Bayer Pharma AG (formerly Bayer Schering Pharma AG) v Pharma Dynamics (Pty) Ltd

Bayer Pharma AG, the patentee of South African Patent 2002/1968 relating to an oral contraceptive containing drospirenone (DSP) and ethinylestradiol (EE), applied under s 51 of the Patents Act 57 of 1978 to amend its patent by deleting certain parts of the specification, removing all claims except claim 1, and narrowing claim 1 by limiting dosage ranges and adding the requirement that DSP be in a 'rapid dissolution form'. Pharma Dynamics (Pty) Ltd, a generic pharmaceutical company marketing a competing product (Ruby), opposed the amendment. The Commissioner of Patents (Potterill J) dismissed the amendment application on the basis that the proposed amendment would render claim 1 unclear, and therefore did not consider objections based on undue delay and reprehensible conduct. Bayer appealed to the Supreme Court of Appeal.

The appeal was upheld with costs. The order of the Commissioner of Patents was set aside and substituted with an order granting the amendment to South African Patent 2002/1968 and directing Pharma Dynamics to pay Bayer’s costs, including the costs of two counsel.

The case is significant for South African patent law as it clarifies the test for clarity of patent claims, particularly in amendment proceedings. It reaffirms that patent claims must be interpreted through the eyes of a skilled addressee and that product claims are assessed by reference to the characteristics of the final product rather than the manufacturing process. The judgment also provides guidance on the discretionary grounds of culpable delay and reprehensible conduct in opposing patent amendments.