Cipla Medpro (Pty) Ltd v Aventis Pharma SA and Related Appeal

• Jurisdiction: South Africa
• Judge: Nugent JA, Heher JA, Snyders JA, Tshiqi JA and McLaren AJA
• Judgment Date: 26 July 2012
• Citation: 2013 (4) SA 579 (SCA)
• Docket Number: 139/2012 and 138/2012 [2012] ZASCA 108
• Hearing Date: 15 May 2012
• Counsel: In the appeal by Cipla Medpro (Pty) Ltd: CE Puckrin SC (with R Michau SC) for the appellant. LG Bowman SC (with APH Cockrell SC and B du Plessis SC) for the respondent. S Cowen (with A Hassim and U Rugege) for the Treatment Action Campaign as amicus curiae. In the related appeal by Aventis Pharma SA and Others: LG Bowman SC (with APH Cockrell SC and B du Plessis SC) for the appellants. CE Puckrin SC (with R Michau SC) for the respondents. S Cowen (with A Hassim and U Rugege) for the Treatment Action Campaign as amicus curiae.
• Court: Supreme Court of Appeal

Nugent JA (Heher JA, Snyders JA, Tshiqi JA and McLaren AJA concurring):

[1] There are two appeals before us. The protagonists in each appeal are one or more companies within the Aventis group, on the one side, C and one or more companies within the Cipla group on the other. There is no need to name each of the companies and for convenience I will refer to the companies in each group interchangeably as Aventis and Cipla respectively.

[2] Both appeals concern South African patent 93/8936, which is D registered in the name of Aventis. [1] The patent is due to expire on 30 November 2013. Claim 1 of the patent specification was amended on two occasions. The first amendment is not relevant to this appeal. The second amendment was made in 2007. For convenience I will refer to the claim before its amendment in 2007 as the 'original claim' and to the claim after that amendment as the 'amended claim'. E

[3] Aventis sells in South Africa a pharmaceutical product known as Taxotere, which has been registered for sale under the Medicines and Related Substances Act 101 of 1965. The active ingredient is docetaxel — a chemical compound in the taxoid family, also referred to as a taxane derivative. Docetaxel was synthesised in 1986 and was the subject F of a patent that expired in 2007. It is used in the treatment of various cancers, diluted in a perfusion solution, typically a solution of saline, [2] and administered by way of a drip. The components of Taxotere are presented for sale separated in two vials. The contents of the two vials are mixed together immediately before use so as to produce a composite solution that is injected into the bag of saline solution. Aventis says that G Taxotere falls within the terms of its patent.

[4] Early in 2011 Aventis became aware that Cipla had applied for registration of, and intended importing and selling, a generic equivalent of Taxotere that it calls Cipla Docetaxel. In all material respects the components of Cipla Docetaxel correspond with those of Taxotere. Its H components are also presented for sale separated into two vials — one containing what it calls Cipla Docetaxel and the other containing Cipla Docetaxel solvent — to be mixed together and administered in the same way as Taxotere.

[5] On 9 May 2011 the attorneys for Aventis wrote to Cipla's attorneys I alleging that 'the exploitation of Cipla Docetaxel and Cipla Docetaxel

Nugent JA (Heher JA, Snyders JA, Tshiqi JA and Mclaren AJA concurring)

A solvent' would infringe its patent, and calling for an undertaking that Cipla would not 'make, use, exercise, dispose or offer to dispose of or import the Cipla Docetaxel or Cipla Docetaxel solvent products' until expiry of the patent.

[6] Cipla declined to give the undertaking and two applications were B brought before the Commissioner of Patents. The first was an application by Cipla for an order setting aside the 2007 amendment of claim 1. [3] That was followed shortly by an application by Aventis for an interim interdict against infringement pending the outcome of an action for a final order to that effect. [4]

C [7] The two applications were heard together by Southwood J sitting as the Commissioner of Patents. Both applications were dismissed and the respective parties now appeal with his leave.

[8] Before turning to the specific issues that arise in each appeal it is convenient to set out some background that is common to both.

D [9] Taxane derivatives are not easily soluble in water. To hold a taxane derivative in solution when it is introduced into the saline solution, according to the patent specification, it had been found necessary first to prepare a stock solution of the taxane derivative, dissolved in a mixture of solvents comprising a surface-active agent (a wetting agent) and E ethanol. For reasons that are not material the ethanol is then withdrawn leaving the taxane derivative dissolved in the stock solution. It was found, however, that when the stock solution was introduced into the saline solution, it formed a gel that inhibited its dissolution. Various techniques existed to prevent the formation of gel or to break down the F gel when it formed, and the patent relates to one such technique.

[10] The invention of the patent consists in an intermediate solution containing the taxane derivative dissolved in a surface-active agent, mixed with an additive (ethanol) that breaks the gel or prevents its formation when the intermediate solution is introduced into the saline solution. The invention — titled 'New Taxoid-Based Compositions' — G was claimed as follows in the original claim 1:

'An injectable composition comprising a taxane derivative in a surface-active agent and an additive which prevents the formation of, or breaks, a gelled phase during the mixing of the solution with an aqueous medium.'

H [11] In 2007 Aventis sought and was granted an amendment to claim 1 under s 51 of the Patents Act 57 of 1978. After amendment the invention was claimed as follows:

'An injectable composition comprising (a) a taxane derivative in a polysorbate and (b) an additive, (a) and (b) being provided in I ampoules, bottles or a double compartment device, the injectable composition being produced by mixing (a) and (b) to form an intermediate solution, wherein the additive prevents the formation of,

Nugent JA (Heher JA, Snyders JA, Tshiqi JA and Mclaren AJA concurring)

or breaks, a gelled phase during mixing of the intermediate solution A with an aqueous medium.'

[12] The 'polysorbate' referred to in the amended claim is a 'surface-active agent' of the kind referred to in the original claim and is not significant. The material amendment lies in the words 'provided in ampoules, bottles or a double compartment device, the injectable B composition being produced by mixing (a) and (b) to form an intermediate solution'.

The first appeal: the amendment of claim 1 (SCA case No 139/2012)

[13] Section 51(1) of the Act allows a patentee at any time to apply to C the registrar for the amendment of a patent specification. Under s 51(1) an amendment that has been made in conflict with the provisions of the Act may be set aside on application to the Commissioner. An amendment will be in conflict with s 51(7) of the Act —

'if the specification as amended would include any claim not wholly D within the scope of a claim included in the specification before amendment'.

That section is aimed at preventing the patentee from broadening the monopoly that was originally claimed. Whether the amendment indeed E does so is a matter for construction and comparison of the claim before and after amendment. [5]

[14] Gentiruco AG v Firestone SA (Pty) Ltd [6] remains the leading case on the construction of patent specifications, in which it was said that —

'the rule of interpretation is to ascertain, not what the inventor or F patentee may have had in mind, but what the language used in the specification means, ie what his intention was as conveyed by the specification, properly construed, . . . since he is presumed to have intended what his language means. To ascertain that meaning the words used must be read grammatically and in their ordinary sense.' [7]

[15] The affidavits in both applications need to be read together for the G purpose of each appeal. They contain considerable evidence by experts on each side concerning the proper construction of the claims. I return presently to the role of experts in construing a specification. For the moment I need only say that it is common cause, and the Commissioner H approached the matter on those lines, that the claim before and after amendment must be given its ordinary meaning. The evidence of the experts does no more than to advance the meaning that each attributed to the claim on the ordinary meaning of language. That evidence is neither helpful nor admissible and I say no more about it at this stage. I

Nugent JA (Heher JA, Snyders JA, Tshiqi JA and Mclaren AJA concurring)

A [16] Counsel on both sides approached the matter on the basis that the amendment altered the original claim so as to claim what was called at times a 'two vial composition' — whatever that might mean — or what counsel for Cipla called a 'kit' from which the composition was to be made. That was said by Cipla to have broadened the original claim, and B by Aventis to have narrowed it. The Commissioner approached the matter in the same way. He summarised the case put forward by Cipla as follows:

'The applicant . . . contends in the founding affidavit that the amended claim 1 is intended to cover an unmixed collection of the specified ingredient substances which Mr Puckrin SC on behalf of the applicant C referred to as a kit to distinguish it from the composition',

but said that —

'amended claim 1 cannot be properly interpreted in that way. It still refers to an injectable composition, ie something which is obtained by mixing the ingredients referred to, and the method of mixing is D expressly provided for',

and he concluded that —

'by amending the claim as it has done the patentee has restricted its monopoly and not extended it'.

E [17] The ordinary meaning of a 'composition' in the present context is 'a substance formed by combination of various ingredients'. [8] It goes without saying that before they were combined the two ingredients described in the original claim existed separately. And if they were solutions then they must necessarily each have been held in impervious F containers — whether bottles or ampoules or any other kind of impervious container. All of that is silently stated by mere description of the invention as a 'composition' of the stated constituents.

[18] The words added by amendment do not purport to claim a different invention. The invention of the amended claim remains a 'composition' G with the same...