Editor's note: Astrazeneca AB company, It's a drug "quetiapine (Quetiapine) " European Patent and supplementary protection certificate holder, Sue Alter The Company and other defendants sold generic drugs containing the active ingredients without authorization. Read on for more details!

[background] Astrazeneca AB company, It's a drug "quetiapine (Quetiapine) " European Patent and supplementary protection certificate holder, Sue Alter The Company and other defendants sold generic drugs containing the active ingredients without authorization. The priority date of the patent in question is earlier than 1986 Annual edition "Spanish patent law" Date of publication, It is valid only in Spain, And its claim covers only the method of producing the compound and not the compound itself.

2007 years 1 month, Astrazeneca AB The company submitted an amended Spanish translation of the European patent in question to the Spanish Patent and Trademark Office, Added product claims. The translation was rejected by the Spanish Patent and Trademark Office, The patentee appealed to the Administrative Disputes Court. 2008 years 7 month, A number of drug manufacturers have obtained market access permission for quetiapine generic drugs, Although a translation of the revised patent has not yet been published in the Intellectual Property Bulletin, Astrazeneca AB The Company continues to file infringement proceedings against the above companies based on the revised product claims. The first and second instance of this case rejected the plaintiff's claim, It was then submitted to the Spanish Supreme Court for a retrial.

[conclusion] First of all, The court noted that a translation of a modified European patent had not been published before the Intellectual Property Gazette, It has no legal effect, The Administrative Disputes Court should therefore review the relevant ruling of the Spanish Patent and Trademark Office. Pending the conclusion of the appeal case, No civil tort action may be instituted. then, Court vs Astrazeneca AB The company's European patent contains product claims, However, the corresponding modification of the translation file is rejected, Whether applicable TRIPS Protocol regulation 27. 1 Articles and regulations 70. 2 The issue of the article was adjudicated. The appellant cites a prior decision of the First Division of the Supreme Court, In this case the court found that it could apply in such circumstances TRIPS Relevant provisions of the agreement, And agreed to convert the method patent into a product patent. The court confirms first, The Supreme Court did hold earlier that the Spanish vs "European patent convention" Reservation clause, All European patents that are effective in Spain as method patents rather than product patents may be applied TRIPS agreement.

TRIPS After the agreement comes into force, The foregoing provisions shall be construed to mean that all the product claims of the patent in question shall be valid. however, The Supreme Court went on to note that, European Court of Justice 2013 years 7 month 18 Japanese pair Daiichi Sankyo/Demo A case (Case number: C-414/11) After the ruling, The Supreme Court's finding is no longer applicable under this decision. In that judgment, the European Court of Justice found that TRIPS Protocol regulation 27 Articles and regulations 70 Provision of article, A patent claim covers both the method of production of the drug and the drug itself, But authorization only includes method claims, Be unable to TRIPS The validity of the agreement requires the conversion to product patent.

Therefore, Judgment of the Supreme Court: "Also in this case, Whereas this European patent was published in Spain at the time of its entry into force was a method claim, The retention of the drug patent in question is in effect when the application is filed, So it can't be TRIPS After the agreement comes into force, The application of this agreement is further requested 27. 1 Articles and regulations 70. 2 Provision of article, Convert the disputed patent's protection in Spain into the drug itself. "

[comment] As described above Daiichi Sankyo/Demo case, And the European Court of Justice later 2014 years 1 month 30 diurnal Warner-Lambert v Minerva case (Case number: C-462/13) and Warner-Lambert v SiegerPharma case (Case number: C-372/13) judgment, A complete reversal of the Spanish court's ruling on the application TRIPS Recognition of conversion of protocol and method patents to product patents. The battle between Spanish drug developers and generics has been going on for two decades. 2012 years 12 month 5 Spain's Supreme Court ruled that it could TRIPS Judgment of agreement, Had been interpreted as a turning point in clarifying the contents of the dispute. however, The European Court of Justice will have the last word, Its content was also confirmed by the Spanish Supreme Court in this case.

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