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This post is provided by Suela Simoni, Student Assistant at Innsbruck University

While the concept of “open source” emerged as a radically open and transparent way of developing software, it is increasingly applied in other contexts as well. In pharmaceutical open source projects, for example, anyone can contribute at any time to the project, methods and data are in the public domain, and data is released as soon as it is acquired. However, compared to the software industry, open source approaches struggle to take ground in the pharma industry. As of December 2021 there has not been a single molecule worldwide, which has been discovered, developed, and brought to market completely open source. There are a few examples of patent-free molecules that have been going through clinical trials: one is the Praziquantel and the second one is the Fexinidazole. Since only a part of the process has been done openly in these cases, they cannot be considered to be completely ‘open source’. Using the example of the initiative “Open Source Malaria” and outlining the challenges they face, I will discuss why developing drugs and vaccines based on open source principles represents a difficult endeavor.

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Building upon a case study of the Medicines Patent Pool, this blogpost aims to set the Medicines Patent Pool/Merck License for Molnupiravir in a processual context.

About the License Agreement

Recently, on October 27, 2021, the Merck & Co., Inc. Kenilworth NJ USA (MSD) and the Medicines Patent Pool (MPP) jointly announced the signing of a license agreement for Molnupiravir. Molnupiravir is an “an investigational oral antiviral medicine“ against Covid-19 that has shown promising results in Phase 3 clinical trials. The drug is currently under review by the European Medicines Agency (EMA). The voluntary license and technology transfer agreement for Molunpiravir allows generic manufacturers from anywhere in the world to produce the drug and supply it to 105 low-and middle income countries (the “territory”). Manufacturers can license royalty free for the time of the pandemic

While the medical non-governmental organization Médecins Sans Frontières (MSF) criticizes the agreement for excluding “half of the world’s population and important upper-middle-income countries (UMICs) with robust manufacturing capacity, such as Brazil and China”, other medicine policy experts such as James Love or Peter Maybarduk celebrate the agreement as an “impressive achievement” or a “starting point and an example” to increasing access to Covid-19 therapies in LMICs. James Love commented that the “licensed area is large enough (more than half the world’s population) to induce efficient generic entry and economies of scale”. 

To understand the impacts of this license agreement, we take a closer look on the patent pool mechanism that is leveraged here. 

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At this year’s Global Congress on Intellectual Property and the Public Interest, which takes place October 25th-29th 2021, Konstantin Hondros and myself presented a working paper titled “Tinkering and Repurposing: How Open Source Vaccine Initiatives Alternatively Organize for Novelty“.

While the innovation brought forward by biotech and pharmaceutical companies was exceptional, many countries still lack access to vaccines. Public debates arose discussing alternative ways of handling IP in vaccine R&D beyond the prettified standards of the western dominated pharmaceutical industry.

Building upon literature on organizational isomorphism (DiMaggio & Powell, 1983) and literature about the emergence of novelty in organizations (Cattani, Ferriani, & Lanza, 2017), we argue that the westernized pharmaceutical industry – mainly in response to regulative standards – has developed highly isomorph organizational practices that might make the entering of outsiders, who apply alternative approaches to vaccine R&D (e.g., open source approaches), quite difficult. Puzzled by the question of how alternative ways of fostering novelty can be embraced and gain legitimacy in organizational fields deeply relying on isomorphism, we ask: how do open source vaccince R&D initiatives alternatively organize for novelty?

Source: PPT Presentation by Milena Leybold

We compare two empirical cases that both build on an open source practice: Vaccinuum and RaDVaC (Rapid Deployment Vaccine Collaborative). Vaccinuum (formerly OpenVax) was initially focused in developing a vaccine against SARS-CoV-2  and is now trying to discover an “Ultra-Broad Spectrum Open Source Vaccine for SARS-CoV-2 Variants and Future Epidemics” through processes of repurposing of already existing, “widely-available, approved, licensed, widely-accepted, non-exclusively manufactured, off- patent, live attenuated vaccines“.

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We, that is Sigrid Quack, Konstantin Hondros, Katharina Zangerle and I, proudly present the article “Between Anxiety and Hope? How Actors Experience Regulatory Uncertainty in Creative Processes in Music and Pharmy”, which has recently been published in “Research in the Sociology of Organizations” (RSO) as part of a volume on “Organizing Creativity in the Innovation Journey”. Check out the abstract below:

Uncertainty about Intellectual Property Regulations (IPR) is prevalent in today’s knowledge-based and creative industries. While prior literature indicates that regulatory uncertainty affects creative processes, studies that systematically analyze the effects of IPR on the experiencing of involved actors in creative processes across fields are rare. We ask how core professional actor groups including creators, legal professionals and managers involved in creative processes experience regulatory uncertainty in the fields of music and pharma. By studying practices of engaging with, circumventing and avoiding regulatory uncertainty about IPR, we show how creative processes in both the music and pharma fields are entrenched with emotional-cognitive experiences such as anxiety, indifference and hope that vary by professional group. Our findings point toward managers and legal professionals observing, exposing and cultivating emotions by ascribing experiences to other actor groups. We conclude that comparing regulation-related emotions of involved actors across fields helps to develop a deeper understanding of the dynamics of creative processes.

In case you or your institution does not have access to RSO please do not hesitate to contact me so I can send you a copy of our article.

(Image, CC0)

This post is provided by Konstantin Hondros, post-doctoral researcher at University of Duisburg-Essen in the DFG-funded research project “Organizing Creativity under Regulatory Uncertainty: Alternative Approaches to Intellectual Property”.

Though “alternative” (both as an adjective and a noun) has widespread meaning in contemporary society, it is not generally clear, what constitutes and conveys something to be (an) “alternative”. This blogpost’s goal is to offer a more nuanced understanding of the concept and ask how this can guide the use of “alternative” as an analytical lens. To begin with, I give an etymological account, then I look at “alternatives” in philosophy and its significance for epistemology, finally, I describe how social sciences make use of “alternative” in an evaluative manner. While from a philosophical perspective, “alternative” is rather a logical operator, in the social sciences “alternative” evaluates institutions, practices, or beliefs. This evaluative use can be either positive and empowering, ambivalent and skeptical, or even negative and destabilizing. I argue that it is this umbrella-term’s multi-facetted and evaluative nature that makes it analytically fruitful for social sciences.

I thus develop the concept of alternative mainly for practical reasons. Our recently kicked-off DFG-funded project Organizing Creativity under Regulatory Uncertainty: Alternative Approaches to Intellectual Property pursues “alternatives” empirically. We take a closer look at how creative processes unfold when intellectual property (IP) is approached “alternatively” and what obstacles and uncertainties these processes encounter. We compare alternatives to the IP-regulations copyright and patent law with case studies from the music economy and the pharmaceutical industries. Differentiating “ alternatives” will inform our methodological and analytical proceeding as it will give as clearer picture of what we are actually dealing with empirically.

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Over at the Käte Hamburger Kolleg / Centre for Global Cooperation Research, we have recently launched Cooperadio – The Global Cooperation Podcast. In its most recent episode on “Patents, Profits & Pandemics”, I had the honor and pleasure to host intellectual property scholar Susan Sell, who echoes a growing consensus that our intellectual property regime, that is so essential for 21st century intellectual monopoly capitalism, is hampering global health outcomes – not just in the current pandemic.

Together, we addressed questions such as the following:

  • While in regions like Europe and North America national vaccination campaigns have been picking up speed over the past months, the less well-off majority of the world has seen little to no vaccine supplies.
  • Why does it have to be like that?
  • Is there a moral obligation to make health innovations easily available globally?
  • What about the intellectual property rights of the researchers and creators of these innovations, should they not profit from their work?

Check it out!

(sigrid)

The Covid-19 pandemic is, without doubt, one of the biggest societal challenges of our times. Since its outbreak in December 2019, more than 3 million people died due to or with a Covid-19 infection. The pandemic hits the world with disastrous side effects such as economies suffering from recurrent or constant lockdowns, children who can’t go to school, or rising case numbers of mentally ill people. The most promising solution to stop the pandemic: vaccination.

In December 2020, the first person got vaccinated with the officially authorized Pfizer/BioNTech mRNA vaccine “COMIRNATY” in UK and Russia started mass vaccination with the vaccine “Sputnik V”. Shortly after, other big pharmaceutical companies such as Moderna, Astrazeneca, Sinovac, or Johnson & Johnson managed to get marketing authorizations for their vaccines. However, the vaccination campaigns proceed slower than expected: the demand for vaccines exceeds the production capacities of the pharma companies. Further, vaccines are not globally distributed at comparable rates. Unequal access to vaccines is not just a matter of injustice but imbalances also increase the risk of mutations developing in non-vaccinated countries.

Overview of vaccination rates by April 28th, 2021 (the darker the more people got vaccinated)
Source: https://www.nytimes.com/interactive/2021/world/covid-vaccinations-tracker.html

In January 2021, WHO Director-General Tedros Adhanom Ghebreyesus described the imbalance of vaccine distribution as “a catastrophic moral failure” and asked countries of the Global North to lift intellectual property protections so that countries around the world could produce vaccines. Similarly, the People’s Vaccine Alliance proposes offering the Covid-19 vaccine as a common good:

Our best chance of all staying safe is to ensure a COVID-19 vaccine is available for all as a global common good. This will only be possible with a transformation in how vaccines are produced and distributed — pharmaceutical corporations must allow the COVID-19 vaccines to be produced as widely as possible by sharing their knowledge free from patents.
Instead they are protecting their monopolies and putting up barriers to restrict production and drive up prices, leaving us all in danger. No one company can produce enough for the whole world. So long as vaccine solutions are kept under lock and key, there won’t be enough to go around. We need a People’s Vaccine, not a profit vaccine.

https://peoplesvaccine.org

This raises the question of this blog post: wouldn’t it be possible to organize the development of an open source vaccine that could be produced and distributed all over the world? Fortunately, media articles and governmental statements provide us with a rich bunch of arguments, why this is not an option. Let’s have a look at those.

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March 12-15, 2019, Freie Universität Berlin, Germany

Creativity is one of the key concepts, yet among the most slippery ones of present-day Western societies. Today, the call for creativity spans far beyond typically “creative” fields and industries towards becoming a universal social norm. Creative processes, however, are fundamentally surrounded by uncertainty. It is difficult to know ex-ante what will become a creative idea and, due to its destructive force, it is also highly contested. This inherent uncertainty associated with creativity thus spills over to other social spheres, too.
The DFG-funded Research Unit “Organized Creativity” is studying creative processes in music and pharmaceuticals – as representatives for creativity in the arts and in the sciences. The goal of the unit is to understand in greater depth those practices of inducing and coping with uncertainty which are employed by various actors involved in creative processes.

Target Group
The Spring School provides space for exchange between advanced doctoral students, early postdocs and several senior scholars that do research on creativity either in the context of innovation research or in the fields of business and management studies, economic geography, psychology or sociology. Combining lectures from renowned scholars (Prof. Dr. Dr. Karin Knorr Cetina, Prof. David Stark, Ph.D., Prof. Dr. Gernot Grabher, Prof. Dr. Elke Schüßler, Prof. Dr. Jörg Sydow) with the presentation, discussion and development of individual papers, this call invites advanced doctoral students and early postdocs from all disciplines concerned with creativity and uncertainty to join our discussion in Berlin. The working language will be English. Read the rest of this entry »

Indiana farmer Vernon Bowman wears Monsanto cap: irony or admiration?
Photo by Dan Charles, NPR
 

The man in the picture above is a self-proclaimed fan of Monsanto Company’s genetically engineered soybeans. In fact, every year until 2007 Vernon Hugh Bowman – a 75-year-old farmer from Indiana – purchased Monsanto’s Roundup-Ready soy seeds (RR) from a licensed retailer in order to plant his crop of soy. RR is a type of genetically modified seed that has in-plant resistance to glyphosate, the active ingredient in Monsanto’s Roundup herbicides. This means RR soy crops can be sprayed with Roundup weed-killers without any damage being done to the soy.

But despite his loyalty and admiration, in 2007 Bowman was sued by Monsanto for patent infringement, and the farmer has taken on a legal dispute that recently reached the U.S. Supreme Court. The case revolves around whether Monsanto’s patent over RR soybeans grants it control over the reproduction of second-generation seeds. But from a broader perspective it raises the question of what institutional framework is most desirable for regulating the scope of patent rights and points to the tension between protecting competitive markets and promoting innovation through patents. Moreover, it brings to the public sphere discussions concerning transformations of the farming sector resulting from the privatization of its basic input – seeds. Read the rest of this entry »

In the light of the ongoing patent war – most prominently the series of Apple v. Samsung lawsuits – in the smartphone and tablet computer industry (see also “The Power of Patents“), the current patent system has garnered harsh criticism. In a lenghty piece in the New York Times, Charles Duhigg and Steve Lohr criticize that “[i]n the smartphone industry alone, according to a Stanford University analysis, as much as $20 billion was spent on patent litigation and patent purchases in the last two years” and summarize the situation as follows:

[M]any people argue that the nation’s patent rules, intended for a mechanical world, are inadequate in today’s digital marketplace. Unlike patents for new drug formulas, patents on software often effectively grant ownership of concepts, rather than tangible creations. Today, the patent office routinely approves patents that describe vague algorithms or business methods, like a software system for calculating online prices, without patent examiners demanding specifics about how those calculations occur or how the software operates.

On his blog, economist and US Court of Appeals judge Richard A. Posner takes the same line, expressing concerns that “both patent and copyright protection, though particularly the former, may be excessive”: Read the rest of this entry »

The Book

Governance across borders: transnational fields and transversal themes. Leonhard Dobusch, Philip Mader and Sigrid Quack (eds.), 2013, epubli publishers.
August 2022
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All texts on governance across borders are licensed under a Creative Commons Attribution-Share Alike 3.0 Germany License.