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IDMA BULLETIN
(Indian Drug Manufacturers Association)
Vol. XXXVI(40)
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PATENTS
The Prescription that changed practice
UNIQUE BENEFITS OF THE PATENTS ACT 1970
By Padma Bhushan Dr. R.D. Lele*
(Based on a lecture given on 5.10.05)
* The author is Hon. Chief Physician & Director, Nuclear Medicine Department, Jaslok Hospital & Research
Centre, Mumbai; Hon. Director of Nuclear Medicine & RIA Dept., Lilavati Hospital & Research Centre, Mumbai;
Emeritus Professor of Medicine (for life) & ex-Dean, Grant Medical College & Sir J.J. Hospital, Mumbai;
Dean (Academic), All India Institute of Diabetes, Mumbai
Unique benefits of the Patents Act 1970
Unique benefits of the Patents Act 1970
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Unique benefits of the Patents Act 1970
patent holder. It set us doctors free. For the Indian • India has become a major net exporter
industry and the Indian consumer this was a much- of pharmaceuticals. This was considered
needed shot in the arm. It changed the face of the impossible before 1972. It is India, which has
industry and the health of the nation. made a dramatic impact worldwide in the drug
treatment of diseases such as HIV/AIDS.
Many of us may not be able to relate to conditions
before 1970. Most of us are now used to the freedom • Over 95 percent of the drugs available today in
to prescribe the best drugs. We are confident that India are produced locally. For us doctors and
our patients can get their medicines at realistic for our patients, this means assured availability
prices. New generations of drugs help us to stay of the drugs we need at prices we can afford.
ahead in practice and patient care. In short, things • Among all drugs approved in the world, 90
are so healthy that we are not even bothered about percent are marketed in India. This is thanks to
something like patents. But we only have to peep our steady demand for the best and the latest,
into what is happening in other countries (even our the advances made in domestic research and
neighbours) to realise how much we owe to the manufacturing and, above all, the Patents Act
Patents Acts Amendment 1970 (see Table 1). 1972.
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Unique benefits of the Patents Act 1970
Amlodipine 10 mg of Pfizer is priced at Rs. Fact: The figure of $800 million is impressive but
7.20 per tablet in comparison to Rs. 1.00 per many believe this is highly inflated. Companies
tablet of other Amlodipine brands. have been known to pass off a number of
non-research expenses like opportunity costs
Also, in cases where there is no competition,
and marketing costs as research expenses.
the MNC prices are exorbitant and beyond the
Much of the new drug research is carried
reach of the Indian patient.
out by government-funded institutions
Xigris 20 mg (Eli Lilly) Rs. 54,450 per vial like universities and public hospitals. These
Pegylated Interferon Rs. 22,830 per vial institutions then transfer their almost-ready
30 mcg (Fulford) research to the industry.
Fentanyl 50 mcg (J&J) Rs. 710 per patch Also, a majority of new molecules invented
today are “me-too” ones and are mere molecular
Visudyne (Novartis) Rs. 72,500 per vial manipulations of existing drugs. Imipenem
was followed by meropenem and ertapenem.
• Argument: About 95 percent of the products
Lovastatin was followed by simvastatin,
marketed today are not covered by patents.
atorvastatin, rosuvastatin and pitavastatin.
Fact: According to the 2005 amendment, Omeprazole was followed by lansoprazole,
products patented internationally after January pantoprazole, esomeprazole and rabeprazole.
1, 1995 can only be marketed by the patent There are many more such examples.
holder in India. In times to come, several
new drugs patented after January 1995 will Do we believe that each such “me-too” molecule
be marketed only by MNCs. These drugs will also costs $800 million for their research and
enjoy monopoly rights and no Indian company development?
will be able to manufacture these products.
• Argument: Government has provided
Chances are because of resistance and other
safeguards to check drug prices.
reasons, these may be the very drugs that
Indian patients might require. Doctors may Fact: Under certain circumstances, the
have to limit themselves to what is available. Government can override the patent and grant
Patients may have to pay exorbitant prices for a licence for the compulsory manufacture of a
the products they need to keep good health. drug. Other safeguards include the provision
of Government intervention and price
• Argument: There are cheaper, alternative non-
negotiations. These safeguards appear adequate
patented drugs available to the patient.
in theory but history shows a different
Fact: As doctors we are aware of how bacterial picture. Various countries, which have similar
resistance can turn yesterday’s magic bullets provisions, have shown that these safeguards
into ineffective duds today. Over time, older are ineffective and impractical to implement.
drugs become less effective and there is a
constant need for new and more effective • Argument: The government is bound to
drugs. If new drugs are beyond the reach of the honour international treaties.
Indian patient because of high prices, physicians Fact: The new patent law is framed under the
will be forced to prescribe older generation World Trade Organization’s Agreement on
drugs. Patients will be deprived of new drugs Trade-Related Aspects of Intellectual Property
unless it suits the interest of the monopoly Rights (TRIPS). The government argues that
patent holder to make the drugs available at an the new patent law is necessary to honour our
accessible price. This is currently the situation commitment under TRIPS. Others counter
in all developing countries, except India. this by questioning why the Indian government
• Argument: The cost of R&D for a new has not done enough to use the flexibilities
molecule is in the region of $800 million and available under the same TRIPS. The agreement
hence the high cost of formulations based on should provide sufficient flexibility to tailor
the patented new molecules. the patent law to suit the country’s needs.
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Unique benefits of the Patents Act 1970
The Government should have provided for India is host to a number of life-threatening
automatic license of right of manufacture to diseases like TB, malaria, diabetes, asthma, AIDS,
someone other that the patent holder, with the cancer, cardiovascular disorders and other tropical
innovator guaranteed a royalty amount. diseases specific to our country. Many of us get to
see almost all of them within a single day. Imagine
• Argument: With its vast pool of scientific the plight of your patients who come back to you
talent and large force of skilled labour, India is because they can’t get or can’t afford what you
capable of inventing new molecules. have prescribed and what they need, as a result of
Fact: There is no doubt of India’s skills in the new Patent Act changes. A situation to be even
science. Possibly, there are already many more feared is the move to further tighten the laws
Indians making a significant contribution to to grant even greater monopoly e.g. scuttling out
path-breaking research in various laboratories the right to information and so on.
in the world. Innovators definitely deserve their The constitution of India guarantees THE RIGHT
rewards but is the Patents Act only for them? TO HEALTH. Non-access to vital and life-saving
Or is our priority to provide quality medicines drugs will be tantamount to genocide. We Indians
at reasonable prices to the less fortunate must resist all attempts to take us back to the old
millions? We do not have a well-organised monopolistic era.
medical insurance system. If we also take away
the competition, the very competition that has That’s the only way we can ensure the future health
been seen to bring prices down, can we expect of the nation.
the MNCs to safeguard the interests of the one
billion Indians? Can our public hospitals that
take care of our masses afford to buy highly
priced patented medicines?
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Unique benefits of the Patents Act 1970
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Unique benefits of the Patents Act 1970
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Unique benefits of the Patents Act 1970
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Unique benefits of the Patents Act 1970
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Unique benefits of the Patents Act 1970
Drug Unit price at launch Current unit price % fall in No. of manufacturers
in Rs. (as on) in Rs. price
Prostate
Bicalutamide 150 mg Tablet 90.00 (Sept. 2003) 35.08 61 2
Tamsulosin 400 mcg Caps 8.90 (June 2002) 5.31 40 8
Finasteride 5 mg Tablet 8.50 (Dec. 96) 6.60 23 6
Anti-allergic
Desloratidine 5 mg Tablet 3.60 (Nov. 2001) 1.99 45 15
Cetirizine 10 mg Tablet 3.00 (Aug. 93) 0.78 74 67
Anti-asthamtic
Montelukast 10 mg Tablet 24.00 (Feb. 2002) 10.50 56 5
Anti-cancer
Zoledronic acid 4 mg Injection 2800.00 (June 2003) 1400.00 50 5
Pamidronic acid 90 mg Injection 5200.00 (Mar 2001) 1800.00 66 6
Letrozole 2.5 mg Tablet 158.00 (April 2003) 6.00 100 4
Obesity
Sibutramine 10 mg Caps 15.00 (Dec. 2000) 7.50 50 8
Source: IDR–May/June 2005
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Unique benefits of the Patents Act 1970