Can information about a drug, like its trade name, interactions, pharmacokinetics, etc., be copyright protected, or is the information free for use in a commercial sense?


1 Answer 1


The information itself is not copyrighted.

  • The fact that a drug is an "antagonist platelet aggregation inhibitor" is not copyrighted.
  • The fact that a drug is indicated for "reducing the risk of thrombotic stroke in patients who have experienced stroke precursors or who have had a completed thrombotic stroke" is not copyrighted.

The label author might make certain choices about how to express those facts, though. "[C]hoices as to selection and arrangement, so long as they are made independently by the compiler and entail a minimal degree of creativity, are sufficiently original" to trigger copyright protection. Feist Pubs., Inc. v. Rural Tel. Svc. Co., Inc..

The FDA has created regulations concerning the selection and arrangement of facts in the context of prescription drug labeling. (An Introduction to the Improved FDA Prescription Drug Labeling, 21 CFR Part 201, Consolidated Final Rule and Changes)

Thus in the context of prescription drug labeling, the selection and arrangement of facts are not "made independently by the compiler".

The only things this leaves for copyright protection are:

  • literal word-for-word copying of phrases where there are suitable alternative ways of expressing the same fact, or
  • other expression not regulated by the FDA.

And, if a certain mode of expressing a particular fact has become industry standard (even if there are alternatives), the scènes à faire doctrine either precludes copyrightability or is a defense to infringement, depending on your district.

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