The Brazilian PTO published a draft guidelines for the examination of patent applications related to the chemical field (please find enclosed an English version thereof). Any comments and suggestions regarding such draft guidelines must be submitted up to May 16, 2017.
These new guidelines are supplementary to the content of Brazilian PTO’s Rules 124/2013 and 169/2016 (Guidelines for Patent Applications Examination – Parts I and II, respectively). In a general aspect, the Brazilian PTO reiterated and exemplified the understanding already adopted during the examination of chemical and pharma patent applications. The main aspects addressed in said draft guidelines are as follows:
i. Chemical compound definition: 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;
ii. Product by process claims: they are accepted in extreme cases in that it is not possible to define the compound otherwise.
iii. Esters, ethers, pro-drugs, solvates, hydrates, clathrates, and co-crystals in the claims: these terms are interpreted as generic expressions and imprecise to define the subject matter;
iv. 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 in order to assess the inventive activity of the invention;
v. Support for polymorph claims: the specification of a patent application as originally 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. On the other hand, if monocrystal XRD technique is not provided, the Powder X-Ray Diffraction (powder XRD) should be used associated with at least another identification method;
vi. 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 order to evidence the new therapeutic activity of the known compound, in vivo tests should be presented. In addition, a medical use claim should define the disease to be treated in an accuracy way.