Teva Confirms District Court Decision in COPAXONE® 40 mg/mL Patent Trial
31 Janvier 2017 - 12:52AM
Business Wire
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
confirmed the U.S. District Court for the District of Delaware
ruling invalidating all asserted claims of the ‘250, ‘413, ‘776 and
‘302 patents for COPAXONE® (glatiramer acetate injection) 40 mg/mL.
The patent infringement case involved five of six Abbreviated New
Drug Application (ANDA) filers. Teva plans to appeal the
decision.
“We intend to move forward with an immediate appeal,” said Erez
Vigodman, Teva President and CEO. “We will continue to vigorously
protect our COPAXONE® franchise against further challenges and
through the duration of this process.”
Separately, a suit was filed against all six ANDA filers on
December 19, 2016 in the U.S. District Court for the District of
Delaware to assert a fifth Orange Book patent, U.S. Patent
9,402,874. Additionally, Teva has brought suit against multiple
ANDA filers to assert a non-Orange Book process patent, U.S. Patent
No. 9,155,775, in various jurisdictions.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
leading global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by millions of patients
every day. Headquartered in Israel, Teva is the world’s largest
generic medicines producer, leveraging its portfolio of more than
1,800 molecules to produce a wide range of generic products in
nearly every therapeutic area. In specialty medicines, Teva has a
world-leading position in innovative treatments for disorders of
the central nervous system, including pain, as well as a strong
portfolio of respiratory products. Teva integrates its generics and
specialty capabilities in its global research and development
division to create new ways of addressing unmet patient needs by
combining drug development capabilities with devices, services and
technologies. Teva's net revenues in 2015 amounted to $19.7
billion. For more information, visit www.tevapharm.com.
Teva's 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 specialty
products, especially Copaxone® (which faces competition from
orally-administered alternatives and a generic version); our
ability to realize the anticipated benefits of the acquisition
of Allergan plc’s worldwide generic pharmaceuticals
business (“Actavis Generics”), and the timing of realizing such
benefits; our ability to fully and efficiently integrate Actavis
Generics and to achieve the anticipated cost savings, synergies,
business opportunities and growth prospects from the combination;
the fact that we are now dependent to a much larger extent than
previously on our generic pharmaceutical business; our ability to
develop and launch new generic products from the Actavis Generics
pipeline on the anticipated timelines; potential restrictions on
our ability to engage in additional transactions or incur
additional indebtedness as a result of the substantial amount of
debt we have incurred to finance the Actavis Generics acquisition;
the fact that we will have significantly less cash on hand than
prior to the consummation of the Actavis Generics acquisition,
which could adversely affect our ability to grow; our ability to
achieve expected results from investments in our pipeline of
specialty and other products; 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; 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; competition for our generic products, both from other
pharmaceutical companies and as a result of increased governmental
pricing pressures; governmental investigations into sales and
marketing practices, particularly for our specialty pharmaceutical
products; adverse effects of political or economic 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 specialty pharmaceutical
businesses from companies with greater resources and capabilities;
the impact of continuing consolidation of our distributors and
customers; 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; our potential exposure to product liability
claims that are not covered by insurance; any failure to recruit or
retain key personnel, including, in particular, former Actavis
Generics personnel who have transitioned to Teva or to attract
additional executive and managerial talent; any failures to comply
with complex Medicare and Medicaid reporting
and payment obligations; significant impairment charges relating to
intangible assets, goodwill and property, plant and equipment; the
effects of increased leverage and our resulting reliance on access
to the capital markets; 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; the possibility of
additional adverse consequences arising from our recent
FCPA-related settlement with the U.S. government, including
limitations on our conduct of business in various countries,
adverse judgments in shareholder lawsuits and fines, penalties or
other sanctions imposed by government authorities in other
countries; and other factors that are discussed in our Annual
Report on Form 20-F for the year ended December 31,
2015 and in our other filings with the U.S. Securities
and Exchange Commission (the SEC). 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
statements or other information, whether as a result of new
information, future events or otherwise.
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version on businesswire.com: http://www.businesswire.com/news/home/20170130006215/en/
Teva Pharmaceuticals Industries Ltd.IR:Kevin C. Mannix,
215-591-8912United StatesorRan Meir, 215-591-3033United
StatesorTomer Amitai, 972 (3) 926-7656IsraelorPR:Iris
Beck Codner, 972 (3) 926-7687IsraelorDenise Bradley,
215-591-8974United StatesorNancy Leone, 215-284-0213United
States
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