Teva faces billions in lost sales as court tosses four long-acting Copaxone patents

Copaxone
A U.S. Court has upturned four patents covering Teva's long-acting version of MS star Copaxone.

It’s déjà vu for Teva Pharmaceutical in a bad, bad way.

Late Monday, the Israeli drugmaker confirmed that the U.S. District Court for the District of Delaware had upturned four of its patents on the long-acting version of multiple sclerosis star Copaxone, putting billions of dollars in revenue at risk.

It’s not an opening of the floodgates for generics makers, who have “several steps still to go” before they can challenge the MS behemoth, as Credit Suisse analyst Vamil Divan put it in a note to clients. Teva CEO Erez Vigodman, for his part, said in a statement that his company “would move forward with an immediate appeal,” and Divan expects the company to request a preliminary injunction preventing any generics from launching until the legal process surrounding all of Teva’s Copaxone IP is completely wrapped up.

Free Webinar

Striving for Zero in Quality & Manufacturing

Pharmaceutical and medical device manufacturers strive towards a culture of zero – zero hazards, zero defects, and zero waste. This webinar will discuss the role that content management plays in pharmaceutical manufacturing to help companies reach the goal of zero in Quality and Manufacturing.

Teva has sued its wannabe rivals on a fifth and sixth patent, too, and an inter partes review appeal is underway at the U.S. Patent and Trademark Office. And of course, if knockoffs are to roll out, they’ll need to win the FDA’s green light first.

Still, Divan doesn’t think it’ll be long before copycats show up. He expects a Novartis/Momenta Pharmaceuticals partnership “and potentially one other competitor to launch later this year and lead to pricing pressure on the brand,” the analyst wrote.

The Petah Tikva-based company has been here before. Back in 2013, a court upturned its patents on the original, 20 mg formulation of its star med, but Teva managed to convert most of its patients to the new-and-improved version before generics hit.

Now, though? There will be no backup med to turn to if Teva’s IP shield is struck down.

That’s not a good prospect for a company whose sales are already struggling. Earlier this month, Teva walked down its 2017 guidance by more than $1 billion after new 2016 launches failed to pan out. It now predicts a top-line haul of between $23.8 billion and $24.5 billion for the year, but some analysts—including Bernstein’s Ronny Gal—have found that figure hard to swallow.

It’s “a tough picture,” Gal wrote in early January.

Suggested Articles

Shionogi's newest antibiotic Fetroja has now earned the FDA's approval, but will a mortality-rate warning scuttle the drug's chances?

Novartis' Sandoz doubled down in Japan as Lupin retreated. Dr. Reddy's posted a loss tied to its Zantac recall. Aslan's varlitinib failed again.

The FDA has slapped the parent of Dollar Tree stores with a warning letter saying some CMOs that made its OTC products were among the world's worst.