Bristol-Myers loses Baraclude patent fight with Teva
A U.S. court has struck Baraclude from the patent list. The Bristol-Myers Squibb ($BMY) hepatitis B drug saw its composition of matter patent invalidated in a court fight with Teva Pharmaceutical Industries ($TEVA), which wants to sell its own version. The patent had been due to expire in 2015.
It's unclear whether the ruling will expose Baraclude to immediate generic competition. Teva hasn't yet won the FDA's blessing for its copy; as soon as it asked the FDA for approval, Bristol-Myers sued, triggering a 30-month waiting period under the Hatch-Waxman Act. Sandoz, the Novartis ($NVS) generics unit, also has an FDA app pending--and has been fighting its own patent-challenge case since last June.
Baraclude brought in $241 million in the U.S. last year, and it's expected to generate $260 million for 2013. That's a small fraction of Baraclude's worldwide sales of $1.4 billion last year, and ISI Group analyst Mark Schoenebaum figures that a Teva knock-off in the U.S. wouldn't damage sales enough to dent Bristol-Myers' 2013 profits forecast, Forbes reports.
Still, with generic competition pushing its former blockbuster Plavix off the sales charts, Bristol-Myers needs all the sales it can get. "We are disappointed with the court's decision and believe it is incorrect," spokeswoman Laura Hortas told Forbes, adding that the company is weighing an appeal.