Life Science Group’s Litigation Strategy Secure Patent Rights For Big Pharma

January 13, 2010

The Mexican Supreme Court, on Wednesday 13th January, made their final decision about how linkage regulations should be applied to pharma patents. The ruling means that pharma companies will be able to protect not only compound pharma products, but also product patents covering pharmaceutical formulations as well. This is a very important decision for R&D Pharma companies doing business in Mexico in their fight against the powerful and ever present lobbyists for the generic manufacturers.

After six years of linkage regulation in Mexico, which was intended to avoid the infringement of pharmaceuticals patents, this January 13, 2010 the Mexican Supreme Court issued its decision on the opposing criteria held by three Mexican Circuit Courts regarding the interpretation of the linkage regulation, particularly, the dilemma of whether the linkage system is limited to compound patents or if product patents covering pharmaceutical formulations should also be listed. The Supreme Court ruled that formulation patents should be listed in the linkage gazette, in consequence, these patents are to be observed by the Mexican Health Authority (COFEPRIS) prior to grant marketing authorizations.

BACKGROUND:

Back in 2003, the linkage regulation was enhanced in article 147 Bis of the Mexican Industrial Property Regulations and article 167 Bis of the Health Regulation. Under the cited provisions, the Mexican Patent Office (IMPI) is bound to publish a specific gazette every six months, listing those patents in force that cover allopathic medicines.

Inter alia, COPEPRIS is bound to observe the patents which are listed in the gazette according to the generic name of the active ingredient, prior to granting marketing authorizations to third parties different to the titleholder, and alternatively request additional information to the applicant. In case of doubt of an eventual violation of patent rights, COFEPRIS can request technical support from IMPI, regarding the scope of the patent rights.

The Mexican Linkage Regulation only excludes from the Gazette those patents that cover processes of manufacture and formulation of drugs. Since the date in which the linkage was in force, under a wrong and limited interpretation, IMPI only published patents covering

active ingredients per se, excluding from the linkage gazette patents covering pharmaceutical formulations and medical uses.

Olivares and Cia. fashioned a litigation strategy and also handled the majority of the cases, contesting this wrong interpretation through constitutional actions to obtain the publication of patents covering formulations and second uses. Our firm obtained more than 40 precedents from District and Circuit Courts ordering the publication of formulation and medical use patents.

After two Circuit Courts out of sixteen ruled that the linkage system is limited to compound patents. The Mexican Supreme Court deemed appropriate to decide which of the opposing criteria should prevail.

It is important to mention that the inclusion of formulation patents in the linkage gazette provides a preventive measure to avoid that the Mexican Health Authorities would grant marketing authorizations which may fall within scope of the listed patents, and, in addition, the publication provides the following benefits:

1. a) Prevents patent infringement;
2. b) It’s a valuable source of information to third parties wishing to obtain authorizations for generic drugs, in order to know the full scope of opposable patents.
3. c) Proves that the patent is in full force and that it covers a product, namely an allopathic medicines. In the event of an infringement action, the publication will help to prove that the patent of interest covers a specific pharmaceutical formulation, therefore no expert opinion would be required during the proceeding.
4. d) In case that the linkage gazette is not observed by Health Authorities, the publication of patents is also useful to challenge marketing authorizations for the patented formulations granted to third parties without authorization of the patent holder.
5. e) The Linkage Gazette is also informative in public acquisition processes, to confirm that the product to be acquired is covered by a patent, especially when the patent of formulation listed in the gazette matches with the description of the product in the National Formulary for purchases of medicines by the Mexican Government.

The Supreme Court decision will be considered as a highly relevant precedent to all the Federal Circuit Courts and the District Courts in Mexico, which means that if IMPI and COFEPRIS disregard formulation patents from the linkage system, they would be ordered to list or observe the patent by court orders, provided that the applicable prongs are met.