Recent P-IV filings And Entresto (Sacubitril/Valsartan): Novartis vs MSN

Contents

Recent P-IV filings

General information

Regeneron and Samsung Bioepis Settle EYLEA® BPCIA Litigations Related to Opuviz™

Brazil Seeks API Localization From India, Eyes Pharma Self-Reliance

Intellectual Property

Entresto (Sacubitril/Valsartan): Novartis vs MSN

Recent P-IV filings

We follow P-IV filings on the FDA website. The recent update was on 02 February 2026.

General information

Regeneron and Samsung Bioepis Settle EYLEA® BPCIA Litigations Related to Opuviz™

On February 11, 2026, Regeneron and Samsung Bioepis dismissed Case Nos. 1:23-cv-00094 (N.D.W. Va.) and 1:23-cv-00106 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.) due to settlement. The preliminary injunction previously granted by the Court and affirmed by the Federal Circuit (previously reported Federal Circuit Affirms Preliminary Injunctions in EYLEA® Biosimilar Litigations Against Samsung Bioepis and Formycon) was also vacated. Under the settlement agreement, Samsung Bioepis can launch its EYLEA® (aflibercept) interchangeable biosimilar Opuviz™ (aflibercept-yszy) starting in January 2027. News here

Brazil Seeks API Localization From India, Eyes Pharma Self-Reliance

Brazil is aggressively pursuing a strategic shift from a buyer-seller dynamic to a production partnership with India for pharmaceuticals, with a specific focus on localizing Active Pharmaceutical Ingredient (API) manufacturing. This initiative aims to significantly reduce the nation's over-reliance on imported APIs, bolster health security, and foster domestic industrial capabilities. India, recognized as the 'pharmacy of the world', is positioned as a key partner in this endeavor. News here

Intellectual Property

Entresto (Sacubitril/Valsartan): Novartis vs MSN

This memorandum opinion and accompanying order, entered January 21, 2026, by Judge Richard G. Andrews in the District of Delaware regarding Entresto (Sacubitril/Valsartan). It resolves Novartis Pharmaceuticals Corporation’s motion for summary judgment on validity, partial summary judgment on infringement, and to preclude defendants from relitigating claim construction by issue or claim preclusion. Defendants are MSN Laboratories Private Limited, MSN Life Sciences Private Limited, MSN Pharmaceuticals, Inc., and Novadoz Pharmaceuticals, LLC (collectively “MSN”). Procedural and factual background

• The dispute concerns asserted claims 1–4 of U.S. Patent No. 8,101,659 (’659 patent), which claim administration of valsartan (an AT1 antagonist) and sacubitril (an NEP inhibitor) in combination in about a 1:1 ratio (the “wherein” clause).
• A prior action between Novartis and MSN resulted in a final judgment that MSN’s ANDA No. 213748 infringed the ’659 patent. In that prior litigation, the court had construed the “wherein” clause to mean its plain and ordinary meaning and later reached judgment on infringement and (after appeal) validity issues.
• Novartis now asks the court to (1) bar MSN from relitigating claim construction; (2) grant summary judgment that the ’659 patent is valid (precluding MSN from asserting invalidity defences or counterclaims); and (3) grant partial summary judgment that MSN’s ANDA product meets the claim elements (i.e., infringes the asserted claims).

Issue preclusion as to infringement (product meets claim elements)

1. The court held that the question of whether MSN’s ANDA product meets the claim limitations was identical to the prior litigation and had been fully litigated and resolved (including a stipulation of infringement entered in the prior case). The stipulation, entered freely and approved by the court, has preclusive effect.
2. The parties had sufficient opportunity and motive to litigate and to appeal; the Federal Circuit ruling did not create new law that would permit relitigation.
3. MSN was fully represented previously; privity issues for Novadoz were resolved as noted above.
4. Fairness arguments by MSN (that they relied on a mistaken view that complexes were included in the plain meaning) were rejected because the construction never changed and relitigation would defeat preclusion’s purpose.
5. The court therefore granted partial summary judgment that MSN’s ANDA product meets the asserted claims’ limitations (i.e., infringes those claim elements).

Disposition

• The court GRANTED Novartis’s motion: issue preclusion bars relitigation of the “wherein” clause; claim preclusion bars any invalidity arguments; summary judgment of validity is entered for Novartis; partial summary judgment that MSN’s ANDA product meets the claim elements (infringement) is granted. An order implementing these rulings was issued on the same date.

In short, Judge Richard G. Andrews granted Novartis’s motion in In re Entresto, holding that prior adjudication precludes relitigation of the ’659 patent’s “wherein” clause (plain and ordinary meaning). The court found that issue preclusion applies to claim construction and, on claim preclusion grounds, barred MSN from asserting any invalidity defences in relation to MSN’s ANDA No. 213748. Interestingly, U.S. Patent No. 8,101,659 (the '659 patent) has expired. The patent expired on January 15, 2025. It also benefited from an additional 6-month period of paediatric exclusivity, extending its legal protection until July 15, 2025. Why the '659 Patent Still Matters in 2026 Even though the patent has expired, it remains a central figure in the litigation for several reasons:

• Past Damages and Litigation: This ruling addresses whether MSN and Novadoz infringed the patent while it was still active and whether they can relitigate its validity.
• Preclusion Strategy: Novartis is using this patent to establish “issue preclusion”. By winning a judgment that this patent was valid and infringed, they prevent generic companies from using the same chemical/technical arguments to challenge other active patents that protect Entresto until 2033 or 2036.
• Active Entresto Patents: The Orange Book still contains several active patents for Entresto, including:
• US 9,388,134: Expires November 2026 (with paediatric exclusivity).
• US 8,877,938: Expires May 2027.
• US 11,135,192: Protects specific dosage regimens until August 2033.

MSN and other generic manufacturers launched after the paediatric exclusivity for the ‘659 patent expired on July 15, 2025.

Status of Other Key Patents in Litigation

Key Developments in the MSN Litigation

• The July 2025 Infringement Loss: Novartis suffered a major setback when Judge Andrews ruled that they did not meet the "preponderance of evidence" to show that MSN's product contained the specific amorphous solid form claimed in the '918 patent. The court even took an "adverse inference" against Novartis for failing to produce a critical chemical sample during discovery.
• Partial Settlements: As of late 2025, reports indicate that MSN and Novartis have settled parts of their dispute, likely regarding specific dosage forms or "skinny labelling" (carve-outs) for certain heart failure indications, though the core patent validity battles continue.
• The "At-Risk" Status: Because MSN launched while these later patents (like '134 and '938) are still being litigated, they are technically in an "at-risk" launch phase. If Novartis wins an appeal of these patents, it could force MSN to pay triple damages or even pull the product off the market until 2027.

The Court granted Novartis’ motion, and the current ruling might help Novartis in pending litigation. Decision here