Teva Announces Favorable United Kingdom Court Ruling In COPAXONE® Patent Litigation Proceeding
11 Juillet 2012 - 12:07PM
Business Wire
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced that
the United Kingdom High Court of Justice issued a decision in favor
of Teva in a patent litigation proceeding against Generics (UK)
Limited, a subsidiary of Mylan Laboratories Inc., on July 11, 2012.
Generics (UK) Limited commenced the proceeding in the UK to seek
the revocation of European Patent (UK) 762,888, a patent for
COPAXONE® (glatiramer acetate injection) expiring May 23, 2015, and
to obtain a declaration that its proposed generic version of
COPAXONE® would not infringe the ‘888 patent. The High Court
specifically determined that the asserted claims of the ‘888 patent
were valid, and also declined to issue a declaration that Generics
UK’s proposed generic version of COPAXONE® would not infringe the
‘888 patent.
Any potential generic version of COPAXONE® would require a
marketing authorization from the Medicines and Healthcare products
Regulatory Agency (MHRA) before it could be commercialized.
About TevaTeva Pharmaceutical Industries Ltd. (NYSE:
TEVA) is a leading global pharmaceutical company, committed to
increasing access to high-quality healthcare by developing,
producing and marketing affordable generic drugs as well as
innovative and specialty pharmaceuticals and active pharmaceutical
ingredients. Headquartered in Israel, Teva is the world's leading
generic drug maker, with a global product portfolio of more than
1,300 molecules and a direct presence in about 60 countries. Teva's
branded businesses focus on CNS, oncology, pain, respiratory and
women's health therapeutic areas as well as biologics. Teva
currently employs approximately 46,000 people around the world and
reached $18.3 billion in net revenues in 2011.
Teva’s Safe Harbor Statement under the U.S. Private
Securities Litigation Reform Act of 1995:This release contains
forward-looking statements, which express the current beliefs and
expectations of management. Such statements are based on
management’s current beliefs and expectations and involve a number
of known and unknown risks and uncertainties that could cause our
future results, performance or achievements to differ significantly
from the results, performance or achievements expressed or implied
by such forward-looking statements. Important factors that could
cause or contribute to such differences include risks relating to:
our ability to develop and commercialize additional pharmaceutical
products, competition for our innovative products, especially
Copaxone® (including competition from innovative
orally-administered alternatives, as well as from potential generic
equivalents), competition for our generic products (including from
other pharmaceutical companies and as a result of increased
governmental pricing pressures), competition for our specialty
pharmaceutical businesses, our ability to achieve expected results
through our innovative R&D efforts, the effectiveness of our
patents and other protections for innovative products, decreasing
opportunities to obtain U.S. market exclusivity for significant new
generic products, our ability to identify, consummate and
successfully integrate acquisitions (including the acquisition of
Cephalon), the effects of increased leverage as a result of the
acquisition of Cephalon, the extent to which any manufacturing or
quality control problems damage our reputation for high quality
production and require costly remediation, our potential exposure
to product liability claims to the extent not covered by insurance,
increased government scrutiny in both the U.S. and Europe of our
agreements with brand companies, potential liability for sales of
generic products prior to a final resolution of outstanding patent
litigation, including that relating to the generic version of
Protonix®, our exposure to currency fluctuations and restrictions
as well as credit risks, the effects of reforms in healthcare
regulation and pharmaceutical pricing and reimbursement, any
failures to comply with complex Medicare and Medicaid reporting and
payment obligations, governmental investigations into sales and
marketing practices (particularly for our specialty pharmaceutical
products), uncertainties surrounding the legislative and regulatory
pathway for the registration and approval of biotechnology-based
products, adverse effects of political or economical instability,
major hostilities or acts of terrorism on our significant worldwide
operations, interruptions in our supply chain or problems with our
information technology systems that adversely affect our complex
manufacturing processes, any failure to retain key personnel
(including Cephalon employees) or to attract additional executive
and managerial talent, the impact of continuing consolidation of
our distributors and customers, variations in patent laws that may
adversely affect our ability to manufacture our products in the
most efficient manner, potentially significant impairments of
intangible assets and goodwill, potential increases in tax
liabilities, the termination or expiration of governmental programs
or tax benefits, environmental risks and other factors that are
discussed in our Annual Report on Form 20-F for the year ended
December 31, 2011 and in our other filings with the U.S. Securities
and Exchange Commission.
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