Dm Kisch Inc. a South African law firm was recently successful in obtaining a landmark copyright judgment in the Pretoria High Court in favour of pharmaceutical giant Beecham Group p.l.c. of the U.K. and its South African counterpart SmithKline Beecham Pharmaceuticals (Pty) Ltd (the Applicant) against Biotech Laboratories (Pty) Ltd (the Respondent). The judgment is expected to have far-reaching implications regarding the use of package inserts of registered medicines, particularly generic pharmaceutical products.
Background And History
In endeavoring to gain successful registration of its generic equivalent of the Applicant's famous and widely used antibiotic, Augmentin, the Respondent copied the Applicant's Augmentin package insert to the extent of exactly duplicating the Applicant's clinical data and test results as well as efficacy claims regarding the excretion and absorption rates. Furthermore, the Respondent copied the shape of the Augmentin tablet which is protected by a
