Cipla Medpro (Pty) Limited v Aventis Pharma SA and Aventis Pharma SA v Cipla Life Sciences (Pty) Ltd (consolidated appeals)

Aventis Pharma SA held South African Patent 93/8936 for an injectable pharmaceutical composition containing docetaxel (a taxane derivative used in cancer treatment) marketed as Taxotere. The patent claimed 1 was amended in 2007. Cipla sought to import and sell a generic equivalent called Cipla Docetaxel. Two applications were brought: (1) Cipla applied under s 51(1) to set aside the 2007 amendment of claim 1, alleging it broadened the original claim; (2) Aventis sought an interim interdict against Cipla for patent infringement pending final action. Both applications were dismissed by Southwood J sitting as Commissioner of Patents. The parties appealed. The Treatment Action Campaign (TAC) was admitted as amicus curiae, arguing that public interest factors including access to affordable medicines should be considered.

• Whether the 2007 amendment to claim 1 broadened the original patent claim in violation of s 51(7) of the Patents Act 57 of 1978
• Whether claim 1 was unclear/vague and therefore invalid under s 61(1)(f)(i)
• Whether the invention lacked novelty under s 61(1)(c) read with s 25(1)
• Whether the invention lacked an inventive step (was obvious) under s 61(1)(c) read with s 25(1), (6) and (10)
• Whether contributory infringement (inducing or aiding infringement) is actionable under South African law
• Whether an interim interdict should be granted considering the balance of convenience and public interest factors including constitutional rights to access healthcare

Case 139/2012: Appeal dismissed with costs including two counsel. Case 138/2012: Appeal upheld with costs including two counsel to be paid by respondents jointly and severally. Order of Commissioner set aside and substituted with an order interdicting respondents from procuring, inducing, aiding and abetting, advising, inciting, instigating or assisting infringement of claim 1 of Patent 93/8936, and from disposing of or offering to dispose of Cipla Docetaxel and Cipla Docetaxel solvent, pending outcome of action for final relief. Respondents to pay costs including two counsel and expert witness costs.

The binding legal principles established are: (1) Contributory infringement of patents (procuring, inducing, aiding and abetting, advising, inciting or instigating infringement) is unlawful and actionable as a delict under South African common law, applying the principles from McKenzie v Van der Merwe (that one who aids and abets commission of a delict is liable) and extending the reasoning in Esquire Electronics v Executive Video from trade marks to patents. (2) Patent claims must be construed according to their ordinary grammatical meaning by the court; expert evidence is not admissible on the question of whether a claim is clear under s 61(1)(f)(i), though it is admissible on the factual question of sufficiency under s 61(1)(e). (3) A patent amendment under s 51 is only invalid under s 51(7) if it broadens the scope of the original claim; amendments that narrow or merely express what was implicit in the original claim are permissible. (4) In exercising discretion to grant interim interdicts in patent cases, courts must consider public interest factors including constitutional rights (such as access to healthcare under s 27), but these do not automatically override valid patent rights where the balance of convenience and strength of prima facie case support the patentee and no significant public detriment would result.

The court made several non-binding observations: (1) The court noted that s 39(2) of the Constitution requiring interpretation to promote the Bill of Rights does not permit changing the clear meaning of statutes; if clear provisions conflict with the Bill of Rights, the remedy is to strike them down, not reinterpret them. (2) Nugent JA observed that refusing an interdict merely to frustrate a patentee's lawful monopoly would be "an abuse of the discretionary powers of a court" (para 56). (3) The court noted that it is common for pharmaceutical patentees to enter the generics market shortly before patent expiry with rebranded, competitively priced products, as Aventis did with Docetere. (4) The court expressed the view (obiter as it did not need to decide) that the other grounds for revocation raised by Cipla (novelty, inventive step) did not place validity "in serious doubt", though obviousness remained to be determined at trial. (5) Reference was made to comparative law from the United States and England on contributory infringement and public interest considerations in patent injunctions, though not binding, informing the court's analysis of South African law principles.

This case is significant for: (1) Confirming that contributory infringement (inducing or aiding patent infringement) is actionable as a delict under South African common law, even without express statutory provision, following general delictual principles established in McKenzie v Van der Merwe and extending the principle in Esquire Electronics from trade marks to patents; (2) Clarifying the distinction between clarity of patent claims (determined by the court applying ordinary language principles) and sufficiency of specification (a factual question where expert evidence is admissible); (3) Establishing that public interest factors, including constitutional rights to healthcare access (s 27 Constitution), are relevant to the exercise of discretion in granting interim interdicts in patent cases, but do not override valid patent rights where alternative products are available at comparable prices and no significant public health disruption would result; (4) Affirming that patent amendments under s 51 are invalid only if they broaden the original claim, not if they merely narrow or clarify it; (5) Providing guidance on balancing competing commercial interests against public health considerations in pharmaceutical patent litigation in South Africa.