2020 years 7 month 9 day, European Court of Justice Santen adjudication (Case number: C-673/18)

　　Apply for a drug auxiliary protection certificate (Supplementary Protection Certificate) One of the requirements of, Marketing authorisation of the drug covered by the certificate (marketing authorisation) It must be the first license for the product to be placed on the market as a medical product ( "Regulation of the European Parliament and of the Council on Supplementary Protection Certificates for medicinal products (The first (EC) 469/2008 No) " The first 3 (d) article) . For some time, Especially the European Court of Justice 2012 years 7 month 19 Japanese pair Neurim The case made no C-130/11 After the announcement of the ruling, The interpretation of the above norms has been widely debated in legal theory and practice. In control C-130/11 adjudication, The European Court of Justice held that, The product has obtained marketing authorization as a veterinary medicine, Without prejudice to the same product may obtain other marketing authorization different from the prior authorization, And in accordance with the new marketing authorization application to obtain the auxiliary protection certificate.

　　however, After the ruling, The following debate arose:

　　· Does the above interpretation apply only if the first marketing authorisation is for a veterinary drug authorisation, The second marketing authorization is in the case of medicinal products for human use? Or say, For the first and second marketing authorizations in the same field (Both are human or veterinary drugs) New applications of active ingredients in pharmaceutical products (new indications) Or new use (new uses) Etc, The same applies? 　　· and, Does this explanation apply to, The first and second marketing authorizations are in the same field (Both are human or veterinary drugs) A new formulation of the active ingredient in a drug (new formulations) The situation of?

　　For the second question, The European Court of Justice 2019 years 3 month 21 Japanese pair Abraxis In the decision in the case (negate) Answer: New formulations of active ingredients cannot obtain secondary protection certificates.

　　now, The European Court of Justice 2020 years 7 month 9 Japanese pair Santen The decision in the case responded to the first of these arguments. Again, the European Court of Justice said no: New therapeutic applications of existing active ingredients (new therapeutic application) The secondary protection certificate cannot be obtained. Dispute of the case, And the reasons of the European Court of Justice for the case are summarized below:

　　The two sides in the dispute are pharmaceutical companies Santen And the French National Office of Industrial Property. Santen It is an enterprise specializing in the production of ophthalmic drugs, On one hand, It is the holder of a patent on an ophthalmic emulsion, The active ingredient protected by its patent is cyclosporine; On the other hand, One of its terms is called "Ikervis" Has obtained marketing authorization for the drug, The active ingredient in the drug is also cyclosporine, The drug is used to treat adult dry eye patients with severe keratitis. Based on the patent and marketing authorization, Santen Apply to the French National Office for Industrial Property for a certificate of auxiliary protection for the above-mentioned drugs. however, The National Office for Industrial Property rejected the application, Considers that the marketing authorisation on which the applicant is based is not in compliance "European Union regulation (EC) 469/2008 No" The first 3 (d) As required by the article "The first marketing authorization" , Because the first marketing authorization for the active ingredient cyclosporine should be 1983 Drugs issued in 2000 "Sndimmun" Marketing authorization, The active ingredient in the drug is also cyclosporine. "Sndimmun" To prevent rejection of solid organs and bone marrow grafts, It also has other therapeutic uses, Such as treating endogenous uveitis in the middle of the eyeball, Including inflammation of the uvea in whole or in part.

　　Santen Disobedience to the aforesaid order of dismissal, Appeal to the Court of Appeal in Paris, The court asked the European Court of Justice for a preliminary ruling on the relevant issues in the case.

　　The reasons given by the European Court of Justice for its conclusions are set out below:

　　· An active ingredient that has received marketing authorization for a therapeutic application, The key factor in determining whether a person can reapply for an auxiliary protection certificate based on a new therapeutic application is, Products approved by prior marketing authorizations and products approved by later marketing authorizations, Whether it is used for different therapeutic purposes, They are considered different.

　　· "European Union regulation (EC) 469/2008 No" Of or relating to an active ingredient "product" Concept of, It does not refer to specific therapeutic applications of the active ingredient. Therefore, An active ingredient already used in a therapeutic application, It cannot be used for new therapeutic applications, And become a "different" Products of.

　　· Therefore, "European Union regulation (EC) 469/2008 No" The first 3 (d) Article shall be understood as, An active ingredient that has been authorized for marketing in other therapeutic applications, The marketing authorisation obtained again for a new therapeutic application does not fall within the meaning of this article "The first marketing authorization" .

　　The decision of the European Court of Justice in this case, overthrew Neurim The rules established in the case, right "European Union regulation (EC) 469/2008 No" The first 3 (d) Article adopts strict interpretation principle. The ruling is unlikely to be welcomed by the pharmaceutical industry, Because they've seen it before, The competent authorities begin to restrict the extension of the period of protection of patents for medicinal products with existing active ingredients for new therapeutic applications. but, As the European Court of Justice pointed out, The legislative purpose of EU regulation "It is not to protect all drug research that has been granted patents and marketing authorizations for new drugs, It's to protect research that puts active ingredients or combinations of active ingredients on the market for the first time" .

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