1.Introduction
The rapid improvement in genome editing technology has paved the way for innovative and disruptive developments in many industry sectors, such as healthcare, agriculture, and clean energy, offering great potential to address global challenges and contribute to achieving the Sustainable Development Goals (SDGs). Among others, the so-called CRISPR-Cas9 technology, leading the way in genetic resource development, is an effective tool that allows precise modifications to the genetic material of living organisms. This technology has tremendous potential to achieve sustainability, by improving progress towards SDG 2 – Zero Hunger, SDG 3 – Good Health and Well-Being, and SDG 7 – Affordable and Clean Energy.
It is widely known that complex legal issues, particularly patent disputes, have an impact on research and development (R&D), commercialisation, and the accessibility of innovations invented using CRISPR-Cas9. Open innovation and intellectual property management can be crucial in driving innovation, facilitating the development and adoption of CRISPR-Cas9 technology, by fostering collaboration, knowledge sharing, and technology transfer among stakeholders, while intellectual property management promotes the protection, licensing, and strategic utilisation of assets.
This Insight explores the potential of CRISPR-Cas9 as a game-changer in tackling global challenges, while inquiring about the role of patent management and open innovation in promoting collaboration with genome editing technologies to achieve the SDGs. The widespread utilisation of CRISPR-Cas9 through open innovation methods and patent agreements could be a solution to address global challenges while supporting inventors’ interests in recouping investments, providing a balance to the present intellectual property rights framework.
2. The Revolutionary Potential of Genome Editing Technologies
The CRISPR-Cas9, an acronym for Clustered Regularly Interspaced Short Palindromic Repeats, is a genome editing tool that allows scientists to make precise modifications to DNA sequences. The origins of CRISPR-Cas9 are rooted in bacterial defence mechanisms that utilise this system to prevent invading viruses by splitting their DNA. The potential of this bacterial system was discovered by Jennifer Doudna and Emmanuelle Charpentier, who demonstrated its use as a gene editing tool. Their research marked a paradigm shift in the scientific community, enabling various applications, from treating genetic disorders to creating disease-resistant crops. Today, CRISPR-Cas9 technology is at the forefront of gene engineering, accelerating research in genomics and molecular biology worldwide, with the potential to help achieve the SDGs.
Regarding SDG 2 (zero hunger), in the field of agriculture CRISPR-Cas9 technology offers opportunities to enhance food security by improving crop traits such as yield, disease resistance, climate change resilience, and nutritional content. This can help increase agricultural productivity, reduce crop losses, and ensure a stable and nutritious food supply. For instance, using CRISPR-Cas9, researchers have successfully edited the genes of crops like rice (golden rice), wheat, and maize to enhance their nutritional value and increase their resistance to pests and diseases. These innovations can be shared and adopted by farmers worldwide, fostering sustainable agriculture and improving food security.
Regarding SDG 3 (good health and wellbeing), in the field of healthcare CRISPR-Cas9 can potentially treat genetic disorders and develop personalised medicine, offering new therapeutic avenues and improving the efficacy of treatments by targeting specific genes responsible for diseases. In addition, CRISPR-Cas9 can be used for disease diagnostics, enabling early detection and intervention. This can contribute to the prevention and management of diseases, ultimately improving global health outcomes and supporting the objectives of SDG 3. The key players include biotech companies [ 1] which are closely associated with the primary patent holders. These companies have been instrumental in advancing CRISPR-Cas9 from research labs into clinical trials.
Lastly, regarding SDG 7 (affordable and clean energy), in the clean energy sector the use of CRISPR-Cas9 in bioenergy can promote clean and sustainable energy sources. Researchers can enhance the efficiency and productivity of biofuel production processes, making them more economically viable and environmentally friendly. These advancements can be disseminated through open innovation methods, facilitating the adoption of cleaner energy sources, and contributing to SDG 7. CRISPR-Cas9 technology is being used, for instance, to engineer microorganisms to produce biofuels and biochemicals.
3. An Overview of the Applicable Patent Law Landscape
The patent landscape surrounding CRISPR-Cas9 is complex. Several institutions have filed patent applications [ 2] since its invention as a gene-editing tool. This has led to numerous patent disputes worldwide. The patent disputes cover different aspects of CRISPR-Cas9 technology, including its components, methods of use, and applications across different organisms and tissues. The most relevant patent dispute involved the Broad Institute in the United States, associated with the Massachusetts Institute of Technology (MIT) and Harvard University, which holds significant patents covering the use of CRISPR-Cas9 in eukaryotic cells, including human cells. The counterparty of the dispute was the University of California, Berkeley (UC Berkeley) and its collaborators, the University of Vienna and Emmanuelle Charpentier, who have claimed ownership of the CRISPR-Cas9 system, including its applications in all cell types. These claims led to a patent litigation saga involving patent offices in the United States, Europe, and other countries, which resulted in several different rulings and decisions.
Amidst the race for innovation in the field of genetic editing, the battle for ownership of critical patents has put institutions into a complex IP maze, slowing the progress of this transformative technology with great potential to solve global issues, which cannot be widely used during patent disputes since innovators feel threatened by IP litigation. Therefore, the legal challenges surrounding patent ownership of CRISPR-Cas9 have significant implications for the research, commercialisation, and market accessibility of this technology. Patent disputes can result in uncertainty and delays in research [ 1] efforts while institutions try to understand patent licensing and the restrictions imposed by conflicting interests.
For the widespread adoption of gene editing inventions, it is crucial to devise a method that simplifies the legal procedures required by patent law without totally excluding it. This includes obtaining all necessary licences and performing due diligence on patent rights to establish who can use CRISPR-Cas9 and under what conditions. The more people and institutions worldwide can use this technology, regardless of their resources or location, the more democratisation will be achieved, ensuring equitable access to its benefits. Once patent rights become more transparent and easier to understand and apply, this will foster greater collaboration among researchers and institutions. When it is clear who holds the rights to use a certain technology to develop new inventions and solutions, it is easier to establish partnerships and achieve progress, lowering production costs and providing equitable access. Patent pools and guidelines for licensing and technology transfer facilitate the sharing of rights and the dissemination of innovation. These initiatives can help to ensure that the benefits of CRISPR-Cas9 are accessible to a broader range of people and institutions around the globe. Researchers, businesses, institutions, governments, and other stakeholders have been trying for years (not quite finding perfect solutions) to find initiatives aiming to balance two essential needs: protecting the intellectual property rights of those who develop innovations and ensuring broader access so that their potential benefits can be realised by society at large. Open innovation, together with patent agreements, could contribute to the overall goal of promoting the broadest possible impact of patented CRISPR-Cas9 technology, once open innovation premises are focused on collaboration, access, and the
sharing of technology and knowledge to address problems and benefit more people around the world.
4. Open Innovation as a Possible Promoter of Patented Technology for Sustainability
Open innovation [ 1] is a modern paradigm based on the idea that businesses can and should use external and internal innovative inventions and know-how to advance technological progress and create economic and social value. This approach could be used as a potential model to address some of the challenges surrounding the R&D, commercialisation, and use of advanced technologies like CRISPR-Cas9. The open innovation model encourages the sharing of knowledge [ 2] and technology across traditional businesses and national boundaries. Unlike the “closed” innovation model, where R&D is heavily protected, open innovation allows for a reciprocal flow of knowledge and inventions. It can occur in different forms, such as alliances, partnerships, crowdsourcing, and open-source projects[G3] . This model thrives on collaboration, allowing entities to exploit the collective power of diverse perspectives and expertise, accelerating innovation.
Open innovation promotes knowledge and technology sharing, a principle enshrined in various international and national legal frameworks on intellectual property rights. These include the TRIPS Agreement, which encourages licensing and technology transfers, and protocols, such as the Nagoya Protocol on Access to Genetic Resources, which promotes the equitable sharing of benefits arising from the utilisation of genetic resources like CRISPR-Cas9, thereby fostering a global environment conducive to inclusive innovation.
Article 7 of the TRIPS Agreement (Trade-Related Aspects of Intellectual Property Rights) states that intellectual property rights should promote technological innovation and benefit both inventors and users, while maintaining a balance of rights and obligations. Article 8 of the same treaty allows its member states to adopt the measures necessary to protect public health and promote the public interest in sectors of vital importance to their socio-economic and technological development. These articles articulate with Article 66, which calls for developed country members to provide incentives to institutions to promote and encourage technology transfer to least-developed country members, thus enabling them to create a sound and viable technological base, and which reinforces the need to encourage agreements to promote technology transfers and ensure broader and equitable access to patented technologies. Similarly, the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits (ABS) is an international agreement operating within the Convention on Biological Diversity, which through its various articles seeks to ensure that benefits arising from the utilisation of genetic resources are shared fairly and equitably. Its Article 5 mandates that benefits arising from the utilisation of genetic resources and any subsequent applications and commercialisation be shared fairly and equitably with the provider or owner of such resources. Article 19 encourages the development of model contractual clauses for benefit-sharing and material transfer. Article 24 emphasises the importance of global participation in implementing the Protocol and encourages cooperation with non-parties. All tools and mechanisms, including the ABS Clearing House, aim to facilitate the implementation of these measures ensuring equitable access to CRISPR-Cas9 technology in low- and middle-income countries by establishing technology transfer programmes, capacity-building initiatives, and affordable licensing options that can help promote inclusivity in the global adoption of CRISPR-Cas9[G1] .
In addition, the World Intellectual Property Organisation (WIPO) plays a significant role[G2] in facilitating technology transfer by providing assistance and resources to support the negotiation and implementation of licensing agreements, particularly in biotechnology. It promotes best practices and guidelines for intellectual property management and technology transfer, fostering a conducive environment for open innovation.
The abovementioned legal agreements and the WIPO aim to foster fair sharing of benefits and technology transfer aligned with the open innovation purpose. They help create an environment conducive to collaboration, sharing, and openness[SSPC3] . By understanding and leveraging these legal frameworks, we can effectively promote the open innovation of patented technology while also ensuring compliance with international law and incentivising innovation. However, additional institutional, national, and international efforts are still needed to fully achieve their benefits.
5. Conclusion: Moving towards a Sustainable Development Future
The powerful potential of gene-editing technologies like CRISPR-Cas9 calls for a balanced approach between protecting the intellectual property rights of inventors and encouraging open innovation for widespread dissemination and access to these vital inventions. This delicate equilibrium is essential to promote worldwide cooperation in key areas such as health, food, and clean energy. Establishing a global patent pool or an open-source platform for disruptive technologies like CRISPR-Cas9 could transform access by making it more equitable, lessen patent disputes, and speed up innovation towards sustainable development. We need urgent solutions to address global challenges and such a structure would be critical in stimulating innovation, decreasing patent conflict, and endorsing the fair use of transformative technologies. Therefore, could open innovation methods and IP management be the answer to creating an effective global structure that defends intellectual property rights and propels international collaboration? Further inquiry into this question could be pivotal to shaping our sustainable future.
