Patenting was created for machines, apparatus, and other items. However, as the biotechnological industry progresses, it is being forced onto living beings. Biotechnology is concerned with both living and non-living species, such as plants, animals, and microorganisms. Biological inventions are usually divided into three groups. They are the procedures for creating or modifying live beings and biological materials, as well as the outcomes of such procedures and the applications of such outcomes. The need to patent living things didn't become obvious until the 1970s, when biotechnology was at its peak, with Hybridoma technology, DNA technology, and other innovations. Enterprises and academics have only been able to utilise and employ biological resources for commercial and large-scale pharmaceutical and agricultural product manufacturing thanks to such technologies. Patenting life forms is a huge and critical issue because of the commercial potential of biotechnology. When compared to plants, human cells, animals, and genes, the subject matter of biotechnology patenting differs from that of machinery patenting, which is more traditional. This blog looks at the legislation surrounding the patentability of biological forms. It will address concerns of standard-setting in the context of the TRIPS [Trade-Related Aspects of Intellectual Property Rights ] agreement on the patenting of living forms.

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Patenting life forms: position of India

Invention is described as a contemporary, modern, and useful way of creating or a material made by a creator in Section 2(1) of the Patent Act of India, 1970. There were no precise definitions of manufacturer's technique or substances in the Act. As a result, the Patent Office adopted a more current definition of a "method of production" as patentable subject matter if it generates a physical non-living substance. A list of inventions that cannot be patented in India may be found in Section 3 of the Patent Act of 1970. Plants and animals, in whole or in part, are exempt under Section 3 clause (j) of the aforementioned Act, including seeds, varieties, and fundamental biological processes for the production of plants and animals.The Indian Patent Act of 1970 erected statutory impediments to achieving the patentability requirements of invention, industrial application, and novelty. Although some inventions are subject to limitations under Section 3 of the Indian Patent Act, 1970.

TRIPs requires member nations to patent microorganisms (Article 27 (3) (b)), in addition to providing the baseline minimal threshold for patentability. Patenting these life forms, however, is difficult due to the lack of a scientific definition for the term microbe. Although the TRIPs agreement protects microorganisms against patents, it does not define them, therefore member countries are left to their own devices. TRIPs encourage member countries to implement a Sui generis (national laws and regulations) framework to protect GEMs and produced biological material.It's uncertain if the term applies just to genetically modified organisms or also to naturally occurring substances.

Amendments made to the Patents Act, 1940.

Between 1999 and 2005, amendments to the Indian Patents Act, 1970 were made to comply with TRIPS directions and to satisfy India's international TRIPS commitments. In instance, the Act was revised in 2002 to allow for patents on microbes. New paths for gaining patent rights for novel microorganisms and other microorganism-related technology have opened up as a result of the amendment.

• In accordance with Article 27(3) (b) [TRIPS], Section 3(j) of Patents Act, 1970 was drafted. Plants and animals, in whole or in part, including seeds, varieties, and species, as well as significant biological processes for the production or propagation of plants and animals, should not be considered inventions other than microorganisms, according to the Act. Microorganisms were removed from the list of patent exceptions, permitting patenting of microorganism-related "processes" as well as non-biological and microbiological processes.
• In 2005, the Patents Act of 1970 was changed once more to bring it into compliance with TRIPS. Only process patents were mentioned in this category after the most recent modification, which removed Section 5 of the Act. The rule applied to inventions that could only be patented as manufacturing processes or procedures. As a result, the omission of this component paved the way for product patents, which ran opposite to the United States' position, which claimed that patenting living organisms can yield considerable benefits. Despite worries regarding the patenting of microorganisms, this strategy may be considered as revolutionary for the biotechnology industry, as it will speed its inevitable arrival.

Case law: Dimminaco A G v Controller of Patent Designs & Ors.[ 2001 A.I.R. 1 (Cal.) ]

Facts: In the case of Dimminaco A G v. Controller of Patent Designs & Ors, the Hon'ble High Court of Calcutta was approached by a Swiss business that had been denied a process patent for the development of a live vaccination for Bursitis. The Patent Office had refused to grant a patent because the so-called invention, which contained a living organism, was not patentable under Section 2(1) (j).

Contention of the parties: The Patent Office argued that using a living creature to make a vaccine is neither a method of production nor a method of generating an object. The vaccine was described as a "natural process" because it needed the processing of specific microbes. Despite the fact that the Indian Patent Act of 1970 did not contain any explicit or implicit prohibitions, patents were typically given to non-living creations that met the patentability requirements. The appellant claimed that the rule of law had been violated because discretionary administrative policy took precedent over the statutory definition of what constitutes an invention, which did not prevent the patenting of a process for making a vaccine containing a live virus.

Court’s Observation: The Court noted that the term 'manufacture' was not defined in the Act and consulted a variety of dictionary definitions to conclude that the process for manufacturing such a vaccine is a new process and that such a new process is patentable under Section 5 read with Section 2(I)(i) of the Patent Act. The vendibility test was used by the Hon'ble Court to evaluate whether a process was patentable. It was found that because the patent claim method results in a vendible product, it is unquestionably a substance after going through the manufacturing process. M/s Bishwanath Prasad Radhey Shyam v Hindustan Metal Industries [ year] station was also cited to clarify the other patentability conditions of novelty and utility.

Despite the fact that many perceived it as a bold move to legalise patentability of living stuff in India before a law modification clearly permitted it, the Court took a cautious approach. It's important to recall that, as the appellant constantly noted, the case was about a method patent for a manufacturing process. It only allowed patenting of a technique that produced a living-matter-based product, not the living matter itself. The case was so fundamentally different from gene patenting, which would have generated concerns about research hurdles and other issues; instead, it included a vaccine process patent.Concerns about all future mutations of a gene being covered by a single patent and the availability of rival research become especially important in the case of a product patent regime. Moreover, even though the case was decided in favour of the Appellant, the Court reserved the right to consider such cases on a factual basis. It was decided that determining whether a patent application was for an innovation or not required a detailed examination of the facts of each case.

Patenting life forms: U.S.A. patent regime

The patentability of 'life patents' in the United States differs from that in India in terms of inclusivity, i.e., the patent law in the United States is 'all inclusive.' Patents have traditionally been used to protect mechanical devices and other similar inventions. Questions about biological material's "inventive" status and private ownership or monopoly over life as a whole have emerged since biological material was added to the list of patentable subject matter. The question of whether new technology breakthroughs demand a new patent regime is being debated. The debate isn't just about whether the current patent legislation should be extended to biological objects. The problem was "not between living and inanimate objects, but between products of nature, whether living or not, and human-made creations," as Chief Justice Burger explained.

Section 101 of the U.S. patent law states that “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title”. Naturally occurring things are not patentable. For e.g. naturally occurring microorganisms are not patentable but genetically engineered microorganisms, animals, plants are patentable as it is manmade. Anything under the sun that is made by man is patentable.

Case law: Diamond v Chakrabarty [447 U.S. 303 (1980) ]

Facts: Ananda Mohan Chakrabarty, a genetic engineer, created the Pseudomonas putida bacterium, which is capable of metabolising the hydrocarbons found in crude oil. Chakrabarty filed a patent application in 1972, which was assigned to General Electric Co. The patent claims filed by Chakrabarty were divided into three categories:

1. process claims for the method of manufacturing the bacteria;
2. claims for an inoculum made up of a carrier substance floating on water and the new bacteria; and
3. Claims for the bacteria themselves.

The claims in the first two categories were accepted, but those in the third were rejected on two grounds: first, that microorganisms are a "product of nature," and second, that being living entities, they are not patentable subject matter under Section 101 of itle 35 U.S.C. of the Patent Act [ year].

Contentions of the parties: The appellant (a scientist) challenged the United States Patent and Trademark Office's refusal to grant a patent on his modified Pseudomonas bacteria, which featured at least two stable energy-generating plasmids. The fact that this human-engineered organism could help break down oil particles and control oil spills was a novel attribute on which the appellant based his arguments for the formation of a process for generating organism and for some unique characteristics of the bacterium per se. The United States Patent and Trademark Office acknowledged that the organism's unique characteristics deemed it non-natural, and hence it could not be categorised as a "product of nature."The USPTO agreed with the applicant's argument that such an organism did not arise naturally in nature and hence could not be denied patent rights as a "product of nature." The sole reason for the patent application's denial was that the subject matter was a 'living organism.'

Court’s observation: The Supreme Court of the United States based the ratio decidendi on the creativity with which the microbes were modified when evaluating these several arguments. The Supreme Court's liberal interpretation of the terms "composition of matter" and "manufacturing" envisioned patent law encompassing man-made objects. The novel bacteria was thought to have unique characteristics not found in nature and could be valuable in a range of fields. A genetically modified creature was determined to be a "creative creation" rather than a "product of nature" by the court.

Challenges with respect to the patenting of life forms globally

According to Section 2(j) of the Indian Patents Act, 1970, a "invention" is defined as "a new product or technique involving an inventive step and capable of industrial application." Patented inventions are those that are protected under the patent law. Because patenting needs both an innovative step and the disclosure of a new invention, proving the same in the field of biotechnology is difficult because it involves subject matter that already exists in nature. Natural, readily available topic matter is an exception to the abovementioned condition because it is not considered 'fresh.' Similarly, patenting life forms presents a few additional hurdles for both the inventor and society as a whole:

Legal challenges: The main question surrounding life form patenting is whether it should be considered under the current legal framework or not. While it is not regarded legal in most countries, the US Supreme Court took a liberal approach and granted a patent to a genetically modified bacterial specie. The Court was especially concerned with the creative step taken to utilise the bacteria's unique capability in this case. The Supreme Court emphasised that the term "manufacturing" was broad enough to cover all man-made products. As a result, under Section 101, 35 USC, it was determined that the discovery was made by the author and not by nature. However, the lack of clarity on whether human intervention is sufficient to designate an invention as patentable, particularly when it comes to Genetically Modified Organisms, raises the question of when human intervention is sufficient to designate an invention as patentable (GMOs). Furthermore, a jumble of legal rulings has failed to provide clear guidelines for patentable biological forms.

Moral challenges: The inclusion of genetically modified organisms (GMOs) in the purview of patentable inventions has prompted ethical and moral questions regarding what constitutes "playing God" and the degradation of "life dignity" for personal gain. Relaxin encoded human gene patenting was asserted, and the European Court addressed this issue in the Relaxin case (T 0272/95). Because it is impossible to replicate a full human being via human gene cloning, it was concluded that patenting a single human gene is not the same as patenting human life, and that the two are unconnected.Due to moral concerns, the patentability of a genetically altered plant was challenged in another case before the European Courts. The yardstick for what is moral and what is capable of disrupting public order, on the other hand, differs per country, as it is mostly established by the collective conscience of diverse social groups.

Conclusion

Biotechnology patents are currently in a fragile situation, requiring a delicate balancing act between individual property rights and the larger public good. The gap between countries must be overcome because the future of 'Bio-patents' is in the hands of people who hold them. In terms of patent rights, TRIPS does not include a classification for microorganisms. Microorganisms must be classified by national authorities to include bacteria, viruses, funguses, and algae. The appropriate classification of all of these microorganisms is a critical step in providing protection to them. Another significant flaw in the context of biological material patent protection is the lack of a definition for the terms "invention" and "discovery."Microorganisms are found in nature, and their discovery cannot be called invention. Microorganisms that have been genetically altered are considered innovations because of human participation. As a result, there is a lot of confusion over whether particular microorganisms are inventions or discoveries, which has an impact on their patentability. The many barriers to microbe patentability can be solved by clearly and methodically defining the term microorganism and interpreting the gaps between discovery and invention. As a result, this stance must be defined and thoroughly investigated.

Author: Anuja Saraswat - a student of NMIMS Kirit P. Mehta School of Law (Mumbai), in case of any queries please contact/write back us at support@globalpatentfiling.com or Global Patent Filing.