JERUSALEM–(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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170130006215/en/
Contacts
Teva Pharmaceuticals Industries Ltd.
IR:
Kevin C. Mannix, 215-591-8912
United
States
or
Ran Meir, 215-591-3033
United States
or
Tomer
Amitai, 972 (3) 926-7656
Israel
or
PR:
Iris
Beck Codner, 972 (3) 926-7687
Israel
or
Denise
Bradley, 215-591-8974
United States
or
Nancy
Leone, 215-284-0213
United States
Source: Teva Pharmaceutical Industries Ltd.
Cet article Teva Confirms District Court Decision in COPAXONE®
40 mg/mL Patent Trial est apparu en premier sur EEI-BIOTECHFINANCES.