In the wake of a decision by a federal court in Delaware that a combination patent held by Novartis on the popular cardiovascular medication Entresto is invalid, the firm has vowed to continue its fight against generic competition by appealing the decision.
The combined patent is scheduled to expire in July 2025, and it has an extension built into it as a result of an exclusivity grant for pediatric use. Other patents on the medication are valid through 2026, 2027, and 2036.
Novartis’ Plans regarding the Entresto Patent
- In light of the development, Novartis announced in a recent statement that it would file an appeal with the U.S. Court of Appeals for the Federal Circuit (CAFC) in a bid to have the verdict overturned.
- The firm has stated that it will “continue to defend” its Entresto patents strongly and has warned that any generic drugs that emerge prior to the decision of the appeal may be in danger of being subject to legal action.
- At present, there are no copycats of Entresto that have received official or provisional clearance from the FDA, so the company is satisfied in that regard.
A West Virginia court decided only last week that Mylan’s planned generics would infringe on two patents held by Novartis that are valid until 2027.
In addition to Novartis’ victory in court against Mylan, the firm highlighted in its statement that it has struck confidential settlements with “several” other general filers, allowing those companies to launch their products on dates that are currently secret.
Since 2019, the pharmaceutical company has been focusing its efforts on defending its Entresto patent by bringing legal action against a number of prospective rivals, including Alembic, Mylan, MSN Pharmaceuticals, Nanjung Noratech, and others. The company cited 18 drugmakers looking to launch generic versions of its products in a document that it submitted to the FDA in September. These drugmakers include Teva, Aurobindo, and Lupin. Novartis demanded in its appeal to the FDA that it postpone the approval of generic Entresto until February because early authorizations might lead to labeling errors.
Novartis was able to retain its financial projection for the year 2023 in spite of the loss of the Delaware patent. The company projects a growth rate of 4% between the years 2022 and 2027.
The University of Michigan and the University of South Florida filed a patent infringement lawsuit against the firm during the previous summer. The lawsuit concerned infringement based on their co-crystal patent, and they asked for a jury trial as well as damages.
As Novartis’s second best-selling product, the heart medication brought in $4.6 billion in revenue for the company in 2022. The drug manufacturer had earlier projected that the blockbuster medication would reach an all-time high in sales worth at least $5 billion.
