Summary
This 8-K filing from Bristol-Myers Squibb (BMY) announces a potential settlement agreement with Apotex Inc. and Apotex Corp. regarding the patent infringement lawsuit for clopidogrel bisulfate, marketed as PLAVIX® in the United States. The agreement, reached with co-marketer sanofi-aventis, aims to resolve litigation concerning the validity of the composition of matter patent for PLAVIX®. While a settlement could provide clarity on future competition, it is contingent upon several conditions, including antitrust review and clearance from the Federal Trade Commission and state attorneys general. There is a significant risk that these clearances may not be obtained, which would reinstate the litigation and allow Apotex to potentially launch a generic version of clopidogrel at risk. Investors should closely monitor the antitrust review process and any further developments concerning the PLAVIX® patent and potential generic entry.
Key Highlights
- 1BMY and sanofi-aventis have reached a conditional settlement agreement with Apotex Inc. and Apotex Corp. to resolve a patent infringement lawsuit related to PLAVIX® (clopidogrel bisulfate).
- 2The lawsuit concerns the validity of the composition of matter patent for PLAVIX®.
- 3The trial, originally scheduled for June 2006, has been suspended pending finalization of the proposed settlement.
- 4The settlement is subject to significant conditions, including antitrust review and clearance by the FTC and state attorneys general.
- 5There is a substantial risk that antitrust clearance may not be obtained, which would terminate the settlement and reinstate the litigation.
- 6If litigation is reinstated, Apotex could launch a generic clopidogrel at risk, as they have received FDA approval for their abbreviated new drug application (aNDA).
- 7The company states it is not possible at this time to reasonably assess the outcome of the lawsuit or the timing of potential generic competition.