The latest in the series “Elgar Intellectual Property Law and Practice,” the title primarily focuses on issues related to U.S. intellectual property law. It also contains a handful of chapters discussing non-U.S. and international legal frameworks. As the editors state in the preface, it is a sequel to Bioinformatics Laws: Legal Issues for Computational Biology in the Post-Genome Era (American Bar Association Publishing, 2013), the “first book-length treatment of the law of bioinformatics.” Reviewed in the Biotechnology Law Report, the earlier edition was lauded: “For the legal professional seeking a summary of the variety of legal issues that surround the application of genomic data and research, Bioinformatics Law is an excellent primer: practical, reasonably current, and with interesting expositions on relevant decisions over the past 20 years or so.”
Given the rapid advances in biotechnology, bioinformatics, and medical informatics, with emphasis on the domestic context and practical implications, the sequel is a welcome research tool, helpful for understanding and exploring recent issues and trends in patent law. Divided into five sections and fourteen chapters, most of which are updates of the earlier edition, the book is well organized and written in simple, concise language, peppered with interesting studies of recent cases. It is an educational and engaging read for both the scientist and non-scientist legal practioner and researcher.
Part I provides an overview of patent law relevant to bioinformatics. Chapter 1 is a systematic exposition of the role of bioinformatics and medical informatics in the discipline of biotechnology for the non-scientist reader. Chapter 2, an addition to the second edition, introduces the conceptual framework of “Medical Information Commons” and the legal and ethical considerations for stakeholders who share the collaborative-networked data resources for research and clinical uses. The concept was adopted by the Human Genome Project (HGP) through the Bermuda Principles, which mandate the daily release of HGP-funded DNA sequences by members into the public domain. These platforms, described in the chapter as “a congeries of semi-autonomous but deeply interconnected resources that constitute a federation of databases, as well as institutions that use and manage them,” facilitate open-science efforts and broad data sharing in genomic biomedical research. Specific issues relating to privacy and consent, particularly in how they impact marginalized and racialized populations, are explored, as are possible solutions for streamlining policies and providing guardrails for the sustainable sharing of biodata.
The three chapters in Part II delve into legal specifics. Chapter 3 focuses on legal issues arising from commercial and customized software, which have transitioned from a traditional on-premise licensing model, largely governed by copyright laws, to cloud-based service models, where developers offer access-related services, which are subject to contract law. Chapter 4 discusses open-source software (OSS). OSS is software with license terms that permit royalty-free access, modification, and distribution. The chapter also includes an interesting discussion of the role played by OSS in genomic data sharing, and how localized customization of the data is used on global platforms to track pathogen evolution in the current COVID pandemic, and for mobilizing public health responses on national, regional, and global scales. Chapter 5 is a rather technical chapter on the commercial development of software for informatics applications.
Part III focuses on significant developments in patent and innovation law with regard to informatics applications. Chapter 6 systematically outlines the patent application, post-grant, and review processes specific to bioinformatics software since 2013. The chapter also includes a chronological list of judicial decisions instrumental to fleshing out the interpretation of current patent eligibility standards under 35 U.S.C. § 101, subsequent to the landmark Supreme Court decision Alice Corp. v. CLS Bank Int'l in 2014. Chapter 7 explains the changes in the U.S. Patents and Trademarks Office, particularly in relation to its patent examination practice.
The chapters in Part IV discuss the institutional stakeholders and current collaborative arrangements among academia, private sectors, and the federal government, as well as the history of these alliances. Chapter 8 centers on licensing issues relating to technology development and technology transfer specific to research conducted by academic institutions and their public-private partnerships, using the development of CRISPR-related technologies as an example for understanding the complications of effects of commercialization on the publication and release of scientific data. The discussions trace the origins of these collaborations under the Bayh-Dole Act of 1980, which permitted scientists, universities, and businesses to patent and profit from discoveries made through federally funded research. It outlines a range of issues that universities should consider when licensing their technology to the private sector—from reservations of rights and limitations on exclusivity, to more equitable and affordable access to medical technologies. Chapter 9 introduces technical standards and how organizations streamline and oversee compliance with these standards. The standards range from genome annotation and taxonomy, to data formats and search engine integration.
The five chapters in Part V focus on data protection and privacy issues, with useful comparative studies between U.S. and EU legal frameworks. Chapter 10 delineates the different forms of legal protection of bioinformatics data and databases in the United States. Existing U.S. intellectual property laws lack an overarching framework providing standardized protection to database information existing in the European model. Instead, laws of copyright, patent, trade secrets, and contracts work together to define the legal rights of stakeholders and provide overall protection to the data and usage of the bioinformatics databases. Chapter 11 starts with an overview of the global genomic data landscape and traces the historical development of data release policies when the Human Genome Project began in 1996. The chapter explains how the complicated web of U.S. federal agencies collaborates internally and externally with regard to policy-making and implementation to facilitate the timely sharing of genomic data and provide regulatory oversight to these public-private partnerships. Chapter 12 focuses on the U.S. legislative and regulatory frameworks regarding the protection of patient privacy and data security. It explains how legislative and regulatory safeguards under the Health Insurance Portability and Accountability Act (HIPPA), the Health Information Technology for Economic and Clinical Health Act (HITECH), and the Genetic Information Non-Discrimination Act (GINA), complement agency rulings and guidance with U.S. state laws to formulate this patchwork system of legal protection for patient data. The chapter also discusses how this domestic legal framework works in managing cyber risks and threats, as it segues into a comparative study with the EU model, the focus of Chapter 13.
Chapter 13 explores the General Data Protection Regulation (GDPR) and related laws. It begins by explaining its territorial scope, followed by an article-by-article discussion of salient provisions on protected personal and health data under the GDPR and pertinent issues of their interpretation, implementation, and compliance. The chapter systematically analyzes issues ranging from general disclosure and reporting and transparency requirements, to the more nuanced topics of specific practical applications, such as data sharing agreements with third parties, cross-border data transfers, and data protection impact assessments. Chapter 14, the last chapter, provides an in-depth analysis of the need for, and the risks of, digital health surveillance, exemplified by those issues brought about by the COVID-19 pandemic. It discusses the use of informatics applications, data for public health modeling, and their legal and privacy implications.
Of the fourteen chapters in the 2022 edition, twelve chapters are of similar thematic foci, often revisions of chapters of the earlier iteration. The two chapters with brand new themes are Chapter 2 on Medical Information Commons and Chapter 13 on the EU model of data protection in the context of bioinformatics. Both new chapters contain timely and not overtly technical discussions. There is an extended Table of Contents and a detailed Table of Cases, Legislation, and Regulations, which help track both the historical and relatively recent legal developments. They would be useful for the scientist and non-scientist legal researcher, as well as law students with a science background seeking a succinct overview of bioinformatics and its related legal frameworks in intellectual property, for the purposes of public health policy research, professional career development, and continuing education. In a practice area such as patent law and scientific innovations, where the legal landscape is interdisciplinary and changing fast, this expert-curated scholarly compilation that explains technical minutiae in language relatable and comprehensible to the non-specialist offers a time-saving pathfinder and an effective learning tool.
