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Historically, the use of legal frameworks to claim proprietary rights in the products of agricultural science was limited to the private sector. Public institutions, including CGIAR, treated their creations as the common heritage of humankind. Scientific, economic, and legal changes unsettled this public–private balance in the 1980s, provoking a reimagination of the role of intellectual property in research and development. Three distinct theories about how CGIAR should respond to the global expansion of intellectual property in agriculture emerged. Maximalists embraced proprietary legal claims, adaptationists advocated for cautious accommodation, and rejectionists viewed intellectual property as ancillary to the CGIAR mission. This chapter traces the history of intellectual property debates within CGIAR from 1990 to 2020, arguing that over time, the adaptationist approach prevailed as institutional governance structures developed. Although current policies permit each CGIAR center to embrace rejectionism or maximalism to a certain extent, the rejectionist theory has been marginalized at the system level, while a global capitalist approach to agricultural science has taken root.
The conceptualization of a proper approach to patent law, as it relates to drug patents and access to medicines, remains contested. This article joins the discourse by positing that an application of the communitarian approach of ubuntu to the might of human rights is a useful framing for normalizing equity-based interventions and would help tilt the balance of power from a narrow profit-seeking imperative to one that prioritizes the public good. It contends that, while private entity ubuntu, corporate social responsibility or charity yield some positive results, they are inadequate and must be buttressed by the right to health, which entails access to the necessary diagnostics, therapeutics and medicine for all. The article argues against the predominant hegemony of current thought, which has so far not yielded meaningful and timely access, and advocates for a rethink of the possibilities of more just outcomes through more just processes.
Computational simplification tools can make complex information sources easier to read for engineering designers. To guide and evaluate such approaches, it is necessary to understand how designers process information and how that information can be enhanced and measured. Here, we establish an approach for enhancing and measuring the comprehensibility of technical information for engineering designers. It is grounded in theories of document search and comprehension and provides theoretically supported principles for enhancing information and methods for measuring comprehension experimentally. It is tailored for engineering design in that it (i) does not summarize or remove potentially important information, (ii) is suitable for long, complex sources of information, (iii) can be applied in experiments that simulate real-life information sharing scenarios, and (iv) enables the measurement of domain-specific comprehension. The feasibility of the approach was tested by using patent documents as a test case since they represent a valuable but underutilized source of technical information. A 2 (patent documents) × 2 (conditions: control vs. modified) experiment was conducted with 28 professional engineering designers. Two patent documents were modified with six information design principles. Comprehension scores were higher for the modified patent than for the control, but the change was not statistically significant (p = 0.073). We attribute this either to redundancy effects causing a smaller than expected overall improvement in performance, or differences in prior knowledge for each patent. Overall, this approach offers a novel method for investigating and measuring information comprehensibility in engineering design; however, its effectiveness in enhancing information comprehensibility remains unvalidated.
Biosimilar drugs enter the United States market well after they enter the European market. That is likely because pharmaceutical companies have many more patents in the United States than in Europe. But why is patent coverage of biological drugs so much more extensive in United States? This case study seeks to answer this question for drug formulation patents.
The US has found it hard to establish competition in the market for biologics, which are therapeutics derived from living cells. In the case of small-molecule drugs, the emergence of direct competition from generic drugs at the end of the exclusivity period has provided the impetus for price competition, leading to lower spending. In 2010, to spur competition in the biologics market, Congress created a simplified pathway for the US Food and Drug Administration (FDA) to approve comparable versions of biologic drugs called biosimilars. Biosimilar competition in the US has nonetheless remained weaker than in European peer countries. For example, as of August 2020, there were 52 biosimilars available in Germany, and only 15 in the US.1 An important contributor to this “biosimilar gap” has been the fact that biosimilars to biologic blockbusters such as adalimumab (Humira) and etanercept (Enbrel) were only (or will only become) commercially available in the US several years after receiving FDA approval, while they were available in Europe years earlier.2 Through the end of 2021, it took biosimilars a median of 301 days between receiving FDA approval and becoming available for use.3 In one recent study, the median length of time between when a biologic drug was approved and when its first biosimilar was made available to US patients was 21.5 years.4 This paucity of competition has contributed to high US spending on biologics. According to the Department of Health and Human Services, in 2022 41% of US drug expenditures was spent on biologics, which represented 16% of US prescriptions.5
This chapter begins by providing an overview of the key features of early chemical subject matter, namely that it was fickle, empirically based, and rapidly changing. After outlining the problems this created for patent law, I look at the way that patent law dealt with one of these problems. This was how to reconcile the way that chemical inventions were created with a mechanical understanding of invention that dominates in patent law.
This book takes as its starting point recent debates over the dematerialisation of subject matter which have arisen because of changes in information technology, molecular biology, and related fields that produced a subject matter with no obvious material form or trace. Arguing against the idea that dematerialisation is a uniquely twenty-first century problem, this book looks at three situations where US patent law has already dealt with a dematerialised subject matter: nineteenth century chemical inventions, computer-related inventions in the 1970s, and biological subject matter across the twentieth century. In looking at what we can learn from these historical accounts about how the law responded to a dematerialised subject matter and the role that science and technology played in that process, this book provides a history of patentable subject matter in the United States. This title is available as Open Access on Cambridge Core.
One of the earliest patents for an automaton in Victorian America was for a steam-powered android, drawn as a caricature of a Black man. Most histories of the so-called Steam Man tend to treat this automaton in one of two ways: Historians of science have addressed the machine indirectly, drawing general connections between Victorian Black androids, white femininity, and imputed inferiority; literary and cultural studies have addressed the Steam Man directly as a product of Reconstruction-era white anxiety over free Black labor. In this chapter, we argue for a different way of understanding the Steam Man and other Victorian Black automata, one that sees them as concealing historical truths about the Black technological self in nineteenth-century America. We follow a counterhistory of the mechanics that underpinned Black automata and show that, although androids like the Steam Man portrayed Black people in pastoral, leisurely, and nontechnological roles, their reliance on blackface minstrelsy ultimately concealed the intimate relationships between Black Victorian Americans, contemporary technologies, and the self
Efficient infringement is when firms opt to “infringe now, pay later,” rather than accepting ex ante a license to use a patented technology. This behavior is particularly attractive when the infringer believes that, even if it is found to have infringed a valid patent, it will not be enjoined from continued infringement. At worst, absent injunctive relief, the infringer will need only pay damages for past infringement, approximating what it would have paid if it had licensed the technology ex ante, and then a royalty rate for future infringement. Essentially, the infringer is in no worse a position that it would be had it accepted a license and may even be in an improved position if the royalty rate set by a court is lower than it could have obtained via negotiation.
Efficient infringement is of particular concern in the standards essential patent (SEP) space because injunctive relief is generally unavailable to SEP owners. This chapter explains that courts are unlikely to grant requests for permanent injunctions and SEP owners are unlikely to even seek injunctive relief, setting up the necessary condition for efficient infringement to flourish. Unsurprisingly, there is evidence that infringers are selecting to “infringe now, pay later” when it comes to SEPs and this chapter sets out the case why this is problematic for a well-functioning innovation system.
One of the world’s greatest experiments in open innovation is mobile wireless. Technology enterprises have invested billions of R&D dollars to develop 2G, 3G, 4G, now 5G, and hopefully 6G soon. Technology developers make investments and look to the patent system and associated regulators to reward them for risky investments, should their patented technologies become included in the standards. In recent years there has been an uptick in the number of technology implementers. But because patents are not self-enforcing, unlicensed use occurs, which is corrosive of the open innovation system that allows non-vertically integrated firms to compete at the device level. This chapter reviews antitrust theories that some implementers have used to avoid paying royalties to patent owners. This is examined in the context of the FRAND licensing regime established by ETSI, a standards development organization. “Hold up” and “hold out” theories are examined. Hold up theories lack empirical support and are misused by some implementers—particularly those in China—who would prefer to free ride on the R&D investments of others. Restoring and revitalizing technology markets for mobile wireless likely requires limits to be placed on the availability of FRAND licenses with respect to recalcitrant technology implementers. Otherwise, the innovation ecosystem will be harmed, and open innovation (that is, licensing) business models will collapse.
In the past decade, standard essential patent (SEP) licensors and implementers of connectivity standards have increasingly used litigation as an instrument in their negotiations with the aim to reach a more favorable deal to them. The wider use of connectivity standards in various IoT verticals means on the one hand that SEP licensors have to negotiate licenses for a broad range of different products with an increasing number of implementers, many of which are less familiar with standards and SEP licensing. Whereas on the other hand, implementers have to take licenses from an increasing number of SEP licensors for the different connectivity standards they may use in their products. If current licensing practices in the telecom sector are replicated in the various IoT verticals, the number of SEP litigations will increase even more over time. This chapter describes a holistic end-to-end solution aimed at creating a smoother SEP licensing ecosystem, in which licensors and implementers will be driven more towards negotiated agreements than towards using litigation to get to a deal. It addresses practical solutions for those elements in SEP license negotiations that are the cause of most litigation, including increasing SEP transparency, increasing the likelihood of the validity of SEPs, incentivizing implementers to seek SEP licenses, assessing a reasonable aggregate royalty for the total SEP stack, and securing a better level playing field among licensees.
Times are changing as our global ecosystem for commercializing innovation helps bring new technologies to market, networks grow, and interconnections and transactions become more complex around standards, all to enable vast opportunities to improve the human condition, to further competition, and to improve broad access. The policies that governments use to structure their legal systems for intellectual property, especially patents, as well as for competition—or antitrust—continue to have myriad powerful impacts and raise intense debates over challenging questions. This chapter explores a representative set of debates about policy approaches to patents, to elucidate particular ideas to bear in mind about how adopting a private law, property rights-based approach to patents enables them to better operate as tools for facilitating the commercialization of new technologies in ways that best promote the goals of increasing access while fostering competition and security for a diverse and inclusive society.
In response to concerns that inefficiencies in standard essential patent (SEP) licensing may have a negative impact on the development of emerging 5G and Internet of Things (IoT) markets, the European Commission (EC) convened an Expert Group on Licensing and Valuation of Standards Essential Patents (SEP Expert Group) which produced a report including 79 proposals aimed at improving the SEP licensing market. A proposal formulated by an individual member of the SEP Expert Group regarding Licensing Negotiation Groups (LNGs) has recently generated a renewed interest in the topic in the context of IoT, where a large increase in the amount of SEP licensing activity is predicted as connectivity becomes ubiquitous across most industries. While LNGs have been previously promoted to solve the perceived problem of patent holdup, we propose that LNGs should be used to solve patent holdout, which is aggravated by a collective action problem among similarly situated IoT implementers. Applying legal, economic, and management principles and norms, the resulting LNG design seeks to significantly reduce transaction costs and patent holdout while curtailing potential antitrust risks, especially regarding SEP implementers situated in the “long tail” of new IoT markets.
Since the Supreme Court’s 2006 decision in eBay, Inc. v. MercExchange, LLC, increasingly large portions of the patentee population have no realistic expectation of securing injunctive relief against adjudicated infringers. This judicially imposed quasi-compulsory licensing regime induces well-resourced infringers to decline a license, appropriate patented technology, and negotiate the terms of use through litigation. Costly and protracted litigation is unlikely to adequately remunerate the patent owner whenever infringers have greater litigation resources, lower opportunity costs, and limited expectations of enhanced damages, which can induce the patent owner to settle for an amount that undervalues its technology. These litigation and settlement dynamics are illustrated through case studies of “holdout” tactics employed by well-resourced infringers in recent litigations involving standard-essential patents. To correct for the underdeterrence and undercompensation effects inherent to a no-injunction regime, it is proposed that courts enhance damages by an appropriately calibrated multiplier in all infringement litigations in which injunctive relief is not a practically available remedy.
Chinese courts began to issue anti-suit injunctions (ASIs) in 2020 against litigants in foreign courts that had filed lawsuits to obtain a FRAND rate setting. Although these ASIs are a legal “transplant” from common law countries, they may also be viewed as “false friends” with significant differences from the jurisdictions from which they were imported. Several distinct vectors stand out: (a) China’s ASI practice and Chinese industrial policies are closely integrated into China’s domestic efforts to become an innovative power and standard essential patent (SEP) litigation norm setter; (b) China’s ASI efforts are part of a continuum of decades-long efforts to exert greater international influence, including in “judicial sovereignty” and global FRAND rate setting; and (c) the lack of transparency around China’s ASI practices, including the small and incomplete cohort of published cases, an apparent slow-down in recent ASI decisions, and Chinese traditions of experimentation in intellectual property (IP) legislation and practice, make it difficult at this time to determine how China’s ASI regime will further evolve into a system that is more compatible with other countries. This chapter more generally contributes to discussions around the appropriability of IP-related legal transplants into China by proposing that the differences between Chinese practices and practices in foreign countries may often be more significant than surface similarities.
In recent months, pharmaceutical manufacturers have brought legal challenges to a provision of the 2022 Inflation Reduction Act (IRA) empowering the federal government to negotiate the prices Medicare pays for certain prescription medications. One key argument made in these filings is that price negotiation is a “taking” of property and violates the Takings Clause of the US Constitution. Through original case law and health policy analysis, we show that government price negotiation and even price regulation of goods and services, including patented goods, are constitutional under the Takings Clause. Finding that the IRA violates the Takings Clause would radically upend settled constitutional law and jeopardize the US’s most important state and federal health care programs.
This chapter discusses the pharmaceutical industry, with specific attention given to the role of intellectual property and R&D. The chapter also explains (broadly) the process by which a new drug is approved by the Food and Drug Administration. The key concept in the chapter is the tradeoff inherent in intellectual property protections: stronger protections spur more innovation but at the cost of higher prices for a longer period of time. On the other hand, weaker protections allow for more affordable products more quickly, but at the cost of reduced innovation. The end of chapter supplement explores the role of international trade agreements in solving research and development coordination problems.
This article explores the early history of two American peanut companies: Planters and Tom’s. Both food manufacturers developed major commercial brands through the ownership of intellectual property. In this case, the sourcing of different peanut types figured into the marketing of salted peanuts. Through a legal dispute involving Tom’s patented retail bag, I examine how food packaging changed the way that peanuts were advertised, distributed, and consumed in the United States. The argument is made for an historical analysis of food brands that considers how intellectual property domains interacted with one another and with the material properties of food itself.
Legal information professionals can play a vital role when it comes to patents, whether that's through undertaking research to assist in infringement cases or by assisting in providing due diligence information by conducting searches to identify a company's patent portfolio. But those doing patent research need to know how to identify patents, how to determine their status and how to investigate the litigation history of patents. Niamh Hanratty, of Bird & Bird, explains how all this is done.