LS&HC Horizons 2023 - Flipbook - Page 39
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | Patents, Litigation, and Beyond
Rise of compulsory licenses in the EAEU
Compulsory licenses have become a matter
requiring monitoring in countries of the
Eurasian Economic Union (EAEU)₁. This is
the case for both compulsory license demands
addressed in court proceedings, and granted
by the governmental authorities.
Compulsory licenses issued by the
governmental authorities still remain an
exception in the region. Back in 2020,
a compulsory license to Gilead Sciences’
patent that protects remdesivir used for
treatment of COVID was provided by virtue
of governmental decree to a local generic
producer without Gilead’s permission for
a one-year period for the territory of Russia.
The Russian government’s stated rationale
for the decree was to meet the needs arising
in the context of the global COVID pandemic,
and Russian courts upheld the compulsory
license on the basis of that reasoning. Since
then, there have been no further precedents
in the region; however, the relevant provision
for a grant of compulsory license by
governmental authorities is provided in the
legislation of EAEU countries and the need for
their issuance has been a subject of discussions,
e.g., in Belarus and Kazakhstan.
The compulsory license court claims can
be based on insufficient use of the original
patent or a dependent invention that enjoys
economic advantages and represents an
important technical achievement. The majority
of compulsory licenses are more likely to arise
from a generic producer obtaining a dependent
patent. For this reason, it has become evident
Natalia Gulyaeva
Partner, Dusseldorf
that constant monitoring of patent applications
in the EAEU countries is a must, as such a
precaution may substantially help in shielding
an originator from a potential compulsory
license claim (e.g., by proceeding with a
patent invalidity claim as soon as the relevant
patent application is granted). It is important
to extend monitoring to both national and
Eurasian patents and in case monitoring has
not been done previously, to check for valid
patents in the region. The latter is important
since in the past the generic producers have
based their compulsory license court claims on
the patents which have been obtained earlier
and have been unused by the generic producers
for some time. Some of such dependent patents
have been successfully invalidated due to noncompliance with patentability criteria but not
all of them.
In the countries of EAEU there is an ongoing
discussion on a need of use of compulsory
licensing for software products and Belarus
has introduced relevant law provisions for this.
While in the life sciences and health care sector
this may be relevant for producers of medical
devices, the real benefit of such compulsory
license is fairly limited: even if the compulsory
license is granted for the initial version of
software, it does not address a relatively
short life circle of a software and a need to
have physical access to updates which is not
provided by the mechanism of compulsory
licensing per se.
₁ The region includes Armenia, Belarus, Kazakhstan,
Kyrgyzstan and Russia.
Elizaveta Semenova
Associate, Dusseldorf
39
