The linkage system

For many years, a usual complaint from patent owners of pharmaceutical products was that the Mexican FDA –Comisión Federal para la Protección contra Riesgos Sanitarios, better know by its acronym COFEPRIS- was encouraging patent infringement by issuing marketing authorizations for patent-infringing drugs.

On 2003, the President amended the Reglamento de la Ley de la Propiedad Industrial or Rules of the Industrial Property Law and the Reglamento de Insumos para la Salud or Rules for Health Supplies to create a “link” between the Mexican Patent and Trademark Office (MPTO) and the Mexican FDA.

According to the amended Rules of the Industrial Property Law, the MPTO must publish every six months an updated list of patented drugs, identified by the name of the active ingredient. The list must include the names of the patentee and recorded licensee (if any), the term of the patent, among some other information about the protected drug. The idea of the list, widely known as the “List of Patented Medicines”, is to inform the public, and especially the Mexican FDA, about the existence of patent rights on certain active ingredients.

On the other hand, according to the amended Rules for Health Supplies, when filing an application with the FDA for marketing authorization of a drug, the applicant must state either there is no patent protection for the drug, or that it is the patent holder or recorded licensee. The Mexican FDA has to review the List of Patented Medicines and even verify with the MPTO to make sure that there would be no patent infringement if it grants the marketing authorization to the applicant. If necessary, the Mexican FDA will request the applicant to provide evidence that it is the patent owner or that it has a license recorded with the MPTO.

The disputes around the linkage system

It was clear that patents claiming new active ingredients should be included in the List of Patented Medicines, and that patents claiming processes were not to be listed.

However, there were a lot of questions about patents for new compositions or formulations and new uses. The language used when amending the Rules of the Industrial Property Law raised some doubts, although the amended Rules for Health Supplies only considers patents claiming new active ingredients as subject of being included in the List of Patented Medicines.

The original position of the MPTO was that new pharmaceutial formulations and compositions should not be included in the List of Patented Medicines. It did not mean that is was ok to infringe patents claiming new formulations or processes, but that the mechanism provided by the linkage system only benefited patents that claimed new active compounds.

Many innovative pharmaceutical laboratories starting filing amparos or constitutional appeals with the district courts in Mexico City against the lack of inclusion of their formulation patents in the List of Patented Medicines, and in most cases the patent owners prevailed, so the MPTO has been forced to publish several addenda to the List of Patented Medicines to include patents for new formulations and compositions.

Although most federal courts of appeals in Mexico City supported the idea that the  List of Patented Medicines should include patents for new formulations, the Fourth Court of Appeals in Mexico City published a ruling[1], stating that only patents on new active ingredients should be included in the List of Patented Medicines.

The expansion of the linkage system

The contradictory rulings between different courts of appeals caused the intervention of the Supreme Court shortly after the Fourth Court of Appeals in Mexico City published the ruling. On January 2010, the Second Chamber of the Supreme Court, specialized in administrative matters, published binding precedent number 2a./J. 7/2010[2], stating that the List of Patented Medicines should include patents claiming new formulations in a very close decision (3 Judges in favor and 2 Judges against).

n the Mexican system, a binding decision from the Supreme Court is binding for all federal, state and administrative courts in Mexico, but not for the MPTO. Technically, the MPTO could continue refusing to include patented formulations in the List of Patented Medicines and the owners of the excluded patents would have to appeal such exclusions, although such appeals should be decided quicker than before the Supreme Court’s decision.

Notwithstanding the above, the MPTO usually tries to adapt its actions and decisions to the binding precedents of the courts, so I would expect that the MPTO will voluntarily include patents on new pharmaceutical compositions and formulations in the next number of the List of Patented Medicines. The ruling of the Supreme Court did not mention patents for new uses of drugs, and we may exact the MPTO to continue opposing the publication of these patents in the List of Patented Medicines.

(Update September 20, 2018. Several decisions from the federal courts of appeals show that the courts favor the publication of second use patents in the linkage system. No  binding precedent has been issued).

Some downside of the linkage system and its expansion

All measures and mechanisms to improve the protection of patents and prevent the infringement are welcome. However, the linkage system and the expansion ruled by the Supreme Court could lead to unfair decisions.

First, and this has nothing to do with including formulation patents in the List of Patented Medicines, I am against the fact that the Rules for Health Supplies force applicants for marketing authorizations to prove that they are the patent owner or a recorded licensee. Why there should be a license and why it should be recorded? If the applicant for the marketing authorization is just distributor, there is no reason for the parties to execute a license; however the Mexican FDA will still demand evidence that the applicant has a license recorded with the MPTO in order to issue the marketing authorization. From my perspective, the demand stated in the Rules for Health Supplies about the existence of a license recorded with the MPTO shows that neither the Mexican FDA not the MPTO understood the legal consequences of recording a license. It also evidences the extremely formalistic mentality of the Mexican bureaucrats and society in general.

Second, considering the restrictive construction that the MPTO originally made of the amended Rules of the Industrial Property Law about what patents should be included in the List of Patented Medicines, I believe that it was not the original intention of the Administration to benefit formulation patents from the linkage system. I think that the courts have been able to expand the system to formulation patents mainly because the lousy language used in the 2003 amendment to the Rules of the Industrial Property Law.

The fact that the Rules for Health Supplies were amended at the same time than the Rules of the Industrial Property Law and that the Rules for Health Supplies clearly limit the scope of the linkage system to patents claiming an active ingredient somehow confirms the above.

Third, the inclusion of formulation patents in the List of Patented Medicines, although it may be a very effective way to prevent infringement of such patents, it may also cause the rejection of marketing authorizations for drugs that use a formulation different from the one claimed in the patent. Unlike many cases of patents claiming active ingredients, the Mexican FDA may have to interpret the claims of the formulation patent to decide whether the applied drug infringes said claims. This is dangerous, because the Mexican FDA is not a patent expert, and it is unclear whether if the MPTO would be able to provide effective, timely and accurate support in this field.

Does it make sense for a non-innovative country such as Mexico to increase the protection to pharmaceutical patents at the risk of blocking non-infringing drugs?

[1] “PROPIEDAD INDUSTRIAL. LAS PATENTES DE MEDICAMENTOS ALOPÁTICOS QUE DEBEN PUBLICARSE EN LA GACETA RELATIVA, DEBEN SER ÚNICAMENTE AQUELLAS QUE PROTEGEN UNA SUSTANCIA, INGREDIENTE O PRINCIPIO ACTIVO”, at Semanario Judicial de la Federación y su Gaceta, Ninth Era, Tome XXIX, May 2009, page 1092.|

[2] “PROPIEDAD INDUSTRIAL. LAS PATENTES DE MEDICAMENTOS ALOPÁTICOS O SUS REIVINDICACIONES QUE NO CONSTITUYAN PROCESOS DE PRODUCCIÓN O DE FORMULACIÓN DE MEDICAMENTOS Y QUE EN SU COMPOSICIÓN FARMACÉUTICA INCLUYAN UN INGREDIENTE, SUSTANCIA O PRINCIPIO ACTIVO, DEBEN INCLUIRSE EN LA PUBLICACIÓN A QUE SE REFIERE EL ARTÍCULO 47 BIS DEL REGLAMENTO DE LA LEY DE LA PROPIEDAD INDUSTRIAL”, at Semanario Judicial de la Federación y su Gaceta, Ninth Era, Tome XXXI, February 2010, page 135.