India’s Supreme Court to Hear Dispute on Drug Patents

Major case involving international patents in India due to be heard in Indian Supreme court.

MUMBAI, India — 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 recognize 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 Indian 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 drug
makers, and Indian drug companies and international aid groups, who
warn that a ruling in favor 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’s 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 drug makers. 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 United States, 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.

The decision could also help determine how much Western drug companies
invest in India at a time when they want to increase sales in emerging
markets to compensate for slowing business in the United States and
Western Europe.

Approved by the United States Food and Drug Administration in 2001 after
a rapid review, Gleevec can cost $70,000 a year in the United States,
though the company says it has programs 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 United States 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 percent of the
generic AIDS drugs it supplies to an estimated 170,000 people in Africa
and elsewhere are made in India.

India’s conflict with Western drug companies over patents dates to 1970,
when the country stopped granting drug patents. India resumedgranting
drug patents in 2005 as part of a World Trade Organization agreement on
patents, but medicines created before 1995 did not qualify. And that’s
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 H.I.V. drugs. “The question is, Do you
get one patent monopoly for the basic ingredient or do you keep
tweaking it to get more patents?”

Tahir Amin, a director of the Initiative for Medicines, Access and Knowledge,
a group based in New York that works on patent cases to foster access
to drugs, said several drugs for AIDS and other diseases have been
denied patents in India because of the clause and manufacturers might
benefit from a victory for Novartis.

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 H.I.V. infection. And Roche is fighting
several court cases to uphold its patent on the anticancer drug Tarceva,
or erlotinib, that Indian drug makers 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 percent
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
United States, 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 United States and European Union often grant patents for
chemical modifications of existing drugs.

Professor Baker of Northeastern University 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 subsidized brand-name drugs to reach the poor.

Dr. 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. So do
the countries that might receive generic versions of Gleevec exported
from India.

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,” Mr. 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.”

I am all for reducing the patent life to 5 years. After all the Pharma companies - for most part - jump in only at the clinical stage after BUYING the rights to the main invention from universities. Many of these "main breakthroughs" are achieved bcz of tax payer money.

Screw the Pharma companies.

Marathadi-Saamiyaar wrote:I am all for reducing the patent life to 5 years. After all the Pharma companies - for most part - jump in only at the clinical stage after BUYING the rights to the main invention from universities. Many of these "main breakthroughs" are achieved bcz of tax payer money.

Screw the Pharma companies.

University researchers don't have the money or the expertise to take a drug from the bench to clinical trials. Very few academicians do that. Patent rights for 'new drugs' are usually bought by the Pharma companies at an earlier initial stage. Or the Univ researchers form a start-up with their new found invention and raise capital through VCs or SBIR grants (which is Tax-payers' money).

Case in point is my drug which is clinical trial phase II. This big pharma company bought over the rights as soon as we filed the patent. They spent a lot of money to take it to this stage. They brought in a lot of expert help through consultants to help us and them file the necessary IND applications with FDA.

Pharma and Biotech (big ones) buy inventions from smaller companies at a later stage of development. These smaller companies have sufficient money to develop their inventions to a much later stage than Univ researchers.

You missed the main point in the article.

5-yr or 10-yr patent life is not the issue with Indian court. It is the 'evergreening' of the existing patents. I think Indian policy needs to change. This could be a victory for Novartis.

doofus_maximus wrote:

Marathadi-Saamiyaar wrote:I am all for reducing the patent life to 5 years. After all the Pharma companies - for most part - jump in only at the clinical stage after BUYING the rights to the main invention from universities. Many of these "main breakthroughs" are achieved bcz of tax payer money.

Screw the Pharma companies.

University researchers don't have the money or the expertise to take a drug from the bench to clinical trials. Very few academicians do that. Patent rights for 'new drugs' are usually bought by the Pharma companies at an earlier initial stage. Or the Univ researchers form a start-up with their new found invention and raise capital through VCs or SBIR grants (which is Tax-payers' money).

Case in point is my drug which is clinical trial phase II. This big pharma company bought over the rights as soon as we filed the patent. They spent a lot of money to take it to this stage. They brought in a lot of expert help through consultants to help us and them file the necessary IND applications with FDA.

Pharma and Biotech (big ones) buy inventions from smaller companies at a later stage of development. These smaller companies have sufficient money to develop their inventions to a much later stage than Univ researchers.

Thanks for agreeing to my basic point. The most fundamental work is done by the Universities, small companies (SBIR/STTR), and/or research organizations (MITRE/BMI) mostly through tax payer money. The pharma companies BUY these with their loot and make even more money for the next 25 years.

It takes just 25 to 40K to file a patent and most dont have that money with the fear of the patent failing to generate any funds. The Pharma companies treat this 40K as insurance money and spend away - and deduct from taxes as development money. IN FACT, THE GOVT and the PEOPLE OWN ALL THE RIGHTS.

Oor thengaiyE vaZhi pillaiyaarukku oDaicha Kadhai.

Marathadi-Saamiyaar wrote:

doofus_maximus wrote:

Marathadi-Saamiyaar wrote:I am all for reducing the patent life to 5 years. After all the Pharma companies - for most part - jump in only at the clinical stage after BUYING the rights to the main invention from universities. Many of these "main breakthroughs" are achieved bcz of tax payer money.

Screw the Pharma companies.

University researchers don't have the money or the expertise to take a drug from the bench to clinical trials. Very few academicians do that. Patent rights for 'new drugs' are usually bought by the Pharma companies at an earlier initial stage. Or the Univ researchers form a start-up with their new found invention and raise capital through VCs or SBIR grants (which is Tax-payers' money).

Case in point is my drug which is clinical trial phase II. This big pharma company bought over the rights as soon as we filed the patent. They spent a lot of money to take it to this stage. They brought in a lot of expert help through consultants to help us and them file the necessary IND applications with FDA.

Pharma and Biotech (big ones) buy inventions from smaller companies at a later stage of development. These smaller companies have sufficient money to develop their inventions to a much later stage than Univ researchers.

Thanks for agreeing to my basic point. The most fundamental work is done by the Universities, small companies (SBIR/STTR), and/or research organizations (MITRE/BMI) mostly through tax payer money. The pharma companies BUY these with their loot and make even more money for the next 25 years.

It takes just 25 to 40K to file a patent and most dont have that money with the fear of the patent failing to generate any funds. The Pharma companies treat this 40K as insurance money and spend away - and deduct from taxes as development money. IN FACT, THE GOVT and the PEOPLE OWN ALL THE RIGHTS.

Oor thengaiyE vaZhi pillaiyaarukku oDaicha Kadhai.

Pharma companies spend a lot of money on clinical trials of a drug.

Marathadi-Saamiyaar wrote:I am all for reducing the patent life to 5 years. After all the Pharma companies - for most part - jump in only at the clinical stage after BUYING the rights to the main invention from universities. Many of these "main breakthroughs" are achieved bcz of tax payer money.

Screw the Pharma companies.

this is what you said and I disagreed with you.

doofus_maximus wrote:

Marathadi-Saamiyaar wrote:I am all for reducing the patent life to 5 years. After all the Pharma companies - for most part - jump in only at the clinical stage after BUYING the rights to the main invention from universities. Many of these "main breakthroughs" are achieved bcz of tax payer money.

Screw the Pharma companies.

this is what you said and I disagreed with you.

I will let you and the Maulana agree with each other and rebond.....

Marathadi-Saamiyaar wrote:

doofus_maximus wrote:

Marathadi-Saamiyaar wrote:I am all for reducing the patent life to 5 years. After all the Pharma companies - for most part - jump in only at the clinical stage after BUYING the rights to the main invention from universities. Many of these "main breakthroughs" are achieved bcz of tax payer money.

Screw the Pharma companies.

this is what you said and I disagreed with you.

I will let you and the Maulana agree with each other and rebond.....

Hindutva idiots used to call Mulayam Singh Yadava Maulana Mulayam. People of UP kicked the hindutvas on their butts and made Mulayam CM of UP.

Rashmun wrote:

Marathadi-Saamiyaar wrote:

I will let you and the Maulana agree with each other and rebond.....

Hindutva idiots used to call Mulayam Singh Yadava Maulana Mulayam. People of UP kicked the hindutvas on their butts and made Mulayam CM of UP.

Is there any surprise that the UP wallas keep voting BSP and Mulayam alternately?

Just look at you.

Marathadi-Saamiyaar wrote:

Rashmun wrote:

Marathadi-Saamiyaar wrote:

I will let you and the Maulana agree with each other and rebond.....

Hindutva idiots used to call Mulayam Singh Yadava Maulana Mulayam. People of UP kicked the hindutvas on their butts and made Mulayam CM of UP.

Is there any surprise that the UP wallas keep voting BSP and Mulayam alternately?

Just look at you.

UP walahs voted for BJP also in the past but BJP betrayed the UP walah.