[This post has been co-authored with Rahul Bajaj. All views expressed are personal].
Market dynamics in the health and innovation space are making the biotech and life sciences sector an industry to watch out for. Trends such as the association of AI with life sciences, the growth of start-ups / non-traditional companies investing in life sciences, reduced spending on small molecule-drugs and promising new biotech treatments, indicate that windows of opportunity for investment in this sector are opening up.
Unlike small molecule drugs, biologics are large and complex substances. Typically, biologics are produced from living cells with the exception of emerging technologies such as the mRNA platform. Since living cells and products of nature are often involved in these inventions, clarity regarding patent eligibility is becoming more important.
The discovery, development and patenting of biologics has been historically tied to the ‘product of nature’ question under patent law. Jurisprudence around product-of-nature subject matter has significantly developed in jurisdictions such as the US and EU. For example, as early as 1981, the US Supreme Court excluded “[l]aws of nature, natural phenomena, and abstract ideas” from patent protection. [Diamond v. Diehr] Over the years, the Supreme Court tried to clarify this exclusion to allow patent protection for inventions that were “significantly more” than just “laws of nature, natural phenomena and abstract ideas”. [Bilski v. Kappos, Mayo Collaborative Services v. Prometheus Laboratories, Ass’n for Molecular Pathology v. Myriad Genetics and Alice Corp. v. CLS Bank Int’l.] Notably, in Myriad, genomic DNA was held to be a ‘product of nature’ and ineligible for patent protection. But complementary DNA (cDNA) that is created with human intervention in labs was held to be patentable subject matter.
Patent laws in India on the question of ‘products of nature’ are much less developed. Section 2(ja) of the Patents Act, 1970 defines an invention as a new product or process involving an inventive step and capable of industrial application and Section 3 specifies various bars to patent protection.
For product-of-nature subject matter, the primary restrictions under Section 3 are:
- Section 3(c): The mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature.
- Section 3(e): A substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance.
- Section 3(j): Plants and animals in whole or any part thereof other than micro organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals.
- Section 3(p): An invention which in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components.
Indian courts have not had the opportunity to interpret the scope of many of these exclusions. Through our research we were able to identify only the following few IPAB cases that discuss (albeit tangentially) some of these exclusions. Note, however, that there is no clarity as yet on the legal force of IPAB orders, whether they are mandatory or persuasive – see here.
Further, many cases discussed below do not relate to biotech inventions. The principles from these cases can, however, be applied to emerging biotech inventions many of which are admixtures and involve microorganisms.
On S. 3(e), in La Renon Health Care Pvt. Ltd. v. Kibow Biotech Inc., the IPAB had to rule on the patentability of a pharmaceutical composition used to treat renal hepatic and gastrointestinal diseases. The IPAB held that the invention was hit by the obviousness bar, as the use of each of the integers involved in the invention was known from the prior art. Also, there was no: “interworking between the integers to result in a synergistic effect.” The invention only involved an admixture of known integers and no inventive step was achieved by the same. As the invention did not entail a new product or a technical advance, it was held to be obvious to a person skilled in the art.
In Asthristis Relied Plus Ltd. v. Controller of Patents and Designs, the IPAB, in ruling on the patentability of a drug formulation, held that the bar under S. 3(e) was not attracted. This was because the synergistic effect of the invention was apparent, namely that the two ingredients used in the formulation, when brought together, were able to have a greater impact on addressing the problem of stiffness of joints. The Court also repelled the challenge to the invention based on S. 3(j). It held that the invention encompassed a topical formulation of comfrey and tannic acid in a particular proportion and was therefore patentable.
The above cases show that a mere admixture of known substances is not inventive but there is a need to show ‘synergistic effect’ achieved by the combination as a whole. Under S. 3 (j), while plants and animals in whole or any part themselves are not patentable subject matter, a ‘formulation’ made from a plant is not excluded.
In addition to these cases, the Patent Manual on Practice and Procedure [2019] offers some guidance on the provisions discussed above. On S. 3(e) it states that the relationship between features/groups of features be one of “functional reciprocity”/ showing a “combinative effect” beyond the sum of their individual elements. On S. 3(j), the manual clarifies that microorganisms, other than those that are naturally occurring, may be patentable.
The issue of gene patents and eligibility under S. 3(j) was discussed in the context of NSAI v. Monsanto in our post here. The case involved Monsanto’s Bt gene technology which makes selected seeds resistant to certain pests and associated issues with licensing, infringement and pricing. While the patent eligibility issue i.e. the Section 3(j) prohibition on patenting of plants, seeds or any part thereof, and whether a patentee should be allowed to seek a gene patent in conjunction with a certain plant genome was one of the central points of policy discussions, to our knowledge this issue was never litigated. Therefore, there still remains legal uncertainty on the scope and extent of gene patents.
Apart from the above, Section 3(i) on diagnostic methods has been subject to considerable debate. Recently, the Madras High Court in Chinese University of Hong Kong and Anr. V. Assistant Controller of Patents, discussed the scope and extent of this provision. A detailed analysis of this judgement will follow in another post.
The meaning and scope of Section 3 exclusions are important to understand as they can have an impact on development of new cures and on innovation. Specifically, the exclusions cannot be too broad, as that would have a chilling effect on investments for new cures. Equally, they cannot be too narrow, so as to harm the public interest in ensuring affordable access and broad dissemination of such innovations. Product of nature patents will continue to remain an important area to monitor in the times to come.
Thanks to Arkadeep Poddar, NUJS, and Ahsnat Mokarim for their assistance.