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Background
Adequate funding of key government agencies such as the Patent and Trademark Office (PTO), the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) is inextricably linked to create the necessary pipeline for continued advancement in cutting edge biotechnologies. The pipeline for innovation begins at the NIH, where biotechnology discoveries arise from NIH funded research. Breakthrough discoveries are then filed before the PTO for intellectual property protection. It is this intellectual property protection that provides incentives for transfer of technology to the private sector and eventually makes the path through the regulatory review process at the FDA. After the long arduous regulatory reviews, one out of five life-saving therapeutics is approved for marketing. Adequate funding of these key government agencies will ensure the security of the biotechnology industry's investment in research and development of life-saving therapeutics. There are currently more than 100 biotechnology drugs and vaccines approved by the FDA but with more than 350 in the pipeline the biotechnology industry is in need of adequate funding for these crucial agencies to help bring those drugs to patients who so urgently need them. In recent years, the lack of adequate funding for these agencies has begun to create government "choke points" for the pipeline of our growing industry.
BIO Position on PTO Appropriations
The PTO is a fully fee funded agency whose funds in the past have been siphoned off for non-PTO programs. The PTO's customers are entitled to receive the best services the agency can provide for the fees they pay. Therefore, a fundamental change in the method by which the PTO is funded is needed. The change is the establishment, by statute, of the principle of no diversion of the fees. With no diversion, the PTO would have access to the fees paid by its customers to process their work, while at the same time continue effective oversight by the Administration and Congress. BIO advocates a permanent end to this diversion.
- BIO letter (1.48 MB PDF) to J. Dennis Hastert (November 5, 2001)
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