Vertex attempted to claim that “about” covered a wide range of concentrations as a “high drug load” that weren’t defined in the patents, ultimately sinking its infringement lawsuit in the US District Court for the District of Delaware over Lupin’s generic version.
“Words can be twisted, but numbers do not lie,” Circuit Judge Stephanos Bibas wrote in a Monday opinion. Vertex “patented a precise compound to treat cystic fibrosis. But now it says that its carefully calibrated percentages really stand for vague ranges. Just as that argument failed before the patent
examiner, so too it fails as an infringement claim.”
Vertex sued Lupin in July 2022. Four patents were at issue in a three-day bench trial in May over which Bibas, sitting by designation from the US Court of Appeals for the Third Circuit, presided.
Two of them—US Patent Nos. 10,646,481 and 11,564,916—cover a drug containing exactly 80% ivacaftor. The other two—US Patent Nos. 10,272,046 and 12,458,635 — claim “about 80%” ivacaftor.
Three of the patents expire in February 2030 and one in August 2033, according to the US Food and Drug Administration’s registry of approved drugs, the Orange Book. Bibas found that Lupin’s generic versions don’t infringe Vertex’s patents literally or under the doctrine of equivalents. Vertex “wisely concedes” Lupin’s copies don’t literally infringe the two patents claiming exactly 80% ivacaftor, the judge said. The plaintiff instead alleged literal infringement of its two “about 80%” patents — the ‘046 and ‘635 patents.
The case, he said, turns on how a skilled artisan would understand “about.”
Bibas found Vertex’s expert witness “unauthoritative” and said his reading of disputed terms was designed to stretch the claims. The witness asked the judge to read “80% ivacaftor” as a shorthand for a “high drug load” covering a wide range from 70% to 90%, but “he gave no reason to think that is true,” Bibas wrote.
Lupin’s expert, on the other hand, was “completely credible” and “meticulous,” the judge said, concluding she “preserved the limits on Vertex’s patents.” Bibas adopted her reading of “about.” “Vertex is trying to claim that its patents cover a range of ivacaftor concentrations that it failed to patent,” Bibas
wrote.
Lupin’s roughly 74% ivacaftor drug varies from Vertex’s by more than a couple of percentage points, so “there is no literal infringement.” In rejecting the drugmaker’s argument for infringement under the doctrine of equivalents, Bibas wrote that “Vertex may not use bioequivalence to effectively outlaw generics.”
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