New Guidelines for Examination of Patent Applications within the Biotechnology field are to be published soon.

In 2019 the Brazilian Patent Office (BPTO) published the new text of the Guidelines for Examination of Patent Applications within the Biotechnology field.

The new text was under Public Consultation and received contributions in 2019.

The final text of the new Guidelines and the reply to the contributions were disclosed on April 2020, but the new Guidelines are not yet in force. 

The Resolution enforcing the New Guidelines for Examination of Patent Applications within the Biotechnology field are to be published soon.

The outcomes of the Public consultation and the main changes expected in the new Guidelines are as follows:

Degenerated sequences

Degenerated sequences may be accepted provided that they generate the same protein. 

Determining the degenerated sequences that would be for expression in organisms already well established (Escherichia coli, Saccharomyces cerevisiae, Arabidopsis thaliana, Zea mays, Glycine max, Drosophila melanogaster, Caenorhabditis elegans, etc.) is not considered undue experimentation.

On the other hand, when the application involves determining the preferred codons in under-studied species, or optimizing expression in specific organisms, claiming degenerate sequences would not be acceptable. In these situations, the person skilled in the art would not be able to determine which sequences to use for the expression of the protein without incurring undue experimentation.

Markush of biological sequences

Markush formula of amino acid sequences, evaluate:

  1. The physical-chemical characteristics (polarity, size, charge, etc.) of the amino acids pleaded for each position, compared to what was concretized in the specification; and 
  2. The region in which the modifications occur, since in areas critical to the function of the polypeptide, even conservative modifications can generate very different results. 

Acceptable amino acid substitutions: 

  • aspartic acid for glutamic acid; asparagine for glutamine; leucine to valine. 

Unacceptable substitutions (without due implementation): 

  • leucine for arginine; alanine for tryptophan; valine for proline.

Markush of nucleotide sequences, evaluate whether the sequence is a protein coding sequence or not:

  1. Coding sequences: alternatives that generate the same protein are acceptable;
  2. Non-coding sequence: only the sequences achieved can be considered acceptable, since the similarities / differences in the physicochemical characteristics of the bases are not sufficient for a person skilled in the art to predict which modifications would be acceptable.

Antibodies

Antibodies whose sequence already exists in nature, will be considered natural and, therefore, cannot be protected.

If the application clearly describes that the antibody was obtained from an organism naturally exposed to the antigen, the antibody is also considered natural, and, therefore, cannot be protected.

Antibodies that would not exist without significant human intervention – e.g. when it depends on exposure to the antigen in a controlled and repeated manner, including the use of adjuvants, to ensure the activation of specific cells for the humoral response – are not considered natural, given that human intervention is decisive for the final result.

Fragments derived from antibodies not found in nature can still be considered natural if they only contain the constant portions (Fc) of the original antibody, because such fragments are identical to the constant portions of other natural antibodies.

Acceptable claims (provided that the sequences cannot be found in nature)

Monoclonal antibody against protein X characterised in that it is produced by the hybridoma HHH, deposited under the number YYYY.

Antibody characterised in that it comprises the complementarity determining regions (CDR1; CDR2; CDR3) consisting of SEQ ID NO: X, SEQ IDNO: Y and SEQ ID NO: Z in the light chain and SEQ ID NO: A, SEQ ID NO : B and SEQ ID NO: C in the heavy chain and constant regions of the human γ-chain .

Unacceptable claims

Antibodies characterised in that they are specific for protein X.

Human monoclonal antibody characterised in that it recognises protein X and has an affinity of 2×10-9 M.

Monoclonal antibody and fragments characterised in that it is capable of binding protein X.

Monoclonal antibody characterized in that it comprises the complementarity determining region (CDR3) consisting of SEQ ID NO: X in the light chain and SEQ ID NO: A in the heavy chain and constant regions of the human γ-chain.

Since such claims do not clearly and accurately define the antibodies and/or fragments that are being claimed, these claims cannot be accepted.

To clearly and accurately define an antibody, at least the sequences of the (three) CDRs of the chains present must be defined.

Stem cells

Stem cells can be obtained directly:

  • From the embryo (from the internal mass of blastocysts from embryos produced by in vitro fertilization); 
  • Various tissues of the adult organism (such as bone marrow, adipose tissue); umbilical cord and placental blood; 
  • Or they can be obtained indirectly from the reprogramming of a differentiated adult cell (induced pluripotent stem cell – iPS).

The Biosafety Law, Law No. 11,105/05, stablishes restricted conditions for using human embryonic stem for research and therapy purposes and prohibits its commercialisation. 

The Guidelines stated that, the protection of products, processes for obtaining and applying human embryonic stem cells does not contravene the Biosafety Law, because the conditions set forth for research and therapy purposes do not exist in equal measure for patenting; and that the commercial prohibition does not extend to patenting, since marketing and patenting are distinct activities.

Genetic technologies for the restriction of use

Refers to any human intervention process for the generation or multiplication of genetically modified plants to produce sterile reproductive structures, as well as any form of genetic manipulation aimed at activating or deactivating genes related to plant fertility by external chemical inducers.

The Biosafety Law, Law No. 11,105/05, prohibits the use, commercialisation, registration, patenting and licensing of genetic technologies to restriction of use. 

Thus, it is not permitted to patent human intervention processes for the generation / multiplication of genetically modified plants with regard to plant sterility (even if partial). 

This will include processes and/or genetic manipulation involving sterile reproductive structures (pollen, egg, stigma, anther, fruit, and tissues thereof), that result in seedless fruits.

Bio Guide – a quick reference guide to biotech patentability in Brazil[1]

FICPI’s view and involvement

Membership of FICPI brings independent IP practitioners to learn and share knowledge around a worldwide community with strong shared interest, and to keep on top of developments to help clients build IP value.  

Next steps

[1] Information compiled from the BPTO’s Guidelines of Examination of Patent Applications within the Biotechnology field.

Co-author: Ludmila Kawakami
Ludmila Kawakami is a pharmacist and holds a Master’s degree in Immunobiological Technology. She co-coordinates the Biotechnology Committee of ABPI and her practice includes patent prosecution; patentability, FTO and infringement analysis; third parties observations and nullity proceedings; support on technical matters in litigation, particularly, in the pharmacy, biotechnology and chemistry fields; and support on proceedings related to the Access of Brazilian Genetic Heritage and Associated traditional Knowledge.