From academic laboratory to the market: Disclosed and undisclosed narratives of commercialization

Abstract

This paper examines how the Weizmann Institute of Science has been telling the story of the successful commercialization of a scientific invention, through its corporate communication channels, from the early 1970s to today. The paper aims to shed light on the transformation processes by which intellectual-property-based commercialization activities have become widely institutionalized in universities all over the world, and on the complexities, ambiguities and tensions surrounding this transition. We look at the story of the scientific invention of Copolymer-1 at the Weizmann Institute of Science and its licensing to Teva Pharmaceutical Industries, which subsequently developed the highly successful drug Copaxone for the treatment of multiple sclerosis. We argue that, in its tellings and retellings of the story of Copolymer-1, the Weizmann Institute has created narratives that serve to legitimize the institution of academic patenting in Israel.

Keywords

intellectual property patents research commercialization technology transfer

Introduction

In the early 1970s, researchers from the Weizmann Institute of Science, led by the biochemist Meir Wilchek, made a series of innovative discoveries associated with processes of affinity chromatography and the avidin–biotin system. Their findings were subsequently developed into a variety of applications that were adopted for industrial use and revolutionized the pharmaceutical industry.¹ As Wilchek later recalled, no patent was issued at the time, ‘because the President of the Weizmann Institute told me that what we are doing, we are doing at public expense, and therefore it belongs to the public, and we do not apply for patents’.²

Yet, another innovative scientific discovery, made during those same years by a different research group at the Weizmann Institute was handled somewhat differently. The research group, led by Professors Michael Sela and Ruth Arnon, developed a synthetic polypeptide, Copolymer-1, which proved to be an effective treatment for experimental autoimmune encephalomyelitis (EAE), an inflammatory and demyelinating condition that is similar to multiple sclerosis (MS) and can be induced in animals. In contrast to Wilchek’s invention, Copolymer-1 was patented in the early 1970s, for reasons that will be discussed here, and was later licensed to Teva Pharmaceutical Industries, which developed the drug Copaxone for treating MS.

Today, it is commonplace for universities to commercialize their research, primarily through the mechanisms of patenting and licensing, whereby a company acquires the right to use a university’s patented invention under specific terms in return for a royalty from the sales of the product developed and sometimes also an upfront payment (Rhoten and Powell, 2007). Accordingly, university ownership of intellectual property (IP) has become a taken-for-granted, normative system that considers legal protection for scientific inventions as a necessary, beneficial and inseparable part of the current public mission of research universities (Berman, 2008; Colyvas, 2007; Kleinman, 2010).

Yet, as suggested by the Institute President’s response to Wilchek in the early 1970s, universities did not always embrace commercialization. The Institute’s stance with regard to Wilchek’s invention corresponded to the normative climate at the time in Israeli universities and in the global scientific community, according to which the idea that academic scientists should seek to patent their work was considered inappropriate, and certainly was not the norm (Berman, 2008; Colyvas, 2007; Colyvas and Powell, 2006; Jones, 2009; Metlay, 2006). Indeed, the worldwide institutionalization of academic research commercialization is the outcome of a gradual process in which specific mechanisms of commercialization – patenting and licensing – have taken precedence over other mechanisms. During this transition process, the act of patenting, once considered a questionable pursuit in terms of scientific ethics and prestige, came to be perceived as mainstream, taken-for-granted and respectable.

In this paper we present a case study of the commercialization of Copolymer-1 and the development of the drug Copaxone. Our interest is in how the Weizmann Institute has communicated the story of Copolymer-1 and its commercialization throughout the years and to different audiences. Analyzing the Institute’s press releases and official publications, in addition to press interviews with Institute scientists, we are able to look into the complexities, internal contradictions and tensions surrounding this transition process. This analysis also allows us to examine the narrative that the Institute has sought to promote to different audiences, and the manner in which this narrative conceptualizes the notion of science, the scientist’s role, and the public role of the Weizmann Institute as an academic research institute.

A substantial body of research focuses on the impact of commercialization and patenting on academic research and culture (e.g. Evans, 2010; Kleinman, 2010; Powell and Owen-Smith, 2002; Powers and Campbell, 2011; Sapir and Oliver, 2016). Comparatively little attention has been given in research to the rhetoric surrounding these phenomena. Most of the studies that explore these issues examine the discourse of science and technology public policy (e.g. Krücken et al., 2007; Lockett et al., 2015; Metlay, 2006). Little attention has been devoted to organizational communication by academic institutions in the context of research commercialization (for an exception, see Gulbrandsen, 2012).

Our study explores how the Weizmann Institute structured, framed and narrated the story of Copolymer-1 from the early days of the scientific breakthrough until its current commercial success. Our interest is not in a case of ‘egregious violations of academic norms’ (Kleinman, 2010: 25), but rather in a scientific, commercial and medical success story, one of the earliest cases of successful technology transfer. We show how the Weizmann Institute told the story of Copolymer-1 in a way that emphasized certain elements of the story, moderated additional elements, and completely silenced other aspects to create an influential narrative of basic research, service of the public good, the merits of technology transfer in general and the Weizmann Institute’s model in particular. In particular, those aspects of the story that are silenced or concealed reveal dilemmas and ambiguities associated with research commercialization: institutional conflicts of interests, unequal power relations between academia and industry, the alleged dispossession of graduate students with regard to their rights in inventions and the effects of the IP regime on academic science.

Methods

To study the story that the Weizmann Institute tells of Copolymer-1, we rely mainly on the Institute’s formal communications, which include press releases, booklets and brochures intended for external audiences, and the Institute’s in-house newsletter. Most of these items were retrieved from the Institute’s public relations archive; others were retrieved from the web. We also rely on press interviews with the inventors, and publications the inventors produced concerning Copolymer-1, such as articles in scientific journals and an authorized biography of one of the inventors. We supplement the archival records with five interviews with scientists and academic managers from the Weizmann Institute and two interviews with managers from Teva Pharmaceuticals.³ Additional supplementary materials include media publications covering the story of Copolymer-1 and the drug Copaxone. The period covered by the data sources ranges from the early 1970s to 2015.

Our focus is on the genre of organizational communications, defined as texts that organizations produce to manage the perceptions of different groups of stakeholders in an effort to construct and maintain a positive image (Caruana and Crane, 2008; Cheney et al., 2004). As such, these texts not only constitute a strategic resource for management, but are also producers and the objects of power relations (Beelitz and Merkl-Davies, 2012; Leonardi and Jackson, 2004).

The invention and commercialization of Copolymer-1

The Institute was founded in 1934 as the Daniel Sieff Institute, a research institute engaged mainly in basic research in chemistry. In 1949 the Institute was re-inaugurated as the Weizmann Institute of Science, in honor of its founder, Dr. Chaim Weizmann, and was transformed into a full-fledged research campus, which housed faculty and research facilities not only in chemistry, but also in all of the basic sciences. In the late 1950s and the early 1960s, it began to offer graduate and postgraduate tutelage in the sciences. Today, the Institute is a public research university and a world-renowned research center with a basic research orientation in the areas of biology, biochemistry, chemistry, physics, and mathematics and computer sciences.

The process leading from the invention of Copolymer-1 to its commercialization as Copaxone can be divided into four periods: the period of scientific research at the Weizmann Institute (1967–1977), the period of clinical trials (1977–1987), the period of industrial development (1987–1996) and the period of sales of the drug (1997–present). For each period we describe dominant themes that emerged in the Institute’s official communications, alongside elements that were omitted or silenced. We show how the narrative transformed over the years, and how this transformation was reflected in the specific use of concepts, categories and metaphors. We take note of the undisclosed elements in the Institute’s communications and discuss the concrete silencing strategies, beyond the use of rhetorical means, that the Institute used in specific cases.

Period 1: Scientific experimentation, 1967–1977

A possible key to combating the dread disease of MS was suggested by Professor Michael Sela … in a lecture he gave this week at the International Health Conference. … A team of scientists, working with Prof. Sela … has shown in recent years that several synthetic substances, which they prepared, can suppress experimental allergic encephalomyelitis, even when they are administrated as late as five days after the initial disease-inducing injection of the protein that causes it. This may have implications for treatment of MS.⁴

In the late 1960s, in the Chemical Immunology Department of the Weizmann Institute, Prof. Michael Sela, Prof. Ruth Arnon and their PhD student, Dvora Teitelbaum conducted experiments aimed at testing the influence of synthetic molecules on the immune system. They synthesized a series of random copolymers of amino acids and attempted to use them to induce EAE in animals; EAE is the animal model that most closely parallels MS. After more than a year of failed attempts, they decided to turn to inhibition experiments and use the copolymers to inhibit the disease. The results showed high efficacy in suppressing EAE for one of these copolymers, Copolymer-1, without toxic effects (Arnon, 1996: 2–4; Goldstein, 2013: 322–324; Scheindlin, 2004: 7–8).

A handful of press releases and items in the Institute’s internal newsletter were published in the early 1970s, reporting on a promising scientific innovation developed by Sela, Arnon and their colleagues, who had ‘found that a synthetic polypeptide, which they call Copolymer-1, is apparently capable of suppressing EAE in guinea pigs, rabbits, and rhesus monkeys, but will not cause EAE in these species’.⁵ The publications were released in the context of reports on research grants awarded to the scientists, and their presentations in scientific conferences. In this period, the publications referred to the nature of the invention as a scientific achievement and, accordingly, used terms that focused on the scientific process: ‘[U]sing a sensitive technique to observe the interaction between antibody and liposomes (artificial globules of fat, microscopic in size, to which antibodies may attach), the scientists hope to learn more about immune reactions specific towards protein and lipid (fatty) components of myelin’.⁶ The publications also incorporated rhetoric from medical discourse that conveys vague therapeutic potential with a highly impressive aim: ‘suppress the disease’, ‘combating disease’ or ‘implications for treatment’.

Notably, none of the publications in this period mentions that when the scientists realized that they had uncovered a potential therapy for MS, they turned to Yeda, the Institute’s technology transfer company, which in 1971–1972 submitted patent applications for the copolymer in Israel and abroad. Although Yeda was established in 1959, its main area of activity in this period was the production of laboratory research materials, instruments and research contracts with industry. IP protection was a relatively minor activity.⁷ As discussed above, during this time period, the patenting of research results was not an accepted norm among Institute scientists. One rationale for avoiding patenting stemmed from the view that the mission of universities was to create knowledge for the public good. Another common concern was the implication for personal scientific reputation. Describing the atmosphere at the Institute in the early 1970s, Sylvia Flowers, who was the secretary of the Institute’s President in the years 1967–1970 (Flowers, 1975: 238, 243), wrote in her dissertation,

As long as external research grants were assured, no great enthusiasm for the scheme was shown by the scientists, and Yeda has never proved to be the hoped-for panacea for Institute financial ills nor has it been instrumental in integrating the scientists more fully in the technological, industrial and pharmacological scene. Their interest has not been engaged, neither has their insularity been breached …. Intellectual snobbery may be an acknowledged factor in the patent disinterest shown.

Yet, in the 1970s, Sela was an eminent scientist who held major scientific awards⁸ and did not have to worry that patenting might compromise his scientific reputation. He also served then as the Institute’s Vice President and was exempt from asking for approval for patenting. His actions would have fit the early institutionalism of technology transfer in Stanford University as described by Colyvas and Powell (2006): Highly prestigious scientists were among the first to engage in technology transfer, thus according it higher legitimacy among their colleagues. In this sense, Sela and Arnon can be considered ‘Engaged Traditionalists’, on the terminology of Owen-Smith and Powell (2001: 13): ‘While sharing the academic exceptionalism of the old school, these scientists take the individualist view that personal commitments to academic values enable scientists to reap largely separate benefits from commercial and academic endeavors’.

Period 2: Clinical trials, 1977–1987

Clinical trials for an Institute-developed material which may someday be helpful in arresting the progression of crippling MS are now underway. … Initial tests on MS patients have been carried out in Hadassah. … The expanded trials are designed to provide more definite answers concerning the possible clinical applicability of the treatment.⁹

By the mid-1970s, the scientists had developed Copolymer-1 to the furthest extent possible within the constraints of the Institute, including carrying out animal toxicology experiments, and began to seek out physicians or pharmaceutical companies that would conduct clinical trials.

Preliminary clinical trials were held at Hadassah Medical School, and were conducted by Dr. Oded Abramsky, who was a doctoral student of Arnon’s. Copolymer-1 was first administered to four patients with advanced MS. The patients showed no improvement in their condition, but there were also no side-effects. The scientists began to look for a clinician who would be able to perform further clinical trials in patients with less severe conditions. Arnon succeeded in persuading two neurologists to do so, Dr. Helmut J. Bauer in Gottingen and Dr. Murray B. Bornstein of the Albert Einstein College of Medicine in New York. Bauer conducted an open-label trial (with no control group) that mainly confirmed the safety of the treatment (Arnon, 1996: 5–8).

In 1978, Bornstein conducted a second preliminary clinical trial with four patients with relapsing–remitting MS and twelve with the chronic–progressive form of the disease. Subsequently, between 1980 and 1985, he conducted two double-blind controlled trials, the first involving exacerbating–remitting patients and the second chronic–progressive patients. The trials were conducted under an FDA Investigational New Drug application and were supported by an NIH grant and other research grants. No industrial sponsor was involved. During most of this period, Sela and Arnon turned their laboratory at the Institute into a production site to supply the needed amounts of Copolymer-1 for the patients participating in the clinical trials. Eventually the researchers subcontracted the penultimate stage of production of Copolymer-1 to the Bio-Yeda company (Arnon, 1996: 5–10; Goldstein, 2013: 324–326; Scheindlin, 2004: 8–9). When the trial with exacerbating-remitting patients was completed in 1985, 56% of the patients on Copolymer-1 suffered no relapses, compared with 26% of the patients on placebo. The frequency of relapses over two years in the placebo group and in the Copolymer-1 group averaged 2.7 and 0.6 per patient, respectively. Adverse side effects were minimal (Goldstein, 2013: 326; Scheindlin, 2004: 8).

In 1985, Sela, who had been appointed as Institute President, contacted his friend Eli Hurwitz, the CEO of Teva Pharmaceutical Industries in Israel, and presented the data to him (Goldstein, 2013: 327–329; Sela, 2004: 41). Teva and Yeda began negotiations, which in 1987 culminated in a licensing agreement. In the same year, the positive results of the clinical trials were published in the New England Journal of Medicine (Bornstein et al., 1987).

In this period the Institute issued several press releases and published items in Interface, the Institute’s science magazine geared toward the general public. As the trials progressed and the clinical potential of Copolymer-1 became clearer, the terms used to describe the potential medical applications of the compound became more concrete, ranging between optimistic and highly enthusiastic. These terms included ‘a possible cure’, ‘a potential drug’, ‘a new therapy’, ‘may also be useful in parallel human situations’ and a ‘very promising drug’. The Institute’s publications also continued to conceptualize the invention as a product of scientific research, emphasizing its innovative nature (‘new approach to MS’) as well as its material aspects (‘anti-MS substance’, ‘man made material’ and ‘Institute-developed compound’).

What the publications omitted was the work that the scientists put into the search for clinicians who would conduct clinical trials, the search for pharmaceutical companies that would develop the drug, and the efforts that the lab was investing in producing the materials for the clinical trials. Arnon wrote about these efforts in an article she published in 1996 in a scientific journal, Immunology Letters, addressed to her scientific peers:

I recall this time as ‘the peddling period’. I participated in almost any conference, large or small, which dealt with MS. I presented our experimental data, wherever possible I screened the film on the baboon and talked to everyone who was prepared to listen. (Arnon, 1996: 5)

We tried to interest various firms in Cop 1. I remember my visits to Johnson and Johnson in New Jersey, and at Upjohn in Kalamazoo, and talking to the Directors of Research, presenting to them our experimental and clinical data. Trying to arouse their interest in Cop 1. To no avail. (Arnon, 1996: 7)

Our role in this trial was to supply the needed amounts of Cop 1. … It is a rather complicated procedure which takes at least 2 weeks in addition to the prior synthesis of the monomeric N-carboxyanhydrides. Using laboratory-scale equipment, we could prepare only gram amounts at a time, and this meant that our laboratory was converted into a mini-factory that was constantly busy for those several years with the preparation and testing of Cop 1. … Considering the fact that we were working under research laboratory conditions and scale, it was a major effort for us to cope with the rate of synthesis and did not leave us much time for research. (Arnon, 1996: 6–7)

These efforts were not mentioned in the Institute’s publications in this period or in interviews with the scientists. In later years, after the drug sales began, the quest for doctors who would conduct the clinical trials was mentioned at least twice in the Institute’s publications,¹⁰ and the scientists’ efforts to arouse the interest of pharmaceutical companies were mentioned at least once, in a press interview with Arnon (Ron, 2008). Yet to our knowledge, not a single one of the Institute’s publications has referred to the extensive production work in the scientists’ lab. In today’s ideological climate, such an activity would be referred to as ‘academic entrepreneurship’, a highly-valued principle in the current academic field. However, entrepreneurship was not a value for the Weizmann Institute in the 1970s -1980s, and it seems not to be a value today. As an institute of basic research, the Institute conveys images of scientists holed up in their labs, engaged in curiosity-driven research, and ‘[embarking] daily on fascinating journeys into the unknown, seeking to improve our understanding of nature and our place within it’ (Weizmann Institute, 2015). This image is a far cry from the image of entrepreneurial scientists ‘peddling’ their ideas at medical conferences and in industry conference rooms, or even worse, converting their laboratory into a ‘factory’ for industrial uses.

Period 3: Industrial development, 1987–1996

The Weizmann Institute announced today that a new drug application for the product Copolymer-1, a drug discovered by the Institute for the treatment of relapsing-remitting MS patients, has been submitted for filing by Teva with the US FDA. … It is the product of a program of basic research at the Weizmann Institute which set out to specifically block the underlying disease process of MS.¹¹

In 1987, Copolymer-1 was licensed to Teva, and the industrial development of the drug commenced. In the first two years after licensing, Teva struggled with manufacturing the drug, adapting the procedure used in the Institute’s laboratories to an industrial scale and developing a production process that complied with Good Manufacturing Practices (Arnon, 1996: 9). Once production problems were solved, Teva began to conduct Phase III multicenter clinical trials. In 1994 Teva announced the completion of clinical trials and its decision to submit the drug to the US FDA for evaluation. The application was submitted in October 1995 and was approved by the FDA in December 1996.

In this period, the Institute’s public relations department produced many materials, press releases and other publications. The scientists, who were continuing research on the copolymer’s mechanisms of action, gave numerous interviews to the press. Copolymer-1 continued to be referred to as both a medical and a scientific innovation, described as an ‘innovative drug’ and a ‘revolutionary treatment for MS’, with emphasis placed on medical impact and patients’ relief. Three new themes emerge from the publications produced during this period, themes that, even today, continue to be present in the Institute’s communications on Copolymer-1: a national ethos, basic science ideology and marketization.

First, the Institute’s collaboration with Teva was framed as a contribution to the national economy and as a source of national pride, as an ‘all-Israeli-developed medication’, and ‘one of the first Israeli medications to receive FDA approval’. For example, omitting mention of the search for pharmaceutical companies in the US and other countries, Sela claimed in an interview that ‘the Weizmann Institute has stipulated that the drug must be produced in Israel. This is going to be a blue-and-white medicine with medical and economic significance’ (Peleg, 1987).

The second dominant theme was an emphasis on basic research, reflected in a number of recurring motifs. The publications emphasized that the applications had been built on a foundation of basic research (‘this drug is the product of a program of basic research at the Weizmann Institute of Science’), that the new drug was a product of curiosity-driven research (‘No one envisioned a defined medical purpose’, ‘the idea was not to cure MS’) and that the research leading to the discovery had been of a long-term nature (‘a quarter of a century of research’, ‘research that started 20 years ago is bearing fruit today’). In addition, the publications pointed to the complex and uncertain nature of basic research (‘research began with a false scientific hypothesis’, ‘failed attempts to induce EAE’).

The Institute’s communications were thus celebrating the ideal of ‘pure’ scientific enquiry, a hallmark of the professional ideology of science. The ideology of science portrays basic research done in universities as a noble vocation, part of a dignified tradition, unhampered by demands for application. The ideal of basic research serves scientists both as a rhetorical resource in bolstering scientific claims for public support and as a source of identification and pride (Gieryn, 1999; Mulkay, 1976; Slaughter et al., 2004). The 1980s and 1990s were a period of economic crisis in the Israeli academic system, especially at the Weizmann Institute, which reached a deficit of $21 million in 1994. The Institute’s use of ‘vocabularies of justification’ (Mulkay, 1976), referring to basic science and the contribution of the discovery to the public good, was directed towards the public, towards the Institute’s donors and especially towards the government, whose support of university budgets had drastically declined in this period.

The third theme that was prevalent in Institute publications in this period was marketization, the use of market concepts, which took shape in an implicit and indirect manner. The patents associated with Copolymer-1 were first mentioned in the Institute’s PR communications in 1987, in the context of the agreement with Teva, as a short statement of fact (‘patented by Yeda’, ‘Yeda licensed the right to develop, produce and market Cop-1 for the treatment of MS to Teva’).

In addition, the wording used to describe the invention – which had previously consisted primarily of medical-therapeutic and scientific-innovative concepts – began to draw from market discourse. Copolymer-1 was now described as a product (‘our product’, ‘a new drug application for the product Copolymer-1, a drug discovered by Weizmann Institute, has been submitted by Teva’). In the mid-1990s, alongside language that commodified the scientific invention, the Institute’s publications began to include a new emphasis on the specificity of Copolymer-1 to MS (‘Cop-1 specifically designed to treat MS’, ‘designed specifically for relapsing remitting MS’, ‘specific to the disease as opposed to other drugs’), and on the issue of side-effects (‘short-lived side effects’, ‘low level of side effects’). This new emphasis on ‘specificity’ was a reaction to the introduction of competing drugs in the market by two leading biotechnology firms: Chiron Corp’s Betaseron in 1993 and Biogen’s Avonex in 1996. Unlike Copaxone, these drugs were based on interferons, a family of naturally-occurring proteins, which attack the immune system and have broader side effects. The Institute’s publications barely mention the commercial competition, but they stress the benefits of Copolymer-1. Publications and interviews with scientists in this period further omit the difficulties Teva encountered in the development of Copaxone, which are, again, described by Arnon (1996: 9) in the article she wrote for Immunology Letters.

Period 4: Commercial sales, 1997–present

Copaxone – interface between past and present. In the 1950s, Ephraim Katzir of the Weizmann Institute of Science, later fourth President of the State of Israel, commenced research on the properties of proteins – the building blocks of all biological systems. This research led to the design of simple synthetic models of proteins, called ‘polyamino acids’. His research student at the time, Prof. Michael Sela … decided to test the influence of these synthetic molecules on the immune system. This research led him to the conclusion that it might be possible to use these synthetic substances to curb symptoms of multiple sclerosis … These experiments eventually led to the development of Copaxone, and clinical trials carried out by Teva showed its efficacy in treating MS. … Today, following ten years of active sales in the U.S. and in 40 countries around the world, Copaxone has made a significant contribution to Israel’s economy.¹²

In 1997, Teva began to market Copaxone worldwide. After a slow and disappointing entry into the American market, sales of Copaxone soon increased. Teva reported sales of $53 million in the 2nd quarter of 2000. Global sales of Copaxone reached $261 million in 2004, and $1.7 billion in 2007. In 2013, sales reached $4.3 billion. Today, Copaxone is the market-leading therapy for relapsing-remitting forms of MS. About 35% of all patients taking a drug for MS take Copaxone (Comer and Looney, 2014; Sheva, 2005).

The Institute’s publications during this period are very similar to those of the previous period (1987–1996), with continued prominence of the three themes of national ethos, basic science and marketization. But a new theme emerged during this period: the ‘Weizmann Institute tradition’ and model of technology transfer, dating back to the Institute’s founder, Chaim Weizmann, a prominent scientist and Israel’s first president, ‘who owned over 100 patents’. In a November 2000 article in the magazine BIOTECH International, the Institute’s former Vice President for Technology Transfer, Prof. Mirelman, was quoted explaining this ‘underlying tradition’ to then-US Vice President, Al Gore, who was visiting at the time: ‘Since Dr Chaim Weizmann was the President of the Institute, it has been believed that if there was a scientific breakthrough, the mechanisms of bringing initial results so that industry and science could benefit had to be in place’. The work of Prof. Arnon is mentioned in the article as ‘an excellent example of this tradition’, and Arnon herself claims that ‘she has no idea why she chose to patent Copolymer-1, but insists that it was one of her most enlightened moments: “without the patent we would never have found a company to produce and market it”’ (BIOTECH International, 2000).

A characteristic of this period is the gap between internal and external publications, as the Institute’s internal newsletter mentions what never appears in press releases and other external publications: the large stream of royalties that the Institute received from Copaxone sales. For example, in a column titled ‘From the desk of the President’, which appeared in June 1997 in the internal newsletter, the Institute’s President at the time, Professor Haim Harari, wrote in reference to Copaxone: ‘In recent years we have been able to prove that a scientific institute that focuses on basic research can also produce remarkable scientific results, that also (and there is no shame in that …) provide us with a nice income’.¹³

As is apparent from Harari’s choice of words, deriving income from the commercialization of academic research may not have been shameful, but it was certainly not considered to be a trivial, fully legitimized source of pride for the Weizmann Institute. In the US in the 1990s, the Association of University Technology Managers made numerous public announcements regarding income and revenues; however, these announcements ceased in the 2000s and were replaced with general ‘public good’ statements and annual reports full of statistics but lacking concrete data about annual income. Greenberg (2007: 61–62) attributes this development to universities’ fear that providing concrete information about their financial gains might cause the public and politicians to believe that when universities act as commercial enterprises they do not deserve their tax-exempt status and other benefits.

In Israel, university officials and technology transfer company managers expressed similar views. ‘If we cultivate the idea that universities may be economically supported by the knowledge that they generate, there is a real danger that the state may free itself from its obligation to support the universities’, warned Prof. Ziv, former President of the Israeli National Academy of Sciences in 2002. Whereas in the 1960s–1980s technology transfer companies did publish their revenues, in recent years, these companies have strongly echoed US Association of University Technology Managers’ approach. There are press releases and interviews in which celebrated success stories and the public benefits of ‘technology transfer’ are praised, but the raw data of income are usually left unpublished.

Silencing and concealment

In previous sections we described what Huckin (2002) refers to as textual silences, ‘the omission of some piece of information that is pertinent to the topic at hand’, and a specific genre of these silences, manipulative silences, ‘those that deliberately conceal relevant information from the reader/listener’ (Huckin, 2002: 348). We have shown how specific topics – the entrepreneurial activities of scientists, difficulties in the commercialization process and the Institute’s income from commercialization – are not mentioned in the Institute’s communications. However, withholding information from corporate communications was not the only mechanism by which the Institute concealed information pertaining to the commercialization of Copolymer-1. Additional activities included behind-the-scenes political activity and the use of legalistic and monetary mechanisms. Below, we briefly discuss three cases in which concrete silencing practices were employed.

Dispute with Teva over Copaxone royalties between the years 1997 and 2000¹⁴

The end of the long and costly process of Copaxone development meant that Teva was obligated to pay the Institute royalties of approximately eight percent of sales (Goldstein, 2013: 342; Weinreb, 2013). Teva had agreed to pay this relatively high percentage of royalties because it had purchased the license after the successful completion of Phase II trials, which had been conducted by Dr. Bornstein of the Albert Einstein College of Medicine in New York. At this stage, Teva formed a strategic alliance with global pharmaceutical company Hoechst Marion Roussel and U.S. pharmaceutical company Marion Merrell Dow to market and distribute Copaxone. Teva received $50 million from these partners as an up-front payment for the rights to distribute the product. There are different versions of the dispute that developed. According to Yitzhak (1997), the Weizmann Institute was denied its part of the up-front payment. According to Sela’s biographer, the Institute was to receive royalties from Teva’s shares of the sales, but not from the subsequent sales by Teva’s partners (Goldstein, 2013: 342). After attempts to talk to Teva’s CEO failed, the Institute decided to sue. Yet the day before the Institute’s lawsuit was to be tried in court, the Institute and Teva agreed to handle the case through confidential arbitration. At the end of the process, a compromise was reached, which was very close to the Institute’s position. Teva had to pay the requested royalties from sales of Copaxone, sales that, at the signing of the original licensing agreement, no one had foreseen would amount to hundreds of millions of dollars per year.

The conflict was rife with hostility, threats and defamations. It was a ‘world war’, as described by one of the Institute managers at the time, but it was the quietest of wars, because both sides had a mutual interest in silencing the dispute and preventing it from being publicized. As a former Vice President at the Institute explained in an interview: ‘Mud can cling to both sides, so we are always very careful. Our prestige comes from the fact that we are working for the benefit of humanity. If it should appear as if we are trying to snatch the last pound of flesh and do not consider the benefit of patients, … that would be a bad thing’.

Royalties dispute with former doctoral student, 2005–2008¹⁵

In 2005, Israeli newspapers reported that Dr. Cynthia Webb, a researcher from the biotech industry, had sued the Weizmann Institute. The researcher was claiming that she was one of the inventors of Copaxone but had never been paid the royalties to which she was entitled. She alleged that thirty years earlier, while a doctoral student at the Weizmann Institute, she had been a member of the team that eventually developed Copaxone and that the patents were based, in part, on her doctoral dissertation. Webb had worked on her doctorate at the Weizmann Institute from 1970 through 1975, and had returned to the Institute as a researcher in 1977, after completing post-doctoral studies in the US. She left the Institute in 1987 and moved to the private sector. She claimed that she had not been aware of the licensing of the invention to Teva and that ‘the Weizmann Institute kept the subject top secret’. She learned about Copaxone royalties only in June 2004, when she read a newspaper article that said $60 million in royalties had been paid by Teva to the Institute. The suit also stated that the Institute had used the researcher’s doctoral dissertation as evidence in patent applications for the drug, so it was clear that she was an important player in the discovery and deserved a share of the profits. This matter was resolved in an out-of-court settlement in 2008 and was not mentioned further in media reports.

This conflict sheds light on the vulnerable position of graduate students and postdoctoral researchers with respect to their rights in inventions. In most Israeli universities the percentage given to students (and other research staff) depends on the principal investigator, with an option for an appeal before the Vice President for research/technology transfer. Such dependence on the discretion of the principal investigator is prone to problems. Shefer and Frenkel (2003) stated that in ‘Tel Aviv University and in Ben Gurion University it was reported that there were cases in which the student had to be protected from unfair distribution[s] of revenues’ (p. 67). When a dispute between a former graduate student and the Institute reached the court, and therefore the press, the Weizmann Institute took care to channel the proceedings toward a settlement of the dispute outside of court, where secrecy could be mandated.

Ethical issues: The Proneuron suit, 2007–2015¹⁶

The third case that was silenced concerns the more ambiguous question of the rationale for the mechanism of licensing (rather than selling) university-owned IP and the accountability of universities regarding industrial companies’ uses and misuses of their inventions. As noted above, a license agreement involves giving a company the right to use a university’s patented invention under certain terms, in return for payment (royalties from the sales of the product developed, and sometimes also an upfront payment). The licensing mechanism is usually justified in terms of its obvious commercial benefits, but it also has other advantages to universities, such as preventing the loss of faculty members to industry, drawing sponsored research to the university and allowing academic scientists to continue their basic research activities while industry handles the development of the product and its commercialization (Powell and Owen-Smith, 1998). Yet another rationale for licensing patents, rather than selling them, concerns the public interest. According to this rationale, academic science and knowledge are a public good, and licensing agreements must provide universities with mechanisms to ensure that their inventions continue to be used in the service of public interests. Moreover, universities are obligated to put safety measures in place to ensure that their inventions continue to be developed in cases of the sale or liquidation of companies, the shelving of projects or the misuse of a patented invention.

However, a legal battle waged at the Tel Aviv District Court, between Teva Pharmaceuticals and a startup company called Proneuron Biotechnologies, raises questions concerning whether universities that commercialize their research indeed uphold their obligation to the public good. In 2001, Yeda, the Weizmann Institute technology transfer company, signed a licensing agreement with Proneuron that allowed the company to use Copolymer-1 to develop drugs to treat neurodegenerative diseases. Proneuron was established on the basis of studies by Prof. Michal Schwartz, head of the Laboratory of Body/Mind Immunology at the Department of Neurobiology at the Weizmann Institute. Schwartz found that Copolymer-1 has neuro-protective capabilities when administered at low doses and when given at low frequency, such as once a week or once a month. These findings were reproduced in preclinical studies performed by Proneuron.

In 2003, Teva, Proneuron and Yeda signed an agreement, under which Proneuron gave Teva a secondary license to use Copolymer-1 to develop and commercialize a molecule to treat neurodegenerative diseases. The agreement was updated in 2005. The two companies established a joint venture and cooperated on preclinical trials, aiming to identify both the specific neurodegenerative disease suited for the clinical trials and the optimal drug regimen to treat the disease. Between November 2006 and November 2007, Teva conducted a Phase I clinical trial at Tel Aviv Sourasky Medical Center, in conjunction with similar trials in five other countries, which involved 13 patients with amyotrophic lateral sclerosis (ALS). The trial failed.

In 2007 Proneuron filed a lawsuit with the Tel Aviv District Court, alleging that Teva ‘was negligent to the point of jeopardizing patients’ lives’. Proneuron asked to nullify the 2003/2005 agreement and to restore Proneuron’s exclusive rights to the development of the drug to treat neurodegenerative conditions. Proneuron argued that Teva had decided to administer the drug to ALS patients on a daily basis in its clinical trials, despite the fact that preclinical trials conducted by Schwartz had shown that the molecule was harmful when given in a daily regimen in ALS models. Proneuron alleged that Teva’s decision to administer the drug daily was motivated by business considerations. Specifically, Proneuron claimed that Teva sought to avoid threatening the sales of Copaxone, based on Copolymer-1, which is given in a daily dosage to MS patients. Teva feared that a clinical trial in which the drug was administered at a low dosage, appropriate for a different neurodegenerative disease, could impair future sales of Copaxone, by showing that a weekly or monthly shot of Copaxone is as effective as daily shots.

Proneuron’s claim regarding Teva’s motivation was confirmed by documents that Teva had to reveal to Proneuron as part of the legal proceedings. In an internal meeting at Teva in 2003, it was said that ‘since Copaxone is marketed now to MS patients with daily injections, it is evidently impossible to use a similar product to treat Glaucoma with a lower dosage regime, without causing significant commercial damage’ (Apelberg, 2011). The guiding principle in Teva’s strategy seemed to be to protect the sales of Copaxone, its flagship product, at any price, regardless of new scientific findings that had emerged.

Proneuron asked to declare the suit as a triangular conflict that also included Yeda. Yeda objected, claiming that it ‘does not consider itself a party and hopes that with its erasure from the suit there will be no place for its further harassment and that the attempts to drag it into a conflict concerning which it has no position, will cease’. The judge accepted Yeda’s motion, referring to ‘hints from Proneuron alleging that so-called extraneous considerations stand behind the position of Yeda also related to royalties from Teva to Yeda from the sale of Copaxone’ and stating that ‘no real evidential basis was presented for this issue’.¹⁷

Although no evidential basis was provided to the Court, this case raises serious concerns about the commitment of the Weizmann Institute to the public interest when financial gains are involved and about the utility of the patent licensing mechanism. There are claims, mainly from university officials, that royalty streams from ownership and marketing of intellectual property can offer ‘benefits greater than their magnitude suggests’, providing a ‘free and clear’ funding stream with no strings attached (Owen-Smith, 2005: 72). Yet, as the Proneuron case shows, there are strings attached to royalties, and these can reach beyond the current deal and stretch to future scientific and commercial endeavors. In the case of Teva’s alleged misuse of Copolymer-1, the Weizmann Institute chose to take a step back to a supposedly neutral position, claiming to have no part in a conflict that involved risks to human lives and public interest. In April 2015, the Court ruled in favor of Proneuron, claiming that Teva had ignored the ‘warning signs’ in its clinical trial on ALS patients (Baum, 2015).

Discussion and conclusions

Although academic patenting is not a new phenomenon, the processes of its expansion since the 1980s have resulted in the ‘transformation of an anomaly into a paradigm’ (Etzkowitz and Webster, 1995: 498). Through the creation of technology transfer offices and the standardization of related policies, practices and contracts, patenting has undergone widespread institutionalization in universities.

The commercialization of Copolymer-1 began in the 1970s, when IP-based commercialization was not a common or legitimized practice in Israel. It resulted in a huge commercial success, from which the Institute has been reaping benefits since the late 1990s. Yet success stories can be told in different ways. Research universities tell the stories of their commercial successes differently from other organizations. With deep sensitivity to public image, scientific reputation, historical mission and commitment to national goals, universities are careful in the information they provide about their commercialization activities. As a public research institute devoted to basic research, the Weizmann Institute communicated the story of Copolymer-1 differently than would have a ‘multiversity’ (Kerr, 2001) – a university that includes engineering, law schools and business.

Examining the story that the Weizmann Institute has told of the invention and its commercialization throughout the years, we gain insights into the complex ways in which market logic has gradually permeated the academic field. One prominent theme in our analysis is the university’s ambivalent attitude towards patenting. Although the Institute established the Yeda Research and Development Company, its technology transfer arm, as early as 1959, and although Yeda applied for patents on Copolymer-1 in the early 1970s, the Institute’s publications did not mention the patents until the licensing agreement with Teva was signed in 1987. From that point on, a short factual statement appeared in formal press releases, stating the existence of patents and of a licensing agreement between Yeda and Teva. As semiologist Barthes (1983: 132) argues, ‘The statement of facts or values without explaining them gives an illusory clarity, making it seem that they are obvious, they go without saying’. Explanations, or rather justifications, appear in some interviews with scientists in the 1990s and since, in which patents are presented as an inevitability in current market system: ‘without the patent we would never have found a company to produce and market it’ (BIOTECH International, 2000). Such arguments should not be seen as a rhetorical strategy, but rather as part of an ‘ideology of intellectual property – a set of taken-for-granted claims about the virtues of legal protections for inventions’ that has been widely internalized in current academic context (Kleinman, 2010: 36).

While the existence of patents was marginalized in the Institute’s communications, it was mentioned; in contrast, information on the huge royalty stream that resulted from these patents was completely omitted from external publications. The silence regarding the Institute’s revenues, on the one hand, and the emphasis on messages of the ‘public good’ and ‘contribution to the economy’, on the other, are characteristic of universities worldwide (Greenberg, 2007: 61; Slaughter et al., 2009). This behavior exposes some of the deep tensions and contradictory pressures related to the commercialization of academic research. While universities and scientists are increasingly encouraged to become entrepreneurial, to engage in technology transfer activities and to generate revenues, at the same time they must exercise constant ‘damage control’ to protect their public image against accusations of greediness, of ‘double taxation’ of the public, and of betrayal of their public mission.

Unique about the Weizmann Institute is its continued rejection of the highly esteemed value of academic entrepreneurship, and its adherence to the ideal of basic research and the associated linear model of technological innovation. This model posits that basic research can lead to applied research and development, which, in turn, produces new technology and economic growth (Slaughter and Rhoades, 2005). As such, this model rests heavily on the assumption of the separation between basic and applied/industrial research and between the university and industry. Accordingly, the Institute’s publications continually stressed how the story of Copolymer-1 exemplifies the significance of basic, fundamental, curiosity-driven science, which can later be transformed into applied and economically useful research.

Finally, the parts of the Copolymer-1 story that were omitted from the Institute’s publications, or that were actively silenced through mechanisms of out-of-court settlement and confidential arbitration, concern institutional conflicts of interest. This is one of the most neglected areas in university policy, neglected as well in research and public discourse (for exceptions, see: Slaughter et al., 2009, 2014). At the heart of the matter is the conflict between the financial interests of the universities and the public interest.

This tension is particularly evident in the Institute’s deliberate avoidance of involvement in the Proneuron lawsuit, a lawsuit alleging that Teva had used Copolymer-1 unethically in clinical trials. In this context, we see that commercialization can create covert conflicts of interest such that universities may turn a blind eye when their financial interests may be at risk, even if they do not engage in actual scientific misconduct. This case also highlights the gap between the rationale that the patent licensing mechanism can be used to protect the public good, and the actual motivation and ability of a university to monitor the use of the patent for which it owns the license agreement.

Secrecy and silencing appear to be common principles for universities and industry, and the public is thus ‘denied a look at a messy and costly underside of commercialized academic science’ (Greenberg, 2007: 34). Universities are traditionally associated with the norms of ‘open science’ and the free dissemination of knowledge. Yet they are also notorious for their lack of transparency and tendency to conceal information in order to avoid scandals. Recent research has focused on the effects of the commercialization of academic science on increasing secrecy at the expense of cooperation and information sharing (e.g. Evans, 2010; Powers and Campbell, 2011). Yet an under-researched aspect concerns the defensive strategy of concealing details from the public in order to protect the reputations of higher education institutions. Given such secrecy, it can be difficult to monitor, evaluate and criticize university-industry partnerships.

These issues may represent disruptions in the process of IP-based commercialization, but these disruptions are hardly unique to the story of Coploymer-1 and stem from tensions and contradictions that are inherent to that process: personal and institutional conflicts of interests; unequal power relations inside and outside the academy and between research students and professors, academic institutions and pharmaceutical companies; and multiple pressures from different stakeholders.

The stories that the Weizmann Institute has told of Coploymer-1 through its organizational communications are obviously idealized versions of complicated sequences of events, highlighting specific issues and marginalizing and concealing others. The Institute’s narrative choices provide us with a valuable resource for learning about the institutionalization of IP-based commercialization and how it was gradually legitimized within the academic field. An enlightening finding in this respect is the manner in which the Institute’s publications established a mutual relation between the ideal of basic research and the commercial mechanism of patenting. On one hand, commercialization is repeatedly presented as the result of curiosity-driven research, and thus the ideal of basic research is used to legitimize the pursuit of commercialization. On the other hand, the Institute’s success in commercializing Copolymer-1, and the resulting development of a beneficial drug, is presented as a justification for the Institute’s research agenda of basic science. This interweaving of the ideal of basic research and IP-based technology transfer, which celebrates ‘curiosity-driven’ and ‘undirected’ research in the context of commercialization, joins other rhetorical and silencing strategies that work by ways of selection, emphasis and omission to justify and legitimize the Institute’s commercial activities and to naturalize the field of academic research commercialization, and its underlying mechanism of IP, at large.

Footnotes

Funding

We are grateful for a Lady Davis Postdoctoral Fellowship at the Department of Sociology, The Hebrew University, which supported the first author while working on this project.

Notes

Author biographies

Adi Sapir is an adjacent lecturer in the Faculty of Education at the University of Haifa. She received her PhD in Organizational Behavior from Tel Aviv University and completed postdoctoral studies in the Department of Sociology and Anthropology at the Hebrew University. Her research focuses on the history and sociology of higher education.

Amalya L Oliver is a Wise Professor and Chair in Organizational Sociology at the Hebrew University. She graduated from the UCLA Sociology department in 1993. Her research focuses on inter-organizational learning networks, university-industry collaborations and technology transfer, knowledge intensive firms and sub-industries, and innovations and research misconduct.

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From academic laboratory to the market: Disclosed and undisclosed narratives of commercialization

Abstract

Keywords

Introduction

Methods

The invention and commercialization of Copolymer-1

Period 1: Scientific experimentation, 1967–1977

Period 2: Clinical trials, 1977–1987

Period 3: Industrial development, 1987–1996

Period 4: Commercial sales, 1997–present

Silencing and concealment

Dispute with Teva over Copaxone royalties between the years 1997 and 2000 14

Royalties dispute with former doctoral student, 2005–2008 15

Ethical issues: The Proneuron suit, 2007–2015 16

Discussion and conclusions

Footnotes

Funding

Notes

Author biographies

References

Dispute with Teva over Copaxone royalties between the years 1997 and 2000¹⁴

Royalties dispute with former doctoral student, 2005–2008¹⁵

Ethical issues: The Proneuron suit, 2007–2015¹⁶