The recent drug challenge before the Indian Patent Office: Gilead’s hepatitis C drug “Sovaldi”

by María Victoria Rivas Llanos

Under Section 3 (d) of the Indian Patent Act[1], a new form of a known substance shall be deemed unpatentable unless “enhanced efficacy” is proved. The purpose of this provision is to prevent what is called “evergreening of drug patents”, a practice used by big pharmaceutical companies to extend the patent monopoly over old drugs by introducing minor changes to their composition.

The most recent rejection of the Indian patent controller pursuant Section 3 (d) of the Indian Patent Act was issued last month against Gilead’s patent application for its hepatitis C drug “Sovaldi”[2]. The patent controller’s decision revives the long-lasting battle commenced by Novartis in 2006 for its cancer drug “Glivec”[3]; where Novartis’ application was rejected due to its alleged lack of novelty.

In the case at hand, Indian generic companies and healthcare activists brought pre-grant opposition procedures against Gilead’s application, challenging the patentability of its updated version for a known drug. In their view, grating a patent for Sovaldi would have set a wrong precedent with detrimental effect directly on the market of pharmaceuticals and drug prices, and indirectly on access to medicines.

On its part, Gilead underlined the imminent lack of incentive for innovation of the Indian patent system that intends to create a higher bar for new substances beyond the purpose of the law itself. In any case, according to Gilead, it should have been granted a patent for Sovaldi, since this drug presents a lower level of toxicity than its predecessor and therefore enhanced efficacy. The question remains, however, whether this argument would have been sufficient to reach the threshold of enhanced efficacy. In this regard, the aforementioned Novartis Supreme Court decision stated that Section 3 (d) refers to “therapeutic efficacy”[4].

The question at stake is once again how to strike a balance between securing access to affordable medicines for the poor and encouraging pharmaceutical companies to invest in research and development for new drugs.

The Novartis case represented a landmark decision with influence on the practice amongst the Indian Intellectual Property authorities regarding pharmaceutical products. Its result has already been seen in the recent patent controller’s decision in Sovaldi and it is expected to have a similar impact on ongoing drugs battles at the Indian Supreme Court, such as Pfizer’s cancer drug “Sutent” and Roche’s hepatitis C drug “Pegasys”.

Nonetheless, essential questions remain unclear under Indian Law, namely what constitutes a “new form of a known substance” and how to apply the enhanced efficacy test.

Maria Victoria Rivas Llanos
Associate Editor, Queen Mary Journal of Intellectual Property

[1] The Patents Act, 1970 (as amended up to Patents (Amendment) Act, 2005).

[2] India patent application No. 6087/DELNP/2005.

[3] Civil Appeal Nos. 2706-2716 OF 2013.

[4] Ibid.