By Karina Daiha
The Brazilian Patent and Trademark Office (BRPTO) published on December 1st, 2020 Rule #118, revoking previous guidelines and setting forth new guidelines for examination of patent applications in the biotechnology field.
We seize the opportunity of this publication to highlight the key takeaways of the BRPTO’s guidelines related to Pharma/Biotech patent applications. The objective of the present article is to provide patent practitioners around the world with practical tips on these type of patent applications when filing in Brazil.
In this regard, it is noteworthy that there are four guidelines in force today dealing with biotech-related matters:
- Guidelines for Examination of Patent Applications – Part I (Rule #124/2013);
- Guidelines for Examination of Patent Applications – Part II (Rule #169/2016);
- Guidelines for Examination of Patent Applications in the Chemistry Field (Rule #208/2017); and
- Guidelines for Examination of Patent Applications in the Biotechnology Field (Rule #118/2020).
Instead of commenting guideline by guideline, we opted to present our insights per subject matter of interest as follows.
- Preliminary considerations
According to the Brazilian practice, claims are divided in two basic types: product (related to a physical entity) and process (related to an activity) claims. For instance, claims directed to an apparatus, object, article, equipment, machine, device, system, compound, composition and kit are considered product claims. Processes, methods and uses are acceptable as process claims.
Generally, a claimed product must be defined by its own features capable of unequivocally identifying it. The Markush structure is acceptable for compounds and biological sequences. Claims directed to a product defining it in terms of its manufacturing process (“product-by-process” claims) are allowed in exceptional cases only in which the product cannot be defined otherwise. Method claims must be defined by its steps.
- Therapeutic Methods
Any method aiming at curing and/or preventing a disease or dysfunction of the human or animal body; relieving symptoms of pain, suffering and discomfort to restore or maintain the normal health conditions is barred from patent protection in Brazil (not considered an invention in light of Article 10, VIII1, of the Brazilian Patent Statute).
Methods characterized by the dosage regimen of a drug for the treatment or prevention of a disease are also considered therapeutic methods.
Methods in which the non-therapeutic effect is inseparable from the therapeutic effect, or even if it is only a secondary consequence of therapy, are not considered an invention.
The following claim formats are rejected for being directed to a therapeutic method:
- Method of treating medical condition Y characterized by administering compound X to a subject;
- Use of compound X characterized by being in the treatment of a medical condition Y in a subject;
- Compound X characterized by being used in a therapeutic method; and
- Compound X characterized by being used in the treatment of medical condition Y.
Nevertheless, the Swiss style (“use of a compound X characterized by being in the manufacture of a medicament for treating medical condition Y”) is potentially patentable as a use claim format (please see item “Second Medical Use Claims” below).
- Surgical/Operative Methods
Any method that requires an operative or an invasive stage in the human or animal body is considered an operative method, and is not considered an invention (Article 10, VIII, of the Brazilian Patent Statute).
If a claim can still subsist after the removal of the operative or invasive step from the claimed method, the objection over Article 10, VIII, can be overcome by such removal.
- Diagnostic Method
A diagnostic method involves a series of steps that lead to the identification of a clinical condition, which include steps of analysis and interpretation of the data obtained. When they are for application to the human or animal body, they are not considered an invention according to Article 10, VIII, of the Brazilian Patent Statute.
A diagnostic method for application to the human or animal body is not an invention when it meets the following criteria: (a) it has direct application on the human or animal body or requires the presence or participation of the patient for its interpretation; and (b) allows the conclusion of the patient’s clinical state, or indicate several probable clinical states, solely based on the processing, analysis or interpretation of data, information and/or results of clinical exams associated with the patient.
If the claimed method includes technical steps performed in vivo, which are inseparable from the in vitro steps, the entire method will be considered as applied on the body and, therefore, not considered an invention.
The treatment of tissues, cells or body fluids after they have been removed from the human or animal body, or methods applied to them, such as in vitro methods are entitled to protection.
- Natural Living Being and Biological Material/Processes Found in Nature
The whole or part of natural living beings and biological materials found in nature – even if isolated therefrom or synthetically produced, but with naturally occurring correspondent such that it is impossible to distinguish them from natural ones – are considered natural biological products and are not considered an invention according to Article 10, IX2, of the Brazilian Patent Statute.
A composition claim characterized only by containing a non-patentable natural product cannot be granted, since it would protect the non-patentable product itself.
Natural biological process means any biological process that occurs spontaneously in nature and in which human intervention does not affect the final result. If technical intervention plays an important role in determining the result, or if its influence is decisive, the process is considered an invention. That is, processes that contain at least one technical step that has a decisive impact on the final result, and that cannot be carried out without human intervention, are considered an invention.
- Second Medical Use Claims
Second medical use claims are potentially patentable in Brazil as swiss-type claims. The invention must reveal the application of a known pharmaceutic product for producing a medicament for treating or preventing a disease different from that known in the art.
Features related to the use of the compound, such as the therapeutic scheme and group of patients do not confer novelty to the use of the compound according to the BRPTO.
The second medical use claims must specify the disease to be treated and excerpts related to the therapeutic scheme or group of patients will be rejected for rendering the subject matter unclear.
Only in vivo results are considered as proof of the new use for purposes of descriptive sufficiency.
The characterization of the crystalline form must be characterized by data obtained by techniques for physico-chemical characterization of solids.
The single crystal X-ray diffraction (XDR) technique is sufficient for the perfect characterization of the solid crystalline structure. In the absence of such data, powder XRD technique must be associated with other methods used for physico-chemical identification of solids, provided that the set of techniques is sufficient for unambiguous identification of crystalline form.
If the state of the art already reveals the claimed crystalline form, even if mixed with other forms, regardless of its concentration, the claimed crystalline form is not considered new.
- Markush Formula
Claims related to compounds in the Markush Formula are acceptable, provided that the manufacturing processes disclosed in the specification substantially enable the preparation of all claimed compounds – i.e., the examples must be representative of all classes of the claimed compounds.
The BRPTO’s opinion is that it is not possible to predict or extrapolate that compounds with substituents belonging to different chemical classes could be obtained by the same preparation method, since the nature of the reactions is different.
Biological sequences can also be presented in the form of a Markush formula containing one or more variable substructures, which are accompanied by a list of definitions of these variable portions.
- Biological Sequences
The set of claims must refer to the biological sequences of interest by means of the corresponding SEQ ID. A DNA or RNA must be defined by its nucleotide sequence, while a protein must be defined by its amino acid sequence in order to clearly define the claimed subject matter.
In some specific cases, the BRPTO accepts biological sequences characterized otherwise. For instance, if a biological sequence is known from the state of the art and it is not the main object of the invention, it can be defined by its name.
Degenerate DNA or RNA sequences defined by a nucleotide SEQ ID can be accepted, as long as they generate the same protein and that such protein is precisely defined (by its SEQ ID).
A biological sequence defined by % identity/homology is not acceptable for lacking clarity.
At last, antibodies are considered non-natural, i.e., patentable, if it would not exist without significant human intervention – i.e., the human intervention is decisive for the final result. On the other hand, if an antibody is obtained from an organism that is naturally exposed to an antigen, for instance, the antibody will be considered to be naturally occurring and will not be patentable pursuant to article 10, IX, of the Brazilian Patent Statute.
Polyclonal antibodies are considered an indeterminate mixture of antibodies. Thus, as the definition of their features lacks clarity, they are not accepted by the BRPTO. Monoclonal antibodies are accepted and must be defined by its SEQ ID (at least the 6 CDRs) or the deposit of biological material.
1 Art. 10, VIII, Brazilian Patent Statute: “The following is not considered invention or utility model: […] VIII. Operating or surgical techniques and therapeutic or diagnostic methods, for use on the human or animal body.”
2 Art. 10, IX, Brazilian Patent Statute: “The following is not considered invention or utility model: […]; IX. Natural living beings, in whole or in part, and biological material, including the genome or germ plasma of any natural living being, when found in nature or isolated therefrom, and natural biological processes.”