Microorganisms And The Indian Patents Scenario – Intellectual Property – India – Mondaq News Alerts

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A microorganism is a microscopic organism, known to be one ofthe earliest life forms on earth. Viruses, fungi, bacteria,archaea, protozoa and algae are the six major forms ofmicroorganisms, exploited expeditiously by the biotechnologists andmicro-biologists for research purposes. From beer brewing, breadmaking to mass production of antibiotics, microorganisms is used inall such processes by the scientists to reach the desired results.Genetic engineering techniques, DNA typing etc., have further pavedway for genetically modified organisms such as the geneticallymodified bacterium, as in the US Supreme court case of Diamond v.Chakrabarty.

The case of Diamond v.Chakrabarty1 in 1980s, opened gates forthe patentability of microorganisms, wherein the claim of aMicro-biologist Dr. Ananda Chakrabarty, for the grant of patent fora live human made & genetically engineered bacterium, capableof breaking the components of crude oil was accepted by the USSupreme Court. In this case, the controller of patents of theUnited States denied the claim for patenting the bacterium per se,stating that, microorganism are product of nature and hence arenon-patentable according to the US patents regime, which wasreversed by the United States Court of Customs and Patent Appeals.Dejected by the decision of the US court of Customs and PatentsAppeal, Sideny A. Diamond, the commissioner of Patents andtrademarks appealed to the US Supreme court2 which againwent in favour of Chakrabarty by establishing that a human made,genetically engineered bacteria was capable of treating oil spillsand 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 ofDiamond v. Chakrabarty, Patent protection was not granted tomicroorganisms as product claims, but only to the process claims inwhich microorganisms was used as a medium ininventions.4

Article 27(3)(b) of the TRIPS 1994, further established thatmicroorganisms and non-biological and microbiological processes arepatentable by stating that, "Members may also exclude frompatentability, plants and animals other than micro-organisms, andessentially biological processes for the production of plants oranimals other than non-biological and microbiologicalprocesses."

'Microorganisms per' se can be patented, however, itshould be noted that a patent is not granted for a discovery ratherfor an invention which is novel, non-obvious, useful and capable ofindustrial application. Therefore, a patent can only be granted fora micro-organism, when there's a human intervention to create anew, non-obvious and useful microorganism by way of geneticmodification/engineering, cell fusion, gene therapy or othermicro-biological or non-biological techniques.5

Further, since the disclosure of details in written descriptionw.r.t., inventions involving micro-organisms is not possible, theBudapest Treaty provides for a mechanism to deposit microorganismwith any "international Depository Authority" for thepurpose of patent procedure of national patent office of all thecontracting states.

The Indian Patents Act, 1970 added microorganisms under thepurview 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 microorganismsare not patentable. Therefore, section 3(j) of the Indian patentsact, allows patentability of microorganisms.

The landmark judgment of the Calcutta High court in the case ofDimminaco A.G. v. Controller of Patents &Designs on 15th January, 2001, prior tothe 2002 amendment in the patents act, 1970 established a benchmarkin the field of micro-biological research. In this case, an appealwas filed against the Assistant Controller of Patents &Designs, wherein, the process for preparation of infectiousBursitis Vaccine was refused on the grounds that the process ofpreparation of vaccine that contained a living virus cannot beconsidered manufacture and that a vaccine comprising of a livingvirus cannot be considered a substance or inanimate object. Thecourt in this case reversed the decision of the Assistantcontroller and held that, the process of preparing a vendiblecommodity containing a living substance is not excluded from thepurview of the word, 'manufacture' and that the controllererred in denying patent protection to the vaccine just because itcontained a live virus. Furthermore, the end product was novel,capable of industrial application and was useful for protectingpoultry against contagious Bursitis infection, thus making theprocess an invention. The court further allowed the appeal anddirected the petitioner's patent application to be reconsideredwithin 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. NuziveeduSeeds6, The plaintiff claimed that theirpatent in the man-made, chemical product called NAS(Nucleotide AcidSequence) containing the gene Bacillus thuringiensis (Bt gene),capable of killing bollworms when inserted in cotton, was not aninfringement under section 3(j) of the patents act, 1970, as heldby the Division bench of the Delhi High Court. Nuziveedu'sclaim was that, NAS was merely a chemical composition in-capable ofreproduction and not a man-made inventive microorganism, capable ofindustrial application7. The Supreme Court in this caseset aside the order of the division bench and restored the order ofthe single bench and reverted back the matter back to the singlebench of the Delhi High Court to be decided on the basis of expertadvice and evidence, who had held that, the claims on NAS wasrightly entertained by the Indian Patent office and that theparties shall remain bound to their sub-lease agreement.

Thus, the current scenario in India w.r.t. patents inmicroorganisms is still at an infancy stage and needsprogression.

The micro-organisms with human interventions, accompanied bynovelty, utility and industrial applicability are patentable. Thetechnological advancements in the field of micro-biology, genetics,etc., have complicated the issues relating to patents inmicroorganisms. Therefore, scientific aspects and legal drafting ofthe invention should be done with due precaution and consideration.Further even though, the issues involved in the Monsanto's casewas highly technical, The Supreme Court missed its opportunity indeciding upon the facts in issue8.

Footnotes

1 447 US 303 (1980)

2 Patenting of microorganisms: Systems and concerns,Ramkumar Balachandra Nair & Pratap Chandran Ramachandranna.Journal of Commercial Biotechnology volume 16, pages337347(2010) access from: https://link.springer.com/article/10.1057/jcb.2010.20

3 Dr. BL Wadehra.Law Relating to Intellectual Property66.(Universal-Lexis Nexis, Fifth Edition, Reprint 2018)

4 Id. at ii.

5 Globalization and Access to Drugs. Perspectives on theWTO/TRIPS Agreement Health Economics and Drugs Series, No.007 (Revised). Essential Medicines and Health Products InformationPortal.A World Health Organization resource. Access from:https://apps.who.int/medicinedocs/en/d/Jwhozip35e/3.4.4.html

6 AIR2019SC559

7 Kluwer Patent Blog.Monsanto v. Nuziveedu: A MissedOpportunity by the Supreme Court?

Access from: http://patentblog.kluweriplaw.com/2020/01/27/monsanto-v-nuziveedu-a-missed-opportunity-by-the-supreme-court/

8 Ibid.

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