Orion Sues Sun Pharmaceuticals in the U.S. to Enforce a Patent for Stalevo
Company states the realisation of generic competition is neither
certain nor imminent
ESPOO, Finland, Nov. 13, 2007--Orion Corporation has filed a patent
infringement lawsuit in the United States to enforce its
formulation patent, U.S. Patent No. 6,500,867, against Sun
Pharmaceutical Industries Inc. and Sun Pharmaceutical Industries
Limited, who seek to market generic versions of Stalevo®
tablets (25/100/200 and 37.5/150/200 mg strengths of
carbidopa/levodopa/entacapone) in the United States. Stalevo is an
enhanced levodopa treatment originated by Orion Corporation and
marketed in the United States by its exclusive licensee, Novartis,
for the treatment of Parkinson's disease. Orion Corporation and
Novartis will vigorously defend the intellectual property rights
covering Stalevo.
As previously reported, Orion Corporation was notified in October
2007 that a generic drug company had submitted an Abbreviated New
Drug Application (ANDA) with the U.S. Food and Drug Administration
(FDA) that included a Paragraph IV certification challenging two of
Orion Corporation's formulation patents protecting Stalevo. By
suing to enforce its patent within 45 days from receipt of the
Paragraph IV certification notice, Orion Corporation is entitled to
an automatic stay prohibiting the FDA from approving the
applicant's ANDA for 30 months, or until an earlier court decision
adverse to Orion Corporation's patent in the patent infringement
lawsuit. As such, the realisation of generic competition is neither
certain nor imminent.
ABOUT ORION
Orion Corporation is dedicated to treating and preventing disease
by discovery and developing innovative medicinal treatments. In
2006, Orion Corporation generated sales of EUR 641.1 million,
invested EUR 84.1 million in research and development and employed
approximately 3,060 people. Orion corporate headquarters are in
Espoo, Finland. For more information, please visit:
http://www.orion.fi/english/.
Orion Corporation
Jukka
Viinanen
Olli Huotari
President and
CEO
Senior VP, Corporate Functions
Contact persons:
Jukka Viinanen, President and CEO, phone +358 10 426 3710
Olli Huotari, Senior VP, Corporate Functions, phone +358 10 426
3054
Statements in this news release other than historical information
are forward-looking statement subject to risks and uncertainties.
Actual results could differ materially depending on factors such as
the availability of resources, the timing and effects of regulatory
actions, the strength of competition, the outcome of litigation and
the effectiveness of patent protection. Additional information
regarding risks and uncertainties is set forth in Annual Report for
2006.
Publisher:
Orion Corporation
Communications
Orionintie 1A, FI-02200 Espoo
Homepage: www.orion.fi
Posted: November 2007
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