[Ip-health] Economic Times (India): Novartis India keeps fingers crossed as SC hears Glivec patent case
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Wed Mar 7 03:16:18 PST 2012
Novartis India keeps fingers crossed as SC hears Glivec patent case
Divya Rajagopal, ET Bureau Mar 5, 2012, 04.13AM IST
MUMBAI: Novartis India will take a last shot at protecting its patent for
anti-cancer drug Glivec in Supreme Court later this month in a ruling that
will have a significant impact on all innovators, past and present, even as
activists seek affordable drugs in developed countries 'occupy Novartis'
offices' in the US.
The Indian subsidiary of Swiss drug maker Novartis is making a final
attempt at getting a patent for its anti-cancer drug Imatinib with the name
Glivec is considered by Novartis as its major medical breakthroughs of the
20th century, which has been replicated with minor process adjustments in
India, with its Indian rivals selling their versions at more affordable
Novartis in 2006 had sued the Indian government for not granting a patent
for Imatinib, and also challenged section 3d of the Indian Patent Act which
deems any incremental or frivolous innovation non-patentable.
"The ruling is important for all innovators, national and global, with a
presence or wanting to have a presence in India. This is about safeguarding
incentives for better medicines so that patients' needs would be met in
future," said Ranjit Shahani, managing director, Novartis India.
Last week, the company declared that an improved version of Glivec received
an approval from the European Commission for selling it in 27 EU countries,
suggesting that the drug's efficacy is not frivolous as claimed by its
opponents. It has reached social media, like Twitter, posting regular
updates on the Glivec case asking its followers to identify 'fact from
Shahani said that through this case Novartis is seeking clarity on whether
it can rely on patents in India. "We want to know that as a research-based
organisation, can we continue to invest in the development of better
medicines for India," he said.
Last week, protestors stormed the annual general meeting of the company,
asking it to withdraw the case. Health activists have occupied the Novartis
offices across the world, and last week 'Occupy Novartis' movement spread
to cities like New York, Boston and Washington.
"What is at stake goes far beyond the granting of a patent for this
anti-cancer drug. In fact, Novartis is acting as a corporate bully for all
big pharmaceutical companies to weaken the Indian Patents Act so as to
allow patenting on trivial changes to all sorts of existing medicines in
the future," said Patrick Durisch, health programme coordinator, Berne
For multinational pharma companies, India's patent laws have always been a
disputed issue, especially section 3d. They feel a provision like section
this is a deterrent for drug discoveries.
"If the patent is valid and it's a new chemical entity, then the patent
should be granted. Indian government should strengthen the patent office
rather than leave it to the courts to decide issue," said Kewal Handa,
managing director Pfizer India. One of the big concerns over granting
patent to Glivec has been the fear of increase in prices of life-saving
drugs. Glivec costs close to 1 lakh in India, but Novartis says that it has
subsidised the drug for the Indian population. "Price in the case of Glivec
is irrelevant," argued Novartis in an email response.
Novartis runs the Glivec International Patient Assistance Programme making
Glivec available free of cost to 95% of the patients receiving the drug in
India. The remaining 5% patients are on a very generous co-pay programme,
Novartis said. "Novartis has in fact distributed Glivec valued at more than
$1.7 billion to patients since its inception in late 2002, way before this
case began," it added.
However, activists are not convinced by Novartis's claims. "Our calculation
says there are estimated 20,000 new patients every year suffering from
cancer, this means after ten years there will be two lakh patients, hence
the programme is not enough," said Durisch. Analysts say that any outcome
in this case would set the ball rolling for a slew of legal battles over
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