1 May 2012AmericasPablo Fuentes

A step forward: new dosage patents in Mexico?

In Mexico, as in most of the IP systems around the world, pharmaceutical patents can be obtained to protect novel drug molecules; intermediate compounds thereof; processes for manufacturing such molecules and intermediates; compositions containing them; and uses of the new molecules in a specific therapeutic way. Likewise, new pharmaceutical formulations, new methods of preparation, new crystalline forms, and new therapeutic uses of already known molecules are also available for protection.

In the specific field of pharmaceutical patents, it takes an average of between 12 and 15 years from the moment the applicant for a new drug begins prosecuting a pharmaceutical patent to the moment at which it obtains a patent and permission to market the new molecule.

So, it is logical and even understandable that, in order to recover an investment of thousands, or even millions of dollars, an average period of five to seven years as the ‘effective market time’ of a new drug protected by a patent may not be enough to cover the needs of the innovator’s business.

Therefore, considering that the costs of developing a novel drug molecule from scratch will definitely be higher for the innovator than the costs of continuing and/or developing a line of investigation on an already known molecule, and adding to this equation the impact that the global financial situation has had on almost all the markets around the world (including those markets in which the pharmaceutical industry plays a key role), nowadays we are witnessing the emergence of new trends and strategies from a sector of the innovators in the pharmaceutical industry in order to improve or strengthen their IP rights—such as the development of new therapeutic regimens for their molecules—which, in some cases, exceed the rate of development of the IP systems around the world, especially in developing countries.

That is why inventions directed towards the protection of new dosage regimes for known drugs are a topic of growing importance around the world.

For these types of inventions, both the active principle and its therapeutic activity have already been described in the literature.

Nevertheless, as a consequence of the continuous search to further develop the technologies already in hand, it has been shown that there is an additional factor with a direct impact on the already known therapeutic activity of a drug, which can dramatically improve its therapeutic effects, or can even lower its secondary effects. This factor is the sequence or the specific intervals of time in which certain doses of the active principles are administered to a patient.

The current situation

In the few years following the now famous decision G2/08 issued by the Enlarged Board of Appeals (EBA) of the European Patent Office (EPO), which established the precedent about the patentability of novel dosage regimes, the idea of patenting this type of invention in Mexico became almost a taboo theme.

Unfortunately, the current form of the Mexican Industrial Property (IP) Law does not contain a passage mimicking the amendments to Article 53 of the new European Patent Convention (EPC 2000), that enabled the EBA to respond positively to the questions raised by the appellant in that particular case. It does not permit the use of purpose-related claims as in other jurisdictions (Japan, Europe) nor allow protection for therapeutic methods of treatment (as in the US or Australia).

In this sense, it is true that the Mexican Law needs to pass through an updating process to better deal with modern exigencies caused by the fast development in all fields of technology, but it is also true that as a result of the continuous efforts made in recent years by applicants’ representatives, some progress has been achieved despite the posture of the Mexican Patent Office.

It seems that there may be a light at the end of the tunnel.

“MEXICAN IP LAW DOES NOT PROVIDE ANY DEFINITION OF THE TERM ‘TECHNICAL FEATURES’ AND, THEREFORE, THE ESTABLISHMENT OF A DEFINITION IS VITAL FOR THE MEXICAN IP SYSTEM.”

Regardless of the fact that the real utility/ benefit that an applicant could obtain from a patent directed to protect a novel dosage regimen (for instance, during the enforcement process) remains to be seen, we cannot deny that the fact of developing a new and more effective way of treating a known disease must be considered to fulfil the universal definition of what is considered as an invention and, therefore, should not be treated differently from any other invention regarding its patentability requirements.

In practice, the position that the Mexican examiners have adopted since decision G2/08 came to light is to recognise that those inventions in which the supposed novel and inventive element is provided by a new dosage regime could indeed be regarded as contributing an additional element to the state of the art and thus solving a technical problem (which is one of the core principles of proving a patent in any field of technology).

It would seem that the key point in order to obtain a patent of this nature will be to have strong in vivo or in vitro experimental evidence that can demonstrate, without any doubt, that the new dosage regimen is responsible for an advantageous technical effect (eg, reducing the length or frequency of the treatment, enhancing drug activity, lowering side effects, etc) in comparison with the effect obtained by following dosage regimes previously known from the state of the art.

Speaking of the challenges that the Mexican IP system has for a new dosage regimen invention, however, and considering that a change in Mexican law can hardly be seen as imminent, there is an immediate need for the Mexican authorities to fix more accurate criteria in order to construct a more solid base to evaluate the patentability of this type of invention.

Further, the current form of Article 29 of the IP law regulations specifically requires that the claim chapter must be drafted based on the technical features of the invention.

This provision has been interpreted by our authorities in the strictest sense: that the technical features of a product (a drug molecule in this case) can be provided only by its structural elements and not by any of its associated functions, which clearly represents a barrier for the introduction of purpose-limited product claims as they are used in many other jurisdictions to define the scope of this type of invention.

However, the truth is that Mexican IP law does not provide any definition of the term ‘technical features’ and, therefore, the establishment of a definition is vital for the Mexican IP system in order to provide a higher degree of certainty to its users.

In the author’s opinion, it could be said that, globally speaking, the Mexican IP system is currently experiencing an evolution of the manner in which the inventions directed to protect novel dosage regimens are understood and evaluated, which despite being a slow process, is a promising sign for applicants that may be interested in obtaining protection in Mexico for these types of inventions.

Likewise, just as in any other naturally occurring processes, external factors will play a key role in determining the future of this type of invention. The applicant’s capacity to obtain and exhibit strong and convincing experimental evidence to demonstrate that a new dosage regimen is responsible for an advantageous technical effect will be the most important factor.

Pablo Fuentes is an attorney at Becerril, Coca & Becerril, SC. He can be contacted at: pfuentes@bcb.com.mx


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