On December 1st, 2020, the Instituto Nacional da Propriedade Industrial (INPI; also known as the Brazilian Patent and Trademark Office (BRPTO)) published Normative Instruction #118 (November 12, 2020), revoking the previous guidelines (Rule #144/2015) and establishing new guidelines for the examination of biotechnology inventions.
Summary of Main Changes Between New Guidelines and Previous Guidelines
A summary of the main changes between the new guidelines and the previous ones are provided below:
- Regarding enablement, the following will not constitute undue experimentation: (i) standard procedures for carrying out the claimed invention (e.g., obvious or routine experiments, such as standardized optimal conditions for conducting a polymerase chain reaction (PCR)), unless the standard procedures are specifically related to the technical problem that is solved by the claimed invention; and (ii) the determination of degenerate nucleotide sequences of preferred codons in species that were well studied at the time of the invention (e.g., filing date of the application).
- Regarding non-statutory matter, medical or surgical techniques and methods of treatment or diagnosis involving human and animal embryos are now explicitly excluded from patentability (article 10 (VIII) of the Brazilian Patent Statute). However, inventions related to products and methods of obtaining and using human embryonic stem cells constitute statutory matter.
- With respect to biological sequences (e.g., amino acid and/or polynucleotide sequences), any sequences not disclosed in the application at the time of filing cannot later be added to the application, even if such sequences can be inferred from the disclosure as filed. In fact, any amendments to the application to include such information will be rejected by the BRPTO as constituting new matter. However, if a biological sequence is known in the art and a specific reference (e.g., citation to a publication, database and/or patent) to the sequence is included in the specification, its later inclusion in the application will be allowed.
- Claims directed to DNA or RNA must be defined by its sequences of nucleotides (SEQ ID NO), while a protein must be defined by its sequence of amino acids (SEQ ID NO) in order to clearly define the subject matter of protection, provided that such sequences are disclosed in the application as originally filed. According to the new guidelines, it is possible to redraft DNA, RNA and protein claims that were not defined as outlined above, provided that their corresponding SEQ ID NO is disclosed in the application as originally filed. For example, a claim to a DNA encoding a polypeptide having a certain sequence of amino acids (SEQ ID NO) can be redrafted to recite a DNA having a certain nucleotide sequence. Moreover, degenerated sequences of a DNA or RNA defined by a nucleotide sequence through their SEQ ID NO are acceptable provided they generate the same protein and the protein is precisely defined in the specification.
Clarification of the Criteria for Written Description and Unity of Invention for Claims Involving Markush Language
Additionally, the new guidelines clarify the criteria to be used for assessing written description support and unity of invention for claims reciting Markush language for polynucleotides and peptides, as summarized below:
- Regarding written description support of alternatives in a claim containing Markush language for amino acid sequences, it is necessary to evaluate: (i) the physical and chemical characteristics of the amino acids claimed at each position in view of what was disclosed in the specification; and (ii) the region in which modifications occur, since in the critical areas involving the function of a polypeptide even conservative modifications can generate different results;
- For written description support of claims containing Markush language for nucleotide sequences, it is necessary to evaluate whether the sequence encodes a protein. In the case of coding sequences, alternatives that generate the same protein are acceptable. If the claimed sequence is not a coding sequence, then the evaluation of alternatives must consider the information presented in the specification, i.e., only the sequences disclosed in the specification will be accepted; and
- Claims containing Markush language should meet the unity of invention criteria specific to Markush groups as set forth in BRTPO´s Rule #124/2013 which establishes that: (i) all alternatives should have a common property or activity; and (ii) a common structure should be presented, i.e., a significant structural element should be shared by the alternatives.
Clarification of Several Issues Relating to Antibodies
The new guidelines also provide clarification on several issues relating to antibodies, such as:
- A better definition of what is considered patentable in connection with antibodies and fragments thereof. For example, if an antibody is obtained from an organism that is naturally exposed to an antigen, the antibody will be considered to be naturally occurring and will not be patentable pursuant to article 10 (IX) of the Brazilian Patent Statute. However, if the antibody can only be obtained through human intervention, such as, for example, by an immunization protocol (e.g., immunization of a mouse), then the antibody will not be deemed to be naturally occurring and will be patentable;
- Methods for obtaining polyclonal antibodies will be considered to be patentable, provided that all of the steps of the methods are sufficiently described in the specification and that the methods are neither of natural occurrence nor invasive. Therefore, methods of immunization/vaccination that comprises an invasive step are not eligible for patent protection;
- Monoclonal antibodies can be claimed by their complementary determining regions (CDRs); however, the claims must recite the three CDR sequences of the light and heavy chains by their SEQ ID NO; and
- Claims directed to chimeric, humanized and human antibodies and methods for obtaining the same must be defined by (i) their CDRs sequences; or (ii) biological sequences to specific regions (e.g., variable region) in order to ensure clarity, precision and support of the claimed subject matter. The new guidelines provide specific examples on how such antibodies can be claimed. Specifically, example 37 provides the following recommendation of how such claims can be worded: (a) A humanized antibody against α-actin characterized by comprising the variable murine region consisting of SEQ ID NO:X and constant regions in the human γ chain; and/or (b) A humanized antibody against α-actin characterized by comprising the complementarity determining murine regions (CDR1; CDR2; CDR3) that consist of SEQ ID NO: X, SEQ ID NO:Y, 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 in the human γ chain.
Patentability of Genetic Use Restriction Technology
Moreover, according to the new guidelines, the processes for the generation/multiplication of genetically modified plants that involve genetic use restriction technology (GURTs) are excluded from patentability, in particular, those directed to the production of sterile reproductive structures (e.g., those which encompass processes that involve the activation or inactivation of plant fertility genes with external chemical inductors), in compliance with the provisions of article 6th (VII) of the Biosafety Law (Law #11, 105/2005). However, methods for restoring the fertility of plants that do not involve the use of external chemical inductors are considered to be patentable.
Requirements for Patent Applications Resulting from Access to Brazilian National Genetic Heritage
Finally, under the new guidelines, if any subject matter claimed in a patent application is the result of access to any Brazilian national genetic heritage, it is mandatory that registration before the Genetic Heritage Management Council (CGEN) via the System for Genetic Heritage and Associated Traditional Knowledge Management occur prior to the filing of a patent application.
Please continue to watch BRICS & Beyond for updates on changes to patent examination guidelines in Brazil.
This post was written by Lisa Mueller and Roberto Rodrigues, Rafaella Oliveira, Luiza Cotia and Danielle Altomari from Licks Attorneys.