innovative-drugs-or-generic
Everett Collection / Shutterstock.com
1 May 2014PatentsXavier Hadad

Patenting drugs in Mexico: innovative or generics?

Over the course of time, and in an increasingly globalised world, the pharmaceutical industry has gained strength and a stronger identity because it integrates two main functions in its structure: ensuring the health of the population in each state or country, and protecting and maximising scientific and technological developments to justify the introduction of a medicine to the population.

Ensuring the fundamental rights of inventors to recover the money and time invested in research to invent new products through patents is also necessary. Even so, there have been several problems for companies known to be innovative and the ones that are known for their generic medicines.

Additionally, there is a regulatory process in each country that does not always go hand in hand with the patent system, which makes it necessary to seek amendments to local laws to achieve a safe and effective governance system.

Because a patent provides a temporary monopoly that the state grants a company to exploit an invention and, because of the resulting benefits and special privileges, markets and industries in which such inventions are protected become attractive because of the excellent economic income that the patent may represent for its owner.

Applying this to the pharmaceutical industry, as it is throughout the world, the launch of an innovative drug generates a series of research protocols that reflect the company’s investment in many years of study and research, plus the investment of hundreds of millions of dollars, to come up with an innovative product that allows it to position itself as a leading company.

The problem is that the investment of years, money and effort to obtain a patentable medicine must necessarily include proof that the medicine is safe and effective.

Even though the readers of this article will be global IP specialists, it may be worth discussing what the expression “safe and effective drug” means in Mexico. Effective means it is used to treat the disease for which it is indicated. Safe means it does not damage or cause side-effects in the patient.

The patent-marketing authorisation issue

In 2003 Mexico introduced a patent-marketing authorisation (MA) linkage system for pharmaceutical products. This system involves the collaboration of two Mexican authorities: the Patent and Trademark Office (IMPI) and the Mexican Commission for the Protection against Sanitary Risks (COFEPRIS). The linkage system requires the IMPI to publish a so-called Linkage Gazette listing all patents granted and valid that cover mainstream drugs.

On the other side, COFEPRIS must study the linkages described in the Gazette and, in relevant cases, 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 Industrial Property Law (Mexico), that states the rules for including patents in the Gazette, and Article 167 Bis of the Health Products Regulations which, in turn, provide the patent rules for issuing and obtaining marketing authorisation for new drugs.

To understand the patent linkage system in Mexico, it is essential to refer to the provisions of Article 25 of the Industrial Property Law, which indicates that to be included in the programme the patent must be for the nature of a product or a process. This means the exclusion of formulation and new-use patents.

The main problem with the patent linkage system in Mexico is that Article 47 Bis of the regulations was ambiguous and subject to interpretation as to which patents were to be included in the Gazette. Taken literally, Article 47 Bis excludes only patents that solely claim a new process. However, in practice, the Mexican authorities adopted another interpretation and, to date, the IMPI allows only patents that claim compounds (that is the active substance of a medicine) per se and not patents that claim formulations (that is the mix of components in a medication) or its uses (the specific therapeutic indications of a medicine).

Supreme Court’s decision

After several proceedings before federal courts, the Supreme Court of Justice (the supreme judicial authority in Mexico) looked at the matter of interpretation and at how to decide on the proper interpretation of the provisions of Article 47 Bis of the regulations.

The Supreme Court issued a majority decision, supporting the broad interpretation: that it includes not only compound patents but also patents claiming pharmaceutical formulations. The justices claimed that the spirit of the linkage system is to provide a simple channel of communication between IMPI and COFEPRIS to avoid the issuance of MAs to products that infringe patents. It further ruled that pharmaceutical products (drugs) are not comprised solely of their active substance but also of the entirety of ingredients that together 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.

The 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.

Obtaining an MA

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.

"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."

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.

This 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. The 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. The problem arises when, despite a 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. The complaint will cite the failure of the authority to list the medication’s patent.

There 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

Already registered?

Login to your account

To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.

Two Weeks Free Trial

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk