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Intellectual Property and Commercial Court



Decision No. 2008-Min-Zhuan-Shang-20
Date March 19, 2009
Decision Highlight

Article 11 of the Constitution provides, “The people shall have the freedom of speech, teaching, writing and publication.” Such freedom of writing encompass copyright as the people’s fundamental right. However, copyright is not an absolute right. The Copyright Act provides for fair use as a best countervailing measure to balance the private interest of copyright owners and the public interest of the society, and thus placing a reasonable limit to the scope of the rights enjoyed by copyright owners. In reference of the concurring opinion in Interpretation No. 509 of the Judicial Yuan, the interests that a specific law protects shall be weighed against the corresponding limitation it imposes on fundamental rights in hopesof accomplishing an optimal balance between them.(1) Except limited differences shown in the attached table and a couple of paragraphs adapted from the original (Nos. 10, 22, 23 in the same table), the rest of the label on Appellee’s drug “Glitos”is identical with that of Appellant’s drug “Pioglitazone”. It is simply copying, without productive or transformative use, and is expressed with words, figures, and tables to demonstrate the characteristics of the drug, which is also the purpose of Appellant’s label, a literary work of authorship. No matter in quality or in quantity, Appellee used more than 95% of the contents on Appellant’s label in her own label.(2) Nonetheless, Appellee’s drug “Glitos” is the generic version of Appellant’s “Pioglitazone”, a monitored medicine. In compliance with Article 20, Paragraph 1, Subparagraph 3, Sentence 1 of the Regulations on Drug Inspection, Registration & Review, Appellee’s label followed the first approved label of its kind (that is, the label of “Pioglitazone”). Additionally, Appellee filed a request of changing the “Glitos” label to the Department of Health on September 6, 2007. But on the 20th Day of the same month and year, the Department of Health replied in the Wei-Shu-Yao-Chu-Zi No. 9613209 letter, stating that the “Glitos” label shall follow the first approved label, the label of “Pioglitazone”, and Appellee could not lawfully request to change it. (See Vol. 2, P. 470 of the record in the lower court.) As a result, there is no free space at all for Appellee todraft the content of “Glitos” drug label.(3)Given the fact that a drug label is distributed in a drug market through marketed with the drug, and that there is no independent “market for the drug label work”, it is therefore hard to recognize that Appellant enjoys any particular market value in the label of “Pioglitazone”. Furthermore, the copyright disputes of drug labels could likely be used as a measure for competing in the drug market or for de facto extending the term of patent protection. In contrast, the principle of label consistency between generic drugs and their brand-name counterparts is adopted for the consideration of drug safety, medicine administration, and efficiency of resource utilization, and is founded on the basis of social interest and public policies. To harmonize private rights and social public interests, in respect of the conflicting interests between brand-name and generic drug companies, it is permissible for Appellee to raise the fair-use defense in the copyright disputes.

Related Provision Copyright Act: Article 84; Article 65
  • Release Date:2020-11-13
  • Update:2020-12-03