Supreme Court to hear Novartis case from sept 11

Supreme Court will hear final arguments in the patent appeal between the Swiss drug company Novartis and Indian patent office. The hearing is expected to last for two months had been first scheduled for last Wednesday. 

Novartis has first challenged the Patent office in 2006 after its application for their cancer drug "GLIVEC" was refused patents by the Chennai Patent office on the ground that drug is not a new invention as it is just an amended version of an existing compound and therefore hit by section 3(d)  of the Indian patent (amendment) Act,2005.

Section 3(d)  of Amended Act states that

" The mere discovery of a new form of  a known substance which does not result in the enhancement of that substance or the mere discovery of any property or new use for a known substance or of the mere use of known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant "

Novartis challenged the constitutional validity of the said section before the Madras High court as well as appealed against rejection of patent application before the Intellectual Property Appellate Board. 

Writ petition on constitutional validity raised the issues of arbitrariness and non compliance with TRIPS. But the Madras High upheld validity of the section 3(d)  and noted that :

" The argument that the amended section must be held to be bad in law since for want of guidelines it give scope to the statutory authority to exercise power arbitrarily has to be rejected since we found that there are in- built materials in the amended section and its explanation itself would control/ guide the discretion to be exercised by the statutory authority"

With regard to Non compliance with TRIPS Agreement, court held that the appropriate forum to decide that issue would be WTO Dispute Settlement Body.

Full judgement available here

In 2009, on its appeal against  decision of Chennai patent office IPAB held that though the claim covered under the patent application is novel and inventive it fails the test under section 3(d)  which required a demonstration of significantly enhanced efficacy.

Novartis against this order of IPAB appealed to the Supreme Court in 2009 which has now entered into  stage of final hearing. The decision of this case is very important to the Indian Generic medicine industry and is also particularly relevant in the light of grant of its first compulsory license.

Source