
Novartis has encountered an obstruction in its multiyear campaign to prevent imitations of its best-selling heart failure medication, Entresto. This comes after the company attempted to prevent the sale of the newly authorized generic version of the drug, which was manufactured by MSN Pharmaceuticals.
Novartis’ accusations of intellectual property infringement against MSN were dismissed by Delaware District Judge Richard Andrews on Monday, who denied the Swiss pharmaceutical company’s request for an injunction against the debut of the generic manufacturer. According to court records revealed this week, MSN was granted FDA clearance for its generic version of Entresto on July 24.
In 2022, Novartis filed a lawsuit against MSN and a number of other pharmaceutical companies about their intentions to approve generic versions of Entresto. According to the documents filed with the court, the corporation asserts that the sued firms violated the so-called ‘918 patent, scheduled to expire in November 2026, which protects the amorphous solid form of a substance in Entresto.
Andrews stated, “Novartis bears the burden of proof, both on infringement and on showing likelihood of success. But it has not met the burden it bears at this stage. As an initial matter, I am skeptical about Novartis’ characterization of its many harms.”
In addition to the charge of infringement, Novartis has also asserted that it will incur irreparable loss if MSN is permitted to commercialize its imitation heart failure treatment without interruption.
Notably, Novartis has argued that an unveiling by MSN that is seen to be at risk would set off an upsurge of generic Entresto launches by other drugmakers. This would result in the destruction of Entresto’s market traction, which would lead to a decline in sales, a reduction in market share, as well as a price erosion.
In dismissing Novartis’ demand for an injunction, Andrews noted he didn’t think it plausible to infer harm from other companies’ activities to MSN’s launch of its own medicine. Additionally, the judge found it inappropriate to blame MSN for the decreased marketing of Novartis’ other cardiovascular treatments, which he stated would arise from Novartis’ own commercial choice to cut its cardiovascular products salesforce in reaction to MSN’s debut.
While Andrews denied the motion for an injunction, he allowed a three-day stay to enable Novartis to file an appeal against the ruling.
Novartis said it’s currently reviewing all possible options and plans to stick to its financial projection for the year.
Besides the Delaware case, Novartis just recently filed a complaint against the FDA in the Washington federal court, alleging that the regulator’s decision to allow MSN’s generic was unconstitutional.
Novartis said it presently anticipates Entresto generics being available in mid-2025, while the firm is defending against that prospect through multiple possible patents in a bid to prolong Entresto’s exclusivity in the market.