otic lincomycin. Upjohn earlier had been turned down on its patent application because the patent office considered it not within its statutory authority. Previously, only certain types of plants and seeds produced asexually could be patented under the Federal Plant Patent Act of 1930. In its Oct. 6 ruling, the court declared that Upjohn's microorganism u is not found in, and is not a product, of nature. It is man-made and can be produced only under carefully controlled laboratory conditions." Central to the issue, in the opinion of the court majority, is whether the U.S. patent code precludes patenting something simply because it is alive. Says the court, u Our conclusion is that it does not." The court adds, "We see no sound reason to refuse patent protection to the microorganisms themselves—a kind of tool used by chemists and chemical manufacturers in much the same way as they use chemical elements, compounds, and compositions which are not considered alive, notwithstanding their capacity to react and to promote reaction to produce new compounds and compositions by chemical processes in much the same way as do microorganisms." The court decision opens the way for inventors to patent all sorts of novel organisms, including those produced by recombinant DNA techniques. But the ruling may have even broader implications that the court tried to avoid as "far-fetched" in the Upjohn decision. Nevertheless, suppose someone wanted to take out a patent on a new and specially bred type of chicken? Strictly speaking, according to Washington patent lawyers, the patent appeals court decision would seem to allow this. Moreover, suppose you wanted to take a patent out on yourself? If you could prove that you were new, useful and "unobvious" (in the legal sense of patent law), then you could probably do that, too. But it would be terribly selfish. D
HEW secretary urges revamping drug law Secretary of Health, Education & Welfare Joseph A. Califano Jr. is calling for sweeping changes in the law governing drug regulation. The basic 40-year-old law under which the Food & Drug Administration operates "needs a top-to-bottom, thorough overhaul," Califano says, adding that "it is time to establish a single, coherent system for regulation of all drugs." The present law, Califano charges, 6
C&ENOct. 17, 1977
Tenneco move clouds Ashland-Corco scheme
Califano: single coherent system
"highlights irrelevant historical distinctions, and perpetuates time-consuming repetitive processes that are closed to effective public review." He points out that under the present system, an application for approval of a new drug averages 34 volumes, takes years to process, and costs millions of dollars. And in many cases, he says, FDA has been "extremely conservative" in its approval process, because the agency has found it very difficult to remove a drug from the market once it has won approval. To correct these problems, he is urging Congress to write a new law that first will recognize that no drug is ever absolutely safe or always effective, and second that any decision to approve a new drug must balance benefits against risks. In addition, means must be specified for getting promising new drugs into the market faster. This could include eliminating the requirement for unnecessary repetition of research to prove safety and efficacy. Now, he says, a new manufacturer of a drug is required to prove the safety and effectiveness of the drug even when other manufacturers have proved the same chemical safe many times over. In addition, FDA needs the authority to set up a comprehensive, accurate surveillance system for adverse drug reactions. The agency also should be given a clear and comprehensive mandate to require patient package inserts for drugs that provide information in understandable language, he says. Califano has requested that FDA commissioner Donald F. Kennedy hold public hearings, before Thanksgiving, to gather other views on what statutory changes may be needed. D
Ashland Oil's potential takeover of Commonwealth Oil Refining Co. (Corco) received bad news and good news earlier this month. The bad news is that Tenneco, which Corco and W. R. Grace were counting on to purchase their money-losing joint venture Oxochem, decided that the whole thing was too uncertain. Tenneco says that it is pulling out of the affair. Tenneco backed away from Oxochem less than a month after the Justice Department had said that it would not oppose the sale of Grace's Hatco group and Oxochem to the Houston-based company. The good news is that the Justice Department has decided that the combination of Corco and Ashland doesn't violate any antitrust laws and that, as far as the government is concerned, the transaction now can proceed. Corco had very much wanted Tenneco to purchase Oxochem, one of Corco's worst profit drains with a pre-tax loss of $9.7 million in 1976. In fact, the sale of the facility is one of the conditions that Ashland put on its investing in the Puerto Rican refiner. The other conditions are approval by the Justice Department and agreements with the Federal Energy Administration on oil and naphtha entitlements, and renegotiation of contracts with PPG Industries regarding the joint venture Puerto Rican Olefins plant controlled by Corco and PPG. The approval of the Justice Department, of course, removes another of the conditions. Assuming that FEA, now the Department of Energy, gives its sanction and PPG renegotiates its supply contracts to Ashland's liking, it remains to be seen if satisfying three out of four of the conditions is enough. It probably will be. Earlier this year, other chemical companies had expressed an interest in Oxochem, if not in the entire Hatco group, if Tenneco decided to back away. The parties affected by Tenneco's pullout are particularly closemouthed at this point. Grace says merely that it will continue to operate the Hatco group. Tenneco will not amplify on its announcement of withdrawal. Corco is referring all inquiries to Ashland, as it has done in the past, on questions relating to the proposed option. And Ashland refuses to comment other than saying that it is continuing to study the situation. D
