The article establishes a levy applicable to companies marketing proprietary medicinal products. It targets practices involving the undue maintenance of exclusivity over a proprietary medicinal product with the aim of delaying the entry of a generic medicine onto the market by more than one year after the expiry of the original patent or supplementary protection certificate (SPC).
The rate of this levy is set at 3% of the pre‑tax turnover generated in France from sales of the medicinal product concerned during the financial year in which the delay is observed. This rate may be increased to 5% in the event of a repeat offence within five years.
This measure specifically targets practices that artificially maintain the commercial exclusivity of a medicinal product and are liable to cause an unjustified delay, namely:
Although the intention of the Assemblée nationale appears to have been to aim at so‑called “evergreening” practices, the wording of these provisions inevitably raises a number of questions.
For example, one may ask what is meant by the “initial patent”, the expiry of which serves as the starting point for calculating the delay. Is it sufficient for this “initial patent” to cover the active ingredient of the medicinal product, or must it explicitly refer to it? Furthermore, must it necessarily be a product patent, or could it also be a patent for a second therapeutic use? Should the SPC only be used as the reference point for calculating the delay if it is based on the “initial patent”?
The article refers to practices “consisting in artificially maintaining the commercial exclusivity of a medicinal product”. The use of the word “artificially” seems to imply a distinction between two situations: one in which efforts to maintain commercial exclusivity would be lawful and therefore permissible, and another in which they would not. However, it remains unclear where this boundary lies, since it is the very nature of patent law to confer exclusivity.
Furthermore, Article L.138‑10‑1 CSS cites as an example of such practices the filing of one or more patent applications aimed at protecting specific categories of inventions. However, as is well known, a patent application does not necessarily result in the grant of a patent – or, at the very least, not a patent with the same scope as the application as filed. In addition, a patent holder is under no obligation to enforce their rights. In this context, it is difficult to understand how the mere filing of a patent application could automatically delay the entry of a generic product onto the market.
It is also interesting to note that only an exhaustive list of inventions is covered by the new provision. Should we therefore understand that the filing of patent applications for new therapeutic uses, or the repeated filing of divisional applications – practices often criticised as potentially anti‑competitive – would not constitute practices likely to cause an unjustified delay?
In this respect, the new article states that filing a patent application is presumed to constitute an unjustified delay where there is no “improvement in the medical service provided”. Yet such a test is entirely unknown in patent law. It is, in fact, a test used by the Haute Autorité de Santé to determine the reimbursement rate of a medicinal product in France. Its inclusion in Article L.138‑10‑1 CSS therefore raises questions as to how it should be interpreted.
Similarly, one may wonder about the nature of the “repeat offence” that would justify an increase in the tax rate from 3% to 5%. Would it be necessary to refrain from filing any further patent applications relating to the medicine in question? Would the patent have to be withdrawn (with retroactive effect)? Or would simply choosing not to exercise one’s rights be sufficient to avoid being classified as a repeat offender?
In summary, the administrative court with jurisdiction to hear appeals concerning decisions made under this new article will have many points to clarify in the coming months.
The teams at Regimbeau stand ready to assist you in developing strategies for the protection and defence of your medicines in light of this new legislation, pending further clarification from the courts.
