Judge Rejects Novartis Bid to Block MSN Pharma's Entresto Generic

A federal court in Delaware has rejected Novartis' request for a preliminary injunction to prevent MSN Pharmaceuticals from launching a generic version of its heart failure medication, Entresto (sacubitril/valsartan). The ruling was made by US District Judge Richard Andrews, who concluded that Novartis had not sufficiently proven its case regarding patent infringement to warrant stopping MSN's release of the drug.

Judge Andrews, in his decision, emphasized that Novartis had the responsibility to prove both the infringement and the likelihood of success in their claims. "I find it has not met the burden," he stated. This ruling may pave the way for MSN to introduce the first generic version of Entresto in the US, potentially impacting Novartis' significant revenue stream from the drug, which generated over $6 billion last year. Nonetheless, Andrews temporarily ordered MSN not to proceed with the drug's sale, granting Novartis a three-day period to file an appeal with the US Court of Appeals for the Federal Circuit.

Novartis also contended that an at-risk launch by MSN could lead to similar actions by other generic drug manufacturers, resulting in "immediate irreparable harm" characterized by lost sales, diminished market share, loss of formulary status, and price reductions. However, this argument did not convince Judge Andrews. He stated, "I do not find it reasonable to attribute harm resulting from the actions taken by other generic drugmakers to MSN's decision to launch its own individual product."

This court decision follows the FDA's recent approval of MSN's generic version of Entresto. In reaction to the FDA's approval last month, Novartis initiated a separate legal action against the agency in a Washington, D.C. district court, aiming to challenge the FDA's decision and block MSN's drug launch. The outcome of Novartis' request in the Washington court remains pending.

The court's decision is a significant development in the pharmaceutical industry, as it involves the introduction of a generic version of one of the top-selling heart failure drugs. Novartis' Entresto has been a key player in the market, contributing substantially to the company's revenue. The entry of a generic version could lead to increased competition and potential price reductions, impacting Novartis' financial performance.

MSN Pharmaceuticals' move to launch a generic version also underscores the broader trend of generic drug manufacturers seeking to introduce more affordable alternatives to brand-name medications. This trend is often met with resistance from original drug manufacturers who aim to protect their market share and revenue by pursuing legal actions to delay or prevent the entry of generics.

The outcome of Novartis' appeal and the separate lawsuit against the FDA will be closely watched by the pharmaceutical industry, as these decisions could set important precedents for future cases involving generic drug launches and patent disputes. For now, the Delaware court's ruling marks a critical step in the ongoing battle between Novartis and MSN Pharmaceuticals over the generic version of Entresto.