History of Pharmaceutical Intellectual Property

WHILE PHARMACOPOEIAS like the Parisian Codex medicamentarius governed the world of apothecaries in ancien régime France, there also existed a parallel and more loosely organized tradition whereby pharmaceutical innovators were granted exclusive royal privileges for the sale of novel therapeutic preparations, called “secret remedies.” These privileges in effect granted legal monopolies over the sale of a given drug. Many privilege holders held no formal medical credentials and were not members of the medical corporations—the faculties and colleges of physicians, or the guilds of surgeons and apothecaries.

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.

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.

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)

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.

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.

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 ...