Generics can now legally infringe IP rights over appearance of drugs
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Law 2011-2012 of December 29 2011 relating to the reinforcement of the sanitary safety of medicines and health products, which was published in the Official Journal on December 30 2011, has introduced a new Article L5121-10-3 in the Public Health Code. The new provision gives prevalence to generics over trademark and other IP rights:
“The owner of an intellectual property right protecting the appearance and texture of the oral pharmaceutical forms of a reference product […] cannot prohibit the oral pharmaceutical forms of a generic drug substitutable to this product [...] from having a similar or identical texture and appearance”.
This is the third time that the legislature has tried to introduce Article L5121-10-3 under the same wording but, after two failed attempts, the provision has now become law.
This provision first appeared on November 26 2009 as part of the Social Security Financing Act 2010. However, on December 22 2009 the French Constitutional Council held that Article L5121-10-3 was contrary to the Constitution and decided that it could not be enacted within the context of a Social Security law.
In May 2011 Article L 5121-10-3 was reintroduced by the French Parliament in a proposal of law concerning the reform of the health system. On August 4 2011 the Constitutional Council again held that the provision was contrary to the Constitution and could not be enacted because it was not sufficiently related to the law at issue.
The main rationale behind the adoption of Article L5121-10-3 was to prevent - or at least significantly reduce the risk of - consumers mistakenly taking the wrong drugs when generics have been substituted to brand-name drugs (under French practice, generics are routinely substituted for brand-name drugs). Another reason was that 20% of hospitalisations for patients over 80 years old are due to serious illnesses caused by drugs, overdoses and therapy interruptions. The French authorities were thus willing to include the new Article L5121-10-3 with a view to improving public health.
The immediate result of the new provision is that, once patent protection has expired, it will not be possible to enforce valid trademark and/or design rights against the manufacturers of generics that are similar in appearance to brand-name drugs. Therefore, generics manufacturers will be able to freely reproduce or imitate the overall shape, colour(s) and/or taste of the original pharmaceutical product without infringing these trademarks or designs.
This raises a couple of questions. First, the consequences of the new provision on Customs recordation and seizures are still unclear. Second, one may wonder whether the new provision applies strictly to national IP rights or extends to IP rights having an effect in France, as the Community Trademark Regulation (207/2009) and the Council Regulation on Community Designs (6/2002) both establish that Community rights “[…] shall have equal effect throughout the Community”.
This being said, as an exception to IP monopolies, the new provision should be interpreted strictly. It remains to be seen how the new Article L5121-10-3 will be interpreted and handled in practice.
Jean-Philippe Bresson and Franck Soutoul, INLEX IP EXPERTISE, Paris
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