On January 2, 2018, things got off to a fast start in Brazil with the publication of new guidelines (Guidelines) by the Instituto Nacional da Propriedade Industrial (INPI; also known as the Brazilian Patent and Trademark Office (BRPTO)) relating to patent applications involving chemical inventions. The Guidelines complement several other guidelines issued over the last few years, such as block I (BRPTO Rule #124/2013) and block II (BRPTO Rule #169/2016).
The issued Guidelines add substantive text when compared to the draft published for public comment in March 2017. Specifically, some highlights of the Guidelines include:
- Definition of a chemical compound: A chemical compound should be defined by its chemical structure or chemical name. Compounds defined only by their physical, physicochemical or biological properties or by its use or application (functional claiming), will not be accepted. An example of a type of claim that will not be accepted is: “A compound characterized by having property Y”.
- Examination requirements for N-oxides: According to item 2.4 of Guidelines, a simple description of a N-oxide/salt/ester/ether of a known compound will be considered to be obvious unless the compound is associated with a non-obvious property or an “unexpected technical effect” over the prior art. INPI uses very specific language in this section of the Guidelines thus giving particularly strong emphasis and meaning to the phrase “unexpected technical effects”. It is important for applicants to keep this phrase in mind when drafting their applications for filing in Brazil.
- Esters, ethers, pro-drugs, solvates, hydrates, clathrates, and co-crystals: These terms alone, in the absence of any specific content (namely, a definition), will be interpreted as generic expressions, and as such, run the risk of receiving an “indefiniteness” type rejection during examination. Applicants should consider defining these terms in the specification to reduce the risk of receiving such a rejection.
- Selection patents: Comparative data between selected compound(s) claimed in an application and those of close structural similarity known in prior art should be provided for the purpose of demonstrating how the selected compounds are non-obvious over the prior art. Specifically, applicants should demonstrate how the selected compounds exhibit an unexpected technical effect over the prior art compounds.
- Written description of polymorph inventions: Advanced techniques used to characterize crystalline solid substances that were not foreseen in the Guidelines will be considered, in addition to x-ray diffraction data, by examiners in light of their relevance in the identification of the claimed crystalline solid. Additionally, a lack of data characterizing a crystalline solid will result in the specification being considered to not clearly and sufficiently describe the claimed subject matter. Moreover, INPI will consider the submission of further data on the characterization of crystalline solids after the filing date to be added subject matter (or new matter) which will not be accepted (however, such a decision could form the basis of a challenge in the Brazilian court system).
- Combination claims: As discussed in the draft of the guidelines, when assessing the obviousness of a combination claim, the combination should not have been disclosed in the prior art in connection with compounds belonging to the same chemical class.
- New medical use claims: The specification should provide evidence supporting a new medical use as of the filing date of the application. Failure to do so may result in the application being considered to lack an essential technical feature thereby resulting in the invention being considered to be insufficiently disclosed. According to the Guidelines, extrapolation of “in vitro” tests to support an in vivo effect will only be possible when complementary information proving equivalence is provided (such as through the use of a scientific publication stating that an in vitro-in vivo correlation exists). Additionally, studies carried out in animal models must be capable of being extrapolated to humans or the animals being treated.
- Submission of additional data during prosecution: Item 9.1.3 of the Guidelines states that an applicant can submit additional data during examination exclusively to complement the information already contained in the specification as originally filed. If no experimental data is provided in the specification at the time of filing, there is a risk that INPI may reject the submission of such new data.
This post was written by Lisa Mueller and Roberto Rodrigues Pinho.