Brazilian PTO's Examination Guidelines for patent applications related to chemistry area open to public consultation

21/03/2017


Dannemann Siemsen Advogados
A public consultation on the new Brazilian PTO's Examination Guidelines for patent applications related to the chemistry area was published in the Official Gazette dated March 17, 2017, from which a period of 60 days was started for the consultation.

The new Guidelines address particularities of the examination of patent applications in the field of chemistry, thus complementing the general aspects of patentability and formalities found in the current Guidelines - Block I (Resolution No. 124/2013) and Block II (Resolution No. 169/2016).

The draft Guidelines address some specific topics which directly impact chemical, pharmaceutical and agrochemical patent applications, mainly those related to the so-called "incremental inventions" or "second generation inventions", such as:

- novelty and inventive activity, clarity and preciseness, and sufficient disclosure of compound claims, including salts, esters and ethers of chemical compounds, prodrugs, intermediate compounds, selection invention of chemical compounds, stereoisomers, polymorphs, solvates, clathrates and cocrystals.
Example:

In a selection invention, the claimed compounds selected from a Markush formula should neither correspond to those exemplified in the prior art nor those disclosed as preferred compounds in such prior art. Further, test results that clearly demonstrate the non-obvious technical effect of the claimed compounds compared to the compounds of higher structural similarity specifically disclosed in the prior art should be presented.

- novelty and inventive activity, clarity and preciseness, and sufficient disclosure of new medical use claims - in vivo tests are required in the specification for the claimed matter to be considered sufficiently disclosed. In addition, features related to the therapeutic regimen (dosage regimen, administration route, posology) and/or the patient group are not accepted in new medical use claims.
Examples:
"Use of compound X for preparing a medicament for treating disease Y" - acceptable;
"Use of compound X for preparing a medicament for treating disease Y in diabetic patients" - non-acceptable, if the invention refers to the patient group;
"Use of compound X for preparing a medicament for the treatment of disease Y consisting of administering the medicament 3 times a day orally" - non-acceptable, since it refers to the treatment, not to the use.

- cases in which "composition for use" claims would be accepted - basically when the composition is also defined by its constituents, which confer novelty on the composition per se, and wherein the claim does not comprise any administering step.

- claims related to a new combination of chemical compounds are accepted, provided that the interaction between such compounds produces an unexpected technical effect, for example, a synergistic or supra-additive effect, which does not correspond to the mere sum of the individual effects of each compound of the combination. However, such claims should meet the requirements of clarity and preciseness.
Example:
"A pesticide composition characterized by comprising a pyrethroid compound and an enzyme X-inhibiting compound" - non-acceptable, since the definition of the combination compounds by their chemical classes or by their mechanism of action in a generic manner, without specifying which are the exact compounds in the combination, is not sufficient to clearly define the subject matter to be protected.

As can be seen from the above examples, although the new draft Guidelines only regulates what the examiners have already done in practice, it is highly recommended that Applicants for chemical, pharmaceutical and agrochemical patent applications submit comments and suggestions to the Brazilian PTO.

The original draft Guidelines in Portuguese can be found in the Brazilian PTO's website: http://www.inpi.gov.br/menu-servicos/DIRETRIZESEXAMEREAQUMICA17032017.pdf. An English version is being prepared by us. Interested parties can send their suggestions by e-mail to saesp@inpi.gov.br until May 16, 2017.