Shire Files Lawsuits Against Watson and Roxane for Infringement of VYVANSE(R) (lisdexamfetamine dimesylate) Patents

By Shire Plc, PRNE
Wednesday, July 6, 2011

DUBLIN, July 7, 2011 -


Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty
biopharmaceutical company, announces that it has filed lawsuits in
the U.S. District Court for the District of New Jersey against
Roxane Laboratories, Inc., (”Roxane”), and in the U.S. District
Court for the Central District of California against Watson
Laboratories, Inc., (”Watson”), respectively, for infringement of
certain of Shire’s VYVANSE patents.

The lawsuits were initiated in response to Abbreviated New Drug
Applications (”ANDAs”) filed by each of Roxane and Watson seeking
FDA approval to market and sell generic versions of all currently
approved doses of VYVANSE.

Under the Hatch-Waxman Act, the FDA must refrain from approving
the Roxane and Watson ANDAs before August 23, 2014, or until a
district court decision finding that the patents are invalid or not
infringed, whichever occurs earlier.

Shire will provide details of any additional Paragraph IV
certifications received advising of ANDA filings on VYVANSE, and
any litigation that is subsequently initiated, in its periodic
filings on Forms 10-Q and 10-K.

Notes to editors


Shire’s strategic goal is to become the leading specialty
biopharmaceutical company that focuses on meeting the needs of the
specialist physician.  Shire focuses its business on attention
deficit hyperactivity disorder (ADHD), human genetic therapies
(HGT) and gastrointestinal (GI) diseases as well as opportunities
in other therapeutic areas to the extent they arise through
acquisitions.  Shire’s in-licensing, merger and acquisition
efforts are focused on products in specialist markets with strong
intellectual property protection and global rights.  Shire
believes that a carefully selected and balanced portfolio of
products with strategically aligned and relatively small-scale
sales forces will deliver strong results.

For further information on Shire, please visit the Company’s
website: href="">


Statements included herein that are not historical facts are
forward-looking statements. Such forward-looking statements involve
a number of risks and uncertainties and are subject to change at
any time. In the event such risks or uncertainties materialize, the
Company’s results could be materially adversely affected. The risks
and uncertainties include, but are not limited to, risks associated
with: the inherent uncertainty of research, development, approval,
reimbursement, manufacturing and commercialization of the Company’s
Specialty Pharmaceuticals and Human Genetic Therapies products, as
well as the ability to secure and integrate new products for
commercialization and/or development; government regulation of the
Company’s products; the Company’s ability to manufacture its
products in sufficient quantities to meet demand; the impact of
competitive therapies on the Company’s products; the Company’s
ability to register, maintain and enforce patents and other
intellectual property rights relating to its products; the
Company’s ability to obtain and maintain government and other
third-party reimbursement for its products; and other risks and
uncertainties detailed from time to time in the Company’s filings
with the Securities and Exchange Commission.

For further information please contact:

Investor Relations    
Eric Rojas (
Sarah Elton-Farr ( href="">  

Jessica Mann (
Matthew Cabrey ( href="">  


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