dimanche, mai 01, 2011

Mexico: Second medical use claims in the new European format

Therapeutic treatment methods for humans or animals are excluded from patentability under most legal systems around the world, and Mexican law is no exception. Article 19(VII) of the Industrial Property Law excludes such methods from patentability because they are not considered inventions. However, it is generally feasible to obtain patent protection in Mexico if method claims are amended to a 'Swiss-type' format - for example, 'the use of a substance X for the manufacture of a medicament for the treatment of disease Y'.

Europe has opened up the prospect of patentability for known compounds that were previously unknown for use in treatment, thus giving rise to medical use claims with the wording:

  • 'a compound X for use in medicine';
  • 'a compound X for use in therapy'; or
  • 'a compound X for use in the treatment of a disease Y'.

However, these types of claim are inadmissible in Mexico unless the compound is new and is the intended object of patent protection. New uses of compounds or compositions can be protected in Mexico if the claims are drafted in Swiss-type format.

Significant changes were made to the European Patent Convention in 2007, which amended Article 54 to introduce a new form of second medical use claim. Article 54(5) expressly permits purpose-related product claims for a new medical use of a known substance. Thus, the new format allowed under the convention is 'product X for use in [new therapeutic use]'. This type of wording may be used for second and subsequent medical uses.

As a result of the changes in Europe, many applications are filed in Mexico containing both types of claim: the traditional Swiss-type format and the new format for second medical use. The criteria applied by the Mexican Institute of Industrial Property (MIIP) are similar to those of the European Patent Office. However, on assessing the monitoring of patent applications in Mexico, it appears that the examiners will not accept the new format for second medical use; only the first medical use format is accepted in applications involving a novel compound.

Thus, MIIP's position - at least at present - appears to be that it will not accept the new format for a claim for a second or subsequent medical use. In effect, the Swiss-style format is the only format accepted in Mexico for claiming such a use.

There seem to be two reasons why Mexican examiners will not accept the new European format. First, the Industrial Property Law has no equivalent to Article 54(5) of the convention. Second, the novelty requirements of the law provide that a claim in respect of a new use for a known compound - 'a compound X for use in the treatment of a disease Y' - is considered to lack novelty in comparison with the disclosure of compound X.

Therefore, amendments to the law would be needed to bring it into line with the convention, thereby ensuring the acceptance of purpose-related product claims for a new medical use of a known substance.

For further information on this topic please contact Jasmin Maqueda at Becerril, Coca & Becerril SC by telephone (+52 55 5263 8730), fax (+52 55 5263 8731) or email (jmaqueda@bcb.com.mx).