Context: Novartis sued MSN in October 2022, alleging infringement of two of its Entresto-related patents in the District of Delaware. Entresto is a drug used to treat chronic heart failure, which brought in over $7.8 billion in sales for Novartis last year. In April, the District of Delaware delayed MSN’s generic version of Entresto from launching to “no earlier than July 16, 2025”. In June, MSN and Novartis settled part of that fight in the U.S. over U.S. Patent No. 8,101,659 (“Methods of treatment and pharmaceutical composition”) (June 17, 2025 ip fray article). Meanwhile, in the other case, Novartis filed a letter requesting the Delaware court to issue a final decision and verdict on the case before July 15, to further reset the effective approval date of MSN’s generic drug until after November 9, 2026 (the expiration date of the other patent-in-suit: U.S. Patent No. 11,096,918 (“Amorphous solid form of compounds containing S—N-valeryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and sodium cations”).
What’s new: Judge Richard Andrews of the United States District Court for the District of Delaware denied Novartis’s injunctive relief request, finding that MSN’s generic would not infringe the remaining patent-in-suit (July 11, 2025 judgment (PDF)).
Direct impact & wider ramifications: While the timing of this decision shows Judge Andrews wanted to create legal certainty ahead of when the other injunction expired (July 16, 2025), Novartis’s failed injunctive relief request means MSN’s Entresto drug could enter as soon as the FDA gives it the green light this week. Novartis will likely file an appeal, as well as attempt to obtain emergency relief in the form of a restraining order on MSN, in the Federal Circuit. An injunction of this kind would normally be very difficult, but if the Federal Circuit disagrees with the case law cited by the District of Delaware on whether a non-moving party should benefit from an adverse inference related to another defendant’s motion, then it’s not entirely impossible. Generally, however, it is much easier to get an injunction stayed by way of an emergency motion than to obtain injunctive relief after the lower court denied it.
Following a bench trial during which Novartis had to prove infringement by a preponderance of the evidence, Judge Andrews concluded the following:
For all foregoing reasons, I think Novartis did not. The reference Raman spectrum that Novartis used to compare to a Raman spectrum of MSN’s ANDA is unreliable as a reference spectrum. Thus, an infringement analysis based on that “reference spectrum” is insufficient. The unreliability of Novartis’ reference Raman spectrum, combined with an adverse interference due to Novartis’ failure to produce the glassy solid sample reflected in the reference Raman spectrum, leads me to conclude that Novartis did not meet its burden to show MSN’s ANDA infringes by a preponderance of the evidence.
Notably, MSN did not bring the adverse interference motion, but a different defendant – Noratech – did. Noratech had asked for production of what the decision calls “Dr. Park’s glassy solid, the material against which ANDA was compared”.
Novartis argued that MSN never made a glassy solid, but wishes to test against it. In his decision, Judge Andrews held that “Dr. Park created a Raman spectrum from her glassy solid that was used by Novartis to show that both Defendants’ ANDAs infringe.”
Now, thanks to Noratech, MSN has benefited in an outcome-determinative way from the fact that Novartis was slapped with an adverse inference because it didn’t give Noratech what it wanted.
Judge Andrews pointed to a Ninth Circuit decision, Payne v. Exxon:
“If Congress had intended to limit the district court’s dismissal authority to claims against the party who propounded discovery, it would not have chosen such sweeping language [under Rule 37(b)(2)]. … The district court reasonably conclude that plaintiffs’ failure to comply with court orders prejudiced both parties.”
If Novartis appeals, the Federal Circuit will then have to apply Third Circuit law, which it means it will not be bound by the Ninth Circuit decision cited above. If the Federal Circuit looks at the injunction quickly (via an emergency motion) and finds that the Delaware court’s approach relying on an old Ninth Circuit decision is wrong, it could grant an injunction very fast.
The success of the emergency motion itself would rely on a few factors:
- The likelihood of success of the appeal;
- The harm to Novartis, MSN and third parties; and
- Public interest
Counsel
Novartis is being represented by McCarter & English LLP’s Daniel M. Silver and Alexandra M. Joyce, as well as Venable LLP’s Christina A. L. Schwarz, Nicolas Kalla, Shannon K. Clark, Susanne L. Flanders, Melinda R. Roberts, and Erin Belfield.
Meanwhile, MSN is being represented by Stamoulis & Weinblatt’s Richard Charles Weinblatt and Stamatios Stamoulis, as well as Ronald M. Daignault, Richard Juang, and Elizabeth Bernard at Daignault Iyer LLP, and RMMS Legal’s Kevin E. Warner.