(Federal Register on February 6, 2019)

The Examination Guidelines of Patent Applications in the Biotechnology Arts currently in force (BRPTO Rule #144/2015) are being reformulated by the BRPTO. On February 6, 2019 the BRPTO invited public comments for the amendments suggested in said guidelines through a publication on Federal Gazette #26. Comments on the proposed guidelines will be received by the BRPTO until April 06, 2019.

The main amendments suggested by the BRPTO in the draft guidelines are the following:

• i. standardization procedures (obvious or routine experiments) for carrying out the invention may not be considered undue experimentation;
• ii. details on the situations where degenerated nucleotide sequences can be accepted, i.e., they must generate the same protein and no undue experimentation is permitted for defining the sequence;
• iii. includes embryos in the definition of “human or animal body” contained in article 10 (VIII) of the Patent Statute;
• iv. clarifies the support and unity criteria for assessing Markush formulae of peptides and nucleotides;
• v. better defines what is regarded as patentable matter in relation to antibodies and fragments thereof. For instance, if an antibody is obtained from an organism that is naturally exposed to the antigen, the antibody will also be considered of natural origin and will fall within the limitations of art. 10 (IX) of the Patent Statute. On the other hand, if the antibody is only possible to be obtained through human intervention, then it is considered a statutory matter;
• vi. defines a statutory matter as a process for obtaining polyclonal antibodies, provided that all the steps of the process are sufficiently described in the application and are not of natural occurrence;
• vii. establishes that when a monoclonal antibody is defined in the claim chart by its CDR sequence, the claim must recite all three CDR sequences by its SEQ ID NO;
• viii. details the clarity, precision and support requirements for pursuing antibodies and processes for obtaining the same;
• ix. includes the possibility of patenting inventions related to products, obtainment processes and applications of human embryonic stem cells, contrary to the previous understanding that said types of invention could not be patented in view of Article 5th of Biosafety Law #11,205/2005;
• x. excludes from patentability processes for generation/multiplication of genetically modified plants involving genetic use restriction technology (GURTs), in compliance with the provision of Article 6th (VII) of the Biosafety Law.

The draft guidelines are available at the BRPTO’s website and can be downloaded from the following link: Patent examination draft guidelines related to biotechnological inventions (original version in Portuguese). Please contact us for its English version.

Suggestions must be electronically sent to saesp@inpi.gov.br in a specific form made available by the BRPTO (here).

Please contact us for more information on this matter at patents@lickslegal.com, we will be glad to assist you.