NEWS OF THE
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zation. "We are very pleased that this has changed." PTO Commissioner Bruce A. Lehman explains that the new guidelines "emphasize that any credible statement of utility consistent with the scope of the claimed invention that is made by the application will satisfy the law. In other words, if an applicant presents a scientifically plausible use for the claimed inventions, it will be sufficient to satisfy the utility requirement." This change eliminates a sort of "catch-22" situation faced by biotech firms, Lehman adds: They were required to provide clinical trial data to support an asserted therapeutic utility and at the same time they were unable to raise funds to perform those trials because the patent situation was unclear. Biotech industry executives praise the policy shift. For example, David W. Beier, vice president for public policy at Genentech in San Francisco says the announcement "represents the culmination of months of work between the executive branch and the private sector. This change should make biotechnology patent prosecution more rapid. The absence of delav and uncertaintv
at this stage in the process will increase the likelihood of early seed capital." Lisa Raines, vice president for government relations at Genzyme Technology in Cambridge, Mass., says smaller biotech companies are very pleased. "Patents are the lifeblood of the biotechnology industry. For smaller companies, the requirement for human clinical trials was particularly burdensome." The new guidelines go into effect immediately, Lehman notes, but there will be a period of public comment to refine any necessary changes. In addition to the changed utility policy, Lehman says PTO is upgrading the training of biotechnology patent examiners to make sure they are familiar with the law and the new guidelines. PTO also will train two or more biotechnology practice specialists to review biotech patents to ensure consistency with the new policy. Although the new guidelines are written to solve the specific problem of clinical trials and biotechnology patents, PTO points out that the guidelines' language is "technology neutral"—and could possibly be used by other industries to speed their patent approvals. David Hanson
Mallinckrodt buys lab supplier J. T. Baker Combining two of the most eminent names in laboratory reagent chemicals, Mallinckrodt Group has agreed to buv J. T. Baker from Procter & Gamble. Mallinckrodt will announce the purchase price when the deal closes. Baker, based in Phillipsburg, N.J., makes lab, industrial, and electronics chemicals—with sales in 1993 of about SI 30 million. The 4,500 or so items in its lab products catalog include organic and inorganic chemicals, high-purity solvents, chromatography supplies, biological reagents, and safety equipment. The firm also sells about 1,000 chemicals in large volumes to the drug, biotechnology, electronics, ceramics, and rubber industries. Its electronics chemicals are high-purity, low-particulate acids, solvents, etchants, and photoresist developer agents used to fabricate semiconductor devices. Baker was founded by John Townsend Baker in 1904. In 1941, it was purchased by Vick Chemical Co., which later became a division of RichardsonMerrell. Procter & Gamble acquired Baker in 1985 as a result of buying Richard8
JANUARY 2, 1995 C&EN
son-Vicks, a prescription and over-thecounter drug company. Mallinckrodt Group, based in St. Louis, makes chemical, medical, and veterinary products, with sales of $1.94 billion in its most recent fiscal year, ending June 30. It will fold Baker into its Mallinckrodt Chemical division, which sold $437 million worth of bulk drugs, catalysts, specialty chemicals, and reagents in its fiscal 1994. "The addition of the J. T. Baker business will nearly double the size of the company's performance and laboratory chemicals group and provide immediate expansion into European markets," notes Mallinckrodt's President and Chairman C. Ray Holman. His firm already has one European site in Chesterfield, England, and now gains Baker's plant in Deventer, the Netherlands. Mallinckrodt is not identical with the chemical company started by Edward Mallinckrodt in St. Louis in 1867, but is a reinvented form of the onetime International Minerals & Chemical Co. (IMC). In 1986, IMC—a $1.2 billionper-year fertilizer producer with gas
and oil properties—sold off all three businesses, acquired Mallinckrodt from Avon Products, and bought human medical and veterinary drug subsidiaries. From 1990 to 1994, the firm was called Imcera, but it switched its name to Mallinckrodt Group last March (C&EN, March 21,1994, page 9). Stephen Stinson
Monsanto to pay $1.08 billion for Merck unit Monsanto will buy Merck's Kelco specialty chemicals division for $1.08 billion. The deal is expected to be completed within the next three months. The move furthers Monsanto's commitment to biotechnology and completes Merck's divestment of its specialty chemicals businesses. But Wall Street's reaction was less than favorable, with some sentiment that the price was too high. The day the deal was announced, Monsanto shares on the New York Stock Exchange plunged $4.00 to $68%, a 52-week low. Headquartered in San Diego, Kelco manufactures and markets alginates and biogums. It had sales in 1993 of about $300 million and currently employs about 1,300 workers. Alginates and biogums are mainly used as thickening agents in food, agricultural chemicals, and health and personal care products. They also have applications in the oil exploration, paper, and textile industries. Merck put Kelco up for sale last sum-
Shapiro: we can build on Kelco's strengths
mer after it decided "to focus its resources on its core human and animal health business." Merck sold its other specialty chemicals division, Calgon Water Management, to English China Clays for $308 million in June 1993. "Kelco has excellent technological competencies, solid regulatory expertise, a strong customer service orientation, and an impressive product pipeline," says Monsanto President and Chief Operating Officer Robert B. Shapiro, who in March will become chief executive officer and chairman, replacing the retiring Richard J. Mahoney. Mahoney will remain as a director and chairman of the board's executive committee. "We believe we can build on [Kelco's] strengths, add greater productivity through our synergies, and create value through growth for our shareholders and customers." Shapiro adds that "The acquisition offers exciting potential, longer term, in the field of agricultural biotechnology and the developing markets for products called nutraceuticals." He describes nutraceuticals as products that "merge health benefits with food and dietary products." Kelco entered the nutraceuticals field early in 1994. Kelco seems to fit into Monsanto's biologically related chemical businesses. Best known for its herbicide Roundup, Monsanto also produces the food and beverage sweetener NutraSweet, prescription pharmaceuticals, and a controversial bovine growth hormone that increases milk yields. Monsanto expects the acquisition to be "neutral to slightly dilutive" to its earnings in the first year. But company officials anticipate an addition to earnings during the second year. However, doubts are expressed by Paul K. Raman, chemical analyst at investment bank S. G. Warburg & Co. in New York City. Raman says Monsanto is overpaying for Kelco by $100 million to $200 million. Raman acknowledges Kelco is an "unquestionably excellent" business, with "twice the market share of the nearest competitor" in many of its markets. But he expects the deal to dilute Monsanto's earnings by about $15 million pretax, because about half the asking price will be funded with debt. "We are also slightly skeptical about the possibility for cost cutting or synergies," Raman adds.
of chlorine CFCs carry into the stratosphere is dwarfed by natural sources such as seawater and volcanic eruptions. These arguments are laid out by Rogelio A. Maduro in his 1992 book, Newly released satellite data confirm "The Holes in the Ozone Scare," and that chlorofluorocarbons (CFCs) are the they have been popularized on radio source of the chlorine that is eroding talk shows. The UARS data solidly refute these Earth's protective ozone layer. Three years' worth of data from the claims. UARS was launched in SeptemNational Aeronautics & Space Admin- ber 1991 to provide a comprehensive istration's Upper Atmosphere Research picture of stratospheric chemistry. Its Satellite (UARS) have enabled NASA 10 instruments gather data on the scientists to prepare the first global chemical composition of the upper atmaps of CFCs and their breakdown mosphere, as well as wind patterns products in the stratosphere—hydro- and solar energy input. gen chloride (HCl) and hydrogen fluoMeasurements of CFC-12 (CC12F2) by ride (HF). The maps refute the claims UARS's Cryogenic Limb Array Etalon of skeptics that natural sources, not hu- Spectrometer indicate high levels of man activities, cause ozone depletion. this refrigerant reach the stratosphere. "We believe these data eliminate the The amounts begin to decrease above possibility [that] there are major natu- about 20 km as the molecules are broral sources of chlorine in the strato- ken apart by ultraviolet light. Simultasphere," says UARS project scientist neous measurements of HCl and HF Mark Schoeberl. "They confirm CFCs by UARS's Halogen Occultation Experare responsible for the ozone loss we iment show levels of these CFC decomposition products rise at heights where are observing." Critics of the theory that chlorine CFCs are photolyzed. "We now have the global distribufrom CFCs catalyzes ozone depletion argue CFC molecules are too heavy to tion of man-made CFCs in the stratorise into the stratosphere. And even if sphere," Schoeberl says. "They are not they did, the skeptics say, the amount just lying around on the ground as some people will have you believe." In addition, by Altitude, km comparing concen60 i trations of HCl and HF, the scientists calculated that virtually all the HCl comes from breakdown of CFCs. "HF has no natural sources, it is not produced by volcanic eruptions or salt spray. It comes only from CFCs. We only see high amounts of HCl in the same places where we see high HF," stresses deputy project scientist Anne Douglass. -80 -57 -33 -10 13 "We have this Latitude thing nailed," she Hydrogen fluoride levels in the atmosphere measured continues. "We have by a National Aeronautics & Space Administration satthe source and we ellite rise from zero in lower stratosphere (dark blue) to have the products. It more than 1.0 ppb in upper stratosphere (yellow). There all adds up. There is are no HF natural sources; HF is produced when chlono other possibility," rofluorocarbon molecules rise high enough into the she emphasizes. stratosphere to be broken apart by ultraviolet light.
George Peaff
Pamela Zurer
Satellite data confirm CFC link to ozone hole
JANUARY 2,1995 C&EN
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