Teva and GSK have been feuding over the common generic carve-out known as "skinny labeling" for years, with contentions centering on GSK’s off-patent blood pressure med Coreg.
But even as the case stretches to the Supreme Court and the U.S. solicitor general, Barnes & Thornburg partner and intellectual property attorney Ron Cahill figures the U.S. Court of Appeals' decision upholding GSK's $235 million win will likely stand.
Why? As Cahill sees it, the Supreme Court in general takes up very few cases on petition. That’s especially true of patent cases, where the high court often defers to the Federal Circuit's judgment, he explained.
Secondly, the lawyer doesn't believe "the Federal Circuit has mucked up the patent law,” Cahill said. He argues that the verdict largely got the legislation “correct.”
The case’s final outcome could have sweeping implications for the common carve-out tactic, with Teva asserting in its appeal that generic medicines launch with skinny labels “almost half the time.” A decision favoring GSK would force generics companies to exercise extreme caution when using skinny labels going forward, lest they be accused of inducing infringement.
Teva has argued the Supreme Court is the ideal venue to resolve this complex legal dispute.
The saga stretches all the way back to 2007, the year GSK’s Coreg went off-patent for its original use and Teva began selling its generic. Shortly thereafter, GSK found the drug held promise as a heart failure treatment, triggering a new era of patent exclusivity through 2015.
In 2011, the FDA asked Teva to add the branded med’s heart failure nod to the generic label, which Teva did. In doing so, GSK argued the generics company improperly muscled in on its market for the patented indication.
After GSK sued, a Delaware court found that Teva’s label encouraged doctors to use its generic to treat heart failure and awarded a $235 million judgment to GSK.
A district court then overturned that verdict, ruling in Teva’s favor. But in 2020, a U.S. appeals court restored the original verdict.
After the U.S. Court of Appeals refused to reopen the case this past February, Teva vowed to appeal to the Supreme Court. GSK slapped back this summer, urging the high court not to rehear the case.
If GSK's win stands, Cahill figures the precedent could be difficult to parse for generics makers and others. During skinny label generic launches, companies would need to market their offerings very carefully to avoid allegations of infringement, he said.
In cases where indications are closely linked and the same doctors treat multiple diseases, that's a lot of responsibility to place squarely on the shoulders of generics makers, Cahill added.
Not all judges have agreed that Teva erred, however. Cahill pointed to Judge Leonard Stark of Delaware, who has stood by his argument that Teva’s not responsible if doctors use the company’s generic drugs off-label.
No matter the outcome of the case, “this is a really close call and judges disagree about it,” Cahill said.