This article has been written by Srijita Goswami, pursuing a Diploma in Intellectual Property, Media and Entertainment Laws from LawSikho.
Microorganisms have multiple applications in methods of scientific development. The use of such microorganisms in developing enhanced processes for medical use, genetic modification, preservation and a range of other useful activities has become a common practice. However, the patenting of processes and products containing living microorganisms was not a universally accepted practice. The landmark case that set the system of patenting of microorganisms in motion was the United States Supreme Court judgment, Diamond v. Chakraborty.
Provisions of TRIPS have expressly obliged its signatories to patent microorganisms while also interpreting the ambit of the term microorganisms widely. Although India has been a signatory to the TRIPS agreement, the stance on the patentability of living microorganisms had been disputed. Therefore, the present case set a benchmark in the Indian patent regime, by illuminating the position of the nation in the context of the patentability of microorganisms.
Facts of the case
The appellant had applied for a patent for the process that he had invented for the creation of a “Bursitis vaccine” to protect poultry from Bursitis infection. The process dealt with the creation of a Bursitis vaccine and involved the use of a live virus both during such creation and in the final vaccine.
The Patent Office Examiner had examined said application under Section 12 of the Patent Act, 1970 (hereinafter referred to as the Act) and upon his findings, rejected said application on the grounds that the claim did not meet the requirements of an “invention” under Section 2 (j)(i) of the Act and that the application fell under Section 5 (a) or 5(b) of the Act as the product of the process was a food/drug. The appellant had then appealed to the Controller of Patents and Designs who further delegated authority to the Assistant Controller of Patents and Designs (hereinafter referred to as Assistant Controller) under Section 73(3) of the Act. The Assistant Controller upheld the decision of the Examiner, thereby, rejecting the application. Consequently, the appellant approached the Calcutta High Court under Section 116 of the Act.
The issues that the learned bench took into considerations were:
- Firstly, whether there is a bar to the patentability of a process of manufacturing when the process and/or the product involves/contains a living organism?
- Secondly, whether such a process of manufacture qualifies under Section 5 of the Act?
- Thirdly, whether such a process qualifies as an invention under Section 2 (j) (i) of the Act?
The Court highlighted that the primary contention of the Assistant Controller had been that the product that had been created contained a live virus, disqualifying the claim as a process or manner of manufacture. The Assistant Controller further insisted that upholding the patentability of such a process had not been previously permitted in India and would lead to growing complexities in the Indian patent regime. To justify their stance on not accepting the wider meaning of “manufacture”, the Assistant Controller relied on the Patent enquiry committee report containing the recommendation of Justice Iyengar. Further, the Assistant Controller emphasized that a product containing a living organism was not a substance as a living organism could not be converted into another product using physical or chemical means.
The Court delved into the procedural matrix of the examination of the patent office to address the appellant’s challenge to the findings on the ground of the absence of any expressed rationale for the rejection by the Examiner. The bench highlighted the procedural intricacies of such an examination under Section 12 of the Act, emphasizing on reference under Section 12 (c) to the report of investigation under Section 13, thereby highlighting the nexus between the two provisions. The bench observed that not only was such an investigation absent from the record but the primary finding that the claim does not qualify as an invention has not been substantiated with any reasoning. Relying on “Terell on the Law of Patents”, the bench highlighted the essence of the adjudicatory nature of the duty of the Examiner, the quasi-judicial nature of their actions by virtue of which their objections have to be accompanied with reasons.
The Court’s interpretation, leaning towards the rationale provided by the appellate counsel, noted that the mere fact that a product contained a living organism would not render the manner of its manufacture un-patentable. The patentability instead would have to be determined through the test of novelty and usefulness. The bench held that the application met the threshold for both criteria as it involved a novel process using specific conditions and was useful to prevent the infectious Bursitis disease in poultry. In such a case, the claim would potentially be granted a patent under Section 2(1) read with Section 5 of the Act.
The bench further explained the intricacies for measuring the patentability of a manner of manufacture using the “vendibility test”. Defining a vendible product as one that can be a subject matter of commercial sale or purchase transactions, the Court explained that the test measures whether the process leads to an improvement, restoration, production, or preservation of such a product. If the invention, in the nature of a manufacturing process, serves any of the aforementioned purposes, the test for vendibility would have been met.
Therefore, the Court held that the contentions of the Controller on the ground that a living organism contained in the final product would amount to a bar to patentability and that such a process of creating such a product did not qualify as manufacture, were incorrect.
The contention of the Controller that in the cases cited by the appellant wherein patents had been previously granted despite the process containing living organisms, was that the end product did not contain such living organisms but instead involved lyophilizing such cells which according to their interpretation, killed such organisms. The Court dismissed this in their verdict, explaining that lyophilizing is a process of preservation and not one of killing such organisms.
The Court proceeded to dismiss the seemingly last resort of the Controller to defend their stance by assuring that previously granted patents with live organisms would be revoked, on the ground that such a step would not meet the provisions of Section 64, rendering it contrary to law. Thereby, the bench directed the reconsideration of the application by a period not exceeding two months.
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Through the course of the present judgment, the High Court of Calcutta established multiple important benchmarks. It is imperative to note that acknowledging the procedural overlaps in the present case was a crucial step in preserving and upholding the need for transparency and accountability in the Patent Office. The emphasis on a reasoned objection and multiple provisions of the Act, the need to adhere to procedural intricacies was entrenched by the bench.
The judgment is considered to be a landmark in the field of patentability of microorganisms. Indian patent law was amended subsequent to this judgment in 2002. Through this amendment that took effect in 2003, the Indian patent system was aligned with the provisions of the TRIPS agreement by expressly providing for the patenting for microorganisms in Section 3(j) of the Act. Through this provision, microorganisms were specifically included within the scope of patentability in India, by excluding them from the exceptions to patentability.
It is essential to know that while this amendment initiated the system for including living microorganisms, such patents were restricted to processes and manners of manufacture by virtue of Section 5 of the Act. Only a subsequent amendment in 2005 that abrogated Section 5 extended such patentability to product patents as well.
The present case was one of the milestones that paved the way for Indian alignment with TRIPs and the global stance on microorganisms as well as microbiological patenting. Intellectual property protection surrounding microorganisms has been instrumental in fuelling innovation and development in the bio-technological arena. The Indian stance with respect to including inventions within the scope of patents, measuring the standards for qualifying as inventions and excluding discoveries has subsequently been cleared of considerable ambiguity.
- Diamond v. Chakraborty, 447 U.S. 303 (1980)
- Dimminaco A.G. v. Controller of Patents and Designs, (2002) I.P.L.R. 255 (Cal), https://spicyip.com/wp-content/uploads/2013/11/Dimminaco-A.G.-v.-Controller-of-Patents-Designs.pdf
- Microorganisms and the Indian Patents Scenario, 3rd March, 2020 – 9:43 Am, https://www.khuranaandkhurana.com/2020/03/03/microorganisms-and-the-indian-patents-scenario/
- Patent Act, 1970, https://www.indiacode.nic.in/handle/123456789/1392?view_type=search&sam_handle=123456789/1362
- Ramkumar Balachandra Nair & Pratap Chandran Ramachandranna, Patenting of microorganisms: Systems and concerns, 16, Journal of Commercial Biotechnology , 337–347(2010), https://link.springer.com/article/10.1057/jcb.2010.20#:~:text=Some%20of%20the%20patentable%20micro,to%3A%20(a)%20a%20form
- The Patents (Amendment) Act, 2002, https://indiankanoon.org/doc/1449261/
- The Patents (Amendment) Act, 2005, https://indiankanoon.org/doc/187742/#:~:text=(a)%20for%20sub%2D%20section,a%20complete%20specification%20shall%20be
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