[In Monday’s decision,
India’s Supreme Court ruled that the
patent that Novartis sought for Gleevec did not represent a true invention.
The ruling is something of a historic anomaly. Passed under international
pressure, India’s 2005 patent law for the first time allowed for patents on
medicines, but only for drugs discovered after 1995. In 1993, Novartis patented
a version of Gleevec that it later abandoned in development, but the Indian
judges ruled that the early and later versions were not different enough for
the later one to merit a separate patent.]
 |
| Big Court Ruling Favors Generic Drugs: The Times's Katie Thomas explains why a ruling in India favoring generic drugs has rippling effects around the world >>. |
NEW DELHI —
India’s Supreme Court rejected a patent application by Novartis for a major
cancer drug on Monday, in a landmark ruling that will permit poor patients
continued access to many of the world’s best medicines, at least for a while.
The ruling allows Indian
makers of generic drugs to continue making copycat versions of the drug Gleevec
— also spelled Glivec in Europe and elsewhere — which provides such a
miraculous cure for some forms of leukemia that the Food and Drug
Administration approved the medicine in the United States in 2001 in record
time.
But the ruling’s effect
will be felt well beyond the limited number of leukemia patients in India who
need Gleevec, made by Switzerland-based Novartis. On the one hand, it will help
maintain India’s role as the world’s most important provider of cheap
medicines, which is critical in the global fight against HIV/AIDS and other
diseases. Gleevec can cost up $70,000 per year, while Indian generic versions
cost about $2,500 a year.
“India, being the
pharmacy capital of the world, can continue to produce affordable, high-quality
medicines without the threat of patents for minor modifications of known
medicines,” Dr. Yusuf K. Hamied, chairman of Cipla, an Indian generic drug
giant, wrote in an e-mail.
On the other hand, the
ruling could cost lives in the future. Drug company executives and others argue
that India’s failure to grant patents for critical medicines – and Gleevec is
widely recognized as one of the most important medical discoveries in decades –
is a shortsighted strategy that undermines a vital system for funding new
discoveries.
In a televised
interview, Ranjit Shahani, vice chairman of Novartis’s Indian subsidiary, said
that companies like Novartis would invest less money in research in India as a
result of the ruling. “We hope that the ecosystem for intellectual property in
the country improves,” he said.
The case grapples with
the contention that rich nations, increasingly reliant on the creation of
idea-based products like computer programs and medicines, require poorer
countries to pay for their ideas. Some countries – particularly India, Brazil
and China – have begun to challenge the price they must pay, especially when
the idea-based products are lifesaving medicines that their people desperately
need.
The question is how to
pay for ideas in ways that maximize their use while encouraging their creation,
two sometimes contradictory goals. Poor countries have tended to focus on the
immediate issue of access while tending to ignore the more uncertain and
far-off issue of innovation, while the United States has long emphasized the
need to finance new discoveries rather than provide access to medicines for
all.
India exports about $10
billion worth of generic medicine every year, more than any other country.
India and China together produce more than 80 percent of the active ingredients
of all drugs used in the United States.
In Monday’s decision,
India’s Supreme Court ruled that the
patent that Novartis sought for Gleevec did not represent a true invention.
The ruling is something of a historic anomaly. Passed under international
pressure, India’s 2005 patent law for the first time allowed for patents on
medicines, but only for drugs discovered after 1995. In 1993, Novartis patented
a version of Gleevec that it later abandoned in development, but the Indian
judges ruled that the early and later versions were not different enough for
the later one to merit a separate patent.
Leena Menghaney, a
patient advocate at Doctors Without Borders, said that the ruling is a reprieve
from more expensive medicines, but only for a while.
“The great thing about
this ruling is that we don’t have to worry about the drugs we’re currently
using,” Ms. Menghaney said. “But the million-dollar question is what is going
to happen for new drugs that have not yet come out.”
Anand Grover, a lawyer
who argued the case on behalf of Cancer Patients Aid Association in India, said
the ruling had a sweeping effect since it confirmed that India has a very high
bar for approving patents on medicines.
“What is happening in
the United States is that a lot of money is being wasted on new forms of old
drugs,” Mr. Grover said. Because of Monday’s ruling, “that will not happen in
India.”
Indeed, the vast
majority of drug patents given in the United States are for tiny changes that
often provide patients few meaningful benefits but allow drug companies to
continue charging high prices for years beyond the original patent life.
In a classic example,
AstraZeneca extended for years its franchise around the huge-selling heartburn
pill, Prilosec, by performing a bit of chemical wizardry and renaming the medicine
Nexium. Amgen has won so many patents on its hugely expensive
erythropoietin-stimulating drugs that the company has maintained exclusive
sales rights for 24 years, double the usual period.
One result is that the
United States pays the highest drug prices in the world, prices that only a
tiny fraction could afford in India, where more than two-thirds of the
population lives on less than $2 a day. While advocates for the pharmaceutical
industry argue that fairly liberal rules on patents spur innovation, academics
are far from united in sharing that view.
But as the economies of
emerging markets grow, their refusal to pay higher premiums for newer drugs
could significantly reduce the money needed for innovation. The drug industry
makes nearly two-thirds of its profits in the United States, a dependence that
many in the industry fear is unsustainable. And even minor improvements in
medicines – making a pill once-a-day instead of twice-a-day – can have
significant impacts on patient wellness, industry executives say.
The United States
government has become increasingly insistent in recent years that other
countries adopt far more stringent patent protection rules, with the result
that poorer patients often lose access to cheap generic copies of medicines when
their governments undertake trade agreements with the United States.
Drug companies have
relied on the American government to lobby on the issue because they have few
tools to punish India and other countries. If the companies decide not to
introduce high-priced drugs in India, the country could legalize generic copies
under international law. And with major drug makers cutting back on research
budgets anyway, large investments in research infrastructure may be unlikely
even if countries adopt patent laws more amenable to the industry.