Lupin granted win against Vertex in Delaware over cystic fibrosis drug patents

Context:

• In 2009, Vertex published its first official findings about ivacaftor – a chemical compound that could be used to improve the working of lung cells in patients with cystic fibrosis – and how to formulate it as a drug. Notably, it stated that an effective ivacaftor drug would comprise “about 10% by weight to about 80% by weight” ivacaftor. Using the 80% or about-80% specifications, Vertex got a range of patents for an ivacaftor drug. The commercial embodiment of those patents is Vertex’s drug Kalydeco.
• Lupin, another major drug maker, submitted an Abbreviated New Drug Application (ANDA) for its own ivacaftor drug in June 2021, which the U.S. Food and Drug Administration tentatively approved a year later. Lupin’s version contains an amorphous solid dispersion comprising 74.257% or 74.258% ivacaftor plus other ingredients. But in July 2022, Vertex sued Lupin over the alleged infringement of four of its patents in the United States District Court for the District of Delaware. Two of them claim a drug containing exactly 80% ivacaftor, while the other two claim “about 80%” ivacaftor. Vertex conceded that Lupin’s copies don’t literally infringe the two patents claiming exactly 80% ivacaftor. Sitting by designation from the US Court of Appeals for the Third Circuit, Judge Stephanos Bibas presided over a three-day bench trial in May.