, offer the state this special service of delivering the anthrax vaccine for FranceÕ. In return 130 for his invention and know-how, Pasteur asked for payment of a rent: ÔThe only remuner131 ation he requested was that he and his family be spared from material concernsÕ. 17 This 132 transaction aimed both at guaranteeing the recognition and reward of the inventor, Pas133 teur, and at putting the invention at the disposal of the state with a view to improving pub134 lic welfare and increasing national wealth
, 141 The organization of the production of vaccines was set out by Pasteur in correspon142 dence with the prefect of the Seine et Marne district during the summer of 1881. The pre143 fect, who had participated in the trial of the vaccine at Pouilly-le-Fort, proposed the 144 creation of a local laboratory for the production of anthrax vaccine: ÔI was in London 145 when you came to talk to me about your wish to ask the Conseil Général 20 of the Seine 146 et Marne for a sum of money to use in setting up a small vaccine production labora147 toryÕ. 21 Thus, in this case, we see that it was the local state authorities that offered to fi148 nance a laboratory for vaccine production. Pasteur refused this proposition which he 149 judged ÔprematureÕ, primarily because the vaccine preparation method was not stable en150 ough to be easily transferred any distance from his laboratory and more particularly out 151 from under his direct control. Clearly, the rapid increase in production would mean the 152 storage and thus the delayed use of vaccines: 22 ÔAll the vaccine that has left my labora153 tory during the past month is from recent cultures. Factories imply stocks, and the use of 154 prepared tubes after long intervalsÕ, Pasteur, the laboratory at Rue Vauquelin for the production and dispatching of vaccines 140 was specifically associated with the subsidies from the Ministry of Agriculture
, An analysis of the 201 pricing structure shows that the culture of the vaccine represented only a very small por202 tion of this sale price. 29 The highest proportion was for packaging and postage (30% of 203 costs), correspondence and administrative costs (25%), and commercial management 204 (30% of the budget). The third reason for the accounting system was to assess the profits 205 generated by this activity in order to allocate them to the inventors and the laboratory and 206 later to the Institut Pasteur itself. The distribution of profit was as follows: ÔThe balance 207 left over constitutes a profit which is divided into five parts: Mr. Pasteur keeps two and 208 allocates two, that is, one equal part to each of his assistants; the fifth part constitutes a 209 legal reserveÕ. 30 This use of earnings thus constituted a form of profit-sharing for the inven210 tors Pasteur, Roux, and Chamberland, Pasteur considered that at that stage he was the only one capable of appropriately mon159 itoring the quality of vaccines and to overcome any difficulties that may arise: ÔMany de160 tails are still to be sorted out, p.32
, Pasteur noted that the 222 laboratory director was exercising insufficient surveillance over these aspects of the vac223 cine: ÔOur production will improve with time, I hope. In November and December the vac224 cines were too weak. We had to strengthen them. They werenÕt strengthened enough 225 though, because they induced a shorter period of immunity. The ratio of virulence between 226 the first and the second doesnÕt satisfy me. In a sense it would be necessary to achieve noth227 ing else but that. That is what I expect from Chamberland, but sometimes his enthusiasm 228 wanesÕ. 34 To test the quality of the vaccine strains obtained, the production laboratory 229 introduced testing on laboratory animals and established scales of virulence. In cases 230 where the virulence weakened, it selected a new ÔoriginÕ for the vaccine production, 215 duction of anthrax vaccines posed problems of standardization and stability that were not 216 entirely overcome in the following years, 1882.
, of laboratory agents, also dispensed in 388 Paris. 389 The second option for transferring the vaccine to India was more radical: ÔThere is 390 another way of proceeding: it would consist in reproducing in India, ab ovo, all the 391 manipulations and tests that are indispensable to the production and preservation of 392 the two vaccinesÕ-in other words, duplicate the Paris laboratory. Pasteur was against 393 this: ÔI believe that this way of proceeding would result in immense difficultiesÕ. He 394 stressed the time and costs involved in testing the virulence of vaccines on animals, The Indian laboratory would remain linked to Paris through the Ôvaccine sporesÕ ÔfixedÕ 387 in Paris and ÔsownÕ in India, and the training
, other know-how that already existed at the laboratory in Paris and could simply be 399 used: ÔAll that has already been done for my laboratory, and does not have to be 400 repeated for FranceÕ. It would furthermore be expensive to create new vaccine colonies 401 when they could simply be put in culture : ÔWe always use the same vaccines, 402 constantly regenerated by culture, for the needs of French breeders. I undertake to 403 use the same starting point, that is, these same French vaccines, for the IndiesÕ. Pasteur 404 justified his laboratoryÕs monopoly, as opposed to the creation of laboratories abroad, 405 by the high cost of reproducing know-how concerning attenuation and other vaccine 406 tests, and by the low cost of the cultured vaccine colonies themselves. We shall see that 407 this monopoly also had a cost, He also highlighted an economic justification: it would be unnecessarily expensive and 397 time-consuming to reproduce a system of measurement and control along with all the, vol.398
, Several ÔspecialÕ laboratories were set up abroad, based on the organizational model fa410 voured by Pasteur himself, that is, they received vaccine spores, culture fluids, and exper411 tise from Paris and then prepared the fresh vaccines and distributed them to veterinarians 412 and breeders. Laboratories of this sort were
,
, Vaccins Contre le Charbon et le Rouget was founded in Budapest under Ôthe patron416 age of the Hungarian ministry for agricultureÕ. 48 417 In 1886, the Pasteur laboratory was instrumental in the creation of a commercial 418 enterprise, La Compagnie de Vulgarisation du Vaccin Charbonneux Pasteur, to exploit 419 the anthrax vaccine abroad. The inventors had noted that there was insufficient diffu420 sion of the vaccine abroad, due to the absence of any commercial network and Ôbecause 421 of the total lack of publicityÕ, as well as problems related to the instability of the vaccine 422 and to Ôdispatching it to various countriesÕ. 49 To get round these problems, the company 423 was to set up a network of agencies and local laboratories, The Laboratoire Pasteur-Chamber415 land, 1996.
, Sainte Marie en vue de la réalisation de laboratoires du Vaccin Charbonneux Pasteur a ` lÕétrangerÕ (ÔTreaty between Mr. Chamberland and Mr. De Sainte Marie with a view to setting up Pasteur anthrax vaccine laboratories abroadÕ), Fonds IP Direction, 1886.
, As Pasteur explained in a letter to Bar589 on Kemeny in 1881, there is a considerable gap between the published principles and 590 the multiple operations that need to be mastered by the technicians. It was precisely by 591 exploiting this gap that Pasteur was able to retain a monopoly over the vaccine. Pas592 teur often referred to the Ôtechnical detailsÕ that only he, or a limited group around 593 him, could understand. The exclusive licences to produce the vaccine mentioned the 594 ÔinstructionÕ that laboratory technicians would receive when they were sent to Paris 595 for several weeks. This period of apprenticeship in vaccine culture, considered by Pas596 teur to require three to four weeks, also gives an indication of the knowledge acquired 597 by the visiting laboratory agents. RouxÕs notebooks on the preparation of the anthrax 598 vaccine are filled with precise details, some added in the margins, for example on how 599 to culture vaccines prepared for foreign use or the need to mix vaccines of two differ600 ent ages. Roux added drawings of the equipment to his notes on Ôthe means of culti601 vating vaccinesÕ. 56 Not all these instructions were published, nor were all the 602 observations made on the animals-for example oedema-used to measure the degree 603 of virulence of vaccines and the ratio of virulence between the two vaccines. On several 604 occasions Pasteur highlighted the cost of developing these scales of virulence. The dif605 ferent tests as well as the different laboratory notebooks on vaccine preparation re606 corded this know-how, the specific nature of which was particularly noteworthy in 607 so far as few bacteriology laboratories existed that would be able to reproduce the 608 method, itself still unstable and largely tacit, Tools for appropriating the anthrax vaccine: know-how, operating licences and industrial 585 property rights 586 Appropriation of the anthrax vaccine was initially based on specific technical know587 how involved in producing large quantities of relatively standardized vaccine, which 588 was exclusively held by the Pasteur laboratory, vol.584
, Do 618 you issue a certificate to certify the competence of persons who have received such 619 training?Õ 58 PasteurÕs reply differentiates between two contexts of acquiring knowledge: 620 on the one hand, training in an academic context, on the other, the learning of tech621 nical know-how in a professional and commercial context. If he wished to remain in 622 the sphere of the first, Dr. Murray could receive academic training at the Institut Pas623 teur: ÔIf a young man who already has some training in biology wishes to learn, from a 56 The inventors also developed specific equipment for vaccine culture, The secrecy of the necessary know-how was protected and its diffusion controlled in 613 the form of contracts or restricted access to knowledge that preserved the commercial 614 monopoly of the Compagnie de Vulgarisation over the anthrax vaccine
, , 1994.
, Fonds IP Direction (1887-1940), DR COR 1, document 27795-6. Reply by Louis Pasteur, vol.27797, 1889.
, Since anthrax vaccines have become a matter of practice, I have been 634 looking for a person to teach this technique abroad. Mr. De Sainte Marie has accepted 635 this mission. It is therefore him that you should approach if you wish to use our vac636 cinesÕ. If the training was authorized by the owner of the foreign rights over diffusion 637 of the vaccine, it would then be given by the head of the technical microbie service ap638 plied to health, Mr. Chamberland, who supervised the preparation of vaccines. This 639 exchange reveals several fundamental points in the appropriation of vaccines. First, 640 while it was possible to have free access to classes on the principles of microbe atten641 uation, access to laboratory expertise and to the service producing the vaccines was re642 stricted. In making this distinction, Pasteur differentiated between two types of 643 knowledge: theoretical knowledge, which was freely available, and practical knowledge, 644 inscribed in semi-industrial devices, which was protected. Second, Pasteur thus had to 645 manage two systems of knowledge appropriation: the academic system, and the com646 mercial system which he had helped to put in place. Whereas he had the authority 647 to grant access rights to classes at the Institut Pasteur, 624 scientific point of view, about attenuation of the anthrax bacterium and the different 625 questions concerning it, he can be admitted to the Institut Pasteur in the technical 626 microbie laboratory under the direction of Dr. Roux
, These licenses acted as a kind of patent, except that their scope was limited to the net653 work of licensees. 60 They effectively delimited operating monopolies for geographic 654 areas. The extension of these areas had to be renegotiated between the commercial 655 company and the Compagnie de Vulgarisation
, France and those colonies directly supplied by the Institut Pasteur. 61 These licenses 657 were not limited to a simple transfer of operating rights, however. As the vaccines were 658 products that were still largely unstable, and the central laboratory in Paris continued 659 to play an essential
, Likewise, laboratory directors who currently have research contracts with industry generally have to submit their publications to the industry before divulging information. They also manage two types of knowledge: that reserved for the industry and that which is accessible for scientific exchange
, DR DOS.1, 10599. of technical know-how and products between the contracting parties. Finally, 665 these contracts established and reinforced the asymmetry of competencies and power 666 between the central laboratory and peripheral local laboratories. 667 The last means of protection was the promotion of the commercial use of PasteurÕs own 668 name and, eventually, the registration of a trade name. Exploitation of the commercial 669 name of a product, in this case the Vaccin Charbonneux Pasteur, and registration of a 670 trade name, were industrial property rights commonly used at the time to protect pharma671 ceutical products which, as we have seen, could not be patented in France. 62 The commer672 cial name Laboratoire du Vaccin Charbonneux Pasteur protected the laboratoryÕs 673 business at home, and this protection was extended to its business abroad starting with 674 the 1883 Paris agreement. The brand name was a distinctive sign of the product. Unlike 675 the patent, it protected neither the composition of the product nor its production process, 676 but only a commercial name: Vaccin Charbonneux Pasteur. Note that licences granted for 677 exploitation of the anthrax vaccine abroad, Third parties have the possibility of freely reproducing the invention of the anthrax vaccine, provided that their knowledge is not obtained through a leak or illicit borrowing, even though the patent monopoly covers all potential users, at least on the territory of the states in which it is issued. 61 Letter from M. de Sainte Marie to Chamberland, pp.1887-1940, 1888.
, In this respect there was an asymmetry between the pro685 tection of his vaccine production techniques, which were not patented, and the protection 686 of the biotechnology processes invented by Pasteur in the agro-food domain, which were 687 protected by several patents and supplementary certificates covering improvements. Pas688 teur had thus found a way of using patents to prevent any attempt at usurping his inven689 tions and to control their industrial diffusion. 64 The absence of patents on the vaccines that 690 he invented cannot be put down to a lack of knowledge on PasteurÕs part concerning intel691 lectual property. The primary explanation is that starting in 1844 France no longer permit692 ted patents on Ôpharmaceutical compositions and remedies of all kindsÕ. This amendment 693 excluding remedies was not initially planned by the government, but French members of 694 parliament introduced it in order to avoid the emergence of a monopoly in the field of 695 health products: ÔAccording to the law and simple common sense there is an incompatibil696 ity between a pharmaceutical composition useful to humanity and the exclusive exploita697 tion for a single personÕs profit, Conclusion: defining an economic and legal status for health products 683 The anthrax vaccine technique, as with PasteurÕs other vaccines for veterinary or hu684 man medicine, was not patented, 2000.
, The contract negotiated with the Australian company in 1896 was the most complete in terms of protection, including an indication of the origin of vaccine spores-the Paris laboratory (Fonds IP Direction, DR.DOS, vol.1, pp.1887-1940, 10597.
, , 2002.
, Chambre des Pairs: Séance des samedi 25 mars, 1843, p.559
, 700 production processes was raised in the inter-war period, 66 when industrial leaders and jur701 ists pleaded for patents on pharmaceutical processes to compensate for the absence of pat702 ents on the pharmaceutical products themselves. 67 703 Despite the lack of patents, Pasteur nevertheless succeeded in gradually building up a 704 technical and commercial monopoly over the production and distribution of the anthrax 705 vaccine. He deliberately avoided putting his vaccine preparation technique into the public 706 domain
, This solution resembled the system of buying back pharmaceutical 711 inventions that the French state had instituted in 1810. Because of the absence of any 712 engagement by the state in the production of the vaccine, it was directly produced and 713 commercialized by PasteurÕs laboratory, and then produced and distributed worldwide 714 by the concession of know-how and operating licences. The construction and defence of 715 this monopoly can be explained in terms of a combination of several factors. First, due 716 to problems of quality control concerning the anthrax vaccine-the efficacy of which 717 was still being questioned-and the need for control over the technical details of its prep718 aration, Pasteur felt it was necessary to control its production and diffusion. Second, the 719 creation of a commercial company devoted to the exploitation of the vaccine reinforced 720 and extended the monopoly held by the Institut Pasteur as the company set out to conquer 721 new territory for the vaccine, vol.708, p.1882, 1881.
, this time between the vaccines for veterinary use, over which there 727 were clear monopolies, and the vaccines for human medicine, where the production meth728 ods were more broadly and more actively disseminated. In 1886, for example, the British 729 commission of inquiry sent to Paris to study the rabies vaccine praised Ôthe speed with 730 which the French scientist informed the commission of the slightest details of his meth731 odÕ. 68 In the case of human medicine, the question of accessibility to vaccines is a quite 732 different ethical issue, as current debate on intellectual property rights in the field of health 733 products attests. 69 Nevertheless
, Professor Delaby of the Faculty of Pharmacy distinguished between Ôidentifiable vaccinesÕ such as the diptheria, TB, and anthrax vaccines, of which the components could be characterized and Ôthe procedures for obtaining these products seems patentableÕ, and Ôkilled vaccinesÕ that Ôcontain diverse products which are impossible to identifyÕ and whose processes do not seem to be patentable, Senac, 1938.
, In the case of the anthrax bacillus this was no simple matter, for it had been in the public domain for several years. It is often said that Pasteur filed the first patent on a living organism by claiming to have Ôpurified yeastÕ in a patent on beer production, The issue of the patentability of the germs themselves was not addressed, 1985.
, , p.1886
, On this topic, see also Swann, 1984.
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DOI : 10.5962/bhl.title.60944
URL : https://www.archive.org/download/39002011128940.med.yale.edu/39002011128940.med.yale.edu.pdf
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