KEI comments to FDA on Prospective Exclusive Patent License for Diagnostic for SARS, SARS-CoV-2, Other Viruses, Bacteria and Bacterial Serovar, to Advion

To: Ken Millburne
Technology Transfer Program
Food and Drug Administration
Via email:

From: James Love
Knowledge Ecology International
1621 Connecticut Avenue NW, Suite 500
Washington, DC 20009

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.