The Intersection of IPR and Biotechnology: Patents on Genes and CRISPR
Introduction
Intellectual Property Rights (IPR) is fundamental to the development of new ideas, leading to investment; especially in the field of biotechnology where research intensively is involved. As medicine, agriculture, and environmental science are being revolutionized by such technologies as genetic modification, and gene editing, the role of patents in this sphere was under sharp critical judgment. Patents give exclusive rights, but when it comes to biology – and genes and such tools as CRISPR, this issue is full of complicated ethical and legal questions. Do natural DNA sequences belong to someone? Are technologies that allow editing the genome of human, animal or plants eligible for exclusive control?
The controversy over biotech patents reaches beyond issues in legal interpretation, forming part of public health, scientific openness, and worldwide equality. Nations need to strike a balance between the protection of inventors and access to salvific innovation. To poor nations, this equilibrium is particularly thin as robust IP regimes can collide with the needs of public health and biodiversity conservation.
India presents a unique perspective. And its patent law, based on the Patents Act, 1970 and informed by the Biological Diversity Act, 2002, clearly does not allow the protection of biological materials in a majority of cases. Such a practice indicates a commitment to biodiversity conservation, the right of access, and constitutional principles in regard to the right to health, and knowledge.
With the change in biotechnological tools, such as CRISPR, the associated legal and ethical requirements should change too. This article examines the nexus between IPR and biotechnology, especially gene patents, the CRISPR copyright battle and the implications for invention, equity and law in India and elsewhere.
The Legal Status of Gene Patents
A form of biotechnological patent, gene patent, confers exclusive rights to given sequences of DNA. These patents had initially been granted on the assumption that if a naturally occurring gene was isolated and was uniquely good for a utilitarian purpose then it was an invention that deserved patent protection. Such a system allowed firms such as Myriad Genetics to patent individual genes including the BRCA1 and BRCA2 genes associated with breast cancer susceptibility. The idea was that getting the gene out of the human genome made it novel enough and innovative enough to deserve a patent.
The legal terrain for gene patents, however, changed radically in the landmark 2013 U.S Supreme Court case Association for Molecular Pathology v. Myriad Genetics. By the Court’s verdict, naturally occurring DNA sequences cannot be patented, because they are products of nature. The decision was important in confirming the fact that nature is not for monopoly. The Court explained that man-made synthetic DNA, including complementary DNA (DNA), designed by scientists, to replicate the only coding part of a gene, is patentable since it is a product of human labor, meaning an invention rather than a discovery. This ruling changed altogether the extent to which genes could be patented, and the outcome was clear: only synthetic, man-made variants of genes could be patented, but not natural ones (SCOTUS, 2013).
The CRISPR Controversy
CRISPR-Cas9 has dramatically transformed biotechnology with its gene-editing potential. The legal rights to CRISPR became the subject of a contentious patent dispute between:
- Jennifer Doudna and Emmanuelle Charpentier (University of California, Berkeley), and
- Feng Zhang (Broad Institute, MIT).
Though Doudna and Charpentier were awarded the 2020 Nobel Prize for discovering CRISPR’s genome-editing potential, the Broad Institute won a key U.S. patent for its application in eukaryotic cells ([USPTO PTAB, 2022]).
Dr. Jennifer Doudna, speaking in a Nature interview, cautioned:
“We need to have a global consensus about what is acceptable and what is not when it comes to genome editing.”
India’s Position on Biotech Patents
In India, the legal environment of gene patents is rather conservative. The Patent Act (Cap 395, 1970) as revised excludes from patentability any biological material which is found naturally. S 3(j) of the Act bars the patenting of “plants and animals in whole or any part thereof other than microorganisms” – apparently a prohibition that effectively blocks patents on naturally occurring genes. India’s legal position is founded on both the pledge to ensure protection of biodiversity, in addition to public health concerns. Further, India’s laws place a significant ethical responsibility for the prevention of biological resources monopolization – belonging to the common heritage of humankind. This is fortified by India’s compliance with international conventions such as the Nagoya protocol; which focuses on fair access and benefit sharing to genetic resources.
The difference between the U.S and India is glaring. Although the U.S. grants patents for synthetic genetic material such as DNA, the more cautious U.S. stance represents a much wider concern in India about international equitable access to genetic resources, as well as global health implications. For instance, India Practice (2001) has always stood against the patenting of traditional knowledge and natural biological resources to ensure that local communities do get benefits from them in the hands of foreign patent holders. This prepares the ground for an interesting debate about the conflict of intellectual property rights with public welfare.
In the advancement of biotechnological research against the background of gene patenting rises on, debates continue to advance. The Myriad Genetics case showed the complexities of patenting living organisms and parts of it, since the questioning of whether or not bringing genes and genetic technologies onto the commercial markets dooms or boosts the development of sciences occurred. The legal infrastructure of India represents different priorities, where the infrastructure of public access and ethical implication of patenting the very life itself are in place
Parallels from Trademark and Semiconductor Law
Biotech patent concerns echo issues explored in related IP contexts:
- In “Can Colors Be Owned?”, the idea of owning color—an inherently natural phenomenon—mirrors concerns about patenting naturally occurring genes.
- In “Patents vs Open Source in India’s Semiconductor Industry,” the tension between exclusive rights and open innovation parallels the debate over repositories like Addgene, which facilitate global CRISPR research while respecting patent boundaries.
Both cases question how far intellectual monopolies can—or should—extend.
Ethical and Global Considerations
Ethics of patenting genes and biotechnological devices like CRISPR are intensely worrisome about access, equity and monopolization of life-saving creations. Although patents can encourage discovery, unnecessary dominance of genetic material/essential technologies may hinder research and access to diagnostics, treatment and food security solutions (backlash). This will particularly be limiting for developing countries.
The need for balance in biotech patenting has been emphasised by such international organisations as World Intellectual Property Organization (WIPO). Their advice requires legal structures that pay for innovation and guarantee wide public use particularly in the case of genetic materials from diverse hotspots but poor areas .
India has been quite supportive of such a balanced approach. It co-led a proposal for a temporary waiver of some obligations under the TRIPS Agreement at the World Trade Organization during the COVID-19 pandemic. The aim was to ensure that the rest of the world has enhanced access to vaccines and treatments, a position which India has continued to champion, that public health supersedes sometimes at the expense of exclusive IP rights. Although not a total acceptance, the waiver moved diplomacy on global biotech a decisive step forward.
With technologies such as CRISPR as the key to public health, agriculture, and climate resilience, the ethical problem persists. How is the law able to defend innovation, not behind a paywall? The nations have to collaborate if they will share the promise of biotechnology equitably: among nations, population, and generations ahead.
Conclusion
It is a complex and fraught situation, standing at the confluence of science, law and ethics, whether they should or should not patent genes and genome-editing technologies such as CRISPR. Although intellectual property rights are used to compensate for innovation, over extending or over aggressive parenting for the case of biotechnology in particular can jeopardize access to life-saving research, medicine, and key agricultural technologies.
CRISPR and this kind of development hold tremendous potential for the public good, but if monopolised then they will present themselves as obstacles to cooperation and affordability. Legal systems have to find moderation: incentivizing innovation at the same time protecting access and ethical integrity. The U.S. approach, which separates natural DNA (unpatentable) from cDNA (patentable) represents an effort to lay down the bounds of invention. India’s tougher attitude, under Section 3(j) of the Patents Act, 1970, promotes the needs of public health, biodiversity and fair access to the life forms over the privatization of the latter needs.
This is a debate that reflects broader questions in IPR—visible in the areas of, say, software, semiconductors, and even colour (brand) marks—to the limits of what ownership should cover. As biotechnology’s societal implications are so great, that technology now calls for a reconsideration of these borders. From now on, global legal structures will need to develop in accordance with innovation not only profitable, but also fair, inclusive and conforming to the public interest.
References
- Supreme Court of the United States. Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013).
- The Patents Act, 1970 (as amended). Section 3(j), Government of India.
- United States Patent and Trademark Office, Patent Trial and Appeal Board (PTAB) Rulings on CRISPR, 2022.
- Nature News. “CRISPR pioneer Jennifer Doudna urges caution in genome editing.” Nature, 2020.
- National Biodiversity Authority, Government of India. Access and Benefit Sharing Guidelines.
- World Intellectual Property Organization (WIPO). “Biotechnology and Intellectual Property.”
- Image generated by CHAT-GPT