- GlaxoSmithKline plc blames Teva Pharmaceutical Industries Ltd. for doctors infringing on a patent that covers the British pharma's heart drug Coreg by prescribing a copycat off label. On Wednesday, a federal judge concluded that argument doesn't hold water.
- The decision from Judge Leonard Stark means Teva doesn't have to fork over about $235 million in lost profits and royalties to its pharma rival, as a jury previously ruled.
- "GSK failed to prove by a preponderance of the evidence that 'Teva's alleged inducement, as opposed to other factors, actually caused the physicians [i.e., as a class or even at least one of them] to directly infringe,'" Stark wrote in an opinion.
At the heart of GSK's lawsuit against Teva is a complex string of drug approvals and patents.
In 1997, U.S. regulators OK'd Coreg (carvedilol) to treat hypertension, congestive heart failure (CHF) and left ventricular dysfunction following a heart attack. Soon after, GSK secured a patent, dubbed '069 for short, which protected the intellectual property related to Coreg. There were problems with the '069 patent, however, and GSK ultimately replaced it with what's known as the '000 patent in 2008.
Yet that newer patent pertained just to the treatment of CHF. As such, Teva sought approval for a generic version of Coreg that would hold a 'skinny label' for just the other two indications. But doctors were prescribing Teva's version of the drug for all indications regardless of the label.
The '069 patent expired in 2007, and the Food and Drug Administration subsequently cleared 14 Coreg copycats for approval, including Teva's skinny-label copycat.
Making matters more confusing, the FDA in 2011 nudged Teva to revise the label for its Coreg generic since the '069 patent was caput. The result was Teva's drug sporting basically the same label as GSK's reference product. (The back and forth was so intricate, Stark included a helpful table in writing his opinion.)
After the patent and labeling dust settled, GSK argued Teva caused doctors to infringe on the '000 — namely by prescribing the Israeli drugmaker's generic for the CHF indication. GSK even provided an expert, a physician named Peter McCullough, to show Teva induced at least one doctor to prescribe generic carvedilol.
But one big problem, as Stark noted, was that McCullough didn't read the generic's label.
"As Dr. McCullough concedes that he did not read Teva's label, he cannot state, for instance, that he noticed or otherwise knew what (if anything) that label said about using carvedilol to treat CHF."
To that end, Stark ruled that while GSK's '000 patent remains valid, the company didn't prove that Teva was the direct cause for prescribers' infringement.
In the pharma sector, $235 million is a relative drop in the bucket. Yet Stark's ruling is surely a welcome reprieve for Teva, which is facing serious problems, including an enormous debt load and looming competition to its blockbuster multiple sclerosis drug Copaxone (glatiramer acetate).