Eli Lilly has already foiled wannabe generic Alimta makers in court—and now it’s prevailed over one company taking the inter partes review route, too.
The Indianapolis pharma has won an IPR challenge from Neptune, keeping a key patent on the blockbuster cancer med intact, Bernstein analyst Tim Anderson wrote to clients Thursday.
And while there’s another lead challenger out there—Novartis’ Sandoz unit—it “seems likely” that the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board “will rule in favor of LLY here,” too, Anderson noted, adding that that would be a wrap on all IPR-related challenges.
As Anderson points out, most investors assumed Lilly would prevail. But that doesn’t mean the stakes weren’t high. Had it lost—opening the floodgates for early generics—“shares could have contracted by high single digits percent, in our view, reflecting the fact that the EPS impact would have been low teens percent,” he said.
Alimta, which bears approvals in non-small cell lung cancer and mesothelioma, is one of Lilly’s top moneymakers; through the first six months of this year, it pulled in $1.02 billion. And right now, thanks to a January ruling from a federal appeals court, Lilly has protection for those sales until May 2022.
Of course, other companies may still be working on efforts to bring “cheaper, quasi-generic Alimta formulations” to the U.S. market, Anderson pointed out. But if any of those meds can snag approval, they won’t bear the FDA’s “substitutable” classification, meaning “their commercial impact would be low.”