On 26 November 2009, the French Senate voted on the law on ‘Financing the National Social Security for 2010’. This law, if endorsed by the Constitutional Council, will amend the Public Health Code, and introduce a new article L. 5121-10-3 relating to generics.
“The owner of an intellectual property right that protects the appearance and the texture of oral pharmaceutical forms of a reference product within the meaning of article L. 5121-1 may not prohibit the oral pharmaceutical forms of a generic drug substitutable to this product under article L. 5125-23, from showing a similar or identical texture or appearance.”
Accordingly, the makers of substitutable generic drugs would be in a position to freely mimic the shape and colour of the tablets or capsules of the brand-name drug. The legislator's intention was to limit risks associated with mistaken intake by the patient, by precisely facilitating the identification (!) of generic drugs, especially by elderly subjects.
If validated by the Constitutional Council, this provision will amount to a significant exemption from trade mark and design rights. Further, besides an increased likelihood of confusion for the public, difficulties can be expected when enforcing such trade marks or designs by Customs seizures pursuant to EC Regulation 1383/2003, for example against unauthorised generic goods (only substitutable generics would benefit from said exemption). Also, from a copyright perspective, it is unclear whether this provision would bar the author or creator of a shape from seeking compensation by solely asserting his/her moral right.
In a widely reported case remitted from the French Supreme Court, on 27 September 2005 the Appeal Court of Versailles had confirmed the validity of Roche’s three-dimensional trade mark ‘comprimé baguette’, corresponding to Lexomil®’s oblong tablet shape bearing three break marks. Under the proposed new provision, such a trade mark could not be used to oppose generic forms of Lexomil®.
By contrast, in a very recent case (also reported in this Update), also remitted from the French Supreme Court, the Appeal Court of Versailles, on 17 September 2009, found for infringement in the case where a generic maker made mention of the trade marked drug brand-name on marketing material. It was held that there is no requirement to refer to the protected brand-name, where the INN (international non-proprietary name) is available. Such analysis would not be impacted by the proposed provision.
The above is still subject to approval from the Constitutional Council. No specific objections were raised against this IP provision in particular. Overall, a two-tier system may arise, wherein a name but not the shape or the colour of a tablet, may be used to protect a drug.