The Hindu Business Line : Appellate board dismisses Novartis objection

The Intellectual Property Appellate Board (IPAB) has dismissed the objection raised by drug-maker Novartis regarding the appointment of Mr S. Chandrasekaran, former Controller-General of Patents, as a technical member on the Board.

However, the IPAB order is unlikely to end the appointment debate, with Novartis expressing its “disagreement” with the order.

The company is “considering all options,” Mr Ranjit Shahani, Vice-Chairman and Managing Director of Novartis told Business Line.

The reasoning behind the order will be understood only on reading the written judgment, he added.

Novartis had objected to Mr Chandrasekaran’s appointment to the IPAB, as he was the head of the Indian Patent Office when it rejected Novartis’s patent application for its cancer drug, Glivec, in January 2006.

In its order, issued on Friday, the IPAB said that the “doctrine of necessity” had been applied in this case.

“The doctrine has been applied, as already noticed, in case of bias where there is no other person who is competent or authorised to be adjudicator or if quorum cannot be formed without him or if no other competent tribunal can be constituted.”

An IPAB representative explained that the Novartis petition on the appointment was dismissed, as Mr Chandrasekaran’s technical expertise on patents was significant.

There are two other technical members, but they handle trademark-related issues, he added.

Also feeling the impact of today’s developments are domestic drug-makers Natco, Cipla, Hetero and Ranbaxy, besides patient organisations like the Cancer Patients Aid Association, which had initially opposed Novartis’s patent application at the Patent Controller’s office.

They were also respondents to an earlier case filed by Novartis at the Madras High Court against the rejection of its application.

But the entire scenario shifted to the IPAB, which was created in April following a notification from the Centre.

Novartis currently also awaits a judgment from the Madras High Court on another case regarding certain constitutional provisions in the Indian patent law; closing arguments had ended in early April.

The company had raised the issue of incremental innovation and whether it was patentable.

Section 3 (d) of the Indian Patent Act excludes important developments in the form of incremental innovation, the company said.

Shareholder concern

Glivec was on the mind of shareholders as well, at the Novartis AGM earlier today, with a majority of them expressing concern on developments around the cancer drug.

Mr Shahani told the gathering that the Patent Law should be designed to award significant incremental innovations.

Novartis runs a patient access programme that supports more than 7,400 patients in India by providing Glivec free to those who are unable to pay for it.

But Novartis Chairman, Dr E. Schillinger, told this correspondent that the company was holding back investments in India until there is more clarity on intellectual property right (IPR) issues.

In less than five years, pharma MNCs like GlaxoSmihtKline, Novartis, Novo Nordisk, Astra Zeneca and Roche have all set up research centres in China, an industry official observed.

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