Table of Contents
Introduction
Genes are the stories of human beings. They are the language of that story too. Genes determine what we are, what we will be, and what we could be. They are a part of ourselves, so vital that without them, we are nothing more than particles made of flesh and bone. Technically, genes are defined as units of heredity, distinct sequences of nucleotides forming part of a chromosome, with their arrangement dictating the sequence of monomers in a polypeptide or nucleic acid molecule.
Given the immense significance of genes in our heritage, discussions about their patentability often stir controversy. The legal landscape has evolved from fundamental debates on “Are these patentable?” to intricate questions of “What exactly is patented?” and “How are they patented?” The crux of the issue lies in the nature of genes themselves. When discussing “gene” patents, we are actually referring to the patenting of DNA sequences. This distinction between a gene and DNA is essential to understanding the debates around what, how, and why these patents are contested. Currently, the legal framework is characterized by a complex array of regulations. In the U.S., the Myriad Genetics case of 2013 overturned the patenting of isolated DNA sequences, while allowing the patenting of complementary DNA (cDNA) under certain conditions. In India, the Patents Act of 1970 excludes natural occurrences from patent protection but remains unclear about the scope of gene patents, leading to ongoing ethical and practical challenges.
To tackle these challenges, a nuanced approach is essential. It’s crucial to define patent eligibility with greater precision while ensuring that patents not only drive innovation but also safeguard access to genetic information. Reforms should aim to harmonize legal standards with ethical imperatives and practical requirements, striking a balance between encouraging scientific progress and protecting public health. We believe that this balanced framework would support both technological advancement and equitable access to genetic resources.
What is Gene and a DNA?
In gene patenting, DNA is the molecule in cells that carries genetic information, composed of nucleotides: adenine (A), thymine (T), guanine (G), and cytosine (C). Genes are segments of DNA that determine traits, with their function dictated by the sequence of these nucleotides. Adenine bonds with thymine (A-T), and guanine bonds with cytosine (G-C). For example, sequences like ATGCATATGC and ATATGCGCATGATGC could represent two distinct genes, but in reality, genes consist of much longer sequences, making their identification complex.
To simplify, imagine the human body as a vast library where each book represents DNA, and the chapters are genes. The “language” of DNA consists of just four letters (A, T, C, G), forming the genetic code. Each gene, like a chapter, has a unique sequence that determines its function. Changes in these sequences can alter genetic instructions, influencing our traits and functions.
Are these Patentable?
In the past, companies sought patents for specific nucleotide sequences in DNA using sophisticated techniques. Before 2013, over 30,000 genetic patents were granted in the U.S., based on principles like Novelty, Non-Obviousness, and Utility[1]. Initially, isolated DNA sequences seemed to meet these criteria as they were new, unique, and had practical applications in diagnostics.
The Diamond v. Chakrabarty case [2](1980) first allowed genetic patents by defining “compositions of matter” to include genetically modified organisms. This interpretation extended to isolated DNA sequences, which were deemed patentable under the broad category of “compositions of matter.” However, in Association for Molecular Pathology v. Myriad Genetics, Inc. (2013)[3], the U.S. Supreme Court invalidated patents on isolated DNA sequences. The Court ruled that while isolating DNA involves some ingenuity, it does not constitute a patentable invention because DNA as a naturally occurring substance cannot be patented simply for being isolated. The Court maintained that the process of isolating DNA did not meet the “non-obviousness” requirement, as it involved routine laboratory techniques. The case highlighted that identifying and isolating complex genetic sequences, like the BRCA1 and BRCA2 genes, which are each about 80,000 nucleotides long, required considerable effort and expertise. However, this effort alone did not suffice for patentability.
Conversely, the Myriad decision permitted patents on complementary DNA (cDNA), which represents synthesized DNA from mRNA and excludes non-functional parts. The Court allowed cDNA patents, recognizing that creating cDNA involves significant human intervention and transforms natural DNA into a new form, justifying its patentability. This distinction emphasizes the complex balance between protecting innovations and acknowledging the natural basis of genetic material. The topic of whether genes may be patented cannot be addressed simply with yes or no; it is a fluid story that changes with time and interpretation, a weave made from moving threads of legal, scientific, and ethical factors.
The Indian Perspective and the Ethical Conundrums:
Currently, India’s legal stance on gene patenting, under the Patents Act of 1970, prohibits patenting natural occurrences including live organisms and non-living substances (Section 3(c))[4], and excludes patentability of plants and animals except microorganisms (Section 3(j)). [5]Shifts in policy have been observed, with initial provisions in the 2005 Draft Patent Practice Manual allowing patentability of biological materials with significant human intervention[6], but subsequent revisions omitting this criterion. [7]
India’s legal framework for gene patenting is relatively sparse, especially concerning isolated DNA sequences. A significant case in this context is Dimminaco A.G. v. Controller of Patents & Designs [8](2001), where Dimminaco A.G. sought to patent a method for preparing a vaccine using a live virus. The Patent Officer initially rejected the application under Section 12 [9]of the Patents Act, arguing that the method did not qualify as an invention under Section 2(j). [10]However, the Calcutta High Court overturned this decision, asserting that the law did not prohibit patenting processes or methods if they were “new and novel,” thus validating the patent under Section 5 of the Act[11]. In contrast, the case of Monsanto Technology LLC v. Nuziveedu Seeds Ltd (2019) [12]addressed the patentability of genetically modified seeds and gene sequences. The Division Bench ruled that such genetic modifications were not patentable subject matter in India. Although the Supreme Court subsequently set aside this decision, reopening the case for further examination, a conclusive ruling on the patentability of isolated DNA and cDNA is still pending. In Novartis AG v. Union of India (2007)[13], the Madras High Court upheld Section 3(d) of the Indian Patents Act, which mandates that modifications of known substances must show “enhanced efficacy” to be patentable. The Court rejected Novartis’ challenge, affirming that Section 3(d) is constitutional and aligns with public health interests by preventing patents from restricting access to essential medicines. This decision underscores the balance between fostering innovation and ensuring affordable access to healthcare
Recent developments show that cDNA can be patented in India. For instance, the Japanese Encephalitis Virus cDNA was granted a patent in 2014[14], under Section 2 of the Patents Act, as “new and novel.” This indicates an evolving stance towards patenting genetic material involving significant human intervention. The ambiguity persists regarding gene patent eligibility criteria, raising ethical concerns and impacting innovation in biotechnology.
Conclusion:
The fundamental challenge in gene patenting lies in balancing public and private interests. Patent law’s “market mantra” suggests that market forces, rather than legal intervention, should primarily guide innovation[15]. However, affordability remains a critical issue. The high costs of genetic tests, as seen in the Myriad case, significantly limit access to essential genetic information. This problem is especially acute in countries like India, where healthcare accessibility is a pressing concern. The Myriad case was brought to the Supreme Court primarily due to concerns regarding accessibility and affordability of the BRCA test. The court’s ruling aimed to take a societal approach to address these issues. However, the impact of the judgement remains questionable. Despite the ruling against patenting naturally occurring DNA, the cost of genetic tests remains high in the United States. [16]The decision did not substantially lower the prices of these tests because companies can still hold patents on cDNA and related technologies, which are crucial for the development of diagnostic tests and treatments. These patents allow companies to maintain exclusivity and set high prices, limiting the accessibility of genetic information and healthcare for many people.
India’s stance on gene patenting should be informed by the lessons learned from the US experience. The focus should be on reducing the prices of genetic tests rather than outright denying patents that involve human intervention. By fostering innovation through a balanced patent policy and implementing measures to ensure affordability, India can advance its biotechnology sector while safeguarding public health interests.
This article is Co-Authored by Mr. Sanjith Gurikar and Ms. Adhya Anil Gowda, students at PES University, Bangalore.
[1] Merz, J.F., & Cho, M.K. (2005). What are gene patents and why are people worried about them? Community Genetics, 8(4), 203-208. doi: 10.1159/000087956. PMID: 16244473; PMCID: PMC2220018.
[2] Diamond v. Chakrabarty [1980] USSC 33
[3] Association for Molecular Pathology v. Myriad Genetics, Inc. (2013) 569 U.S. 576
[4] Indian Patents Act [1970], s 3(c)
[5] Indian Patents Act [1970], s 3(j)
[6] Draft Patent Practice and Procedure Manual (2005, Controller General of Patents, Designs and Trademarks, India)
[7] Ravi, Bhavishya. “Gene Patents in India: Gauging Policy by an Analysis of the Grants Made by the Indian Patent Office.” Journal of Intellectual Property Rights (2013)
[8] Dimminaco A.G. v. Controller of Patents & Designs, 2002 I.P.R.L. 255 (Cal. H.C.)
[9] Indian Patents Act [1970], s 12
[10] Indian Patents Act [1970], s 2(1)(j)
[11] Indian Patents Act [1970], s 5
[12] Monsanto Technology LLC v. Nuziveedu Seeds Ltd, AIR 2019 SC 559
[13] Novartis AG v. Union of India, (2007) 4 MLJ 593 (Mad. H.C.)
[14] Ravi, Bhavishya. “Gene patents in India: Gauging policy by an analysis of the grants made by the Indian patent office.” Journal of Intellectual Property Rights, 2013.
[15] Jurek D, “Patents, Innovation, and Market Entry” (2024) 10 Journal of Open Innovation: Technology, Market, and Complexity 100246
[16] Sherkow JS, Cook-Deegan R and Greely HT, “The Myriad Decision at 10” (2024) 25 Annual Review of Genomics and Human Genetics
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