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Warner Chilcott Announces New Information in USPTO Reexamination of Taclonex Patent
HAMILTON, Bermuda, September 17 /PRNewswire/ --
Warner Chilcott Limited (Nasdaq: WCRX) announced today that LEO Pharma
A/S ("LEO") has received a non-final Action Closing Prosecution from the U.S.
Patent and Trademark Office (the "USPTO"). In September 2006, the USPTO
ordered a reexamination of LEO's US Patent No. 6,753,013 (the "013 Patent")
in response to a request made by Galderma R&D. The 013 Patent covers TACLONEX
and certain of LEO's products in development. Warner Chilcott markets and
sells TACLONEX in the United States under a license agreement with LEO and
has license rights to certain products in development.
In the non-final Action Closing Prosecution the patent examiner allowed
the specific formulation claim for TACLONEX ointment, but rejected the
remaining pending claims in the reexamination of LEO's 013 Patent. LEO
intends to vigorously defend the 013 Patent and will file a response with the
USPTO.
While we can offer no assurance as to the ultimate outcome of the
reexamination proceedings, including any related appeals, Warner Chilcott
continues to believe that LEO will succeed in maintaining the important
elements of the patent protection for TACLONEX, particularly based on the
timing, extent and quality of the development work conducted by LEO with
vitamin D analogues in combination with corticosteroids.
About Warner Chilcott
Warner Chilcott is a specialty pharmaceutical company focused on
developing, manufacturing, marketing and selling branded prescription
pharmaceutical products in women's healthcare and dermatology in the United
States. WCRX-G
Read more on http://www.warnerchilcott.com.
Warner Chilcott's Forward Looking Statements:
This press release contains forward-looking statements, including
statements concerning our product development efforts. These statements
constitute forward looking statements within the meaning of Section 27A of
the Securities Act of 1933 and Section 21E of the Securities Exchange Act of
1934. The words "may," "might," "will," "should," "estimate," "project,"
"plan," "anticipate," "expect," intend," "outlook," "believe" and other
similar expressions are intended to identify forward-looking statements.
Readers are cautioned not to place undue reliance on these forward looking
statements, which speak only as of their dates. These forward-looking
statements are based on estimates and assumptions by our management that,
although we believe to be reasonable, are inherently uncertain and subject to
a number of risks and uncertainties.
The following represent some, but not necessarily all, of the factors
that could cause actual results to differ from historical results or those
anticipated or predicted by our forward-looking statements: our substantial
indebtedness; competitive factors in the industry in which we operate; our
ability to protect our intellectual property; a delay in qualifying our
manufacturing facility to produce our products or production or regulatory
problems with either third party manufacturers upon whom we may rely for some
of our products or our own manufacturing facility; pricing pressures from
reimbursement policies of private managed care organizations and other third
party payors, government sponsored health systems, the continued
consolidation of the distribution network through which we sell our products,
including wholesale drug distributors and the growth of large retail drug
store chains; the loss of key senior management or scientific staff; an
increase in litigation, including product liability claims and patent
litigation; government regulation affecting the development, manufacture,
marketing and sale of pharmaceutical products, including our ability and the
ability of companies with whom we do business to obtain necessary regulatory
approvals; our ability to successfully complete the implementation of a
company-wide enterprise resource planning system without disrupting our
business; our ability to manage the growth of our business by successfully
identifying, developing, acquiring or licensing and marketing new products,
obtain regulatory approval and customer acceptance of those products, and
continued customer acceptance of our existing products; and other risks
detailed from time-to-time in our periodic reports filed with the Securities
and Exchange Commission, our financial statements and other investor
communications.
We caution you that the foregoing list of important factors is not
exclusive. In addition, in light of these risks and uncertainties, the
matters referred to in our forward-looking statements may not occur. We
undertake no obligation to publicly update or revise any forward-looking
statement as a result of new information, future events or otherwise, except
as may be required by law.
Web site: http://www.warnerchilcott.com






