Maurice Cassier

Public Knowledge, Private Property and the Economics of High-tech Consortia

The management of knowledge in research consortia raises new appropriability issues, such as copying with the tension between individual protection and data sharing which is required in any process of collective invention. Based on case studies carried out in the field of biotechnology, the paper discusses these issues and develop some policy implications.

Scaling Up and Reverse Engineering: Acquisition of Industrial Knowledge by Copying Drugs in Brazil

HAL is a multi-disciplinary open access archive for the deposit and dissemination of scientific research documents, whether they are published or not. The documents may come from teaching and research institutions in France or abroad, or from public or private research centers. L’archive ouverte pluridisciplinaire HAL, est destinée au dépôt et à la diffusion de documents scientifiques de niveau recherche, publiés ou non, émanant des établissements d’enseignement et de recherche français ou étrangers, des laboratoires publics ou privés. Scaling up and reverse engineering Acquisition of industrial knowledge by copying drugs in Brazil Maurice Cassier, Marilena Correa

Producing, Controlling, and Stabilizing Pasteur's Anthrax Vaccine: Creating a New Industry and a Health Market

When Pasteur and Chamberland hastily set up their small biological industry to meet the agricultural demand for the anthrax vaccine, their methods for preparation and production had not yet been stabilized. The process of learning how to standardize biological products was accelerated in 1882 when vaccination accidents required the revision of production norms as the first hypotheses on fixity, inalterability, and transportability of vaccines were invalidated and replaced by procedures for continuous monitoring of the calibration of vaccines and the renewal of vaccine strains. Initially, the incompleteness and ongoing development of production standards justified Pasteurs monopoly on the production of the anthrax vaccine under his immediate supervision. Later on, the Pasteur Institute maintained control of these standards in the framework of a commercial monopoly that it established on the veterinary vaccines first sent and then cultivated abroad by the Société de Vulgarisation du Vaccin Charbonneux Pasteur, founded in 1886.

New ‘Enclosures’ and the Creation of New ‘Common Rights’ in the Genome and in Software

Scott Kieff, ed., Perspectives on Properties of the Human Genome (Amsterdam: Elsevier Academic Press, 2003), 538 pp., 126.00, ISBN 0120176505. John Sulston and Georgina Ferry, The Common Thread. A Story of Science, Politics, Ethics, and the Human Genome (Washington: Joseph Henry Press, 2002), 310 pp., 12.30, ISBN 0309084091. Kevin Davies, Cracking the Genome. Inside the Race to Unlock Human DNA (Baltimore: Johns Hopkins University Press, 2002), 327 pp., 18.00, ISBN 0801871409. Bronwyn Parry, Trading the Genome. Investigating the Commodification of Bioinformation (New York: Columbia University Press, 2004), 319 pp., 37.50, ISBN 0231121741. Magali Franceschi, Droit et marchandisation de la connaissance sur les g?nes humains (Paris: CNRS Editions, 2004), 247 pp., 25.00, ISBN 2271062004. Richard M. Stallman, Free Software, Free Society. Selected Essays (Boston, MA: GNU Press, 2002), 220 pp., 18.00, ISBN 1882114981. Special Issue on Open Source Software Development, Research Policy 32 (2003), Elsevier Science.

Knowledge production and distribution and the economics of high-tech consortia

This paper deals with the issue of management of knowledge and intellectual property in research consortia. We develop a framework based on three axes describing the processes and procedures of collective invention (the collective production of knowledge, the appropriation and distribution of results, the composition of the group and the mode of managing externalities). We, then, use this framework to analyse various tensions and conflicts between the degree of distribution and collectiveness of the production and circulation of knowledge, the degree of collectiveness of the appropriation of results, and the scope and level of organisation of final dissemination. Based on case studies carried out in the field of biotechnology, the paper develops some policy implications with a particular focus on European policy.

Nationalizing Efavirenz: Compulsory Licence, Collective Invention and Neo-Developmentalism in Brazil

This chapter examines the legal, technological and industrial trajectory of an antiretroviral drug, efavirenz, which has been distributed free of charge to HIV/Aids patients by the Brazilian Ministry of Health since the early 2000s. In May 2007 a presidential decree suspended the exclusive rights of the patent owner, Merck, to the exploitation of the molecule in Brazil, and authorized the production of a generic version by local laboratories. This compulsory license by the Brazilian state is also intended to perpetuate the policy of universal access to treatment, with a view to combatting the Aids epidemic and boosting the country’s pharmaceutical industry. Nationalization of efavirenz has given rise to experimentation with collective production in the form of an industrial consortium and inaugurated a policy of partnerships between public and private pharmaceutical laboratories.

Regulating the Copy Drug Market in Brazil: Testing Generics and Similar Medicines (1999–2015)

The chapter, written by Marilena Correa, Maurice Cassier and Maria Andrea Loyola, shows the formation, expansion and regulation of the similar and generic medicines’ markets since the 1990s. In particular, it explores the diffusion of bio-equivalence tests for the copy of both similar and generic medicines. The bio-equivalence tests carried out in centres authorized by ANVISA measure the quality of copies to guarantee their interchangeability with first medicines. The growth of the bio-equivalence test market and the extension of the network of bio-equivalence centres approved by the Health Surveillance Agency is a keystone in the construction of the pharmaceutical innovation system. In 2000, the national bio-equivalence centres performed only 27 percent of all bio-equivalence tests, whereas in 2010 they performed 87 percent of them. The process of standardizing Brazilian copies has until now been oriented primarily towards the needs of the domestic and regional markets. Obtaining the WHO prequalification standard could represent a new frontier of this standardization, aimed at international donor markets such as those of the Global Fund. To date, no Brazilian firm has acquired WHO prequalification, in contrast to Indian firms which make substantial use of them to conquer global generics markets.

A Consortium in Times of Crisis: Producing Brazilian Sofosbuvir? (2014–2017)

In 2014, as Brazil entered a severe economic, financial and political crisis, a new class of antiviral medicines for hepatitis was put on the market at unaffordable prices. The civil society organizations that had led the struggles for access to HIV/AIDS medicines since the 1990s urged the government to invest in the local production of sofosbuvir and called for the cancellation of the patent owned by Gilead Sciences. Three private laboratories coordinated their technological and industrial capabilities to produce a generic medicine. In 2016, a consortium was formed, coordinated by the private company Microbiologica, which had become, in 1992, the first to copy AZT in Brazil. Microbiologica had also contributed to the development of sofosbuvir in the early 2000s, in collaboration with the US company Pharmasset and had mastered the technology perfectly. As soon as the patent is declared invalid by the Brazilian National Industrial Property Institute (INPI), the Brazilian consortium will be able to produce the drug and supply it to the Ministry of Health. Once again, in the context of the Brazilian crisis, this story mobilized the industrial and civil society actors set up to produce HIV/AIDS medicines in the 1990s and now involved in the local production of molecules to treat hepatitis C, which affects two million people in Brazil.