Generic Medicine: Case Glaxo Wellcome Against ‘Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS), Brought Before the Conseil D’Etat, 31ST MAY 2000
- France
- 11/01/2000
- J.P. Karsenty et Associés
FACTS AND PROCEDURE
The Director General of the AFSSAPS registered on 28th July 1999 in the “Répertoire des médicaments génériques” the original medicines Zovirax 200 tablets and Zovirax 800 tablets marketed by GLAXO laboratories, and corresponding generic medicines from GNR-Pharma laboratories.
GLAXO laboratories have lodged an appeal as an action ultra vires against the decision cited above, notably in that the Agency has registered in the “Répertoire des médicaments génériques” the two generic medicines from GNR-Pharma laboratories.
GLAXO laboratories make their claim on, among other grounds, an alleged interference with their intellectual property rights, and more precisely with their ‘Certificat Complémentaire de Protection’(CCP) which runs until 2002. This CCP protects a process for manufacturing Acyclovir as well as the product obtained by this process, and the generic medicines marketed by GNR Pharma laboratories, according to GLAXO’s allegations, infringe this CCP.
The Conseil d’Etat, by a judgment dated 31st May 2000, granted GLAXO’s appeal and annulled the 28th July 1999 decision of the Director General of the AFSSAPS registering in the “Répertoire des médicaments génériques” the medicines Zovirax 200 tablets and Zovirax 800 tablets marketed by GNR-Pharma laboratories.
COMMENTARY:
On the interpretation of article L601-6 of the Public Health Code (CSP):
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Article L.601-6 of the CSP sets out that:
“Without prejudice to articles L. 611-2 and following of the Intellectual Property Code, the generic medicine of an original medecine is defined as that which has the same qualitative and quantitative composition of its active constituent, the same pharmaceutical form and whose bioequivalence with the original medicine is shown by the appropriate biodisponibility studies”.
While article L.613-3 of the Intellectual Property Code (CPI) sets out that:
“Is forbidden, without the consent of the patent-holder: (…) c) to offer, to market (…) the product directly obtained by the patented process.”
The provision of article L. 601-6, while being specific on the scientific level, can on the other hand lend itself to confusion on the legal level.
How indeed ought one to interpret “without prejudice to articles L. 611-2 and following of the Intellectual Property Code”?
The ‘commissaire du gouvernement’ (expert in administrative law at ‘Conseil d’Etat’) in his findings, substantially develops this interpretation which can in fact take two opposing routes:
one can consider that “without prejudice to” means “independently of”,
but one can equally deem that it means “taking into account”
The preparatory work for the law of 23rd December 1998 introducing this provision throws no light on the debate and the ‘commissaire du gouvernement’ concluded that “one cannot derive a lot from the provisions of article L. 601-6”.
The ‘Conseil d’Etat’, for its part, considered that the combined provisions of article L.601-6 of the CSP and article L.613-3 of the CPI “do not prohibit, in principle, the registration in a generic group of an original medicine which is still protected” by a patent or a ‘certificat complémentaire de protection’.
The ‘Conseil d’Etat’ nevertheless deems that the provisions “prescribe that the administrative authority, before proceeding with the registration of a generic medicine in the same group as the original medicine, should assure itself, by consulting documents produced by the interested manufacturers, that the industrial property rights have been conceded”
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This interpretation being given, the ‘Conseil d’Etat’ observed that GLAXO was the holder of a CCP running until 2002, protecting a process of the synthesis of Acyclovir and the original medicines ZOVIRAX 200 mg and 800 mg.
The ‘Conseil d’Etat’ has equally observed that the companies GLAXO and GNR are opposed in litigation upon the alleged violation by GNR of the CCP.
The ‘Conseil d’Etat’ has deemed that it was not up to the Director General of the AFSSAPS to get involved with or make a decision on this dispute but that “it could not legally register the medicine marketed by GNR-pharma in the “Répertoire des médicaments génériques” without firstly assuring itself of the existence of an exploitation agreement in favour of the latter. That by refraining from proceeding with such a verification, it has committed an error before the law”
In passing let us note that this is an extra step with regard to the obligation recently introduced by article L. 5121-10 of the CSP, according to which it is up to the AFFSSAPS to inform the holder of the original product of the granting of an Authorisation to be put on the market (AMM) for a generic product before the expiry of the patent rights relating to this original product.
The position of the ‘Conseil d’Etat’ therefore makes the registering of a generic product in the Répertoire reliant on the goodwill of the innovating laboratory, which may or not have accepted to grant a licence to the manufacturer of the generic, and who will have set its price.
Moreover, by asking the AFSSAPS to control the only concession of a licence, the ‘Conseil d’Etat’ does not follow through to the end of its reasoning.
On the examination asked of the AFSSAPS by the ‘Conseil d’Etat’
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The granting of a patent by the INPI, if it does not constitute proof of the validity of the title, confers, however, to its holder rights presumed to be valid, which can nevertheless be put into question before the courts.
Thus, at the end of the infringement litigation brought by GLAXO against GNR, the CCP of GLAXO may be found to be invalid or even, one will notice, that GNR is not committing an infringement because it does not use the process protected by the CCP to manufacture its product…
Besides, everyone knows the numerous defence patents registered by the innovating laboratories. When one knows that certain active ingredients, via diverse synthesis processes, diverse formulations or even applied therapeutically, are the object of more than 300 patents, it is permissible to doubt that any one of these patents predates another and that all the inventions thus claimed are indeed truly inventive…
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In the present affair, the AFSSAPS invokes the legislative independence of patents and the organisation of the authorisation to put on the market (AMM) and registrations in the Répertoire and thus deduces that it does not have to take into account the problems of industrial property rights. The ‘Commissaire du gouvernement’, for its part, considers that the AFSSAPS should take account “in its field of competence” of intellectual property rights, that it should “check the title rights belonging to the establishments that produce them” and concludes that a licence to exploit a patent can be granted.
But what is the “field of competence” of the AFSSAPS in the subject of industrial property rights? And what does it mean to “check the title-rights”: their existence, their validity?
The ‘Conseil d’Etat’, for its part, limits itself to taking up again the conclusion of the ‘commissaire du gouvernement’, that is to say to require of the AFSSAPS to check that the industrial property right has been conceded. As for the question of knowing how the AFSSAPS makes itself acquainted with this right and of the possible concession of this, the ‘Conseil d’Etat’ specifies that the AFSSAPS should rely on “documents produced by the interested manufacturers”.
The administrative authority should therefore be satisfied with:
the appearance of the validity of the title-rights cited by the innovating laboratory, which is not satisfactory with regard to the doubtful validity, that we have remarked upon above , of the numerous defence patents,
but also with the appearance of infringement, which is at least as worrying.
Thus, in order to prevent the manufacturers of generic products being registered in the “Répertoire des médicaments génériques”, it will be sufficient for the innovating laboratories to invoke any one of their numerous patents still in force relating more or less directly to the active constituent concerned (formulation patent, application in therapy patent, manufacturing process patent) in order for the AFSSAPS to then block all registering of the generic product in the Répertoire.
Its of little importance therefore that the formulation patent pointed out to the AFSSAPS doesn’t in reality cover the pharmaceutical presentation of the generic manufacturer or that the patent of the process invoked protects a process different to that used by the generic manufacturer!
The question remains to know whether the registration or the withdrawal of a generic product from the Répertoire complies with regulations of administrative law that may be in opposition to this judgement by the ‘Conseil d’Etat’.
On the lack of provisions relating to the registration in or the withdrawal from the Répertoire
The registration of a generic product in the Répertoire is published in the official journal and grants legal rights having immediate effect since this authorises the pharmacist to substitute the medicine prescribed by one of its generic products registered in the Répertoire.
It is advisable from now on to ask oneself under what conditions the withdrawal of such a right may take place.
Yet it must be noted that, contrary to the suspension or the withdrawal of the AMM which is governed by the provisions of article R 5139 of the CSP, nothing is foreseen as to the registration and above all the withdrawal of the registration in the “Répertoire des médicaments génériques”.
It would therefore be opportune and urgent that precise provisions are arrived at to organise these procedures.
CONCLUSION
The position adopted by the ‘Conseil d’Etat’ in its judgement of 31st May 2000 appears to us to be open to criticism: the ‘Conseil d’Etat’ requires of the AFSSAPS that it takes account of industrial property rights and refuses to recognise the independence of the provisions of the CPI and the CSP, but does not follow through to the end of its reasoning. Indeed, the ‘Conseil d’Etat’ asks of the AFSSAPS to take account of appearances, as much for the validity of the patent right invoked as for the infringement allegedly committed.
The ‘Conseil d’Etat’ shows itself to be undeniably in favour of innovating laboratories. Indeed, when one knows that registration in the Répertoire is the necessary condition in delivering the generic product by the pharmacist, one can already measure the terrible impact of such a judgement on the development of generic medicines in France.
