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Court upholds previous decision of High Court of England affirming
that asserted claims of UK patent 762,888 are valid
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Decision denies application from Generics [UK] Ltd to grant
non-infringement declaration for purported generic version
JERUSALEM--(BUSINESS WIRE)--Jul. 29, 2013--
Teva Pharmaceuticals Industries Ltd (NYSE:TEVA) announced today that the
Court of Appeal for England and Wales has found in favor of Teva,
upholding the validity of the asserted claims of UK patent 762,888
relating to Copaxone® (glatiramer acetate injection), following an
appeal brought by Generics [UK] Limited, a subsidiary of Mylan
Laboratories Inc.
In the litigation, Generics [UK] had applied to the court to revoke the
patent and also grant a declaration of non-infringement for its
purported generic version of Copaxone®. The High Court and the Court of
Appeal have now both upheld the validity of the patent and denied the
application for a declaration of non-infringement. The patent is not due
to expire until May 2015.
Teva’s President and CEO, Dr. Jeremy Levin, welcomed the court’s
decision: “This decision upholding the patent strengthens Teva’s
exclusivity of Copaxone® in the UK until at least the date of the patent
expiry. Thousands of patients in the UK and elsewhere depend on
Copaxone® for relief in relapsing-remitting multiple sclerosis, and we
are pleased that the English Court of Appeal has upheld the validity of
the patent until its expiry in 2015.”
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.
Given the complexity of COPAXONE®, unpredictable differences between a
proposed generic product and COPAXONE® could lead to immunogenic effects
in patients. The inability to fully characterize the active ingredients
of the product leads many experts to believe that the only way to ensure
the safety, efficacy and immunogenicity of any purported generic version
of COPAXONE® would be through full-scale, placebo-controlled clinical
trials with measured clinical endpoints (such as relapse rate) in
relapsing-remitting multiple sclerosis (RRMS) patients.
About Teva
Teva 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
1,000 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 $20.3 billion
in net revenues in 2012.
Indication
COPAXONE® (glatiramer acetate injection) is indicated for reduction of
the frequency of relapses in patients with Relapsing-Remitting Multiple
Sclerosis (RRMS), including patients who have experienced a first
clinical episode and have MRI features consistent with multiple
sclerosis.
Important Safety Information about COPAXONE® (glatiramer acetate
injection)
Patients allergic to glatiramer acetate or mannitol should not take
COPAXONE®.
Some patients report a short-term reaction right after injecting
COPAXONE®. This reaction can involve flushing (feeling of warmth and/or
redness), chest tightness or pain with heart palpitations, anxiety, and
trouble breathing. These symptoms generally appear within minutes of an
injection, last about 15 minutes, and go away by themselves without
further problems. During the post-marketing period, there have been
reports of patients with similar symptoms who received emergency medical
care. If symptoms become severe, patients should call the emergency
phone number in their area. Patients should call their doctor right away
if they develop hives, skin rash with irritation, dizziness, sweating,
chest pain, trouble breathing, or severe pain at the injection site. If
any of the above occurs, patients should not give themselves any more
injections until their doctor tells them to begin again.
Chest pain may occur either as part of the immediate post-injection
reaction or on its own. This pain should only last a few minutes.
Patients may experience more than one such episode, usually beginning at
least one month after starting treatment. Patients should tell their
doctor if they experience chest pain that lasts for a long time or feels
very intense.
A permanent indentation under the skin (lipoatrophy or, rarely,
necrosis) at the injection site may occur, due to local destruction of
fat tissue. Patients should follow proper injection technique and inform
their doctor of any skin changes.
The most common side effects of COPAXONE® are redness, pain, swelling,
itching, or a lump at the site of injection, flushing, rash, shortness
of breath, and chest pain. These are not all of the possible side
effects of COPAXONE®. For a complete list, patients should ask their
doctor or pharmacist. Patients should tell their doctor about any side
effects they have while taking COPAXONE®.
Patients are encouraged to report negative side effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch
or call 1-800-FDA-1088.
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 purported 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, the effects of increased leverage as a result of
recent acquisitions, 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, 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 pathways for the registration and approval of
biotechnology-based products, adverse effects of political or economical
instability, corruption, 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
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, 2012 and in our other filings with the U.S. Securities and Exchange
Commission. Forward-looking statements speak only as of the date on
which they are made and the Company undertakes no obligation to update
or revise any forward-looking statement, whether as a result of new
information, future events or otherwise.
Source: Teva Pharmaceuticals Industries Ltd
Teva Pharmaceuticals Industries Ltd
IR:
United States
Kevin
C. Mannix, 215-591-8912
or
Israel
Tomer Amitai, 972
(3) 926-7656
or
PR:
Israel
Iris Beck Codner, 972
(3) 926-7687
or
United States
Denise Bradley, 215-591-8974
or
Europe
Paul
Williams, 31 346 290 312