Editor's note: F. Hoffmann-La Roche AG File a patent infringement suit in the Estonian courts, Sue Accord Healthcare Limited The generic drugs that are produced (generic drug) Infringement of the relevant patent rights. Estonia's Supreme Court applied to the Court of Justice of the European Union, Made preliminary determinations on the two issues raised in the case (preliminary ruling) . Read on for more details!

[background] F. Hoffmann-La Roche AG (Hereinafter referred to as "Roche" ) File a patent infringement suit in the Estonian courts, Sue Accord Healthcare Limited (Hereinafter referred to as "Accord" ) The generic drugs that are produced (generic drug) Infringement of the relevant patent rights. Estonia's Supreme Court applied to the Court of Justice of the European Union, Made preliminary determinations on the two issues raised in the case (preliminary ruling) . The case disputes are as follows: Roche Is the holder of an Estonian patent and a supplementary protection certificate, Related to one of its drugs "Xeloda" . Accord Preparation for production and "Xeloda" It has the same active substance (active substance) Generic version of, And put it on the Estonian market. Roche Knowing the situation, Apply to the Estonian court "Provisional injunction" , Request for prohibition Accord Manufacture and market the said generic drug, The reason is that Accord s behavior violated Roche in "Xeloda" Patent rights on drugs, The patent rights are protected by the Estonian Supplementary Protection Certificate. Accord Raise an objection, Think that Roche The supplementary protection certificate has expired. About the validity period of the supplementary protection certificate, "Eu Regulation on Supplementary Protection Certificates for medicinal products (The first 469/2009 No) " (Hereinafter referred to as "European Union regulation 469/2009 No" ) stipulation, The period of validity of the supplementary protection certificate shall be calculated from the date on which marketing authorisation for the medicinal product covered by the certificate was first obtained in the territory of the European Union. In this case, medicine "Xeloda" For the first time, it received marketing authorization in Estonia (2001 years 6 month 8 day) when, Estonia has not joined the European Union (2004 years 5 month 1 Officially acceded to) . Before that, Roche Used to be in Switzerland-European economic area (European Economic Area) Member state, Access to medicine "Xeloda" Marketing authorization (1998 years 6 month 10 day) . Roche claim, As a result of its marketing authorization in Estonia, Estonia has not joined the European Union, Therefore, their supplementary protection certificates should apply to Estonian domestic law and not the above "European Union regulation 469/2009 No" . If applicable in this case "European Union regulation 469/2009 No" , Then the starting time of validity of the supplementary protection certificate involved should be "Xeloda" When marketing authorisation was first obtained in the European Economic Area, namely 1998 years 6 month 10 day, No longer valid at the time this case was filed. And if Estonian domestic law applies in this case, Then the validity period of the supplementary protection certificate involved should be from Roche From the date of marketing authorisation obtained in Estonia, namely 2001 years 6 month 8 day, It was still in effect when this case was brought. The trial court upheld Roche claim, approve "Provisional injunction" Apply for. The appeals court rejected it Roche Application for, The reason is that Roche The supplementary protection certificate has expired. The Court of Appeal held that this case should apply "European Union regulation 469/2009 No" , Because in the Ordinance No 21 article 2 The scope of supplementary protection certificates regulated by the Regulation has been specified in the transitional provisions of the paragraph: "2004 years 5 month 1 Before the sun, Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Malta, Poland, Domestic laws of Slovenia and Slovakia, and 2007 years 1 month 1 Supplementary protection certificate passed before today in accordance with Romanian domestic law" . Roche Against the decision of the court of appeal, Appeal to the Estonian Supreme Court. Roche In his appeal, he argued that the court of Appeal vs "European Union regulation 469/2009 No" The first 21 article 2 The interpretation is contrary to the principles of EU law. As the appellate court interpreted it, Means that EU law gives rise to a supplementary protection certificate approved in accordance with national law "retroactive" Effect of, This is a fundamental principle of EU law-Protect existing rights and prohibit retroactive law-contravene. The Estonian Supreme Court addressed two questions to the Court of Justice of the European Union in this case and requested a preliminary ruling: first, "European Union regulation 469/2009 No" The first 21 article 2 Paragraph is applicable to supplementary protection certificates approved before the accession of a Member State to the EU? second, If applicable, Then consider the fundamental principles of EU law regarding the protection of existing rights and the prohibition of retroactivity of law, Whether this ordinance is valid?

[discover] The Court of Justice of the European Union took up the second issue first, namely "European Union regulation 469/2009 No" The first 21 article 2 Validity of payment. The court of Justice of the European Union first stated the context in which the clause was set, "Czech Republic, Republic of Estonia, Republic of Cyprus, Republic of Latvia, Republic of Lithuania, Republic of Hungary, The Republic of Malta, Republic of Poland, Agreement on the accession of the Republic of Slovenia and the Slovak Republic to the European Union" After signing, According to the agreement "European economic community (European Economic Community) Regulations on the Establishment of a system of Supplementary Protection Certificates for Drugs (The first 1768/92 No) " The corresponding corrections made. The Court of Justice of the European Union stated, The article is based on an agreement between the EU member states and the applicant countries, Except as provided for in the original treaty, It shall not be suspended in accordance with other procedures, Amend or overturn the clause. The Court of Justice of the European Union therefore ruled, It has no right to evaluate the validity of the above provisions. secondly, Court of Justice of the European Union ruling, "European Union regulation 469/2009 No" The first 21 article 2 Paragraph applies to member States (In this case, the Republic of Estonia) The status of supplementary protection certificates for medicinal products approved prior to accession to the EU. Thus, The European Court of Justice concluded, A pharmaceutical product has been granted marketing authorisation within the European Economic Area, It will then obtain a supplementary protection certificate for medicines in countries that have not yet joined the European Union, When the supplementary protection certificate comes into force, the country has already joined the European Union, The date of approval of the first marketing authorisation obtained for the medicinal product within the European Economic Area shall be taken as the expiry date of the supplementary protection certificate obtained later. On this point, The Court of Justice of the European Union stressed, consider "European Union regulation 469/2009 No" The first 13 The purpose of the article, A marketing authorisation obtained for the first time in the European Economic Area has the same effect as in the European Union area (European Union) The effect of marketing authorisation obtained for the first time.

[comment] It's worth noting, The verdict in this case is negative Roche claim, namely, Supplementary protection certificates requiring approval prior to a Member State's accession to the EU apply "European Union regulation 469/2009 No" , Fundamental principles of EU law-Protect existing rights and prohibit retroactivity of law-Go against. In this case, When the supplementary protection certificate in question takes effect (The underlying patent becomes effective when it becomes invalid) , namely 2014 years 11 month 18 day, Estonia has joined the European Union. correspondingly, "European Union regulation 469/2009 No" It has also been implemented in Estonia. In the preliminary determination of this case, The European Court of Justice said yes "European Union regulation 469/2009 No" Is set up to ensure consistent protection of supplementary protection certificates throughout the EU. As the European Court of Justice in its ruling No 38 segmental, Only will "Initial marketing authorization" It is interpreted as the first marketing authorisation obtained in any Member State of the European Union or European Economic Area, In order to ensure that the duration of protection of medicinal products recorded in supplementary protection certificates is consistent in all Member States of the European Union.

author: Enrique ARMIJO CHÁVARRI, A partner at Esaberi compile: Li Fangqian, The Esaberi intern proofreading: Liu Dan, Esabarry Legal Counsel source: Esabaril (ELZABURU) Intellectual property rights