[Ip-health] Brian Druker (Glivec scientist): Don't abuse patents: scientists

Wed Aug 15 06:00:05 2007

<SNIP>

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

<SNIP>

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.

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http://www.livemint.com/2007/08/15003521/Don8217t-abuse-patents-sci.html

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

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 =91imatinib=92 (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=92t
reach patients and save lives because of pricing strategies and patent
policies such as =93patent evergreening=94 (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 =93accelerated phase=94 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 ofeffort.

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

---------------------------------
Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
voice +41.22.791.6727
fax +41.22.723.2988
mobile +41 76 508 0997
thiru@keionline.org