THE MEXICAN LINKAGE SYSTEM Obtaining an MA
“SOME ARGUE THAT AN ISSUE FOR ALL THE AUTHORITIES HAS NOW BEEN RAISED WITH THIS DECISION THAT SHOULD, AT LEAST MORALLY, OBLIGE THEM TO ACT IN ACCORDANCE WITH IT.”
provide the required therapeutic effect as well as the necessary security and efficacy properties, thereby making it necessary to include patents granted for formulations as part of the linkage system.
Te Supreme Court’s decision is now in full effect. However, the decision does not oblige the administrative authorities, such as IMPI and COFEPRIS, to follow it since it is a judicial decision with a scope that is restricted to the judicial authorities. It is therefore possible that the administrative authorities will maintain their current practices without regard to what the Supreme Court has determined. Some argue, however, that an issue for all the authorities has now been raised with this decision that should, at least morally, oblige them to act in accordance with it. For the time being, neither IMPI nor COFEPRIS has issued or acted upon their official standpoint on the matter.
In any case, this ruling establishes an important precedent for all the Mexican federal courts in future cases because even if IMPI and COFEPRIS were to maintain their current practices and deny the inclusion of formulation patents in the Gazette, cases taken to trial before the courts would stand a very high possibility of success in obtaining a court order that would force their publication in the Gazette even, possibly, through a ‘fast-track’ procedure.
In conclusion, the decision of the Mexican Supreme Court has now clarified that patents that claim a formulation for a mainstream medicine, as well as those for the active compound, must be included in the Gazette published by IMPI and, furthermore, must be observed by COFEPRIS to avoid the issuance of MAs for drugs that infringe patent rights.
In this more practical approach, the decision provides a substantial and welcome benefit for pharmaceutical innovators since the inclusion of formulation patents in the Gazette will now provide them with stronger and faster protection against infringers.
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With the entry to the market of generic medicines, a conflict was born between innovative patentable medicines and generic medicines that use the innovative medicines as a base.
As pointed out previously, the regulatory process for medicines is intended to be able to demonstrate that a drug is safe and effective and that work on it has included the performance of various and complex research protocols, along with the millions invested in testing and basic trials up to the preparation of the pre-clinical studies on animals and then the clinical studies on people, to demonstrate that it is safe and effective.
Companies wanting to market a medicine in Mexico have to receive an MA, which is awarded by COFEPRIS, for which they have to submit a dossier including all the results of
their investigations,
trials and tests to demonstrate that the drug to be marketed is safe and effective.
With this, the health authority has all the elements it needs to study the dossier and determine whether the medicine meets the requirements of safety and efficacy to obtain authorisation.
Now, with the birth of generic drugs, competing companies can monitor innovative medicines very closely and, once the term of the patent that protects the innovative medicine is imminent, can ask COFEPRIS to give them a health registration in order to market a generic version of the drug or medicine.
Tis works as follows. As the innovative medicine has already been determined to be safe and effective, the generic version does not have to prove it. Te manufacturer needs only to affirm to the health authority that the generic is the same as the innovative medicine because it has already been determined that the original complies with the requirements of safety and efficacy. All the manufacturer has to do is perform bioequivalence and bioavailability studies, which are much simpler than the studies performed previously by the innovator.
Given this, and even if it is fair to recognise that competition can generate lower-cost drugs, the competition must be fair because drug development, without a doubt, incurs more investment in money, research and time.
Inclusion of a patent in the Gazette and legal remedy
In Mexico, the usual way to ask the IMPI to include a patent in the Gazette is relatively simple: a written request is made to the authority to include it in the next edition. Te problem arises when, despite a
World Intellectual Property Review Annual 2014
Xavier Hadad works in the litigation department of Uhthoff, Gomez, Vega & Uhthoff, where he has more than 11 years of experience. He holds a law degree from the Tecnológico Autónomo de México, and is a member of the Mexican Association for the Protection of Intellectual Property and Barra Mexicana—Colegio de Abogados. He specialises in IP litigation and counselling, IP enforcement, antipiracy and domain names.
www.worldipreview.com
request for inclusion in the Gazette, the authority decides to not include it, violating the IP rights of the patentee.
Under Mexican law, if the authority omits to include the patent in the Gazette, there is a remedy consisting of the presentation of an appeal before a federal judge within 15 days of the date on which the Gazette was published. Te complaint will cite the failure of the authority to list the medication’s patent.
Tere are a number of favourable precedents for this type of procedure that conclude with a higher authority, the Federal Court, ordering a special issue of the Gazette in which the requested medication’s patent is included.
In conclusion, the medication patent-linkage system in Mexico has undergone many changes and advances that keep it functioning properly, and that ensure publication in the official Gazette of patents for existing medications. Moreover, there is an obligation on the health authorities to check the Gazette before granting permission for a generic version to be marketed.
Xavier Hadad is a senior associate at Uhthoff, Gomez, Vega & Uhthoff. He can be contacted at:
xhadad@uhthoff.com.mx
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