Nelson Quoted on Viability of Carveouts in Generic Drug Marketing

Partner Kevin Nelson was quoted on a Federal Circuit Court ruling in GlaxoSmithKline v. Teva, which has caused concern among some generic drug manufacturers regarding their ability to sell generic drugs that leave patent-protected uses off the label.

Currently, generic drug makers are allowed to keep patent-protected uses off the label under Section vii of the Hatch-Waxman Act, a so-called carveout or skinny label.

Kevin said, “Practitioners can say that we're still going to be focused on carveouts, that's still a viable option, and that Teva is a different animal entirely.” But he added, "We're looking at being more careful with what's said in press releases."

Read the full article here. (Subscription required)


Continue Reading