Teva Files Amended Complaint Against Momenta/Sandoz to Include Infringement of Three COPAXONE(R)-Related Patents

JERUSALEM, Nov 10, 2009 (BUSINESS WIRE) --
TEVA | Quote | Chart | News | PowerRating -- Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA | Quote | Chart | News | PowerRating) announced today it is
seeking to amend its existing complaint against Momenta Pharmaceuticals,
Inc./Sandoz Inc. to include patent infringement of three additional
patents related to the characterization of COPAXONE(R) (glatiramer acetate
injection). The proposed updated complaint has been filed under seal
with the U.S. District Court for the Southern District of New York along
with a motion requesting that the Court grant Teva leave to amend.

Teva originally filed suit against Momenta/Sandoz in August 2008 for
infringement of multiple patents (seven in the Orange Book which extend
through May 24, 2014), covering the chemical composition of COPAXONE(R),
pharmaceutical compositions containing it and methods of using it. Teva
seeks leave to amend its complaint to include the additional patents
related to the characterization of the active ingredient in COPAXONE(R).
These patents do not expire until several years after the patents
currently in litigation.

COPAXONE(R) is a highly-complicated product to develop and
manufacture, and given the inability to fully characterize the active
ingredients of COPAXONE(R), Teva has serious doubts about any
generic applicant's ability to demonstrate conclusively that the
composition of its product is identical to that of COPAXONE(R).
Internal research at Teva has indicated that even minor changes in the
synthetic process and/or molecular weight distribution of a glatiramoid
(glatiramir acetate-like substance) can have severe ramifications on the
safety and mechanism of action of the product.

Teva contends that any company that files an application for any
glatiramoid, via an ANDA or 505(b)(2) application, should conduct
pre-clinical testing as well as full-scale, placebo-controlled clinical
trials with measured clinical endpoints in MS patients to establish
safety, efficacy and immunogenicity in this patient population.

Teva remains committed to vigorously defending its COPAXONE(R)
intellectual property rights against infringement wherever they are
challenged and intends to pursue all relevant regulatory avenues via the
U.S. Food and Drug Administration (FDA). In September 2009, Teva
received a Paragraph IV certification notice from Mylan Pharmaceuticals
Inc./Natco Pharma Ltd. relating to their ANDA containing a Paragraph IV
certification for COPAXONE(R). On October 16, 2009, Teva filed
a lawsuit in the U.S. District Court for the Southern District Court of
New York with respect to Mylan's filing. A trial date has not been set.

About Teva

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is the
world's leading generic pharmaceutical company and is among the top 20
pharmaceutical companies in the world. The Company develops,
manufactures and markets generic and innovative human pharmaceuticals
and active pharmaceutical ingredients, as well as animal health
pharmaceutical products. Over 80 percent of Teva's sales are in North
America and Europe.

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
successfully develop and commercialize additional pharmaceutical
products, the introduction of competing generic equivalents, the extent
to which we may obtain U.S. market exclusivity for certain of our new
generic products and regulatory changes that may prevent us from
utilizing exclusivity periods, potential liability for sales of generic
products prior to a final resolution of outstanding patent litigation,
including that relating to the generic versions of Neurontin(R), Lotrel(R),
Protonix(R) and Eloxatin(R), the current economic conditions, competition
from brand-name companies that are under increased pressure to counter
generic products, or competitors that seek to delay the introduction of
generic products, the effects of competition on our innovative products,
especially Copaxone(R) sales, dependence on the effectiveness of our
patents and other protections for innovative products, the impact of
consolidation of our distributors and customers, the impact of
pharmaceutical industry regulation and pending legislation that could
affect the pharmaceutical industry, our ability to achieve expected
results though our innovative R&D efforts, the difficulty of predicting
U.S. Food and Drug Administration, European Medicines Agency and other
regulatory authority approvals, the uncertainty surrounding the
legislative and regulatory pathway for the registration and approval of
biotechnology-based products, the regulatory environment and changes in
the health policies and structures of various countries, supply
interruptions or delays that could result from the complex manufacturing
of our products and our global supply chain, our ability to successfully
identify, consummate and integrate acquisitions, the potential exposure
to product liability claims to the extent not covered by insurance, our
exposure to fluctuations in currency, exchange and interest rates,
significant operations worldwide that may be adversely affected by
terrorism, political or economical instability or major hostilities, our
ability to enter into patent litigation settlements and the intensified
scrutiny by the U.S. government, the termination or expiration of
governmental programs and tax benefits, impairment of intangible assets
and goodwill, environmental risks, and other factors that are discussed
in this report and in our other filings with the U.S. Securities and
Exchange Commission ("SEC").

SOURCE: Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd. 
Elana Holzman, 972 (3) 926-7554 
or 
Teva North America 
Kevin Mannix, 215-591-8912

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