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Since the Mexican Linkage system was created in 2003 as a
consequence of some amendments to the regulations of the General
Law of Health and of the Industrial Property Law, the Mexican
Institute of Industrial Property (MIIP) had been including in its
Special Gazette (created to compile the patents subject to be
included within such system) only those patents that protect
an active substance per-se but not any other kind of
pharmaceutical patents, as for example, those patents granted to
protect pharmaceutical compositions or formulations.
The criterion, on which the authorities of such Institute based
this selective inclusion, had been grounded on a misinterpretation
of such amendments to the Linkage system provisions. Under their
point of view, these provisions were not clear enough in their
wording. Therefrom, according with the MIIP, the linkage system was
created to only include patents granted for active substances per
se, so they prevented the inclusion of any other type of
pharmaceutical patents.
As a consequence in the application of such questionable
criterion, the inclusion in the special gazette of any other type
of pharmaceutical patents that were not granted to protect an
active substance per-se, was rejected by the MIIP. To
achieve the inclusion of these rejected patents in the special
gazette, the patent holder had to appeal the rejection through
litigation in order to obtain a Court decision that ordered the
MIIP to include them.
The rejected patents were included only after the conclusion of
the litigation procedure, which resolution ordered the MIIP to
include them into the mentioned publication. This represented a
considerable delay in the application of the linkage system, as
well as a significant increase in the necessary budget of the
patent holders. .
In view that the interpretation of the MIIP to the linkage
provisions was highly questioned and that it was revoked through
several Court decisions, which confirmed that other type of
pharmaceutical patents could also be included into the linkage
system, the Mexican Supreme Court of Justice (MSCJ) began a
discussion in order to determine if the interpretation of the MIIP
to such provisions was correct, and in case of concluding
otherwise, to determine the proper interpretation of the applicable
regulations for the linkage system.
On February 2010, after a thorough analysis, the MSCJ concluded
that the proper interpretation of the Mexican Linkage system
provisions enacted on 2003, do not refer only to pharmaceutical
patents that protect active substances per-se, but also
embraces pharmaceutical patents that do not protect an active
substance per-se, i.e. a pharmaceutical composition.
This recent decision of the MSCJ allows the patent holders to
directly obtain from the MIIP the inclusion into the linkage system
of pharmaceutical patents that do not protect an active substance
per-se, but that protect a pharmaceutical composition of
formulation patent. Thus, this kind of patents may, from now on, be
included within the corresponding publication created for the
linkage system. Patents that protect processes are still excluded
from the linkage system.
Such a decision will improve the efficiency of the Linkage
System. It will allow the patent holders to obtain the inclusion of
their pharmaceutical patents granted for active substances
per-se or for a pharmaceutical compound(s) that protect a
new product, into the linkage system in lesser time, and to avoid
significant expenses for unnecessary litigations, as it used to be
with the past criterion assumed by the MIIP. With this new
criterion, the MIIP will be obliged to include (from a written
petition formally filed by the patent holder) all the
pharmaceutical patents granted to protect pharmaceutical
compositions or formulations besides an active substance
per-se.
The improvement of the linkage system as a consequence of this
new criterion, will be extremely important, particularly for patent
holders that are extremely concerned that the health authorities
observe these new provisions, to prevent the granting of health
marketing approvals for generic products to someone that is not a
licensee or a patent holder as well as to consider them to carry on
public acquisition proceedings.
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