Pharma giant Mylan N.V. said on Thursday that a UK court has ruled in favor of the company and its European partner Synthon, regarding a challenge to the patent of Teva Phamaceutical Industries Ltd. flagship drug Copaxone.
In a statement, Mylan, which earlier this month got regulatory approvals to market the generic versions of the drug for multiple sclerosis, said that the UK’s High Court of Justice has found all patent claims of Teva regarding Copaxone 40 milligrams “invalid based on obviousness.”
“This victory is yet another important milestone for Mylan, and this UK court decision only further increases Mylan’s confidence in its ability to bring high quality, lower-cost generic versions of Copaxone to the multiple sclerosis community and patients around the world,” Mylan said in the statement.
Over the course of the last eight years, Mylan has overcome Teva’s four waves of US patent litigation, eight citizen petitions, injunction proceedings in India and more than 15 regulatory challenges, patent litigations or commercial actions across Europe, and now the litigation in the UK, the statement said.
Thursday’s ruling will pave the way for Mylan’s future launches of Glatiramer Acetate injection in the 40mg dose, the generic version of the Copaxone in the 40mg dose, in certain European markets, Mylan said.
Teva said it plans to appeal the ruling in the UK Court of Appeal. “We are disappointed and disagree with the decision of the UK High Court invalidating the patent for Copaxone 40mg,” Teva said in a text message. The Copaxone 40mg, three-times-a-week medication “is protected throughout Europe by additional intellectual property rights and Teva will continue to defend the Copaxone franchise.”
“Copaxone is currently the most prescribed therapy for relapsing MS worldwide benefiting from more than 2 million patient-years of exposure,” the Teva statement said.
Launched in 1996 by Teva as its first major brand-name drug, Copaxone is still the leading medication for multiple sclerosis patients.
The drug’s patents are now expiring, and in 2015, competitors started marketing a generic version of this drug. While the classic dosage consists of 20mg to be injected daily, Teva had managed to stave off some of the competition by developing a 40mg, three-times-a-week injection of Copaxone, which most patients have now switched to.
Copaxone 40mg accounted for over 85 percent of total Copaxone prescriptions in the US, and over 75% of European Copaxone prescriptions are now filled with the 40mg version, Teva said in its second quarter financial results report. Global revenues for the drug, in its 20mg and 40mg versions, were $1 billion in the second quarter, 10% lower than in the same quarter a year earlier, the Israeli drug-maker said.