Stephanie Saul Sobers Up: Generic Plavix is Blocked

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  • 09/01/2006

Remember the nearly gleeful article Stephanie Saul wrote about Apotex had outfoxed Bristol and Sanofi just a couple of weeks ago? And the fawning piece that described Apotex CEO Bernard Sherman as both a wily businessman, consumer crusader and man of charity? Well, now that Apotex has had the law shoved down its throat, Stephanie seems a bit dazed and uncharacteristically plays it straight for once … almost like the news jarred her back to the default settings of objective reporting…

September 1, 2006
Generic of Plavix Is Blocked


A federal judge in Manhattan ordered a Canadian company yesterday to stop distributing its generic version of the blockbuster anticlotting drug Plavix, granting a reprieve to Bristol-Myers Squibb and Sanofi-Aventis, which co-market the brand-name drug.

The Plavix marketers had seen a drastic erosion of their United States sales since the Canadian company, Apotex, introduced its generic version on Aug. 8 in a challenge to the patent held by the big companies. Analysts say that the large supplies of the generic drug already on the market could continue to impinge on sales of Plavix for several months …

Judge Stein did say that the patent was likely to be enforceable, based on the evidence and testimony so far. He also observed that Bristol-Myers and Sanofi had suffered “irreparable harm” as a result of the patent infringement.

He nonetheless required Bristol-Myers and Sanofi to post a $400 million bond to compensate Apotex in the event the generic company won in a trial on the validity of the patent, now set to begin in his court next January …”

Apparently the judge did not buy, as did Stephanie, Bernie’s claim that he never intended his wheeling and dealing (getting BMS and Sanofi to pay for only half of generic sales if it lost its patent suit) to really mean anything, citing as evidence letters he sent to Chuck Grassley in which he wrote that he hated all the wheeling and dealing. The judge saw it for what it was: a shakedown that was part of an effort to void the patent without exploring the validity of the patent itself …

“In his 57-page ruling, Judge Stein wrote, ‘The public interest in lower-priced drugs is balanced by a significant public interest in encouraging the massive investment in research and development that is required before a new drug can be developed and brought to market.’”

Those of you who want to see Judge Stein’s entire ruling can go to this link:


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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