Teva Pharmaceutical Industries Ltd.
) recently announced another favorable decision regarding its
Copaxone patent. The company said that the United Kingdom High
Court of Justice ruled in its favor in its patent litigation
) subsidiary, Generics (UK) Limited.
Generics (UK) Limited had asked the Court to revoke Copaxone's
European Patent (UK) 762,888, which is scheduled to expire on May
23, 2015. Generics (UK) Limited was also seeking to get a
declaration that its generic version of Copaxone would not infringe
on the '888 patent.
The Court not only ruled that the '888 patent is valid, but it
also refused to state that Generics UK's generic version of
Copaxone would not infringe on it.
The favorable UK ruling comes just a few weeks after the US
District Court for the Southern District of New York ruled in the
company's favor in its Copaxone patent infringement lawsuit. Teva
had filed a patent infringement lawsuit against
Momenta Pharmaceuticals, Inc.
)/Sandoz Inc. and Mylan/Natco Pharmaceuticals, which were looking
to launch their generic versions of Copaxone.
Copaxone is approved for the reduction of the frequency of
relapses in relapsing-remitting multiple sclerosis (RRMS),
including patients who have experienced a first clinical episode
and have MRI features consistent with multiple sclerosis.
Given the US court ruling, Copaxone should be protected from
generic competition in the US until May 24, 2014, when the Orange
Book patents are scheduled to expire. Teva believes that the
protection could extend up to September 1, 2015, when the process
patent is slated to expire.
The favorable rulings are a major positive for Teva. With
Copaxone contributing 19.5% to total revenues in 2011, the
earlier-than-expected entry of generic versions would have been a
major setback for the company. Teva can now focus on extending
Copaxone's life cycle.
The company recently announced positive top-line results on
Copaxone from a phase III study, GALA, which was conducted to
evaluate the efficacy, safety and tolerability of Copaxone (40mg)
administered thrice a week compared to placebo in patients with
RRMS. The 40mg dose being evaluated in the GALA study is a higher
strength compared to the 20mg dose currently available (daily
Results showed that Copaxone 40mg significantly reduced disease
activity. The safety and tolerability profile was also found to be
The positive rulings have removed a major overhang on the
shares. We currently have a Neutral recommendation on Teva, which
carries a Zacks #3 Rank (short-term Hold rating).
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