Genome editing using Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)/CRISPR-associated 9 (Cas-9) technology holds great potential to accelerate life science research, improve biotechnology, and diagnose and treat human diseases. All over the world, big pharma companies and universities have been investing in this technology and the number of patent applications/patents has been increasing.

Examples of claim categories directed to CRISPR/Cas-9 technology

According to Article 10 (VIII) of Brazilian IP Law #9,279/96, therapeutic methods applied to the human or animal body are not considered to be inventions, therefore, it is not possible to directly protect a method for modifying a human/animal using the CRISPR/Cas-9 system. However, there are many ways to claim patent protection for a gene therapy using CRISPR/Cas-9 technology in Brazil, such as inventions directed to:

i) compositions and kits containing Cas-9, guideRNA (gRNA) and/or other components,

ii) modified polynucleotides and nucleic acids that encode the gRNA,

iii) microorganism modified cells,

iv) Swiss-type use claims,

v) in vitro or ex vivo methods of modifying a target DNA, and

vi) methods for modifying an organism, provided that said organism is a microorganism, which according to Brazilian Biotech Guidelines is a bacteria, archaea, fungi or single cell algae not classified as plants and protozoa.

Protection of the therapeutic use of CRISPR/Cas-9 related inventions

Unlike the prosecution before the USPTO, for example, (where therapeutic method claims are permitted), in order to protect a therapeutic application of a CRISPR/Cas-9 technology in Brazil, the claim set should be of the Swiss-type format (second medical use) with the following format: “use of compound X in the preparation of a medicament for the treatment of a disease Y”.

An example of a Swiss-type claim in Brazil reflecting the therapeutic use of CRISPR/Cas-9 in Brazil, is set out below (emphasis added):

Use of a composition comprising a CRISPR-Cas system characterised in that it is for the preparation of a medicament for treating a genetic ocular disease by localised administration in the eye of a subject, wherein the CRISPR-Cas system comprises:

A. a polynucleotide encoding an RNA of a CRISPR-Cas system comprising

a) a guide sequence capable of hybridizing to a target sequence of the genetic eye disease,

b) a tracr mate sequence, and

c) a tracr sequence,

wherein (a), (b) and (c) are arranged in a 5’ to 3’ orientation; and

B. a polynucleotide encoding a Cas-9;

each of A and B being: formulated to be administered together in a delivery vehicle, such vehicle being an adeno-associated viral (AAV) vector, wherein the AAV is AAV1, AAV2 or AAV5; and capable of, when administered together into the eye of a subject, forming a CRISPR-Cas complex comprising Cas-9,and RNA from the CRISPR-Cas system.

In vitro and ex vivo methods directed to CRISPR/Cas-9 technology

Regarding methods of gene editing per se, since the in vivo human/animal application is not patentable in Brazil, in vitro and ex vivo methods can be patented, such as in the examples below (emphasis added):

An in vitro or ex vivo method of altering an eukaryotic cell characterised by comprising: providing to the eukaryotic cell a plurality of guide RNA sequences complementary to different target nucleic acid sequences, wherein the plurality of guide RNA sequences binds to the different target nucleic acid sequence, and providing to the eukaryotic cell a Cas-9 protein that interacts with the plurality of guide RNA sequences.

A method of modification of a target DNA, characterised by comprising contacting the target DNA with a complex comprising:

(a) a Cas-9 polypeptide, and

(b) a DNA-targeting RNA of an individual molecule comprising:

(i) a DNA-targeting segment comprising a nucleotide sequence that is complementary to a sequence in the target DNA, and

(ii) a protein-binding segment that interacts with said Cas-9 polypeptide, wherein the protein-binding segment comprises two complementary stretches of nucleotides that hybridize to form a double-stranded RNA (dsRNA) duplex, wherein said dsRNA duplex comprises complementary nucleotides of a tracrRNA and a CRISPR RNA (crRNA),

wherein said two complementary nucleotide stretches are covalently linked through intervening nucleotides,

wherein said contact is in vitro or in a cell ex vivo; and

wherein said modification is cleavage of target DNA.

We expect the number of inventions based on CRISPR/Cas-9 technology to increase over the years and having knowledge of current guidelines and legal provisions, the processing of patent applications will become easier, without so many obstacles. Depending on the applicant’s strategies, Brazil also provides possibilities for expedited examination, significantly shortening the total processing time.

FICPI's view and involvement

FICPI uniquely combines education and advocacy on topics around patents and trade marks, with a focus on developing the professional excellence of its individual members. FICPI Forums, Congress, committees and meetings are opportunities to gather insights from the international IP attorney community on any issue, whether it be practice-related or topics of patent and trade mark law.

Next steps

Previous Post
Case study: transitioning to more efficient online communication