NEW DOSAGE REGIMES The current situation
“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 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).
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), 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 around the world.
growing importance
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.
36 Life Sciences Intellectual Property Review 2012
www.worldipreview.com
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.
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
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