E-drug: Patent law
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[Copied as fair use. HH]
Patent law
Lancet 361, 9362, 22 March 2003
Sir--In response to Amir Attaran's criticisms of our report (Feb 15, p
613),1 we think that Attaran raises important issues, but our
interpretation of most of them is different.
Attaran's first point is that patents apply to individual products not
to a class, so they do not automatically create a monopoly. In
theory yes, but in practice no. Implementation of the patent system
in a situation characterised by market failure has contributed to
poor access to many drugs, even in developed countries. True price
competition is absent between patented products of the same
class, which effectively puts whole classes of new drugs out of
reach of many countries that do not provide drug coverage.
The point we were trying to make with esomeprazole is that
(effectively) it is omeprazole. It is the S-isomer. This case is a
classic example of evergreening. In our view, esomeprazole's
development as a so-called new product is an exercise in marketing,
not science, which is only possible with the current patent system
and in the presence of market failure. Development of this drug
means that large amounts of money were spent with no prospect of
great medical progress. Patents are being used to exploit the rather
naive belief of doctors, consumers, and the media in the value of
new drugs.
Attaran's third point is the much-debated issue of in-country
patents. Here, two issues are at work. The absence of patents in
small developing countries is unimportant if those countries cannot
import a low-cost generic version because of patent protection in
countries that have the capacity to manufacture generics. In the
African situation that Attaran discusses, patenting an antiretroviral
in large markets such as South Africa may effectively remove
incentive for generic manufacturers to produce and export to small
African markets that do not have patent protection. The second
issue is that when drugs are given the level of patent protection
they enjoy in lucrative markets, they are priced so that a very high
rate of return is guaranteed to manufacturers, and this conditions
future expectations of return on investment. Even large developing
countries may remain unattractive markets compared with North
America, Europe, or Japan. More competition in developed markets
and tighter margins--eg, by reduction of patent protection--could
force large international manufacturers to cut their high costs and
look at expansion of their markets in middle-income and low-income
countries.
We agree partly with Attaran's penultimate point: government
interventions modify the patentee's theoretical ability to set prices.
However, price controls are not solely used: the buying power of
government-subsidised programmes--coupled with sensible use of
reference-based price negotiations (or tendering)--provide some
countries with prices that are much lower than in the free market of
the USA.
Our response to Attaran's last point is that no one perspective can
cover all dimensions of these complex issues. Patents are not the
sole problem: the way they have been granted and used has led to
the mess we are in.
David Henry, Joel Lexchin
School of Medical Practice and Population Health
University of Newcastle, NSW 2298, Australia (DH)
and
Department of Family and Community Medicine
University of Toronto, Canada (JL)
(e-mail:mddah@mail.newcastle.edu.au)
1. Attaran A. Physicians and patent law. Lancet 2003; 361:
613-14.
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