Teva Pharmaceutical Industries Ltd. (TEVA - Analyst Report) 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 against Mylan’s (MYL - Analyst Report) 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. (MNTA - Snapshot Report)/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 injection).
Results showed that Copaxone 40mg significantly reduced disease activity. The safety and tolerability profile was also found to be favorable.
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).