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GENERIC DRUG INSERTS DO NOT INFRINGEMENT COPY-RIGHT
There have been an increasing number of cases in which the insert (the user instruction leaflet included in the packaging) of a generic drug is alleged to infringe copyright. But the courts have taken widely differing views on the issues of whether the inserts of pharmaceutical products are works subject to protection under the Copy-right Act, and whether compliance with the pro-visions of the Department of Health's Guidelines for the Examination of Drug Registration (GEDR) provides a valid defense against allega-tions of copyright infringement. However, both of the Taiwan High Court and the Taichung Branch of the Taiwan High Court have held in recent appeal judgments on 13 February 2007 and 14 January 2007, respectively, that generic drug inserts did not infringe copyright.
Article 4 Subparagraph 2 of the GEDR defines a generic drug as a drug with the same constituents, format, dosage, and therapeutic effect as a pharmaceutical product already approved in Taiwan. Such previously approved drugs are typically unpatented, or the patents on them have expired, so the manufacture and sale of generic drugs generally does not give rise to patent in-fringement issues. But in practice, manufactur-ers of generic drugs have faced a major crisis in the form of actions for copyright infringement against such drugs' inserts.
Such disputes have mainly centered on three issues: whether a drug insert is a work protect-able under the Copyright Act; who is the copy-right owner of such a work; and whether generic drug inserts infringe against such copyright. The question of whether drug inserts are copyright-able works remains controversial in current practice, but many courts have taken the view that they are. The ownership of copyright in such a work must be determined on a case-by-case basis. As for the question of whether copyright is infringed when the insert of a generic drug is identical in content to the insert of a previously approved product, the courts have been more divided than their opinions.
In a 2005 civil judgment, the Taipei District Court affirmed on 31 March 2005 that a drug insert was a protected work under the Copyright Act, and held that the unauthorized use of con-tent from the insert of a previously approved drug in the insert of a generic drug did infringe copyright. The manufacturer of the generic drug cited in its defense Article 20 Subparagraph 3 of the GEDR, which provides that in the case of a monitored drug, the insert of the generic drug should disclose content in the same form as ap-proved for the insert of the first-approved manufacturer, and that in the case of a non-monitored drug, the content of the insert should be faithfully translated from the insert of the original manufacturer. The generic drug manufacturer argued that this provision of the GEDR left it no freedom to create new content for the drug's insert. However, the Taipei Dis-trict Court held that the GEDR, being merely an administrative directive, could not have the ef-fect of overriding a provision of the Copyright Act.
On the other hand, in a 2006 civil judgment in another case regarding a generic drug, the Nan-tou District Court took the opposite view on 23 March 2006, holding that the provisions of the GEDR could be relied upon as a defense against a charge of copyright infringement.
Furthermore, in the area of criminal law, in De-cember 2006 the Taipei District Prosecutor's Office decided not to bring a prosecution in a similar case, because it found that the generic drug manufacturer had produced the allegedly infringing insert in compliance with the GEDR, and had had no criminal intent.
Appeals were brought against both of the above civil judgments of the district courts, and the Taiwan High Court and the Taichung Branch of the Taiwan High Court rendered judgments on 13 February 2007 and 14 January 2007, respec-tively, holding in both cases that the generic drug inserts concerned had not infringed against copyright. Notably, the Taichung Branch of the Taiwan High Court also denied that a drug insert is a work capable of enjoying protection under the Copyright Act.
Both the above cases can be appealed to the Su-preme Court. The Supreme Court's opinion will greatly influence the trial of the future similar cases by the courts at all levels.