After fighting a long battle over the IP shield on lead drug Copaxone, Teva ($TEVA) is feeling the heat from generics makers over the patent on its new, long-acting version of the drug. Monday, though, it got some good news in Europe that'll keep knockoffs makers at bay--for now.
The European Patent Office upheld the validity of the Israeli drugmaker's patent--good through 2030--against copycats from Synthon, Actavis and Mylan ($MYL), the company said in an SEC filing. And while the ruling is subject to appeal, Teva expects any challenger's case will take up to two years to be heard.
The verdict came despite an initial opinion issued by the office earlier this year that was unfavorable for Teva, Evercore ISI analyst Umer Raffat wrote in a Monday note to clients. According to Raffat, Mylan and Synthon had alleged the lack of an "inventive step" for the 40 mg version.
Now, Teva will have to hope the U.S. follows suit. Amid Copaxone's original patent scuffle, Teva managed to convert 70% of patients over to the new version of the drug. But that med came under the U.S. Patent and Trademark Office (PTO) lens in August, when the body instituted inter partes review proceedings against the Petah Tikva-based drugmaker's patents.
As Raffat pointed out, "investors were tracking EPO proceedings to read across to ongoing IPR proceedings" in the U.S. But the way Bernstein analyst Ronny Gal sees it, the chance of the U.S. upturning Teva's patents is still "roughly 50%."
Teva recently filed IPR briefs to support its case, he wrote in a note to investors Monday, but the language in the decision to institute the review "suggest the reviewers are undecided." "Teva is adding to its argument, hoping it would be enough to allow it to prevail on 'preponderance of the evidence'," he wrote. "However, for now we do not see the case as any stronger."
- see Teva's filing
Special Reports: Top 10 Drug Patent Losses of 2015 - Copaxone | Top 10 Generics Makers by 2012 Revenue - Teva - Novartis (Sandoz)