Non-Patentable subject matter according to the New Guidelines of the PTO
New guidelines for the examination of patent applications (related to chemical-pharmaceutical inventions) were approved in Joint resolution No. 118/2012, 546/2012 and 107/2012 (Ministry of Industry, Ministry of Health and National Institute for Industrial Property). This resolution was published in the Official Bulletin on May 8, 2012 and entered into force on May 9, 2012.
Hereinafter, you will find a summary of patentability criteria introduced by the new guidelines.
- The processes for the obtention of enantiomers, if novel and inventive, may be patentable if they are clearly described in the specification and the result obtained therewith is sufficiently disclosed in the description.
- Compounds included within a Markush formula shall be admissible as long as there is a reasonably logical and proportional relationship between the scope of the claims and the content of the description. The examples should be representative of all the compounds to be protected.
- New formulations and compositions, as well as processes for their preparation, should generally be deemed obvious in the light of the prior art. Similarly, claims related to pharmacokinetic parameters, micronisation of a known product or particle distribution within a given diameter or weight should not be deemed admissible. Manufacturing processes must produce an industrial result in order to be patentable.
- Exceptionally, claims reading on a formulation could be patentable when a long standing need is solved in a non-obvious way.
- Manufacturing processes must produce an industrial result in order to be patentable.
- New crystalline forms of a substance previously known in the art are not admissible. Furthermore, processes to obtain polymorphs are not patentable. Pseudo-polymorphs (solvates and hydrates) are not patentable separately from the active ingredient from which they derive. The processes to obtain pseudo-polymorphs; the Entantiomers and diastereomers are also not patentable.
- Selection patents shall not be granted as they are not considered to be novel over the general disclosure of the state of the art. Similarly, pharmaceutical compositions as well as their preparation processes and the medicaments containing them are not considered to be novel (when they are specifically related to an element or group of elements selected from a larger group of elements).
- New salts of known active ingredients, esters and ethers of known alcohols as well as other derivatives of known substances (such as amides and complexes) are not patentable. Active metabolites are not patentable separately from the active ingredient from which they derive.
- Patents over prodrugs, if granted, should disclaim the active ingredient as such, if said active ingredient was previously disclosed or otherwise non-patentable.
- Claims directed to a new dosage regime are not patentable, even if they are formulated as product claims. Claims relating to the use of a product, including the second indication of a known product, are also not admissible.
- Manufacturing or pharmaceutical processes (often called analogy processes) that are not by themselves novel and inventive are not patentable as such, regardless of whether the starting materials, the intermediate compounds or the end product are novel and inventive.
- Sufficiency of disclosure: For the purpose of any type of evaluation, working examples will be accepted to be added for a better understanding of the claimed invention, as well as data and/or information required by the examiner, as long as such information does not extend the scope of the original disclosure.
This is merely a selection of the most significant modifications. If you are interested in receiving the complete analysis of this resolution, please contact us. We will be glad to receive you request or coments.
Sources: Joint resolution No. 118/2012, 546/2012 and 107/2012