[A2k] Paul Herrling in Nature: Patent sense

[Thiru Balasubramaniam]

http://www.nature.com/nature/journal/v449/n7159/full/449174a.html


Outlook

Nature 449, 174-175 (13 September 2007) | doi:10.1038/449174a;
Published online 12 September 2007

Neglected Diseases

Patent sense

Paul Herrling1


Protecting intellectual property saves lives in the developing world,
argues Paul Herrling.

Many diseases are endemic in the developing world, yet for a number of
these there are few safe and effective treatments. This lack of
medicines results from an industrial model that has been in place for
more than 50 years. Basic scientific research carried out in the public
sector is translated into life-saving medicines mainly by
pharmaceutical companies. This is a lengthy, onerous and expensive
process =97 taking about 15 years and costing hundreds of millions of
dollars per drug =97 and comes with a high risk of failure. Nevertheless,
more than 90% of new molecular entities discovered and developed as
medicines between 1990 and 1999 originated from pharmaceutical
companies1, 2.

Drug firms may be the main source of new therapies, but they remain
commercial entities that can invest the considerable resources required
to translate basic science into an effective medication only when there
is a reasonable chance of financial return.

There is little opportunity to get an adequate return on investment for
infectious diseases such as tuberculosis (TB), dengue fever, malaria,
leishmaniasis and African trypanosomiasis (sleeping sickness), which
mainly affect people living in resource-poor regions. In other words,
market mechanisms fail in these cases, and there is insufficient
drug-discovery research and development (R&D) for these common
infectious diseases.
No secrets

Some organizations interested in improving access to medicines in the
developing world, such as M=E9decins Sans Fronti=E8res and Oxfam, think
that a major impediment to affordable medicines is the patent system.
But this is not the case. This system protects intellectual property in
countries whose economies are based, to a large extent, on innovation.
A patent is defined as a grant by the state of exclusive rights for a
limited time in respect of a new and useful invention. These rights
usually imply that, for a limited time, only the innovator, or a person
or entity licensed by the innovator, can sell products based on the
invention. This offers the innovator an opportunity to recover the
investment needed to develop the invention into a practical product.
Without this incentive, important discoveries would never be developed
into useful products. Modern patent law provides protection for 20=9625
years, which should be compared with the 15 years, on average, needed
for the discovery and development of a new drug. In return for these
rights, the innovator discloses a description of the invention that
allows other experts to reproduce the key findings. This process is
firmly based on the premise that knowledge is gained only through a
full understanding and appreciation of previously published advances.

In the absence of a patent, the only way inventors can protect their
inventions is throughtotal secrecy, which is counter to furthering
innovation, a fact often ignored by those who consider that patents
prevent research. It is only when patents are used excessively to
protect information =97 to the extent that researchers cannot use a
patent-protected invention in their studies =97 that the system is a
considerable barrier to further innovation. To prevent such abuse of
patents, several countries have implemented the 'research exemption',
which allows scientists to use patent-protected technology freely for
their research provided they do not exploit it commercially. In light
of these issues, the protection of intellectual property with patents
is crucial for pharmaceutical companies to discover and develop new
drugs for the developing world.

Neglected no longer

In the past decade or so, the drug industry has formed partnerships
with the public sector, generating pipelines of early-stage potential
medicines for certain neglected diseases. These partnerships include
the Global Alliance for TB Drug Development, the Drugs for Neglected
Diseases Initiative (DNDi) and the Medicines for Malaria Venture. In
2004, 63 new drugs were being pursued by this approach3.

Most of these drugs originate from R&D programmes in pharmaceutical
companies and are patented accordingly. But these patents are not used
to enforce unaffordable prices in the developing world or to prevent
manufacturers from selling generic versions of these drugs in
developing regions.

An example of this is Coartem, an artemisinin-based combination
therapy. One of the most effective treatments for malaria at present4,
Coartem is included on the list of essential medicines by the World
Health Organization5. One of its components was discovered by Chinese
scientists, and this was then clinically characterized, and developed
and produced as a combination therapy, by Novartis. Coartem is patented
in 49 countries but is available at cost price to patients in all
countries in which malaria is endemic. In 2006, Novartis delivered more
than 62 million treatments of Coartem to more than 30 countries at cost
price. A generic version of the drug is being manufactured by Indian
pharmaceutical companies and sold in the developing world.

Another example is a new artemisinin-based combination therapy for
malaria, developed by sanofi-aventis in collaboration with the DNDi.
This treatment, also on the World Health Organization's list of
essential medicines5, will be available in most of sub-Saharan Africa
next year. Sanofi-aventis has set aside its patent rights and will
supply the medicine at cost price to the poorest populations in
countries in which malaria is endemic.

In general, drugs developed by pharmaceutical companies as part of
public=96private partnerships are patented by industry, as it is the
discoverer. But they are exclusively licensed for treating neglected
diseases in agreements stipulating that the drugs will be available at
cost price to the developing world.
Necessary system

So why are patents even necessary? There are three main reasons. First,
commercial entities, including drug companies, can allocate resources
to non-profit projects only if they are financially sound. Research-
and innovation-based companies earn sufficient returns on their R&D
investments only if they are permitted a marketing-exclusivity period =97
accorded by patents =97 for their innovative products. In countries
without this protection in place, the drug industry is not research
intensive and innovation based. Indeed, this was the case in India
while there was no patent protection for new pharmacologically active
molecules.

The randomness of evolution provides a second reason for patenting
drugs for neglected diseases. Nature does not distinguish between the
biology of diseases of the poor and the rich. So therapeutic molecules
or pathways that are targeted by drugs for neglected diseases might
also be relevant for treating diseases that affect people in more
affluent regions. For example, the Novartis Institute for Tropical
Diseases in Singapore takes all molecules that have activity against
dengue virus and systematically tests them against the West Nile and
hepatitis C viruses, which belong to the same family as dengue and
cause disease also in developed countries. If a molecule has activity
against dengue virus or another family member, it is developed and
patented. Considerable financial returns could be generated in the
developed world, and a portion of these is earmarked for refinancing,
and for providing long-term sustainability to, the institute's
non-profit initiatives.

A third reason to patent such drugs relates to emerging economies such
as those of Brazil (see page 180) and India. In these countries, there
are populations of very poor patients, and the non-profit model would
certainly apply. But in the same countries, there are growing numbers
of more affluent patients, who are increasingly able to buy their
medication, either directly or through health insurance. For these
patients, the company that developed the medicine could expect to
generate revenue as a result of patent protection. Such differential
pricing within a country (see page 176) would encourage further
innovation not only by global companies but also by local enterprises.
This model would require legislation that prohibits copying before
patents have expired but that allows generic-drug production after
patent expiry.

For the foreseeable future, the discovery and development of new
medicines will be driven almost exclusively by commercial
pharmaceutical companies. The only way that these firms can remain
viable is through a robust intellectual-property protection system.
This system, therefore, contributes to saving lives. Without it, there
would be few new drugs for any disease, regardless of whether it
afflicts the rich or the poor.

# Reichert, J. M. & Milne, C. P. Am. J. Ther. 9, 543=96555 (2002). |
Article | PubMed |
# DiMasi, J. A., Hansen, R. W. & Grabowski, H. G. J. Health Econ. 22,
151=96185 (2003). | Article | PubMed | ISI |
# Moran, M. PLoS Med. 2, e302 (2005). | Article | PubMed |
# Mutabingwa, T. K. et al. Lancet 365, 1474=961480 (2005). | Article |
PubMed | ISI | ChemPort |
# World Health Organization Model List of Essential Medicines.
http://www.who.int/medicines/publications/EML15.pdf (2007).

Paul Herrling is head of Corporate Research, Novartis International,
Basel, Switzerland.



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Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
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