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Healthy Skepticism Library item: 19961

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: news

Bajaj V, Pollack A
If Novartis wins, prices of drugs could sky-rocket
The Deccan Herald 2012 Mar 8
http://www.deccanherald.com/content/232801/if-novartis-wins-prices-drugs.html


Notes:

Originally published in the New York Times


Full text:

The case before SC has implications for all medicines and availability
of their cheap variants
While China was becoming the world’s shop floor, India took its place
as the world’s pharmacy, and in recent decades has been the largest
provider of cheap, lifesaving medicines in poor countries across the
globe
But most of that medicine has been generic copies of brand-name drugs
protected by patents in Europe and the United States. Now a big Swiss
drug company, Novartis, may be one legal step away from upending the
Indian supply chain by forcing the Indian government to recognise a
patent for a cancer treatment heralded as a breakthrough for people
with a deadly form of leukemia.

The case, involving the drug Gleevec, is before the Supreme Court,
which is preparing to hear final arguments this month. It represents a
high-stakes showdown between defenders of intellectual property
rights, who say the generic knockoffs stifle innovation by drugmakers,
and Indian drug companies and international aid groups, who warn that
a ruling in favour of Novartis could dry up the global supply of
inexpensive medicines to treat AIDS, cancer and other diseases.

The case has attracted international attention. AIDS activists and
others protested recently outside Novartis’ annual shareholders
meeting in Basel,Switzerland, and also at Novartis offices in New
York, Washington and Cambridge, Mass., demanding that the company drop
the case. “There will be nothing left to defend if we lose,” said
Leena Menghaney, a manager based in New Delhi for Doctors Without
Borders, which advocates for generic drugs. “People are definitely on
edge about this case.”
The Indian government denied the patent for Gleevec, as it has for
many other drugs made by many western drugmakers. Novartis sued, and
the case has been winding through the Indian legal system for six
years. The government is under some pressure from its trading
partners, including the US, to relent in the dispute.
The Obama administration and the Pharmaceutical Research and
Manufacturers of America, the drug industry’s main lobbying group,
object to the section in the Indian patent law at issue in the case.
And perhaps fearful that the section might be adopted elsewhere,
Washington wants the nations negotiating a new Pacific Rim trade
agreement, the Trans-Pacific Partnership, to agree to grant patents in
situations similar to that involving Gleevec, according to a leaked
text of the government’s position.
Approved by the US Food and Drug Administration in 2001 after a rapid
review, Gleevec can cost $70,000 a year in the US, though the company
says it has programmes through which patients in poor countries can
get it for a hefty discount or, in some cases, free. Indian generic
versions cost about $2,500 a year. The drug, which is sold outside the
US by Novartis as Glivec and known generically as imatinib mesylate,
has turned deadly chronic myelogenous leukemia into a manageable
chronic disease for many patients. It is also used to treat a form of
gastrointestinal cancer.
India is the world’s third-largest drug producer by volume and exports
about $10 billion worth of generic medicines every year, more than any
other country, primarily selling to other fast-growing developing
countries that are expected to become significant new markets for big
drug companies. Doctors Without Borders says that 80 per cent of the
generic AIDS drugs it supplies to an estimated 170,000 people in
Africa and elsewhere are made in India.

India’s conflict
India’s conflict with western drug companies over patents dates to
1970, when the country stopped granting drug patents. India resumed
granting drug patents in 2005 as part of a World Trade Organisation
agreement on patents, but medicines created before 1995 did not
qualify. And that is where the disagreement arises over Gleevec.
The case before the Supreme Court involves a section in India’s patent
law that prohibits a newer form of a known substance from receiving a
patent unless it significantly improves the medicine’s ‘efficacy,’ or
effectiveness. The standard was aimed at preventing a practice known
as evergreening, in which a pharmaceutical company makes minor changes
to existing drugs and earns new patents, thereby providing many more
years of protection from generic competition.

“The implications of the case go to all medicines,” said Brook K
Baker, a professor of law at Northeastern University in Boston and a
policy analyst for the Health Global Access Project, which works to
improve access to HIV drugs. “The question is, do you get one patent
monopoly for the basic ingredient or do you keep tweaking it to get
more patents?”

Gilead Sciences, for instance, is appealing India’s rejection of a
patent application for its drug Viread, or tenofovir disoproxil
fumarate, which is used to treat HIV infection. And Roche is fighting
several court cases to uphold its patent on the anti-cancer drug
Tarceva, or erlotinib, that Indian drugmakers argue does not meet the
effectiveness standard.
Courts have allowed generic versions of that drug to be sold in India
while the case is being litigated. India’s patent law does not define
‘efficacy’ or say how it should be measured. Novartis is arguing that
the term should encompass modifications that might make a drug safer
or easier to use, not just more effective in treating a disease. It
says more than 40 other countries have granted a patent on Gleevec.
Novartis maintains that the current version of Gleevec is 30 per cent
easier for the body to absorb than an older chemical that it developed
but never marketed as a drug. The older compound was patented in the
US, Europe and elsewhere in the early 1990s, but not in India because
India did not allow patents on drugs at that time.
Paul Herrling, chairman of the Novartis Institute for Tropical
Diseases in Singapore, said this was not a case of evergreening
because the initial compound was never marketed or intended for
market. He said that when drug companies discovered a compound that
fits some specifications in a test tube or animal study, they patented
it to protect themselves from copycats.
But that initial compound is often not suitable for use as a drug
because it might not be absorbed into the bloodstream well enough, or
it might be chemically unstable, or unsafe. So, modifications are made
until a suitable form is found, and that new form is then also
patented. The US and European Union often grant patents for chemical
modifications of existing drugs.

Northeastern University’s Baker said a victory for Novartis would not
shut off the production of generic Gleevec or of other existing
generics, but could impede the ability of Indian manufacturers to
develop generic versions of future drugs. Pharmaceutical companies
“want India shut down as a place that can make early versions of
generic medicines that can compete with them,” he said.
Novartis executives argue that a victory for it will not have the
far-reaching consequences that its opponents claim because there are
other legal ways for generic and subsidised brand-name drugs to reach
the poor. Herrling said Novartis was not dropping the case because,
“We wanted to have clarity about what kind of innovation is and is not
patentable in India.” He also contended that the outcome of the case
would have little or no financial impact on Novartis because India
accounts for a minuscule proportion of Gleevec’s sales, which were
$4.7 billion last year.
Shamnad Basheer, a law professor who has filed a friend-of-the-court
brief suggesting ways the effectiveness standard could be clarified,
said both sides of the case have valid points. It would be impractical
for drug companies to seek patents only after they have conducted
years of clinical trials that could provide definitive proof that
updated drugs work better than their older versions. At the same time,
he said, Indian lawmakers are rightly concerned about evergreening and
an efficacy standard that can protect patients and the country’s
generic-drug industry.
“It is important that the court take on the matter,” Basheer, a
professor at the West Bengal National University of Juridical Sciences
in Kolkata, said, “and interpret the law in a way that balances the
need for innovation against public health concerns.”


http://novartisboycott.org/petition

 

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