HEffiSEO FEEHEt WEEK PHARMACEUTICALS
PLAVIX Clopidogrel bisulfate lowers risk of heart attack or stroke.
COURT HALTS SALES OF GENERIC PLAVIX BMS and Sanofi claim a minor victory in fight over patent for blood thinner
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FTER SEVERAL MISSTEPS,
Bristol-Myers Squibb (BMS) and Sanofi-Aventis have won the latest chapter in what is shaping up to be an epic legal battle over the blood thinner Plavix. A U.S. district court has granted the companies' request for a preliminary injunction ordering Canadian
C L I M A T E
generic drug firm Apotex to stop selling a generic version of Plavix (clopidogrel bisulfate). The presiding judge, however, stopped short of recalling product that had already been shipped to distributors and wholesalers, causing BMS to lower its earnings estimates for 2006. The ruling bars Apotex from selling clopidogrel until patent litigation among the three companies is settled. As part of the injunction, BMS and Sanofi must post a $400 million bond to ensure Apotex will be compensated should it win the patent trial, which is scheduled to begin on Jan. 2 2 , 2 0 0 7 BMS and Sanofi were caught off guard when Apotex launched
C H A N G E
SCIENTISTS SUPPORT CURBING C02 In a Supreme Court brief, researchers call for federal regulation of motor vehicle C 0 2 Molina
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C&EN / SEPTEMBER
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N AUG. 31, l 8 PROMINENT CLI-
mate-change researchers filed a brief with the Supreme C o u r t expressing their support for regulating C 0 2 emissions from motor vehicles in a global warming case that is before the high court. Among the signers are F. Sherwood Rowland and Mario J. Molina, who shared the 1995 Nobel Prize in Chemistry for their work in atmospheric chemistry. T h e Supreme C o u r t case— Commonwealth ofMassachusetts v. U.S. EnvironmentalProtection Agen-
1 1 . 2006
cy—has a long history. In 1999, various environmental groups petitioned EPA, asking it to set motor vehicle emission standards for greenhouse gases. EPA denied the petition, saying that the Clean Air Act provides no authority to regulate C 0 2 . In 2 0 0 3 , Massachusetts, 11 other states, and environmental groups challenged EPAs ruling in the U.S. Court of Appeals for the District of Columbia. The court upheld EPAs decision last year. In March of this year, Massachusetts and 28 other parties
clopidogrel on Aug. 8, five years ahead of schedule. The move was facilitated by loopholes in a pact among the three companies to settle patent litigation over the drug (C&EN,Aug.21,pagel2). BMS says it has yet to get a handle on just how much generic product was shipped in the weeks leading up to the injunction, but it assumes that distributors and wholesalers have received enough of the Apotex drug to supply the U.S. market through the end of the year. As such, BMS has lowered its earnings estimate for 2006 to $0.95 per share from earlier guidance of between $1.15 and $1.25 per share. Banc ofAmerica Securities analyst Christopher T. Schott says the ruling is a good sign that BMS and Sanofi "have a strong probability of prevailing in their patent defense." Furthermore, he points out that between recently launched drugs and a strong late-stage oncology pipeline, BMS could soon have one of the freshest portfolios in the industry.—LISA JARVIS
requested Supreme Court review of the case, and in June, the court agreed to hear it (C&EN, July 3, page 7). In their brief, the scientists say they originally believed they would not see strong signs of human-induced climate change during their lifetimes. But by the beginning of this decade, "we observed that global temperatures are rising, plant and animal ranges are shifting, glaciers are in retreat globally, and Arctic sea ice is retreating " In addition, "sea levels are rising, and the oceans are becoming more acidic," they write. T h e evidence of the changes is so compelling, the researchers write in their brief, that a consensus has crystallized within the scientific community: Global warming is happening, and it is virtually certain human activities are causing it. The high court will hear oral arguments in the case in December.—BETTE H1LEMAN
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