July 21, 2008
U.S. Federal Circuit Court of Appeals Rules Patent for ACIPHEX(R) Valid and Enforceable
RARITAN, N.J., July 21, 2008 /PRNewswire/ -- PriCara,(TM) Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., announced today that the U.S. Federal Circuit Court of Appeals affirmed the judgments of the United States District Court for the Southern District of New York that the patent for ACIPHEX(R) (rabeprazole sodium 20 mg tablets) is valid and enforceable.
Today's decision ensures that the patent for ACIPHEX remains in force and also directs the U.S. Food and Drug Administration to change the effective date of Teva Pharmaceutical's approval to market its generic version of rabeprazole sodium to no earlier than May 2013, the date of the ACIPHEX patent expiration. The court's decision also affects Dr. Reddy's pharmaceutical company's application for approval for its generic version of the drug, which now will not receive final approval before May 2013.Eisai Co., Ltd. of Tokyo, Japan, holds the patent for ACIPHEX. PriCara and Eisai Inc. co-promote ACIPHEX in the United States.
"We are pleased by the court's decision, which reflects our belief that the patent for ACIPHEX is both valid and enforceable," said Jim Mitchell, General Manager, PriCara.
ACIPHEX is used for the treatment of persistent heartburn and other symptoms associated with acid reflux disease. It also is used for the short- term treatment in the healing and symptom relief of erosive acid reflux disease -- gastroesophageal reflux disease -- and to maintain healing of erosion and relief of heartburn symptoms that happen with acid reflux disease.
ACIPHEX has a well-established safety profile. The most common side effect possibly related to ACIPHEX is headache. Symptom relief does not rule out other serious stomach conditions. Patients on warfarin (such as Coumadin(R)) may need to be monitored closely by their doctor. For more information, visit http://www.aciphex.com/.
About PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
PriCara(TM), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is a major healthcare organization in the United States dedicated to the needs of primary care providers who serve a vital role on the frontlines of medicine. For more information about the company, please visit http://www.pricara.com/.
Ortho-McNeil-Janssen Pharmaceuticals, Inc. is a wholly owned subsidiary of Johnson & Johnson.
[This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from PriCara's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov/, http://www.jnj.com/ or on request from Johnson & Johnson. PriCara does not undertake to update any forward-looking statements as a result of new information or future events or developments.]
PriCara,(TM) Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
CONTACT: Media: Greg Panico, +1-908-927-3715, [email protected],PriCara(TM), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.;Investors: Louise Mehrotra, +1-732-524-6491, or Lesley Fishman, +1-732-524-3922, Johnson & Johnson
Web site: http://www.pricara.com/http://www.jnj.com/http://www.aciphex.com/