registration. For the copyright to vest in the State, the production of the work needed to be the principal object of
State direction and control, and not merely an incidental consequence, as was the case in the present matter.
The copyright in the insert clearly vested in the Respondents. The appeal was dismissed with costs.
Notes
For Copyright see LAWSA Reissue (Vol 5(2), paras 1 98).
Cases referred to in judgment
South Africa
Commissioner, South African Revenue Service v Dunblane (Transkei) (Pty) Ltd 2002 (1) SA 38 (A)
Jacana Education (Pty) Ltd v Frandsen Publishers (Pty) Ltd 1998 (2) SA 965 (A)
Klep Valves (Pty) Ltd v Saunders Valve Co Ltd 1987 (2) SA 1 (A)
Van Rooy v Law Society (OFS) and another 1953 (3) SA 580 (O)
Australia
The AttorneyGeneral for New South Wales v Butterworth & Co (Australia) Ltd [19371938] 38 NSW State Reports 195
United Kingdom
British Broadcasting Company v Wireless League Gazette Publishing Company [1926] 1 Ch 433
Ironside v HM AttorneyGeneral [1988] RPC 197 (ChD)
Ladbroke (Football) Ltd v William Hill (Football) Ltd [1964] 1 All ER 465 (HL)
Warwick Film Productions Ltd v Eisinger and Others [1969] 1 Ch 508
View Parallel Citation
Judgment
HARMS JA:
[1]
The battle about generic drugs is fought on many grounds usually ethical, political, commercial or patent law
considerations. In this particular case the ground happens to be copyright law. All turns on the copying of an
approved package insert for a medicine. The copyist, the appellant ("Biotech"), seeks to justify its admitted
plagiarism on two grounds namely (a) that the respondents have failed to prove that the package insert was
Page 655 of [2002] 3 All SA 652 (SCA)
"original" and (b) that, if original, the copyright therein vests in the State by virtue of the provisions of section
5(2) of the Copyright Act 98 of 1978. In the court below, Swart J, holding that the insert was��an original work
and that second respondent ("SmithKline Beecham") is the author and owner of the copyright therein,
interdicted Biotech from infringing the copyright. The appeal is with his leave.
[2]
SmithKline Beecham markets Augmentin, a medicine consisting of two substances: amoxycillin (a semi
synthetic penicillin) and potassium clavulanate. Amoxycillin is an antibiotic and potassium clavulanate protects it
against penicillin resistant organisms. Augmentin is registered in the name of SmithKline Beecham under the
Medicines and Related Substances Control Act 101 of 1965. This Act prohibits the sale of medicines that are
subject to registration unless registered (section 14(1)). Applications for registration have to be submitted to
the Registrar appointed under the Act in the prescribed form and have to be accompanied by the prescribed
particulars and samples (section 15(1)). If the application complies with the Act and regulations and the
Medicines Control Council (the "MCC") is satisfied that the medicine in question is suitable for its intended
purpose, it "shall approve of the registration thereof". If it is not so satisfied, the applicant is notified and given
the opportunity of responding to the reasons of the MCC. If the MCC is ultimately not satisfied, it rejects the
application (section 15(3)). Regulations may, amongst other things, prescribe the particulars in regard to the
use
View Parallel Citation
of medicines, which have to be furnished when they are sold, and the manner in which the particulars have to
be furnished (section 35(1)(viii)).
[3]
The general regulations1 under the Act require that a package insert must accompany each package of
medicine sold. They also provide that package inserts must be in the prescribed format and must contain
certain particulars such as the scheduling status of the medicine, its proprietary name and dosage form,
composition, pharmacological classification and action, indications and contraindications, warnings and so forth
(Regulation 10). A proviso permits the MCC (a) to allow an applicant to omit a prescribed heading, (b) to
authorise the applicant upon application to deviate from the prescribed format or content or (c) to authorise
upon application the inclusion of additional material.