[Ip-health] Washington Post feature on Katalin Kariko (and Luis Abinader's November 2020 analysis, Foundational mRNA patents are subject to the Bayh-Dole Act provisions)

Thiru Balasubramaniam thiru at keionline.org
Sun Oct 3 11:20:48 PDT 2021

In November 2020, KEI's Luis Abinader published the following analysis
(Foundational mRNA patents are subject to the Bayh-Dole Act provisions)
which can be found here: https://www.keionline.org/34733

Abinader wrote:

Katalin Karikó and Drew Weissman are often described as the pioneers of the
mRNA discoveries that underpin the first COVID-19 vaccines. In 2005 both
scientists published a paper
that a slightly tweaked version of mRNA that can be administered without
triggering the immune system, a discovery that is now seen as foundational
to the development of mRNA vaccines. Karikó and Weissman secured patents on
these discoveries and licensed them non-exclusively to Moderna and BioNTech
RNA, the company that has been collaborating with Pfizer for the
development of a mRNA vaccine. Several of these patents are subject to the
provisions of the Bayh-Dole Act.

In this blog I briefly overview the US government funding and patents filed
by Karikó and Weissman.


Moderna and BioNTech, the companies behind the two leading COVID-19 vaccine
candidates, have both obtained non-exclusive sublicenses over mRNA patents
assigned to the University of Pennsylvania. The licenses have been
disclosed to the SEC, but with heavy redactions that keep in secret the
numbers of the covered patents.

The University of Pennsylvania exclusively licensed certain mRNA patents
and applications to CellScript and its affiliate, mRNA RiboTherapeutics, on
December 20, 2016. CellScript further entered into non-exclusive worldwide
sublicenses with Moderna on June 26, 2017
with BioNTech on July 14, 2017
Although the patent and application numbers are redacted, the Moderna
sublicense agreement does explain that they relate to “technology which was
developed by Drs. Drew Weissman and Katalin Kariko of Penn’s Perelman
School of Medicine.” As such, it is likely that these licenses include at
least some of the patents listed in Table 1. In particular, it seems likely
that these licenses cover the ‘036 patent, which has broad claims directed
to mRNA methods.

Both licenses contain a “U.S. Government Rights” clause, stating that they
are “expressly subject to all applicable United States government rights,
including, but not limited to, any applicable requirement that products,
which result from such intellectual property and are sold in the United
States, must be substantially manufactured in the United States […]” This
is an acknowledgement that at least some of the licensed patents are
subject to Bayh-Dole rights.



Carolyn Y. Johnson <https://www.washingtonpost.com/people/carolyn-johnson/>
October 1, 2021 at 7:00 a.m. EDT

JENKINTOWN, Pa. — Nearly three decades ago, Katalin Kariko called her
husband and 10-year-old daughter into her home office in the Philadelphia
suburbs to share a thrilling new scientific idea.

“You have to sit down and now listen to my argument!” she told them.

Kariko, a research assistant professor at the University of Pennsylvania
School of Medicine, told her family about a fragile genetic material called
messenger RNA. This profound molecule, a simple strand of four chemical
letters, instructed cells how to make proteins.

In Kariko’s experiments with her lab-generated messenger RNA, she used as a
control a naturally occurring kind of RNA, called transfer RNA. It did not
trigger an inflammatory response. It was a clue.

Kariko and Weissman tried modifying their messenger RNA chemically to mimic
the transfer RNA. They discovered that replacing a single letter of its
four-letter alphabet could stop the messenger RNA from activating the
immune system and increase tremendously the amount of protein cells

They published their findings <https://pubmed.ncbi.nlm.nih.gov/16111635/> and
patented the work in 2005. A year later, Kariko and Weissman founded a
company called RNARx to commercialize this modified RNA. They won a
grant <https://www.sbir.gov/node/294073> from the National Institutes of
Health with the idea messenger RNA could be used to treat anemia.

The idea was ahead of its time. Two biotechnology companies — BioNTech in
Mainz, Germany, and Moderna in Cambridge, Mass. — would recognize the
potential even as RNARx struggled to find investors.

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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