Editor's note: 2012 years 10 month 25 day, The European Commission approves drugs Adcetris Marketing authorization. 2012 years 10 month 30 day, The applicant received formal notification that the marketing authorization was approved. 2012 years 11 month 2 day, Seattle Genetics To the Austrian Patent Office Adcetris Supplementary protection certificate (Supplementary Protection Certificate, SPC) Apply for, The application was subsequently approved. The Austrian Patent Office considers that the commencement date of the term of the supplementary protection certificate shall be 2012 years 10 month 25 day, The date the marketing authorisation was granted by the European Commission, correspondingly, The supplementary protection certificate shall be 2027 years 10 month 25 Day due. Seattle Genetics Disobey the above decision, appeal, It is considered that the validity of the supplementary protection certificate shall expire 2027 years 10 month 30 day. Read on for the future.

[background] The main dispute resolved by this decision is, How to determine "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 on Certificates for the Supplementary Protection of Medicines" ) The first 13. 1 prescribed "For the first time, it obtained the marketing authorization in the EU market (Marketing Authorisation) date" . Brief introduction of the case: 2012 years 10 month 25 day, The European Commission approves drugs Adcetris Marketing authorization. 2012 years 10 month 30 day, The applicant received formal notification that the marketing authorization was approved. 2012 years 11 month 2 day, Seattle Genetics To the Austrian Patent Office Adcetris Supplementary protection certificate (Supplementary Protection Certificate, SPC) Apply for, The application was subsequently approved. The Austrian Patent Office considers that the commencement date of the term of the supplementary protection certificate shall be 2012 years 10 month 25 day, The date the marketing authorisation was granted by the European Commission, correspondingly, The supplementary protection certificate shall be 2027 years 10 month 25 Day due. Seattle Genetics Disobey the above decision, appeal, It is considered that the validity of the supplementary protection certificate shall expire 2027 years 10 month 30 day. The Austrian Patent Office pleaded, On the issue of determining the validity period of supplementary protection certificates, The actual practice of national patent offices in different member states varies. In view of this, The Austrian court decided to suspend the case, And asked the European Court of Justice (Court of Justice) Make a preliminary determination, clarify "European Union Regulation on Certificates for the Supplementary Protection of Medicines" The first 13. 1 prescribed "Date of first EU marketing authorisation" concept. For this reason, The hearing court asked two questions: First of all, "Date of first EU marketing authorisation" The concept should be determined by EU law; second, If the answer to the first question is yes, Which date shall be used to calculate the duration of the supplementary protection certificate——Marketing authorization approval date, Or the date on which the applicant receives notice of the approval decision?

[conclusion] For the first question, The European Court of Justice held that, Specific concepts provided for in EU law, If there is no explicit requirement to refer to the laws of the member States, The concept should be interpreted separately and uniformly throughout the EU. Therefore, whereas "European Union Regulation on Certificates for the Supplementary Protection of Medicines" The first 13. 1 prescribed "Date of first EU marketing authorisation" Reference to any member state law is not required, Therefore, this concept belongs to the concept of autonomy of EU law, It should be interpreted uniformly within the EU. To sum up, European court of justice ruling, "Date of first EU marketing authorisation" The concept shall be determined by EU law. For the second question, The European Court of Justice stated that, understand "Date of first EU marketing authorisation" This concept, The starting point should be "European Union Regulation on Certificates for the Supplementary Protection of Medicines" Legislative purpose—— "Establish an adequate and effective period of protection for the underlying patent" . For that matter, European court of justice, Only upon receipt of notification of approval of marketing authorisation, Supplementary protection certificate right holder to market corresponding products. Therefore, "Date of first EU marketing authorisation" Should be understood as, The date on which the applicant receives the notice of approval of the license, Not the date the license was granted.

[comment] For the owner of the supplementary protection certificate, Correct understanding "Date of first EU marketing authorisation" Is of great significance, This directly affects the validity period of the supplementary protection certificate. The ruling is certainly the outcome the drug industry has long hoped for, As the facts of this case show, The term of the supplementary protection certificate is only increased 5 day, Can seriously affect the financial interests of the drug patentee. After the European Court of Justice's ruling in this case, Spain's Patent and Trademark office said in a notice published in the Spanish Intellectual Property Gazette, Supplementary protection certificate application that is still in the application process, Will be as of the date on which the applicant receives the notification of marketing authorisation approval "Date of first EU marketing authorisation" . literally, The notice does not apply to supplementary protection certificates already issued. But how on earth, We need to wait for the court ruling.

[Related reading] " [European patent] The conclusions of the European Court of Justice on the duration of the subsidiary protection certificate have retrospective effect (C-492/16) "

compile: Liu Dan, Esabarry Legal Counsel source: Esabaril (ELZABURU) Intellectual property rights