Drug Patent Policies Blasted - C&EN Global Enterprise (ACS

Nov 6, 2010 - Drug Patent Policies Blasted. Kefauver committee hears proposals to curb patentability of drugs or abolish drug patents. Chem. Eng. News...
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GOVERN M ENT PATENT POLICY DISPARAGERS. Economics professors Dr. Fritz Machlup of Princeton (center) and Dr. Colston Warne of Amherst (right) confer with staff economist Dr. John Blair of the Kefauver committee at Washington hearings. Dr. Warne urged that all product patents on drugs be abolished

Drug Patent Policies Blasted Kefauver committee hears proposals to curb patentability of drugs or abolish drug patents Standards for patenting drugs were sharply criticized at hearings before the Senate Subcommittee on Antitrust and Monopoly. One witness even urged eradication of all product patents on drugs. The occasion was the second round of hearings on the patent provisions of S. 1552, Sen. Kefauver's drug control bill. Under this bill, minor modifications of patented drugs could not be patented unless they showed greater therapeutic effect. In addition, the bill would require licensing of all drug patents after three years. Patents Curb Research. "There are signs that drugs are being regarded as useful and therefore patentable without any objective and critical examination of their therapeutic value," said Dr. A. Dale Console, a former medical director of E. R. Squibb who now conducts a private medical practice in Princeton, N.J. As a result, he says, drug firms turn their research efforts to devising and patenting apparently different drugs which are virtually identical in therapeutic effect. 48

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According to Dr. Console, the present standard of patentability produces this sequence of events: A drug company develops and patents a new drug which turns out to be very profitable. Competitors put their research staffs to work devising their own versions of the drug. A point is soon reached, he says, where successive modifications represent no further improvement in utility. Yet, he adds, part of the industry's limited supply of skilled research workers continues to be directed to developing minor variants instead of being allowed to pursue more significant research. Patents on these compounds are not rewards for invention, he says. Such patents discourage research and invention by offering short cuts to commercial success. Since these short cuts are relatively risk free, he says, they will be selected, when commercial success is the primary goal, in preference to the greater risk of significant exploration. Molecule manipulation is indispensable in drug research and is properly

used when the goal is a significant improvement over the parent drug. But, he adds, the method is easily abused; the ease of obtaining patents encourages using molecular manipulation to create insignificant facsimiles. By providing stiffer standards of patentability, S. 1552 should help to close the door to some short cuts to commercial success, Dr. Console says. This should benefit drug research and help to restore the protection intended for true inventions. No Drug Patents. "Congress should abolish patents on drugs," said Dr. Colston E. Warne, professor of economics at Amherst and president of Consumers Union. "It is now evident that the drug houses have subjected the patent system to such widespread abuses by jiggling names in the molecular composition of drugs so as to create public confusion while charging exorbitant prices that there has developed the need to call a halt. The public interest is not served by a halfway measure, such as the provisions of S. 1552," he adds. Dr. Warne feels that drugs can be as important to life as air and water. They are not gadgets, he says, and should not be subject to a patent monopoly. In Dr. Warne's opinion, abolition of drug patents would do no serious harm to drug research. If there were no drug patents, he says, drug firms would continue to push research for fear of falling behind the competition and to build prestige. S. 1552 Opposed. The American Bar Association opposes the patent provisions of S. 1552, said Joseph G. Jackson, representing the Patent Section of ABA, for the same reasons advanced by witnesses at previous hearings (C&EN, Oct. 30, page 34). ABA feels that restrictions would kill incentives for drug research and be an opening wedge for similar restrictions on other industries. Mr. Jackson thinks Congress should consider ways to enhance patent rights to spur drug research.