Patents covering technology that relates directly to solving health problems, either pharmaceutical or biotechnology, had and will always be controversial, and of huge commercial interest; specially, when it comes to obtaining patent protection in emerging economies such as Brazil, Russia, India and China, following by the next five largest markets South Korea, Mexico, Indonesia, Turkey and Saudi Arabia.
Mexico represents a very attractive and large market to pursue pharmaceutical related patent protection; however considering the overall patent requirements (novelty, inventiveness and industrial applicability) and most important the exceptions for patentability and non-statutory matter of protection and their particular criteria and legal basis, is vital in order to secure the desire technology protection in Mexico.
The key points of patent prosecution in Mexico should start from considering what could (or could not) be subject to patent protection. As defined in the Mexican Intellectual Property Law (IPL), only inventions that are new, the result of an inventive step and industrially applicable are subject of patentability, with the exceptions of: essentially biological processes for obtaining, reproducing and propagating plants and animals; biological and genetic material as found in nature; animal breeds; the human body and the living matter constituting it; and plant varieties.
The following key point is defining what is not considered as an invention, and regarding pharmaceutical related patents, IPL provides that theoretical or scientific principles; discoveries that consist in making known or revealing something that already existed in nature, even though it was previously unknown to man; methods of surgical, therapeutic or diagnostic treatment applicable to the human body and to animals are not inventions.
Considering the above, a technology that relates directly to solving a health problem and, in accordance to the provisions of the IPL, does not represent an exception or is not covered by the definition of not being an invention, is subject of patentability, thus meaning that patents related to a compound, process, medical use, formulation and even dosage, may be prone to patentability. The term “may” is emphasized because, although the diversity of possible figures of protection, all of them are prone of subjectivity of an Examiner during the substantive examination, where compounds, formulations, polymorphs, stereoisomers, or compounds with new medical uses must demonstrate their novelty, inventiveness and industrial applicability.
Regarding the novelty requirement, the definition is very straightforward as “new” means anything not found in the prior art, “industrial application” refers to the possibility of an invention of being produced or used in any branch of economic activity; but lastly and the most ambiguous requirement is “inventive step”, which refers to products of a creative process which are not obvious or deductible from the prior art to a person skilled in the art.
Further to the intrinsic complication of proving that a pharmaceutical invention is the result from a creative process and which is not obvious from the prior art to a person skilled in the art, other factor that should be considered is the fact that there are no clear guidelines under Mexican Legislation to establish what is obvious and not obvious. Local practice is to clearly define a technical feature that demonstrates an enhancement over what is defined as the prior art. This is a commonly used strategy to demonstrate inventiveness. This means that for new molecules, data highlighting the technical feature(s) solving a technical problem for the first time would be enough to fulfill the inventiveness requirement. However, if an already known compound or new composition comprised by known compounds is solving a new technical problem, then a new use has been invented. The case of wherein the new compound is very similar, or is based from a known compound, such as a new polymorph, salt, formulation, stereoisomer, … etc., providing comparative data proving a specific technical enhancement would most likely be required; hence, although it is not required by law, including comparative data in the specification as filed should be a must in order to avoid further obstacles during patent prosecution.
Lastly, the sort of data used to prove the new technical features and/or the enhanced technical features, described in either the first or second scenario above, is not regulated nor has a properly defined legal basis in the Mexican Industrial Property Law, being the most important the clinical data, secondly experimental data and lastly, and sometimes accepted, simulation data.
Whatever the case, Mexico represents a very attractive and large market to pursue pharmaceutical related patent protection, and now with the Governmental disposition of a patent Linkage between Health and Patent related authorities, the patent rights enforceability have been simplified and in favor of the Innovative Pharmaceutical Companies.