This content is from: Mexico
Mexico: Applying the experimental use exception in patent infringements
Armando Arenas of Olivares explores how Mexico has interpreted the experimental and academic use exception

For
many years, the experimental and academic use exception was incorrectly applied
in Mexico to declare third parties who imported raw materials while the patents
that protected the correlative active principle were still in force, as
infringers. This is because the companies alleged that, according to their
import requests, these authorisations had been granted by the sanitary
authorities for experimentation purposes without commercial aims.
Therefore,
to avoid patent infringement, it was sufficient for the defendant to exhibit
the import authorisation granted by the sanitary authority (Federal Commission
for the Protection against Sanitary Risks COFEPRIS). The import authorisation also
had to include a legend stating that the importation had been authorised for
experimentation purposes.
Additionally,
some infringing companies enforced the Roche-Bolar exception and the
experimental use exception at the same time, generating confusion in the
Mexican Institute of Industrial Property (IMPI). The institute chose to declare
the raw material importing companies (trading companies) as infringers,
considering that their activity was only for commercial purposes and denied the
infringement if the defendants proved that they were pharmaceutical companies
applying the benefit of the Roche-Bolar exception.
Recently,
in cases handled by Olivares, two different circuit courts have clarified the
correct interpretation of the experimental and academic use exception. The
rulings stated, in accordance with the
most basic rules of the burden of proof, that it was not enough to exhibit an
import permit that indicates that the destination of the raw material to
consider that such exception is applicable. It stated that it was however necessary
to demonstrate with another type of evidence, as they constitute their own
facts and it was the defendants who asserted the said exception, which is the
type of activity that was specifically carried out for purely experimental
purposes. These new criteria have now caused the IMPI to correctly apply this
exception for the benefit of the patent protection system and its holders.
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