After a Delaware federal court ruled a Novartis combination patent on big-selling cardiovascular drug Entresto is invalid, the company pledged to continue its efforts to block generics with an appeal.
The combination patent, which includes an extension thanks to a pediatric exclusivity award, is set to expire in July of 2025. Other patents on the drug run until 2026, 2027 and 2036.
Now, Novartis will head to the U.S. Court of Appeals for the Federal Circuit in an effort to reverse the decision, the company said in a recent statement. The company will “continue to defend” its Entresto patents “vigorously” and warned that any generics that launch before the outcome of the appeal “may be at risk” of litigation. Currently, there are no Entresto copycats with tentative or official FDA approvals, the company noted.
Just last week, the company chalked up a win against Mylan when a West Virginia court ruled that the company's proposed generics would step on two Novartis patents that last through 2027.
Besides the Mylan courtroom win, Novartis has reached confidential settlements with “several” other generic filers allowing them to launch on confidential dates, the company noted in its statement.
The drugmaker has been on the Entresto defense since 2019, filing lawsuits against potential competitors Mylan, Alembic, Crystal Pharmaceutical, MSN Pharmaceuticals, Nanjung Noratech and others. In a September filing with the FDA, the company named 18 drugmakers seeking generic launches, including Teva, Aurobindo and Lupin. In its petition to the FDA to hold off on generic Entresto approvals until February, Novartis argued that early authorizations could lead to labeling inconsistencies.
Despite the Delaware patent loss, Novartis maintained its 2023 financial guidance. The company expects to deliver 4% growth between 2022 and 2027.
Last summer, meanwhile, the company found itself on the other side of a patent suit from the University of Michigan and the University of South Florida. The two institutions alleged infringement based on their co-crystal patent and sought damages and a jury trial.
The heart drug pulled in $4.6 billion last year as Novartis’ second top-selling medicine. The drugmaker has previously estimated peak sales of at least $5 billion for the blockbuster.