INDIA BUSINESS WORLD - APRIL 2007
The Month that was ...

NOVARTIS SHIFTING CASE FOCUS IN ITS CHALLENGE TO INDIAN PATENT LAW

LAWYERS representing domestic drug makers said on Monday that Novartis is shifting the focus on its challenge to the Indian patent law from a substantive provision to its explanation. The hearing at the Madras High Court on the case, challenging India's patent law and a decision to reject its patent application for cancer drug Glivec, resumed on Monday and would continue for another two days.

They also said the Swiss pharmaceutical company is charging arbitrariness on the government's part by introducing efficacy as criteria in the patent law while it should have been be part of only the law for granting marketing approvals. Novartis was not immediately available for comment on Monday about its rejoinder to the arguments made by the Indian companies.

The controversial section 3 d of the patent law says improvements over existing drugs are not eligible for patent protection unless there is a "significant improvement in their known efficacy. And the explanation says minor improvements such as salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers and complexes would be regarded as the same as the already known substance unless their efficacy is significantly improved.

"Novartis, which earlier wanted this section to be struck down, is now objecting to the explanation to the section besides questioning the criteria of efficacy. This exceeds the scope of their initial pleading and therefore, Indian companies shall, once again, get opportunity to respond to all the points Novartis has raised in its argument", a lawyer representing one of the Indian companies in the case quoted.