Patentability of any biological matter differs based on the national and regional laws and on the Rules and Sections of the particular territory/country where the patent is applied for. It should be noted that the new corona virus popularly known as SARS CoV 2 is a wild type strain, i.e., a virus already found in nature and is not been genetically modified. The disease caused by this virus has been officially named as COVID-19.

Indian Patent Office and Patentability Criteria

1Section 3(j): plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals;

Section 3(j) of the Indian Patent Act forbids patenting of plants and animals in whole or any part thereof other than microorganisms (provided they are modified), and essentially biological processes for production or propagation of plants and animals. Inventions claiming biological entities like antigens/ antigen binding fragments without any modifications, isolated antibody, host cells, cell lines comprising novel nucleic acids, virus like particles, etc. are considered to fall within the scope of section 3(j) and hence, not patent eligible subject matters. The three statutory requirements for the patentability are: Novelty, Non-obviousness and Industrial Applicability. Further, Sections 3 and 4 of the Indian Patents Act determine whether the invention relates to a patentable subject-matter.

Novelty

Novelty is an important criterion in determining patentability of an invention; novelty or new invention is defined under 1Section 2(l) of the Patents Act as "any invention or technology which has not been anticipated by publication in any document or used in the country or elsewhere in the world before the date of filing of patent application with complete specification, i.e., the subject matter has not fallen in public domain or that it does not form part of the state of the art". For the Novelty, the strain of the virus must be new, i.e., shall not have been disclosed or made available to the public by any means prior to the filing date of the patent application. This implies that patent protection will not be granted if, for example, it was previously deposited in a public collection, or if its nucleic acid sequence was disclosed in a scientific paper, a poster, a presentation at a conference or a database before filing the application. Basically, the novelty requirement states that an invention should never have been published in the public domain. It must be new with no same or similar prior arts.

Inventive Step

Inventive step is defined under 1Section 2(ja) of the Patents Act as "a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art". The strain must contain inventive step and must not be obvious to a person skilled in the same field, which means that, having regard to the state of the art, it must not be obvious to a person skilled in the art. After the development of automated sequencing techniques, the mere sequencing of a gene is no longer considered inventive, but a routine technique. In practice, to meet this requirement, the isolation of a new strain of a virus must be accompanied by the discovery of a technical effect or unexpected advantage with respect to other known strains, or the overcoming of a technical prejudice which means that the invention must not be obvious to a person skilled in the same field as the invention relates to.

Industrial application

Industrial applicability is defined under 1Section 2(ac) of the Patents Act as "the invention is capable of being made or used in an industry". This essentially means that the invention cannot exist in abstract. It must be capable of being applied in any industry. The strain of the virus must be capable of industrial application, i.e., it can be used in any kind of industry. If the virus is defined by its genomic sequence, the patent application must describe a specific, substantial and credible utility for this sequence, for example, for the production of a vaccine. It is not enough to make a speculative reference regarding its possible uses. When a gene sequence is used to produce a protein, it is necessary to specify which protein is produced and what function it has.

Conclusion

The coronaviruses are a group of RNA viruses that includes at least 20 pathogenic species. Most of them affect animals, but some can infect humans. In human beings, coronaviruses cause respiratory conditions, including Severe Acute Respiratory Syndrome, caused by the SARS-CoV virus, which hit several countries in between 2002-2003; and Middle East Respiratory Syndrome, caused by the MERS-CoV virus. Till date, only 7 strains of human coronaviruses are known. The latest of them, the recently discovered in Wuhan (SARS-CoV-2), belongs to the Beta-coronavirus genus, with a nucleotide sequence showing approximately 80% identity with the SARS-CoV virus sequence. The genetic sequence of the new coronavirus was made public in January 2020. Therefore, to meet the novelty requirement, if a patent application for the new coronavirus has to be filed, it should be filed before the publication of its sequence anywhere. However, in India the patentability of the novel virus may face the objection under the Section 3 of the Patent Act, especially Section 3(j). To conclude, patentability of any invention is subject to satisfaction of all patentability requirements provided under the Patents Act.

1: Indian Patents Act, 1970

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