[Ip-health] International landscape of molnupiravir patents

Luis Gil Abinader luis.gil.abinader at keionline.org
Wed Oct 20 11:07:37 PDT 2021


Link: https://www.keionline.org/36779

International landscape of molnupiravir patents

KEI has built a dataset of patents related to molnupiravir based upon a
study by Imran et al (2021), the Medicines Patent Pool (MPP) MedsPal
database, and our own searches. Our molnupiravir patent applications
dataset, which will be updated regularly, is available here:
https://docs.google.com/spreadsheets/d/1ee7-2jHuyFz6qNOnaTiBT6CYcuCi1LHMUbMkBHlzpN0/edit?usp=sharing


According to our analysis, Emory University has filed applications related
to molnupiravir in over 20 patent offices. A number of Chinese and Indian
companies also have applications related to dosage forms, crystal forms,
and manufacturing processes. Most of the applications related to
molnupiravir are pending and some of the international fillings are well
within the deadline to enter the national phase in additional countries,
which indicates that the global patent landscape around this drug can still
grow.

Geographical scope

Emory has filed applications related to molnupiravir in all of the major
targets for patent prosecution, namely Australia, Canada, China, Japan,
Korea, Russia, the European Patent Office, and the United States. Emory
also has applications in several developing countries with strong
small-molecules manufacturing capacity, such as Brazil and India.

Nonetheless, most of the published patent applications related to
molnupiravir are still pending a final decision. Similarly, there are
likely several applications that have already been filed at their
respective patent offices but are waiting for publication. Moreover,
because some of the international applications are relatively recent, those
procedures can still enter the national phase in a large number of
jurisdictions that are members of the Patent Cooperation Treaty (PCT). This
means that the number of countries with patent applications related to
molnupiravir can grow significantly in the upcoming months. As noted above,
KEI will regularly update our molnupiravir patent applications dataset.

Type of claims

Imran et al. and the MPP reviewed the claims filed to date by Emory and
other applicants. As their analysis reflects, Emory has filed applications
describing compounds, Markush structures, synthesis, and methods of
treatment. One of them, PCT publication WO2021159044, specifically relates
to methods of treating SARS-CoV-2 with molnupiravir.

In addition to Emory, a handful of companies based in China and India have
filed secondary patent applications generally related to molnupiravir. In
May 2020, Jubilant Generic filed an application in India directed to
transmucosal sublingual tablets of molnupiravir. In January 2021, Hangzhou
filed an application in China describing a molnupiravir crystal form.
Similarly, Fermenta Biotech, Nanjing Huaguan, Optimus Drugs Private, Divi’s
Laboratories, and Hangzhou have recently filed applications related to
molnupiruvir manufacturing processes. Although so far those applications
have only been published in China or India, there is still enough time to
file them in additional countries.

Licensing agreements

In March 2020, Emory announced an exclusive license to Ridgeback
Biotherapeutics for the development of molnupiravir. Less than two months
later Ridgeback entered into a collaboration with pharmaceutical giant
Merck, which took over the clinical development molnupiravir. Although
neither of the parties have disclosed which specific intellectual property
rights were licensed under those agreements, we believe that they involve
some or all of the applications and patents assigned to Emory listed in our
dataset.

According to an announcement in April 2021, Merck has entered into
non-exclusive licensing agreements for molnupiravir with five Indian
generic manufacturers. Those manufacturers are Cipla Limited, Dr. Reddy’s
Laboratories, Emcure Pharmaceuticals, Hetero Labs and Sun Pharmaceutical
Industries. Merck says that they have also engaged with the MPP to explore
the potential of additional non-exclusive licenses.

Patentability challenges

Molnupiravir is a prodrug of EIDD-1931, an old compound first reported
decades ago, and investigated by scientists from Russia and Poland as a
potential treatment for smallpox in the 1970s. Making a prodrug is a
standard practice in drug design aimed at improving the pharmacokinetics of
a known compound. In fact, Emory scientist and molnupiravir co-inventor
George Painter recognizes that making this compound to improve upon the
pharmacokinetics of EIDD-1931 “wasn’t some major eureka moment.”

Since they claim a prodrug of an old compound, the applications filed by
Emory will face opposition from third parties. Some of those applications
will also face challenges in countries where methods of treatment are
excluded from patentability. In fact, several third parties have already
filed pre-grant oppositions against some of the Emory applications. For
instance, Low Cost Standard Therapeutics, the Entrepreneurship Development
Center, the Cancer Patients Aid Association, and Keelu Lakshminarayana have
raised pre-grant oppositions against two of the Emory applications filed in
India. Their oppositions generally argue that those applications are devoid
of novelty, inventive steps, and sufficient disclosure to merit patent
protection. Similarly, an anonymous party filed an observation against one
of the applications filed at the European Patent Office.

Under the World Trade Organization (WTO) Agreement on Trade-Related Aspects
of Intellectual Property Rights (TRIPS), member states have considerable
maneuvering space to determine what constitutes a patentable invention.
Article 27.3(a) of the TRIPS agreement also allows WTO members to exclude
“diagnostic, therapeutic and surgical methods for the treatment of humans”
from patentability. With most of the molnupiravir applications still
pending a final decision, the geographical scope of the rights Emory ends
up holding will depend heavily on whether and which national patent offices
implement the flexibilities currently available to them under international
law.


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