Published:
Warner Chilcott Announces New Information in USPTO Reexamination of TACLONEX Patent
ST. DAVID'S,Bermuda, July 24 /PRNewswire-FirstCall/ -- Warner Chilcott
Limited (Nasdaq: WCRX) announced today that LEO Pharma A/S ("LEO Pharma") has
received a Right of Appeal Notice from the U.S. Patent and Trademark Office
(the "USPTO"). In September 2006, the USPTO ordered a reexamination of LEO
Pharma'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(R) products and certain
of LEO Pharma's products in development. Warner Chilcott markets and sells
TACLONEX(R) products inthe United States under a license agreement with LEO
Pharma and has license rights to certain products in development.
In the Right of Appeal Notice, the patent examiner allowed the specific
formulation claim for TACLONEX(R) ointment, but rejected the remaining pending
claims in the reexamination of LEO Pharma's 013 Patent. LEO Pharma intends to
vigorously defend the 013 Patent and will file an appeal with the USPTO.
While we can offer no assurance as to the ultimate outcome of the appeal
of the reexamination proceedings, Warner Chilcott continues to believe that
LEO Pharma will succeed in maintaining the important elements of the patent
protection for TACLONEX(R) products, particularly based on the timing, extent
and quality of the development work conducted by LEO Pharma with vitamin D
analogues in combination with corticosteroids.
About Warner Chilcott
Warner Chilcott is a leading specialty pharmaceutical company currently
focused on the women's healthcare and dermatology segments of the U.S.
pharmaceuticals market. It is a fully integrated company with internal
resources dedicated to the development, manufacturing and promotion of its
products. WCRX-G
Read more on http://www.warnerchilcott.com.
Forward Looking Statements
This press release contains forward-looking statements, including
statements concerning our operations, our economic performance and financial
condition, and our business plans and growth strategy and 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 believed 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
(including the approval and introduction of generic or branded products that
compete with our products); 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; adverse outcomes in our outstanding litigation or an
increase in the number of litigation matters to which we are subject;
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 manage the growth of our business by successfully identifying,
developing, acquiring or licensing new products at favorable prices and
marketing such new products; our ability to obtain regulatory approval and
customer acceptance of new products, and continued customer acceptance of our
existing products; changes in tax laws or interpretations that could increase
our consolidated tax liabilities; the other risks identified in our Annual
Report on Form 10-K for the year ended December 31, 2007; and other risks
detailed from time-to-time in our public filings, 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.
SOURCE Warner Chilcott Limited
Copyright © 2009, PRNewswire
Copyright © 2009, NewsBlaze,
Daily News
Tags: ,MTC,HEA,LAW,PLW,WarnerChilcott-patent
_ _