*Also co-authored by Tatiana Costa
Vaccination plays a crucial role in the prevention of diseases caused by etiological agents. The origins of vaccines trace back to the late 18th century, when Edward Jenner demonstrated the effectiveness of using cowpox as an immunizing agent against smallpox.
Vaccines have made an undeniable contribution to public health by reducing and even eradicating several diseases. However, challenges remain in developing vaccines for both emerging and neglected infectious diseases. These challenges include technological hurdles, immunization timelines, limited use in immunocompromised individuals, and the need to respond rapidly to evolving pathogens. The emergence and re-emergence of infectious agents—exemplified by the COVID-19 pandemic—underscore the urgent need to accelerate vaccine research and approval processes.
Patent law plays a central role in incentivizing vaccine development, though standards and requirements vary by jurisdiction. This article focuses on the Brazilian patent framework as it pertains to vaccines, providing an overview of how the Brazilian Patent and Trademark Office (BRPTO) evaluates biotechnology inventions. It outlines the applicable legal provisions, key patentability criteria, and practical considerations for applicants. Selected case studies illustrate how these standards are applied in vaccine patent applications.
Technological Approaches to Vaccine Development
Current vaccine development methods fall into two broad categories: classic/traditional and emerging/innovative. Examples of classical technologies include:
- Inactivated vaccines: Contain dead/inactivated viruses or bacteria.
- Attenuated vaccines: Use live pathogens weakened through physical, chemical, or biological processes.
- Toxoid vaccines: Based on inactivated bacterial toxins.
- Subunit vaccines: Contain a fraction of proteins or polysaccharides from pathogens that, when presented to the immune system, can trigger a specific response against the agent of disease.
- Conjugate vaccines: Comprise polysaccharides associated with protein carriers to enhance the immune response, resulting in stronger and longer-lasting immunity, which is particularly important for pediatric applications.
Emerging and innovative technologies include:
- mRNA-based vaccines: Use messenger RNA to instruct cells to produce a specific protein of the pathogen and induce an immune response.
- Nanoparticle-based vaccines: Employ nanoparticles developed from lipids, proteins, or polymers to enhance antigen stability and presentation to the immune system, resulting in improved efficacy.
- Viral and bacterial vector vaccines: Utilize modified viruses and bacteria to deliver genetic material from the pathogen to stimulate an immune response.
- DNA-based vaccines: Comprise genetically engineered DNA to induce an immune response.
Legal Aspects Under Brazilian Patent Law
In Brazil, modified genetic and protein molecules are considered patentable subject matter, provided the patentability requirements are met. The specification upon filing must disclose the precise nucleotide and amino acid sequences to ensure clarity and enablement.
The BRPTO’s Biotechnology Examination Guidelines explicitly prohibit reach-through claims (i.e. broad claims that extend beyond the disclosed content). Claims must be limited to sequences expressly disclosed and substantiated by experimental data.
The Guidelines also provide interpretative direction on Article 18(III) of the Brazilian IP Statute, which excludes living beings from patentability, with the exception of transgenic microorganisms.[1] For a transgenic microorganism to be eligible for patent protection, it must exhibit technical features not found in nature and must result from demonstrable human intervention. In cases involving genetically modified microorganisms used in vaccine development or production, particularly where the microorganism is new and its characterization and reproduction depend on cells samples, a deposit of the biological material in an international depository authority recognized by the Budapest Treaty may be necessary to meet enablement requirements.
In addition, Article 10 of the Statute excludes natural biological substances, including unmodified isolated antigens, from being considered inventions. However, compositions comprising such antigens may still be deemed patentable when combined with novel adjuvants, delivery mechanisms, or genetically modified viral vectors, provided, of course, that they fulfill the patentability requirements.
Following the assessment of what constitutes patentable subject matter, careful attention must be paid to how the invention is defined in the claims. Nucleic acid molecules, for instance, must be defined by their specific nucleotide sequences rather than by their function (e.g., the protein they encode), and proteins must be defined by their exact amino acid sequences, i.e., definitions based on homology or identity percentages are not permitted. The level of characterization required for microorganisms, in contrast, is more flexible and depends on the state of the art. For example, if the invention involves inserting a gene already known in the prior art, simply naming the gene is sufficient. However, if the invention concerns a new strain, definition by means of a deposit number is required.
With regard to enablement and support, when sequences are presented in a Markush formula, variables in amino acid sequences are permitted provided that they have similar properties (polarity, size, charge) to those exemplified. In the case of nucleotide sequences, variations are acceptable if they encode the same amino acid.
Examples of How the BRPTO Examines Vaccine Applications
To illustrate how the principles above are applied by the BRPTO in practice, this article will now present four representative vaccine patent applications, two of which were granted and two of which received adverse opinions from the patent office.
In the application by National Cheng Kung University (BR 10 2020 025455 3), the claimed vaccine composition was properly defined by means of the SEQ ID Nos. for the antigenic polypeptides, as the invention lay in the truncated NS1 polypeptide fusion protein per se.
An application by Curevac AG (BR 11 2016 001192 9), currently under appeal, was initially rejected due to the lack of a specific SEQ ID No. defining the mRNA of interest. The BRPTO determined that the coding region of the rabis virus G glycoprotein was an essential element of the invention and, therefore, needed to be defined by its nucleotide sequence.
Another interesting case is a patent granted for Zoetis Services LLC (BR 10 2019 002793 2), which concerns a vaccine comprising gonadotropin and a specific carrier. Because gonadotropin was known in the state of the art, referencing it by name alone was deemed sufficient to meet the clarity requirement.
Finally, we have an application filed by Nykode Therapeutics ASA (BR 11 2018 013881 9), still under examination. In that case, the patent office raised objections to the vaccine claims based on an understanding that the immunogenicity obtained by a polynucleotide vaccine could not be extrapolated to a vaccine based on the corresponding polypeptide. This shows the importance given by the BRPTO to examples demonstrating the efficacy/technical effect for inventions in the Biotechnology field.
Conclusion
Collectively, these cases highlight the importance of carefully tailored strategies when drafting and prosecuting vaccine-related patent applications in Brazil.
[1] Bacteria, archaea, fungus, single-cell algae not classified in the Plant Kingdom and protozoaria.
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