8-KOther Events

BRISTOL MYERS SQUIBB CO 8-K Report, Corporate Update (Sep 3, 2004)

Filed September 3, 2004For Securities:BMYCELG-RIBMYMP

Summary

This 8-K filing from Bristol-Myers Squibb (BMY) announces a significant event concerning Abilify (aripiprazole), a key antipsychotic drug. On August 11, 2004, Otsuka Pharmaceutical Co., Ltd., a partner, filed a Request for Reexamination with the USPTO regarding the primary composition of matter patent (U.S. Patent No. 5,006,528) for Abilify. This reexamination is prompted by an error in the original patent application where a prior art reference was misidentified, and Otsuka is also introducing new citations for the USPTO to consider. The patent is set to expire in 2009, with potential extensions to 2014.

Key Highlights

  • 1Otsuka Pharmaceutical has requested a reexamination of the core U.S. patent for Abilify (U.S. Patent No. 5,006,528).
  • 2The reexamination is due to an error in identifying a prior art reference in the original patent application and the inclusion of new citations.
  • 3Abilify is a significant antipsychotic agent used for schizophrenia and is a projected growth driver for Bristol-Myers Squibb.
  • 4The Company and Otsuka believe the patent claims will be reconfirmed, but acknowledge there is no guarantee of the outcome.
  • 5If patentability is not reconfirmed, it could lead to an earlier-than-expected loss of market exclusivity for Abilify and the introduction of generic competition, which would be material to the Company.
  • 6Bristol-Myers Squibb holds marketing rights for Abilify in the U.S. and Puerto Rico until November 2012 and in the EU until June 2014.
  • 7The announcement is made in connection with the expected effectiveness of a shelf registration statement.

Frequently Asked Questions

The main reason is to inform investors that Bristol-Myers Squibb's partner, Otsuka Pharmaceutical, has requested a reexamination of the primary U.S. patent for Abilify. This is due to an error in the original patent application and the introduction of new prior art.

Abilify (aripiprazole) is an antipsychotic medication used to treat schizophrenia. It is considered a significant product for Bristol-Myers Squibb and is expected to contribute to the company's growth over the next several years.

If the patentability of the '528 Patent is not reconfirmed, Bristol-Myers Squibb could face an earlier-than-expected loss of market exclusivity for Abilify. This would likely lead to the introduction of generic competition, which the company states would be material to its financial performance.

The USPTO is expected to make a final decision on the reexamination within the next ten to fifteen months from the filing date of the request.