Patents are given to protect
the interests of the inventor(s) for a period of 17-20 years and the patent
shall not be exploited or copied by anybody else during this period for commercial
purposes. It is expected that this period gives enough time to realize the
value of the invention/patent. Pharmaceutical companies which own patents for
new drug molecules enjoy an exclusive marketing right during this patent period
and usually some such drugs become block-busters for the company. Drug
discovery is expensive and time consuming.
Unless the new drug fails in
the market due to unexpected fatal side effects, the company makes a premium in
the first few years of sales. To maintain a monopoly on the drug and prevent
other companies from introducing similar or better drugs many companies have
resorted to what is called “ever-greening” of block buster drugs. This means
the original drug molecule is re-patented claiming under the existing patent
law, some unique features and presumed benefits, the sole intention being to
extend the monopoly on the original drug.
This practice is in vogue in
many advanced countries and hence it is possible to “ever-green” and to extend
monopoly on the original drug, albeit under a new “dress-up”. India is
extremely good in reverse engineering and it showed the world how basic
chemistry skills could be used for the benefit of the (economically poor)
society. Till today, India is the largest manufacturer and supplier in the
world of drugs which have gone-off patent (the generics), the largest
beneficiary being HIV-AIDS patients in the world. Indian companies ventured to
extend this strategy for anti-cancer drugs, the costs of which are prohibitive
throughout the world. This practice is being opposed by the patent holding
companies. In 2005 our parliament introduced Indian Patent Act with some
modifications to protect the interest of the poor people. One such modification
introduced as section 3(d) emphasizes that “mere discovery of a new form of a
known substance which does not result in the enhancement of the known efficacy
of that substance” is not an invention — for the purpose of patenting.
The Swiss pharmaceutical
giant, Novartis, has been fighting a case, for seven years now, against
Government of India and other stakeholders for the anti cancer drug the beta
crystalline form of “Gleevec” or “Glivac” as superior and better compared to
originally patented as Imatinib mesylate. No data was submitted to substantiate
“better or improved therapeutic efficacy” and hence the Supreme Court rejected
the petition and denied patent to the newer version. This is a landmark
judgment and it will open the gates for Indian pharmaceutical companies to go
for generic version of all off-patent drugs and make them affordable to the
society. The generic version of the drug Glivac is made available by Indian
pharmaceutical company at “a tenth” of the cost to the patients. The cry of
“end to R & D”, “drug discovery”, “innovation” have no basis and on the
contrary this judgment will ensure that money is spent on original inventions
and entirely new drugs and not on frivolous claims on existing molecules for
newer specifications. Many countries, I am sure, will follow India in this and
make drugs affordable to poor people in their country.
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