Positive Decision Requires Federal Circuit to
Reconsider its Invalidity Ruling in the Case, Teva Pharmaceuticals
USA, Inc. et al. Petitioners v. Sandoz Inc. et al. regarding Teva’s
‘808 Patent
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced
the U.S. Supreme Court’s decision in Teva Pharmaceuticals USA, Inc.
et al. Petitioners v. Sandoz Inc. et al. that reversed the Federal
Circuit Court’s judgment of invalidity of Teva’s ‘808 patent for
COPAXONE® (glatiramer acetate injection) 20 mg/mL. The Supreme
Court remanded the case to the Federal Circuit for further review
in light of the applicable standard the Supreme Court laid out for
appellate review of claim construction.
“We are encouraged by the U.S. Supreme Court’s Decision and look
forward to the Federal Circuit’s review,” said Erez Vigodman,
President and CEO of Teva. “We will continue to explore all
available avenues to protect our intellectual property for
COPAXONE® 20mg/mL. COPAXONE® will remain a proprietary, global
market leading product for the reduction in the frequency of
relapses in patients with relapsing forms of MS over the product’s
lifecycle.”
The U.S. Supreme Court heard oral arguments in Teva
Pharmaceuticals USA, Inc. et al. Petitioners v. Sandoz Inc. et al.
on October 15, 2014 to determine if claim construction rulings in
patent cases are entitled to deference when the district court
makes factual findings in the process.
A ruling last year by the U.S. Court of Appeals for the Federal
Circuit upheld four Teva patents that expired in May 2014, while
invalidating another patent (the ‘808 patent) that is set to expire
on September 1, 2015. Prior to the appellate court’s decision, in
July 2012 the U.S. District Court for the Southern District of New
York ruled in favor of Teva and upheld the ‘808 patent for
COPAXONE® 20 mg/mL.
“There is currently no FDA-approved follow-on version of Teva’s
COPAXONE®,” added Rob Koremans, MD, President and CEO of Global
Specialty Medicines at Teva, “We are encouraged by the FDA’s
willingness to date to have dialogue regarding the complexities of
COPAXONE® 20 mg/mL and the potential limitations and other unknowns
of purported follow-on versions.”
COPAXONE® is available in 20 mg/mL around the world; Teva
launched a less frequent dosing formulation, 40 mg/mL
three-times-a-week, in the US in Jan 2014.
ABOUT COPAXONE®
COPAXONE® (glatiramer acetate injection) is indicated for the
treatment of patients with relapsing forms of multiple sclerosis.
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. See additional important
information at: www.CopaxonePrescribingInformation.com For hardcopy
releases, please see enclosed full prescribing information.
COPAXONE® is now approved in more than 50 countries worldwide,
including the United States, Russia, Canada, Mexico, Australia,
Israel, and all European countries.
Important Safety Information about COPAXONE®
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 postmarketing 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 postinjection 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.
About Teva
Teva Pharmaceutical Industries Ltd. 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 approximately 60 countries. Teva's
Specialty Medicines businesses focus on CNS, respiratory, oncology,
pain, and women's health therapeutic areas as well as biologics.
Teva currently employs approximately 45,000 people around the world
and reached $20.3 billion in net revenues in 2013.
Safe Harbor Statement under the U.S. Private Securities
Litigation Reform Act of 1995:
This release contains forward-looking statements, which 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
orally-administered alternatives, as well as from potential
purported generic equivalents); the possibility of material fines,
penalties and other sanctions and other adverse consequences
arising out of our ongoing FCPA investigations and related matters;
our ability to achieve expected results from the research and
development efforts invested in our pipeline of specialty and other
products; our ability to reduce operating expenses to the extent
and during the timeframe intended by our cost reduction program;
our ability to identify and successfully bid for suitable
acquisition targets or licensing opportunities, or to consummate
and integrate acquisitions; the extent to which any manufacturing
or quality control problems damage our reputation for quality
production and require costly remediation; our potential exposure
to product liability claims that are not covered by insurance;
increased government scrutiny in both the U.S. and Europe of our
patent settlement agreements; our exposure to currency fluctuations
and restrictions as well as credit risks; the effectiveness of our
patents, confidentiality agreements and other measures to protect
the intellectual property rights of our specialty medicines; the
effects of reforms in healthcare regulation and pharmaceutical
pricing, reimbursement and coverage; governmental investigations
into sales and marketing practices, particularly for our specialty
pharmaceutical products; uncertainties related to our recent
management changes; the effects of increased leverage and our
resulting reliance on access to the capital markets; any failure to
recruit or retain key personnel, or to attract additional executive
and managerial talent; 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 internal or third-party information technology
systems that adversely affect our complex manufacturing processes;
significant disruptions of our information technology systems or
breaches of our data security; competition for our generic
products, both from other pharmaceutical companies and as a result
of increased governmental pricing pressures; competition for our
specialty pharmaceutical businesses from companies with greater
resources and capabilities; decreased opportunities to obtain U.S.
market exclusivity for significant new generic products; potential
liability in the U.S., Europe and other markets for sales of
generic products prior to a final resolution of outstanding patent
litigation; any failures to comply with complex Medicare and
Medicaid reporting and payment obligations; the impact of
continuing consolidation of our distributors and customers;
significant impairment charges relating to intangible assets and
goodwill; potentially significant increases in tax liabilities; the
effect on our overall effective tax rate of the termination or
expiration of governmental programs or tax benefits, or of a change
in our business; variations in patent laws that may adversely
affect our ability to manufacture our products in the most
efficient manner; environmental risks; and other factors that are
discussed in our Annual Report on Form 20-F for the year ended
December 31, 2013 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 we assume no obligation to
update or revise any forward-looking statement, whether as a result
of new information, future events or otherwise.
Teva Pharmaceutical Industries Ltd.IR:United StatesKevin C.
Mannix, 215-591-8912Ran Meir,
215-591-3033orIsraelTomer Amitai, 972 (3)
926-7656orPR:IsraelIris Beck Codner, 972 (3)
926-7687orUnited StatesDenise Bradley, 215-591-8974Nancy
Leone, 215-284-0213
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