Biotech innovation in India: Patent law and challenges

Statutory Hurdles to Patentability

Basic criteria for Patent protection are almost same across geographies but patentable subject matters vary. Apart from patentability requirements i.e. novelty, inventive step, enablement and industrial application, a biotech invention must constitute patentable subject matter. Some inventions are excluded from patentability under Section 3 of the Patents Act 1970 – for biotech patents, Sections 3 (c), (d), (e), (h), (i), (j) and (p) are relevant.

Section 3(c) mandates that the “discovery of any living thing or non-living substances occurring in nature” does not constitute patent-eligible subject matter. For example, the extraction and isolation of of DNA sequence/Gene is generally considered the mere discovery of a naturally occurring substance and is therefore barred under this provision. If any biological materials obtained as a result of substantial human intervention are considered patentable. Section 3(d) is another controversial provision of Indian patent law. For biotech patents, this section is frequently cited in respect of modifications of an existing substance. A limited exception in the sense that it does not set an absolute bar, it rules out patentability if modification of an existing substance does not yield a “new form of a known substance” which exhibits “enhancement of the known efficacy”. However – akin to ambiguities surrounding enhanced efficacy under Section 3(d) – synergism regarding biotech patent applications lacks a clear statutory definition. As a result, IPO has to determine patentability on a case-by-case basis.

Section 3(e) excludes from patentability “a substance obtained by mere admixture” and any process for its preparation. Combination vaccines invariably invite proscription under this clause. Under existing practice, a composition comprising known components is considered patentable only if it exhibits synergism. Applicants also face difficulties in Section 3(h), which stipulates that “a method of agriculture or horticulture” is unpatentable subject matter, the India patent office automatically objects to biotech inventions pertaining to the fields of agriculture and horticulture. But the March 2013 guidelines have helped to some extent by clarifying that Section 3(h) is applicable only to “conventional methods” performed on open fields.

According to Section 3(i) “any process for the medicinal, surgical, curative, prophylactic, diagnostic, therapeutic or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products” is not patentable. However, in several instances the IPO has granted patents for in vitro diagnostic methods. The guidelines brought in vitro diagnostic methods under the remit of Section 3(i), so the IPO is unlikely to grant such patents in future. The guidelines do not have the force of law and are subject to revision based on interpretations by higher judicial authorities.

One of the biggest barriers to the patentability of biotech inventions is Section 3(j). It prohibits patenting of “plants and animals in whole or any part thereof other than microorganisms but including seeds, varieties and species and essentially biological processes for production and propagation of plants and animals.” The expression “essentially biological process” has not been specifically defined either in the statute or through judicial decision. IPO rejected most of the applications relate to transgenic plants containing recombinant DNA sequences tolerance to biotic and abiotic stress by objecting that these are essential biological process of regeneration and selection which are excluded from patentability under Section 3(j) of the patent statute. To the extent that the IPO guidelines expressly state that sequences isolated directly from nature are not patentable, they are consistent with the international treaties, which require claimed sequences to be structurally different from those found in nature. IPO issued biotechnology guidelines in March 2013, but with no reference as to what constitutes “essentially biological processes”. The guidelines list several illustrative examples in relation to Section 3 (j) of the Patents Act. One of them states that a claimed method involving the step of cross-breeding for producing pure hybrid seeds, plants and crops would be an essentially biological process and thus not allowable under Section 3(j) But the guidelines do not lay down minimum standards for human intervention. In this regard, it will be interesting to see whether the IPO and judicial authorities align with developed countries policy in appropriate occasion to allow applicants to seek protection for cDNA or other recombinant DNA sequences that may be clearly distinguished from naturally occurring DNA. If we look at international treaties to find uniform benchmarks in this area, there is much room for divergence. The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement allows member countries to exclude certain subject matter from patentability. Such excluded subject matter covers “essentially biological processes”. However, in order to define the threshold of patentability, TRIPS does provide leverage for member countries to define expressions such as “essentially biological processes” or set specific criteria for their patentability. The Patents (Amendment) Act 2002 introduced Section 3(j) which prohibits patenting of “plants and animals in whole or any part thereof other than microorganisms but including seeds, varieties and species and essentially biological processes for production and propagation of plants and animals.” The expression “essentially biological process” has not been specifically defined either in the statute or through judicial decisions or the manual of the patent office. On the other hand, it would appear that the US and the EU have taken steps towards defining in the statute or through judicial pronouncements the broad criteria for what constitute “essentially biological processes”.

Additional Substantial Requirements since 2005

Section 10(4)(ii)(D) was introduced in 2005 to complement the Biological Diversity Act 2002, which aims to protect sovereign rights over genetic resources and requires prior approval from the independent National Biodiversity Authority (NBA) before applying for a patent for inventions that use biological material from India. It mandates the disclosure of the source and geographical origin of biological material whenever these are mentioned in a patent specification, but not sufficiently described in it or made available to the public. A declaration in the patent application form stating that “the invention as disclosed in the specification uses biological material from India and the necessary permission from the competent authority shall be submitted before the grant of patent” is a supplementary requirement. However, practice was slow to comply with the 2005 amendment and the NBA approval requirement remained largely theoretical. Obtaining NBA approval poses a serious challenge as this is a cumbersome and lengthy process. Making it a mandatory prerequisite to the grant of a patent will likely contribute to delays in securing a patent successfully.

Conclusion

Indian biotech institutes and companies have lot of potential to innovate and compete globally. It is the high time to encourage regional innovation and subsequent IP protection that brings positive image. Biotechnology itself is a complex business that requires significant investment. We expect that IPO and judicial authorities would provide clear guidelines for human intervention, revisit statutory framework and procedural bottlenecks to smoothen the process. It would be good idea to align with international treaties to find uniform benchmarks especially for patentable subject matter. TRIPS have provided leverage for member countries to set specific criteria for their patentability. IPO should utilise this opportunity, review and allow protection which would eventually demonstrate regional technological capacity, level of expertise, and specialization in global market.

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