Patenting Biotech Inventions

19 September 2012

In past few decades, biotechnology has seen huge strides, and this knowledge-based sector is booming in India. In 2010-11, revenues generated were US$4 billion and, if enabling policies are implemented, it is expected to touch the US$10 billion mark by 2015. To encourage investment in biotechnology and for fostering growth in biotech sector, it is essential for India to provide a strong IPR regime.

Indian intellectual property laws do not limit patentablity to the triple criteria of novelty, inventiveness and applicability. Biotech applications are evaluated by taking into consideration other factors as well. Biotechnology patenting is complex, in that a single genomic gene can be patented in several ways (ex: fragments, SNPs, peptides) and social, ethical and religious issues make the situation more challenging. The nonavailability of judicial precedents further adds to complexity leading to subjective treatment.

In the prevailing circumstances, the applicant has to be proactive while preparing biotechnological patent applications for eventual filing in India. Currently, four provisions of the Indian Patent Act must be borne in mind before preparing and prosecuting biotechnological application in India, viz., Section 3(c), 3(h), 3(i) and 3(j).

Section 3(c) stipulates that the living entities of natural origin are non patentable. Section 3(h) precludes the patenting of method of agriculture or horticulture. Section 3(i) restrains patenting of method of treatment, such as medicinal, surgical for treatment, curative, prophylactic, diagnostic including screening and therapeutic. Section 3(j) prohibits the patenting of plants and animals in whole or any part including any essentially biological processes for the production or propagation of plants and animals.

In spite of these restraints, the past few years have witnessed an exponential rise in biotechnology patent filing and grant of applications in this area. During 2005-2010, 9,396 biotechnology patents were granted. By keeping in view a few considerations during the drafting and prosecution of application, one can successfully secure a biotech patent in India. An objection under Section 3(c) can be obviated by claiming modified organisms which per se do not exist in nature. For meeting objections under Section 3(h), compounds, formulations and devices relating to method of agriculture can been claimed instead of claiming the method of agriculture per se.

Similarly, to avoid rejections under Section 3(i), instead of treatment method, compounds, composition and applications thereof can be claimed. Section 3(j), can be circumvented by claiming method of producing plants and animals, avoiding essentially biological processes. Presented below is an overview of the kind of biotechnological application granted in India to steer a potential applicant to the kind of inventions allowed in India.

The nucleotide sequence, including DNA and RNA sequences, are allowed in India provided the description sufficiently discloses the functionality of the claimed sequences. In absence of the functional disclosure, the nucleotide sequence shall not be considered patentable. Even the pharmaceutical compositions comprising nucleotide sequences are patentable in India.

Promoter sequences are also allowed and several patents exist in this area. Enhancers sequences have been allowed in some patents; expressed sequence tags (ESTs) and siRNA were also considered patentable. Claims pertaining to cDNAs have proceeded to grant in several patents, while polymorphs sequences have also been allowed in several patents.

Cloning vectors are also patentable, including bacterial, expression and viral vectors. In addition to cloning vectors, isolated host cells transformed with expression vectors and amino acid sequences (proteins) have been allowed.

Antibodies, including polyclonal and monoclonal antibodies, have been granted in Indian patents, and nucleic acid probes are patentable. Diagnostic kits are patentable in India, with several patents having been granted. Machines and devices pertaining to medical use are also allowable.

Cell lines are patentable if artificially produced. A patent was allowed in the hybridoma technology domain, and inventions pertaining to anti-sense technology and gene therapy have proceeded to grant.

Micro-organisms and the microbiological processes are patentable. Also the processes for producing new micro-organisms using recombinant DNA technology, the products that result out of this process,including plasmids and viruses (non-living existence per se) are allowed in India. In addition, whole genomes, individual exons and mutations are also considered patentable, as is the method of producing transgenic plants and animals. Method of agriculture patents, including terminator gene technology are, however, not.

The Indian patent office practice pertaining to biotechnology patents is still in its infancy, and there is a considerable element of subjectivity in deciding the patentability of such inventions. However, a large number of examiners and controllers have undergone training in major foreign patent offices, which has resulted in a little harmonization of practices.

India’s biotech sector, powered by a vast pool of technical and scientific manpower, is poised for huge growth. Companies and investors from the biotech sector fully understand the value of intellectual property for commercialization of their inventions in India due to its huge market potential; however, at times, such companies and investors are cautious due to the fact that the patent system in India for biotechnological invention has not evolved fully.

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