Life Sciences Horizons Brochure 2025 - Flipbook - Page 69
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2025 Horizons Life Sciences and Health Care
EAEU compulsory licensing: Spot and address threats
Compulsory licenses remain a matter that requires
constant monitoring in Eurasian Economic Union’s
(EAEU) countries.9 While the governmental
compulsory licenses have been exceptional to date,
they have also been sought by generic drug (“Gx”)
producers before the courts due to patent non-use
or insufficient use, or based on dependent patents.
Proactive monitoring may substantially help in shielding
originators from potential compulsory license grants (e.g., by
proceeding with a patent invalidity claim against “dependent”
patents filed by Gx producers when the relevant patent
application is granted. Equally important remains proactive
reaction to Gx producers’ requests for licenses, because an
originator’s silence enhances the Gx’s chance to obtain a
compulsory license.
Addressing compulsory license requests can be accomplished in
full compliance with applicable EU, UK, U.S., and other regulatory
restrictions and limitations introduced against EAEU countries
(such as Russia and Belarus); however, ignoring compulsory
license requests makes originators vulnerable in the EAEU and
beyond. This is partly because the EAEU region has the potential
to become a manufacturing platform for supply of Gx products
– not only to local distributors, hospitals, and patients, but also to
those located in so-called “friendly” countries in Africa, Asia, and
Latin America. The risk is very high for those countries where
patent enforcement is not straightforward, where benefits
of “launch at risk” are higher than the liability for patent
infringement, or where compulsory licenses can be
easily obtained.
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Such business expansion, apart from respecting patent rights, will
require Gx producers to obtain regulatory authorizations, both
for export and import of the pharmaceutical products; therefore,
when monitoring Gx activities in the EAEU, it is wise to do so in
parallel with regulatory efforts in EAEU friendly countries such as
India, China, and Brazil. However, depending on local laws,
export of pharmaceutical products can be accomplished without
obtaining marketing authorization in the importing country
(e.g., if import is necessary for a particular patient due to
vital indication).
Taken together, these factors highlight the importance of
monitoring developments in the EAEU and taking action –
while adhering to regulatory restrictions – to prevent requests
for compulsory licenses for the manufacturing of Gx products
in the EAEU.
Natalia Gulyaeva
Partner
Dusseldorf
EAEU single pharmaceutical market includes Armenia, Belarus, Kazakhstan, Kyrgyzstan, and Russia and continues to provide for a simplified generic marketing authorization
approval for the EAEU member states.
