Shire Files Lawsuit Against Natco Pharma for Infringement of FOSRENOL(R) (lanthanum carbonate) Patents
NASDAQ: SHPGY) announces that it has filed a lawsuit in the U.S. District
Court for the Southern District of
(“Natco”) for infringement of two of Shire’s patents: U.S. Patent No.
5,968,976 (“’976 Patent”); and U.S. Patent No. 7,381,428 (“’428 Patent”);
The lawsuit was filed in response to an ANDA (Abbreviated New Drug
Application) filed by Natco seeking FDA approval to market and sell generic
versions of Shire’s 500 mg, 750 mg, and 1 g FOSRENOL(R) (Lanthanum Carbonate)
products.
Under the Hatch-Waxman Act, because Shire filed its patent infringement
lawsuit within 45 days of receiving Natco’s Paragraph IV notification letter,
the FDA must refrain from approving Natco’s ANDA for 30 months, or until a
district court decision finding that the patents are invalid or not
infringed, whichever occurs earlier. The stay on generic approval will expire
on
Shire has asserted the ’976 and ’428 patents based upon information
provided to it by Natco. Shire will continue to evaluate the situation
throughout the litigation and will take all necessary actions to protect its
rights to the fullest extent possible. Shire has a robust patent estate and
is confident that it will protect the FOSRENOL franchise.
Shire Plc
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:
http://www.shire.com.
“SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995
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 Pharmaceutical 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.
SOURCE Shire Plc