[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]

　　Abraxis Bioscience LLC It's a pharmaceutical company (Hereinafter referred to as "Abraxis company" ) , Selling a drug used to treat cancer "ABRAXANE" . The drug in question has already received marketing authorization (marketing authorisation) .

　　drug "ABRAXANE" The active ingredients included are "nab-paclitaxel" , It's the active ingredient "paclitaxel" (Has been put on the market in other forms by other companies) New formula of. Compared to existing active ingredients, The new formula is better at treating certain cancers.

　　Abraxis The company has a protection "nab-paclitaxel" Patent of. Based on the patent and "ABRAXANE" Marketing authorization of a drug, Abraxis The company applied to the UK Patent Office for active ingredients "nab-paclitaxel" The supplementary protection certificate (Supplementary Protection Certificate) .

　　The UK Patent Office says, basis "Regulation of the European Parliament and of the Council on Supplementary Protection Certificates for medicinal products (The first (EC) 469/2008 No) " (Hereinafter referred to as "European Union regulation (EC) 469/2008 No" ) The first 3 (d) Article provision, The marketing authorisation on which the application is based must be the first marketing authorisation of the product as a medicinal product, And the disputed application does not meet that requirement, Should be rejected. The UK Patent Office noted, Despite new and creative therapeutic uses for existing active ingredients, Additional protection certificates may be granted; But for creative new formulations that already have active ingredients, A supplementary protection certificate cannot be granted.

　　Abraxis The company is against the administrative ruling, to (England and Wales) The Patent Division of the High Court appealed. The hearing court decided to suspend the proceedings, Request the European Court of Justice to clarify its understanding of the relevant EU legal provisions governing supplementary protection certificates for medicinal products.

　　 [conclusion]

　　The European Court of Justice stated that, In response to questions raised by the court of Admissibility, First, there is a need for clarity:

　　- "European Union regulation (EC) 469/2008 No" The first 1 (d) prescribed "product (product) " Concept of, Should be understood as, New formulations of existing active ingredients, Is it a product that is different from a product that consists only of existing active ingredients?

　　- and, New formulations of existing active ingredients, As in this case "nab-paclitaxel" , Marketing authorization obtained, Whether it can be regarded as "European Union regulation (EC) 469/2008 No" The first 3 (d) prescribed: The first marketing authorisation of a product as a medicinal product?

　　For the above questions, The answer from the European Court of Justice is:

　　- First of all, "European Union regulation (EC) 469/2008 No" The first 1 (d) Article shall be understood as: supra "nab-paclitaxel" And new formulations of existing active ingredients——It consists of the active ingredient and a carrier that has no therapeutic effect on its own——Even though the new formulation enables the active ingredient to exert its therapeutic effects with greater efficacy, Nor does it constitute a product different from a product containing only the active ingredient.

　　- secondly, If the active ingredient has been authorized for marketing, So in this case "nab-paclitaxel" Etc, Marketing authorisation has been obtained for a new formulation of the existing active ingredient, Do not belong to "European Union regulation (EC) 469/2008 No" The first 3 (d) prescribed——The first marketing authorization obtained for a product as a pharmaceutical product.

　　 [comment]

　　The European Court of Justice "European Union regulation (EC) 469/2008 No" The first 1 (d) Articles and regulations 3 (d) prescribed "product (product) " and "Initial marketing authorization (first marketing authorisation) " The concept takes a strict interpretation. 　　The European Court of Justice's ruling in the case attracted widespread attention when it was published, Because of a previous ruling (Neurim Pharmaceuticals case, C-130/11) In the, The court has made it clear, The same product for which marketing authorization has been granted, The possibility of obtaining a supplementary protection certificate for the different therapeutic uses or effects they have. however, In this decision, The European Court of Justice explained, in Neurim Pharmaceuticals The conclusion in this case is not in dispute, because:

　　- in Neurim Pharmaceuticals Case and decision in this case, The European Court of Justice upheld the decision "product (product) " A strictly constricted interpretation of a concept, That is, nonconformities cannot be covered "Active ingredient" or "Active component composition" Defined substance.

　　- in Neurim Pharmaceuticals Pair in case "Initial marketing authorization (first marketing authorisation) " The concept makes exceptions to the strictly restricted interpretation, Under no circumstances shall it be construed as, Refers to a new formulation of the product at issue.

　　compile: Liu Dan, Esabarry Legal Counsel

　　source: Esabaril (ELZABURU) Intellectual property rights