It’s Day 2 of the 7-day district court hearing into patent protection on Teva’s newer version of multiple sclerosis blockbuster Copaxone, and at this point, things aren’t looking great for the Israeli drugmaker.
So far, trial proceedings “provide little reason to believe that [the] district court may produce a different decision” from the inter partes review process at the U.S. Patent and Trademark Office’s Patent Trial and Appeals Board. That board recently nixed three 2030 patents on Teva's 40-mg formulation of its big-earning MS drug.
At least, that’s the word from Evercore ISI analyst Umer Raffat, who wrote to clients on Wednesday that “we didn’t find anything needle-moving” from the hearing’s first couple of days.
He’s not the only one who thinks Teva may be in some trouble against the group of defendants, which Teva sued for patent infringement. The patent suits, now consolidated, comprise two teams working on Copaxone 40-mg copies--Momenta and Sandoz, and Mylan and Natco--as well as solo copycats Amneal, Dr. Reddy’s and Synthon.
As Barclays analyst Douglas Tsao wrote in his own investor note on Wednesday, the Israeli drugmaker “appears at the mercy of the court at this point,” and he predicts the company will “try to stall proceedings in order to later introduce additional witnesses and arguments.”
Seeing its patents upturned would be a crushing blow for the Petah Tikva-based pharma, which only recently saw the original formulation of its superstar come under generic attack by the Novartis/Momenta team. Luckily for Teva, it managed to switch most of its patients over to the long-acting version before the competition hit, but if its generic rivals prevail in court, it could see all that hard work--and all those protected sales--go out the window.
That’s not exactly a scenario Teva’s cool with, especially as it looks to bolster the specialty side of its business. After sealing a $40-billion-plus deal for Allergan’s generics unit this summer, it’s now scouting “attractive specialty assets, or branded drug assets or pipeline assets” that fit in with the therapeutic areas it’s already tackling, including pain, neurodegenerative disease and respiratory conditions, CEO Erez Vigodman said last month.
Best way for Teva to deal with Copaxone threat? Settle, analyst urges
With Allergan deal sealed, Teva turns its attention to branded M&A
Teva's Copaxone finally succumbs to copycats, putting a drag on 2015 sales
Why is Novartis' Copaxone copy lagging? It's all about coverage, analyst explains
U.S. patent office puts new Copaxone's IP shield under the lens
Mylan, Momenta, Sandoz join assault on Teva's new-and-improved Copaxone
Teva's early Copaxone-switching success turns analysts into believers