Editor's note: 2014 years 9 month, MSD The company submits an application for a secondary Protection certificate to the UK Intellectual Property Office, The target is a drug used to lower cholesterol levels "Atozet" Of the two active ingredients. MSD When the company submitted its application, A copy of the notice of completion of the dispersion procedure was also submitted, Simultaneous request of applicant, Wait until the medicines covered by the certificate have been given marketing authorisation in the UK, The UK Intellectual Property Office continues the protection certificate approval process. The UK Intellectual Property Office examiner rejected the application for a secondary protection certificate, Read on for more details!

[background] The High Court of England and Wales accepted the American company MSD (Subordinate to Merck & Co. Inc. company) And the UK Intellectual Property Office (UKIPO) After the lawsuit between, To the European Court of Justice for a preliminary ruling on the relevant issues in this case: -2014 years 9 month, MSD The company submits an application for a secondary Protection certificate to the UK Intellectual Property Office, The target is a drug used to lower cholesterol levels "Atozet" Of the two active ingredients (active ingredients) . basis "Directive of the European Parliament and of the Council on the Community specification for medicinal products for human use (The first 2001/83/EC No) " (Hereinafter referred to as "Community Directive on the Regulation of medicinal products for Human use" ) The first 28. 4 article, MSD When the company submitted its application, A decentralized program was also submitted (decentralised procedure, An EU procedure for the mutual recognition of the assessment results of the respective main authorities among member States, It aims to unify and simplify the drug evaluation process, It applies to medicines that have not received marketing authorisation at the time of application——Translator's note) Copy of final notice, It contains the EU code for medicinal products for human use issued by the German Medicines Agency. Simultaneous request of applicant, Wait until the medicines covered by the certificate are authorised for marketing in the UK (marketing authorisation) after, The UK Intellectual Property Office continues the protection certificate approval process. -The UK Intellectual Property Office examiner rejected the application for a secondary protection certificate, On the grounds that the application does not meet "Regulation of the European Parliament and of the Council on Certificates of Supplementary Protection for medicinal products (The first (EC) 469/2009 No) " (Hereinafter referred to as "Regulations on the Certificate of Auxiliary Protection of Drugs" ) The first 3 (b) Requirement of strip, That is, the application lacks proof that a valid marketing authorisation has been obtained in the UK. -2014 years 11 month, MSD The company sent a letter to the UK Intellectual Property Office from the Medicines and Healthcare Products Regulatory Agency 2014 years 10 A copy of the marketing authorization issued in January. however, The UK Intellectual Property Office rejected MSD Supplementary documents submitted by the Company, The reason is this defect——The application documents do not meet the requirements——It is not modifiable. -MSD The company then sued the British court for the above-mentioned decision of the British Intellectual Property Office. The accepting court decided to suspend the case, How does the European Court of Justice understand this "Regulations on the Certificate of Auxiliary Protection of Drugs" The first 3 (b) Articles and regulations 10. 3 Article, etc. , to make a preliminary determination: ·Before the underlying patent expires, "Community Directive on the Regulation of medicinal products for Human use" The first 28. 4 The basic member states stipulated in the article (Reference Member State) Notice of completion of decentralized proceedings issued, Is it equivalent to the marketing authorisation required in the application for supplementary protection certificate, Based on this notice, the secondary protection certificate is finally obtained? ·If the answer to the previous question is no, Then the application for supplementary protection certificate is rejected without submitting the marketing authorisation certificate, Can it be based on "Regulations on the Certificate of Auxiliary Protection of Drugs" The first 10. 3 The provisions of the article are amended?

[conclusion] The European Court of Justice's answer to the first question is no, Emphasize only fit "Community Directive on the Regulation of medicinal products for Human use" "Decentralized program" The form required by the terms, Is a valid marketing authorization. In this regard, European court of justice "Community Directive on the Regulation of medicinal products for Human use" The first 28. 4 prescribed "End-of-program notification" It's just an intermediate step in the dispersion process, Does not have the same legal effect as a valid marketing authorization. secondly, The European Court of Justice made it clear "Regulations on the Certificate of Auxiliary Protection of Drugs" The first 10. 3 Meaning of article. The European Court of Justice held that, Failure to submit a marketing authorisation certificate resulting in rejection of an application for a subsidiary protection certificate, Does not fall within the scope of the amendment which the applicant may request under this clause. The European Court of Justice stressed, Basis control 10. 3 Provision of article, Only secondary protection certificates protect principals——medicine——When there is a defect in itself, There is the possibility of correction, If the application for auxiliary protection certificate is defective, It cannot apply to require an amendment. For that matter, The text of the law is clear.

[comment] The European Court of Justice "Regulations on the Certificate of Auxiliary Protection of Drugs" The first 3 (b) Articles and regulations 10. 3 The explanation of the article is clear and explicit, That leaves no room for uncertainty or rebuttal.

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