History of Pharmaceutical Intellectual Property

The passage of the United Nations Convention on the Rights of Persons with Disabilities (CRPD or the Convention) has been hailed as the culmination of a “paradigm shift” from the biomedical model of disability to the social and human rights-oriented model. The CRPD’s assertion of equal recognition before the law applying to all persons with disability, including mental health and psychosocial disability, and thus amounting to universal legal capacity, in Article 12 and in the subsequent General Comment, Number 1 on Article 12 issued by the Committee on the Rights of Persons with Disabilities (CRPD Committee), has been the subject of considerable debate. While many have argued that this is a long overdue protection and a manifestation of nondiscrimination and freedom from coercion on the basis of disability, some have raised concerns based on perceived impracticality or risk. Among the obligations of States parties to the Convention is the mandate to shift from coercion, in the form ...

2010 sees the 50th anniversary of the introduction of the oral contraceptive pill in 1960. This development was made possible by the synthesis of the first orally active progestin some 9 years earlier. The contraceptive pill is the most popular means of family planning in developed countries, and arguably the most effective. It is the most common method of contraception in the USA (18%), Canada (14%), Australia (27%), New Zealand (20%) and most European countries, including the UK (26%)1. Reproductive health and success have in the past and continue today to be important contributors to our survival as a species. However, even from ancient times, there have been attempts to limit the effect of Eve's curse by reducing the number of children and spacing of successive pregnancies. However, it was only with advances in both scientific knowledge and understanding, together with social reforms, that information about birth control and the means to control fertility became widely avail...

In 1856, William Henry Perkin in London prepared the first aniline dye, later known as mauve. The eighteen-year-old inventor sought, but failed, to find a licensee for his process, and then embarked on manufacture, with the backing of his father and a brother. The opening of their factory and the sudden demand for mauve in 1859 foreshadowed the growth of the modern organic chemical industry. The search throughout Europe for novel colorants made scientific reputations and transformed the way in which research was conducted, in both academic and industrial laboratories. Accordingly, the sesquicentennial of mauve provides an opportune moment to review the early years of what became the first sciencebased industry and examine how its foundation has been celebrated through commemorative events in 1906, 1956, and 2006.

This paper examines the current situation concerning the poor protection of industrial property in Mexico, a country rich in plant species. In addition, plant species have been employed medicinally by indigenous communities, and an important plant products research has been developed. The protection of industrial property remains an issue of recent introduction in the Mexican economy. The lack of a

The book is as the title states a critical history of the industry since 1880 which is the time I trace its beginnings to. The first chapter can be downloaded here and the book can be ordered from Amazon and other online bookstores, including the publisher: https://www.worldscientific.com/worldscibooks/10.1142/11889 - for 30% discount use this code when ordering: WSPHARMIND30 (valid until 31 Jan. 2021)

One philosophically neglected aspect of current practice in medicine is the promise of speeding up of the research and development process, most explicitly present in translational medicine. Biomedical research, including both the development of drugs and therapeutic practices, is especially dedicated to time-sensitive outcomes. In recent years, translational medicine is an emerging approach supposed to bridge the gaps between laboratory, clinics, guidelines, practices, prevention, and finally, health politics. The idea is to make research more end-users centered, translating it into clinical practice and health politics in a more productive and patient-sensitive way, while maintaining rigor on the safety part. I focus on three time-related issues in current translational medicine: (1) unintegrated strategies in early drug discovery (2) translational time lags and problems with their measurement, and (3) time-insensitivity in measuring the effectiveness of medical interventions. I suggest that synchronicity is the key feature of a desirable “speedy” or “time-sensitive” translation. To exemplify these problems I analyze a paradigmatic example of translational research, the research on adrenals in the 1930s and 1940s which eventually led to discovery, synthesis, and therapeutic application of cortisone. Though it took place before the formalization of translational procedures, it is important to highlight what is so paradigmatic about this case and how it relates to current translational practice. I argue that the efforts to tactically speed up the development of new drugs and therapies have only limited success, unless speeding means synchronizing.

This article reviews current trends in patent claims regarding personalised, stratified and precision medicine. These trends are not particularly well understood by policymakers, even less by the public, and are quite recent. Consequently, their implications for the public interest have hardly been thought out. Some see personalised and other secondary drug patent claims as promoting better targeted treatment. Others are inclined to see them as manifestations of 'evergreening' whereby companies are, in some cases quite cynically, trying to extend market monopolies in old products or creating new monopolies based on supposedly improved versions of such earlier drugs. The article claims that the relaxation of 'novelty' is a privilege unavailable to inventions in other fields and that on balance the patent system does privilege this industry and that no adequate case has yet been made thus far to prove the public benefits overall.

A discovery, synthesis and therapeutic application of cortisone present a paradigm for modern translational medicine (Hillier 2007, Saenger 2010), since they represented a joint achievement of discoveries by biochemists, Edward Calvin Kendall and Tadeus Reichstein; large scale synthesis by an industrial chemist, Lewis Hastings Sarett, and therapeutic application by a rheumatologist, Philip Showalter Hench. The goal of translational medicine is to speed up the process between basic research and clinical practice, and to integrate multiple disciplines in order to understand diverse outcomes (Zhang et al. 2014). In this paper conditions that made this basic/applied/clinical research interface possible will be presented: the rise of steroid chemistry, simultaneous individual accomplishments as well as continuous cooperation among scientists, military competitiveness, and cooperation among pharmaceutical companies.

This chapter is about science, patent law and the use of language that supports the extension of patent claims ever deeper into the realms of nature. By language I refer in particular to the use of figures of speech, terminologies and epistemologies that both express and support powerful explanatory and justificatory conceptual systems. Undoubtedly, chemical, informational and mechanistic ways of understanding life have all been enormously helpful to scientists, as are the metaphors and analogies which frame their verbal and written forms of expression. The point of the chapter is not to undermine them, but to examine critically what implications they have for patent law and policy, in particular their consequences for the positioning of boundaries between the patentable and the unpatentable. NB These are uncorrected proofs.

The so-called biotechnology revolution has changed the institutional and knowledge environment of the pharmaceutical industry. The industry incumbents have faced the challenge of adjusting to the new conditions for innovation in drug discovery and development. Drawing on the theoretical framework of the organizational capabilities of the firm, this contribution aims at capturing the changes in the knowledge environment and exploring the adjustment of 4 German corporations (2 companies rooted in the coal tar dyestuff industry and 2 traditional pharmaceutical companies) to the advent of modern biotechnology. Despite the firm-specific capabilities in organic chemical synthesis, the representatives of the coal tar dyestuff industry seem to have been better able to adjust to the external discontinuity in their knowledge environment.The existence of research and development activities, the science-based research tradition together with interactions to access the extramural knowledge base of the firms seem to have been crucial in the perception and adoption of the new technological possibilities of biotechnology after the 1970s, rather than prior competence in biotechnology or the employees with the skills to develop the capabilities to exploit it.

Abstract: The dramatic increase of firm patenting in the US during the last two decades may give the impression that the acquisition of patents is becoming increasingly important for protecting and leveraging technological competencies. A historical perspective on how firms acquire technological competences and leverage them in different markets reveals, however, that it is far from obvious that the possession of patents will lead to long-term competitive success.

This article examines the efforts of pharmacist and physician
Francis E. Stewart to legitimize the commercial introduction of new drugs by reinterpreting the ethical status of patent rights in pharmaceutical manufacturing. I argue that patents had long been understood by the orthodox medical community as an unethical form of medical monopoly and that, as a result, drug companies that marketed their goods primarily to physicians in the years immediately following the Civil War had little room to develop or introduce new products. In collaboration with George S. Davis and the pharmaceutical manufacturing firm Parke, Davis, & Company, Stewart worked to redefine patents as an ethical means of encouraging scientific and commercial innovation. In doing so, he sought to reconcile medical science and commerce so that they were mutually beneficial to one another. However, I also suggest that his efforts had an ironic effect in that they helped legitimatize a form of patent protection that Stewart himself came to believe to be unethical in nature.

The hormones era from 1900 to the 1960s was a period of intensifying pharmaceutical industry internationalisation and competition within and across national boundaries. Patents and patent strategy were essential aspects of this evolutionary process. Hormones are chemical messengers produced by living organisms including humans. They form a wide range of products from anti-inflammatories to contraceptives. As soon as hormones were found to have commercial potential, industry faced the challenge of how to mass-produce them. This was obviously a scientific matter, but it was also a business issue and an intellectual property one. Both production pathways of extraction and hormone synthesis turned out to be equally capable of resulting in patentable subject matter. This was so even when said matter was based on a substance produced by an organism or else was a laboratory-produced copy of one. This set a historic precedent for the patenting of “natural” things like antibiotics, genes, cells, microbes, plants and animals. Thus, the patenting of hormones helped allow us to conceive of biotechnological products as patentable inventions.

L’« ère des hormones », de 1900 aux années 1960, a été une période intense pour l’industrie pharmaceutique quant à la mondialisation et à la concurrence à l’intérieur et au-delà des frontières nationales. Les brevets et les stratégies liées aux brevets étaient des éléments essentiels de ce processus d’évolution. Les hormones sont des transmetteurs chimiques produits par les organismes vivants, dont les humains. Elles se retrouvent dans un large éventail de produits, notamment les médicaments anti-inflammatoires et les contraceptifs. Dès la découverte du potential commercial des hormones, l’industrie a dû relever le défi de les produire en grande quantité. Évidemment, il s’agissait d’une question scientifique, mais touchait éaglement au monde des affaires et de la propriété intellectuelle. Les modes de production - extraction ou synthèse - des hormones se sont avérés tous les deux également capables de produire de la matière brevetable. Tel était le cas, même lorsque la matière était basée sur une substance produite par un organisme ou une copie produite en laboratoire. Cette situation a créé un précédent historique en ce qui a trait à l’octroi de brevets pour les « choses naturelles », comme les antibiotiques, les gènes, les cellules, les microbes, les plantes et les animaux. Par conséquent, le fait de breveter des hormones nous a permis de réaliser que les produits biotechnologiques peuvent être des inventions brevetables.

The hormones era from 1900 to the 1960s was a period of intensifying pharmaceutical industry internationalisation and competition within and across national boundaries. Patents and patent strategy were essential aspects of this evolutionary process. Hormones are chemical messengers produced by living organisms including humans. They form a wide range of products from anti-inflammatories to contraceptives. As soon as hormones were found to have commercial potential, industry faced the challenge of how to mass-produce them. This was obviously a scientific matter, but it was also a business issue and an intellectual property one. Both production pathways of extraction and hormone synthesis turned out to be equally capable of resulting in patentable subject matter. This was so even when said matter was based on a substance produced by an organism or else was a laboratory-produced copy of one. This set a historic precedent for the patenting of “natural” things like antibiotics, genes, cells, microbes, plants and animals. Thus, the patenting of hormones helped allow us to conceive of biotechnological products as patentable inventions.

Blurb: This book is a highly readable and entertaining account of the co-evolution of the patent system and the life science industries since the mid-19th century. The pharmaceutical industries have their origins in advances in synthetic chemistry and in natural products research. Both approaches to drug discovery and business have shaped patent law, as have the lobbying activities of the firms involved and their supporters in the legal profession. In turn, patent law has impacted on the life science industries. Compared to the first edition, published by Ashgate in 2003, which told this story for the first time, the present edition focuses more on specific businesses, products and technologies, including Bayer, Pfizer, GlaxoSmithKline, aspirin, penicillin, monoclonal antibodies and polymerase chain reaction. It also does exclusively with health whereas the first edition also covered agriculture. Another difference is that this second edition looks into the future, addressing new areas such as systems biology, stem cell research, and synthetic biology, which promises to enable scientists to “invent” life forms from scratch.