As per patent office journal dated 16/07/2021, patent number 371434 has been granted to VIB VZW, UNIVERSITEIT GENT & WETENSCHAPPELIJK INSTITUUT VOLKSGEZONDHEID that is titled MYCOBACTERIUM MUTANTS FOR VACCINES WITH IMPROVED PROTECTIVE EFFICACY. The primary independent claim of this patent states mycobacterium comprising a genetically engineered inactivated mutation in the endogenous gene SapM gene that does not encode the hypothetical protein MAP3432.
During the patent prosecution, the patent examiner objected to this patent under section 3(d) of the Indian Patents Act. The patent applicant responded to this objection by stating that the mutation in the SapM gene of Mycobacterium which is a member of the Mycobacterium tuberculosis complex, led to vaccines with improved vaccine efficacy. Moreover, it was evaluated that the mice infected with mutant Mycobacterium showed long-term survival as compared to parent BCG. Therefore, the claimed Mycobacterium and vaccine are novel and are not mere discovery of a new property or new use of a known substance or microorganism. Thus, the claimed invention does not fall under the purview of section 3(d) of the Patents Act.
This patent falls under the category of Traditional Knowledge Biotechnology. Overall, this patent covers mutation of mycobacterium components for vaccine purposes. Vaccines with BCG mutant in genes coding for ManLAM capping a-l, 2-mannosyl transferases and the PI3P phosphatase SapM evaluated as TB vaccines showed significantly longer survival than the parent BCG. It was evaluated that the mice vaccinated with the said vaccine showed unaltered phagocytosis, replication, lysosome colocalization and oxidant activity in macrophages. Additionally, replication and granuloma formation in mice was unaffected, indicating BCG-equivalent safety of these vaccines.
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