Aventis Pharma SA v Cipla Life Sciences (Pty) Ltd

• Jurisdiction: South Africa
• Judge: Southwood, J
• Judgment Date: 20 October 2011
• Citation: 2011 JDR 1741 (CP)
• Docket Number: 93/8963
• Court: Commissioner of Patents

Southwood J:

[1]

The applicants, respectively the patentee and sub-licensees of South African patent number 93/8936, seek an order:

(a)

Interdicting and restraining the respondents pending the final determination of the action for final interdicts to be instituted by the applicants simultaneously with the present application –

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(i)

from procuring or inducing, aiding and abetting, advising, inciting or instigating or assisting any other person to infringe claim 1 of South African Patent No. 93/8936 by, in the Republic, disposing or offering to dispose of CIPLA DOCETAXEL or CIPLA DOCETAXEL solvent;

(ii)

from infringing claim 1 of South African Patent No. 93/8936 by, in the Republic, making a premix of CIPLA DOCETAXEL and CIPLA DOCETAZEL solvent or any other product falling within the scope of this claim:

(b)

directing that the respondents pay the costs of this application, including the costs of two counsel, alternatively that such costs be reserved for determination in the action.

At the end of his argument in reply, Mr. Bowman SC on behalf of the applicants handed to the court a draft order (which is marked Exhibit 'X' and filed at pp1032-3) in which interim relief is sought in a different form. Mr. Puckrin SC on behalf of the respondents objected to the amendment of the relief sought by means of the draft order. He submitted that the modified relief sought cannot be granted and that the modified relief demonstrates the lack of clarity in the relevant claim of the patent.

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[2]

The first applicant is the proprietor of South African Patent No 93/8936 ('the patent') entitled 'New Taxoid-Based Compositions' which, according to the applicant, claims compositions containing taxane derivatives including the taxane derivative known as docetaxel. Taxane derivatives such as docetaxel are used as chemotherapy treatments for a number of cancers. The first applicant uses the trade mark Taxotere for its commercial formulation containing docetaxel which the first applicant claims falls within the scope of the patent.

[3]

This application is concerned with the threatened infringement of claim 1 of the patent which was amended on 3 July 2007. The claim reads:

'An injectable composition comprising (a) a taxane derivative in a polysorbate and (b) an additive, (a) and (b) being provided in 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, or breaks, a gelled phase during the mixing of the intermediate solution with an aqueous medium.'

During March 2011 the applicants discovered that the respondents are about to import into South Africa two products made in India, CIPLA DOCETAXEL and CIPLA DOCETAXEL solvent, which, when mixed in accordance with the relevant product insert will constitute an infringement of claim 1 of the patent. The respondents clearly intend to distribute and sell the two CIPLA products in South Africa to oncologists and other healthcare professionals involved in the

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treatment of cancer. The applicants seek an interdict to prohibit the respondents from mixing the CIPLA products in accordance with the patent and an interdict to prohibit the respondents from selling the products to any person who will mix them in accordance with the patent. The applicants seek the second interdict on the grounds of contributory infringement of the patent. They concede that if the respondents simply import the products into South Africa and/or distribute and sell the products in South Africa, whether separately or together, the respondents will not infringe the patent.

[4]

All the applicants are members of the French Sanofi Group of Companies. The second applicant is a licensee of the patent and sells the Group's pharmaceutical products, including Taxotere in South Afirca. The third applicant is also a licensee of the patent and is a wholly owned subsidiary of the second applicant.

[5]

The respondents are all subsidiaries, directly or indirectly, of Cipla Medpro SA Ltd. The second respondent imports into and distributes and sells in South Africa pharmaceutical products manufactured by an Indian company, Cipla Limited. The second respondent distributes all Cipla Limited's products in South Africa. The first respondent is a wholly owned subsidiary of the second respondent and holds the registrations granted by the Medicines Control Council ('MCC') in terms of the Medicines and Related Substances Control Act 101 of 1965 ('the Medicines Control Act'). The third respondent sells products imported

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and marketed by the first and second respondents. The third respondent will be responsible for selling the CIPLA DOCETAXEL and CIPLA DOCETAXEL solvent products.

[6]

The complete specification of the patent was lodged at the South African Patent Office on 30 November 1993 and was granted on 26 October 1994. Subject to the attack on its validity in the respondents' affidavits the patent is in full force and will expire on 30 November 2013. Since 1995 when the second applicant obtained authorisation to sell Taxotere from the MCC the product has been extremely successful. It is currently the applicants' largest selling oncology product in South Africa and its global sales during 2010 exceeded €2 billion. Since these proceedings commenced, and clearly prompted by them, the applicants have launched as a second brand their product called Docetere, an equivalent of Taxotere.

[7]

In March 2011 the applicants discovered that the respondents intended to import into and/or distribute and sell in South Africa the CIPLA DOCETAXEL and CIPLA DOCETAXEL solvent products which the applicants fear will infringe the patent. In March 2011 the second respondent launched an application in terms of section 51(10) of the Patents Act 57 of 1978 ('the Act') to set aside the amendment of the patent allowed by the Registrar in 2007. The second respondent alleged that the amendment was allowed in conflict with section 51(7) of the Act.

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[8]

The applicants obtained samples of the Indian products and examined them in the light of the patent. Satisfied that, when mixed in accordance with the product insert, the mixture would infringe the patent the applicants consulted their attorneys, Adams & Adams, and instructed them to take steps to protect their rights in terms of the patent.

[9]

On 9 May 2011 the applicants' attorneys of record, Adams & Adams, addressed the following letter to the respondents' attorney of record, Brian Bacon & Associates:

'RE: SOUTH AFRICAN PATENT NO 93/8936 IN THE NAME OF AVENTIS PHARMA SA

1.

We are writing to you on behalf of our clients Aventis Pharma SA, Sanofi-Aventis South Africa (Pty) Ltd and Winthrop Pharmaceuticals (Pty) Ltd.

2.

As you are aware, Aventis Pharma SA is the patentee of South African Patent No 93/8936 entitled 'New Taxoid Based Compositions' ('the patent'). This patent covers the product Taxotere® which contains the active ingredient Docetaxel.

3.

Sanofi-Aventis South Africa (Pty) Ltd and Winthrop Pharmaceuticals (Pty) Ltd are recorded as licensees under the patent.

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4.

We are advised that the Registrar of Medicines, appointed in terms of the Medicines and Related Substances Control Act 101 of 1965, has granted Cipla Life Sciences (Pty) Ltd registrations for a Docetaxel product called CIPLA DOCETAXEL (in a 20 and 80mg dosage form).

5.

It is evident from the Government Gazette CIPLA DOCETAXEL is manufactured by Cipla Limited at Unit V, Verna, Salcette, Goa, India. As is also evident from the package insert, the directions for use require that a vial of CIPLA DOCETAXEL be mixed with a vial of solvent (referred to as CIPLA DOCETAXEL solvent) to prepare a premix solution, which premix solution is added to a perfusion solution before use.

6.

Equivalent products to CIPLA DOCETAXEL and CIPLA DOCETAXEL solvent are the subject of registrations, and are being sold in other countries. For example, in India the same products are being sold as DOCETAX and DOCETAX solvent, respectively.

7.

We have advised our clients that the exploitation of CIPLA DOCETAXEL and CIPLA DOCETAXEL solvent in South Africa would amount to an infringement of the patent.

8.

We are advised that shortly after the Medicines Control Council ('MCC') registration was granted, and...