Novartis (NOVN.S), opens new tab has lost a bid to keep a generic version of its top-selling heart failure drug Entresto off the U.S. market by blocking regulators from approving it, though the generic’s launch faces other legal roadblocks.
U.S. District Judge Dabney Friedrich in Washington, D.C., in an order made public on Tuesday, said the U.S. Food and Drug Administration did not overstep its authority in approving MSN Pharmaceutical’s generic of Entresto, despite a slightly different label and alleged differences between the drugs.
Novartis said in a statement that it disagreed with the ruling and is appealing the decision.
MSN and the FDA did not immediately respond to requests for comment.
Entresto is Switzerland-based Novartis’ best-selling drug, earning the company more than $6 billion in revenue last year. MSN’s version of Entresto was approved by the U.S. Food and Drug Administration last month and would be the first U.S. generic of the drug.
Novartis has separately sued MSN for patent infringement, and in August lost a bid in that case to block MSN’s generic. However, MSN remains barred from launching its generic while Novartis appeals that order.
Novartis sued the FDA in July, shortly after the agency approved MSN’s application to sell generic Entresto, alleging that the approval was arbitrary and capricious and violated the federal Food, Drug, and Cosmetic Act (FDCA) in multiple ways.
Novartis said the application should not be approved because MSN’s generic label was slightly different from Entresto’s.
Entresto was originally approved in 2015 to lower death and hospitalization risk in heart failure patients with reduced ejection fraction, which is the measurement of how much blood the left ventricle of the heart pumps out with each contraction. Following the initial approval, Novartis conducted a clinical trial showing that the drug was effective in patients without reduced ejection fraction, added that indication to the drug’s label and obtained patents covering its use in such patients.
To avoid infringing those patents, MSN omitted the indication for patients without reduced ejection fraction from its label. Such label carveouts are known as “skinny labels” and have generally been allowed by courts, including by the D.C. Circuit Court of Appeals in a 1996 decision, Bristol-Myers Squibb v. Shalala.
Novartis, however, said that the federal Food, Drug, and Cosmetic Act prevented MSN from “reverting” to an older label that had been suspended and replaced. It also said the Bristol-Myers ruling was no longer binding precedent after the U.S. Supreme Court’s June decision in Loper Bright Enterprises v. Raimondo, which found that courts do not have to defer to federal agencies’ interpretations of ambiguous statutes.
Friedrich rejected that argument, finding that the D.C. Circuit’s decision had been based on its own reading of the federal Food, Drug, and Cosmetic Act, not deference to the FDA.
Novartis also argued that MSN’s generic was not identical to Entresto because it was a simple mixture of the drug’s two active ingredients, rather than linking the two molecules together in a crystal structure.
Friedrich said that, under longstanding FDA guidance, “different physical forms do not prevent a demonstration of active ingredient sameness” and that the agency’s scientific judgment deserves deference.