Editor's note: 2015 years 10 month 6 day, The European Court of Justice "Seattle Genetics" The case was decided, Clarifying pair "The date the product first received marketing authorization in the EU market" Understanding of concept. basis "Regulation of the European Parliament and of the European Commission on Certificates of Supplementary Protection for medicinal products (The first (EC) 469/2009 No) " The first 13. 1 Section Calculates the protection period of the secondary protection certificate, The date needs to be determined first. Look down together!

[background] 2015 years 10 month 6 day, The European Court of Justice "Seattle Genetics" (Case number: C-471/14) The case was decided, Clarifying pair "The date the product first received marketing authorization in the EU market" (Hereinafter referred to as "First marketing authorization date" ) Understanding of concept. basis "Regulation of the European Parliament and of the European Commission on Certificates of Supplementary Protection for medicinal products (The first (EC) 469/2009 No) " (Hereinafter referred to as "European Union Regulation Regulating Supplementary Protection Certificates for medicinal products" ) The first 13. 1 Section Calculates the protection period of the secondary protection certificate, The date needs to be determined first. in "Seattle Genetics" Pending judgment, Many patent offices of member states "First marketing authorization date" Interpret as the date of approval of marketing authorization. "Seattle Genetics" In judgment, European Court of justice "First marketing authorization date" It shall be the date on which the licensee receives the notification of approval of marketing authorization. Because technically speaking, The grantee of the auxiliary certificate only receives the notice of approval, Before you can start selling goods. Therefore, Calculate the protection period of the secondary protection certificate, If using the date of approval of marketing authorisation rather than the date of receipt of the notification of approval, Eventually it goes down for no reason (It's only a few days) The period of protection granted by law to the corresponding right holder. for "Seattle Genetics" New applications for secondary protection certificates filed after the decision and pending proceedings, The patent offices of the member States of the European Union refer to the judgment, The date on which the applicant receives the notice of approval rather than the date of approval is the basis for calculating the protection period of the auxiliary protection certificate. For cases where the application process has been completed, Patent offices of most member states (Specifically include, Germany, Portugal, Britain, Ireland, Belgium, Latvia, Holland, Bulgaria, Czech Republic, Croatia, Greece, Denmark, Slovakia, Estonia and Romania) Agreed upon request of applicant, Fixed the protection period where there was an error. but, There are still patent offices of some member States (France, Hungary and Spain) It rejected the request of the relevant right holders to modify the protection period which had been determined before the judgment based on this judgment. The Patent Office said, A judgment made later shall not have retrospective effect on an administrative decision made earlier and already in force. After the petition was denied, Auxiliary protection certificate owner basis "Regulation of the European Parliament and of the European Commission on Supplementary Protection Certificates for plant protection products (The first (EC) 1610/96 No) " (Hereinafter referred to as "European Union Regulation Regulating the Certificate of Auxiliary Protection of Plants" ) The first 17. 2 article (In accordance with the preamble to the Regulation 17 The expression of a paragraph, This article on the Supplementary Protection Certificate of Medicines Regulation No 18 Article also applies) , Take the administrative rejection to the court of jurisdiction of the member State. The first 17. 2 Article provision, Applying for auxiliary protection certificate "First marketing authorization date" exist "error" when, The holder of the auxiliary protection certificate has the right to file a lawsuit at any time, Correct the resulting protection period error. The prosecution argues that it will "First marketing authorization date" Interpret as the date of approval of marketing authorization and not the date of receipt of notification of approval, Versus the European Court of Justice "Seattle Genetics" The verdict in the case was contradictory, exist "error" , Can be based on control 17. 2 Article of action. This is exactly the case at issue. prosecutor——Incyte Pharmaceutical company——Have a secondary protection certificate (The application process has been completed) . The Hungarian Patent Office rejected the company's grounds "European Union Regulation Regulating the Certificate of Auxiliary Protection of Plants" The first 17. 2 article (That is "European Union Regulation Regulating Supplementary Protection Certificates for medicinal products" The first 18 article) A request to modify the certificate protection period. Given the complexity of the legal issues involved in the case——Question of the retrospective effect of European Court of Justice decisions in preliminary adjudication proceedings, The Hungarian court hearing the case asked the European Court of Justice for a preliminary ruling, Clarify how to understand the No 17. 2 Strip and "Seattle Genetics" The relationship between the case and the decision. The question posed by the Hungarian court to the European Court of Justice is: "European Union Regulation Regulating the Certificate of Auxiliary Protection of Plants" The first 17. 2 article ( "Regulations on the Certificate of Auxiliary Protection of Drugs" The first 18 article) Should be understood as, Determine a secondary protection certificate "First marketing authorization date" Without reference to the European Court of Justice "Seattle Genetics" Judgment of the case, error, Therefore, Even for secondary protection certificates that had been approved prior to the above judgment, You can still request that the error be fixed?

[conclusion] The European Court of Justice stated in its ruling in this case, If the protection period is calculated, the time is determined "First marketing authorization date" In the way of the European Court of Justice "Seattle Genetics" The verdict went against him, Then the owner of the auxiliary protection certificate has the right to basis "European Union Regulation Regulating the Certificate of Auxiliary Protection of Plants" The first 17. 2 article ( "European Union Regulation Regulating Supplementary Protection Certificates for medicinal products" The first 18 article) , Request an amendment to this period of protection. The reason is that: -First of all, "Seattle Genetics" Verdict of the case "First marketing authorization date" The clarification of concepts is effective from the beginning (ex tunceffects) , Because the meaning of a clause exists from the day it enters into force, The preliminary adjudication procedure is merely a clarification of that meaning. -secondly, In a situation like this one, Will apply for the auxiliary protection certificate "First marketing authorization date" It is wrong to interpret as the date of approval rather than the date on which the Licensee receives the approval notice, Therefore, The basis of the right holder of the certificate whose protection period has not expired "European Union Regulation Regulating Supplementary Protection Certificates for medicinal products" The first 18 article ( "European Union Regulation Regulating the Certificate of Auxiliary Protection of Plants" The first 17. 2 article) Sue at any time, Request the issuing authority to correct the error. -Finally, Correct duration errors for issued secondary protection certificates, It is also in line with the two objectives of the legislation relating to subsidiary protection certificates——On the premise of not affecting the principle of legal certainty, Fully protect the rights of the holder of the auxiliary protection certificate, And achieve uniform application of EU law.

[comment] The ruling by the European Court of Justice will affect "Seattle Genetics" The protection period of the auxiliary protection certificate obtained before the judgment is wrong, This is undoubtedly good news. in "Seattle Genetics" The right holder whose application for a subsidiary protection certificate has been completed before the judgment may rely on the clarification of the decision of the European Court of Justice in the case, Request correction of protection period errors. The only limitation that the European Court of Justice has proposed is, When the obligee makes a request for amendment, The auxiliary protection certificate has not been terminated. The implications for Spain are particularly important. As mentioned earlier, In Spain it was the administrative body that explicitly refused to apply the secondary protection certificate that had been granted "Seattle Genetics" One of the few EU member states to be decided in the case. It will also encourage the many parties in similar cases who, at the time of writing, have yet to be decided by the Madrid High Court, Administrative dispute proceedings may be brought accordingly. It is expected that the Madrid court will rule in favour of the claim by the holder of the secondary protection certificate, Reversing an earlier rejection by the Spanish Patent and Trademark Office, And asked the bureau to correct the wrong period of protection.

compile: Liu Dan, The source of Aisabri Legal Counsel: Esabaril (ELZABURU)