BRPTO releases updated version of Patent Examination Draft Guidelines related to Biotechnology Arts

June 10, 2020

BRPTO releases updated version of Patent Examination Draft Guidelines related to Biotechnology Arts

On June 8, 2020 the BRPTO published an updated version of the new Patent Examination Draft Guidelines related to Biotechnology Arts, resulting from the review of the comments and suggestions received last year after the invitation for public comments on said Guidelines. This document is not final and must be approved by the BRPTO’s Federal Attorney.

In the updated version of the draft Guidelines, the BRPTO established that in order to be defined in a clear and precise manner, the following amendments can be carried out in DNA and PROTEIN claims, provided that there is support in the application as filed:

  • a DNA characterized by codifying a polypeptide sequence can be redrafted to be defined by its nucleotide sequence and its degenerations; and
  • a PROTEIN characterized by being codified by a nucleotide sequence can be redrafted to be defined by its amino acid sequence.

Moreover, the BRPTO clarified that patent applications directed to production of sterile reproductive structures, which encompass processes that act over the activation or inactivation of plants fertility genes, are not liable to patent protection as per the provisions of Law #11,105/2005 (Biosafety Law).

In addition to the above, the main differences proposed by the BRPTO for Public Consultation, in view of the Guidelines in force (Rule #144/2015), were maintained as summarized below:

  1. standardization procedures (obvious or routine experiments) for carrying out the invention may not be considered undue experimentation, unless specifically related to the technical problem;
  2. provision of 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;
  3. inclusion of embryos in the definition of “human or animal body” contained in article 10 (VIII) of the Patent Statute;
  4. clarification on the support and unity criteria for assessing Markush formulae of peptides and nucleotides;
  5. better definition of 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 prohibitions 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;
  6. definition of a process for obtaining polyclonal antibodies as statutory matter, provided that all the steps of the process are sufficiently described in the patent application, are not of natural occurrence or invasive;
  7. establishment that when a monoclonal antibody is defined in the claim chart by its CDR sequence, the claim must recite at least three CDR sequences by its SEQ ID NO;
  8. definition of the clarity, precision and support requirements for claiming antibodies and processes for obtaining the same;
  9. inclusion of 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 art. 5 of the Biosafety Law;
  10. exclusion of processes for generation/multiplication of genetically modified plants involving genetic use restriction technology (GURTs) from patentability, in compliance with the provisions of art. 6 (VII) of Biosafety Law.

The updated version of the Draft Guidelines is available at the BRPTO’s website and can be downloaded from the following link: Updated version of Patent Examination Draft Guidelines related to Biotechnology Arts (original version in Portuguese).

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