Dear Rich: I just wonder whether a package insert for drugs is copyrightable in the U.S.? I understand that the package insert has a standard form and should include specific information, both of which are usually required by the FDA or law. Moreover, all the descriptions in the package insert are about factual issues, say scientific research results, ways to take medicines, etc, and most of them can only be described in wording of very limited choice. In this case, can we also put some wording like "copyright reserved" in the package insert and claim copyright over the package insert? Package inserts can be protected under copyright law (as
this article points out -- check out the "Warnings and Instructions" section). However, you may have trouble protecting the legally mandated requirements of the insert if, as you note, there are limited ways to express the statement. When that's the case, the
merger doctrine kicks into effect and others can get away with copying.
What about adding 'copyright reserved'? You can add any wording you like about copyright being reserved -- that may scare off some interlopers -- but that doesn't necessarily mean that a court will enforce your claim to copyright. It will all come down to whether you've demonstrated sufficient creativity and can justify your exclusive rights to the work.
