The Guidelines for Examination (Guidelines) of the Brazilian Patent & Trademark Office (BRPTO), also known as the National Institute of Industrial Property, establish a three-step test for examining the non-obviousness of a claimed invention. This three-step test involves: (i) determining the closest prior art; (ii) identifying the distinguishing features of the invention and/or the technical problem actually solved by the invention; and (iii) determining, in view of the technical problem, and considering the closest prior art, whether an invention is obvious to a person skilled in the art (items 5.9 to 5.21 of the Guidelines).
However, a detailed review of recent decisions from the BRPTO indicates that different tests for non-obviousness are being applied by Examiners in the examining division (e.g., first instance) when compared to Examiners handling appeals (e.g., Board of Appeals). This conclusion was obtained based on a review of cases being handled by Examiners in the pharmaceutical unit art divisions. The results demonstrate that Applicants must be strategic when dealing with an Examiner. In other words, a one-size-fits all type of approach during patent prosecution may lead to higher denials at first instance. Nonetheless, understanding the experience and background of the Examiner may result in a better result (e.g., allowance) for an Applicant.
The cases considered in this analysis had an appeal decision issued in 2020 and were examined (at the first instance) after the issuance of BRPTO’s Rule #169/2016 (i.e., the current Guidelines). The results show that the BRPTO conducts a much more detailed analysis (based on its Guidelines) during appeals (i.e. appeal stage) than during examination at first instance. Specifically, while 83% of the analysis carried out by the Examiner during the appeal stage applied the non-obviousness test as defined according to the Guidelines (e.g., BRPTO’s Rule #169/2016), only 20% of the analysis performed by Examiners during first instance applied the test.
In general, we observed that at first instance Examiners failed to: (1) identify the closest prior art; and (2) determine a starting point for a person skilled in the art. In most of the analysis examined it was not clear whether the closest prior art consisted of a combination of documents. Moreover, general allegations stating that an invention “would be obvious” over the prior art, without explaining how one skilled in the art would have arrived at such a conclusion, were commonly found to form the basis for rejection. Some examples of such allegations include:
“Upon analyzing the present application in view of documents D2 to D4, we noted that it is obvious. The methods claimed in claims 1 to 58 have the same goal and the same steps encompassed in the teachings of D2 to D4. The chromatographic techniques employed are non-inventive variations of those presented in said documents”. (PI0709726-3)
“Hence, a person skilled in the art that knew the state of the art at the time [previously described by means of 8 prior art documents] would have been motivated to carry out a similar process for the preparation of 2-oxoindoline products comprised in the state of the art to arrive at the 2-oxoindoline compounds claimed in the present patent application with reasonable expectation of success and obtain the additional beneficial compounds useful in the treatment of rheumatoid arthritis or cancer, for instance”. (BR 11 2015 022431 8)
“Claims 16 to 23, which refer to the lentiviral recombinant vector, are not inventive in view of any of the teachings of D1 or D2. Considering the vectors disclosed therein and that Flavivirus proteins are known from the state of the art, the construction of Ptrip lentiviral recombinant vectors expressing Flavivirus proteins derives in an obvious way for a person skilled in the art”. (PI0510016-0)
“(…) document D4 already disclosed Fe compounds close to the claimed compounds for the same function claims, namely, fighting tuberculosis. Thus, the claimed matter is not inventive”. (PI0300770-7)
“Even though the document cited in table 4 refers to serotoninergic receptor modulators, D1 does not motivate a person skilled in the art to carry out the structural modifications to obtain the compounds of the present application”. (PI0312176-3)
With respect to second medical use claims, we reviewed 37 second medical use inventions examined by the BRPTO during the appeal stage after issuance of BRPTO’s Rule #169/2016. Surprisingly, we found that the three-part test for obviousness was applied in only 53%[1] of the second medical use inventions examined by the BRPTO (during the appeal stage) compared to 83% overall as discussed above. Moreover, examination at first instance only applied the three-part test in 23% of the cases[2].
In fact, with respect to the patentability of second medical use inventions, the BRPTO relies most frequently on Rule #208/2017, which establishes examination guidelines for chemistry-related applications (Chemistry Guidelines). Unfortunately, the Chemistry Guidelines take a very strict view regarding the patentability of second medical use inventions. Specifically, general standards have been established for determining the novelty and non-obviousness of these inventions. For example, if an invention claims a particular dosing regimen or the treatment of a specific patient population, these types of claims are automatically deemed to lack novelty and be obvious. In other words, in most instances, the three-part test defined in the Guidelines is simply not even applied to these types of inventions.
Because Applicants must submit counter arguments to the BRPTO’s obviousness objections raised in an Office Action, the methodology by which the non-obviousness of a claimed invention is assessed by an Examiner can have a huge impact on the outcome of the examination. Therefore, as illustrated by the above, replying to Office Actions at the BRPTO represents an extra challenge, which can be even greater in the case of second medical use inventions. Thus, when defending the patentability of a claimed invention, Applicants must come up with an argument regarding the non-obviousness of the claimed invention which can often be challenging in view of the harsh conditions pre-defined in the Guidelines. As illustrated by the above, Applicants for pharmaceutical inventions in Brazil need to have a good understanding of the experience and background of the Examiner handling their case at first instance, and if need, be, at the appeal stage, as well.
This post was written by Lisa Mueller and by Yasmin Kronemberger, Luiza Cotia and Roberto Rodrigues of Licks Attorneys.
[1] Only the cases which assessed non-obviousness at the appeal stage were considered.
[2] A total of 22 cases were considered. These cases were examined at first instance after the issuance of Rule #169/2016.