1 Introduction

Synthetic biology is an interdisciplinary field that merges principles from molecular biology and engineering to design and construct new biological parts, devices, and systems. This field views living systems as programmable entities at the genetic level, enabling the creation of novel functionalities not found in nature (Agapakis, 2014; Freemont, 2019). The rapid advancements in synthetic biology have led to the development of platform technologies that facilitate the design, build, test, and learn (DBTL) cycle, which is crucial for constructing new biological systems (Young et al., 2020). The synthetic biology industry has seen significant growth, with start-up companies receiving substantial investments and the global market value projected to reach $14 billion by 2026 (Freemont, 2019). Applications of synthetic biology span various sectors, including biotechnology, medicine, environmental sciences, and materials science, highlighting its transformative potential (Lu et al., 2009; Tang et al., 2020).

Intellectual property (IP) plays a critical role in fostering innovation within the synthetic biology sector. The protection of IP rights ensures that inventors and companies can secure returns on their investments, thereby encouraging further research and development (Freemont, 2019). However, the synthetic biology industry faces unique challenges related to IP, such as balancing open technology sharing with the need for commercial success (Freemont, 2019). The establishment of robust IP frameworks is essential to navigate these challenges and promote sustainable growth in the field. Effective IP management can prevent monopolies and ensure that innovations are accessible, fostering a competitive and dynamic industry landscape (Agapakis, 2014; Freemont, 2019).

This study aims to explore the innovations in synthetic biology and the associated intellectual property issues. The objectives are to provide a comprehensive overview of the current state of synthetic biology, highlighting key technological advancements and their applications. Examine the role of IP in promoting innovation within the synthetic biology industry. Identify the challenges and opportunities related to IP management in synthetic biology. And propose strategies for achieving a balance between open technology sharing and commercial success.The scope of this study includes an analysis of recent literature on synthetic biology innovations, IP frameworks, and case studies of successful IP management in the field. By addressing these aspects, the study seeks to offer insights into the future balance and coordination of synthetic biology innovations and intellectual property.

2 Fundamentals of Synthetic Biology

2.1 Definition and key concepts in synthetic biology

Synthetic biology (SynBio) is an interdisciplinary field that merges principles from biology, engineering, and computational sciences to design and construct new biological parts, devices, and systems, or to redesign existing natural biological systems for useful purposes (O’Malley et al., 2008; Gupta et al., 2021). It involves the creation of genetic circuits, which are functional assemblies of DNA, RNA, and proteins, designed using iterative cycles of design, build, and test (Gupta et al., 2021). These circuits enable the reprogramming of biological pathways to achieve desired functions, making biology a true engineering discipline (Rai and Kumar, 2007). SynBio encompasses three broad approaches: DNA-based device construction, genome-driven cell engineering, and protocell creation, each with distinct aims, methods, and constructs (O’Malley et al., 2008).

2.2 Overview of major advancements and applications

The field of synthetic biology has seen significant advancements in various applications, including gene editing, bioengineering, and the production of pharmaceuticals and biofuels. One notable achievement is the engineering of yeast to produce artemisinic acid, a precursor to the antimalarial drug artemisinin, which can be adapted for the development of other biofuels, biomaterials, and drugs (König et al., 2015). The development of CRISPR/Cas9 technology has revolutionized gene editing, allowing precise modifications in crop improvement and other areas (Gupta et al., 2021). Additionally, synthetic biology has enabled the creation of living factories that produce drugs, biofuels, and fine chemicals, as well as living pills that can autonomously detect and treat diseases in vivo (Ausländer et al., 2017). The Registry of Standard Biological Parts at MIT supports the goal of creating modular gene parts that can be synthesized and assembled to produce various devices and systems (Rai and Kumar, 2007).

2.3 The interdisciplinary nature of synthetic biology and its potential impacts on various sectors

Synthetic biology is inherently interdisciplinary, combining expertise from cell biology, engineering, chemistry, and computational sciences to address complex biological problems (Church et al., 2014; Moses et al., 2017; Gupta et al., 2021). This interdisciplinary approach has the potential to revolutionize natural product discovery, industrial biotechnology, and environmental conservation. For instance, synthetic biology can be used to engineer unicellular organisms for the commercial production of high-value plant metabolites, meeting global demand in a sustainable manner (Moses et al., 2017). The field also holds promise for addressing real-world problems, such as developing green fuels, detecting environmental pollutants, and creating programmable cells for medical and computational applications (Rai and Kumar, 2007; Redford et al., 2014). The integration of synthetic biology with other disciplines not only enhances its applications but also raises important bioethical and regulatory considerations that need to be addressed to ensure responsible innovation (Church et al., 2014; Keeler and Foley, 2015).

3 Intellectual Property Landscape in Synthetic Biology

3.1 Current IP frameworks governing synthetic biology innovations

The current intellectual property (IP) frameworks governing synthetic biology are complex and multifaceted, reflecting the interdisciplinary nature of the field. Synthetic biology, which involves the design and assembly of biological parts, circuits, pathways, cells, and genomes, intersects with various existing fields such as biotechnology, genetic engineering, and systems biology (Oldham and Hall, 2018). The patent landscape for synthetic biology is evolving, with a significant number of patents being filed globally. For instance, a comprehensive study identified 7 424 first filings and 71 887 family members related to synthetic biology, highlighting the extensive patent activity in this area (Oldham and Hall, 2018). Additionally, the Synthetic Biology Open Language (SBOL) initiative aims to standardize data exchange and interoperability among researchers, although it faces challenges related to IP issues similar to those encountered in other high-tech fields (Contreras et al., 2015).

3.2 Types of IP protection relevant to synthetic biology

Several types of IP protection are relevant to synthetic biology, including patents, trade secrets, copyrights, and trademarks. Patents are particularly crucial as they provide exclusive rights to inventors for their novel and non-obvious inventions, thereby encouraging innovation and investment in the field (Knabel et al., 2015). Trade secrets protect confidential business information that provides a competitive edge, while copyrights can be used to protect software and databases used in synthetic biology research (Spinello, 2019). Trademarks, although less common in synthetic biology, can protect brand names and logos associated with synthetic biology products and services (Spinello, 2019). The importance of IP protection in synthetic biology is underscored by the need to secure investment and facilitate commercialization of new technologies (Knabel et al., 2015).

3.3 Challenges in applying traditional IP laws to synthetic biology inventions

Applying traditional IP laws to synthetic biology presents several challenges. One major issue is the ambiguity and overlap of IP rights, which can create an "anti-commons" problem where excessive fragmentation of IP rights hinders innovation (Wellhausen and Oye, 2007). Additionally, recent legal rulings and legislative changes have introduced obstacles for obtaining patent protection for synthetic biology inventions, causing hesitation among investors and delaying the formation of start-up companies (Knabel et al., 2015). The interdisciplinary nature of synthetic biology further complicates the IP landscape, as it involves contributions from multiple scientific fields, making it difficult to apply traditional patent classification systems effectively (Oldham and Hall, 2018). Moreover, the rapid pace of innovation in synthetic biology often outstrips the ability of existing IP frameworks to adapt, necessitating ongoing dialogue and policy adjustments to balance the interests of inventors, investors, and the public (Minssen et al., 2015; Zimmeren et al., 2016).

4 Patenting Synthetic Biology Inventions

4.1 Criteria for patenting in synthetic biology

The criteria for patenting synthetic biology inventions are consistent with those applied to other technological fields, focusing on novelty, non-obviousness, and utility. According to the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), patents must be available for any inventions, provided they are new, involve an inventive step, and are capable of industrial application (Rutz, 2009). This non-discriminatory approach ensures that synthetic biology inventions are evaluated under the same standards as other technologies, providing legal certainty to applicants and third parties (Rutz, 2009).

4.2 Key cases and precedents in synthetic biology patent law

Several key cases have shaped the landscape of synthetic biology patent law. The Myriad decision, for instance, has had a significant impact on the patentability of genetic material. This case highlighted the challenges of patenting naturally occurring DNA sequences versus synthetic sequences, which are more likely to meet patentability criteria (Rimmer and McLennan, 2012). Additionally, the Bilski v. Kappos case has influenced the patent eligibility of biotechnological inventions, emphasizing the need for a clear inventive step and industrial application (Rimmer and McLennan, 2012).

4.3 Ethical and legal controversies surrounding patenting living organisms and genetic material

The patenting of living organisms and genetic material in synthetic biology raises several ethical and legal controversies. One major issue is the balance between intellectual property rights and access to essential medicines and technologies. The contrasting approaches of Craig Venter's chassis school and the BioBricks school illustrate the tension between proprietary and open-access models in synthetic biology (Belt, 2013). The ethical implications of patenting life forms are profound, as they touch on global health, justice, and the equitable distribution of biotechnological advancements (Belt, 2013).

Moreover, the debate extends to the moral clause in patent law, which questions the appropriateness of granting patents for inventions that may contravene public order or morality (Schneider, 2012). This clause is particularly relevant in the context of synthetic biology, where the creation of new life forms and genetic modifications can provoke significant ethical concerns (Schneider, 2012). The need for a balanced approach that considers both the promotion of innovation and the protection of public interests is crucial in navigating these controversies (Torrance, 2010; Minssen et al., 2015).

5 Balancing Innovation and Access

5.1 Tensions between protecting IP and ensuring access to synthetic biology technologies

The field of synthetic biology (SynBio) is characterized by its potential to revolutionize various industries through the application of engineering principles to biological systems. However, this potential is often tempered by the complex interplay between intellectual property (IP) protection and the need for open access to foster innovation. The creation of synthetic pathways, such as those for producing artemisinic acid, highlights the importance of IP in securing commercial viability while also posing challenges for widespread access (König et al., 2015). The “anti-commons” problem, where overlapping IP claims hinder innovation, is a significant concern in SynBio, as it can deter researchers from pursuing new projects due to legal uncertainties (Wellhausen and Oye, 2007). This tension is further exacerbated by the differing approaches to IP, such as the proprietary stance of Craig Venter's chassis school versus the open-source ethos of the BioBricks school, which underscores the broader debate between IP protection and access to knowledge (Belt, 2013).

5.2 Impact of IP on innovation ecosystems in synthetic biology

IP rights play a crucial role in shaping the innovation ecosystems within SynBio. On one hand, strong IP protection can incentivize investment and development by ensuring that innovators can reap the benefits of their inventions. This is particularly evident in the structured approach of synthetic biology start-ups, which often employ a mix of in-bound and outbound IP strategies to balance protection and collaboration (Tang et al., 2019). On the other hand, the restrictive nature of IP can stifle innovation by limiting the free exchange of ideas and technologies. The patent landscape for synthetic biology, especially in the context of fine chemical production, reveals that while IP can drive innovation, it can also create barriers that hinder the iterative design/build/test/learn cycles essential for progress (Carbonell et al., 2016). Moreover, the broader economic and philosophical implications of IP in biotechnology suggest that while IP can promote growth, its impact on innovation is nuanced and varies across different contexts (Neves et al., 2021).

5.3 Potential models for balancing proprietary rights with open access and collaboration

To address the challenges posed by IP in SynBio, several models have been proposed to balance proprietary rights with the need for open access and collaboration. One such model is the concept of Responsible Research and Innovation (RRI), which integrates ethical considerations into the IP framework, ensuring that innovations are not only patentable but also socially responsible (König et al., 2015). Another approach is the adoption of open IP strategies, such as permissive licensing, which allows for broader use of IP while still providing some level of protection for the original innovators (Tang et al., 2019). The establishment of registries, like the MIT Registry of Standard Biological Parts, also exemplifies how standardization and modularity can facilitate collaboration while maintaining a degree of IP control (Rai and Kumar, 2007). Additionally, the co-evolution of patent law and technology, as seen in the contrasting approaches within the SynBio community, highlights the need for flexible and adaptive IP frameworks that can accommodate both proprietary and open-access models (Belt, 2013). These strategies collectively aim to create an environment where innovation can thrive without being unduly hampered by IP constraints.

6 Global Perspectives on IP and Synthetic Biology

6.1 Comparison of IP laws and practices across different countries and regions

Intellectual property (IP) laws and practices vary significantly across different countries and regions, impacting the development and commercialization of synthetic biology innovations. For instance, the European Union has been proactive in organizing expert meetings to address IP concerns in synthetic biology, as seen in the initiatives by the Danish Agency for Science, Technology and Innovation (Figure 1) (Minssen et al., 2015; Zimmeren et al., 2016). These meetings highlight the importance of harmonizing IP laws to facilitate cross-border collaborations and innovation. In contrast, the United States has a more established framework for biotechnology patents, which can sometimes lead to patent disputes, as seen in other high-tech sectors like telecommunications and semiconductors (Contreras et al., 2015). The differences in IP frameworks can create challenges for synthetic biologists who operate in a global context, necessitating a nuanced understanding of regional IP laws to navigate potential legal hurdles effectively.

Figure 1 Belval, Luxembourg: site of the ERASysAPP workshops “Networking industry-academia” and “Networking of research centres” (Adopted from Zimmeren et al., 2016)

6.2 International agreements and their influence on synthetic biology IP

International agreements such as the Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the Convention on Biological Diversity (CBD) play a crucial role in shaping the IP landscape for synthetic biology. TRIPS aims to standardize IP laws across member countries, thereby reducing barriers to international trade and fostering innovation. However, the implementation of TRIPS can vary, leading to disparities in IP protection and enforcement (Belt H., 2013; Belt H., 2014). The CBD, on the other hand, emphasizes the fair and equitable sharing of benefits arising from the use of genetic resources, which can influence IP policies related to synthetic biology. These international frameworks are essential for balancing the interests of innovators with those of the global community, ensuring that synthetic biology advancements contribute to global health and justice (Belt H., 2013; Belt H., 2014).

6.3 Cross-border collaborations and the harmonization of IP standards

Cross-border collaborations are vital for the advancement of synthetic biology, but they also necessitate the harmonization of IP standards to ensure smooth cooperation. The European Research Area Network in Synthetic Biology (ERASynBio) has been instrumental in fostering such collaborations by organizing expert meetings and providing recommendations for IP management (Minssen et al., 2015; Zimmeren et al., 2016). These efforts aim to create a more cohesive IP framework that can support international research and commercialization efforts. Additionally, the development of interoperability standards, such as the Synthetic Biology Open Language (SBOL), highlights the need for clear IP policies to avoid patent disputes and facilitate data exchange (Contreras et al., 2015). Harmonizing IP standards across borders can mitigate the “anti-commons” problem, where ambiguous IP claims hinder innovation and collaboration (Wellhausen and Oye, 2007; Oye and Wellhausen, 2009). By aligning IP practices, countries can better support the global synthetic biology community and drive forward technological advancements.

7 Case Study: CRISPR-Cas9 Patent Dispute

7.1 Background on CRISPR-Cas9 technology and its significance in synthetic biology

CRISPR-Cas9 is a revolutionary gene-editing technology that allows for precise, directed changes to genomic DNA. It has transformed synthetic biology by enabling researchers to edit genes with unprecedented accuracy and efficiency. The technology is based on a natural defense mechanism found in bacteria, which uses RNA molecules to guide the Cas9 enzyme to specific DNA sequences, where it makes precise cuts. This capability has vast applications, including gene therapy, agriculture, and the development of new biotechnological products.

7.2 Overview of the patent dispute between key institutions

The CRISPR-Cas9 patent dispute primarily involves two major research institutions: the University of California, Berkeley (UC Berkeley) and the Broad Institute of MIT and Harvard. The conflict began when both institutions filed patent applications for CRISPR-Cas9 technology. UC Berkeley, led by Jennifer Doudna and Emmanuelle Charpentier, filed their application in May 2012. However, Feng Zhang from the Broad Institute filed a competing application seven months later and requested expedited review, resulting in the Broad Institute receiving the first patent in April 2014 (Sherkow, 2016; Sherkow, 2017).

The dispute escalated when UC Berkeley requested a patent interference proceeding to determine the rightful owner of the CRISPR-Cas9 patents. The US Patent Trial and Appeal Board (PTAB) ruled in favor of the Broad Institute, stating that Zhang’s work constituted a “nonobvious” advance over Doudna and Charpentier's earlier work (Sherkow, 2017; Sherkow, 2018). This decision was upheld by the Court of Appeals for the Federal Circuit, effectively granting the Broad Institute control over the use of CRISPR-Cas9 in eukaryotic cells (Cohen, 2017; Francisco, 2018).

7.3 Implications of the dispute for future IP policies in synthetic biology

The CRISPR-Cas9 patent dispute has significant implications for future intellectual property (IP) policies in synthetic biology. The case highlights the complexities and challenges of patenting foundational technologies that have broad applications. One major implication is the potential for increased litigation and prolonged legal battles over IP rights, which could stifle innovation and collaboration in the field (Sherkow, 2016; Ratner, 2018).

Moreover, the dispute underscores the need for clearer guidelines and policies regarding the patenting of biotechnological inventions. The differing decisions by the US and European patent offices on the same technology illustrate the inconsistencies in patent law and the importance of harmonizing IP regulations globally (Sherkow, 2017; Cross, 2018). Additionally, the case has prompted discussions about the ethical and practical considerations of commercializing scientific discoveries, emphasizing the need for a balance between protecting IP and fostering open scientific research (Sherkow, 2016; Cohen, 2017).

8 Future Trends and Challenges in Synthetic Biology IP

8.1 Emerging technologies and their potential IP implications

The rapid advancements in synthetic biology are being driven by emerging technologies such as AI-driven bioengineering and synthetic genomes. AI-driven bioengineering leverages machine learning algorithms to predict and design biological systems, which can significantly enhance the efficiency and precision of synthetic biology projects. This integration of AI with synthetic biology is expected to generate vast amounts of data, necessitating robust IP frameworks to manage and protect these innovations (Gilliot and Gorochowski, 2020; Gallup et al., 2021). The creation of synthetic genomes, which involves the design and assembly of entirely new genetic sequences, also presents unique IP challenges. As these technologies evolve, there will be a need to balance the protection of intellectual property with the promotion of open science and collaboration (Karoui et al., 2019; Zhao, 2020).

8.2 The role of digital sequence information and its IP challenges

Digital sequence information (DSI) refers to the digital representation of genetic sequences, which can be easily shared and accessed globally. While DSI facilitates research and innovation by providing a wealth of genetic information, it also poses significant IP challenges. The ease of access and distribution of DSI can complicate the enforcement of IP rights, as traditional IP frameworks may not be well-suited to address the nuances of digital data (Serrano, 2007; Carbonell et al., 2016). Additionally, the use of DSI in synthetic biology raises questions about ownership and benefit-sharing, particularly when genetic information from diverse biological sources is utilized. Developing new IP policies that address these challenges while fostering innovation and equitable access will be crucial (Stemerding et al., 2019; Hamilton et al., 2021).

8.3 Anticipating future disputes and areas of legal uncertainty

As synthetic biology continues to advance, several areas of legal uncertainty and potential disputes are anticipated. One major area of concern is the dual-use nature of synthetic biology technologies, which can be used for both beneficial and harmful purposes. This dual-use potential necessitates stringent biosecurity measures and clear legal frameworks to prevent misuse while encouraging positive applications (Figure 2) (Brooks and Alper, 2021; Hamilton et al., 2021). Another area of potential dispute is the patentability of synthetic biology inventions, particularly those involving naturally occurring genetic sequences or minimal modifications thereof. The legal landscape surrounding the patentability of such inventions is still evolving, and future disputes are likely as stakeholders navigate these complexities (Serrano, 2007; Carbonell et al., 2016). Additionally, the global nature of synthetic biology research and the varying IP laws across different jurisdictions can lead to conflicts and inconsistencies in IP protection and enforcement. Harmonizing international IP policies and fostering collaboration among countries will be essential to address these challenges (Karoui et al., 2019; Stemerding et al., 2019).

Figure 2 Design strategies for outside-the-lab deployment of synthetic biology systems (Adopted from Brooks and Alper, 2021)

9 Strategies for Coordinating IP and Innovation

9.1 Best practices for navigating the IP landscape in synthetic biology

Navigating the intellectual property (IP) landscape in synthetic biology requires a comprehensive understanding of existing patents and potential areas for innovation. One effective strategy is to conduct large-scale computational studies to map the patent landscape, as demonstrated by the use of the PatSeq database and the Derwent Innovations Index to screen sequences in heterologous pathways (Carbonell et al., 2016). This approach helps identify novel pathways and assess their patentability, ensuring that new innovations do not infringe on existing patents.

Additionally, the development of a “patentability index” (PI) that includes parameters such as novelty, inventive step, and industrial application can provide a quantitative measure of an invention's potential for patenting. Incorporating a “responsibility” parameter ensures that ethical considerations are also taken into account, promoting responsible innovation (König et al., 2015).

9.2 Collaborative IP strategies

Collaborative IP strategies, such as patent pools and public-private partnerships, can significantly enhance innovation in synthetic biology. Patent pools allow multiple stakeholders to share their patents, reducing litigation risks and fostering a collaborative environment. This approach has been successfully implemented in other industries and can be adapted to synthetic biology to facilitate data exchange and interoperability (Contreras et al., 2015).

Public-private partnerships, particularly those involving universities and industry, can also play a crucial role. Trust formation between university and industry partners is essential for successful collaborations. Flexible and transparent university IP policies, along with shared governance, can enhance trust and improve collaboration outcomes (Taylor et al., 2023). The involvement of collaboration champions can further amplify these positive effects, ensuring that both parties are actively engaged in the project (Taylor et al., 2023).

9.3 Policy recommendations for promoting innovation while safeguarding public interest

To promote innovation in synthetic biology while safeguarding public interest, several policy recommendations can be made. First, policies should encourage open IP strategies, such as permissive licensing, which can make IP freely available for others to use. This approach has been shown to promote innovation and protect economic returns for firms (Tang et al., 2019).

Second, the concept of Responsible Research and Innovation (RRI) should be integrated into policy frameworks. RRI emphasizes the importance of considering societal objectives and ethical implications in the innovation process. Collaborative and interactive processes, such as real-time technology assessments and stakeholder workshops, can help align technological advancements with societal needs (Stemerding et al., 2019).

Finally, policies should address the global justice implications of synthetic biology. The co-evolution of patent law and technology must be considered, ensuring that patents do not hinder access to essential medicines or create imbalances in innovation. New institutional systems and practices should be designed to meet the demands of global justice, promoting equitable access to the benefits of synthetic biology (Belt, 2013).

10 Concluding Remarks

The intersection of synthetic biology and intellectual property (IP) rights presents a complex landscape filled with both opportunities and challenges. Key insights from the review highlight the importance of balancing innovation with IP protection to foster sustainable growth in the field. Several papers emphasize the need for clear and coherent IP frameworks to avoid the “anti-commons” problem, where overly restrictive IP rights can stifle innovation. The role of standards and data exchange is also crucial, as highlighted by the need for interoperability frameworks that consider IP issues from the outset. Additionally, the concept of responsible research and innovation (RRI) is gaining traction, advocating for the inclusion of societal and ethical considerations in the development of synthetic biology technologies.

Looking forward, achieving a balance between synthetic biology innovations and IP protection will require a multifaceted approach. The future landscape will likely involve a combination of open-source models and traditional IP protection to encourage both collaboration and commercialization. The development of common languages and frameworks for IP, as well as the introduction of new metrics like the "patentability index," can help navigate the complexities of IP in synthetic biology. Moreover, lessons from other high-tech sectors, such as telecommunications and semiconductors, can provide valuable insights into managing IP issues in synthetic biology. Policymakers and stakeholders must work together to create an environment that supports innovation while ensuring that IP rights do not become a barrier to progress.

For Researchers, engage in interdisciplinary collaborations to develop robust IP strategies that consider both scientific and legal perspectives. Participate in the creation and adoption of standards that facilitate data exchange and interoperability while addressing IP concerns. And incorporate RRI principles into research projects to ensure that societal and ethical implications are considered alongside technical advancements. For Policymakers, develop clear and coherent IP policies that balance the need for protection with the promotion of innovation. Foster international cooperation to harmonize IP regulations and standards, reducing barriers to global collaboration and commercialization. Support initiatives that encourage open-source models and the sharing of knowledge and resources within the synthetic biology community. For Industry Stakeholders, invest in IP education and training for scientists and engineers to enhance their understanding of IP issues and strategies. Collaborate with academic and public institutions to develop IP frameworks that support both innovation and commercialization. Advocate for policies that promote responsible innovation and consider the long-term societal impacts of synthetic biology technologies.

Acknowledgments

We sincerely appreciate the valuable opinions and suggestions provided by the two anonymous reviewers, whose meticulous review helped us improve the quality of this article.

Conflict of Interest Disclosure

The author affirms that this research was conducted without any commercial or financial relationships that could be construed as a potential conflict of interest.

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