Wednesday, 28 April 2010

Mexico, pharma patents and linkage: compositions can benefit too

"Supreme Court decision promises more efficient linkage system" is the title of an article by Juan Carlos Amaro (Becerril, Coca & Becerril SC) for International Law Office. The linkage system to which the title refers was created in 2003 by amending the General Health Law and the Industrial Property Law. It produces the consequence that only patents that protect an active substance per se are included in the Mexican Institute of Industrial Property's special gazette (which sets out the patents eligible for inclusion in this system). Other kinds of pharmaceutical patent, e.g. those granted to protect pharmaceutical compositions or formulations, are excluded.

Following some disagreement and indeed litigation concerning the correct interpretation of the amendments, the Supreme Court concluded that, on a the proper construction, the linkage system extends to pharmaceutical patents that do not protect an active substance per se and therefore includes pharmaceutical compositions. In result, patent holders can apply directly to the Institute for inclusion in the linkage system. Patents that protect processes however remain excluded. The author observes that, following this ruling, the linkage system will run more smoothly and costly litigation will be avoided. He adds:
"Patent holders will be particularly alert to the question of whether the health authorities observe the new provisions. The changes should help them to prevent the authorities from granting health marketing approvals for generic products to a party that is not a licensee or a patent holder, and will also be relevant in the context of public acquisition proceedings".

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