After whittling down Genentech’s defenses at a bench trial last fall, Novartis’ Sandoz unit has removed a major hurdle on the path to launching its Esbriet copycat.
A Delaware federal judge has swatted down the Roche unit’s argument that Sandoz’ proposed label for its generic version of the lung disease blockbuster would infringe on multiple Genentech-held patents. In an opinion filed in the U.S. District Court for the District of Delaware, Judge Richard Andrews also found several of Genentech’s Esbriet patents invalid.
Genentech filed its patent infringement lawsuit in early 2019, arguing Sandoz and several other drugmakers, including Amneal Pharmaceuticals and Teva Pharmaceutical, would violate six Esbriet patents with their proposed generics, Reuters notes.
The company argued that Sandoz’ generic label would encourage doctors to prescribe the drug in a way that treads on Genentech’s patents.
Sandoz, for its part, argued that since its proposed label doesn't "affirmatively encourage the use of any patented method of treatment," Genentech couldn't "prove intent to induce infringement," Judge Richard Andrews explained in a recent opinion. The judge ultimately sided with Sandoz's argument.
Further, Andrews agreed with Sandoz that certain Genentech patents were invalid for obviousness.
Esbriet is used to treat idiopathic pulmonary fibrosis, where it competes with Boehringer Ingelheim’s Ofev (nintedanib) in a multibillion-dollar market. Esbriet ginned up 1.04 billion Swiss francs ($1.12 billion) in 2021. At 2021’s midpoint, meanwhile, Ofev generated €1.2 billion (about $1.32 billion). In 2020, BI’s drug reaped more than €2 billion ($2.19 billion). Boehringer is set to release full-year 2021 results early next month.
After the ruling, Genentech and Sandoz are expected to confer about how to proceed with their case. They’ve been asked to submit a joint status report within one week, “preferably with a jointly proposed final judgment,” Andrews said.