Southern District Court of New York Rules Patent for ACIPHEX(R) Enforceable
Posted on: Friday, 11 May 2007, 18:00 CDT
RARITAN, N.J., May 11 /PRNewswire/ -- PriCara,(TM) Unit of Ortho-McNeil, Inc., announced today that the Southern District Court of New York ruled that the patent for ACIPHEX(R) (rabeprazole sodium 20 mg tablets) is enforceable. PriCara and Eisai Inc. co-promote ACIPHEX in the United States.
In an earlier ruling, the Court confirmed the validity of the ACIPHEX composition of matter patent. Today's decision and the earlier court ruling ensure that the patent is protected and that FDA approved generic versions of rabeprazole sodium will be available no earlier than the date of the patent expiration, May 2013, unless overturned on appeal.
"We are pleased by the Court's decision, which reflects our belief that the patent for ACIPHEX, previously found to be valid, is enforceable," said Jeffrey N. Smith, president, Ortho-McNeil, Inc.
Eisai Co. Ltd. of Tokyo, Japan, holds the patent for ACIPHEX, and Eisai Inc. of Woodcliff Lake, N.J., is the exclusive licensee.
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,(TM) Unit of Ortho-McNeil, Inc.
PriCara,(TM) Unit of Ortho-McNeil, Inc., a subsidiary of Johnson & Johnson, is a major healthcare company in the United States dedicated to the needs of primary care providers who serve a vital role on the frontline of medicine. For more information about the company, please visit http://www.pricara.com/.
(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 the Company'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 the Johnson & Johnson Annual Report on Form 10-K for the fiscal year ended December 31, 2006. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov/ or on request from Johnson & Johnson. The Company does not undertake to update any forward- looking statements as a result of new information or future events or developments.)
PriCara,(TM) Unit of Ortho-McNeil, Inc.
CONTACT: media, Greg Panico of PriCara,(TM) Unit of Ortho-McNeil, Inc.,+1-908-927-3715, Gpanico1@gpcus.jnj.com, investors, Louise Mehrotra,+1-732-524-6491, or Stan Panasewicz, +1-732-524-2524, or Lesley Fishman,+1-732-524-3922, all of Johnson & Johnson
Web site: http://www.pricara.com/http://www.aciphex.com/
Source: PRNewswire
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