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Opposition against Sovaldi™ European Patent

On 10th February 2015, the NGO Médecins du Monde (MDM) filed an opposition before the European Patent Office against the grant of the European Patent EP2203462-B1 to the pharmaceutical company GILEAD PHARMASSET LLC.

The EP2203462-B1 patent protects a chemical whose formula compound corresponds with the active ingredient of sofosbuvir under claim 2, according to the statement of opposition filed. Regarding claim 6, a composition comprising the said compound and a pharmaceutically acceptable medium are protected, which would be equivalent to the drug for the treatment of hepatitis C that PHARMASSET LLC markets under the name Sovaldi™.

The statement of opposition filed has been made publicly available on the website by the NGO itself. According to the same, among other reasons the claimed compound is not considered to be novel enough. Once the opposition is found admissible, GILEAD PHARMASSET LLC must reply to it providing arguments in defense of their patent.

For an European patent to be granted, the European Patent Convention (EPC) prescribes that it has to pass a previous examination phase that assesses, among other patentability requirements, whether the claimed invention is new and inventive in comparison to the disclosed before the effective date of the patent application, the so called “State of the Art” (Prior Art).

If a patent application passes successfully the referred examination phase, the patent is granted and the grant is published in the European Patent Bulletin. After that, a period of nine months begins. During this term, third parties may file an opposition against the patent, just as Médecins du Monde did. An opposition must be reasoned and it must be based on evidence that supports the reasons for which the granted patent is not considered valid (provisions of Article 100 EPC).

It is not unusual that a procedure of opposition against an European patent takes several years to be resolved. After the exchange of written arguments in defense of the patent grant and against it on the basis of the opposition filed, the involved parties are summoned to attend a hearing (“Oral Proceedings”) before the Opposition Division in charge of the case at the European Patent Office. The parties discuss outstanding key issues in detail so that the Opposition Division can issue a decision. The decision may be to maintain the patent in the form in which it was granted (favorable to the owner of the patent), to revoke the patent (favorable to the opponent) or to maintain the patent, but to introduce modifications, i.e. reducing the scope of the initial protection.

There is no doubt that the development of this case will followed closely due to the impact that the outcome may have. 


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