ommendations are expected in three months.

FDA's Kessler is expected to decide very quickly on marketing of breast im­plants after receiving the advisory pan­el's recommendations. Rylee says his company has not made a profit on im­plants in the past five years, but has con­tinued to market them because physi­cians and women "were counting on us." About 2 million U.S. women have

Sixteen months and 617 million miles after leaving Earth, spacecraft Ulysses last week reached Jupiter.

During a 10-day swing around the giant planet, largest in the solar system and 11 times Earth's diameter, Ulysses detected unexpected changes in the Jo­vian system. The spacecraft also picked up a "gravity assist" that boosted it out of the ecliptic plane—the plane in which planets orbit the Sun—and pro­pelled it on its way toward its primary mission: to explore for the first time the polar regions of the Sun.

Results of the Jupiter encounter were described at a press conference last week at the National Aeronautics & Space Ad­ministration's Jet Propulsion Laboratory in Pasadena, Calif. The five-year mission is a joint NASA-European Space Agency (ESA) project. Built by ESA, the 807-lb spacecraft carries nine scientific instru­ments designed to study the Sun, mag­netic fields and streams of particles it

had silicone breast implants, 80% for breast enlargement and 20% for recon­struction after cancer surgery.

Rylee hints Dow Corning won't con­tinue to make implants if Kessler rules they can only be sold for reconstructive purposes: "A segmentation of the mar­ket would be unworkable. I think he should ban them outright or allow them to be sold for all purposes."

Lois Ember

generates, and interplanetary space above it.

Until now, spacecraft have made only very limited forays out of the ecliptic plane. Ulysses' flight path will be nearly perpendicular to it. It is the fifth space­craft to fly by Jupiter, preceded by Pio­neers 10 and 11 in 1973 and 1974, respec­tively, and Voyagers 1 and 2 in 1979. Ul­ysses' superior instruments and its trajectory enabled it to make observa­tions the others couldn't.

The maneuver around Jupiter gave scientists an opportunity to study its huge magnetosphere, gathering data on its magnetic fields, plasma, energet­ic particles, waves, dust, and x-rays. Ju­piter has the most intense radiation belts in the solar system. The space­craft's path took it right between the orbits of two Jovian moons, Io and Eu-ropa. Of special interest is Io's 93,000-mile-thick torus, a doughnut-shaped plasma ring containing sulfur and oxy­

gen ions that encircles Jupiter, formed by material released at 1 metric ton per second from Io's volcanoes.

The spacecraft's findings are still pre­liminary. However, they show the mag­netosphere to be much larger than in 1979, requiring "a major change in the magnetic field model." But the torus is only about half as dense as in 1979, and its source, Io, is apparently less volcani-cally active. The torus also varies greatly in density, with "hot spots" dotted along its length. Also, clocklike pulsing of the whole magnetosphere, at a tempo set by the 10-hour rotation of Jupiter, seems to extend to the heart of the planet.

Scientists say "everything worked perfectly." Indeed, notes mission scien­tist Klaus-Peter Wenzel of ESA, the dis­coveries mean that "some of the text­books will have to be rewritten."

Richard Seltzer

U.S. moves up CFC phaseout by four years President Bush last week unilaterally moved up the deadline for the U.S. to cease production of chlorofluorocar-bons (CFCs) and other ozone-depleting chemicals to the end of 1995.

That's four years earlier than required by 1990 amendments to the Montreal protocol. Bush also called on other na­tions to agree to accelerate the phaseout schedule. Under terms of the 1990 Clean Air Act, he can impose the new policy in the U.S. without Congress' consent.

Bush's action was prompted by re­cent bad news about the stratospheric ozone layer. The National Aeronautics & Space Administration earlier this month released data showing that ozone erosion is faster and more wide­spread than earlier believed, with a high likelihood of an "ozone hole" de­veloping in the Northern Hemisphere (C&EN, Feb. 10, page 4).

The new policy applies to CFCs, halons, methyl chloroform, and carbon tetrachloride. It provides exemptions, however, for "essential uses" such as fire extinguishers (the primary use of halons) and medical inhalers for asth­matics. It also exempts CFCs needed to service existing equipment, like refrig­erators that cannot use substitutes.

U.S. producers support Bush's an­nouncement, saying they can meet the new targets without strain. Du Pont, the

Ulysses gets boost from Jupiter to exit ecliptic plane

North Polar pass (June-September 1995)

Jupiter encounter (February 1992)

South Polar pass (June-November 1994) South trajectory

100 Days

Spacecraft Ulysses spies Jupiter changes

FEBRUARY 17,1992 C&EN 5

Solar ecliptic plane

Earth orbit

Launch (October.

1990) /

Ecliptic crossing (February 1995)

Sun

Orbit of Jupiter

NEWS OF THE WEEK

largest CFC producer, announced last fall it would voluntarily cease produc­tion of CFCs by the end of 1996 and of halons by the end of 1994. After Bush's announcement, the firm said it "will maintain its 1994 phaseout for halons and will accelerate its CFC end date."

Bush set no deadline for phasing out hydrochlorofluorocarbons (HCFCs), but said their fate is being reviewed. HCFCs are being introduced as substitutes for many CFC applications. They are less damaging to the ozone layer than fully halogenated compounds, but still carry some chlorine into the stratosphere. The industry-backed Alliance for Responsi­ble CFC Policy says HCFCs are needed as transitional compounds until totally ozone-safe compounds are available.

Environmental groups welcome the changes, but complain they do not go far enough. "Much more aggressive ac­tion is needed," says Liz Cook, ozone campaign director for Friends of the Earth. Last December, FOE and two other groups petitioned to ban CFCs af­ter 1994 and halons after 1991 (C&EN, Dec. 9,1991, page 5).

Pamela Zurer

NIH files second human gene patent application The National Institutes of Health last week filed its second patent application covering human brain gene sequences identified by one of its researchers, de­spite the controversy raised by its first patent application last summer.

"NIH [will] continue filing patents while an important debate unfurls as to what is the best way to deal with intel­lectual property issues surrounding par­tial or full gene sequences," NIH direc­tor Bernadine Healy told a press confer­ence. "If we had chosen not to file, it would have closed doors on any future options, should these materials be found to have intellectual property value."

The application covers 2375 genes identified and partially sequenced by a novel strategy developed by J. Craig Venter and coworkers at the National Institute of Neurological Disorders & Stroke. It is an extension of NIH's previ­ous application, still pending, which covered about 350 genes. NIH filed the extension simultaneously with publica­tion of Venter's research in last week's Nature [355,632 (1992); also see page 25].

Critics of the patenting policy fear it will choke commercial development of the new knowledge, and inhibit free flow of information among scientists. For example, the American Society of Human Genetics declares that the ge­nome project "should not be a compe­tition between laboratories and be­tween countries to see who can 'own' the largest portion of the human ge­nome to exploit. Under such conditions the information would not be shared between the competing groups until af­ter patents were secured."

But Healy responds, "Filing of patents does not promote secrecy, it promotes openness." She points out that Venter has made his data available through GenBank, a computer database of gene sequences available free to the public. "We want to see this information rapid­ly translated into understanding human disease and the development of prod-

Hoffmann-La Roche last week an­nounced a new licensing policy for poly­merase chain reaction (PCR) technolo­gy—hailed by many as a breakthrough scientific discovery with wide-ranging medical and research applications that offers potential commercial sales of more than $500 million by 1996.

The policy eases restrictions on diag­nostic uses, and is expected to expand PCR's availability for current applica­tions, and to accelerate research into new uses.

PCR technology rapidly amplifies genetic material to facilitate detection of genetic and infectious diseases or identification of DNA. PCR was in­vented, developed, and rigorously pat­ented by Cetus, an Emeryville, Calif.-based biotechnology firm.

Roche acquired all rights to PCR last December when Cetus merged with Chiron (C&EN, Dec. 16, 1991, page 7). For the rights, Roche paid Cetus $300 million, and will pay up to $30 million more in royalties. Roche also acquired Cetus' interest in a PCR instrumenta­tion joint venture with Perkin-Elmer. In addition, Roche is a party to ongoing arbitration between Cetus and Eastman Kodak regarding rights to certain PCR diagnostic uses stemming from a three-year agreement terminated in 1989.

Until now, licensing restrictions set by Cetus have limited how broadly

ucts to treat disease." If the patents are issued, NIH will decide then how to handle them, she says. It could donate them to the public or grant exclusive or nonexclusive licenses.

The Industrial Biotechnology Associ­ation supports NIH. "Under the exi­gencies of patent law, we think the NIH filing is a good idea," IBA presi­dent Richard D. Godown tells C&EN. "It protects these inventions for the U.S. If you publish without filing, you're in danger of losing foreign patent rights."

Healy says she wants debate to con­tinue, both at a national and interna­tional level. An interagency task force under the White House Office of Sci­ence & Technology Policy is studying the issue, and informal talks are under way with scientific leaders in Japan, France, and the U.K., she says.

Pamela Zurer

PCR can be applied, and have restrict­ed rights to new developments. Roche consulted leading scientific institutions in developing its new policy, and is said to have been influenced by con­cern in Congress that PCR be made more accessible.

Under the new policy, all laboratories will be able to use PCR for diagnostic testing. This includes the right to per­form tests for a wide variety of diseases and conditions—including infectious diseases, genetic diseases, cancer, tissue typing, and parentage determination.

Academic and nonprofit institutions conducting diagnostic testing will no longer be required to pay licensing fees up front, or to make annual minimum payments, and royalty rates will be as low as 9%. Licenses with commercial labs will be established on an individu­al basis. Transfers of technology devel­opments by licensees to Roche now will be optional instead of required.

PCR diagnostic tests already are avail­able for human immunodeficiency virus and other viruses and for certain genetic diseases such as sickle cell anemia. In 1992, Roche expects to seek Food & Drug Administration approval for diag­nostic tests it has developed for Lyme disease and tuberculosis, genetic disor­ders such as cystic fibrosis, and cancers such as leukemias and lymphomas.

Ann Thayer

Polymerase chain reaction licensing eased

6 FEBRUARY 17,1992 C&EN