Editor's note: Pharmaceutical company Merck Sharp & Dohme Corp (Hereinafter referred to as "Merck company" ) in 2001 years 7 month 5 I filed an application for patent registration. 2007 years 3 month 21 day, Merck The company obtained patented drugs "JANUVIA" Marketing authorization. 2007 years 9 month 19 Today, the company applied to the Icelandic Patent Office for a certificate of secondary protection for the drug patent, The Icelandic Patent Office rejected the application. Read on for more details!

[background] What did the Supreme Court of Iceland say "Regulation of the Council of the European Union on the creation of Certificates of Supplementary Protection for medicinal products (The first 1768/92 article) " (Hereinafter referred to as "European Union regulation 1768/92 No" ) The relevant provisions on approving the auxiliary protection certificate of drugs, To the Court of the Association of European Free Trade Countries (the Court of Justice of the European Free Trade Association States, Hereinafter referred to as "EFTA court" ) Ask for guidance. The first thing to point out is that, Due to "European Union regulation 1768/92 No" Have been included in "European Economic area agreement (European Economic Area) " in, It therefore applies to all countries in the European Economic Area: Eu member states and European Free Trade Association countries (Iceland, Liechtenstein and Norway) . For the European Free Trade Association countries, The European Court of Justice having jurisdiction over the question of uniform interpretation and application of the above-mentioned regulations, is EFTA Court of Justice rather than the European Court of Justice (Court of Justice) . The Icelandic court based the request on a case before it, The background is summarized as follows: Pharmaceutical company Merck Sharp & Dohme Corp (Hereinafter referred to as "Merck company" ) in 2001 years 7 month 5 I filed an application for patent registration. 2007 years 3 month 21 day, Merck The company obtained patented drugs "JANUVIA" Marketing authorization. 2007 years 9 month 19 Today, the company applied to the Icelandic Patent Office for a certificate of secondary protection for the drug patent. The Icelandic Patent Office rejected the application, The reason is that according to "European Union regulation 1768/92 No" The specified method of calculation, The duration of the secondary protection certificate is negative. The ordinance 13. 1 Article provision, " (Secondary protection certificate) The term is equal to the date of the first marketing authorization in the European market minus the date of the underlying patent application minus 5 years" , Calculate in this way, Merck The term of the company's patent auxiliary protection certificate is negative 106 day. Merck The company stated that the reason for its application for the Auxiliary Protection Certificate was, Although the secondary protection certificate protection period is ultimately negative, But it's for its own sake "Regulation of the European Parliament and of the European Commission on Medicinal Products for Paediatric Use (The first 1901/2006 No) " (Hereinafter referred to as "European Union regulation 1901/2006 No" ) Required application for 6 Pediatric medication for a month to extend the protective period in preparation. The company has run into the same problem in Germany, In the end, the European Court of Justice decided "Merck Sharp &Dohme" A case (Case number: C-125/10) The dispute was settled with a judgment. In that judgment, The European Court of Justice stated that "European Union regulation 1768/92 No" The first 13. 1 Article does not prohibit the drug supplementary protection period when the actual result is negative, No application for a secondary protection certificate may be made. Here's the problem with the Iceland case, in Merck When the company applies for auxiliary protection certificate, "European Union regulation 1901/2006 No" Not yet included in "European Economic area agreement" in, That is "6 A month of pediatric medication extends the protection period" Has not yet come into force in the country. So it doesn't exist yet "Just cause" , To approve an agreement "European Union regulation 1768/92 No" The prescribed method of calculation, Secondary protection certificate whose duration is actually negative. In view of this, The Supreme Court of Iceland requested EFTA Court clarification, "European Union regulation 1901/2006 No" Has not yet come into force in the country, "European Union regulation 1768/92 No" Whether to allow approval of a secondary protection certificate with an actual negative protection period?

[conclusion] EFTA Court confirmation, regardless "European Union regulation 1901/2006 No" Has gone into effect in the country, "European Union regulation 1768/92 No" Allows the approval of a secondary protection certificate with an actual negative protection period. The reason is that: - "European Union regulation 1768/92 No" The negative value of the secondary protection certificate is not specified, The first 13 The article does not specify the duration of the secondary protection certificate, Nor is there any provision in the Ordinance that says the term of a secondary protection certificate cannot be negative. -In addition, The ordinance 3 Article specifies the conditions under which a secondary protection certificate can be obtained, There is no requirement "The term of the secondary protection certificate is positive" . This ordinance 7 Article to regulation 9 In the procedural elements specified in the article, There is no such requirement. -simultaneously, The ordinance 10 Article provision, After the applicant meets the above terms and conditions, The competent authority shall approve the issuance of an auxiliary protection certificate, Unless there are circumstances that warrant rejection under that article (There is no provision for negative terms) . EFTA The court stated that, The conclusion is consistent with "European Union regulation 1768/92 No" Legislative purpose, The term of the auxiliary protection certificate should provide effective protection for the certificate owner. It is also pointed out that, The term of a secondary protection certificate is negative, Does not violate the Ordinance's two limits on the length of time: The period of exclusive protection enjoyed by the owner of patent rights and subsidiary protection certificates shall not exceed fifteen years from the date of first obtaining the market access permit; and, The term of the auxiliary protection certificate shall not exceed five years.

[comment] Therefore, EFTA The court cited the European Court of Justice in "Merck Sharp & Dohme" A case (Case number: C-125/10) verdicts "European Union regulation 1768/92 No" Interpretation of provisions, Confirm that supplementary protection certificates approved by EEA countries may have a negative term, No matter when applying for the auxiliary protection certificate "European Union regulation 1901/2006 No" Whether it has taken effect. EFTA The court's conclusion was no surprise, contrary, This conclusion is consistent with "European Economic area agreement" goal: Create a single market, In the contracting parties within that market (Iceland, Liechtenstein, Norway and the EU member states) Establish equal economic relations and abide by the same rules. if EFTA The court's interpretation is at odds with an earlier interpretation of the same regulation by the European Court of Justice, Would undermine the principle above.

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