Biotech Laboratories (Pty) Ltd v Beecham Group plc and Another

Smith-Kline Beecham Pharma (Pty) Ltd, a subsidiary of Beecham Group plc, registered the medicine Augmentin under the Medicines and Related Substances Control Act 101 of 1965. As part of the registration process, it prepared a package insert containing prescribed information, which underwent revisions during engagement with the Medicines Control Council (MCC). After the patents for Augmentin lapsed, Biotech Laboratories applied to register a generic equivalent, Bio-Amoksoklav. In doing so, Biotech copied Smith-Kline Beecham’s approved package insert almost verbatim, allegedly at the behest of the MCC. Smith-Kline Beecham sued for copyright infringement. Biotech admitted copying but argued that the insert was not original and, alternatively, that any copyright vested in the State under s 5(2) of the Copyright Act 98 of 1978.

The appeal was dismissed with costs, including the costs of two counsel. The interdict restraining Biotech from infringing the copyright in the package insert was confirmed.

The case is a leading South African authority on originality in copyright law, particularly in relation to compilations and regulatory documents. It clarifies the interpretation of s 5(2) of the Copyright Act and limits the circumstances in which copyright will vest in the State. The judgment is especially important for the pharmaceutical industry, confirming that regulatory oversight does not deprive private parties of copyright in documents submitted for approval.