A microorganism is a microscopic organism, known to be one of the earliest life forms on earth. Viruses, fungi, bacteria, archaea, protozoa and algae are the six major forms of microorganisms, exploited expeditiously by the biotechnologists and micro-biologists for research purposes. From beer brewing, bread making to mass production of antibiotics, microorganisms is used in all such processes by the scientists to reach the desired results. Genetic engineering techniques, DNA typing etc., have further paved way for genetically modified organisms such as the genetically modified bacterium, as in the US Supreme court case of Diamond v. Chakrabarty.
The case of Diamond v. Chakrabarty1 in 1980s, opened gates for the patentability of microorganisms, wherein the claim of a Micro-biologist Dr. Ananda Chakrabarty, for the grant of patent for a live human made & genetically engineered bacterium, capable of breaking the components of crude oil was accepted by the US Supreme Court. In this case, the controller of patents of the United States denied the claim for patenting the bacterium per se, stating that, microorganism are product of nature and hence are non-patentable according to the US patents regime, which was reversed by the United States Court of Customs and Patent Appeals. Dejected by the decision of the US court of Customs and Patents Appeal, Sideny A. Diamond, the commissioner of Patents and trademarks appealed to the US Supreme court2 which again went in favour of Chakrabarty by establishing that a human made, genetically engineered bacteria was capable of treating oil spills and thus was an invention accompanied by novelty, usefulness, utility, non-obviousness and industrial applicability3, which a naturally occurring microorganism was incapable of.
Before the US Supreme Court's decision in the case of Diamond v. Chakrabarty, Patent protection was not granted to microorganisms as product claims, but only to the process claims in which microorganisms was used as a medium in inventions.4
Article 27(3)(b) of the TRIPS 1994, further established that microorganisms and non-biological and microbiological processes are patentable by stating that, "Members may also exclude from patentability, plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes."
'Microorganisms per' se can be patented, however, it should be noted that a patent is not granted for a discovery rather for an invention which is novel, non-obvious, useful and capable of industrial application. Therefore, a patent can only be granted for a micro-organism, when there's a human intervention to create a new, non-obvious and useful microorganism by way of genetic modification/engineering, cell fusion, gene therapy or other micro-biological or non-biological techniques.5
Further, since the disclosure of details in written description w.r.t., inventions involving micro-organisms is not possible, the Budapest Treaty provides for a mechanism to deposit microorganism with any "international Depository Authority" for the purpose of patent procedure of national patent office of all the contracting states.
The Indian Scenario:
The Indian Patents Act, 1970 added microorganisms under the purview of patentability through the Patents (Amendment) Act, 2002, in compliance with the TRIPS.
According to Section 3(j) of the Patents Act, 1970, a plant, animal, seeds and biological processes, apart from microorganisms are not patentable. Therefore, section 3(j) of the Indian patents act, allows patentability of microorganisms.
The landmark judgment of the Calcutta High court in the case of Dimminaco A.G. v. Controller of Patents & Designs on 15th January, 2001, prior to the 2002 amendment in the patents act, 1970 established a benchmark in the field of micro-biological research. In this case, an appeal was filed against the Assistant Controller of Patents & Designs, wherein, the process for preparation of infectious Bursitis Vaccine was refused on the grounds that the process of preparation of vaccine that contained a living virus cannot be considered manufacture and that a vaccine comprising of a living virus cannot be considered a substance or inanimate object. The court in this case reversed the decision of the Assistant controller and held that, the process of preparing a vendible commodity containing a living substance is not excluded from the purview of the word, 'manufacture' and that the controller erred in denying patent protection to the vaccine just because it contained a live virus. Furthermore, the end product was novel, capable of industrial application and was useful for protecting poultry against contagious Bursitis infection, thus making the process an invention. The court further allowed the appeal and directed the petitioner's patent application to be reconsidered within two months of the publication/delivery of the judgement.
In the recent Supreme Court's judgment in the case of, Monsanto Technology Pvt. Ltd. v. Nuziveedu Seeds6, The plaintiff claimed that their patent in the man-made, chemical product called NAS(Nucleotide Acid Sequence) containing the gene Bacillus thuringiensis (Bt gene), capable of killing bollworms when inserted in cotton, was not an infringement under section 3(j) of the patents act, 1970, as held by the Division bench of the Delhi High Court. Nuziveedu's claim was that, NAS was merely a chemical composition in-capable of reproduction and not a man-made inventive microorganism, capable of industrial application7. The Supreme Court in this case set aside the order of the division bench and restored the order of the single bench and reverted back the matter back to the single bench of the Delhi High Court to be decided on the basis of expert advice and evidence, who had held that, the claims on NAS was rightly entertained by the Indian Patent office and that the parties shall remain bound to their sub-lease agreement.
Thus, the current scenario in India w.r.t. patents in microorganisms is still at an infancy stage and needs progression.
The micro-organisms with human interventions, accompanied by novelty, utility and industrial applicability are patentable. The technological advancements in the field of micro-biology, genetics, etc., have complicated the issues relating to patents in microorganisms. Therefore, scientific aspects and legal drafting of the invention should be done with due precaution and consideration. Further even though, the issues involved in the Monsanto's case was highly technical, The Supreme Court missed its opportunity in deciding upon the facts in issue8.
1 447 US 303 (1980)
2 Patenting of microorganisms: Systems and concerns, Ramkumar Balachandra Nair & Pratap Chandran Ramachandranna .Journal of Commercial Biotechnology volume 16, pages 337–347(2010) access from: https://link.springer.com/article/10.1057/jcb.2010.20
3 Dr. BL Wadehra.Law Relating to Intellectual Property 66.(Universal-Lexis Nexis, Fifth Edition, Reprint 2018)
4 Id. at ii.
5 Globalization and Access to Drugs. Perspectives on the WTO/TRIPS Agreement – Health Economics and Drugs Series, No. 007 (Revised). Essential Medicines and Health Products Information Portal.A World Health Organization resource. Access from:https://apps.who.int/medicinedocs/en/d/Jwhozip35e/3.4.4.html
7 Kluwer Patent Blog.Monsanto v. Nuziveedu: A Missed Opportunity by the Supreme Court?
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