As a result of an appeal by sixty French deputies, the French Constitutional Council ruled on 22 December 2009 that Article 36 of the Social Security Financing Act for 2010—a provision favourable to generic pharmaceutical manufacturing companies—infringed the French Constitution.
Article 36 purported to introduce a new Article L. 5121-10-3 to the French Public Health Code, permitting generic manufacturers to use for orally administered forms of their generic drugs appearances and textures which are identical or similar to those used for the corresponding originator drugs even if such appearances and textures are protected by intellectual property rights.
The provision resulted from amendments to the Social Security Financing Act introduced during the bill’s passage through Parliament. In the debate before the French National Assembly, an amendment was introduced stipulating that the registration of trade marks or designs relating to organoleptic properties of originator drugs would not preclude the adoption by generic drugs, substitutable with such originator drugs under Article L. 5125-23 of the French Public Health Code, of identical or similar organoleptic properties.
The objectives behind the amendment were two-fold: first, to support the marketing of generic drugs by preventing originator companies, following expiry of their patent rights, from relying upon other intellectual property rights, such as trade mark and design rights, in order to obstruct the entry of generic drugs on the market; and second, to reduce social security costs by encouraging consumers to purchase generic drugs by permitting those drugs to adopt the same organoleptic properties as those used for the corresponding originator drugs with which consumers were already familiar.
During the debate before the Senate, the original wording of Article 36 was amended to limit the right of generics manufacturers to use identical or similar appearances and textures to orally administered forms of generic drugs. But express references to trade mark registrations and design rights were replaced by more general wording which did not distinguish between different types of intellectual property right.
Thus Article 36, as amended by the Senate, read as follows :
“Art. L. 5121-10-3. - The owner of an intellectual property right relating to the appearance and the texture of orally administered forms of a drug within the meaning of Article L. 5121-1 cannot preclude orally administered forms of a generic drug substitutable with said drug under Article L. 5125-23 having identical or similar appearance and texture”.
However, on 22 December 2009, the French Constitutional Council decided that this provision infringed the French Constitution on the grounds that it had no significant effect on the expenses incurred by social security bodies and that therefore its inclusion within the Social Security Financing Act was inappropriate.
The Constitutional Council’s decision arrests, for the time being at least, a trend in favour of generic companies highlighted by the decision of the French Supreme Court of 26 March 2009, this time in the context of comparative advertising, in which it was held that a generic company is entitled to use the trade mark of an originator drug to advertise its own generic version. However, if the Constitutional Council’s decision is a setback for generics manufacturers, it may merely be a temporary one, since it appears that Article 36 infringes the French Constitution only to the extent that it is irrelevant to the Social Security Financing Act.
For further information on this subject or any other IP issues please contact:
Marianne Schaffner, Partner, Paris on + 33 1 56 43 59 60 (marianne.schaffner@linklaters.com)
Romain Viret, Associate, Paris on + 33 1 56 43 59 18 (romain.viret@linklaters.com)
