A federal judge has ruled in favor of Lupin Ltd. in its patent infringement case against Vertex Pharmaceuticals Inc. for the cystic fibrosis treatment Kalydeco. According to reports from CNBC TV18 and Bloomberg Law, Circuit Judge Stephanos Bibas ruled that Lupin's proposed generic versions of Kalydeco do not infringe four patents held by Vertex. The case was heard in the US District Court for the District of Delaware over Lupin's generic version of the cystic fibrosis treatment.
The case centered on two patents that specifically cover 'about 80%' ivacaftor by weight, while two other patents claim 'about 80%' ivacaftor. As reported by CNBC TV18 and Bloomberg Law, Vertex attempted to argue that 'about' covered a wide range of concentrations as a 'high drug load' that wasn't defined in the patents. Judge Bibas rejected this interpretation, stating that 'Words can be twisted, but numbers do not lie.' He found that Vertex's expert witness was 'unauthoritative' and that his reading of disputed terms was designed to stretch the claims.
According to the court ruling reported by CNBC TV18 and Bloomberg Law, Lupin's generic version contains approximately 74% ivacaftor, which varies from Vertex's by more than a couple of percentage points. Judge Bibas found that there is no literal infringement of the patents claiming exactly 80% ivacaftor, as Vertex 'wisely concedes.' The judge also rejected Vertex's argument for infringement under the doctrine of equivalents, stating that 'Vertex may not use bioequivalence to effectively outlaw generics.'
As reported by CNBC TV18 and Bloomberg Law, three of the four patents at issue expire in February 2030, while one patent expires in August 2033. The case was originally filed by Vertex in July 2022 and went through a three-day bench trial in May. The ruling provides clarity for the generic version of Kalydeco, which is used to treat cystic fibrosis, a serious genetic disease affecting the lungs and digestive system.
