Maurice Cassier CNRS, Paris

1. The relationships between public research and industry : creation of technology and intellectual property management Maurice Cassier CNRS, Paris

2. 1- The creation of the modern biotechnology between academic laboratory and industry : the work of Pasteur • Pasteur developped several microbiological processes (wine, vinegar, beer) in interaction with industrialists and he organizes himself the diffusion of theses technologies in the industry • He filed 6 patents and supplementary certificates covering improvements in order to guarantee the accessibility of his inventions • For the technology of the anthrax vaccine, Pasteur separate two types of knowledge : theoretical knowledge, which was freely available, and pratical knowledge, which was protected

3. 2- The cooperation between the Pasteur Institute and the Poulenc company (1911-1939) • Circulation of researchers between the private sector and the Pasteur Institute : Ernest Fourneau • A research focused on the copy of the german pharmaceutical patents • The association of chemistry and physiology to study the molecules • Transfer of technology from the Laboratory of Therapeutical Chemistry of the Pasteur Institute to the Poulenc Company who took the process patents

4. 3- When University regulates the pharmaceutical industry : the early development of insulin in the interwars (1922-1939) • The development of the production of insulin and the standardisation of the new biological drug were achieved through a cooperation between university and industry • The University of Toronto decides to take patents both on the product and the processs of production of insulin in order to control the industry and the market of insulin • The university set up an original management of IP : a « patent pool » open to all licensees

5. 4- Innovating through networks : the growth of contractual collaborations between the public research sector and industry • Since the 1980, a growing number of research partnerships between public research and industrial research : the biotech sector is a product of this networking • Mutual learning between partners on the technology • The efficiency of cooperation increase over time ; on the other hand, the contractual relationship is reversible

6. 5- equilibruim between basic and applied research ? • generally, the results of the R&D contracts are intermediates results rather than final products or final processes • Sometimes, academic researchers must follow the technology that is tranferred to the industry • Industrial contract are likely to play an active part in the creation of knowledge and technology, as far as the public research sector is able to select contracts which fit into his scientific strategy

7. 6- compromises between public property and private property • The contract must establish the anteriority of the public laboratory’s work and its rights over the subjet : the transfer of ownership to the industrialist concerns only the new results obtained throug the contract • Co-ownership of IP or all the IP transfered to the industrialist : with co-owernship, public lab is able to control the effective development of the technology • The possibility of re-using the results in the event of their non use by the first contracting party

8. 7 - compromises between publication and secrecy • The public lab is under the obligation to respect strictely confidentiality • The company must acknowledge the rigtht of his academic partner to publish some results : negociation on the delays and the scope of the publication • For a firm, a reputation of excessive secrecy may diminish the interest of a collaboration for the public researchers.

9. 8- A trilateral system of innovation in the field of biomedicine and pharmaceuticals • A new division of scientific labor between university’s labs, private societies specialized in research and pharmaceutical labs • Conflicts between open science and the privatisation of scientific data (cf. human genome data) and between the biotech start up and the pharmaceutical industry for the sharing of the revenues of innovation • Sometimes alliances between the pharmaceutical industry and the public sector to switch the private companies of science and to create public goods (SNPs consortium 1999)

10. 9 - Collective invention and the management of research consortia • Consortium to support collective invention : pooling of data and creation of common tools accessible for all the participants (collection of strains of microorganisms, collection of human families for genes hunting, etc.) • Controlling the dissemination of data produced by the consortium : 3 circles of dissemination • « individual data » Individual rights during 3 or 6 months • « Collective data » : data are shared between all the consortium members (3 or 6 months) • Public data : transfer of data in the public domain An original compromise between secrecy and publication

11. 10- Two solutions for IP : disjoint property or common property • In some consortia, if research data are shared, biological material and technological developements remains strictely private • In other one, the participants choose a system of common property • This collective property can be manage by a Charity trust, a non profit organisation • Common property avoids the fragmentation of knowledge among several users and reduced the costs of negociating rights for users

12. 11- The creation of « common or mixed laboratories » between the public research sector and industrial research • Common laboratories : association of academic and industrial researchers and co-governance of the laboratory • Advantages for mutual learning and the captation of the technology by the firm • How to manage the scope of exclusivity devoted to the industrial firm ? • Sometimes, several firms can access to the results /versus exclusive access for one single firm

13. 12- The management of IP and publication : how to keep science open ? • A concern about restrictions of publication within university/industry cooperations • the building of common data or common technology available for all users • For basic data, policy of immediate release and non patentability ; the patentability could be only for industrial applications and final products • The General Public License (GPL) experimented in software and genomics ( the HAP MAP project adopts the GPL).

14. 13- The creation of patent pools and knowlege pools by the public research sector • Fragmentation of knowledge and inefficiency of the patents portefolios of universities • Creation of patents pools by several public organisms in the field of plan genetics • Its more easier for the industralists to access to the complete technology through a patent pool

15. 14- Patenting and licensing policy of university • Industrialists frequently requires exclusive licenses • This issue is controversial in the field of medicines : in 2001 international controversy on the exclusive licensing of DDI to BMS by the University of Yale • The controversy about the exclusive licence granted to Myriad Genetics on BRCA1 and BRCA2 by the University of Utah and the Federal Government of US

16. 15- The building of research networks between university, public and private pharmaceutical labs in Brazil • Informal exchange of knowledge and services between FM, private labs and university’s labs • Joint R&D agreements between FM and private companies for the development of synthesis process • Research on new families of Arvs in the context of partnerships between Universities, private and public labs : for exemple, the agreement between Cristalia and FM in 2002 ; the collaboration between Cristalia and the University of Sao Paulo, etc.

17. 16- Spin off from university and public laboratory • The creation of Microbiologica from the Federal University of Rio in 1981 • The creation of Nortec in the context of an agreement with FM in 1982 • Academic scientists as consultants for industry

18. 17- a policy of technology transfer between the public and private sector • From FM to the private sector transfer of process of synthesis, of analytical methods, of technical documentation • From the Private sector to FM Transfer of technologies of formulation • FM as a reference laboratory for the other pharmaceutical labs : the analytical department, the synthesis department

19. 18- internalization of R&D networks in Brasil or externalization • The trajectory of Microbiologica : from a generic producer to a society specialized in research • Microbiologica is involved in networks with US labs and european public labs : Microbiologica licenses her technology and her patents • The emergence of pharmaceutical networks involving brazilian companies : Cristalia and Universities ; FM and several universities ; FM with Cristalia in 2002

20. 19- The creation of technology needs long term cooperations and contracts • R&D in pharmaceuticals or in biomedicine requires long term contracts and sometimes the creation of new research organisations (common laboratories between universities and industry) • Creation of technology is not compatible with short term contracting and instability of the partnerships • Research consortia could be useful to create large kowledge bases, research tools available for several users, reverse engineering for essential drugs

21. 20- IP and cooperation between the public and the private sector • Brazilian universities, public and privates pharmaceutical labs use patents to protect their pharmaceutical innovations (product and process patent) : • A way to prevent opportunistic appropriation and to secure industrial partnerships • As universities and public labs are owners or co-owners of the patents, they can use their property to control and regulate the market of health products (drugs, vaccines, biologicals tests, etc.)

22. conclusions • Diversity of partnerships : common labs ; technological platforms ; R&D consortia ; short or long term contracting ; thesis co-financed by gvt and industry • a balance between open science and the protection of industrial applications • For universities and public research sector, patenting can be a way for regulating IPR : patent pools, non exclusive licenses, active dissemination of inventions and knowledge through public licenses and public patents • Public labs can play a major role in redistribution of knowledge and technologies