Constitutional considerations tested in South African patent litigation

By Nico Vermaak and Jaco Theunissen, DM Kisch
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The South African Supreme Court of Appeal (SCA) was tasked during 2012 to adjudicate in appeal proceedings between Cipla Medpro v Aventis Pharma, pertaining to South African patent no. 1993/8936 registered in the name of Aventis.

The Treatment Action Campaign (TAC) intervened, unopposed, in the proceedings and argued that constitutional considerations, and mainly the public interest, should be applied when deciding whether Aventis should be granted the interdict it sought.

Nico Vermaak DM Kisch律师事务所 专利部 高级合伙人 Senior Director Patent Department DM Kisch
Nico Vermaak
DM Kisch律师事务所
专利部
高级合伙人
Senior Director
Patent Department
DM Kisch

Interim interdict

Aventis sought an interim interdict to prevent Cipla from infringing its patent, relating to an oncology product by the name of Taxotere, by its intended marketing of a generic alternative to Aventis’ Taxotere, the active ingredient of which is docetaxel.

Taxotere is administered via a drip, the method being that two separate vials containing the constituent components of Taxotere are mixed together, with the resulting mixture then being injected into a saline drip and delivered to a patient via an intravenous line.

Possible infringement

During 2011, Aventis became aware that Cipla had applied to the Medicines Control Council for the registration of a generic version of Taxotere, which it intended to commercialise as Cipla Docetaxel. The intended mechanism of administration of Cipla Docetaxel largely corresponds to that of Taxotere, including the packaging in two separate vials – entitled Cipla Docetaxel and Cipla Docetaxel solvent, respectively – and the mixture thereof shortly before administration. Aventis accordingly instituted patent infringement proceedings against Cipla.

Cipla’s turn

Following Aventis’ application for an interim interdict, Cipla in turn applied for the setting aside of an earlier amendment of the patent. Both applications failed at first instance before the Court of the Commissioner of Patents, and both parties appealed to the SCA.

We shall not dwell on the first appeal, which did not succeed, relating to the application to set aside the earlier amendment of the patent.

Aventis’ appeal against the refusal of the commissioner to grant the interdict sought did, however, succeed.

The unique aspect of the case was that the TAC, an activist group lobbying for cheaper medicines, was admitted as amicus curiae only at the SCA stage of the matter.

The TAC based its first argument against an interdict on section 27(1) of South Africa’s constitution, which provides that: “Everyone has the right to have access to … healthcare services, including reproductive healthcare”; this provision has been held by the Constitutional Court to include a right to have access to affordable medicines.

The TAC submitted that the Patents Act must be construed “through the prism of the constitution” and in a way that appropriately balances the rights of a patentee against the constitutional rights of others.

Jaco Theunissen DM Kisch律师事务所 专利部 高级律师 Senior Associate Patent Department DM Kisch
Jaco Theunissen
DM Kisch律师事务所
专利部
高级律师
Senior Associate
Patent Department
DM Kisch

Unimpressed

The court was not impressed by this proposed approach. It remarked:

“What we are to make of viewing the legislation through the prism of the constitution was not developed by the TAC. Section 39(2) indeed calls upon a court to ‘promote the spirit, purport and objects of the Bill of Rights’ when interpreting legislation, as pointed out by the TAC, but that does not open the door to changing the clear meaning of a statute … On the assumption that the patent is not revocable for want of an inventive step, I cannot see how section 39(2) or the prism of the constitution comes into play so as to deny Aventis its right to enforce its patent.”

So nothing came of the strictly constitutional ground which the TAC sought to advance in support of its argument against the granting of an interdict in favour of Aventis.

Stronger ground

The SCA, however, indicated that the TAC was on stronger ground with its further submission that the broader public interest, and not only the interests of the litigating parties, must be placed in the scales when weighing where the balance of convenience lies. The SCA dealt in some detail with a number of cases decided in the US, where injunctions against patent infringement have been refused on the ground of public interest. In respect of each of these cases the SCA, however, found that the Aventis/Cipla matter was distinguishable on the facts.

The SCA accordingly decided in favour of Aventis due to the public interest not being materially affected. One of the reasons for this finding was that Aventis itself intended to launch a significantly cheaper generic version of Taxotere, namely Docetere, which was to be only marginally more expensive than Cipla Docetaxel.

Judgment

The court significantly held at paragraph 56 of its judgment:

“Where the public is denied access to a generic during the lifetime of a patent that is the ordinary consequence of patent protection and it applies as much in all cases. To refuse an interdict only so as to frustrate the patentee’s lawful monopoly seems to me to be an abuse of the discretionary powers of a court. But in any event there will be no material prejudice of that kind on the facts of this case.”

Public interest

Although the public interest considerations were therefore not in this particular instance held to constitute a bar against the granting of an interim interdict, it is to be expected that future applications for interim interdicts in patent proceedings will feature substantial supporting evidence to show that such interdict will not detrimentally affect the public interest.

Nico Vermaak is a senior director and Jaco Theunissen is a senior associate in the patent department at DM Kisch

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