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New Guidelines for Patentability Examination of Patent Applications directed to Chemical and Pharmaceutical Inventions

Joint Resolution 118/2012, 546/2012 and 107/2012 issued by the Ministry of Industry, the Ministry of Health and the National Industrial Property Institute of the Argentine Republic adopted the “Guidelines for Patentability Examination of Patent Applications directed to chemical and pharmaceutical inventions”.
The first paragraph of these guidelines establishes that: “These Guidelines give instructions about the consideration to be given to patentability examination of patent applications directed to chemical and pharmaceutical inventions. The application of these Guidelines to patent applications is the responsibility of the National Patent Authority. They are addressed primarily to the staff of the National Patent Authority, but it is also expected to be of assistance to the parties involved in the prosecution and practices regarding patent application. Furthermore, these Guidelines are intended to cover usual cases. Therefore, they must be considered as general guidelines; any exception should be duly justified.”

The new guidelines for patentability examination give guidance on the patentability of different types of claims within chemical and pharmaceutical inventions, specifying those which will not be accepted upon substantive examination. Thus, for example, they include guidelines for patentability examination of patent applications directed to polymorphs, enantiomers, prodrugs, metabolites, new salts of known compounds, forms, combinations, products characterized by parameters, and uses, among others.

It is worth mentioning that these guidelines are applied when performing the substantive examination of an application and not at the time of its filing. Therefore, an application including claims affected by the guidelines may be filed, i.e. filing will not be stopped. The National Industry Property Institute (INPI) will issue an Office Action and the applicant will have the option to submit arguments and amendments, including the option to appeal to the courts.

Among the most relevant aspects, it is established that claims reciting polymorphs and pseudomorphs (hydrates and solvates) and the procedures for obtaining them are not considered patentable. Enantiomers claims will not be accepted, but processes for obtaining individual enantiomers will be patentable.

Compounds claimed by a Markush formula shall be admissible provided that the existence of unity of invention is demonstrated, that they comply with the requirements for patentability and that the description provides sufficient support to obtain all the compounds within the Markush formula.

Use claims , including second medical indications (or other medical uses) of known compounds are not admissible.

INPI has just begun to issue Office Actions based on the new guidelines and it is too soon to give an opinion on the prevailing level of strictness of their application; however, it is important to note that it will be possible to file arguments and amendments to the claims which may be rejected under the guidelines.

Carmen Sánchez-Puelles