Navigating Patent Law in the Era of Synthetic Biology and CRISPR

Introduction

Synthetic biology and gene editing technologies like CRISPR-Cas9 have changed the biotech landscape, providing potent instruments to engineer life itself. Their use is diverse and profound, from precise gene therapies and engineered microorganisms to climate-adapted crops. But these advances have also given rise to a legal dilemma: how are current intellectual property frameworks supposed to cope with innovation that plays with the components of life? Classic patent legislation was crafted to encourage invention in return for temporary monopolies, offered in exchange for public disclosure. But synthetic biology, in demarcating the boundary between nature and invention, challenges the presumptions of this system. The stakes are especially high for nations such as India, whose public health concerns and regulatory prudence have to weigh against the need to stay competitive in the international biotechnology competition.

This article critically assesses the relationship between patent law and nascent biotechnologies, especially synthetic biology and CRISPR. It discusses how legislatures and courts across India and elsewhere have reacted to these advances, and whether licensing schemes, ethical protection, and global harmonization can be used to bridge gaps among innovation, ownership, and public interest.

The paper argues that present patent systems, particularly in India, must change to meet ethical bounds, innovation needs, and worldwide inequities in access, by adopting adaptive licensing, judicial reform, and international collaboration.

CRISPR and the Shifting Nature of Innovation

Synthetic biology involves the engineering of novel biological components, systems, or organisms. It is distinct from traditional genetic engineering in that it enables researchers to design entirely new DNA sequences as opposed to just altering existing genes. CRISPR-Cas9, in turn, has become a foundation of gene editing in the present era. With CRISPR, researchers can target and precisely edit specific DNA sequences, providing a cheap and effective tool to fix genetic mutations or improve biological functions.

These technologies pose a challenge to traditional concepts of patentable subject matter. While traditional inventions are easily differentiated from natural phenomena, synthetic biology is the manipulation of materials that come from nature. This raises the essential legal issue: is life, or manipulated life, ownable?

Patentability and Evolving Legal Standards

Internationally, patent systems typically mandate inventions to be novel, non-obvious (presenting an inventive step), and industrially applicable. But in the case of biological inventions, these standards are watered down. The United States Supreme Court explained this in Association for Molecular Pathology v. Myriad Genetics (Myriad, 2013), wherein it struck down patents of isolated BRCA1 and BRCA2 genes on the ground that naturally occurring DNA is not an invention. But it explained that complementary DNA (cDNA), which is not naturally occurring, is patentable.

While the U.S. drew a nuanced line between natural and synthetic genetic materials, Europe and India have charted distinct paths of their own.

In India, the Patent Act (Indian Patent Act, 1970) takes an even stricter approach. Section 3(b) prohibits patents on inventions against public order or morality, whereas Section 3(j) prevents patenting of plants, animals, and basically biological processes for their manufacturing or propagation. Further, Section 3(d), famously used in Novartis AG v. Union of India (Novartis, 2013), rejected a patent on the beta crystalline form of the cancer drug Glivec for not demonstrating enhanced “therapeutic efficacy.”

Although these regulations were not created with CRISPR or synthetic biology in mind, they have significant implications. For instance, a CRISPR-edited plant may not be patentable in India, though it may enjoy protection in the United States or Europe (EPO, CRISPR).

The Court held that while the beta crystalline form was indeed novel and involved an inventive step, it did not meet the “enhanced efficacy” requirement under Section 3(d). The Court interpreted “efficacy” in the context of medicines to mean “therapeutic efficacy” and concluded that improved bioavailability alone was insufficient to meet the threshold. This decision was lauded globally for upholding public interest and preventing evergreening, especially in a country where access to affordable generic medicines is a lifeline for millions.

Although these regulations were not created with CRISPR or synthetic biology in mind, they have significant implications for such technologies. For example, a CRISPR-edited plant may be a basically biological process or a component of a living creature and hence not patentable in India, although being protected in the United States or Europe.

CRISPR Patent Disputes Across Jurisdictions

The legal battle over the CRISPR-Cas9 gene-editing technology stands as one of the most significant and complex disputes in recent biotechnology history. At the heart of the conflict are two major institutions: the Broad Institute of MIT and Harvard and the University of California, Berkeley. While UC Berkeley’s Jennifer Doudna and Emmanuelle Charpentier were among the first to publish findings on CRISPR's gene-editing potential, the Broad Institute secured key U.S. patents by demonstrating its application in eukaryotic cells, which include plants, animals, and humans.

In 2022, the U.S. Patent Trial and Appeal Board ruled in favor of the Broad Institute in Broad Institute v. UC Berkeley (Broad v. UC, 2022), holding that UC Berkeley had not sufficiently proven its invention enabled CRISPR in eukaryotic cells at the relevant date. The outcome was different in Europe, where the European Patent Office ruled in favor of UC Berkeley due to a procedural flaw in Broad’s priority filing (EPO, CRISPR).

China's patent system is fast shifting to meet its objectives for biotech supremacy. The China National Intellectual Property Administration (CNIPA) grants patents on modified genes and biotechnology techniques if the innovation has demonstrable economic use. While China has not witnessed litigation on CRISPR equivalent to the United States or the European Union, it has released rules supporting gene-editing technologies, establishing itself as a competitive and strategic actor in this sector.

These conflicting decisions underscore the challenges posed by fast-evolving scientific fields and highlight the urgent need for greater international consistency in biotechnology patent law. For researchers and companies worldwide, especially those in developing countries, the fragmented ownership of CRISPR increases licensing complexity, raises costs, and potentially slows innovation in crucial areas like medicine and food security.

Fragmented Licensing and Access Barriers

The complicated ownership of CRISPR patents has created a fragmented licensing landscape. Though the Broad Institute has provided non-exclusive licenses for research and agricultural purposes, it gave Editas Medicine exclusive rights to therapy. This twofold model of licensing has been criticized as delaying open access and possibly concentrating power in a limited number of biotech companies. Small research institutions and new biotech companies can become priced out of the market or caught in overlapping patents.

To meet these challenges, new models of licensing have emerged. Patent pools like those fostered by the BioBricks Foundation OpenMTA (BioBricks, n.d.) encourage open access to foundational biotechnologies. The OpenMTA enables the sharing of genetic parts under standardized conditions. Companies like Ginkgo Bioworks have also pioneered adaptive licensing, where partners retain rights to production outputs while using shared synthetic platforms.

Furthermore, real-world CRISPR licensing shows both collaboration and fragmentation. Editas Medicine has exclusive therapeutic rights from Broad, while Caribou Biosciences and Intellia Therapeutics license UC Berkeley's intellectual property. Exclusive sublicenses have resulted in siloed development and significant transaction costs for multi-party research. These instances highlight the importance of patent pools, open transfer agreements, and ethical licensing rules specific to synthetic biology.

Bioethical and Regulatory Challenges

In addition to legal principles, synthetic biology and CRISPR pose pressing ethical issues. Human germline editing, in which genetic alterations are inheritable, may result in eugenics or unforeseen health effects on generations to come. Ecological editing, for example, in the form of gene drives to remove invasive pests, may destabilize ecosystems in unpredictable manners. Synthetic organism creation also presents biosecurity threats, as malevolent actors could theoretically create pathogens or harmful biological weapons.

Patent law by itself cannot solve these issues. But ethical licensing practices can offer a halfway solution. Such licensing agreements may include restrictive clauses against specific use, e.g., military use or human embryo editing. They may also insist on biosafety obligations, along with benefit-sharing arrangements for communities granting access to biological resources. These measures, although voluntary, can direct biotechnology towards socially sound directions.

India’s Patent and Regulatory Positioning

India is at the crossroads as far as accepting synthetic biology is concerned. Its patent law is one of high novelty and inventiveness thresholds, and its constitutional pledge of public health has found expression in policy choices quite frequently where access over monopoly is preferred. Where synthetic DNA sequences qualify for protection by way of a patent if they are clearly different and industrially useful, edited organisms are a grey area. In addition, the impact of the Novartis decision indicates that the Indian Patent Office will review applications based on substantive merit instead of incremental changes.

India also has a strong legal weapon in the form of compulsory licensing under Section 84 of the Patent Act (Indian Patent Act, 1970). This provision can be invoked in public health emergencies, or if a patented product is unaffordable or underutilized in India an important safeguard in the age of high-cost gene therapies.

India has also cautiously begun to advance CRISPR innovation in agriculture. A significant example is researchers from the National Institute of Plant Genome Research (NIPGR) in New Delhi, who employed CRISPR to generate mustard plants with lower glucosinolate levels in seeds while maintaining insect resistance in leaves. This method improves the edibility and nutritional content of mustard oil while preserving plant defence systems (Crop Biotech Update, 2023).

Moreover, the Department of Biotechnology (DBT) issued the Guidelines for Safety Assessment of Genome Edited Plants (2022). These recommendations exclude genome-edited plants developed using SDN-1 and SDN-2 techniques those that do not include foreign DNA from biosafety standards under Rules 7-11 of the 1989 GE Rules, provided they are proved to be free of exogenous DNA (DBT, 2022). This proactive posture lowers regulatory barriers and is likely to promote CRISPR research and commercialisation in Indian biotech laboratories and agriculture.

Global Harmonization and the Path Forward

With the jurisdictional fragmentation and the ethical uncertainties of synthetic biology, global coordination is needed. International agencies like the World Intellectual Property Organization (WIPO) have initiated initial discussions on the impact of gene editing and synthetic life on IP regimes. (WIPO, 2022) But there is as yet no consensus. Nations are at odds with each other regarding whether genetic materials can be owned, the boundaries of patentable subject matter, and the ethical limits of biotechnology.

India has the potential to be at the centre of these discussions. Its own strategy based on public interest, biodiversity conservation, and bioethics is a model of caution and progress. To be competitive, yet retain regulatory integrity, India must revise its patent examination guidelines to reflect advances in synthetic biology. It must also encourage collaborative approaches to licensing, facilitate open science initiatives, and advocate international legal standards that are both innovative and equitable.

India's regulatory framework likewise shows a cautious approach. The Department of Biotechnology (DBT) and the Genetic Engineering Appraisal Committee (GEAC) supervise synthetic biology approvals, with current rules emphasising restricted usage and environmental risk. However, India lacks a cohesive framework unique to CRISPR or synthetic organisms, frequently relying on biosafety requirements from previous GMO procedures.

Conclusion

Patent law in the synthetic biology era and CRISPR must walk a tightrope. On the one hand, it needs to safeguard legitimate innovation and give inventors the assurance they require to bring game-changing technologies to market. On the other, it must resist monopolies over underlying biological processes, particularly if public health, food security, and environmental sustainability are implicated. The commodification of CRISPR technologies presents a case study on the ways in which legal instruments can either foster cooperation or solidify exclusivity. As India develops its intellectual property regime, it has to make sure that its laws are not only technologically updated but also ethically founded and socially inclusive. In so doing, it can assist in developing a legal frontier that is both respectful of human ingenuity and protective of the common good.

To chart a course forward, nations, particularly emerging economies like India, should create strategic frameworks that include: (1) revised patent guidelines for synthetic constructs; (2) ethical licensing clauses prohibiting dual-use and monopolisation; (3) regional patent cooperation models to reduce transaction costs; and (4) incentivised open-source platforms to democratise access. Only a balanced, transparent, and internationally harmonised intellectual property policy can ensure that synthetic biology serves humankind as a whole.

References:

1.Association for Molecular Pathology v. Myriad Genetics, 569 U.S. 576 (2013)

2.Novartis AG v. Union of India AIR 2013 SUPREME COURT 1311

3.Broad Institute v. UC Berkeley, Case: 22-1653

4.Indian Patent Act, 1970 – Sections 3(b), 3(j), 3(d), and 84

5.European Patent Office decisions on CRISPR patents

6.TKDL (Traditional Knowledge Digital Library) – https://www.tkdl.res.in

7.BioBricks Foundation OpenMTA – https://biobricks.org

8.Intergovernmental Comm. on Intell. Prop. & Genetic Res., Traditional Knowledge & Folklore, WIPO/GRTKF/IC/45/4 (2022), available at https://www.wipo.int/meetings/en/doc_details.jsp?doc_id=584306.

9.Crop Biotech Update. (2023, August 16). CRISPR Mustard Produces Oil with Low Pungency. Knowledge Center CBU Gene Editing Supplement. Retrieved from https://www.isaaa.org/kc/cropbiotechupdate/article/default.asp?ID=20233

10.Department of Biotechnology (DBT). (2022). Guidelines for Safety Assessment of Genome Edited Plants. Ministry of Science & Technology, Government of India. Retrieved from https://dbtindia.gov.in/sites/default/files/Final_%2011052022_Annexure-I%2C%20Genome_Edited_Plants_2022_Hyperlink.pdf

Disclaimer: The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Authors:

Mohit Porwal, Associate Partner

Krupa Vyas, Associate

Shubham Naphade, Intern