(BRPTO’s gazette of January 2 nd , 2018)
The Guidelines for Examination of Patent Application – aspects related to the examination of patent applications in the chemistry area – complement the contents of block I (BRPTO Rule #124/2013) and block II (BRPTO Rule #169/2016) of the guidelines for the examination of patent applications, with particularities about the examination of patent applications in the chemical art units. According to BRPTO’s instructions, the patent examination guidelines related to the chemistry area should be read together with block I and block II. Additionally, Rule #208/2017 revokes the old Biotech and Pharma guidelines of 2002, directed to applications filed after December 31, 1994.
As informed in our client alert of March 17, 2017 (available here), the guidelines formally implement the current practice of the examiners of the chemical and pharma fields. Comparing the issued guidelines to the draft put under public comments, the following information have been added:
1) An example of a compound claim, considered as undefined for being characterized solely by the compound’s property;
2) Inclusion in item 2.4 of N-oxides’ examination requirements. It is established in this item that the simple description of a N-oxide/salt/ester/ether of a known compound is obvious when it is not associated with a non-obvious property or an unexpected technical effect considering the prior art;
3) In item 2.8 related to selection patents claiming chemical compounds, the BRPTO redrafted the paragraph “The selected compounds represent a small group among the compounds disclosed in general form in the prior-art document, as they have not been specifically disclosed among the exemplified compounds, or among possible compounds taken as preferred, they are considered to be novel (Guidelines for the Examination of Patent Applications, Block II, paragraphs 4.21 to 4.23).” to exclude the passage in bold, thus broadening the interpretation of “specifically disclosed” compounds;
4) Exclusion of the expression “geometrical position” in item 3, in which enantiomers, diastereoisomers and atropisomers are defined. In view of that, the final guidelines establish that enantiomers, diastereoisomers and atropisomers differ in the spatial position of their atoms;
5) A disclaimer has been added to item 4.1 related to the enablement of polymorph inventions.
According to it, more advanced techniques to characterize crystalline solid substances, not listed in the guidelines, will be assessed by the examiner in light of its relevance in the identification of the claimed crystalline solid. Additionally, it is established that the submission of further data on the characterization of crystalline solids after the filing will be considered as added subject matter;
6) The definition of clathrates has been added to item 5;
7) For the assessment of obviousness of a combination claim, the combination could not have been disclosed in the state of art for compounds belonging to the same chemical class instead of for compounds sharing similar chemical structures as established in the draft;
8) For the enablement of medical use claims, the specification must contain evidence demonstrating the new use on the filing date. Additionally, it was further established in item 9.1.3 that:
a. “in vitro” results can be extrapolated to demonstrate the real therapeutic application provided that complementary information showing equivalence of effect is submitted; and
b. When studies are carried out in animal models, it must be possible to extrapolate them to human beings or animals to be treated.
9) Item 9.1.3 further establishes that the applicant can submit additional data during the examination procedure exclusively to complement the information already contained in the specification as originally filed.
The guidelines are available at the BRPTO’s website and can be downloaded from the following link: Patent examination guidelines related to chemical area (original version in Portuguese). The English version of the draft guidelines will be available soon.