1 January 2010PatentsRodrigo Calderon Ponce

Mexico backs innovators in pharmaceutical debate

The ruling provides that formulation patents, and not just compound (or active substance) patents, should be included as part of the linkage system, says Rodrigo Calderon Ponce.

Mexico introduced the patent/marketing authorisation linkage system for pharmaceutical products in 2003. This system involves the interparty collaboration of two Mexican authorities: the Mexican Patent and Trademark Office (IMPI) and the Mexican Commission for the Protection Against Health Risks (COFEPRIS). The linkage system provides that IMPI publishes a so-called Linkage Gazette, listing all patents granted and valid that cover allopathic drugs.

COFEPRIS in turn must observe the referenced gazette and deny marketing authorisation for a drug that infringes any of the listed patents. The regulatory template for this system is provided by two articles: Article 47 Bis of the Regulations of the Law of Industrial Property (MLIPR), which states the rules for including patents in the Linkage Gazette, and Article 167 Bis of the Health Products Regulations, which sets out the rules for issuing and obtaining marketing authorisation for a new drug.

From its inception, the draft of Article 47 Bis MLIPR was ambiguous and subject to interpretation as to which patents were to be included in the gazette. From its literal meaning, Article 47 Bis only excludes patents that solely claim processes.

However, in practice, IMPI has adopted another interpretation: so far, it has only included patents that claim compounds (i.e. the active substance of a medicament) per se and not patents that claim formulations (i.e. the mixed components of a medicament) nor uses (i.e. the specific therapeutic indication of a medicament).

This limited interpretation has led to repeated court challenges to IMPI’s practice by patent holders. A number of trials have been brought before the district and circuit courts to challenge IMPI’s decisions on excluding formulation and use patents.

Of these, more than 40 decisions were resolved in favour of the patentees. IMPI was then obliged to publish its formulation and medical use patents in the Linkage Gazette. Out of 18 circuit courts, only two have backed IMPI’s interpretation of Article 47 Bis, while the remaining 16 have favoured a broader interpretation of which formulation and use patents should also be included in the gazette.

In light of the importance of the debate, the issue reached the Mexican Supreme Court, whose justices determined that it was necessary to analyse and decide on the correct interpretation of Article 47 Bis MLIPR.

“The recent decision of the Mexican Supreme Court has clarified that patents that claim a formulation for an allopathic medicament, as well as those claiming an active compound, must be included in IMPI’s Linkage Gazette and, furthermore, that COFEPRIS must use the gazette to avoid issuing marketing authorisations for drugs that infringe patent rights.”

On January 13, 2010, the Supreme Court issued its majority decision. Three out of the five justices that constitute the relevant chamber of the court supported the broad interpretation for including not just compound patents, but also patents claiming pharmaceutical formulations. In their analysis, the justices claimed that the aim of the linkage system is to provide a simple channel of communication between IMPI and COFEPRIS to avoid issuing marketing authorisations to products that infringe patents. The court further underlined that pharmaceutical products do not consist solely of their active substance but comprise all the ingredients that provide the therapeutic effect, as well as elements necessary for product safety and efficiency. Therefore, the court found it necessary to include patents granted for formulations as part of the linkage system.

The Supreme Court’s decision is now in full effect, but the administrative authorities, such as IMPI and COFEPRIS, are not obliged to follow it, since it is a judicial decision with a scope that is circumscribed to judicial authorities. So it is possible that the administrative authorities will maintain their current practice without prejudice to what the Supreme Court has determined.

It is arguable however that the court’s decision puts a moral obligation on administrative authorities to follow it. To date, neither IMPI nor COFEPRIS have issued or acted out their official standpoint on the matter.

In any case, this ruling establishes an important precedent for all Mexican federal courts for future cases, meaning that even if IMPI and COFEPRIS were to maintain their current practice and deny the inclusion of formulation patents in the gazette, cases taken to trial before the courts will stand a very high possibility of success in obtaining an order to force their publication in the gazette.

The recent decision of the Mexican Supreme Court has clarified that patents that claim a formulation for an allopathic medicament, as well as those claiming an active compound, must be included in IMPI’s Linkage Gazette and, furthermore, that COFEPRIS must use the gazette to avoid issuing marketing authorisations for drugs that infringe patent rights.

The decision provides a substantial and welcome benefit for pharmaceutical innovators, since the inclusion of their formulation patents in the gazette will provide them with stronger and more expedient protection against infringers.

Of course, a number of issues are still undecided. For example, patents claiming a new use of an active substance (i.e. a new therapeutic indication) were not specifically addressed in the Supreme Court’s decision and therefore are not within its scope. So the debate on the interpretation of the legal precepts around the linkage system will still be undetermined, because it is currently unclear whether pharmaceutical use patents are to be interpreted and enforced as product or process patents in Mexico.

Rodrigo Calderon Ponce is an associate at Uhthoff, Gomez Vega & Uhthoff SC. He can be contacted at: rcalderon@uhthoff.com.mx

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