Biotech Laboratories (Pty) Ltd v Beecham Group PLC and another
 3 All SA 652 (SCA)
Transvaal Provincial Division
25 March 2002
Nienaber, Harms, Zulman, Navsa and Nugent JJA
M.Snyman and D.Cloete
2002 (4) SA 249 (SCA)
. Editor's Summary . Cases Referred to . Judgment .
 Intellectual property Copyright State copyright Generic drugs Issue Whether the copyright vested in the State
Section 5(2) Copyright Act 98 of 1978 Whether the insert was made by or under the direction or control of the State
Held that the State did not direct the making or initiate the process Held that the copyright vested in the company.
Page 653 of  3 All SA 652 (SCA)
 Intellectual property Copyright State copyright Generic drugs Package insert Plagiarism Issue Whether the
insert was "original" Works are only considered eligible for copyright if they are "original" Section 2(1) Copyright Act
98 of 1978 Held that the appellant substantially copied the "work" of the respondent Appeal dismissed.
The Appellant was accused of having copied a package insert for a generic drug (called Augmentin) that it
manufactured. The Respondents manufactured the original drug, and it was common cause that the Appellant's
package insert for the generic version was a plagiarism of that of the Respondents. The Appellant's defence was
that the Respondents had not proved that the package insert was original, and that if it was, then copyright therein
vested in the State in terms of section 5(2) of the Copyright Act 98 of 1978 ("the Act"). Swart J in the court a quo
found that the insert was an original work and interdicted the Appellant from infringing the copyright. This appeal is
with his leave.
Held In terms of the Medicines and Related Substances Control Act 101 of 1965, all medicines and generic drugs
are required to be registered by the Medicines Control Council ("MCC") before they can be marketable. As part of
the registration process, the applicant has to provide a package insert detailing the format, dosage, warnings, etc
relating to the particular drug or medicine. In the present matter, the Respondent became engaged in lengthy
discussions with the MCC regarding registration of Augmentin. As a result, the patent that the Respondent held
over Augmentin lapsed, which resulted in other companies being able to freely market the drug, provided that they
could register it. This is precisely what the Appellants did, and in the process of obtaining registration, they provided
the MCC with a copy of the same package insert that was used by the Respondent in its application.
The first issue faced by the Court was that of originality. Works are only eligible for copyright if they are
"original." Evidence adduced demonstrated that the Respondent and its medical directors supplied the data used
for the invention of Augmentin. The Court concluded that the work was essentially a compilation.
The Appellant argued that a party claiming copyright has the duty to identify those portions of a work for which
the originality is being claimed. It submitted that the Respondent had failed to comply with this requirement. In this
regard, it relied upon the judgment of Jacana Education (Pty) Ltd v Frandsen Publishers (Pty) Ltd 1998 (2) SA 965 (A).
The Court distinguished this case from the present matter, pointing out that in terms of the Act,��it was required to
decide not whether the parts of the insert were original, but whether the compilation as embodied in the insert,
was original. It was noted that a second version of a specific work would be entitled to its own copyright provided
that it differs in substance from the first version, and is not merely a replica. As was previously stated, it was
common cause that the Appellant had copied the Respondent's "work", and not merely a part of it.
The second issue for determination involved State copyright, and whether the copyright in the insert vested in
the State. The determination turned on the interpretation of section 5(2) of the Act. Owing to the fact that the MCC
was an organ of State, the critical question was whether the insert was made by or under the direction of the
State. The Court stated that the State certainly did
Page 654 of  3 All SA 652 (SCA)
not direct the making of the insert, as it was not involved in the manufacture of Augmentin. With regard to the
question of "control," it was submitted that since the MCC was empowered to approve or disapprove the insert,
and since it was an organ of State, then the insert was made under State "control."
The Court concluded that the Appellant's arguments were without merit. The argument lost sight of the issue;
namely that what had to be determined was not whether the MCC had the power to approve or disapprove an
insert, but whether the insert was made under its control. Augmentin was essentially the brainchild of the
Respondent, and the only time that the State became involved, was when the Respondent wished to apply for