經通國際智慧產權事務所

On June 28, 2007, following the Taiwan Intellectual Property Office’s (TIPO) decision of rejecting the filed request for patent term extension for the invention patent certification number 120976 with the title of “Pharmaceutical Formulations Containing Voriconazoie” ,and the Committee of Appeal of the Ministry of Economic Affairs’ and the Taipei High Administrative Court’s rejections against the subsequent appeals, the said decisions were upheld by the Supreme Administrative Court. In the said decision by the Supreme Administrative Court, the Court noted that the appellant, Pfizer Inc., was able to import and distribute the subject drug as soon as the drug permit license was issued by the Department of Health, Executive Yuan. Nevertheless, because the claimed reason of delayed distribution of the said drug was due to potential trademark infringement instead of matters related to the pharmaceutical laws, Article 51-1 and 51-2 of Patent Act were not applicable to grant the said request for patent term extension.

The said request for patent term extension was rejected by the defendant, the Taiwan Intellectual Property Office, based on the reason of that the said request for patent term extension was not filed within three months counting from the appellant’s receipt date of the said drug permit license. The Court noted that as set forth in Article 51-1 and 51-2 of Patent Act, “In the case of invention patents covering pharmaceuticals, agrichemicals, or processes for preparing the same, a patentee may apply for an extension of his/her patent term for two (2) to five (5) years, if, pursuant to other acts or regulations, a prior government approval must be secured to practice such patents, for which the processing exceeds two (2) years after the publication of the patents. Only one such extension shall be permitted provided” and “Any application for an extension of the term of a patent right must be filed with the Patent Authority by submitting a written application together with supporting evidence within three (3) months from the date of the first government approval involved provided, however, that no extension application shall be filed within six (6) months prior to the expiration of the original patent term”, and the said articles were purely purposed to cure the delayed practice of such patents caused by pharmaceutical laws. However, the appellant claimed that because the original name of the said drug was similar to a registered trademark used on an existing drug, the delayed distribution of the said drug was due to the process of filing and awaiting the grant of a request of changing the name of the said drug with the Department of Health, Executive Yuan so that the potential trademark infringement could be avoided. Therefore, as the said claim by the appellant was based on laws outside of the scope of pharmaceutical laws, Article 51-1 and 51-2 of Patent Act were deemed inapplicable by the Court. Furthermore, the Court confirmed the defendant’s decision by pointing out that the appellant received the said drug permit license on February 26, 2003, and exceeding the three months period set forth in Article 51-2 of Patent Act, the said request for patent term extension was only filed on June 9, 2003.

Based on the reasons above, the Court confirmed the decisions by the TIPO, the Committee of Appeal and Taipei High Administrative Court to be lawful and rejected the appellant’s claims.

Organized and translated by Eunice Yang

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