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NATURE’S PRODUCT PATENT ELIGIBILITY IN THE INDIAN CONTEXT

INTRODUCTION

The doctrine of “product of nature” was a concept that evolved in US patent laws. This doctrine acted as a tool to prevent the patenting of discoveries of new plants and animals. However, as science advanced, this doctrine acted as a barrier in US patent law for patenting microorganisms and biotechnology inventions. Synthetic products that are identical to naturally occurring products are not patentable subject matter under this doctrine, which makes it extremely difficult to obtain patents for genes. The “product of nature” doctrine is reflected in Indian statutes as well. According to Section 3(c) of the Indian Patent Act, both living and non-living substances are not patentable. This provision is more flexible as compared to the US Patent Law doctrine. As long as the substance turns into a useable form, it could be patented. In the Indian context, the doctrine of the product of nature has a different dimension. The article aims to present the doctrine of the product of nature in the Indian context.

PRODUCT OF NATURE DOCTRINE IN US

The product of nature doctrine was widely used in US patent law in the nineteenth century and is still in use today. In May 2019, the district court of the U.S. denied a patent for a pure form of cannabinoid on the claims of UCANN’s U.S. Patent No. 9,730,911 for “a liquid cannabinoid formulation, wherein at least 95% of the total cannabinoids is” a specified cannabinoid” (CBD or THC or a combination). [1]The court refused to deviate from the prevailing doctrine and denied the patent. In the landmark case of Diamond V. Chakraburty, the patent claim was put forward for both the process and the final product. It was for a genetically modified micro-organism that was capable of digesting crude oil. In this case, for the first time in the history of US Patent Law, a question as to whether a natural object can be patented was not raised. Surprisingly, the claimant, i.e., Chakraburty, was granted a patent on the trade secret or the process, but no patent was granted on the actual bacteria, which was developed on the ground that it is a natural product and does not fall under the ambit of patentable subject matters, which excludes all living objects and bacteria, which inter-alia includes micro-organisms.[2]

The decision in the case showed the strict application of the doctrine of the product of nature, which acts as a hindrance to patenting genetically modified organisms, which are new products developed out of recombinant DNA technology. Despite the ratio in the above decision, the process of producing GMOs can be patented in the US. The flexibility in this aspect is brought by the liberal interpretation of this doctrine in the case of Merck & Co. v. Olin Mathieson Chemical Corp.[3] in which the product was found to be patent-eligible as it existed in a different form in nature than that which it was produced by the patentee. The main difference between eligible and ineligible products is that they should not exist in the same form as the patentee produced. The product of nature has a wider application in US patent laws. The US patent laws check whether an identical product already exists in nature or not.

PRODUCT OF NATURE DOCTRINE IN INDIA

In India, novelty plays an important role in checking the patent eligibility of a product that is being produced to be patented. The product must be distinct from the prior art. Section 3(c) of the Patent Act contains a reflection of the product of nature doctrine. The product or the process employed must be a novel invention and have never existed in nature before. This is how the doctrine of the product of nature is applied in India.  Section 3(j) specifies the “products of nature “which are not eligible for a patent. It states that “plants and animals in whole or any part thereof, other than micro-organisms, including seed varieties and species, are essentially biological processes for production or propagation of plants and animals.” The act itself specifically states that microorganisms are patentable. For the protection of farmers’ rights, there is an express bar on patenting seeds and animals. But the term “essentially biological” gives scope for patent eligibility in the field of biotechnology, which technically cannot be considered as essentially biological. As a TRIPS signatory, India proposed two amendments in 2002 to grant patents for genetically modified crops. The term “or plants” was removed from section 3 (i). Such an amendment was added to 3 (j) as well. An observation was made by the Intellectual Property Appellate Board in the case of Monsanto Technology v. Controller General of Patents, which rejected the patents as they contained only “new use of the known substance.” The attempt was made to patent a plant. Another ground that was pointed out by the IPRB was that it was an attempt to patent an essentially biological substance.

The scenario in the case of microorganisms also correlates with the product of nature doctrine. India follows the laws established in the TRIPS agreement. Article 27(3) b of TRIPS 1994 specifies that the microorganisms, biological and microbial processes are patentable similar approach is taken by India in the Indian patent act as well as through judicial precedents. A case before the amendment in 2002 also allowed the patent of such inventions which involve microorganisms as in the case of Dimminaco AG v. Controller of Patents and Drugs[4] the process of propagation of vaccine was kept for patent application but was refused as it contains microorganisms but the appellate court redirected to grant the patent. Patenting of plants and microorganisms is under discussion in India as it affects the lives of common people and poor farmers. The relaxation offered by the product of nature doctrine will be reflected in the lives of poor farmers. India has to consider this aspect with more care and caution as a larger proportion of our population consists of farmers. They keep seeds for the future and produce new plants. When the seeds of plants are patented, the practice of keeping seeds will amount to an intellectual property crime. This has always been an issue for farmers as it will affect their livelihood as they have to purchase the seeds. When the whole plant is patented, the companies could monopolise the seed production. In India, farmers’ rights are protected under the plant variety protection and farmer’s rights act of 2001. There are several instances of such disputes that have occurred in India. A year ago, the PepsiCo Company had a conflict with the farmers in Gujarat, which was solved by the farmers. They were seeking 1.05 corers from farmers for patent infringement. Here, PPVRF acts as a saviour.

The act makes natural plants and animals ineligible for patenting. Under Section 13 of the Protection of Plant Verities and Farmers Act 2001, the government keeps a registry of plant verities. The effective management of such data will make it easier to protect against the patenting of such plant varieties. In such circumstances, the registration could be done by breeders and farmers for their verities. Such varieties will be farmers’ varieties. These varieties are products “derived from nature”. The doctrine of the product of nature has only very limited application in such cases. There is no strict application of such a doctrine in the Indian context. Other than the strict application of the product of nature doctrine, India has developed its own method of preventing the misuse of naturally occurring substances. When a substance is classified as essentially biological, it is ineligible for patent protection. These essentially biological substances could be called “products of nature.” The application of this, the product of nature doctrine was not hindering the biotechnology development process as the doctrine is flexible.

CONCLUSION

The product of nature doctrine was evolved in the US to protect naturally occurring substances from being patented on discovery. It was to distinguish between invention and discovery. The same doctrine got a new dimension with the evolution of science and technology. Patents in the fields of biotechnology and genetic engineering were strictly limited under this doctrine. In India, this doctrine is not present as such and it is reflected in sections 3 (c) and 3 ( j ) of the statute. In India, the doctrine of the product of nature does not have a strict application compared to that in the US. In India, the patenting of microorganisms and plans is legal. Legalizing such patents will affect the lives of farmers. A balanced approach is required in such cases. The product of nature doctrine could not be followed strictly as it would detrimentally affect science and technology.

Author(s) Name: Krishnapriya

References:

[1] United cannabis for v Pure Hemp Collective Inc Case no. 1:18-cv-01922-NYW

[2] Diamond v chakraburty [1980], 447 US 303

[3] Merck & Co v Olin Mathieson Chemical Corp [1958], 253 F 2d 156

[4] Dimminaco AG v. Controller of patents and drugs [2002], IPLR July 225