By Moeller IP Advisors
According to data from the Chemical Abstract Service (CAS), a division of the American Chemical Society, the number of patents related to chemical products has grown tremendously in the last 20 years: the CAS Registry collects data on more than 132 million organic and inorganic substances. Brazil makes no exception to this trend.
It’s therefore particularly relevant that the Brazilian Institute for the protection of Industrial Property (INPI) had published, last January, a new set of guidelines for the examination of patent applications related to the chemical field.
The guidelines have been issued on January 2 with the Rule 208/2017 and following a request for public consultation on a draft version of the same guidelines, submitted in March 2017.
Rule 208/2017 complements the previously issued Rules 124/2013 and 169/2016 – respectively guidelines for the Examination of Patent Applications – Parts I and II. The new guidelines replace the previous guidelines published in 2002 by the INPI Brazil for the examination of patent applications in the biotechnological and pharmaceutical field.
Content of the new guidelines
The recently published guidelines contain additional content when compared to the draft published in March 2017. What are the main aspects of the newly issued guidelines?
- Definition of a chemical compound: according to the new INPI guidelines, a chemical compound must be defined by its chemical structure or chemical name. This implies that compounds defined solely by their physical, physicochemical or biological properties or by their use or application (so-called functional claiming), cannot be accepted.
- Esters, ethers, pro-drugs, solvates, hydrates, clathrates, and co-crystals: these terms alone, lacking any specific definition, will be interpreted as generic expressions with the consequence that the application risk to be rejected.
- Selection patents: applicants should provide comparative data between selected compounds claimed in an application and those of close structural similarity known in prior art. Clearly, this is necessary to demonstrate how the selected compounds contain an inventive step.
- Polymorph claims: the application should contain a precise characterization of the crystalline solids. Single-crystal X-Ray Diffraction is an analytical technique that, for the INPI, is sufficient to characterize the crystalline structure of the solid. Alternatively, INPI admits that the Powder X-Ray Diffraction – considered a “bulk characterization technique”- can be used in association with at least another identification method. Lack of data for characterizing a crystalline solid will likely result in a rejection of the claim.
- New medical use claims: this is particularly relevant for the pharma industry. According to the guidelines, the application should contain evidence supporting the new medical use of the compound, otherwise the examiners may reject it. In this regard, the guidelines adopt a more flexible approach compared to the draft published in March last year. Indeed, in the new version, the INPI admits that in vitro studies can be used to support an in vivo effect if the applicant submits complementary information – for instance, a scientific publication – proving the equivalence between the two methods.