European court of justice ruling, Supplementary protection certificate (SPC) It cannot be granted to a marketing authorisation of a medicinal product for which a new medical use has been discovered. Julius, a patent law expert．Fabe (Jules Fabre) representation, The ruling by the European Court of Justice could have major implications for drug manufacturers, And clarifies the application of EU law and prior case law.

In EU law SPC It is designed to allow patent holders to effectively extend monopolies on drugs they have spent a lot of time and money developing. The term of patent protection is 20 years, But pharmaceutical companies develop new drugs, It can take years to run legally mandated clinical trials and get marketing approval.

That means drug makers typically get much shorter periods of patent protection to commercialize their products than in other less-regulated fields. European Union SPC The framework aims to compensate for the former. Pharmaceutical companies have to satisfy the EU "Supplementary Protection Certificate Regulations" (Hereafter called "SPC regulation" ) To obtain the standard of protection SPC. No doubt, Drug companies cannot now rely on new uses for old products SPC, Subject matter for which prior marketing authorisation has been granted for older products. SPC ordinance 3 (d) Article provision, as SPC Application basis for marketing authorisation must be "First license to place a product on the market as a medical product" .

in 2012 annual Neurim In the case, The European Court of Justice ruled No 3 (d) The regulation does not prohibit drug companies from obtaining different applications of the same product for which marketing authorization has been granted SPC, As long as the app is in SPC Within the scope of protection of the essential patent on which the application is based.

In this dispute, The product was the subject of an earlier marketing authorisation for veterinary medicinal products, Neurim Based on marketing authorization application for human medicinal products SPC. Neurim The case is controversial, Because it's different from earlier case law and what it means "Different applications" No guidance is provided.

Patent offices and courts in EU member states vs Neurim The verdict has been interpreted in different ways, Leading to the decentralization of power of pharmaceutical companies in the internal market. in 2019 annual Abraxis In the case, The European Court of Justice provided further clarification. The court said that a new form of an old active ingredient was not available SPC protection.

now, The European Court of Justice made it clear, The first 3 (d) The article must be interpreted as: "For the purposes of this clause, If the marketing authorisation relates to a new therapeutic application of an active ingredient or a combination of active ingredients, And the active ingredient or combination has been the subject of marketing authorisation for another therapeutic application, The marketing authorization shall not be deemed to be the first marketing authorization. "

The European Court of Justice ruled in accordance with its judges Pitruzzella suggestion. Pitruzzella Issues submitted to the Court by interested parties were evaluated and a non-legally binding opinion was issued.

The European Court of Justice, at the request of the Paris Court of Appeal, dealt with the No 3 (d) Article interpretation problem. In the case before the Paris Court of Appeal, Pharmaceutical laboratory Santen Trying to overthrow the French Industrial Property Office (INPI) It had previously rejected its application for cyclosporine to treat keratitis SPC Decision of, INPI The reason for the rejection was that cyclosporine had previously been approved for the treatment of another eye condition, This kind of treatment 1983 Marketing authorization was obtained in 2005.

Farb representation: "The Paris Court of Appeal specifically asked the European Court of Justice to clarify its decision Neurim award, The European Court of Justice has now clarified. No doubt, Old products that have previously been authorized for marketing cannot be accessed for new uses SPC. "

(Compiled from www. pinsentmasons. com)

Reprinted from China Intellectual Property Network  translation: Rason group　proofread: Wang Dan

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