The
landmark judgment by the Supreme Court of India on 1 April,2013 was a major
blow for the Swiss pharma giant Novartis. The court rejected its plea for a
patent on a blood cancer drug Glivec, and the judgment will pave the way for
Indian firms to provide affordable drugs to lakhs of cancer patients in the
country.
The
Supreme Court's decision has came up as great shock to pharma MNC companies. This decision taken by the Supreme Court will give a
boost to the Indian pharma lobby. It's a great decision taken by the SC and
will definitely result in a positive effect on the country's health care
sector. The
fight is not between Novartis and the SC but between people of the country and
the people of the third world nation and the monopoly of the entire pharma MNCs.
lobby.
The All India Drug
Action Network (AIDAN) also welcomed the judgment of the Supreme Court. Dr.
Gopal Dabade, co-convener of AIDAN, told, “I am very thrilled with the
judgment. In fact, I was waiting for such a decision for a long time. Not only
India but all the developing countries in the world will be
benefited with this decision. He further said that, “The MNCs have
started disinvestment from 2000 onwards as they are demanding equal drug price
globally, so this decision will not effect everyone.”
R&D in India will also not get affected as the research starts at public institutions, and the pharma companies just formulate it into a medicine and market it. Imatinib mesalyte (Glivec), the drug in question, is a very important medicine to treat a type of blood cancer. A patient suffering with this type of blood cancer needs to take this medicine life-long. As this medicine is very essential, it is critical to make it affordable for patients. But Novartis wanted to have an absolute monopoly of the drug so that it can dictate its price. But the patent application was rejected by the SC on the grounds that it was not an innovation.
Apart from this, Novartis also
challenged the provisions like Section 3(d) of the Indian Patent Act. This act
was designed to safeguard the laws and also to prevent companies from abusing
the patent system. Section 3(d) of the Indian Patent Act, prevents companies
from gaining patents on modifications to existing drugs, in order to gain
indefinite, interminable monopolies, reported Doctors without Borders.
India is still a developing
country, and there is large population in the country who are in need of such
intervention and medication. A major battle has been won in this context
following the Novartis verdict. But now the danger is from the multinational
drug companies, as they will try to push in fresh agendas through other
strategies. Like the one they are currently trying - by means of bilateral
trade agreement. Eternal vigilance seems to be the only solution in this battle
to save millions of lives.
Before India was
compelled to comply with the Trade-Related (Aspects of) Intellectual Property
Rights (TRIPs) by January 1, 2005, the so-called pro-market economists, while
trying to calm our frayed minds, wrote little about the situation in
the US, the epitome of capitalism. They didn’t let us know that the Americans
were gasping under skyrocketing healthcare costs, attributed to the rising
prices of prescription drugs. There was debate all over the US on the
legality of drug re-importation from Canada. The news on the high costs of
HIV/AIDS drugs in countries of sub-Saharan Africa, with HIV infected people
constituting more than 25 per cent of the adult populations, where people were
— and are — dying despite the medicines available for the disease’s treatment,
was being played down. Pro-market Indian economists were; instead, trying hard
so that the pharmaceutical and biotechnology companies, guilty of monopolizing
life-saving drugs, don’t appear like villains.
Because pro-market economists were then — after the Madras High Court rejected Novartis AG’s plea to declare Section 3 (d) of the Indian Patents Act as incompatible with TRIPs, they have tempered down their rhetoric — as starry-eyed about anything American just like Marxist economists are still romantic about anything Soviet. Full explanations of the implications of the US law on patents would have at least made Indians desist from the delusions of a balanced regime post-2004. The law grants the patent owner "the right to exclude others from making, using, offering for sale, or selling the invention throughout the United States or importing the invention into the United States" for a period of 20 years beginning from the filing date of the patent application.
This means time-bound monopoly on the
patented invention. The inventor can collect monopoly rents on sales of his
product until the patent expires. And this inefficiency is justified with the
law’s logical converse: The inventor says, "If you don’t protect my
invention, I will simply not invent."
Agreed, bringing certain medicines to the
market may need a massive capital investment, especially for R&D. A lot of
money that is spent can’t be ’seen’: To know that a new drug works and is safe
on patients — human beings can’t be treated like guinea pigs — they must be
subjected to extensive laboratory tests and costly clinical trials. Further,
whenever an experiment fails, all the money that went into it is, in a way,
wasted. Given this scenario, a businessman can’t be expected to invest in a
project like this without being assured of a Government-granted cushion of, at
least, a limited monopoly. But then, such scientists-turned-entrepreneurs must
stop the pretension of serving science and humankind.
Of course, the 1970 Indian Patent Act cannot
be supported absolutely either. It simply prohibited the granting of patents on
pharmaceutical products. In a country where academic education is still about
cramming and passing exams, this law further guaranteed intellectual lethargy.
Between 1970 and 2004, some 16,000 copycats sprouted all over the country to
develop generic versions of medicines that were painstakingly invented abroad.
They reverse-engineered — that is, determined how the drug compounds were made
by foreigners — and rehashed the ingredients for mass production. Since that
entailed minimal R&D, the Indian versions became, obviously, dirt-cheap.
But eventually the Uruguay round of the General Agreement on
Tariffs and Trade (GATT) giving way to the World Trade Organization
(WTO), and India’s membership
thereof, played spoilsport. India
and other developing countries were served the deadline of January 1, 2005, to
adopt an intellectual property regime that mimicked the corresponding system of
much of the developed world, including, most important of all, the 20-year
patent rights on pharmaceutical products.
The other half-truth capitalists forwarded
was that the prices of some drugs would fall as much as those of others would
rise. We know now that only the second happened. Let alone ’rich man’s
diseases’, the laidback Indian industry did not even try to cure malaria and
tuberculosis, which affect mostly the poor in large numbers, with any new
medicine.
The allaying of fears of drug prices shooting
up was faulty to start with. First, product patents mean that generic companies
are no longer able to market a drug simply by developing a new manufacturing
method. Naturally then, there is no competitive pressure on a drug until its
patent expires. Without competing brands, therefore, the drug prices can only
increase.
And what was the fault in the argument that
the drugs whose prices would drop would shockproof those that shot up? Well, India could not be forced to amend the
Patent Act with retrospective effect. Therefore, drugs those were already
patented elsewhere and were being produced generically before the Amendment of
the 1970 Act, remains unprotected by patent in India. Medicine for pneumonia was one such
case. But the population of pneumonic patients is minuscule as compared to that
of malaria and tuberculosis patients. This statistic underscores the blunt
truth that the capitalist economists were manipulating laymen’s minds.
Further, the West already had decades of
experience of playing in the patents market. They have the clout to remain the
masters of the market, and thus dictate drug prices at will.
That does not mean that January 1, 2005 was a
quantum jump into an unknown regime for India.
Though Articles 27-34 of the WTO Agreement made compliance to TRIPs mandatory
for us as a signatory country, before allowing product patents, we had an Act
permitting exclusive marketing rights for new products between 2000 and 2005.
That statute, despite making India comply with Articles 70.8 and 70.9 of
TRIPs, did not prevent the marketing of generic copies under different names.
The Government also put in place a ’mailbox provision’ for the filing of
product patent applications during the transitional period of 1995-2005; such
applications could be filed during this time, but patents was not being granted
on these inventions until 2005. This means that the Indian firms in slumber,
too lazy to innovate, were not jolted out of their sleep into a new world suddenly
on January 1, 2005 morning. They knew they had this coming for 10 long years.
Finally, it is the plight of patients that
must count. It may have become unfashionable to dispute the ’legitimate right’
of the market to dictate our lives after the ’Chicago school of economics’, as
it has come to be known, gained popularity about two decades ago. But for once
we must put our foot down. The desire of a human being to live is not
consumerism. It’s a stronger argument than the market’s ’legitimacy’, of which
the drug monopolists themselves refuse to be a part.
This is one field where Government
intervention is a must — not to pamper lazy Indian pharmacists, but to save
poor Indians from dying without treatment. When India had passed the Patent Act in 1970, it
also instituted a Drug Price Control Order (DPCO). Then having observed the
unfairness of controlling the prices of all drugs, it started deregulation.
Yet, the prices of about 75 essential allopathic compounds remained under
Government control. This regulation must be extended to new drugs that are
patented and approved for sale after 2005.
Not only will this prevent unscrupulous
companies from cashing in on a dying person’s desire to live, it will also
serve a notice to the lazy Indian biotechnology industry. To allay the fears of
innovative foreign companies, the Government must, at the same time, assure
them that the drugs whose prices are regulated for the developing countries
will not be allowed to sneak into Europe and the US to
be sold with huge profit margins.
And yes, this policy must apply only to
emergency situations, covering fatal diseases like cancer and AIDS.
Many organizations in India strongly support
the Supreme Court decision to uphold access to essential medicines and deny
patent protection to dummy innovations as claimed by Novartis. Novartis had
sought a patent for Imatinib (brand name Gleevac or Glivac) which noted lawyer
and UN Human Rights Commissioner Anand Grover said was the same molecule with
little 'tweaking'.
The cost of this drug is INR 120,000 per
month for blood cancer (leukemia) patients. After Supreme Court ruling, the
price of the drug may fall steeply from INR 120,000 to perhaps INR 8000 – this
is a huge step forward in terms of advancing access to essential medicines and
also in protecting public health from interference from profit-driven
corporations and markets.
According to MD Ranjit Shahani of Novartis,
“The decision taken by the Supreme Court of India will discourage innovative
drug discovery. We give 95% of Glivec free to patients prescribed for CML
(chronic myeloid leukemia) in India and the balance 5% are on a generous co-pay
programme. The greatest loss here is to patients who suffer from
life-threatening illnesses and are in need of new treatment options. India can
have a much more powerful future if only we foster an environment that
encourages innovation. Patents are the lifeblood of innovation and medical
science will not progress if we destroy that. Patents, in fact, are the
lifeline of generics. Without innovation there will be no new medicines, and
without new medicines there will be no new generics.”
Further he added, “This ruling is a setback
for patients and will hinder medical progress for diseases without effective
treatment options. We should be more worried about what impact this will have
on patient well-being and the ability to address the challenge of unmet medical
needs. Meanwhile, all R&D investments in any case have moved to China with
seven global companies having invested billions of dollars after the patent law
was promulgated in India. These are Novartis, Roche, Sanofi, Pfizer, GSK, Astra
Zeneca and Eli Lilly. Not a single investment came to India - that speaks
loudly about the innovation ecosystem we have here.”
According to a news network the Pharma giant
hails the supreme court judgement in the US.The
pharma lobby railed against the decision but the overwhelming sentiment, from
physicians to politicians, from academia to media, particularly in a country
groaning from the high cost of health care, was that the Indian judiciary did
good by workaday people -- not just by the poor in the developing world but
also those struggling in the developed world.
Sometimes the behavior of large
multinationals seems to be similar to organized crime gangs. They are willing
to go to any extent to extract maximum benefits. I was watching TV news and one
group from abroad was telling the news channel that Indian Supreme Court didn't
understand meaning of innovation and patents. Such fools should be told that we
understand innovation and patents but we fail to understand the profiteering
that companies like Novartis are engaging in. Spending a few million dollars on
drugs (that too, many drugs are simply minor modifications of old medicines)
and then extracting billions of dollars in profits from poor patients is the
trademark of these companies. Supreme Court of India must be praised for taking
a clear stand on this case.
Many more players may enter the Indian
market. There may be additional executive pressure to segment among the big
drug manufacturing companies. Therefore, production may not be able to keep up
proportionately with internal demands. Neither the prices may remain stable.
The fact is that India is
first of all not China where the MNC patents are more or less protected.
India’s SC cannot so overtly deny a patent to a MNC no matter how urgent
internal situation be. The fact is that it is possible if and only if all get
benefited. Otherwise, the White House and
10 Downing Street may put executive pressure on 7 Race Course. But they don’t
do because theirs and other Western population also get benefited. The price is
lower for all consumers. The particular company Novartis may suffer some losses
but not all drug manufacturing MNCs.
The fact is that if the law be applied
consistently the SC verdict is not a wrong decision as it lets the big becoming
bigger. Surely in rarest of examples the SC verdict does not make small any
smaller. The middle classes and poor may get some reprieve but if Indian laws
are understood then the enhanced quality of treatment would require more money.
On the flip side the verdict may result in more production of fake drugs all
around the world but particularly in India. The rich would get world class
treatment, poor not much and the middle class may come somewhere in between.
This is the story of all of the Rest—class divisions would grow with time. The
value of moolah would increase.
It is a lesson for every company which wants
to indulge in ever-greening of patents. No doubt the credit has to be given to
the company which has strived hard in research and development and produced
answers to some of the dreadful diseases. However, the companies should also
understand that it is wrong to continue to have the patent rights forever. And
should not claim rights for small changes .
Ever-greening of patents is a complex issue where one can talk for or against the motion hours together. Finally, it is up to the law to decide. It is wrong to say that companies would not come forward to do research in India just because a case or two. I think the companies are smart enough to identify the rightful way to conduct research and churn money out of it.
Apart from all, things like Education and
Health Care etc. should not go purely in commercial terms. It should have the
charity spirit. Governments and organizations like W.H.O. should have lead in
all aspects of welfare subjects like Education and Health Care etc ; unlike the
Commercial organizations. Novartis like companies cannot be allowed to justify
the huge gap between price for its Imatinib mesalyte (Glivec) and the generic
drugs produce by Indian pharma in the name of funding research and extending
charity in its style. The said judgment of Supreme Court of India may be viewed
as statesman like act, as the governments and its heads supposed do for its
poor citizens. In the contrary the governments being roped in by the provisions
of World Trade Organization and imposed Intellectual Property Rights laws etc.
are acting as facilitator for such greedy commercial corporations, who are
marching ahead towards their goal to put the whole world under Economic
Imperialism in the name of DEVELOPEMENT.
Siddhartha
Shankar mishra,
Sambalpur
, Odisha