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Introduction: plurality in patenting: medical technology and cultures of protection

Published online by Cambridge University Press:  28 November 2016

JAMES F. STARK*
Affiliation:
School of Philosophy, Religion and History of Science, University of Leeds, Leeds, LS2 9JT, UK. Email: [email protected].
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Abstract

Type
Introduction
Copyright
Copyright © British Society for the History of Science 2016 

Patenting has had neither a single strategy nor a simple meaning. In almost all developed countries the process of securing a patent has become increasingly convoluted, whilst the functions of patents once conferred reach far beyond the confines of these narrow, complex legal documents. Indeed, even the very text of patents themselves has contested legal and political significance and can fulfil multiple social functions.Footnote 1 Recent historical research on electrical technologies in Britain has shown that patents could at once be used to make profit, subsidize future research activities, support family income through investment, attract capital investment in business with the promise of patent-protected returns, bargain with other corporate entities, assure purchasers of quality and efficacy, and provide legal protection over creative assets against predation by competitors. Similarly, when patenting did not take place it could be for comparably diverse reasons, whether because the claimed invention lacked novelty; or the company or individual sought instead to profit in non-monetary terms through professional, moral credit; or because patenting was regarded by the inventor(s) as being unprincipled and a breach of gentlemanly etiquette.Footnote 2 That the narrative of patents in this collection, as multi-functional documents and key architects of inventive strategy, relates largely to Britain and the United States during the critical decades around 1900 serves to further highlight the disparate meanings, practices and cultures associated with patenting and the use of patents. In other national patent systems and time periods we see very different approaches to regulating, protecting and making available the details of new innovations; the difficulties associated with establishing more integrated international patent systems further reflect this diversity.Footnote 3

The concurrent development of different national systems of patenting across the world has yielded an international landscape of patent law and practices characterized by diversity. Furthermore, beyond the confines of patents as legal entities, the process of obtaining and using a patent has become cloaked in layers of sociocultural meaning. These wider ‘patent cultures’ – the ideas, meanings and motivations associated with invention – have been to a large extent informed by professional norms and practices in a wide range of fields, including electrical and aeronautical engineering and plant breeding.Footnote 4 Disciplinary constraints of professionalism, profit and ethics, as well as the limitations of patents themselves, provided the backdrop against which corporate interests and entrepreneurial individuals attempted to expand the meaning and function of intellectual property. Others shunned the mechanism of patenting, trademarking and copyright in favour of softer, broader forms of intellectual property, preferring instead to exercise moral property rights through strategies such as eponymity and professional credit and recognition.Footnote 5

The relationship between commercial activity and medical practice is now well established in current scholarship, emerging from landmark studies by Dorothy Porter and Roy Porter focusing on the eighteenth century.Footnote 6 Medicine, and in particular medical technologies and pharmaceuticals, therefore offer another lens through which to examine the use (and non-use) of patenting strategies; the implications of these for the inventive process; and the wider cultures of ownership, consumerism and protection within health care. Accounts of both contemporary and historical patenting within biomedicine have focused largely on pharmaceuticals and big business, thus presenting a misleading view both of the role of intellectual property in medicine and of patenting itself.Footnote 7 By taking seriously not just patents themselves as historical source materials, but the wider cultural, professional and technological context in which patenting took place, the essays in this collection move beyond a narrow view of intellectual property which still dominates within the literature.Footnote 8

The essays in this collection focus on patent cultures in the Anglo-American context. They represent diverse examples within the development, implementation and impact of patenting regimes – from patent medicines in Georgian England to early twentieth-century pharmaceuticals in the US. These differences serve to highlight the multiplicity of patent approaches across the period, even within the confines of the Anglo-American model. The meaning and function of patents changed radically over the course of the long nineteenth century, with far-reaching consequences for medical practices. It is in some ways a messy history – littered with dissenting voices, intra- and inter-professional conflict, and a complex and heterogeneous landscape of different patent systems, each reflecting different national cultures and priorities. Nevertheless several clear themes are visible across this longue durée.

First, choices about whether or not to engage in patenting and other forms of protection were rooted in a wide range of factors, from the desire to establish control in a given market to a need to prevent others from doing so. The motivations underpinning these decisions were similarly diverse, whether to protect professional integrity, to profit from commercial activity or to enable investment in future research. Second, patents themselves functioned in different ways for consumers, acting variously as symbols of ownership, markers of efficacy and claims to novelty. In the context of medical practice, these different meanings became the source of intense negotiations, not infrequently leading to damaging, lengthy and expensive legal battles. Third, it is clear that the relationship between patenting and the medical profession was transformed during this period, from one of cautious denial to active engagement. Ultimately, professional medical bodies recognized that patenting was just one of many different ways of establishing credit, alongside, for example, eponymity; yet patenting acquired new legitimacy and respectability as the value and necessity of the collaborative relationship between practitioners, entrepreneurs and manufacturers became more widely recognized during the early twentieth century.

Until the turn of the twentieth century it was far from certain that protecting innovations using patents in any field of scientific or technical endeavour conferred authority and expertise on the patentee. However, amongst the many examples of extensive patentees in Britain, individuals such as William Thomson (later Lord Kelvin), James Swinburne and Sebastian de Ferranti were increasingly able to maintain scientific credibility (all became fellows of the Royal Society) whilst at the same time engaging in commercial activities and taking out a significant number of patents.Footnote 9 Thomson himself used the proceeds from his business ventures to provide financial backing for his Glasgow laboratories, and his collaborators were able to enjoy similar benefits, demonstrating the synergy between science and commerce.

The successful claiming of intellectual integrity and profit in science was by no means universally transferrable to other domains, however. Even in the early twentieth century the relationship between physicians, entrepreneurs and patenting remained complex in the realm of devices related to medicine and health. Guglielmo Marconi was able to exploit his status as an outsider to successfully repurpose the thermionic valves which underpinned his radio technology (first patented by his collaborator John Ambrose Fleming) to launch the Marconi otophone in 1923. The technology which was patented by Fleming, then assigned to the Marconi Company, had become far less valuable by the early 1920s as the patent expired.Footnote 10 Marconi therefore sought to extract an alternative form of value from the valves by producing a new ‘scientific aid to the deaf’ and the first widely marketed electronic hearing aid: the otophone.Footnote 11 By employing the services of the prestigious hearing aid and medical manufacturer T. Hawksley Ltd, Marconi further established his credibility in the field and was able to reassert the philanthropic and benevolent reputation of his company after a series of damaging court battles concerning the ownership of key aspects of radio technology. Although the otophone was heavy, ill-suited to the subtleties of hearing loss, and in many respects inferior to the then more popular, lighter, cheaper and more effective acoustic hearing aids, the Marconi Company persisted with several different models into the 1930s in order to assert its reputation as an innovator, making novel use of a formerly patented technology which was now freely available to their competitors.Footnote 12

In a different vein, obtaining new patents formed a key part of the marketing strategy for a number of influential medical devices in the early twentieth century, such as the Kromayer lamp and the Overbeck rejuvenator. The first of these emerged from patents taken out by the Berlin-based dermatologist Ernst Kromayer; the second was the brainchild of British entrepreneur Otto Overbeck.

Kromayer collaborated with the Newark-based Hanovia Chemical and Manufacturing Company, who manufactured a new design of ultraviolet lamp based on Kromayer's specifications.Footnote 13 In a phototherapy marketplace dominated by the prestigious (unpatented) Finsen lamp, Kromayer claimed that his device offered improved clinical outcomes for patients in the case of numerous skin complaints.Footnote 14 Although it bore his name, Kromayer himself remained at a distance from the commercial world inhabited by Hanovia (he was not mentioned in their promotional material, for example) and instead sought to use the device to increase his professional standing through improved medical practice.Footnote 15 Meanwhile the Hanovia Company were free to engage in litigation to try and protect their devices from infringement, the kind of action which would have been damaging for Kromayer's reputation as an impartial medical practitioner.Footnote 16 Kromayer therefore followed in a long tradition of eponymity as a form of professional credit in medicine, despite in fact taking out patents to protect his invention.

Whilst Kromayer was encumbered by his professional status and chose to pursue alternative forms of credit, despite lending his name to a medical device, there were no such barriers for inventors outside the medical profession. Otto Overbeck was a British brewer's chemist who used patents as part of an aggressive marketing strategy associated with his eponymous electrotherapy device, first produced in 1925.Footnote 17 Overbeck used patents to enhance his credentials as an innovator and purveyor of efficacious medical devices for use in the home. These patents formed part of a commercial culture which saw protection of intellectual property function as a form of authority alongside testimonials from professionals and users, appeals to novelty, and claims of scientific authenticity on the part of the inventor. For Overbeck, the patents which he took out were not designed to protect against infringement from competitors, but rather to reinforce the status of the rejuvenator as a trustworthy and effective alternative to mainstream medical practice.Footnote 18 The use of patents as marketing tools in this way elevated their meaning and significance from legal documents, conferring a recognition of novelty, to statements of effectiveness.

Whilst patenting could therefore form an important part of the commercial efforts of individuals and medical manufacturers, we know, for example, that many large companies and individual practitioners chose to approach patenting with caution. In the case of Burroughs, Wellcome and Co. it was not self-evident that seeking to protect new products through intellectual property was an appropriate or commercially desirable strategy. During the interwar period the company balanced scholarly publication with active patenting in an attempt to ‘preserve the reputation of the laboratories’ from which these products originated.Footnote 19 This approach – favouring publication over patenting – was only abandoned as competitors began to cramp the field by taking out so-called ‘blocking patents’ in order to prevent the exploitation of potentially fruitful research areas.Footnote 20 In a similar vein, the fruitful collaboration from the 1960s in the development of modern total hip-replacement prostheses between the noted orthopaedic surgeon Sir John Charnley (1911–1982) and the Thackray Company was originally characterized by the absence of patenting. Only after infringement by US competitors led to a spate of inferior imitations did Charnley and his collaborators attempt to protect the integrity of their products by taking out patents.Footnote 21 The function of patents in both of these cases was therefore primarily defensive; they were designed to prevent potential infringers from dominating the market. Seen in this context, patents and the motivation to obtain them offer a window into professional and commercial norms in biomedicine.

In this collection of papers, just as in the case of these three medical devices from the early twentieth century, we therefore encounter patents and patentees acting in a diverse range of ways. Alan Mackintosh begins with the secret, owned, Georgian medicines which were normally known as patent medicines, though few had a current patent. Up to 1830, only 118 medicines had been patented, while over 1,300 were listed in that year for taxation purposes as ‘patent medicines’. So what were the benefits of patenting and why did so many owners prefer to forgo them? Did medicine patenting affect consumer perception, and how was this used as a marketing tool? Could any medical device or therapy be patented?

Mackintosh shows that the authority of the patent was primarily a marketing tool for medicines: owners relied on recipe secrecy to maintain the value of their product, not the legal uncertainties of what was a disorganized, chaotic and expensive patent system. The patent was also exploited as a form of copyright to define ownership of a medicine's name. In contrast to later periods, novelty was not a prerequisite for obtaining a patent, and few applications seem to have been refused. Medicine patenting grew and declined, peaking in the 1750s. It was deterred by the high cost and inconvenience of application, but particularly by the increasing legal uncertainty about maintaining recipe secrecy, the growing reputational considerations for the proposer, and the provision, from 1783, of the excise stamp as an alternative form of authority.

For the consumer, Mackintosh argues, the patent provided an apparent government guarantee of the source and composition of a widely available product. Wholesalers sought to extend this assurance to all their medicines, resulting in the common name for all these owned medicines. In contrast to medicines, the patenting of medical devices or other therapies was largely unknown before the last third of the eighteenth century and seems to have been used for its stated purpose, the granting of a temporary monopoly for the inventor's benefit. Improved mechanical devices dominated this group with the patenting of other forms of therapy, such as electrical machines, being restrained by developing codes of conduct, demonstrating that this period saw the emergence of sophisticated and complex cultures of patenting in the field of medicine.

In contrast to the more clearly defined scope of patenting in relation to a single mechanism or product, the apportioning of credit and ownership in the case of surgical procedures and other forms of tacit knowledge was far more complex. Sally Frampton begins her examination of the place of surgical procedures in nineteenth-century Britain with an episode during the 1840s which seemed to clarify to the British medical profession the inapplicability of patents to surgical practice: the controversial attempt by two American practitioners to patent the anaesthetic agent ether under the name ‘Letheon’. A growing consensus emerged soon after that patenting in surgery was both morally dubious and practically untenable. Instead, surgeons pursed other routes in order to secure credit – both social and financial – for their inventions, although the nature of surgical practice, where constant modifications to operations were taking place, meant that negotiating credit was rarely a straightforward process.

While surgical methods were not deemed patentable in the nineteenth century, Frampton argues, surgeons were nonetheless embedded within a culture which increasingly valued the intellectual labour of successful innovators. In an atmosphere of heightened awareness about the role of the inventor in society, and while new operations were being introduced into practice, the question of how surgeons should be recognized and rewarded for their inventions was considered one of paramount importance, both within the surgical community and outside it.

Forms of ownership, protection and recognition associated with tacit knowledge have always been ambiguous, and surgical procedures exemplify this. On the other hand, the pharmaceutical industry appears to be inextricably bound up with patenting and profitability. Joseph Gabriel explains changes in attitudes towards the patenting of drugs in the American medical market from the mid-nineteenth century to the period immediately following the Second World War. Gabriel argues that protracted, yet substantial, shifts took place in the ethical sensibilities surrounding these practices. Manufacturers and physicians alike initially viewed patenting as a morally questionable activity; reputable manufacturers did not engage in patenting, while medical practitioners frequently refused to prescribe drugs which had been patented.

This scorn towards patenting, mirroring in some ways the case of earlier English medical patenting discussed by Mackintosh, was gradually softened in the latter part of the nineteenth century. As Gabriel shows, by the outbreak of the First World War many physicians had begun to argue that patenting and the associated profitability enabled companies to pour greater resources into developing new products, even if physicians themselves were unable to profit from their own patented preparations. The stipulation from professional bodies that physicians could not receive financial reward for their innovations was, however, eventually to make way for an ethical framework which permitted medical practitioners to protect their innovations using patents and to receive profit from the use of these drugs.

Gabriel therefore charts a significant sea change in both the informal attitudes towards, and formal ethical governance of, the wider patent culture of drug development, manufacture and usage in the United States. Meanwhile, for the British case, Claire Jones examines the parallel context of medical and surgical patenting around the turn of the twentieth century. Jones argues that many in the medical profession regarded patenting of medical and surgical devices as a dangerous hindrance which impacted negatively on the treatment options which they could recommend to patients. However, Jones argues, the strict codes of conduct which arose from this approach led many practitioners to consciously rebel and assert their right to protect and profit from their innovations. The legacy of the discord outlined by Jones was long-lived, and the repercussions of an assertive approach to regulating medical practitioners’ patenting habits continue to affect the landscape of medical practice in Britain, where the regulation governing innovation in pharmaceuticals and devices is markedly different.

It is clear that the professional status of patented medicines, practitioners and the companies who sought to explore the market for new products was transformed in the period from the 1780s to around the 1920s. Through wider cultures of ownership, invention and practice in medicine, patents became associated with expertise, authority and efficacy to a degree which far exceeded the legal meaning of the patents themselves. Indeed, the very meaning of the word ‘patent’, especially in relation to pharmaceutical preparations, became virtually unrecognizable, whilst attempts to protect surgical devices and procedures during the nineteenth century met with various degrees of resistance from the medical establishment. Parallels between Britain and the US are clearly visible as both countries shared a similar model of patenting and common professional ethical guidelines for practitioners.

The overall argument which emerges from the papers is threefold: first, that the motivations for choosing to patent or not to patent were highly variable. Within the medical profession some sought financial gain from sales or patent licensing achieved by legal protection from infringements by rivals, whilst for others the imperative was to make their devices freely available, often in exchange for other forms of professional credit or eponymous recognition. By contrast, manufacturers and others outside the medical profession were able to capitalize on their exemption from medical codes of conduct, being free to use the patent system more creatively and without fear of professional repercussions. Second, patents associated with a device affected not just its status as novel or new, but also its price, availability, and even perceived therapeutic or diagnostic efficacy. When patents expired this had a knock-on effect on the commercial and clinical role of medical technologies. Consequently, patented instruments and/or products, and those named eponymously after specific individuals, influenced the cachet and credibility of their inventors among both professionals and high-street entrepreneurs. Finally, this collection demonstrates that initial, strong taboos against proprietary appropriation seem eventually to have been overcome by the precepts of Anglo-American liberalism that privileged novelty above ethics. In essence, potential commercial encroachment into medicine was rationalized and justified through claims of increased innovation. However, existing scholarship does not explain how, why and when this transition occurred.

The transition from abstention to engagement with patenting cultures reflected a broader shift which took place from the late nineteenth century onwards, with a particular form of Anglo-American liberalism coming to dominate the landscape of intellectual property. This model, in which patenting was a key strand, challenged traditional resistance to proprietary appropriation in medicine and has come to dominate the global medical industry. Further, whilst the origins of this particular approach did indeed lie in the patenting systems of the US and Britain, other countries, such as Japan, looked to these as a model for implementing strategies of their own. The essays in this collection explore the development of and resistance to the implementation and export of new approaches to patenting in biomedicine, the role of physicians and manufacturers in both directing and responding to these changes, and the impact of this complex interplay between invention and market on health care practices.

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