[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 ruling in this case was to resolve the protection subject matter for "protein D" A dispute between the holder of a European patent and the Austrian Patent Office. "protein D" The app is available in a app called "Synflorix" In pediatric pneumococcal vaccine, The drug has obtained marketing authorization. protein D Not in its original form Synflorix drug, It binds covalently to other active ingredients (covalent binding) Formal presentation of. protein D in Synflorix In addition to playing a covalent role in drugs, It is also immune to Haemophilus influenzae. but, Aim at Synflorix Marketing authorisations for drugs are issued only for proteins D It's a carrier protein, No mention is made of its own pharmacological effects (therapeutic effect) (Immune action against Haemophilus influenzae) .

　　The Austrian court of Justice appealed to the European Court of Justice (Court of Justice) There are three issues for adjudication:

　　 (1) Whether an active ingredient present in a medicinal product in covalent form with other active ingredients can be granted a supplementary pharmaceutical protection certificate?

　　 (2) The pharmacological action of an active ingredient is not clearly documented in the marketing authorisation granted, Whether a supplementary protection certificate for the active ingredient can be applied for under this marketing authorisation? and,

　　 (3) Carrier proteins that do not have any pharmacological or immunological effects documented in the approved marketing authorisation, Whether it belongs to the supplementary protection certificate system "Active ingredient (active ingredient) " ?

　　 [conclusion]

　　The European Court of Justice concluded as follows:

　　First of all, For active ingredients that form pharmaceutical ingredients by covalently binding with other active ingredients, "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" ) Allow them to apply for a supplementary protection certificate.

　　secondly, "European Union regulation (EC) 469/2009 No" stipulation, Active ingredients whose pharmacological or immunological effects are not clearly stated in the marketing authorisation, A supplementary protection certificate cannot be obtained. The European Court of Justice held that, There is no protein in this case D Tests or relevant data on immunity to Haemophilus influenzae, However, the lack of such data does not affect the commercial exploitation of the underlying patented drug with marketing authorization. Therefore, If you allow for proteins D Additional protection is also carried out, Would be contrary to the purpose of the system established by EU law——Compensation for loss of commercial life for patented medicinal products due to the time it takes to obtain initial marketing authorisation within the EU.

　　Finally, "European Union regulation (EC) 469/2009 No" The relevant terms shall be understood as: A carrier protein conjugated with a polysaccharide antigen by covalent binding, Only its own pharmacology, Immunological or metabolic effects have been clearly documented in the relevant marketing authorisation, To be recognized as an active ingredient. but, This is something that the court has to accept after fully considering all the facts of the case, Make a judgment in accordance with the above clause.

　　 [comment]

　　The case combines several previous rulings by the European Court of Justice on how to understand "European Union regulation (EC) 469/2009 No" Article 1 and Article 3 on the provisions of the Supplementary protection certificate of pharmaceuticals related conclusions. In this case, The European Court of Justice clarified the subject of protection as a supplementary protection certificate "medicine (product) " The definition and scope of. The European Court of Justice is particularly emphatic, The prerequisite for a pharmaceutical product or active ingredient to be granted a supplementary protection certificate is, It can produce specific pharmacology on its own, Immune or metabolic action; secondly, The independent pharmacology, Immune or metabolic effects must be clearly documented in the relevant marketing authorisation.

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