Intellectual property pertains to the creations of the human mind, and if they possess commercial value, they can be considered assets. It includes inventions, industrial designs, literary and artistic works, symbols, and more. The term “patent” has its roots in the Latin word “patent-em,” which means open, although this apparent contradiction requires clarification. The optimal dissemination of new knowledge plays a crucial role in achieving the highest level of economic efficiency. We discuss Conceptual issues in patenting of life forms.
A patent is a form of intellectual property right granted to an individual, providing them with exclusive control over their invention while necessitating its complete disclosure. The invention can be a product or a process, but it must be applicable in an industrial context.
The concept of patentability for life forms and its associated challenges emerged during the late 1900s with the rapid advancement of gene technology and biotechnology research. Researchers in these fields began manipulating naturally occurring life forms to benefit society on a larger scale, introducing concepts like bio-patenting or patenting life forms.
Presently, this concept encounters diverse legal and ethical dilemmas due to its commercial utilization and the absence of well-defined regulations. Furthermore, specific terminologies related to bio-patenting still need to be clarified within the framework of the Patent Act of 1970. These complexities highlight the need for comprehensive and precise laws to govern the patenting of life forms and related practices.
Overall, intellectual property rights, including patents, play a crucial role in incentivizing innovation, fostering economic growth, and safeguarding inventors’ rights while balancing commercial interests and ethical considerations.
Why should life forms be patented?
The famous case of Diamond v. Chakrabarty (1980) acknowledged that genetically modified organisms (GMOs) are living entities but are not naturally occurring in nature. In this case, the U.S. Supreme Court ruled that a genetically modified bacterium capable of breaking down crude oil components could be granted a patent. The court justified this decision by highlighting that the modified bacterium did not exist naturally, nor did any naturally occurring bacteria exhibit its specific capabilities.
Furthermore, the court recognized that the modified bacterium met the essential criteria for patentability, being a product of human intellect with its distinct name, characteristics, and specific application. This verdict significantly impacted the field of genetic engineering, leading to a surge in patent activities. Numerous patent applications were put on hold pending the case’s resolution, but they have since been processed. Currently, the National Centre for Biotechnology Information (NCBI) reports approximately 500 pending patent applications related to genetic engineering, with more expected in the near future. As a result, the rate of patent activity in the field of genetic engineering is growing at approximately twice the speed of similar technologies.
It is essential to consider that genetic modification is a costly and time-consuming process. Suppose the creators of genetically modified products are not granted the benefits of their creations. In that case, they will need more motivation and financial support to continue their research, potentially resulting in stagnation within the field. Allowing these creators to benefit from their work incentivizes further innovation and ensures the progression of genetic engineering, enabling ongoing discoveries and advancements.
Position in India
A significant case regarding the patentability of life forms was Dimminaco A.G, which established that manufacturing involves a specific procedure, often incorporating vaccines containing living organisms. The application of Article 27 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) resulted in notable changes to the definition of invention within the Patent Act of 1970.
However, the Act lacks explicit definitions related to life forms, leading to ambiguity and arbitrariness in interpreting the provisions. Standard terms like “microorganism” and similar terminology are left to the discretion of the interpreter, occasionally referencing the TRIPS Agreement.
The patenting of life forms in India faces several challenges due to the need to consider multiple factors when interpreting the Act. Apart from meeting criteria such as novelty, inventive step, and industrial applicability, other factors present obstacles to granting patents for inventions involving life forms. These include provisions in the Patent Act’s sections 3(a) to 3(p), encompassing considerations like “against public order or morality,” “discovery of a living substance,” and “inventions directed to methods of agriculture,” among others.
In many instances, inventions involving life forms are categorized as preexisting natural matter and are therefore deemed ineligible for patent protection. Additionally, utilizing such naturally occurring matter in an industrial context raises various legal and ethical concerns, often conflicting with the public interest. Thus, it is essential to carefully analyze the conceptual issues surrounding the patenting of life forms.
Patents in microorganisms
Before 1980, the answer to the question of whether microorganisms could be patented was a clear “no.” Microorganisms were considered natural products and thus ineligible for patent protection. However, the advent of DNA manipulation between organisms changed this perception.
According to the Mashelkar committee report, microorganisms are now recognized as patentable subject matter in India. Unlike many developed countries, India allowed product patents for inventions involving microorganisms and other biological materials. From May 20, 2003, India began granting patents for microorganism-related inventions, although it was not obligated to introduce laws for patenting microorganisms before December 31, 2004.
Patenting microorganisms are classified as a product patents offering a protection period of either five years from the grant date or seven years from the date of application filing.
Currently, patents for microbiological inventions are granted for 20 years from the filing date.
The primary difference in legal practices between India and developed nations is that India prohibits patenting microorganisms that already occur naturally.
Such cases are considered discoveries and fall under section 3(d) provisions, making them ineligible for patents. However, genetically modified versions of these microorganisms, which enhance their known efficacies, can be patented.
The granting of patents for microorganisms in India depends on regulations related to the deposition of microorganisms under the Budapest Treaty, of which India is a member. Accessibility of the microorganism from the depositories is also a crucial factor. As per proviso (ii) of section 10(d), if a microorganism is not entirely and specifically described and is not available to the public, it must be deposited with the International Depositary Authority under the Budapest Treaty.
Conceptual Issues of Patenting Life Forms
1.The Legal Issues –
According to the Patent Act of 1970, a product or process can only be eligible for a patent if it involves innovation and complete disclosure. However, when considering innovations in the biotechnology field, it becomes evident that they may be perceived as naturally occurring subject matter, falling within the exclusion clauses of Section 3 of the Act.
Furthermore, using a substance that is naturally available but excluding it from the general public may be considered against the public interest, thereby excluding it from patentability. Some cases describe this as the transformation of “naturally occurring material created by a higher power” into private objects using technology.
An illustrative case highlighting this is Funk Bros. v. Inoculant Co., which involved culturing Rhizobia to immunize leguminous plants. The court ruled that the inherent characteristics of bacteria were merely a “work of nature” and, therefore, not patentable.
However, the case of Diamond v. Chakrabarty presents a contrasting perspective. In this case, the U.S. Supreme Court adopted a liberal approach and granted a patent for a genetically improved bacterial species. The court focused on the inventive step taken to harness the bacteria’s unique capability. It emphasized that the term “manufacture” encompassed all man-made creations.
Following this landmark decision, several patents were granted with little regard for moral considerations. The need for more clarity regarding when an invention should be examined from the standpoint of public morality raises the question of when human intervention alone is sufficient to deem an invention patentable, particularly in the context of Genetically Modified Organisms (GMOs). Furthermore, inconsistent court rulings need to establish clear guidelines concerning patentable life forms.
2.The Moral and Ethical Issues-
The inclusion of genetically modified organisms (GMOs) in the realm of patentable inventions has sparked ethical and moral debates, questioning whether these actions amount to assuming the role of a higher power and degrading the sanctity of life in pursuit of private interests.
A critical case to consider is Relaxin, where the court differentiated between patenting a single gene and patenting human life itself. The court reasoned that since cloning technology had not advanced to the stage where an entire human could be cloned from a single gene, the two could not be equated. Additionally, particular inventions hold significant societal importance, making their patentability apparent. In the case of isolating Relaxin for genetic coding, it was considered more than a mere discovery.
In another case before the European Courts, the patentability of a genetically modified plant faced opposition based on moral grounds. During this case, the Board explained the terms “morality” and “public order.” However, these concepts vary among nations, as the criteria for determining what is moral or disruptive to public order largely depend on the collective conscience of different segments of society.
For many, patenting life forms is often deemed immoral, as manipulating genes can present a perspective where life is reduced to a mere commodity, exploited for profit by private entities or individuals.
3. Ownership Issues-
The issue of ownership rights over modified life forms has been a subject of discussion in various instances. For instance, consider the case of the T-Lymphocyte, where a patent was granted based on an invention derived from a cancer patient’s spleen without their consent or knowledge. This action led to legal disputes and raised questions about whether researchers should obtain explicit consent to claim ownership rights over genetically modified materials. Additionally, what benefits should be provided to contributors involved in the research?
Despite these concerns, it is crucial to recognize that the primary objective of patenting life forms is to benefit humanity as a whole. The commercial aspect should be seen in collaboration rather than in the context of promoting the public interest. It is essential to acknowledge that research can only be incentivized if a fair reward exists. Granting patents encourages efforts towards advancing society, particularly in areas that aim to improve quality of life or revolutionize healthcare. Temporary monopolization is seen as a minor trade-off for the greater goal.
However, other aspects can lead to discontents, such as the potential advantages developed countries have over developing ones and their involvement in the appropriation of biological materials from various communities. It is evident in the pharmaceutical industry, where affluent nations derive financial benefits from others by requiring periodic payments for the use of patented inventions deemed essential for survival.
GMO Patent Laws in India
GMO (Genetically Modified Organism) patent laws encompass the legal framework governing the protection and ownership of genetically modified organisms. Before the 2002 amendment to India’s patent law of 1970, there was limited or no significant patent safeguard for inventions related to life forms and genetically modified organisms within the country. However, the Dimminaco A.G v. Controller of Patent and Design ruling changed this. The Calcutta High Court determined that a process for producing vaccines containing live viruses is eligible for patent protection. The court reasoned that the term “manufacture” encompasses non-living entities and living organisms. Even if the final product includes a live virus, the process involved in its creation can be considered an invention.
The landmark case of Monsanto Technology LLC v. Nuziveedu Seeds Ltd further supported the case for patenting G.M. and living organisms. In this particular case, the renowned Supreme Court of India made a ruling stating that genetically modified cotton seeds could be patented, thereby granting permission to the U.S. company Monsanto to proceed with their patent claims.
These legal decisions have contributed to shaping the landscape of G.M. and living organism patents in India, clarifying the scope of patentability and recognizing the innovative aspects involved in developing and commercializing genetically modified organisms.
Patents on life forms have negative consequences for research, indigenous economies, and genetic diversity. They create monopolies and drive-up prices, making essential products unaffordable for many. Patents also hinder the exchange of information and impede cooperative scientific efforts. Taxpayer-funded research is exploited by corporations profiting from patented products, making citizens pay twice for medicines and other goods. Patents can lead to unsustainable and inequitable agricultural practices and a decline in genetic diversity. The patenting of genetically modified organisms makes it easier for corporations to maintain control while promising benefits that often fail to materialize. Patents on genetic resources from developing countries allow the wealthy industrial nations to accumulate more wealth at the expense of the South. Additionally, patenting life forms raises significant religious and ethical concerns. While the biotechnology revolution presents opportunities, it is essential to prioritize societal well-being over conflicting ideologies when making regulatory decisions.
Read our Article:Biotechnology Patents In India: A Complete Outlook