Mexico: Which pharmaceutical-related claims are allowable?
According to the Mexican Industrial Property Law (IPL) the following types of pharmaceutical-related claims are exceptions to patentability:
biological and genetic material as found in nature;
the human body and the living matter constituting it.
and the following shall not considered as inventions:
forms of presentation of information;
methods of surgical or therapeutic treatment or diagnosis applicable to the human body, and those relating to animals; and
the juxtaposition of known inventions or mixtures of known products, their variation of use, form, unless they actually are combined or merged to obtain an industrial result or a non-evident use to a person versed in the subject matter.
Furthermore, the Mexican practice also objects to product-by-process (in most cases) and omnibus claims.
According to IMPI's Patent Gazette, the following subject matters have been granted:
pharmaceutical product claims;
formulations and compositions claims;
pharmaceutical combination claims;
polymorph claims; and
pharmaceutical use claims (Swiss-type claims and EPC2000 format).
Nevertheless, all the above types of claims usually face objections involving lack of novelty and inventive step. These objections are usually overcome by drafting the claim in terms of its technical features, and not based on its function or result and supporting it with the examples and proofs including in the description.
At present, dosage and polymorph claims are not well accepted based on the argument that they do not involve an inventive step and thus it is necessary to point out in a clear and concise manner in the description the unexpected effect of said dosage or polymorph, which must be duly supported by examples and comparative examples.