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

Bayer Pharma AG, a German company, was the patentee of South African patent 2002/1968 for a pharmaceutical contraceptive combination containing ethinylestradiol and drospirenone. The patent was filed on 27 February 2002 with a priority date of 31 August 1999. In March 2011, Pharma Dynamics, a generic pharmaceutical company, obtained approval to sell Ruby, a generic equivalent of Bayer's Yasmin contraceptive product. Bayer alleged infringement and brought applications for interim and final interdicts. During the litigation process, Bayer applied to amend the 2002 patent in terms of section 51(1) of the Patents Act 57 of 1978. The proposed amendments included deleting numerous paragraphs from the specification, deleting all claims except claim 1, and limiting claim 1 by adding features, limiting dosage ranges, and adding the words "and in a rapid dissolution form". Pharma Dynamics opposed the amendment application. The Commissioner of Patents (Potterill J) dismissed the application with costs, finding the amended claim 1 would be unclear. Bayer appealed to the Supreme Court of Appeal.

• Whether the proposed amendment to patent claim 1 would render it unclear and thus invalid under section 61(1)(f)(i) of the Patents Act 57 of 1978
• Whether the amendment application should be refused on grounds of culpable delay by the patentee
• Whether the amendment application should be refused on grounds of reprehensible conduct by the patentee
• Whether costs should follow the event in patent amendment proceedings or be awarded to the unsuccessful objector

The appeal was upheld with costs, including costs of two counsel. The order of the Commissioner of Patents was set aside. The amendment to South African Patent 2002/1968 was granted. Pharma Dynamics was ordered to pay Bayer's costs in both the Supreme Court of Appeal and the court a quo, including costs of two counsel.

1. In determining whether a patent claim is sufficiently clear under section 61(1)(f)(i) of the Patents Act, the claim must be read through the eyes of a skilled addressee who applies reasonable skill and intelligence, rules out illogical interpretations, and seeks technically sensible meanings. 2. For product claims (as opposed to method claims), clarity must be assessed based on the constituent elements and properties of the final product; the manufacturing process is irrelevant to determining infringement or clarity. 3. A claim requiring both that an ingredient be "in micronised form" and "in rapid dissolution form" is not unclear where both terms have ascertainable meanings (one being non-technical, the other defined in the specification) and a skilled person would understand both requirements must be satisfied. 4. An objection to patent amendment based on culpable delay requires proof of actual or potential prejudice; mere delay is insufficient. 5. In patent amendment proceedings, costs should ordinarily follow the event, particularly where amendments limit patent claims, as it is in the public interest not to discourage patentees from narrowing overly broad claims.

The court observed that non-technical words in a patent may have a different meaning to a person skilled in the art than their literal meaning to a layperson, requiring sophisticated analysis even where words appear unclear on their face. The court also noted that it would be "most unlikely" that generic companies would seek to market formulations not commercialized by the innovator, as this would require extensive investment in regulatory approval. Brand JA commented that allegations of procedural abuse should be dealt with in the proceedings where they arise, potentially through special costs orders, rather than being carried over to subsequent amendment applications. The court further observed that arguments about obtaining "two patents for the same invention" had been previously dismissed in earlier litigation between the same parties.

This case provides important guidance on patent claim clarity in South African law. It establishes that product claims must be assessed based on the final product's elements and properties, not manufacturing processes. The judgment clarifies the standard for clarity in patent claims under section 61(1)(f)(i), emphasizing that claims must be read through the eyes of a skilled person in the art who applies reasonable intelligence and technical sense. The case also provides guidance on discretionary grounds for refusing patent amendments, confirming that culpable delay requires proof of prejudice and that amendments limiting patent scope should not be discouraged through adverse costs orders as they serve the public interest. The decision reinforces that patent validity objections in amendment proceedings must meet substantive requirements and that procedural abuse allegations should be dealt with in the appropriate proceedings.