To Patent or Not to Patent: The Case of Natural Substances

Abstract

The question of whether naturally occurring substances can be patented has been a controversial topic in both legal and scientific fields for many years. While patents grant inventors sole rights to their inventions, applying them to things found in nature raises ethical and practical questions.

Introduction:

In recent years, the global legal landscape has seen a surge in patent applications and disputes involving natural substances, particularly in the fields of pharmaceuticals, biotechnology, and agriculture. The U.S. Supreme Court has ruled that claims related to abstract ideas, natural phenomena, or laws of nature are not eligible for patent protection. To determine if a claim involving a natural product meets the patentability requirements, the U.S. Patent and Trademark Office compares the entire composition to its closest naturally occurring counterpart. This approach differs from analysing each individual component separately. For instance, gunpowder, while composed of natural elements, is considered patentable due to its unique explosive properties not found in its individual components.

In India, the patenting of natural substances has become increasingly prominent in recent years, with a growing number of patent applications and disputes in sectors such as pharmaceuticals, biotechnology, and agriculture. The Indian legal landscape, influenced by both domestic laws and international agreements, has specific guidelines for determining the patentability of natural products. These guidelines consider factors like novelty, inventiveness, and industrial applicability, while also addressing the unique challenges posed by the protection of traditional knowledge and biodiversity.

National and International Laws

National Laws:

• The Patents Act, 1970: This is the primary legislation governing patents in India. It outlines the criteria for patentability, procedures for filing and granting patents, and the rights and obligations of patent owners.
• The Biological Diversity Act, 2002: This Act aims to conserve biological diversity and regulate access to biological resources. It establishes the National Biodiversity Authority (NBA) to regulate access to genetic resources and traditional knowledge.

International Laws:

• The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)[1]: As a member of the World Trade Organization (WTO), India is bound by the TRIPS Agreement. It sets minimum standards for intellectual property protection, including patents.
• The Convention on Biological Diversity (CBD): India is a signatory to the CBD. It requires countries to protect biodiversity and ensure the fair and equitable sharing of benefits arising from the use of genetic resources.

Exceptions and Limitations

The Indian Patents Act, 1970[2], excludes certain subject matter from patentability, including:

• Discoveries: This includes the discovery of a natural substance in its natural state.
• Mathematical methods, business methods, and computer programs per se: These are generally not considered patentable subject matter.

Additionally, the Biological Diversity Act, 2002, imposes restrictions on the patenting of biological resources and traditional knowledge. It requires prior informed consent from the relevant communities and equitable sharing of benefits arising from the use of such resources.

Case Studies

Basmati Rice:

An American company, RiceTec, had patented a genetically modified strain of Basmati rice, claiming it as a new variety. This sparked significant controversy as Basmati rice is indigenous to the Indian subcontinent and has been cultivated for centuries. Indian authorities challenged the patent on the grounds of prior art and misappropriation of traditional knowledge. The case highlighted the concerns surrounding the patenting of natural products that have been part of cultural heritage for generations.

Neem:

The neem tree (Azadirachta indica) is another example of a natural substance that has been the subject of patent disputes. Neem-based products have been used for centuries in traditional Indian medicine. However, foreign companies have attempted to patent neem extracts and formulations, claiming them as novel inventions. These patent applications have faced opposition from Indian organizations and activists, who argue that the knowledge of neem's medicinal properties is part of the country's traditional knowledge heritage.

• Diamond v. Chakrabarty (1980): This landmark case established that genetically engineered organisms could be patented, even if they were derived from naturally occurring organisms. The Court held that the creation of a new, distinct organism constituted an invention.
• Myriad Genetics, Inc. v. Association for Molecular Pathology (2013): In this case, the Supreme Court held that isolated DNA sequences, even if they were not found in nature, were not patentable. The Court reasoned that isolating DNA from the human genome did not create a new product, but merely identified a naturally occurring molecule.
• Association for Molecular Pathology v. Myriad Genetics, Inc. (2014): The Supreme Court clarified its ruling in Myriad by stating that synthetic DNA sequences, which are not found in nature, could be patentable.
• Genetic Technologies, Inc. v. Merial S.A. (2016): The Supreme Court held that a method of isolating a naturally occurring gene was not patentable. The Court reasoned that the method was merely a law of nature, and therefore not eligible for patent protection.

Current Trends

1. Patenting of Gene Sequences:

The patenting of gene sequences remains a subject of debate in India. While there is potential for innovation and commercialization, concerns have been raised about the monopolization of genetic resources and the impact on research and development. The Indian government has been working to balance the interests of innovators and the public domain.

1. Synthetic Biology:

The emergence of synthetic biology has introduced new dimensions to the patenting of natural substances. Synthetic biologists can create novel organisms or modify existing ones, raising questions about the patentability of these artificially created entities. India is actively exploring the regulatory framework for synthetic biology and its implications for intellectual property rights.

1. Traditional Medicine:

The protection of traditional knowledge associated with natural substances remains a priority for India. The government has implemented measures to document and safeguard traditional knowledge, and to prevent its misappropriation. There is a growing emphasis on promoting the commercialization of traditional medicine products while ensuring that the benefits are shared equitably.

Incentives for Innovation

Patents can serve as powerful incentives for innovation in the development of products derived from natural substances. By granting exclusive rights to inventors, patents provide a potential for:

• Profitability
• Risk mitigation
• Market exclusivity

Barriers to Entry

While patents can incentivize innovation, they can also create barriers to entry for smaller players in the market. This can limit competition and hinder innovation in several ways:

• Licensing costs
• Patent thickets
• Patent trolls

A biochemistry student argued, and showed her frustration towards a new USPTO Guidance[3] that makes it difficult to patent natural products. She believes this guidance is an unreasonable extension of the Myriad ruling, which only applied to isolated DNA.

She also argues that patenting natural products, even with minimal modification, can be beneficial because it allows for:

• Enhanced sustainability and affordability
• Increased production and performance

She was concerned if the new Guidance will:

• Discourage universities and small companies from pursuing natural product research
• Hinder the development of new drugs and therapies

Economic Benefits and Costs

The economic benefits and costs associated with patenting natural substances are complex and depend on various factors, including:

Benefits:

• Increased revenue: Patent holders can potentially increase their revenue by charging licensing fees or selling their patented products at premium prices.
• Job creation: Patenting can stimulate innovation and economic growth, leading to job creation in industries related to research, development, manufacturing, and marketing.
• Technological advancement: Patents can encourage the development of new and improved products, contributing to technological advancement.

Costs:

• Litigation costs: Patent disputes can be expensive and time-consuming, involving significant legal fees and potential losses.
• Reduced competition: Patents can limit competition, leading to higher prices for consumers and reduced consumer choice.
• Innovation stifle: In some cases, excessive patent protection can stifle innovation by discouraging competitors from entering the market or developing alternative technologies.

Policy and Regulatory Issues for Patenting Naturally Occurring Substances in India

International Cooperation

The patenting of natural substances often involves cross-border issues, as many of these substances have global applications and may be sourced from different countries.

• Harmonization of IP Laws: International organizations like the World Intellectual Property Organization (WIPO)[4] can play a crucial role in harmonizing intellectual property laws related to natural substances. This would help to create a more predictable and equitable environment for inventors and innovators.
• Sharing of Information: International collaboration can facilitate the sharing of information on traditional knowledge, biodiversity, and the potential for commercialization of natural substances. This can help to prevent the misappropriation of traditional knowledge and ensure that indigenous communities receive fair compensation for the use of their resources.
• Addressing Biopiracy: International cooperation is essential to combat biopiracy, which involves the unauthorized exploitation of genetic resources and traditional knowledge from developing countries. By working together, countries can develop effective mechanisms to protect their biodiversity and prevent the misappropriation of their natural resources.

Author’s POV:

According to me, a balanced approach to patenting natural substances in India, acknowledging both the potential benefits and drawbacks should be followed. To emphasize the importance of striking a delicate equilibrium between incentivizing innovation and protecting traditional knowledge, biodiversity, and equitable access to essential goods. Patents can foster research and development, leading to new products and therapies derived from natural substances. Patenting natural substances raises concerns about the appropriation of traditional knowledge, the protection of biodiversity, and the potential for market monopolies. But at the same time, it is crucial to balance the interests of inventors, consumers, and society as a whole when considering the patenting of natural substances. There is a need of developing robust national policies in India to regulate the patenting of natural substances, protect traditional knowledge, and ensure equitable access to essential goods. Overall, my perspective is that while patenting natural substances can be beneficial, it is essential to approach this issue with caution and consider the broader implications for society and the environment.

[1] TRIPS — Trade-Related Aspects of Intellectual Property Rights. (2023). WTO ORG. Retrieved October 24, 2024, from https://www.wto.org/english/tratop_e/trips_e/trips_e.htm

[2][2] THE PATENTS ACT 1970. (2015, March 11). IP INDIA GOV. Retrieved October 24, 2024, from https://ipindia.gov.in/writereaddata/portal/ipoact/1_31_1_patent-act-1970-11march2015.pdf

[3] GUIDANCE DOCUMENTS USPTO. (n.d.). USPTO.GOV. Retrieved October 24, 2024, from https://www.uspto.gov/guidance

[4] World Intellectual Property Organization (WIPO). (n.d.). WIPO.INT. Retrieved October 24, 2024, from https://www.wipo.int/portal/en/index.html