Newsletter
COPYRIGHT CRISIS LOOMS FOR GENERIC DRUG INSERTS
Subparagraph 2 in Article 4 of the Guidelines for Examination of Drug Registration of the De-partment of Health (DOH) defines a generic drug as a drug with the same constituents, format, dosage, and therapeutic effect as a pharmaceu-tical product previously approved in Taiwan. The "previously approved drugs" are typically unpatented, or the patents on them have expired, so that the manufacture and sale of generic drugs generally does not involve patent infringement issues. In practice, however, the sale of generic drugs now faces a major crisis in the form of copyright infringement actions against the in-serts (the user instruction leaflets inserted in the packaging of pharmaceutical products).
Such copyright disputes mainly center on three issues: whether a drug insert is a work protected under the Copyright Act; who is the copyright owner in such a work; and whether a generic drug insert infringes such copyright. Under current practice, there is still controversy as to whether drug inserts are protected works, but many courts have taken the view that they are. The specific ownership of the copyright in such a work must be determined on a case-by-case basis. On the issue of whether copyright is infringed when a generic drug's insert is identical in con-tent to the insert of a previously approved prod-uct, the courts have been more divided in their opinions.
In a civil judgment dated 31 March 2005, the Taipei District Court affirmed that a drug insert was a protected work under the Copyright Act, and that the unauthorized use of content from the insert of a previously approved drug in the insert of a generic drug did indeed infringe copyright.
In this case, the manufacturer of the generic drug cited in its defense Subparagraph 3 in Article 20 of the DOH's Guidelines for Examination of Drug Registration, which provides that in the case of a monitored drug, the insert of a generic drug should disclose content in the same form as approved for the insert of the first-approved manufacturer; and in the case of a non-monitored drug, it should be faithfully translated from the insert of the original manufacturer. The generic drug manufacturer argued that the DOH re-quirements left it with no freedom to create new content for the drug's insert. However, the Taipei District Court held that the Guidelines, being merely an administrative directive, could not have the effect of overriding a provision of the Copyright Act.
On the other hand, in a civil judgment dated 23 March 2006 in a case also regarding a generic drug, the Nantou District Court took the opposite view, holding that the provisions of the above Guidelines could be relied upon as a defense against a charge of copyright infringement.
There has been an increasing number of such copyright infringement cases, but the courts are very much divided as to whether the DOH re-quirements offer a valid defense against such allegations. It will therefore be worth watching whether the issue of copyright infringement will hinder the development of the generic drug sec-tor.