[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] 　　 "Eu legislative gazette (2003 years) " Published in the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia joined the European Union, right "European Union convention" And changes made to relevant laws. The European Court of Justice's ruling relates to an annex to Chapter II of the communique IV prescribed "Special mechanism (specific mechanism) " Interpretive problem.

　　 "Special mechanism" stipulation, When submitting an application for a drug patent or a supplementary protection certificate, The new Member States whose national laws do not yet protect medicines, After the countries mentioned above have joined the European Union, The holder of the patent or supplementary protection certificate shall have the right to prohibit third parties from importing the relevant pharmaceutical products from the above-mentioned newly acceding Member States to other Member States of the European Union. The statute is an exception to the principle of exhaustion of patent rights, Require any product from the new member State to be imported into another Member State of the EU which has granted patent or supplementary protection certificate for the product, Or the perpetrator of the sale in that country, The owner or beneficiary of the relevant patent or supplementary protection certificate must be notified one month in advance of the plan to import or sell the drug product.

　　In this case Merck Canada Company-owned drug "Singulair" European patent, And a supplementary conservation certificate in the UK. Merck Sharp and Dohme company (Hereinafter referred to as "MSD" ) Is the exclusive licensee of the said patent and supplemental Protection Certificate. Sigma Subsidiary of a company Pharma XL Ltd. , An application to import medicines from Poland into the UK "Singulair" . After the above application is approved, Pharma XL Ltd. to MSD Multiple notice, That it was preparing to import drugs into the UK "Singulair" Plan of. after, PharmaXL Ltd. Began importing medicines into Britain "Singulair" . receive PharmaXL Ltd. After the notice of, Merck Canada Company and MSD Express one's opposition Sigma To import medicines into the UK "Singulair" , And filed a patent infringement lawsuit in the country.

　　The issue in this case is how does it apply "Eu legislative gazette (2003 years) " prescribed "Special mechanism" . On one hand, Sigma insist, The code obligates importers to notify the holders of relevant patents or supplementary protection certificates one month in advance that they intend to import protected products, Therefore, The obligee or beneficiary does not claim his or her rights within one month after receipt of the said notice, The importer shall have the right to obtain the consent of the competent authority, Import the products in question into the Member State for sale. Therefore, Sigma It is believed that the right holder or beneficiary of the disputed patent should be within the time limit stipulated in the above specification (A month) Within the, Explicitly stated its opposition to the import of related products under its patent rights. Otherwise, Importers would be left in legal limbo, Detrimental to the realization of their legitimate interests and expected interests.

　　On the other hand, Merck Think that, "Special mechanism" There is no requirement for patent or supplementary protection certificate holders or beneficiaries to explicitly state in advance that they will block parallel imports in accordance with their patent rights. It's only written in the law, And have a precise definition of how to fulfill the corresponding obligations, To prove the existence of the obligation.

　　In view of this, The accepting court decided to suspend the case, And asked the European Court of Justice (Court of Justice) How to apply "Eu legislative gazette (2003 years) " prescribed "Special mechanism" , Make a preliminary determination. 　　

[conclusion] 　　The European Court of Justice stated first, In accordance with "Special mechanism" stipulation, When the owner or beneficiary of a patent wishes to object to the parallel importation of the drug in question, There is no need to notify the importer one month in advance that it intends to object to the import of the drug in accordance with its patent rights. but, If the patent owner or beneficiary fails to express his opposition to the parallel importation within one month after receiving the notification from the importer that he intends to import the relevant drug product, Then the importer after obtaining the approval of the relevant competent authority, It may be imported and marketed on the market of the corresponding Member State. Therefore, Only express an intention to exercise its patent rights, Only the owner or beneficiary of a patent or supplementary protection certificate can prohibit others from importing and selling the disputed drug. 　　

[comment] 　　In this case, it was decided that the rights conferred on the obligee by balancing the patent and the supplementary protection certificate, And the principle of free movement of goods within the EU market, clarify "Eu legislative gazette (2003 years) " prescribed "Special mechanism" Definition and scope of application. 　　

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