Sandoz Inc has persuaded a Delaware federal judge to throw out a lawsuit that claimed its proposed generic version of a blockbuster lung-disease drug would violate the patent rights of the drug’s original maker, Roche’s Genentech Inc.
On Tuesday, U.S. District Judge Richard Andrews rejected Genentech’s infringement claims and found that parts of the Genentech patents were invalid.
Genentech’s Esbriet is used to treat idiopathic pulmonary fibrosis (IPF). Roche earned over $1 billion last year from worldwide Esbriet sales.
Idiopathic pulmonary fibrosis (IPF) is a rare, progressive illness of the respiratory system, characterized by the thickening and stiffening of lung tissue, associated with the formation of scar tissue. It is a type of chronic scarring lung disease characterized by a progressive and irreversible decline in lung function. The tissue in the lungs becomes thick and stiff, which affects the tissue that surrounds the air sacs in the lungs. Symptoms typically include gradual onset of shortness of breath and a dry cough. Other changes may include feeling tired, and abnormally large and dome shaped finger and toenails (nail clubbing).Complications may include pulmonary hypertension, heart failure, pneumonia or pulmonary embolism.
San Francisco-based Genentech sued Switzerland-based Sandoz and several other drugmakers, including Amneal Pharmaceuticals Inc and Teva Pharmaceutical Industries Ltd, for patent infringement in 2019 over their proposed generic versions of Esbriet.
Genentech’s patents cover methods of using Esbriet to treat IPF, and Genentech said the label of Sandoz’s generic would encourage doctors to prescribe it in a way that infringes.
Andrews ruled for Sandoz on Tuesday and found Sandoz’s label only encouraged non-infringing uses of the drug.
Sandoz’s label included some infringing uses as “options, not recommendations,” Andrews said.
Andrews also said that parts of some of the patents were invalid based on earlier publications that, taken together, made Genentech’s innovations obvious.