ALLEGATIONS OF BIAS IN THE NOVARTIS PATENT LITIGATION

Whilst most of us await the Madras High Court judgment on the constitutionality of section 3(d) of the Indian Patents Act, here’s an update on what’s going on at the IPAB (Intellectual Property Appellate Board), the specialized IP tribunal in India. As mentioned in an earlier post, the Novartis litigation was split up—the patentability issue was referred to the IPAB and the constitutionality issue was to continue with the Chennai High Court.

Before the IPAB could even begin to wade into the turbulent waters of what it means to be a more “efficacious” salt form, Novartis has raised objections to the presence of Mr Chandrasekharan (ex Controller of the Patent Office) on the IPAB panel. Novartis alleges that the Gleevec application was rejected by the patent office at a time when Mr Chandrasekharan was Controller. Therefore, having Chandrasekharan sit in judgment over whether he got it right the first time around violates cardinal principles of natural justice. To complicate matters, Chandrasekharan filed an affidavit at the earlier stages of the Novartis litigation before the Madras High Court, supporting the rejection of Novartis’ patent application.

The Financial Express Reports:

“The Intellectual Property Appellate Board (IPAB), which has been formed to give a verdict on various patent cases across the country, may reject Novartis objection on the presence of S Chandrasekharan, the former patent controller, on IPAB. Novartis had objected to Chandrasekharan’s presence on the board saying he was responsible for Glivec being denied product patent in 2006, when he was the controller general of patents.

Novartis has challenged section 3(d) of Indian Patent Law, according to which, any new use or a new variant of an old substance cannot be patented without having any significant efficacy. On this basis, the Chennai Patent Office had rejected Novartis¹ patent application for anti-leukemia drug, Glivec. Novartis approached the Madras High Court against the verdict arguing that Section 3 (d) of Indian Patent Act is not compliant with the Trade Related Aspects of Intellectual Property Rights (TRIPs) agreement that India had signed in 2005.”

No doubt, Chandaraskeharan was not directly involved with the rejection of the Novartis patent application by his Assistant Controller, Rengaswamy. One might argue that his involvement was in an administrative capacity, as head of the patent office. Whether this distinction between judicial versus administrative capacity is sufficient to enable him to adjudicate on the matter in an appellate capacity is a moot issue. However, what is damaging is his direct involvement at a time when Novartis appealed the patent office order before the Madras High Court. He filed an affidavit before the court defending the rejection of the patent application by the patent office. This being so, having him continue on the IPAB flouts cardinal principles of natural justice, particularly the one stating that no one can be a judge in his own cause (for those of you with a penchant for dead languages, “nemo debet essa judex in propria cause”). There is a clear and legitimate apprehension of bias here and as many of us were taught in law school “Justice must not only be done, but must also be seen to be done”.

The government should take immediate steps to recuse him—(or he should do it himself). Else, an otherwise strong case for the government (on merits) may suffer. But if he is so recused, what happens?

Should the IPAB go ahead and decide the matter without him? Doesn’t seem like a particularly sensible option for me. Justice Ansari (Chairman of the IPAB), who is on the IPAB panel along with Chandrasekharan may have excellent credentials –but is no patent expert. In fact, the IPAB never functioned till recently because it had no technical member. Chandrasekharan’s appointment was with a view to fill in this lacuna.

But more importantly, Chandrasekharan was hastily appointed in the wake of the Novartis litigation and the governments’ desire to have the matter shifted to the IPAB. One can only second-guess the reasons for the government wanting to do so— perhaps from fears that one of the Madras High Court judges was pro Novartis—as the learned judge had, in an earlier matter involving the exclusive marketing right (EMR) of Novartis over Gleevec, upheld the validity of the EMR and injuncted several generics (in sharp contrast with a Mumbai High Court order that questioned the validity of the EMR in question).

Whatever be the reasons, it is paradoxical that the government tries to get away from a supposedly biased judge by running into the warm embrace of another one. But “paradox” is a familiar bedfellow as far as IP law/policy in India goes.

One hopes that better sense prevails and a new technical member is appointed to the IPAB to replace Chandrasekharan in this matter. Perhaps the IPAB may end up getting an excellent technical member and may begin churning out excellent patent jurisprudence in the coming years. Or perhaps the matter will continue as it is—and Chandrasekharan’s presence will make a dent in an otherwise strong case for the Indian government. We’ll have to wait to see how this saga unfolds….