[Ip-health] Novartis Image Shaken with GIPAP Scandal

[Joana Ramos]

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Novartis Image Shaken with GIPAP Scandal, Remains Undeterred on Patent
Litigation Front
Aparna Krishnan
6 March 2007
Global Insight Daily Analysis [1]
www.globalinsight.com ( via factiva)
[2]
Copyright 2007, Global Insight Limited. All Rights Reserved.

A new accusation directed at Swiss drugmaker Novartis, relating to cancer drug
Glivec/Gleevec (imatinib myselate) has emerged in ongoing patent-law
litigation in India. Businessworld reports allegations that the GIPAP (Glivec
International Patient Assistance Programme), which offers free drugs to
myeloid leukaemia patients in India, could be running an unauthorised clinical
trial. Novartis has denied this, indicating that the "non-interventional
clinical trial" form under Serious Adverse Event (SAE) documentation is part
of the post-marketing data collection and monitoring required by international
regulators including the U.S. FDA (Food and Drug Administration).

The ongoing litigation relates to the rejection of the Glivec patent by the
Indian authorities; Novartis is currently challenging the viability of section
3(d) in the amended Indian Patent Act.Significance: The GIPAP allegations add
a new dimension to the battle which has seen consumer patient groups and the
government join ranks against the pharma firm. The litigation has so far
attracted comments from European members of parliament and the U.S. Republican
Senator Henry Waxman, requesting that Novartis withdraw the case. But the
GIPAP allegations are likely to evoke a larger debate over ethical disclosure
of patient information, an issue that has remained untouched in India so far.
This is the second blow for Novartis, after its earlier submission of a
government-sponsored committee report was found to be plagiarised and was
later withdrawn (see India: 23 February 2007: )

--
Joana Ramos, MSW
Cancer Resources & Advocacy
7303 23rd Ave. NE
Seattle, WA  98115
206-229-2420
http://ramoslink.info/[3]

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