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BRISTOL MYERS SQUIBB CO 8-K Report, Corporate Update (Sep 25, 2006)

Filed September 25, 2006For Securities:BMYCELG-RIBMYMP

Summary

Bristol-Myers Squibb Company (BMY) announced on September 21, 2006, a significant legal development concerning its blockbuster drug PLAVIX® (clopidogrel bisulfate). The United States Court of Appeals for the Federal Circuit has denied Apotex's motion to stay a preliminary injunction, meaning Apotex must continue to halt sales of its generic version of PLAVIX®. This ruling is a positive outcome for BMY and its partner sanofi-aventis, as it upholds the existing injunction and protects PLAVIX® from generic competition in the immediate term. The Court of Appeals has also set an expedited schedule for Apotex's appeal, with oral arguments scheduled for October 31, 2006. This suggests a swift resolution to the ongoing patent dispute, which is crucial for maintaining PLAVIX®'s market exclusivity and revenue stream.

Key Highlights

  • 1Court of Appeals denied Apotex's motion to stay the preliminary injunction against generic PLAVIX® sales.
  • 2Apotex must continue to halt sales of its generic clopidogrel bisulfate product.
  • 3The preliminary injunction was initially issued by the United States District Court for the Southern District of New York.
  • 4The Court of Appeals has established an expedited schedule for Apotex's appeal.
  • 5Oral arguments for Apotex's appeal are scheduled for October 31, 2006.
  • 6This development is a positive for Bristol-Myers Squibb and sanofi-aventis, protecting PLAVIX® sales.
  • 7The press release from September 21, 2006, is attached as Exhibit 99.1.

Frequently Asked Questions

The main impact is the continued protection of PLAVIX® from generic competition. The denial of the stay means Apotex cannot sell its generic version while its appeal is pending, preserving BMY's revenue from PLAVIX®.

The legal dispute is not yet fully resolved, but the expedited schedule for the appeal, with oral arguments on October 31, 2006, suggests a resolution will be reached relatively soon after that date.

Apotex is a company that is attempting to sell a generic version of PLAVIX® (clopidogrel bisulfate). The legal action is part of a patent dispute where Bristol-Myers Squibb and sanofi-aventis are seeking to prevent the sale of generic versions that they believe infringe on their patents.

PLAVIX® is a medication used to prevent blood clots in patients who have had a heart attack or stroke, or who have peripheral artery disease. It is a significant product for Bristol-Myers Squibb.