Cipla Medpro Ltd. v. Aventis Pharma SA

Case No: 139/2012 and Case No: 138/2012; [2012] ZASCA 108
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Aventis, a pharmaceutical company, applied for a preliminary injunction against infringement of its patent on its cancer drug Taxotere in order to restrain Cipla, an Indian pharmaceutical company, from importing, manufacturing or selling Cipla’s generic equivalent of the drug. Prior to this, Cipla had applied for revocation of Aventis’ amended patent on a number of grounds. The Commissioner of Patents dismissed both applications. This appeal followed.

The Treatment Action Campaign (TAC), a non-governmental organization, was admitted to the appeal as amicus curiae. TAC objected to the preliminary injunction on two grounds, both founded upon section 27(1) of the Constitution, which guarantees the right to have access to health care services, including the right of access to affordable medicines. TAC argued that the Patents Act should be construed “through the prism of the Constitution” in a way that “appropriately balances the rights of a patentee against the constitutional rights of others.” TAC further contended that that Act “must be interpreted and applied to ensure the public interest in patent protection is in fact served and ensuring other rights are not unreasonably limited thereby.”

The Court first held that it was “clear” that Cipla’s generic drug was to be imported and sold with “the specific and sole intention” that it would be used in a manner that would infringe Aventis’ patent. Its conduct in doing so would thus be unlawful. The Court next held that, except for the question of “obviousness,” no grounds had been established for revocation of the patent. It stated that the question of obviousness, however, would be determined in another venue. The Court held that the material before it established, prima facie, that Aventis’ patent was valid, and that Cipla was “intent upon inciting, aiding and abetting its infringement.” The Court noted that there was “some mention” in Cipla’s affidavits of the prejudice cancer patients were likely to suffer if an injunction were granted; however, it stated that it was “perfectly plain that in reality Cipla’s resistance to an [injunction was] founded upon its commercial interests.”

The Court next considered the objections raised by TAC to the granting of a preliminary injunction to Aventis to restrain Cipla from importing and selling its generic version of Taxotere. As to TAC’s first contention, that the Patents Act was to be construed “through the prism of the Constitution,” the Court noted that section 39(2) of the Constitution already calls upon the courts to “promote the spirit, purport and objects of the Bill of Rights” when interpreting legislation. The Court noted that this does not grant courts the authority to change the meaning of a statute, but only to strike down legislation that conflicts with the Bill of Rights. In this case, however, the constitutional validity of the Patents Act (the Act) had not been challenged and there was no suggestion that the meaning of the relevant provisions was unclear. The dispute instead involved the application of the Act to the facts of the case. The Court thus declined to pursue this contention.

The Court held that TAC was “on stronger ground” with its contention 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.” Aventis also accepted that “public-interest factors” ought to be taken into account in the Court’s decision whether to grant the injunction. In weighing the public interest, the Court noted that Aventis had registered its own generic version of Taxotere in order to compete with generic manufacturers when its patent expires. The Court noted that there was no suggestion that Aventis was not able to meet the market demand for Taxotere, nor that Cipla’s generic version offered “superior medicinal benefits.” Finally, the Court considered the relative cost of the three versions of the drug and declared that Taxotere was “considerably more accessible” than Cipla’s generic version to patients who used public health care. It concluded that the only health-related consequence of granting the injunction was that patients receiving private health care who were unable to recover the cost of treatment from a private medical fund, would pay 10 percent more for treatment with Taxotere than if Cipla’s generic drug was available to them.

Last, the Court held that the commercial prejudice likely to be suffered by Cipla if the injunction was granted was equivalent to the commercial prejudice to Aventis if the injunction was not granted: the loss of the advantage of having the first generic on the market. The Court held that under these circumstances the fact that the doubt as to the validity of the patent was “slight” became decisive. There was thus no proper ground upon which to deny the preliminary injunction.

"[46] The TAC is on stronger ground when it advances factors to be taken account of when weighing the balance of convenience. In that respect it submitted 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. Apart from decisions to that effect in this country, we were referred to cases in other jurisdictions, particularly the United States, where injunctions against infringement have been refused on that ground."

"[56] The TAC's opposition to the grant of an interdict really comes down to no more than opposition to the monopoly that the law confers upon a patentee. It submits that those who cannot afford Taxotere, but are able to afford the price of Cipla Docetaxel, will be prejudiced if distribution of the latter were to be prohibited. 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."

"[61] ... In either event the public interest will not have been materially affected. The most that can be said is that patients who receive private health-care, and who are not able to recover the cost of treatment from a private medical fund, will have been required to pay 10% more for treatment than they might otherwise have done. In those circumstances the balance of convenience does not seem to me to fall substantially on one side or another and the prospects of success or failure in the action become prominent."

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