Teva Pharmaceutical Industries Ltd.
announced that while the Chief Justice of the United States found that Teva had demonstrated “a fair prospect of success on the merits” in its appeal of a decision from the United States Court of Appeals for the Federal Circuit that invalidated the claim of U.S. Patent 5,800,808 (the “’808 patent”), he denied the Company’s application to stay the Federal Circuit's decision due to the potential for the Company to recover patent infringement damages. The ‘808 patent expires on September 1, 2015 and claims a process for manufacturing the active ingredient of Teva’s relapsing-remitting multiple sclerosis (RRMS) product, COPAXONE® (glatiramer acetate injection) 20mg/mL. Teva will continue pursuing its appeal in the Supreme Court and defending its intellectual property for COPAXONE
Teva previously prevailed in the District Court, which upheld the validity of nine COPAXONE
patents, including the ‘808 patent. A ruling last year by the Court of Appeals for the Federal Circuit upheld some of the COPAXONE
patents that expire in May 2014, while invalidating the ‘808 patent that is the subject of Teva’s now-granted
Any purported generic version of COPAXONE
would be required to obtain the approval of the Food and Drug Administration prior to being made available to the public. The inability to fully characterize the active ingredients of the product leads many experts to believe that the only way to ensure the safety, efficacy and immunogenicity of any purported generic version of COPAXONE
would be through full-scale, placebo-controlled clinical trials with measured clinical endpoints (such as relapse rate) in RRMS patients.
The Company is confident COPAXONE
will remain a proprietary, global market leading product for the reduction in the frequency of relapses in RRMS patients over the product’s lifecycle, given the strength of its intellectual property rights.
Teva Pharmaceutical Industries Ltd. is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in approximately 60 countries. Teva's branded businesses focus on CNS, oncology, pain, respiratory and women's health therapeutic areas as well as biologics. Teva currently employs approximately 45,000 people around the world and reached $20.3 billion in net revenues in 2013.