By Juan Serrano --
Back in 2003, Mexico enacted linkage regulations to
avoid the granting of marketing authorizations in violation of patent
rights. The system created by
these regulations is far less elaborate than the one set forth by the
Hatch-Waxman act in the U.S., as there is no extension/term restoration, and
there is no possibility for Paragraph IV-type applications.
This system was intended to be simple: two provisions were added to the health
and IP law regulations establishing that the Mexican Patent Office (IMPI) is
bound to publish a specific gazette every six months, listing those patents in
force that cover allopathic drugs.
The regulatory authority (COFEPRIS) has to observe the patents listed in
this gazette, request information from IMPI if necessary, and deny applications
for marketing authorizations which would invade patent rights.
Nevertheless, controversy arose from the
moment the provisions were enacted.
IMPI immediately stated that the linkage benefit would only be
applicable to patents covering active ingredients per se, and therefore
formulation patents were not to be listed nor observed by COFEPRIS. Thus, the first gazette was published
including only active ingredient patents.
R&D Pharma companies decided to challenge this
criteria through individual constitutional actions before Mexican District
Courts, arguing that a correct interpretation of linkage provisions should
cause for all pharmaceutical product patents to be published. Most courts agreed on this, resulting
in over 40 decisions in favor of patent holders over a period of six
years. The vast majority of these
cases were handled by the Mexican IP Firm Olivares & Cia.
As two Circuit Courts issued opposing decisions,
indicating that the linkage system was indeed limited only to active ingredient
patents, the case was brought to the attention of the Mexican Supreme Court,
which recently made its decision public.
In a closely contested 3-2 decision,
the Supreme Court determined that product patents, including those covering
pharmaceutical formulations are to be included in the Gazette. The Court also made reference to the
co-related obligation by COFEPRIS to observe these patents.
Even though this decision is only mandatory for
Courts, and not for administrative authorities, we expect that both IMPI and
COFEPRIS will observe it, which is a step in the right direction for a strong
IP system in Mexico.
Additional information regarding this topic can be obtained here.
Juan
Serrano is a Mexican Attorney with a Master of Laws Degree from the
University of Toronto. He can be
contacted at jls@olivares.com.mx.
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