[Ip-health] Foundational mRNA patents are subject to the Bayh-Dole Act provisions

Luis Gil Abinader luis.gil.abinader at keionline.org
Mon Nov 30 13:51:57 PST 2020

Link: https://www.keionline.org/34733

Foundational mRNA patents are subject to the Bayh-Dole Act provisions

Posted on November 30, 2020 by Luis Gil Abinader

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 reporting 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.

Government funding to Karikó and Weissman

Drew Weissman appears as the principal investigator on a total of 42
projects funded by the National Institutes of Health (NIH) between 1998 and
2020, representing $18,323,060 in costs. Two of these grants, AI050484 and
AI060505, started before the foundational mRNA patent applications were
filed and are acknowledged in six of the patents listed in the tables
presented below. Katalin Karikó was the principal investigator of four
projects funded by the NIH between 2007 and 2011, totaling $1,234,462 in
costs. The patents also acknowledge DE14825, a grant to Daniel Malamud, a
New York University professor formerly at the University of Pennsylvania.

U.S. patents filed by Karikó and Weissman

As Table 1 shows, Katalin Karikó has been listed as co-inventor in eleven
patents. All of these patents are generally directed to RNA preparations
and uses. Ten of these patents also name Drew Weissman as a co-inventor and
are assigned to the University of Pennsylvania. The remaining one is
assigned to BioNTech RNA. At least six of these patents are subject to the
Bayh-Dole provisions, as their government funding acknowledgements indicate.


In other words, the United States government funded and has certain rights
over at least some of the foundational Karikó and Weissman patents directed
to mRNA discoveries.

Some of these patents include broad claims. For instance, Claim 1 of the
U.S. patent 8,278,036 (the ‘036 patent) is directed to “[a] method for
inducing a mammalian cell to produce a protein of interest comprising:
contacting said mammalian cell with in vitro-synthesized modified RNA
encoding a protein of interest, wherein said in vitro-synthesized modified
RNA comprises the modified nucleoside pseudouridine.” The method described
in this claim emcompases any “protein of interest.” This patent was filed
in the United States on August 21, 2006, issued on October 2, 2012, and
acknowledges being subject to the Bayh-Dole Act provisions.

Other jurisdictions where Karikó and Weissman patents have been filed

Karikó and Weissman have filed twin applications in a number of countries
in addition to the United States. Table 2 provides a list of countries
where at least one pair of the Karikó and Weissman patents were filed. This
analysis, based on the priorities, is limited by data availability, since
patent status information tends to be unreliable in some countries.


As shown in Table 2, the Karikó and Weissman patents are linked to
applications filed in at least 19 countries outside of the United States
and the European Patent Office (EPO). This analysis only reflects if a twin
application was filed, regardless of whether it was granted. Most of the
countries where twin applications were filed are high income. U.S. patent
10,006,007 has a pair in at least 18 additional jurisdictions.

Sublicenses to Moderna and BioNTech RNA

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 and 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.

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