The Brazilian PTO published in January 2nd Rule 208/2017, which provides guidelines for the examination of patent applications related to the chemical field. As informed by our firm on 03/31/2017, a draft version of these guidelines was submitted to public consultation in March 2017. This new Rule is supplementary to the contents of BRPTO’s Rules 124/2013 and 169/2016 (Guidelines for the Examination of Patent Applications – Parts I and II, respectively).
Rule 208/2017, in a general aspect, reaffirms the BRPTO’s understanding already adopted during the examination of chemical and pharma patent applications. The main aspects can be summarized as follows:
- Definition of chemical compounds: according to the guidelines, the most accurate form to define a chemical compound is by its chemical structure or chemical name, that is, compound independent claims defined only by its physical, physicochemical or biological properties, as well as by its use or application, are not accepted;
- Product by process claims: they are accepted in specific cases in that it is not possible to define the product otherwise;
- Esters, ethers, pro-drugs, solvates, hydrates, clathrates, and co-crystals: these terms are interpreted as generic expressions and imprecise to define the subject matter and thus, restrictive definitions, if supported by the application initially filed, may be required when they are present in the claims;
- Selection inventions: comparative data between the selected compound(s) of the invention and those having higher structural similarity of the prior art should be presented to assess the inventive activity of the invention;
- Support for polymorph claims: the specification of a patent application as initially filed must contain identification data obtained from physicochemical characterization techniques for solids. For example, the Single-Crystal X-Ray Diffraction (monocrystal XRD) is sufficient to characterize the crystalline structure of the solid. If the monocrystal XRD technique is not provided, the Powder X-Ray Diffraction (powder XRD) should be used associated with at least another identification method;
- Composition definition: a composition independent claim should be defined by its constituents in a qualitative and/or quantitative form. Additional features related to the physical form and application of the composition, for instance, may be presented in the independent or dependent claims; and vii. New medical use claims: features related to the use of the compound, such as the therapeutic scheme (dosage, administration/application form, dose interval) and/or group of patients do not confer novelty to the known use of the compound. In addition, a medical use claim should define the disease(s) to be treated in an accurate way, since broad definitions such as those defining the disease by features or by the mechanism of action thereof (e.g. “use of compound X for preparing a medicament to treat a disease caused by excessive proliferation of cells”) are usually not acceptable.
Some newly introduced modifications, however, deserves attention:
- Polymorph inventions: if more advanced techniques, different from those described in such guidelines, are used to characterize the crystalline form, the Brazilian PTO will evaluate the relevance of such a technique to identify the crystalline solid claimed; and
- New medical use inventions: the Brazilian PTO presented a more flexible position regarding the presentation of in vivo/in vitro tests to evidence the new therapeutic use. In the draft guidelines, it was stated that “In vitro test results may show evidence of new therapeutic use; however, only in vivo tests are evidence of the new use, guaranteeing its accomplishment by a person skilled in the art”. On the other hand, according to Rule 208/2017 in vitro tests would be acceptable, provided that supplementary information proving equivalence of drug effect within the organism is submitted. In the case of animal studies, the models adopted should present the possibility of extrapolation for humans. It is worth mentioning that the patent application as originally filed should present evidences regarding the new medical use, otherwise, any proofs submitted along with the examination procedure will have additional character to demonstrate the support of the claims and probably will not be accepted by the Brazilian PTO.