[Editor's note] Like most countries and regions in the world, The rulings of the Court of Justice of the European Union have important guiding significance and predictive value for understanding the legal norms of the European Union. Esabaril (ELZABURU) At the beginning of each year, typical cases of the Court of Justice of the European Union in the previous year are summarized and published, And a brief review of each case, In order to help customers and partners to understand the EU intellectual property norms. Given the importance of Chinese customers and partners, We try to publish the Chinese version of typical cases on a weekly basis, It is convenient for Chinese partners to learn the latest information in a timely manner. 　　

[background] 　　

The German Federal Court of Justice appealed to the European Court of Justice (Court of Justice) On how to understand "Regulation of the European Parliament and of the Council on Supplementary Protection Certificates for medicinal products (The first (EC) 469/2009 No) " (Hereinafter referred to as "European Union regulation (EC) 469/2009 No" ) The first 2 Provision of article, Make a preliminary determination. The article relates to the acquisition of supplementary protection certificates for combination products of medicines and medical devices (Supplementary Protection Certificate) Stipulation of. 　　

Boston Scientific Ltd (Hereinafter referred to as "Boston Scientific" ) Has a European patent (EP0681475) , The object of protection is medical articles for restenosis after angioplasty. The patent covers the use of paclitaxel (The main active ingredient in the treatment of certain cancers) Pharmaceutical preparation of agents to maintain the area of vascular lumen after dilation. 2003 years 1 month, Boston Scientific Access to medical equipment TAXUS? , Eu Certificate of Conformance for a paclitaxel coated scaffold. In the process of obtaining the certificate, The Dutch Medical Evaluation Board is in accordance with "European Council Directive on medical devices (The first 93/42/EEC No) " (Hereinafter referred to as "European Union regulation 93/42/EEC Number instruction" ) attachment I The first 7. 4 article 1 Paragraph and clause 2 Provision of paragraph, An adjunct to the medical device——paclitaxel——Conduct a prior assessment. 2011 years 3 month, Based on the European Patent and EU Certificate of Conformity mentioned above, Boston Scientific Apply to the German Patent Office for a secondary protection certificate of taxol. The German Patent Office rejected the application, One of the reasons for the rejection, Marketing authorisation has not been obtained for the product to be protected (Marketing Authorisation) , Do not conform to "European Union regulation (EC) 469/2009 No" The first 2 Requirement of strip. 　　

At issue in this case is, Whether the prior assessment conclusions of the Dutch Medical Evaluation Board are "Directive of the European Parliament and of the Council on the Community specification for medical products for human use (The first 2001/83/EC No) " (Hereinafter referred to as "European Union regulation 2001/83/EC Number instruction" ) The required marketing authorization certificate? 　　

[conclusion] 　　

European court of justice ruling, basis "European Union regulation 93/42/EEC Number instruction" Provides for an prior evaluation procedure for medical devices constituting drugs, It shall not be regarded as a marketing authorisation procedure for medicinal products, The reason is that: 　　

- paclitaxel, As an integral part of the disputed medical equipment and plays an auxiliary role in the equipment, Shall not be regarded as "European Union regulation 2001/83/EC Number instruction" The first 2 prescribed "Marketing authorization may be applied for" Independent drug, Because these two concepts are mutually exclusive, The definitions in the respective legislation are completely different. For that matter, The European Court of Justice has adopted the functional standard, Think even the drug (paclitaxel) It has an independent drug effect, Because it played only an auxiliary role in the medical device at issue, It cannot be recognized as an independent pharmaceutical product for which marketing authorisation can be applied. 　　

- The procedure for obtaining a prior mandatory certificate for medical equipment containing paclitaxel is not "European Union regulation 2001/83/EC Number instruction" The administrative procedures prescribed. For that matter, The European Court of Justice stated that, Evaluate the quality of a drug, Security and functionality, Must abide by "European Union regulation 93/42/EEC Number instruction" attachment I The first 7. 4 Provision of article, That is, the drug should be considered as part of a medical device, And the intended purpose of the medical device. 　　

- Finally, European Court of justice, although "European Union regulation (EC) 469/2009 No" The first 4 The article provides that medical equipment used as a drug may obtain a certificate of auxiliary protection, However, it cannot be analogues that drugs or adjuvants that play an auxiliary role in the medical equipment can also obtain the auxiliary protection certificate separately. Therefore, The drug paclitaxel in this case does not fall within the scope of this provision. 　　

[comment] 　　

The case ultimately ruled that the active substance in the medical device contributed to the therapeutic effect, That conclusion, though, may disappoint medical-device makers, But it basically conforms to the interpretation principle of maintaining legal certainty. 　　

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