[Ip-health] Three areas in Section 202 of the Bayh-Dole Act that require action to ensure sufficient rights in patents on coronavirus relevant inventions | Knowledge Ecology International

James Love james.love at keionline.org
Sat Mar 14 08:01:06 PDT 2020


As the US anther governments begin to expend large amounts of money on
research and development related to the control, prevention and treatment
of the coronavirus pandemic, there are important issues to address
regarding the ownership and regulation of patent rights related to those
public sector outlays. KEI has written about the issues related to the
first Congressional emergency appropriation for COVID-19 here, with regard
to the problematic language in HR 6074 on the pricing and affordability of
diagnostic tests, vaccines or drugs.

While there is some awareness that the government has the ability to use
march-in rights on federally funded inventions, or use a global royalty
free right in patents, there is less awareness of other elements of the
Bayh-Dole Act that are important, particularly for the COVID-19 pandemic.
These include provisions the US can use to assign rights in patents to the
World Health Organization or other entities, to retain title to contractor
patents, and to leverage U.S. funding to obtain open licensing of
contractor patents not funded by the U.S. government.

On March 13, 2020, KEI sent a letter to DHHS Secretary Alex Azar, regarding
these three areas in Section 202 of the Bayh-Dole Act that require action
to ensure sufficient rights in patents on coronavirus relevant inventions.
KEI urges Congressional staff and others to become familiar with these
issues, as all three require timely pro-active actions by the U.S.
government, and while the benefits of timely action may not be immediately
apparent, when and if federal funding is associated with useful diagnostic
tests, drugs or vaccines, the stakes will be very high, and the
consequences of action or non-action today will be clear.

The options described in the Azar letter require actions up front, and
cannot be retroactively invoked. Specifically, these actions need to be
taken before funding agreements are signed. They will enable the best and
most robust access to yet to be invented diagnostic tests, drugs or
vaccines, not only in the U.S, but worldwide, and for that reason, they
deserve attention by policy makers.

A PDF version the Azar letter is available here:
Azar-COVID19-35USC202-March 13, 2020.


And html version follows:
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James Love.  Knowledge Ecology International
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