How long back would you have to look if you wanted to find the
link between patents and politics? Probably at the very inception
of patents. The linkage between the two can be traced to the first
letters patent granted by royal decree. When patent rights were
born, they were translated by the political will of the monarch. In
the 1990s, when the Agreement on Trade-related Aspects of
Intellectual Property Rights (TRIPS) was signed, world politics
stood divided between developed vis-à-vis developing and
least developed countries. Amid a lot of upheaval an uneasy treaty
forged its way ahead.
Free patent years
In the 1970s India had a free patent regime which, combined with
drug price control, kept drugs at reasonable price. Post the
signing of TRIPS in 1995, India was given a transition period of 10
years to become fully compliant in view of its status as a
developing country. This 10-year period paved the way for the
Indian pharmaceutical industry to flourish.
India reverse engineered foreign patented drugs without
licensing and was able to make less expensive copies (aka generics)
of the world's best-selling patent protected drugs. India now
is the top supplier of generics. This transition from virtually
non-existent to a leading drug manufacturer happened over these
free patent years.
The protection debate
On the flip side patent protection of drugs and medicines is
accorded a special status in the pharmaceutical industry because of
the very fact that drugs and medicines can easily be reverse
engineered or imitated and all the major research and development
spending and the high risks associated with the development of a
new drug will flow down the drain. The innovator companies contend
that exclusive patent rights and the resulting high prices are
required for pharmaceutical companies to recoup the large
investments needed for research and development.
The developing countries argue that poor people in both the
developed and developing world cannot afford the high prices for
patented drugs that the innovators charge. Another allegation is
that pharmaceutical companies direct their patents towards
incrementally improving treatments for diseases prevalent in
wealthy countries and away from diseases that cause devastation in
the developing world.
Finding a balance
Public opinion swings like a pendulum unable to find balance.
Allegations and counter- allegations both from innovators and moral
police cloud the real picture beyond recognition.
There have been public campaigns for improving access to
medicines. India being a socialist and a developing country was
bound to be pulled into this quagmire. As Bloomberg
Businessweek rightly wrote "only lawyers win in patent
wars." A middle path needs to be carved.
There has been overwhelming public concern for "preventing
the over-reach" of intellectual property protection including
patent protection, and "to retain a public balance in property
rights". There has been hue and cry from the generics world
that through a stringent patent regime a patent holder would be
able to prevent all generics manufacturers that might have been
able to make the drug available in the market at affordable
The outright ousting of patent rights in India may encourage
bulk generic drug production at cheap prices, but generic drugs
will not result in the development of new and more effective drugs
and by not acknowledging innovation India would run the risk of not
having access to future medicines, which would in turn affect
Denying patents and allowing the generic companies to freely
copy new drugs cannot be the solution to deliver medications to
patients too poor to buy them. The generic drugs intended for the
poor may be frittered away by way of re-imports. In the long run it
is the introduction of product patents which will help in
development of new and more effective drugs.
The fact remains that both the innovator companies and the
generics makers are in the market for profits. Any philanthropic
gesture will only be to a limited degree. However, the
pharmaceutical industry, both innovators and generics, owes moral
responsibility to the society. Therefore the exclusivity granted by
patents to the drug companies should be exercised with
The standard set out in the Doha Declaration on TRIPS and public
health is "access to medicine for all". This standard has
to be upheld by India. The government needs to ensure a reliable
system that delivers cheap medicines to the poor, as intended.
India has to safeguard not only its people and generics but also
its reputation for upholding IP rights. We may consider using
differential pricing and parallel imports to provide medication to
the poor without compromising on innovation.
Originally published November 2013.
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The Patents Act 1970, along with the Patents Rules 1972, came into force on 20th April 1972, replacing the Indian Patents and Designs Act 1911. The Patents Act was largely based on the recommendations of the Ayyangar Committee Report headed by Justice N. Rajagopala Ayyangar. One of the recommendations was the allowance of only process patents with regard to inventions relating to drugs, medicines, food and chemicals.
An Invention Disclosure Form is the documentation of the invention. This is a means to document particulars of your invention and submitting it to the patent attorney who is filing your patent application.
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