BRAZIL
May 04, 2017
Brazil has experienced several developments in recent months. Even though some of them may be seen as merely symbolic or drafts pending approval, all of them show that things are moving forward in the country to ease and update the prosecution of patent and trademark applications.
On April 12, a Memorandum of Understanding was signed between the BPO (INPI) and the Brazilian Health Regulatory Agency ("ANVISA"), which intends to address the problem related to the faculties assigned to ANVISA in the examination process of pharmaceutical patent applications.
In accordance with this MOU, ANVISA would only be responsible for analyzing aspects related to public health, not related to patentability criteria. Also, it is worth noting that the INPI issued a draft of guidelines for patent applications in the chemical field and is accepting comments until May 16, 2017.
The new guidelines address important issues which, as the draft is right now, are regulated as follows: chemical compounds defined by its physical, physicochemical or biological properties are not accepted; product by process claims can only be accepted when there is no other way to define the compound; the crystalline structure of a polymorph may be characterized by Single-Crystal X-Ray diffraction although, if this is not provided, the Powder X-Ray diffraction could be used associated with at least another identification method; a new use of a known compound defined by its dose, administration, etc.
is not considered as novel, even though new therapeutic activity of a compound could be patented if in vivo tests are presented.
As of today, these guidelines are only a draft and will be closely monitored to see how the INPI addresses this important issues. However, we understand they are a good sign showing the INPI's intention to update its guidelines and provide more legal certainty in a traditionally conflictive area.
A Normative Instruction has been issued to reduce and simplify the scope of the examination by the INPI of technology transfer and IP license agreements. The INPI should now focus, strictly, on formalities applicable to this agreement and not on the merits of the agreement.
In particular, the INPI will no longer examine the payment clause of IP license agreements and, therefore, they will merely state that they do not examine if the rules pertaining to tax and foreign exchange control law are meet by the parties in the agreement.
Finally, as explained in our previous Newsletter, the shock produced by the issuance of Resolution 174 in relation to the assignment of priority rights has finally cleared up.
In accordance with Resolution 179, which revokes Resolution 174, assignments of priority documents signed after the filing date of the PCT application are valid and everything goes back to normal again.
The assignment document will still need to be filed within 60 days of the national entry in Brazil and translated into Portuguese. Also, if the change of ownership has not been registered yet at the WIPO, a copy of the assignment needs to be filed upon entering the national phase in Brazil.
The above changes will have to be monitored but we think it is fair to say that they show that the Brazilian authorities are trying to improve the prosecution of patent and trademarks in the country.