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Warning: Research Dollars At Risk!

By Richard J. Warburg and Stephen B. Maebius
April 01, 2003

Before the clinical trials are run, before the Food and Drug Administration approves, before hope is held out to millions of patients, new drugs start with scientists asking elemental questions about human life. Now, the pipeline that leads from their laboratories through drug development to the FDA may be shut off at the source.

Contrary to the interests of everyone, the monies that fund small biotechnology companies and university labs could dry up. The villains are a few seemingly unrelated judicial decisions and the increasing complexity of biotech research itself. Together, they may serve to discourage the basic science on which medical advancement depends. Biotech companies anchor one end of the pipeline that produces new drugs. Along with major universities, they perform the risky experiments that lead to possible breakthroughs in medicine. They also develop the cutting-edge tools that permit this research, such as screening methods for new chemicals that might be transformed into medical cures, and computer programs to better design those chemicals. Then, their patented ideas are licensed or sold to the large pharmaceutical companies. The strength of “Big Pharma” lies in refining those research results into the next generation of medical treatments and devices – and then selling them. To keep the new drugs flowing, therefore, it is critical that patent law and practice support the ability of biotech companies and universities to stay in the lab. Unfortunately, the balance between the needs of patent holders and researchers may be upset.

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