Patents in Biotechnology at the Crossroads of Innovation and Ethics

Mansi Ahuja
Oct 13
4 min read

This article is written by Adv. Mansi Ahuja. (B.Tech., LLB (DU), LLM (Buckingham University)

In the past patent law sought to encourage innovation by giving creators temporary exclusivity over their works. This made genes, genetically modified organisms, and genetic engineering techniques patentable in the field of biotechnology. The above approach first encouraged funding for research and development which resulted in ground breaking findings and biotechnology,

However as genetic engineering methods advanced moral questions surfaced. Policymakers, bioethicists, and the general public were alarmed by the monetization of living forms, the possibility of genetic discrimination, and the environmental effects of genetically modified organisms. As a result, the development of patent law in biotechnological breakthroughs has made it necessary to move toward resolving these ethical quandaries.

A pivotal moment in this transformation was the landmark US Supreme Court ruling of Diamond v. Chakrabarty¹ in 1980. The Court determined that humans could patent living organisms they have engineered, setting a crucial precedent for the patenting of genetically modified organisms (GMOs). This ruling initiated a broader framework for biotech patent laws. However, it also sparked discussions regarding the ethical concerns of granting patents on living entities. Following this, patent offices and legislative groups around the globe began to address the ethical aspects of biotechnology.

Regulations and limitations regarding the patentability of biotech were established to prevent the patenting of specific forms of genetic material, especially those occurring naturally or relating to human genes linked to health issues. These initiatives were designed to find a balance between promoting innovation and upholding ethical standards. Additionally, international treaties such as the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) provide worldwide benchmarks for patent protection while granting member countries some leeway to implement precautions in biotechnology patent legislation to handle ethical considerations.

PATENTING LIFE FORMS & GMOs IN INDIA

The advancement of science in genetic engineering and related biological fields has surged rapidly since the identification of DNA's double-helix structure in 1953. This progress has resulted in thousands of patents being issued for various DNA sequence rights, alongside a rise in the commercialization of scientific research. Nevertheless, the patenting of living organisms and Genetically Modified Organisms (GMOs) remains a contentious issue.²

A unit or organism present in the natural environment can be classified as a life form. For example, it might be a virus, an animal, a plant, or any human being. This prompts the inquiry of whether life forms can be eligible for patent protection. Over the years, India's stance on patenting living organisms has gradually changed. Several decades ago, India had a strong opposition to the patenting of life forms. This is reflected in India’s call for a reassessment of Article 27.3(b) of the Trade-Related Aspects of Intellectual Property Rights (TRIPS)³ and its backing of the African group's proposal in 1999 which advocated for the prohibition of patents on living organisms and microbiological processes.

TRIPS, in contrast, mandated that member nations provide patents for all technologies and microorganisms. As a whole, Article 27 of the TRIPS Agreement defines which inventions governments are obliged to make eligible for patenting, and what they can exclude from patenting. Inventions that can be patented include both products and processes, and should generally cover all fields of technology. Broadly speaking, part (b) of paragraph 3 (i.e. Article 27.3(b)) allows governments to exclude some kinds of inventions from patenting, i.e. plants, animals and “essentially” biological processes (but micro-organisms, and non-biological and microbiological processes have to be eligible for patents). However, plant varieties have to be eligible for protection either through patent protection or a system created specifically for the purpose (“sui generis”), or a combination of the two.

Between 1999 and 2005, modifications were implemented to the Indian Patents Act of 1970 to ensure compliance with TRIPS and fulfill India’s international commitments under the agreement. Specifically, in 2002 the Act was revised to allow patents for microorganisms. This amendment enabled the acquisition of patent rights for innovative microorganisms as well as other domains involving microorganisms.

In a significant development regarding the case Dimminaco A G v. Controller of Patent Designs & Ors,⁴ a Swiss company sought the intervention of the Hon'ble High Court of Calcutta after being denied a process patent for creating a live vaccine for Bursitis. The Patent Office rejected the patent application on the grounds that the invention included a living organism, which is not considered patentable under Section 2(1)(j) of the Indian Patents Act.⁵ The Patent Office contended that employing a living organism to create a vaccine does not qualify as a production method or an object-generating method. The vaccine was characterized as a "natural process" since it required the handling of particular microbes. The Court observed that the definition of 'manufacture' was not provided in the Act and referenced various dictionary definitions to determine that the process of producing such a vaccine is novel, making it patentable under Section 5 in conjunction with Section 2(1)(j) of the Patent Act.⁵ The Hon'ble Court applied the vendibility test to assess the patentability of the process. It was concluded that since the method of the patent claim leads to a marketable product, it is undoubtedly classified as a substance after undergoing the manufacturing process.⁶

ETHICAL DILEMMAS IN PATENTING LIFE FORMS

Patenting living organisms may be perceived as commodifying them solely for profit, diminishing the notion that life holds inherent value beyond financial gain. Concerns emerge regarding the ownership rights to inventions that originate from human or animal material, particularly when the individual or animal involved has not provided explicit consent or is unaware of the use. This also raises questions about the benefits that should be afforded to the contributor. A patent provides exclusive rights, which can restrict others from exploring the same genetic material, potentially hindering the development of cures and treatments for illnesses. This may restrict access to crucial technologies and health-related methods. There are those who contend that naturally occurring genes and biological processes belong to our collective heritage and should not be privately owned or monopolized. The concept of "inventing" a living organism raises concerns, particularly with regard to more complex organisms.⁷

CONCLUSION

The current state of biotechnology patents is precarious, necessitating a careful equilibrium between personal property rights and the broader public interest. The disparities among nations need to be addressed, as the future of 'bio-patents' lies with their holders. Regarding patent rights, TRIPS does not provide a category for microorganisms. National authorities must categorize microorganisms to encompass bacteria, viruses, fungi, and algae. Responses from various countries differ, with nations such as Canada prohibiting patents on higher life forms entirely.

Concurrently, agreements like the Nagoya Protocol aim to promote fair access to genetic materials worldwide. The current debates regarding patents on living organisms highlight wider societal issues related to genetic modification, corporate influence, and the moral management of the environment.

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