Teva Pharmaceutical Industries confirmed the PTAB’s decisions from an inter-partes review on two patents protecting the multiple sclerosis drug, adding on 24 August that it plans to take its appeal to the US Court of Appeals for the Federal Circuit.
Erez Vigodman, president and CEO of Teva, said: “We remain confident in the strength of our intellectual property surrounding Copaxone.”
“We are prepared to defend the full suite of our intellectual property through the PTAB and US courts regardless of the time required.”
“We believe patients, physicians and payers will continue to value the efficacy, safety and tolerability of Copaxone and that it will remain a proprietary, global market-leading product for the reduction of relapses in RRMS patients.”
Teva said that the PTAB had declined a request for a post-grant review on an additional Copaxone patent.
“Teva will defend four patents, all listed in the Orange Book with expiry dates into 2030, against a number of Abbreviated New Drug Application filers in the US District Court for the District of Delaware trial scheduled to begin in September 2016,” Teva said in a statement.
Copaxone has long been a target for generics manufacturers keen to take a slice of its estimated $5 billion per year in revenue.
In June last year, the US Court of Appeals for the Federal Circuit invalidated Teva’s US patent covering Copaxone, finding it indefinite under the Supreme Court’s new standard.