ROCKAWAY (dpa-AFX) - Warner Chilcott plc (WCRX) said Monday that the U.S. District Court for the District of New Jersey upheld the validity of the U.S. patent covering the company's DORYX 150 mg product, but determined that neither Mylan Inc.'s (MYL) nor Impax Pharmaceuticals, Inc.'s proposed generic version of the DORYX 150 mg product infringed the '161 Patent.
As a result of the court's ruling, Mylan has entered the market with its FDA approved generic equivalent of the company's DORYX 150 mg product.
Warner Chilcott said it is reviewing the court's decision, and plans to appeal the non-infringement determinations.
Warner Chilcott markets and sells DORYX, a tetracycline-class oral antibiotic, in the United States under a license agreement with Mayne Pharma International Pty. Ltd., which owns the '161 Patent. The DORYX 150 mg product currently represents all but a de minimis amount of the company's DORYX product net sales.
In connection with the court ruling, Warner Chilcott expects to record an impairment charge in the range of $90 to $108 million related to its DORYX intangible asset, which had a book value of $111 million as of December 31, 2011. The charge is expected to materially reduce the company's 2012 GAAP net income.
In addition, the company is reviewing Mylan's claims for damages resulting from the issuance of the temporary restraining order. An estimate of the range of potential loss, if any, resulting from such claims is not possible at this time.
Warner Chilcott expects to include the impact of the DORYX impairment charge and update its revenue, adjusted cash net income and other items included in its full 2012 financial guidance when it reports its first quarter 2012 financial results on May 4.
Earlier Monday, Warner Chilcott confirmed that it is conducting a process to explore a broad range of strategic alternatives to enhance shareholder value, which include preliminary discussions with potential offerors.
The discussions are at a preliminary stage and may or may not lead to an offer for the company, Warner Chilcott said.
Copyright RTT News/dpa-AFX
