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).<\/p>\n\n\n\n
The rate of this levy is set at 3% of the pre\u2011tax turnover generated in France<\/strong> 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<\/strong>.<\/p>\n\n\n\n This measure specifically targets practices that artificially maintain the commercial exclusivity of a medicinal product and are liable to cause an unjustified delay, namely:<\/p>\n\n\n\n Although the intention of the Assembl\u00e9e nationale appears to have been to aim at so\u2011called \u201cevergreening\u201d practices, the wording of these provisions inevitably raises a number of questions.<\/p>\n\n\n\n For example, one may ask what is meant by the \u201cinitial patent<\/em>\u201d, the expiry of which serves as the starting point for calculating the delay. Is it sufficient for this \u201cinitial patent<\/em>\u201d 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 \u201cinitial patent<\/em>\u201d?<\/p>\n\n\n\n The article refers to practices \u201cconsisting in artificially maintaining the commercial exclusivity of a medicinal product<\/em>\u201d. The use of the word \u201cartificially\u201d 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.<\/p>\n\n\n\n Furthermore, Article L.138\u201110\u20111 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 \u2013 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.<\/p>\n\n\n\n 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 \u2013 practices often criticised as potentially anti\u2011competitive \u2013 would not<\/em> constitute practices likely to cause an unjustified delay?<\/p>\n\n\n\n In this respect, the new article states that filing a patent application is presumed to constitute an unjustified delay where there is no \u201cimprovement in the medical service provided<\/em>\u201d. Yet such a test is entirely unknown in patent law. It is, in fact, a test used by the Haute Autorit\u00e9 de Sant\u00e9 to determine the reimbursement rate of a medicinal product in France. Its inclusion in Article L.138\u201110\u20111 CSS therefore raises questions as to how it should be interpreted.<\/p>\n\n\n\n Similarly, one may wonder about the nature of the \u201crepeat offence<\/em>\u201d 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\u2019s rights be sufficient to avoid being classified as a repeat offender?<\/p>\n\n\n\n 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.<\/p>\n\n\n\n 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.<\/p>\n","protected":false},"excerpt":{"rendered":" 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...<\/p>\n","protected":false},"author":10,"featured_media":0,"template":"","tags":[1291,833,822],"class_list":["post-28789","insight","type-insight","status-publish","hentry","tag-patents-2-en","tag-pharmaceuticals-en","tag-ccp-2"],"acf":[],"yoast_head":"\n\n