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August 15, 2007
Don't abuse patents: scientists
The public sector has a key role in drug R&D. Patenting minor changes to
extend monopoly prices spells misuse
By Dr. Brian Druker
In the recent debates on patents, pharmaceutical prices and access to
essential medicines, the critical role of scientists and resources of the
public sector and academic institutions involved in medical research have
often been overlooked. As one of the scientists behind the development of
the medicine "imatinib" (marketed as Glivec by Novartis), which has allowed
the effective control of a devastating form of cancer, I have witnessed the
vital role that academic researchers and public institutions play in
bringing new medicines to the market.
Many scientists, if not most of those I have collaborated with in these
settings, are engaged in research primarily motivated by the pursuit of
knowledge as a means to help patients. For many of these scientists it is,
therefore, of great concern that the results of their efforts can't reach
patients and save lives because of pricing strategies and patent policies
such as "patent evergreening" (minor changes to existing molecules designed
to extend patent monopolies) used by partners further down the drug
development process.
Chronic Myeloid Leukaemia (CML) is a disorder of blood cells that
transforms through an "accelerated phase" to an invariably fatal leukaemia.
Imatinib has radically improved the success of treatment for this disorder
and patients treated with the medication can retain a high quality of life.
The development of this drug is a journey in scientific discovery that
highlights the collaborative and open process of innovation, where both the
private and public sectors play an indispensable role. The marketing
approval of imatinib was the result of research conducted over decades,
marked by international collaboration of scientists from different academic
institutions and the private sector.
The basic research that led to the identification of enzyme inhibitors for
CML dates back to 1960 with the identification of the Philadelphia
chromosome in patients with CML by researchers at the University of
Pennsylvania, Peter Nowell and David Hungerford. In 1973, Janet Rowley at
the University of Chicago determined that the abnormal chromosome was due
to a translocation of genetic material. In the 1980s, several labs,
including my own, played an important role in showing how the Philadelphia
chromosome produced a cancer causing protein (Bcr-Abl). This research also
clearly suggested that the selective blockade of the Bcr-Abl enzyme could
provide a means to control and prevent the progression of CML.
In the late 1980s, I began collaborating with industry scientists at
Ciba-Geigy (now Novartis Pharmaceuticals) who were developing inhibitors
for the class of enzymes to which Bcr-Abl belongs. Both the scientific
community and the pharma industry were highly sceptical of the utility and
selectivity of these enzyme inhibitors, and interest was limited. Despite
this, I suggested that the CML enzyme (Bcr-Abl) would be an ideal target
for therapy.
In 1993, I moved to Oregon Health Sciences University in Portland and had a
single goal of finding a company that had the best inhibitor for Bcr-Abl
and to bring it into clinical trials. My work in Oregon on a therapy for
CML was primarily funded by public sources, particularly the National
Cancer Institute. My persistence with scientists at Ciba-Geigy (now
Novartis) helped to keep the development of imatinib on their agenda
despite uncertainty from product managers. As imatinib progressed through
early and late clinical trials and demonstrated outstanding results,
scientific and media interest in our discovery increased. The approval of
imatinib by the FDA in May 2001 for use in CML was the culmination of a
10-year project for me, something I had dreamed of since medical school.
However, the price at which imatinib has been offered for sale by Novartis
around the world has caused me considerable discomfort. Pharmaceutical
companies that have invested in the development of medicines should achieve
a return on their investments. But this does not mean the abuse of these
exclusive rights by excessive prices and seeking patents over minor changes
to extend monopoly prices. This goes against the spirit of the patent
system and is not justified given the vital investments made by the public
sector over decades that make the discovery of these medicines possible.
Public institutions around the world have continuously played a critical
role in the research that leads to vital new medicines reaching the market.
Without access medical research becomes a luxury good. Most of my
colleagues would be very uncomfortable if we felt that this would be the
result of our decades of effort.
Brian Druker, chair of Leukemia Research and professor of medicine at the
Oregon Health and Science University Cancer Institute, is recognized as the
key researcher behind the discovery of STI571 or imatinib (marketed as
Glivec by Novartis). Comment at theirview@livemint.com
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