Rise of the (3D printing) machines in healthcare.

Three-dimensional printing (3D printing) or "additive manufacturing" first came to prominence in the field of engineering, in particular in the transport sector where the value of its fast and accurate prototyping and manufacture of spare parts was quickly recognised. However, over the last ten years, this revolutionary technology has disrupted established manufacture in an increasingly diverse range of technical areas. Perhaps the most unexpected of these is pharmaceuticals - not merely the manufacture of products such as surgically inserted implants, but also of dosage formulations themselves - now available in all manner of printed delivery forms and vehicles and showing promising control of release properties though 3D printing process choices. This review will provide an overview of how 3D printing technology has developed and expanded across technological boundaries during the past decade, with a closer look at the current opportunities and barriers to its widespread adoption, particularly in the medical and pharmaceutical sectors. Special attention has been paid to patents as a boost and barrier to the expansion of 3D printing in the medical and pharmaceutical sector, with a focus on the patent literature.

Intellectual property law protection for energy-efficient innovation in Saudi Arabia.

Laws and policies are important instruments to protect and promote innovation. Intellectual property laws like copyright, patent, and confidential commercial information law facilitate can increase business outputs, economic growth, and green production standards. The objective of the article is to analyze copyright, patent, and confidential commercial information laws in Saudi Arabia to see the availability of these laws in encouraging and protecting energy-efficient innovation while contributing to achieving sustainable development. Content analysis, doctrinal research method, and comparative legal analysis were used to achieve the research objective. The research findings demonstrate that the three selected legislation could be extended to protect energy-efficient innovation in Saudi Arabia though there is a need to amend some of the provisions of the existing laws. However, creating public awareness of the availability of laws and proper implementation of the laws are necessary to protect energy-efficient innovation. The article proposes recommendations to the policymakers about the need for further improvement of the law and its enforcement. The findings of this research could fill the gap in the literature on the assessment of intellectual property law to protect energy-efficient innovation in Saudi Arabia.

Intellectual property protection for traditional medical knowledge in China's context: a round peg in a square hole?

This article is an examination of the extent to which traditional medical knowledge in China can be protected by intellectual property laws. The analysis begins by providing a global picture with regard to the historic origin of intellectual property, exploring the reasons why China does not have indigenous counterparts to the western system of intellectual property rights protecting its traditional knowledge (including traditional medical knowledge) and stating the problems of transplanting western intellectual property standards in China. A discussion follows on how China, under foreign pressure, has made efforts to comply with the changing standards mandated by various international, regional, and bilateral arrangements related to intellectual property, with examples of the development of China's patent law. China's approach towards the protection of traditional medical knowledge in various international fora related to intellectual property is explored. Finally, there is a specific examination of the compatibilities between the western system of intellectual property rights and traditional medical knowledge in China, at the national and community levels. This article argues that the system of intellectual property rights does not easily fit with China's traditional medical knowledge because of China's unique cultural traits, distinctive historical context and wide ethnic, religious, and local community diversity.

India's Traditional Knowledge Digital Library and the Politics of Patent Classifications.

This article analyzes India's Traditional Knowledge Digital Library (TKDL) as a potential intervention in the administration of patent law. The TKDL is a database including a vast body of traditional medical knowledge from India, aiming to prevent the patenting and misappropriation of that knowledge. This article contextualizes the TKDL in relation to documentation theory as well as to existing research on the uses of databases to protect traditional knowledge. It explores the TKDL's potential consequences for India's traditional medical knowledge and the wider implications that traditional knowledge databases can have for the safeguarding of traditional knowledge in general. The article concludes that on the one hand the TKDL bridges the gap between the main branches of Indian traditional medicine and the formal knowledge system of International Patent Classifications. Furthermore, it has also inspired revisions of the International Patent Classification system, which makes it better adapted to incorporate traditional medical knowledge. On the other hand, critical research on traditional knowledge documentation argues that traditional knowledge databases, like the TKDL, can decontextualize the knowledge they catalogue and dispossess its original owners. The TKDL, however, also fits into a national, Indian agenda of documenting and modernizing traditional medicine that predates the formation of the TKDL by several decades and challenges the dichotomy between traditional and scientific knowledge systems that originally motivated the formation of the TKDL.

International Tale on Gene Patents - between Medical and Legal Uncertainties / Cuento internacional sobre patentes genéticas: entre la incertidumbre médica y jurídica

This work is inspired by the international litigation chronicle of Myriad Genetics that remains of topical importance in the judicial and academic discourse regardless of the time that passed since. It discusses approaches of various jurisdictions to the problem of gene patenting as well as patenting of geneticdiagnostic testing. The article takes under scrutiny the judgments rendered in the U.S., Australia as well as the decisions by the European Patent Office and placesthem into interdisciplinary background of genetic science. The issue is significant, both theoretically and practically. Notwithstanding the expiration of patents that constituted the subject matter of the Myriad’s various lawsuits, the problem still remains currently relevant. Firstly, because the judgments in individual cases did not answer all the questions, but – in some way – only prepared a path for future decisions. Secondly, it is on account of new scientific breakthroughs in the area of human genetics. Consequently, the domain of genetic diagnostics is under continuous development and in the future may continue to reveal new scientific discoveries and (possibly) inventions. The lack of uniform and transparent rules in this field, and well-defined boundaries for potential monopolies constantly brings not only uncertainty for medical practitioners and scientists, but also real disadvantagesfor the patients. (AU)

Esta obra se inspira en la crónica del litigio internacional de Myriad Genetics, que sigue siendo de actualidad en el discurso judicial y académico a pesar del tiempotranscurrido desde entonces. En él se examinan los enfoques de diversas jurisdicciones sobre el problema de las patentes de genes, así como de las patentes de pruebas de diagnóstico genético. El artículo examina las sentencias dictadas en Estados Unidos y Australia, así como las decisiones de la Oficina Europea de Patentes, y las sitúa en el contexto interdisciplinario de la ciencia genética. La cuestión es importante, tanto desde el punto de vista teórico como práctico. A pesar de la expiración de las patentes que constituyeron el objeto de los diversos pleitos de Myriad, el problema siguesiendo de actualidad. En primer lugar, porque las sentencias dictadas en los casos individuales no respondieron a todas las preguntas, sino que –en cierto modo– sólo prepararon el camino para futuras decisiones. En segundo lugar, debido a los nuevosavances científicos en el ámbito de la genética humana. En consecuencia, el ámbito del diagnóstico genético está en continuo desarrollo y en el futuro puede seguirrevelando nuevos descubrimientos científicos y (posiblemente) invenciones. La falta de normas uniformes y transparentes en este ámbito y de límites bien definidos para los monopolios potenciales no sólo genera constantemente incertidumbre para losmédicos y científicos, sino también desventajas reales para los pacientes. (AU)

Metal 3D printing: Patent law, trade secrets, and additive manufacturing.

There has been significant investment in research and development in respect of metal 3D printing in the United States (as well as a number of other jurisdictions). There has been growing conflict over the ownership of intellectual property in respect of metal 3D printing (involving not only patents but also trade secrets and confidential information, as well as contract law and unfair competition). In 2018, Desktop Metal Inc. launched litigation against Markforged Inc. and Matiu Parangi in relation to intellectual property and metal 3D printing in the United States. As well as complaints of patent infringement, Desktop Metal Inc. has alleged that the defendants had engaged in acts of trade secret misappropriation, unfair and deceptive business practices, and breach of contract. Markforged Inc. made various counter-claims of its own. In July 2018, a Federal Jury found that Markforged Inc. did not infringe two patents held by its rival Desktop Metal Inc. Claims of further violations of trade secrets and contract law were also considered. In the end, the dispute was settled, with neither party obtaining an advantage in the litigation. There was further conflict over whether the terms of the settlement in respect of non-disparagement were honored. The parties have also faced further intellectual property conflict. In 2021, Continuous Composites has filed a patent infringement lawsuit against Markforged Inc. In 2021, Desktop Metal Inc. brought legal action against SprintRay in Germany. Drawing upon this case study, this paper considers whether metal 3D printing will disrupt patent law, policy, and practice. It also explores the tension between the use of trade secrets in commercial 3D printing (such as in metal 3D Printing), and the open source ethos of the Maker Movement. This paper considers the larger implications of this intellectual property dispute over metal 3D printing for scarcity, regulation, and the abundance society. It also explores the innovation policies of the Biden administration in respect of advanced manufacturing-with a focus upon metal 3D printing and additive manufacturing.

When speed matters: a discussion on the benefits of a grace period in patent law to accelerate pharmaceutical innovation in times of pandemic.

The unprecedented coronavirus disease 2019 (COVID-19) pandemic is a solemn reminder of the need to accelerate pharmaceutical innovation. The desire for fast access to vaccines triggered discussion of unrestricted access to research findings with the hope of facilitating the drug discovery process to combat COVID-19. Increasingly, abolition of the patent system is being discussed in connection with the fight against the pandemic. This may accelerate discovery of and increase access to medicines. However, society's desire for immediate disclosure of research findings conflicts with the inventor's legitimate interest to protect his or her invention as well as the need to recover investments made to develop the drug. The call for immediate disclosure of research results contradicts the interest of the inventor, whose primary goal is to secure his intellectual property rights, usually by applying for patent protection. In Europe, where patent law is based on the principle of absolute novelty, disclosure of the results reduces novelty and prevents subsequent patenting. Consequently, patenting remains the top priority for pharmaceutical companies in Europe, while disclosure of the results is secondary. The following article looks critically at the idea of using the grace period in European patent law to reconcile the conflicting interests of society and inventors in times of pandemic. In this paper, we investigate whether the implementation of a grace period in European patent law like that known in the USA, Japan, or Korea benefits the disclosure of results and increases the flow of information, ultimately leading to the promotion of innovation and rapid drug discovery. This article questions whether the use of a grace period provides a sufficient incentive to the inventor for rapid disclosure.

SARS-CoV-2 and Patent Activity.

The article provides information on the patent activity of inventors in relation to applications for inventions related to coronaviruses, in particular, to SARS-CoV-2. The presence of a steady interest in this topic for the period 1996-2020 is illustrated. It is indicated what objects of patent law can be inventions related to vaccines.

Patents, Governance and Control: Ethics and the Patentability of Novel Beings and Advanced Biotechnologies in Europe.

This article focuses primarily on to what extent novel beings, and particularly, beings which display something akin to human consciousness or agency would be (or should be) patentable under current European patent law. Patents grant the patent holder a right to exclude others from using the patented invention for the period of patent grant (usually 20 years). This allows the patent holder to control how that invention can or cannot be used by others downstream, granting patent holders a governance like function over the patented technology for the duration of the patent. Accordingly, the potential for patentability of novel beings gives rise to a myriad of ethical issues including: to what extent is it appropriate for patent holders to retain and exercise patents over "novel beings"; how issues of "agency" displayed by any "novel beings" would fit within the current patent framework, if at all; and to what extent existing exclusions from patentability might exclude patents on "novel beings" or whether changes within patent law may be needed if patents in relation to "novel beings" are deemed ethically problematic. This article focuses on such issues, and in doing so, also sheds light on the role of ethical issues within the patenting of advanced biotechnologies more generally.

Avoiding hindsight in non-obviousness determination: case law review of pharmaceutical patents and guidance from the KSR v Teleflex decision.

Introduction: Hindsight bias is the tendency to estimate an outcome once it is known. Legal systems are often prone to hindsight bias. In patent law, the non-obviousness or inventive step is the most critical determinant of patentability and often subjected to hindsight bias.Areas covered: Scholarly literature confirms the existence of hindsight bias in different patent systems. This communication hence addresses factors, which lead to hindsight bias specifically in chemical and pharmaceutical arts, guidance from the case law that can be helpful in avoiding hindsight bias in non-obviousness determination.Expert opinion: The Supreme Court in 2007, advocated a more expansive and flexible approach to where the Teaching Suggestion or Motivation test could come from. In the case of chemical and pharmaceutical active compounds, the considerations such as i) was there sufficient motivation to modify the lead compound and arrive at the claimed compound and its properties, ii) was there a reasonable expectation of success to achieve the claimed property and other such considerations highlighted in this review may contribute to avoid hindsight bias in non-obviousness determination.

MEDICINE AND COLONIAL PATENT LAW IN INDIA: A Study of Patent Medicines and the Indian Patents and Designs Act, 1911 in Early- Twentieth-Century India.

This paper investigates the history of drugs sold as "patent medicines" in India in the early twentieth century. The paper investigates their legitimacy as patenting of medicines was forbidden by the Indian Patents and Designs Act, 1911 (IPDA). The paper argues that the instrument of letters patents functioning as the prerogative of the Crown that gave monopolistic rights to grantees to sell any compound without having to disclose its constituents was the reason behind this seemingly conflicting historical relationship between the law and the market. Colonial law-making left sufficient space within the ambit of the IPDA for letters patents to have their ill effects. The colonial state made attempts to address this as a public health issue by incorporating concerns related to this class of medicines within regulations addressed to the drugs market in the 1930s. The currency of patent medicines in the market was further added to by Indian indigenous entrepreneurs fueled by cultural nationalism of Swadeshi ideology in Bengal in the early twentieth century. However, even such indigenous responses or attempts at hybridization of manufacturing and selling practices related to patent medicines were mostly informed by upper-caste/ upper-class interests and not so much by those of consumers of these medicines.

Weighing intellectual property: Can we balance the social costs and benefits of patenting?

The scale is the most famous emblem of the law, including intellectual property (IP). Because IP rights impose social costs on the public by limiting access to protected work, the law can be justified only to the extent that, on balance, it encourages enough creation and dissemination of new works to offset those costs. The scale is thus a potent rhetorical trope of fairness and objectivity, but also an instrument the law thinks with - one that is constantly invoked to justify or to question the extent of available IP protection. The balancing act that underlies the legitimacy of IP is, however, literally impossible to perform. Because we are unable to measure the benefits that IP has for inventors or the costs it has for the public, the scale has nothing to weigh. It conveys a clear sense that IP law can be balanced, but in fact propagates only a visible simulacrum of balance - one that is as empty as it is powerful.

Ghosts of inventions: Patent law's digital mediations.

This article examines the shifts in the material ordering of inventions in patent law organization and their effects on the meaning and scope of inventions as intellectual property. Formats and media are constitutive of the establishment and stabilization of inventions as objects of intellectual property. Modern patent law's materiality had been dominated by paper documents but ever more consists of digital images, files, and networked data. The article traces and analyzes such effects of digital media on the meaning of intellectual/intangible property and argues that inventions increasingly matter as digital data in the legal realm.

Property and human genetic information.

Do donors (of samples from which genetic information is derived) have some sort of pre-legal (moral) or legal property right to that information? In this paper, we address this question from both a moral philosophical and a legal point of view. We argue that philosophical theories about property do not seem to support a positive answer: We have not mixed our labour with our genes, and the human genome cannot be said to be a fitting object for private ownership based on some idea of self-ownership. An analysis of the term 'property' as seen from a legal perspective yields the conclusion that property is, at best, a linguistic prop whose real content has to be defined at least partially conventionally. Relevant interests that may be seen to be protected seem to be interests of privacy or interests against exploitation. To the extent that the logic behind the patent system holds true limiting incentives decreases innovation in society. A balancing of interest must take place, and we have to make sure that patent protection serves general societal interests and not just those of special interest groups be that inventors or donors.

How to Start a Biomedical Device Company: Physicians Can Lead the Team Effort.

Taking a solution for a clinical unmet need from a mere idea to a profitable medical device company is a long and complex process. After developing a prototype solution, the physician-inventor must quickly file a patent to protect his or her intellectual property. After the patent is secured, the first major business decision arrives: should the inventor sell the patent or maintain ownership? If the inventor decides to maintain ownership, he or she will face a series of hurdles from obtaining additional funding to device development, and ultimately, commercialization and marketing of the product. Although this process is daunting at first glance, and physicians certainly face unique challenges in this endeavor, clinicians are uniquely and strategically positioned to identify clinical unmet needs and, therefore, have the ability to fundamentally transform the way we treat our patients.

Problems in China pharmaceutical compulsory licensing system and their solutions / 中华医学图书情报杂志

The Doha Declaration has entrusted to the members of WHO the right to use the compulsory licensing for drug patents in the face of global public health crises.Although the basic compulsory licensing system for drug patents has been established in China, the efficiency of its implementation is low, the responsibility of its executive departments is unclear, the related rules are not fully understood by pharmaceutical enterprises, it is thus necessary to improve and perfect the relevant legal provisions and systems in order to effectively improve the accessibility of drugs.

Compulsory licensing of patents in India.

This article deals with compulsory licensing scenarios in India, provides a background of relevant provisions in the Patents Act and examines how these provisions are Trade-Related Aspects of Intellectual Property Rights compliant. This article further discusses the procedure followed by India in granting a compulsory license, provides an overview of compulsory license applications filed in India to date and judicial precedence regarding the same. This article also highlights how compulsory licensing is a great safeguard that balances the interests of the innovators and the public at large.