Editor's note: The dispute in the first and second cases of this case is Spain vs "European patent convention" Declare the retention clause and the protectability of the product patent. All the time, Spain's tendency to judge such disputes is to allow retroactive application TRIPS stipulation, But European Court of Justice (Court of Justice) 2013 years 7 month 18 A ruling in Japan (Case number: C-414/11) Negate this tendency of refereeing. Read on for more details!

[background] Lundbeck A/S (Hereinafter referred to as "Lundbeck" ) Wait for the plaintiff to file a European patent subsidiary protection certificate infringement action, The defendant is making generic drugs "Escitalopram" A number of pharmaceutical factories. The European patent on which the action is based is in 1989 years 6 month 1 Daily application, concurrence 1995 years 3 month 15 Daily publication authorization. When the patent came into force in Spain, The claims submitted include only the relevant active ingredients (active ingredient) Preparation method of, The active ingredient product itself is not included.

2006 years 8 month 24 day, Lundbeck Submit to the Spanish Patent and Trademark Office the translation and amendment of the said European patent——Add product claims that do not appear in the original translation. The Spanish Patent and Trademark Office rejected the application for translation modification, The third Chamber of the Administrative Disputes Chamber of the Spanish Supreme Court ruled that Lundbeck The right to submit an application and request the publication of the translation modification. The dispute in the first and second cases of this case is Spain vs "European patent convention" Declare the retention clause and the protectability of the product patent.

All the time, Spain's tendency to judge such disputes is to allow retroactive application TRIPS stipulation, But European Court of Justice (Court of Justice) 2013 years 7 month 18 A ruling in Japan (Case number: C-414/11) Negate this tendency of refereeing. but, The plaintiffs argue that the ECJ's ruling applies only to "TRIPS agreement" The first 70. 2 A patent that has been applied for and granted before the entry into force, Cannot be applied to "TRIPS agreement" The first 70. 7 A patent filed before the entry into force but not granted until after the entry into force. The Supreme Court ruled against the plaintiff's appeal.

[conclusion] First of all, The Supreme Court rejected a motion to refer the case to the European Court of Justice for a preliminary decision. A week before the verdict, The plaintiff argued that the Supreme Court should apply to the European Court of Justice for a preliminary ruling, Confirmation of the European Court of Justice 2013 years 7 month 18 Whether the decision of the day applies only to the TRIPS Protocol regulation 70. 7 Article covered and not regulated 70. 2 The article contains the patent?

however, The Supreme Court said, Only for "The prior jurisprudence of the European Court of Justice only applies TRIPS The first 70. 2 Bar cover case, Not applicable to regulation 70. 7 Bar cover case" When the conclusion is in doubt, It is necessary to apply for preliminary adjudication. And when the hearing court was faced with a "Clear rules" , The interpretation of EU law is clear and unquestionable, There is clearly no need to request a preliminary determination. The Supreme Court held that, Such is the case in this case.

The judgment explicitly states that, 2015 years, The Supreme Court did as required, According to the European Court of Justice 2013 years 7 month 18 As determined by the ruling of the day TRIPS The first 70. 2 Interpretation of article, Relevant precedents have been amended. European court of justice, A method patent has been granted and is in force, Not cause "TRIPS agreement" To extend its claims to pharmaceutical products manufactured under the method. The same precedents apply "TRIPS agreement" European patents that are not authorized until they come into force. The Supreme Court held that, European patent applicants have the right to basis TRIPS The first 70. 7 Article requires the substitution of product claims for methodical claims when the patent is in force in Spain. but, If the patent applicant has not used the above change option, The patent then became effective in Spain as a method patent, The European Court of Justice should apply 2013 years 7 month 18 Judgement of Japan. That is to say, Determination of judgment, In order to avoid the application of the reservation clause and the eventual entry into force of its product patent in Spain, The applicant shall be at an appropriate time (The patent was filed prior to licensing) Request for modification of application documents, Not after the patent has been granted and is valid as a method patent.

[comment] Spain's innovative drug and generic drug industry for whether applicable TRIPS The war over the protocol's conversion of method patents into product patents is drawing to a close. European Court of Justice 2013 years 7 month 18 Japan's ruling reversed that, A change from previous precedent-practice in which the patentee bore full responsibility. Paradoxically, Instead, it is in a place that is more favorable to the patentee (TRIPS The first 70. 7 article) The fallout from the European Court of Justice's ruling was felt earlier. The inertia and consistency of this change in jurisprudence may inject a sense of balance into innovative industrial theory.

compile: Liu Dan, The source of Aisabri Legal Counsel: Esabaril (ELZABURU)