Indian patent practice and jurisprudence with respect to biological materials (including antibodies) is relatively new and thus not well-settled and/or uniform, unlike in the USA or Europe. In these circumstances, presenting a concrete picture re patenting of monoclonal antibodies in India is not feasible at this stage. Notwithstanding this constraint, this analysis presents various techno-legal issues that arise and which need to be addressed – vis-à-vis patenting of biotechnological inventions. Like any other field of invention, biological materials – such as therapeutic antibodies against a protein or genetic sequence – are generally considered patentable and qualify as an invention in India so long as such antibody gene sequence(s) or amino acid sequence(s) are (1) novel, (2) involve an inventive step, and (3) are capable of industrial application. However, notwithstanding compliance with these three cardinal requirements, an isolated biological material in contradistinction to a modified (genetically or otherwise) biological material is still considered prima facie not to fulfill the requirement of patentability by the Indian Patent Office (IPO). In short, merely discovered (isolated) antibodies are considered not to constitute patentable subject matter per se by the IPO even though such antibodies are identified by the specific functions they are capable of facilitating or carrying out. Conversely, if a biological material is one which has been (genetically) modified (preferably through substantial human intervention), it fulfils these requirements, and will likely be regarded favourably by the IPO. In fact, subject also to the satisfaction of the other technical and formal requirements laid down by the Patent Act 1970, such biological material will have a reasonable chance of qualifying as patentable subject matter.
Link :
