Marketing Contraception and Control

The PillBy Agata Ignaciuk, University of Granada

Since its first commercialization in the early 1960s, the contraceptive pill has been the subject of complex and contradictory scientific, religious and social debates to an extent incomparable with any other pharmaceutical product. A gendered drug per excellence, the pill has been simultaneously embraced as a much needed effective female birth control method, separating sex and reproduction, and opposed for its dangerous side-effects and contribution to the already excessive medicalization of female bodies.

Much has been written about the introduction and circulation of this drug, especially in the national contexts of West Germany, Britain, France, Canada and the US. In my own research I aim to complete these stories through visual and material evidence collected from pill advertising in Western countries. I am particularly interested in how national differences in the practice of gynaecology and the legal status of contraception affected transnational pill marketing practices. While in the US and West Germany there were no federal restrictions on contraception during the 1960s, its trade and advertising were banned in Spain till 1978, and contraceptive advice in France was legally restricted to married women until the late 1960s. Also in Canada, Criminal Code banned sale and advertisement of contraception till 1969. Similarly, the shape of gynaecological professions and practices has also differed substantially across these countries.

Advertising campaigns for prescription drugs aimed at doctors, were and continue to be designed (as first suggested by the historian of medicine, Ludmilla Jordanova) to promote and sell not only the actual pharmaceutical products themselves, but also gendered, raced and classed ideas about women’s bodies and health, together with particular visions of a patient-doctor relationship. The historians Johnatan Metzl, Elizabeth Siegel Watkins, Irina Singh, Heather Molynaux, Ally Haggett, Carrie Eisert, Ulrike Thoms, and Lisa Malich have all made outstanding contributions to the analysis of gendered dimensions of pharmaceutical advertising, especially of psychotropic drugs and, indeed, oral contraceptives.

In early pill adverts during the 1960s aimed at the US and Western Europe, pharmaceutical companies were cautious to frame contraception as an essential ingredient for the well-being of a white, middle class family: the potential the pill had to enhance a woman’s sexual autonomy was troubling. The companies had to approach doctors and gynaecologists carefully, to convince or reassure them that family planning counselling was a legitimate part of their medical practice. This was achieved through a variety of visual and textual strategies, the aim of which was to promote the doctor’s authority as an indispensable intermediary, a gatekeeper to effective birth control.  I will focus here on discussing one such visual strategy: the use of representations of doctors in pill advertising.

Anovlar, booklet for doctors, Austria, 1965. Source: Schering Archives, Bayer AG.

Anovlar, booklet for doctors, Austria, 1965.
Source: Schering Archives, Bayer AG.

In one of the first advertising campaigns for Anovlar aimed at the West German and Austrian market, the West German company Schering – the leading European manufacturer of the pill – employed photographic representations of a conversation in a doctor’s surgery between the practitioner and a mother of two young children. A wedding ring – a symbol of marriage and, indirectly, legitimate sexual relations – was strategically placed on the seated woman’s hand encircling her baby. The doctor, standing over the patient, appeared to be patiently explaining the properties of Anovlar, while a toddler poked his lab coat pocket. The text read “Two children so narrowly spaced have been simply too much for me”.

Throughout the 1960s, similar photographic representations of medical professionals – as wise, compassionate advisers of married mothers – were frequently used by most oral contraceptive manufacturers for adverts placed in the American Journal of Obstetrics and Gynaecology, one of the main US journals for the discipline. Texts that accompanied the images of middle-aged doctors often appealed directly to control over women’s bodies, with slogans such as “For better and for worse? Often for better when the physician takes the initiative in overcoming fear of unwanted pregnancy with Norinyl” (Syntext, 1964) or “Today … at any time in a woman’s marriage… you can help her PLAN FOR A LIFETIME” (Mead Johnson, 1967) (my emphasis).

While in the US such representations and slogans were used into the early 1970s, in West Germany – as German historian Ulrike Thoms argues in a recently published book chapter– they were redundant by the mid 1960s, having fulfilled their purpose: the majority of German doctors had accepted their role as pill prescribers, initially to married women, eventually to single women as well.

In France such representations were unusual throughout the 1960s and 1970s. Another German scholar, Lisa Malich, attributes this lack of representations of doctors to the heterogeneity of the French gynaecological profession, which included a significant proportion of women practitioners. The white-middle-aged male figure, therefore, did not possess the same “advantage” of identification it had in the US or West Germany.

Similarly, in Spain, photographs of doctors rarely appeared in pill adverts, despite the profession being almost entirely masculinized till the 1970s. The national branch of Schering AG was one of the few pharmaceutical companies operating on the Spanish market that opted to use photographic representations of doctors in pill adverts during the mid-1970s. Although the pill had circulated in Spain since the mid-1960s, due to legal restrictions imposed by the national-Catholic, military dictatorship, it was officially prescribed as a therapeutic drug for menstrual irregularities. However, as I have discussed elsewhere, Spanish women were increasingly using the pill as a contraceptive, especially from the 1970s onward. In 1975 – the year dictator Franco died and the democratic transition began – Schering launched an unusual advert for Neogynona. Five professionals, all middle-aged men in suits with the central figure smoking a cigar, are described in the heading as “the satisfied”. Although the smaller text below specifies this satisfaction has derived from finally being able to “have a perfect oral contraceptive for all women”, I cannot help but see other satisfaction-related connotations in the main heading, including the sexual one.

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Patent Cultures, Unpatentable Processes: How did Victorian surgeons negotiate credit for their inventions?

Sally Frampton, University of Oxford In the vast and complicated realm of intellectual property, it can often seem like medical innovations have an ever-growing profile. Controversies surrounding gene patenting for example –  last year saw a Supreme Court decision to invalidate patents on gene sequences in the US – strike at the heart of concerns about the commodification of the human body; while the patenting practices of pharmaceutical companies remain the subject of scrutiny, particularly as a potential barrier to those in the developing world accessing medicines. In other areas of medical practice however, the role of intellectual property is less obvious. One such area is surgery. In Europe, while you are able to obtain a patent on a surgical device, you may not patent a surgical operation. [1] This is because of fears that practitioners’ freedom to operate in the manner they deem most appropriate would be limited by concerns of patent infringement, possibly endangering patient care. Thus, in today’s fast-expanding patent culture, surgery occupies a somewhat exceptional position, in that, for the most part, it is excluded from patenting. In the mid-nineteenth century, the situation was not so different; surgeons operated – quite literally – in a world in which patenting played an increasingly important role. During this time the social value placed upon invention was growing. Inventors were being re-imagined as heroic Britons who fulfilled a productive role in society, while the term ‘innovation’ began to be understood more positively, rather than signifying radicalism or instability as it previously had. Patent law began to be reformed to ensure inventors’ rights were acknowledged and the elevated place of patents in the cultural milieu reflected the issues of competition, profit and plagiarism that industrialisation brought. In a professional culture where profit-making and proprietary gestures had to be negotiated with extreme care, the place of patenting in medicine was rather more complex. In the sphere of surgery this would be exemplified by the ‘Letheon’ controversy. In 1846 two American practitioners, physician Charles T. Jackson and dentist William T.G Morton, had discovered the effects of ether in eradicating pain during operations, and had attempted to patent the substance under the name ‘Letheon’, even claiming infringement when London surgeon Robert Liston had used the method to anaesthetise his patients soon after. The British medical press emphatically condemned such use of patenting, and in an editorial of that year, the Provincial Medical and Surgical Journal  advocated a division between (patentable) surgical instruments and (unpatentable) surgical methods and modes of practice, not dissimilar to that which exists today. In reference to anaesthesia, the journal remarked that any ‘attempt to place restrictions on the mode of using a known medical agent by qualified medical practitioners, is as absurd, as its success would be mischievous.’[2] Despite this, the question of how one rewarded credit in operative surgery did not go away. In my paper for Rethinking Patent Cultures, I’ll be exploring how Victorian surgeons sought recognition for their unpatentable operations, while working within an increasingly patent-orientated culture. Should surgeons simply be satisfied with the reward of improving the lot of humanity? Or should they, as some argued, be rewarded financially for their innovations? Was it even possible to define intellectual ‘ownership’ of an operation, when procedures rapidly deviated and changed? Additionally, I’ll also be investigating how this played out on the international stage. In the second half of the nineteenth century, surgery was one of Britain’s most important and successful exports; operations like ovariotomy – thought of by British surgeons as ‘their’ invention – paved the way for abdominal surgery and the success of the operation was considered a fundamental milestone in surgical practice. As such, it was an important asset in asserting British dominance in the realm of scientific invention, particularly in relation to France. Ultimately what I hope to show is that while at first glance there may seem little to connect operative surgery with patenting at this time, it was connected to a broader patenting culture. In an atmosphere of heightened awareness about the role of the inventor in society, and while striking innovations were occurring in surgery, the question of how surgeons should be recognised and rewarded for those inventions was of paramount importance.   [1] European patent Office; 4.2 Surgery, therapy and diagnostic methods http://www.epo.org/law-practice/legal-texts/html/guidelines/e/g_ii_4_2.htm (accessed 17th June 2014). [2] ‘Inhalation of Aether in Surgical Operations’  Provincial Medical and Surgical Journal, 2 (27th January 1847) 55.

The Role of Patents and the Wireless Medical Device Market

Vena WristcuffTaken from the NERAC blog on medical innovation

Introduction to Mobile Medical Devices

Wireless mobile devices have the potential to significantly reduce medical costs, which makes the technology valuable to doctors, consumers, and insurers. Consequently, several industries are allocating R&D spending to mobile health (mHealth) technologies. A wireless medical device is defined as a medical device that utilizes Radio Frequency communication. Wireless medical devices can monitor patients in hospitals, collect vitals, monitor physiologic data for patients with chronic conditions, and dispense medication remotely. The benefits of wireless medical devices include more thorough and consistent monitoring, fewer doctor visits, increased efficiency, and reduced health costs.

By 2020, over 160 million Americans with chronic conditions will be monitored and treated remotely. The potential revenues are significant, which explains why so many industries are participating in this technological revolution. The continuing speed and volume of innovation, as well as inter-industry competition, are adding to the already dense patent thicket in the mobile medical device market. There may be some conflict between developers in the mHealth industry due to the rapid evolution of these technologies, number of industries involved, and volume of patent applications. The number of patents filed relating to the wireless aspect of devices, or medical device connectivity, has increased at a much faster rate than other device components, which suggests that there may be overlap in the scope of these claims.

What is the role of Patents in the Wireless Medical Device Market?

The purpose of patents is to protect intellectual property. Patents serve to protect a company’s investment in R&D and the value of IP while a product is being developed, and to prevent others from stealing the idea after the product is released. Patents are particularly important for high-tech companies because the initial investment in research and development is so steep. Until a product comes to market, most of the value of a new tech company lies in IP. IP can still be a company’s greatest asset, even after the R&D phase. Different companies are developing similar ideas concurrently in the mobile medical device industry. These companies are becoming more aggressive about enforcing their IP rights in an attempt to stay afloat. Given the competitive nature of this industry, it is important to understand the IP landscape and how to protect yourself and your product.

The mHealth Patent Landscape

Who owns patents in the wireless medical device market?
There are more industries involved in the development of wireless medical devices than there are for other medical devices. Only around half of the top twenty patent holders in the industry have a primary focus in the healthcare industry. Other industry players include those in communications, computer, and networking. Collaboration between industries is required because mobile medical devices require both FDA and FCC approval. Large companies in these industries hold the majority of patents.

Non-practicing entities make up another large group of patent holders. For example, the Intellectual Ventures (IV) Invention Science Fund owns several hundred patents. IV is a patent aggregator, defined as a non-practicing entity that purchases patent portfolios as an investment (not for the purpose of developing the acquired technologies.) Patent aggregators profit by claiming fees for the use of their acquired IP or selling patents to other parties for enforcement.

What Are the Causes of Increased Contention?
Historically, patent infringement conflicts in the mobile medical device market have been rare because litigation is expensive and the value of IP is not clear in the early stages of development. In 2009, over 9700 patents involving wireless communications and medical device technology had already been issued. The volume of patent litigation in the industry may increase because separately owned rights must be used collectively to develop new technologies, and the number of separately issued and pending patents is only increasing. Since patents from these different industries relate to the same technology, there may be overlap in the scope of their claims even if they evolved separately.

Inter-industry competition and the high value of IP are driving litigious action and patent contention in the industry. IP in the mobile medical device industry has become a market of it’s own. Failed companies with IP rights are immune to patent infringement counterclaims, and as a result, are becoming more aggressive about enforcing their patents in an attempt to recoup investments. Patent aggregators like IV have also created a market for companies to buy and sell rights.

Patent Thicket in the Wireless Medical Device Market

Patent thickets make it difficult to innovate within—or enter— an industry. It is more expensive to acquire licensing rights when multiple organizations own the individual patents to be used collectively. The increased cost to do business in the mHealth industry could be a barrier to entry for smaller companies. The time it takes to process patents could also slow innovation. It generally takes around three years for a patent to be issued after the initial application. Given the current speed of innovation, new technologies may become widely adopted during this time period, and subsequent technologies will develop before the original technology is officially patented. In some cases, the same technology, or the application of one component, may evolve separately. In both cases, the overlap between patent applications makes the entire process more complicated.

It is difficult to navigate the complex web of IP rights and acquire the necessary licenses. When adaptations of existing technologies develop within an industry concurrently, patent infringement is practically inevitable. All companies, big and small, must take measures to decrease risk and secure patent rights.

What purpose patenting?

I am keen that there is greater public understanding of the patent system which I see as being generally beneficial for the commercialisation of innovation in developed economies – with some caveats of course!  No system is ever perfect and patent law is no exception.  Both at the international/European level and nationally, there are more or less constant debates over changes and improvements.

The purpose of the patent system is to drive innovation (through the publication of all patent applications – and the requirement for an enabling disclosure of the claimed invention to be present in an application).  The patent is supposed to be the result of a notional bargain between the state and an inventor where a limited monopoly is granted in exchange for a full disclosure of the invention so that others can explore the invention further.

The existence of a monopoly right in an economic system based on the principles of the free market might seem strange but it is supposed to be a balance between competing interests – the need to reward and protect innovation and the need to foster technical progress.  The principle has a long historical precedent back to the Statute of Monopolies of 1624 in England & Wales and Article 1, Section 8, Clause 8 of the US Constitution (amongst others):

“To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries”

Patents are limited in terms of scope (by the granted claims), in territory (national rights only at present) and in time (20 years from filing date of patent application, with exceptional extensions for certain authorised medical/agrochemical products in some countries of up to 5 years, with the potential for 6 months extension in Europe on top of the 5 year extension also under special circumstances).  The point is that the rights are defined and limited.

Patent rights are also “exclusive rights” in the sense that a patent can only “exclude” others from performing the invention defined in the claims without a licence.  A patent is not a right to do anything.  This is an important point as there is often confusion about having a patent permitting a patent proprietor to do all kinds of things – whereas the exploitation of the patent may itself require a licence from other patent owners.

Venture capital investors often require some form of security for the investments made in a start-up company where the only assets are the people and the ideas.  Although, the company can be years away from any product, the existence of a patent application can often make the difference between securing the investment or not (so potentially some social good also).  This may be more relevant in the area of healthcare where products can take 10 to 15 years to develop and market, compared to the IT/electronics sector where product life-spans are only a few years. 

In the area of high-tech electronic devices, patents may almost be irrelevant and it is more important to be the first entrant in the market (the “first-mover advantage”).  The controversies in the IT field are currently over the existence of patents which cover technical standards and the issue of licensing to parties on fair, reasonable and non-discriminatory terms (FRAND).  The solution in the IT sector to such patents has often been to create so-called “Patent Pools” in which standards relevant patents from different companies are pooled for cross-licensing purposes.

The life sciences sector is also now looking at such ideas of “patent pools”, see for example http://www.medicinespatentpool.org/, however such concepts of patent pools may not work in all situations.

There are now plenty of savings in patent law to avoid patent infringement merely by conducting experiments on the subject matter of an invention – and in reality the costs of litigation and requirements to explore settlement pre-trial mean that patent infringement actions in the UK are only brought where there is a significant commercial issue at stake. 

Most companies and institutions are only too aware of the negative publicity arising from even possibly threatening academic institutions with patent infringement and that it is not worth the potential reputational damage.  So most companies will agree royalty-free licenses with academics of technology for research purposes (but clearly such licenses do not extend to subsequent commercial development).

Patents are not immune from challenge.  There is an application process where the Patent Office will examine the application for conformity with the standards for patentability (mostly harmonised internationally but with some exceptions).  Patent Offices are also exploring ideas of a public “crowd-sourcing” referee process too.  However, even granted patents can be challenged and revoked.  It is also necessary for a patent applicant or patent proprietor to pay renewal fees to keep the patent application pending and granted patent alive.

In the medical field, patents are possibly a slight red-herring in that the ability to place a medicine on the market in a developed economy is also controlled by regulations, so it is necessary for a new medicine to pass the necessary clinical trials standards set for safety/efficacy.  Manufacturers or importers of generic competitor products based on new chemical entities (NCEs) usually will not undertake independent clinical trials (to keep costs down), so there is a brake on their ability to rely on the clinical trial data of the innovator company of up to 10 years in Europe – which can be a more significant barrier in some cases than any patent (so-called “data-exclusivity”).  For tissue/cell based therapies generic competition is not yet a factor and data exclusivity does not apply.  Official reimbursement policies of government health departments and insurance companies may be more relevant in determining which of the new cell/tissue based therapies are actually used in a clinical setting.

Clearly an issue has been recognised in less developed economies about access to medicines – which has resulted in initiatives from the World Intellectual Property Organisation (WIPO) and others: http://www.wipo.int/policy/en/global_health/trilateral_cooperation.html | http://www.accesstomedicineindex.org/ | http://www.gatesfoundation.org/what-we-do.

The other curious thing about the sale of medicines is that consumers are very loyal to strong brands – e.g. “Nurofen” and “Anadin” are still on the market and selling well at a premium when the generic versions of ibuprofen and aspirin are available everywhere.  There are no patents now on the basic ordinary tablet forms of ibuprofen and aspirin – so the ability to charge a premium for a product can sometimes also be affected by other factors such as a strong brand.

Of course, the recent saga of the Myriad patents in the USA has shown up other issues with respect to ethics and patent law – but I think that says more about the US legal system (and healthcare industry which is driven by diagnostic testing of patients).  Myriad are not in the same position in other countries where the patent systems are different to the US.

The final irony in all this is that often our pensions are heavily invested in pharmaceutical company shares because they are seen by investment managers as being good growth stocks given the ability of the companies to make a decent level of return on investment by the companies (in the past at least).  That model is, though, possibly coming unstuck in that large pharma seems to be less able to innovate nowadays.  If patents are taken out of the equation, would there still be such a rush to invest in large pharma shares by our pension funds?  I don’t know.

The ability of the Wellcome Foundation and the Bill & Melinda Gates Foundation to invest in charitable work and projects is driven by the invested wealth of the Foundations (principally from patent royalties in the case of Wellcome; I believe that the Gates Foundation is founded more on the basis of copyright licensing royalties) but hopefully you can see at least the possibility for some social good from patents and intellectual property in general.

Nick BassilNick Bassil is a partner at Kilburn & Strode patent and trade mark attorneys. He specialises in intellectual property in relation to pharmacology and biochemistry, particularly cell and molecular biology. His work ranges from drafting original patent applications and devising filing strategies, to advising on intellectual property aspects of company mergers and acquisitions, including due diligence on intellectual property rights. His European portfolio includes post-grant opposition proceedings at the EPO, contentious proceedings in other foreign jurisdictions, as well as obtaining Supplementary Protection Certificates for pharmaceuticals.

Patenting and the Humanities

PatentFor this first blog it seems appropriate to reflect a little on an event which I attended recently at the British Library. My experience gave me a further indication that histories of intellectual property, particularly in the sciences, can bring to light important issues which are often glossed over or marginalised.

Public-facing discussions, lectures, debates, exhibitions or displays can often lead to hand-wringing, eyebrow-rolling, and a whole host of other hyphenated, physical signs of inward strife and frustration for researchers. I knew this, of course, when I signed up for the latest event in the British Library’s fascinating and stimulating Talk Science series, which ties in with a current exhibition: Beautiful Science: Picturing Data, Inspiring Insight. I also knew that the panel for the discussion event – entitled Inventions and Discoveries in Biomedicine: Patently Obvious? – was composed solely of those working in the field of science and/or innovation. The subject attracted a large audience, and there was genuine engagement with the key questions which underpinned the process of obtaining and defending patents in the biomedical sciences. This then seemed like an excellent opportunity to showcase the value of the humanities: by demonstrating the more nuanced nature of historical concepts of ownership and patenting, scholars in the arts can complexify and demythologise the debates about “good” versus “bad” habits of patenting, secrecy and protectionism.

To an extent, this was true, and the panel batted away the odd challenging comment from the floor about the dangers of a slow, cumbersome and expensive patent system. However, the ethical and historical dimensions of the question were almost totally unexplored, whilst the issue of pharmaceuticals in the developing world was entirely absent. We talked about acyclovir, Alzheimer’s, biomarkers and personalised medicine, but nowhere did malaria crop up. Tuberculosis was mentioned only in passing, and there was a corporate, Western-style market-economy-led slant on everything. I almost imagined one of the panellists shrugging his shoulders and saying: “You know, you gotta spend money to make money, kids.” There’s nothing wrong with reaching that conclusion, of course, but there was a dissenting voice missing from the panel, and the format of the event – think Question Time, but with fewer back-to-back audience comments – did not naturally lend itself to audience members stirring things too much.

This lack of a critical voice, putting things in perspective, was one which a sociologist, philosopher or historian could have easily provided. What we (well, I, at any rate) really wanted to know was why this system of intellectual property had emerged as one of the dominant forces governing the direction and structure of scientific research.

This isn’t a total tale of doom and gloom, though. After the end of proceedings I managed to have a quick chat with the Chair for the evening: Professor Jackie Hunter. As Chief Executive of the BBSRC, she is perhaps as well-placed as anyone to judge the current research landscape in the biological sciences. Within a few moments, she was very open to the idea of using history to move and inform the debate on the ethics of patenting in biomedicine, and even expressed dissatisfaction at the way in which some of her earlier research activity had been handled with respect to patenting and protection. It is important to highlight the fact that debates about seemingly ring-fenced scientific subjects often benefit from input from the humanities. This was one case in point, and the sooner a wider group of academic administrators appreciate the value of the arts subjects to inform such debates, the quicker we will have discussions which balance the economic, social and cultural impacts of academic research with issues of how scientific patenting processes actually operate. Perhaps Rethinking Patent Cultures can help.

Dr James Stark is a Research Fellow at the University of Leeds, and co-investigator on the Rethinking Patent Cultures Project. He is organising the second workshop in the programme, to be held at the Thackray Medical Museum on 14-15 July 2014.