June 30, 2010
Shionogi & Co., Ltd.
CRESTOR
®
PATENT UPHELD BY US DISTRICT COURT, DISTRICT OF DELAWARE
Osaka, June 30, 2010 – Shionogi & Co., Ltd. (Head Office: Osaka; President: Isao Teshirogi; hereafter
“Shionogi”) announced today that Judge Joseph Farnan, Jr., US District Court, District of Delaware, has
found that the substance patent protecting CRESTOR
®
(RE37,314 – the ‘314 patent) is valid and enforceable.
In its ruling, the court found that no inequitable conduct was committed by any Shionogi employee. The court
also held the ‘314 patent to be non-obvious and properly reissued.
Judge Farnan also held that Apotex USA was liable as a submitter and is therefore bound to the court’s
decision.
Shionogi sees intellectual property as very important resources and intends to take legal responses against
infringements or the risk of infringements of our intellectual property in the future.
About the Trial
Beginning in 2007, eight generic drug manufacturers filed ANDAs along with Paragraph IV certifications of
non-infringement, invalidity, or unenforceability with respect to the CRESTOR
®
patents. Shionogi (the owner
of the ‘314 patent) and AstraZeneca filed patent infringement suits against eight manufacturers (Apotex,
Aurobindo, Cobalt, Mylan, Par, Sandoz, Sun and Teva) who had challenged the ‘314 substance patent. The
‘314 patent, which expires in 2016, covers rosuvastatin calcium, the active ingredient in CRESTOR
®
. These
suits were consolidated by order of the Judicial Panel on Multidistrict Litigation and tried in the US District
Court, District of Delaware. Trial commenced on February, 2010 before Judge Farnan and ended on March 4
(Japan time), 2010.
Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, unavailability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
For further information, contact: Corporate Communications Department Shionogi & Co., Ltd. Telephone: +81-6-6209-7885
Fax: +81-6-6229-9596