| MUMBAI, March 27
MUMBAI, March 27 Global drugmakers, battered by
recent intellectual property decisions in India, are girding for
a landmark court ruling next week that could have broad
consequences for their ability to sell lucrative patented
medicines in the country.
India's Supreme Court is due to decide on April 1 whether or
not an amended form of Swiss giant Novartis AG's
cancer treatment Glivec deserves a patent in the country.
"Big Pharma is nervous because nothing has gone in their
favour in the recent past," said Ajay Kumar Sharma, associate
director of the pharmaceutical and biotech practice at business
consultancy Frost & Sullivan.
"With this verdict, at least, things will get clearer about
what is the definition of patented medicines."
Novartis has been fighting since 2006 to win a patent for an
amended form of Glivec, which many oncologists view as a major
advance in treating chronic myeloid leukaemia, which kills 80-90
percent of sufferers, and some gastrointestinal cancers.
India has refused protection for Glivec on the grounds that
it is not a new medicine but an amended version of a known
compound - a decision consistent with domestic patent law which
sets tight restrictions on multiple patents for a drug.
By contrast, in the United States, amended versions can be
Novartis is seeking to overturn a clause in Indian Patents
Law that restricts patent protection for newer forms of existing
molecules, and next week's ruling could set a precedent for how
other similar patent claims are treated.
"India is a formidable world power with international rights
and obligations," Ranjit Shahani, vice chairman and managing
director of Novartis India Ltd, the firm's India unit,
said in an email to Reuters.
"Novartis understands and recognizes the contribution of
generics once drug patents expire; our concern is with the
non-recognition of intellectual property rights that ultimately
help sustain and advance pharmaceutical research and
PROMISE AND PERIL
While Western firms see huge potential in India's rapidly
growing $13 billion drugs market, 90 percent of which is made up
of generics, they worry that India is failing to recognise
valuable medical innovation.
Among Big Pharma's setbacks in the country, India last year
allowed local drugmaker Natco Pharma to sell cheaper
copies of Bayer AG's cancer drug Nexavar through the
controversial mechanism of "compulsory licensing".
A global agreement, known as Trade-Related Aspects of
Intellectual Property Rights or TRIPS, allows countries to issue
compulsory licences for certain drugs that are deemed
unaffordable to large sections of their populations.
Also last year, India revoked patents granted to Pfizer
Inc's cancer drug Sutent, Roche Holding AG's
hepatitis C drug Pegasys, and Merck & Co's asthma
treatment aerosol suspension formulation. They were all revoked
on grounds that included lack of innovation.
In another potential hit, Mumbai-based BDR Pharmaceutical
International this month applied for a compulsory licence on a
blood cancer drug, dasatinib, sold as Sprycel by U.S.-based
Bristol-Myers Squibb Co.
Last month, an Indian government panel proposed that prices
of patented medicines be based on the country's per capita
income, a move that would substantially reduce prices of costly
drugs made by global pharmaceutical firms.
"In the minds of global drugmakers, the recent developments
will definitely hamper India's image," said lawyer Dominic
Alvares, of S. Majumdar & Co which represents Indian drugmakers.
But he said social justice and the public interest should
come ahead of India's reputation as a future drugs market. "The
developments would impact reputation but for the sake of
reputation, do you sacrifice on public interest?"
PATENTS VS AFFORDABILITY
In almost every patent dispute, India has held affordability
as a key reason to allow generic drugmakers to launch copycat
versions of patented medicines in a country where nearly 40
percent of the population lives on less than $1.25 a day.
For example, Natco Pharma was told by the patents office in
its compulsory licence ruling to offer generic Nexavar at 8,800
rupees ($162) for a month's dose - a fraction of Bayer's price
of 280,000 rupees. Natco must pay a 7 percent royalty to Bayer.
BDR Pharma, in its application, has offered generic Sprycel
at 8,100 rupees for a month's dose compared with Bristol-Myers'
price of 165,000 rupees.
Generic versions of Glivec, which won its first patent in
1993, cost about $2,500 for a year's dosage in India, compared
with nearly $70,000 in the United States where only the branded
version is sold.
Discount programmes mean the branded version is available
for much less in poor countries. In India, more than 95 percent
of patients using branded Glivec receive it free under a company
donation scheme, Novartis has said.
U.S. industry groups this month demanded that the United
States increase pressure on India to reform high-tech,
agricultural and pharmaceutical policies they said blocked
export access and damaged patent rights.
"India has essentially created a protectionist regime that
harms U.S. job creators" in favour of India's generic drug
manufacturers, Roy Waldron, chief intellectual property counsel
for Pfizer, said in testimony to a U.S. House panel.
India's $25 billion drugs industry, a major exporter of
generics, is growing at 16 to 17 percent a year.
"You can expect more muscle-flexing from the respective
countries of the big pharmaceutical companies in the future,"
Frost & Sullivan's Sharma said.