BBC News, 1
April 2013
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Many poorer people rely on India's generic drug industry |
The Swiss
drugmaker had been denied a patent by Indian authorities on the grounds that
the new version was only slightly different from the old.
There were
concerns that, if granted, a patent could threaten access to cheap generic
versions of life-saving drugs in poorer countries.
Novartis
said the decision "discourages future innovation in India".
"This
ruling is a setback for patients that will hinder medical progress for diseases
without effective treatment options," said Ranjit Shahani, vice-chairman
and managing director of Novartis India.
Glivec,
which is used to treat chronic myeloid leukaemia and other cancers, costs about
$2,600 (£1,710) a month.
The generic
equivalent is currently available in India for just $175.
"This
will go a long way in providing affordable medicine for the poor," said
Anand Grover, a lawyer representing Cancer Patients Aid Association, adding
that he was "ecstatic with the ruling".
Long battle
Novartis
applied for a patent in 2006 for its new version of the drug, arguing that it
was easier to absorb and therefore qualified for a fresh patent.
However,
the Indian patent authority rejected the application based on a law aimed at
preventing companies from getting fresh patents by making only minor changes to
existing drugs, a practice known as "evergreening".
Officials
also turned down a subsequent appeal by the company three years later.
On Monday,
India's Supreme court rejected the firm's appeal to get patent protection for
the drug.
The AFP
news agency quoted the court as saying that the updated drug "did not
satisfy the test of novelty or inventiveness" as required by the law.
Setting a
precedent?
Patents
usually protect the companies for 20 years of exclusive sales. After that, it
is open to other firms who can make cheaper copies of the original drug.
Once the
protection expires, the first company to challenge the patent gets an exclusive
right to sell the copy for 180 days.
After 180
days, more companies can sell the generic versions, potentially resulting in a
further price drop.
It is
estimated that drugs with combined annual sales of $150bn will go off-patent by
2015.
India's
generic drug makers are among the biggest in the world and many expect them to
benefit from these patents expiring in the coming years.
However,
there have been concerns that if firms are granted patents for updated versions
of their drugs, it may not only deny access to cheaper medicines to poor
people, but also hurt the makers of generic drugs.
Pratibha
Singh, a lawyer for the Indian generic drug manufacturer Cipla, said the ruling
had set a precedent that would prevent international pharmaceutical companies
from obtaining fresh patents in India on updated versions of existing drugs.
"Patents
will be given only for genuine inventions, and repetitive patents will not be
given for minor tweaks to an existing drug,'' she said.
Shares of
Novartis India fell almost 5% on the Bombay Stock Exchange, while stocks of
generic drugmakers such as Cipla and Natco rose after the judgement.
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