James Love
Knowledge Ecology International
1621 Connecticut Avenue NW, Suite 500
Washington, DC 20009
https://keionline.org

Date: November 30, 2020

Re: Prospective Grant of an Exclusive Patent License: Field-Deployable Mass
Spectrometer Diagnostic for SARS, SARS-CoV-2 and Other Viruses, Bacteria
and Bacterial Serovar, and Drug Impurities to Advion, Inc. located in
Ithaca, New York, as noticed in 85 FR 72672

Dear Ken Millburne,

The following are the comments of Knowledge Ecology International (KEI)
regarding the proposed grant of a worldwide exclusive patent license to
Advion, Inc. to practice the inventions listed in the Federal Register at
85 FR 72672, in fields of use that may be limited to the manufacture and
commercialization of a field-deployable mass spectrometer diagnostic for
the rapid detection of SARS, SARS-CoV-2 and other viruses, bacteria and
bacterial serovar, and drug impurities.

1. KEI notes that if the value of the inventions is estimated to exceed $3
million, the Food and Drug Administration (FDA) must acquire the advice of
the Attorney General, pursuant to 40 U.S.C. § 559.

2. If the exclusive license is granted, the FDA should require that any
company using the inventions make products or services available to US
residents at prices that are no higher than the prices in a set of
countries with large GDPs, and that have a per capita income of at least
half that of the United States , as measured by the World Bank Atlas
method. Alternatively, the FDA could include language similar to that in a
recent contract that the US government has entered into with Sanofi, for a
COVID-19 vaccine candidate:

“. . . agrees that it will not sell any [product ] using a licensed
invention under this Agreement to any nation that is a member of the Group
of Seven plus Switzerland (“Covered Nation”) at a price that is more
favorable than those set forth in this Project Agreement.”

3. The record should reflect that the FDA refused to answer a simple
question posed by KEI via email prior to filing these comments, asking if
there were a negotiation over the waiver of the preference for U.S.
industry (35 U.S.C. § 204). This is a very relevant question for any
exclusive license to a publicly-owned invention, particularly one
concerning a COVID-19 diagnostic technology.

4. Given the public sector funding of COVID-19 technologies, we are
skeptical of the FDA’s claim that “without such exclusivity, the invention
would not be made available to the public.” As evidence to the contrary,
Moderna has waived enforcement of its own patent rights for its COVID-19
vaccine, for example.

5. The Public Health Service (PHS) has a policy of making inventions
affordable in developing countries. Specifically, the “United States Public
Health Service Technology Transfer Policy Manual, Chapter No. 300, PHS
Licensing Policy,” states that “PHS seeks to promote commercial development
of inventions in a way that provides broad accessibility for developing
countries.” The FDA should address this concern in the license.


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