Novartis AG (NYSE:NVS) reportedly faced a legal setback as it failed to convince a federal court to block MSN Pharmaceuticals from launching a generic version of its heart-failure drug, Entresto.
On Monday, U.S. District Judge Richard Andrews in Delaware ruled that Novartis' likelihood of winning its patent-infringement lawsuit was too low to justify stopping MSN Pharmaceuticals' launch.
Also Read: Novartis Sues to Block Maryland's New Drug Discount Law.
Despite this ruling, the judge temporarily suspended MSN Pharmaceuticals' sales while Novartis appealed to the U.S. Court of Appeals for the Federal Circuit.
Entresto is Novartis' top-selling drug. In the second quarter, it generated sales of $1.89 billion, up 25% year over year (+28% on constant currency).
The FDA approved MSN Pharmaceuticals' version of Entresto in July, making it the first generic available in the U.S.
Novartis, which initially sued MSN Pharmaceuticals and other companies in 2022 over patent infringement, requested a preliminary injunction on August 2 to halt MSN Pharmaceuticals' launch, but the court denied this request.
Reuters noted that Judge Andrews dismissed Novartis' concerns about potential "irreparable harm" that could arise from a wave of generic launches by other manufacturers if MSN Pharmaceuticals' version were released.
The judge's ruling places additional pressure on Novartis, now considering "all available options" to defend its intellectual property rights.
Despite the legal challenges, the company maintains its financial outlook for 2024.
As the legal battle continues, Novartis has also sought to block MSN Pharmaceuticals' launch through a separate lawsuit in a Washington, D.C. district court, challenging the FDA's decision to approve the generic. The outcome of that case remains pending.
Price Action: NVS stock is up 0.25% to $111.69 at the last check on Tuesday.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
据报道,诺华公司(纽约证券交易所代码:NVS)因未能说服联邦法院阻止MSN Pharmicals推出其心力衰竭药物Entresto的仿制药而面临法律挫折。
周一,特拉华州的美国地方法院法官理查德·安德鲁斯裁定,诺华赢得专利侵权诉讼的可能性太低,不足以证明停止MSN Pharmaceuticals的上市是合理的。
另请阅读:诺华起诉阻止马里兰州的新药品折扣法。
尽管作出了这一裁决,但法官暂时暂停了MSN Pharmaceuticals的销售,而诺华则向美国联邦巡回上诉法院提出了上诉。
Entresto是诺华最畅销的药物。在第二季度,它创造了18.9亿美元的销售额,同比增长25%(按固定汇率计算增长28%)。
美国食品药品管理局于7月批准了MSN Pharmaceuticals版本的Entresto,使其成为美国首款上市的仿制药。
诺华最初于2022年以专利侵权为由起诉MSN制药和其他公司,于8月2日要求发布初步禁令,以阻止MSN Pharmaceuticals的推出,但法院驳回了这一请求。
据路透社指出,安德鲁斯法官驳回了诺华的担忧,即如果MSN Pharmaceuticals的版本发布,其他制造商的仿制药发布浪潮可能会造成潜在的 “无法弥补的损害”。
法官的裁决给诺华带来了额外的压力,诺华现在正在考虑 “所有可用的选择” 来捍卫其知识产权。
尽管面临法律挑战,但该公司仍维持其2024年的财务前景。
随着法律斗争的继续,诺华还试图通过华盛顿特区地方法院的另一项诉讼阻止MSN Pharmaceuticals的上市,质疑美国食品药品管理局批准该仿制药的决定。该案的结果仍悬而未决。
价格走势:在周二的最后一次支票中,NVS股价上涨0.25%,至111.69美元。
免责声明:此内容部分是在人工智能工具的帮助下制作的,并由Benzinga的编辑审阅和发布。