IN a move designed to give the American biotechnology industry a much needed fillip, the US Patent and Trademark Office has decided to relax the requirements for granting patents to drugs produced by biotechnology.
Under US patent law, an invention must be shown to be 鈥渦seful鈥� before it can be granted a patent. In the case of drugs produced by biotechnology, the PTO has insisted that 鈥渦sefulness鈥� could be proved only by conducting expensive clinical trials in humans. Under the new rules, companies or researchers can apply for a patent based on the results of in vitro tests or tests on animals, which are quicker and cheaper.
The change will remove a major obstacle to the development of commercial products, say industry officials. Under the old rules, biotechnologists were caught in an impossible position. Before they could apply for a patent, they had to conduct clinical trials. But until the drug was protected by a patent, investors were reluctant to put up the money for trials.
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鈥淲e were creating problems for the biotechnology industry,鈥� says Bruce Lehman, head of the patent office, who was appointed by President Clinton.
The change 鈥渟hould attract more investors and hopefully make those investors who are already in the game feel more secure鈥�, says Richard Burgoon, patent attorney at Cephalon, a biotechnology company in Pennsylvania.
While giving the industry a jump start, the move will not compromise safety, say government officials. The US Food and Drug Administration will still require human tests before approving a drug for routine medical use.
Burgoon says Europe has not insisted on clinical trials to establish the usefulness of drugs produced by the biotechnology industry. His company is developing a range of drugs to treat neurological diseases such as Lou Gehrig鈥檚 disease, narcolepsy and Alzheimer鈥檚 disease.
As an example, he says the new rules should speed up the patenting of drugs for Alzheimer鈥檚. Because there are no satisfactory animal models for Alzheimer鈥檚, the company will be able to apply for a patent on the basis of its results from test-tube experiments. 鈥淚t鈥檚 a real step forward,鈥� Burgoon says.