India’s Patent Office has recently published draft guidelines for the examination of patent applications related to biotechnology inventions. The guidelines are intended to bring in uniform practice for the examination of applications related to biotechnology.
Biotechnology is the use of living systems and organisms to develop, make or modify useful products. For thousands of years, biotechnology has been used in agriculture, food production and medicine. In recent decades, the concept has expanded to include new and diverse sciences such as genomics, recombinant gene technologies, applied immunology, and the development of pharmaceutical therapies and diagnostic tests.
Biotechnological inventions include products and processes of recombinant gene technologies, methods of producing organisms, methods of isolation of micro-organisms from culture medium, methods of mutation, cultures, mutants, transformants, plasmids, and processes and cell lines for making monoclonal antibodies. The application of genetic engineering in plants and animals has resulted in exciting if debatable technological developments such as transgenic plants, animals and isolation of human genes for use in medical treatments.
Patent applications related to biotechnological inventions are to be examined in the light of the Patents Act, 1970, most importantly the following sections: 2(1)(j), novelty, inventive step and industrial applicability of products or processes; 3(b), inventions contrary to morality or which cause serious prejudice to human, animal or plant life or health or environment; 3(c), discovery of any living thing or non-living substance occurring in nature; 3(d), mere discovery of new form of known substance which does not result in enhancement of known efficacy or mere discovery of any new property or new use for a known substance; 3(e), mere admixture resulting only in aggregation of the properties; 3(h), method of agriculture and horticulture; 3(i), method of treatment and diagnosis; 3(j), plants and animals in whole or any part other than micro-organisms, but including seeds, varieties and species, and essentially biological processes; 3(p), inventions which are in effect traditional knowledge; 10(4), sufficiency of disclosure and the best method of performing the invention; and 10(5), unity of invention and clarity, succinctness and support of the claims.
Patent Office proposals
Under the draft guidelines a claim to a product obtained or produced by a process is anticipated by any prior disclosure of that particular product, regardless of its method of production. This means that a product cannot be considered novel only because it is obtained through a novel process. Rather, technical advancement is to be proved.
A polynucleotide sequence cannot be claimed as novel if it is part of a library, even if the sequence of the polynucleotide was not previously determined. Further, if any sequence of a polynucleotide/polypeptide from a prior art does not exactly match with the claimed sequence of polynucleotide/polypeptide, then the subject-matter of such claims cannot be said to be anticipated by the prior art sequence.
In order to prove lack of inventive step for claiming a sequence of polynucleotide/polypeptide, it would be sufficient to show similarities in structure of the claimed sequence of polynucleotide/polypeptide as well as activity.
An invention claiming mutation in a known polynucleotide/polypeptide must result in significant change in activity of the claimed polynucleotide/ polypeptide. A mutation in a known sequence of polynucleotide/polypeptide which does not result in any unexpected property lacks inventive step.
A useful purpose must be disclosed to claim patent for an invention claiming a gene sequence or a protein encoded by it. A practical way of using the invention is to be mentioned and the invention’s industrial applicability should be clearly established.
Special attention is given to the examination of applications which claim subject matter that is contrary to public order, morality or causes serious prejudice to human, animal or plant life or health or to the environment. The intentions of such inventions will be carefully examined.
Further, products directly extractable from nature such as micro-organisms, nucleic acid sequences, proteins, enzymes and compounds are not considered as patentable subject-matter.
Unless the therapeutic efficacy of a three-dimensional or crystal structure of a polypeptide is mentioned, the polypeptide will be considered as non-patentable under section 3(d).
To claim antibodies with therapeutic or diagnostic potential, a proper role for the target protein in a specific disease has to be proved with sufficient data.
Biotechnological inventions involve so much research and development that patenting has always been a concern. Guidelines for the examination of applications will bring more clarity to the patentability of such inventions. We hope it will make the examination process clearer and remove any qualms for patent applicants.
Manoj K Singh is the founding partner of Singh & Associates, a full-service international law firm with headquarters in New Delhi.
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