Source: Novartis
On July 7, 2023, Novartis received a negative decision from the US District Court regarding the validity of a patent covering its drug Entresto and combinations of sacubitril and valsartan. The company plans to appeal this decision to the U.S. Court of Appeals for the Federal Circuit. Novartis believes that the combination patent is valid and will vigorously defend its intellectual property rights relating to Entresto.
The negative decision raises the possibility of generic versions of Entresto entering the market earlier than expected. Novartis warns that any commercial launch of a generic Entresto product before the final outcome of the appeal or ongoing infringement litigations involving other patents may face future litigation risks.
Despite this potential challenge, Novartis remains confident in the growth and profitability outlook for both the short and mid-term. The company expects growth from other key brands such as Kisqali, Pluvicto, Leqvio, Kesimpta, Scemblix, and iptacopan.
Novartis maintains its full-year 2023 group guidance to investors, which includes mid-single-digit sales growth and high-single-digit core operating income growth. The company also maintains its mid-term outlook of +4% sales growth and a 40% core operating income margin for Novartis ex-Sandoz from 2022 to 2027.
The US District Court for the District of Delaware has ruled against the validity of US Patent No. 8,101,659, which is included in the Orange Book for Entresto. This specific patent, along with its pediatric exclusivity, will expire on July 15, 2025.
It is worth noting that Novartis has been involved in patent infringement litigation since October 2019 with various Abbreviated New Drug Application (ANDA) filers seeking approval to market generic versions of Entresto. The drug is currently protected by multiple Orange Book-listed patents, with expiration dates between 2023 and 2036, including any pediatric exclusivity. In a recent decision, the US District Court for the Northern District of West Virginia ruled that the proposed generic Entresto products from Mylan Pharmaceuticals infringe on certain Novartis patents.
On July 6, 2023, the US District Court for the Northern District of West Virginia issued a decision that the proposed generic Entresto products from Mylan Pharmaceuticals will infringe US Patent Nos. 8,877,938 and 9,388,134. That decision only pertains to Mylan.
Novartis has previously entered into confidential settlement agreements with several ANDA filers, allowing them to launch a generic version of Entresto in the United States on agreed-upon dates or earlier under certain circumstances.
Overall, Novartis remains focused on its growth strategy, driven by key brands in the market and a robust pipeline of high-value innovative medicines.
