Intellectual property in engineering biology: a new paradigm

Introduction 

Engineering biology can be defined as the development of new biological systems assembled from standardized DNA parts, and the application of these systems to solve real-world problems [1]. Examples include microbes engineered with new metabolic capabilities allowing them to produce drugs or break down pollutants in the environment, plants engineered to make new foods and materials, and animal cells engineered as disease models or to produce vaccines. Governments worldwide are increasingly acknowledging the need to strengthen their support for Engineering Biology and Biomanufacturing. For example, the United States, United Kingdom, China, and India are rolling out comprehensive strategies to boost domestic biomanufacturing. These initiatives include targeted investments in research infrastructure, bioprocessing capabilities, workforce training, and streamlined regulatory frameworks with the goal to speed up commercialization and ensure critical bioproducts can be produced locally, reducing vulnerability to global supply chain disruptions. 

This growing emphasis on engineering biology reflects its role as a translational extension of the field of synthetic biology, which focuses on designing and fabricating DNA parts as foundational building blocks. Such engineered biological systems represent the cutting edge of biotechnology and therefore offer a compelling opportunity to consider how intellectual property (IP) law addresses new technological developments shaping innovation pathways in this rapidly growing field.  

Trends and tensions in engineering biology IP

One of the most striking IP trends in engineering biology is the contrast between the handling of components and tools. Although more than 5000 patents have been granted covering DNA sequences, there is a strong case for open innovation with respect to components that support engineering biology, including shared resources and distributed manufacturing [2]. Conversely, there is dense patenting around core tools and techniques, including broad foundational patents covering basic synthetic biology technologies such as gene synthesis. In this context, companies may hold overlapping patents on methods and platforms, while also protecting parts of their assembly processes as trade secrets. Nowhere is this more apparent than with respect to DNA editing technology [3]. For example, Sangamo Biosciences holds dozens of patents on zinc-finger proteins, which can be engineered to bind and manipulate almost any nucleotide sequence. There is also a vast CRISPR patent landscape comprising more than 11,000 patent families, notwithstanding the continuing priority disputes between the CVC group [4] and the MIT-Broad Institute in the USA and Europe [5].

This complex landscape creates friction, as foundational patents combined with patents on some basic components but also on many tools, create extensive “patent thickets” that can necessitate multiple licenses from different entities in order to ensure freedom to operate. Interestingly, European, Chinese and Japanese patent offices have upheld key CVC group patents whereas the contrary position has been adopted in the USA, resulting in differing cross-border licensing conditions [6]. The economic potential of engineering biology has also led to cases of IP theft, underlining how DNA sequences, process know-how, and arising products remain vulnerable to industrial espionage [7,8].

A new IP paradigm in engineering biology

The difficult and sometimes insurmountable IP hurdles facing innovators in engineering biology have the potential to be addressed through open or hybrid IP protection models covering the fundamental enabling technologies and major tools. Open models have already been developed for DNA sequences and other materials. For example, BioBricks are DNA sequences listed in the Registry of Standard Biological Parts, which provides open-access information on more than 20,000 such components [9]. The BioBrick Public Agreement treats these parts as open-source standards rather than conventional biotech IP [10]. OpenMTA extends this logic to physical samples: a standardized material transfer agreement allows the redistribution and commercial use of biological materials, reducing transaction costs and preserving attribution, safety and other institutional conditions [11]. In engineering biology, an open model is also the basis of the Open Bio Research Alliance, a distributed network that shares validated DNA parts and chassis under OpenMTA, links them to subsidized domestic DNA synthesis partners, and recovers costs from for-profit users [12].

If we consider instead a hybrid approach, patent pools and clearinghouses have been proposed as collaborative licensing models to address patent thickets in the life sciences, offering one-stop “package” licenses that reduce transaction costs and litigation risks, while preserving value appropriation [13]. Examples of this approach include the SARS genome patent pool, the Medicines Patent Pool, the Pool for Open Innovation against Neglected Tropical Diseases, and MPEG LA’s Librassay clearinghouse for molecular diagnostics [14]. In engineering biology, similar hybrid approaches could be introduced based on shared biofoundry platforms, as envisaged in the proposed Canadian national biofoundry network [2]. However, experience in genomics shows that no single IP model is likely to fit all engineering biology platforms. Genomics pools are difficult to assemble, depend on voluntary participation and antitrust constraints, and are only one option among many mechanisms for bundling patents and securing freedom to operate, demanding case-by-case analysis rather than a default template [15,16]. 

Other fast-moving technology sectors face similar IP challenges. In software, developers and providers have shifted over decades from relying mainly on trade secrets and copyright, to a more layered mix of IP protection including patents, open-source licenses and standards [16,17]. Large open-source projects such as the Linux ecosystem show that freely licensed code can successfully co-exist with proprietary products and services [17], supported by defensive patent pools like the Open Invention Network that share core patents [18]. Hardware and connectivity standards such as Wi-Fi and Bluetooth rely on standard-essential patents licensed on fair, reasonable and non-discriminatory terms, often via patent pools that cover thousands of necessary patents [19]. Together, these examples suggest that for fast-evolving, modular technologies, hybrid arrangements combining open standards, open-source components and collaborative licensing can keep pace with innovation more effectively than any single IP protection model [17].

More recently, the rapid expansion and integration of artificial intelligence (AI) has exposed similar IP protection and commercialization issues, but with an added twist. AI solutions blur the line between human and machine-generated outputs, challenging assumptions about authorship, ownership and the value of individual creations – as a result, in this context, open innovation requires new models for tracking and sharing value [20]. Companies already juggle complex configurations of patents, trade secrets and open or closed innovation models rather than relying on a single dominant strategy [21].

Recommendations to foster innovation and collaboration

New IP models for engineering biology should consider borrowing from software’s layered approach: open standards and shared defensive patent pools as the foundation, with proprietary models built on top. Looking again at the Linux ecosystem as an example, the Open Invention Network operates a defensive patent pool to protect open-source collaboration while still allowing innovators to commercialize their own products. Open patent pool strategies tend to increase rather than suppress innovation while creating value for the members contributing or sharing the IP [17]. Similar architectures combining open biological standards, OpenMTA-style material sharing and patent pools for fundamental enabling technologies and major tools such as those used for genome editing could lower transaction costs in engineering biology without abandoning the tenets of legacy IP [11].

Canada has a narrow window to embed these provisions into its broader innovation strategy. The federal government’s Intellectual Property Strategy launched in 2018 explicitly aims to help Canadian companies understand, protect and share IP, including via a pilot patent collective [22]. Furthermore, a 2023 Senate report, entitled Needed: An Innovation Strategy for the Data-Driven Economy, warns that current policies are not yet fully adapted to the intangible economy and that without coordinated reforms, Canada risks continued erosion of investment and living standards [23]. Furthermore, the Centre for International Governance Innovation argues that Canada still lacks a coherent vision for innovation and continues to lose IP and talent abroad, despite its strong research assets [24]. The Canadian Science Policy Centre’s recently launched National Conversation on Canada’s Innovation Strategy is now convening sectors to address these gaps [25]. Engineering biology should be treated as a priority, where Canada pilots open and pooled IP architectures that attract foreign investment, diversifies the economy, and promotes Canadian innovation in the life sciences.

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