Litigation Details for Novartis Pharmaceuticals Corporation v. MSN Pharmaceuticals Inc. (D. Del. 2021)

Novartis Pharmaceuticals Corporation v. MSN Pharmaceuticals Inc. (D. Del. 2021)

Docket		Date Filed	2021-06-17
Court	District Court, D. Delaware	Date Terminated	2025-02-04
Cause	35:271 Patent Infringement	Assigned To	Jennifer L. Hall
Jury Demand	None	Referred To
Parties	ASTEX THERAPEUTICS LTD.
Patents	10,799,506; 8,324,225; 8,415,355; 8,685,980; 8,962,630; 9,193,732; 9,416,136; 9,868,739
Attorneys	Seth W. Lloyd
Firms	Young, Conaway, Stargatt & Taylor LLP
Link to Docket	External link to docket

Details for Novartis Pharmaceuticals Corporation v. MSN Pharmaceuticals Inc. (D. Del. 2021)

Date Filed	Document No.	Description	Snippet	Link To Document
2021-06-17				External link to document
2021-06-17	1	Complaint	expiration of U.S. Patent Nos. 8,324,225 (“the ’225 patent”), 8,415,355 (“the ’355 patent”), …’225 patent, the ’355 patent, the ’980 patent, the ’630 patent, the ’732 patent, the ’136 patent, the…’225 patent, the ’355 patent, the ’980 patent, the ’630 patent, the ’732 patent, the ’136 patent, the…’225 patent, the ’355 patent, the ’980 patent, the ’630 patent, the ’732 patent, the ’136 patent, the…’225 patent, the ’355 patent, the ’980 patent, the ’630 patent, the ’732 patent, the ’136 patent, the	External link to document
2021-06-17	4	Patent/Trademark Report to Commissioner of Patents	the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 8,324,225 ;8,415,355 ;8,685,980… 17 June 2021 1:21-cv-00870 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2021-06-17	5	Patent/Trademark Report to Commissioner of Patents	the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 9,416,136 ;9,868,739 ;10,799,… 17 June 2021 1:21-cv-00870 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Novartis v. MSN (1:21-cv-00870) Litigation Summary: What’s the Patent at Issue, What Happened, and What It Means for Generic Entry

Last updated: June 25, 2026

What is the Novartis v. MSN Pharmaceuticals Inc. case 1:21-cv-00870 about?

Executive summary: The docket reference 1:21-cv-00870 is a federal Hatch-Waxman patent litigation brought by Novartis Pharmaceuticals Corporation against MSN Pharmaceuticals Inc. The litigation posture is tied to an FDA small-molecule generic entry attempt, with disputes focused on Orange Book-listed patents and the statutory grounds for infringement (typically under 35 U.S.C. § 271(e)(2)).

What can be stated from the provided identifier: The case number indicates a U.S. District Court matter filed in 2021 involving a Hatch-Waxman infringement claim. However, no further docket facts, asserted patent numbers, procedural events, settlement terms, or judgment details are included in the prompt.

Result: A complete litigation summary (asserted patents, claim construction, injunction posture, trial dates, settlement agreement terms, and current status) cannot be produced without adding docket-specific facts.

What patents does Novartis allege MSN infringes in 1:21-cv-00870?

Short answer: The prompt does not include the asserted patent numbers or the Orange Book identifiers. Without that, the patent estate at issue cannot be mapped.

Which Orange Book-listed patents were asserted?

No patent numbers, Orange Book drug listing identifiers, or NDA/ANDA references are provided, so the asserted patent list and their expiration timelines cannot be extracted.

What kind of claims are typically at issue in this docket?

Hatch-Waxman cases like this usually center on one or more of:

• Composition-of-matter patents
• Method-of-use patents
• Formulation or dosage-form patents
• Manufacturing method patents
  But the prompt does not name which category applies here.

What procedural events occurred in Novartis v. MSN (1:21-cv-00870)?

Short answer: No procedural milestones are provided. A litigation timeline cannot be built.

Was there a preliminary injunction, TRO, or PI hearing?

No hearing or injunction docket entries are provided.

Was the case dismissed, stayed, or resolved on the pleadings?

No disposition order date or outcome details are provided.

What is the current case status?

No current status (active, stayed, closed, settled, or decided) is provided.

When did Novartis sue MSN, and how does that timing affect launch risk?

Short answer: The case number indicates a 2021 filing, but the prompt provides no filing date, no paragraph IV notice date, and no NDA/ANDA reference. Those dates are required to connect the lawsuit to exclusivity and regulatory launch windows.

What is the “30-month stay” relevance in this matter?

A 30-month stay depends on:

• The ANDA filing trigger
• The first notice of paragraph IV certification
• The date of the court’s lead-infringement determination
  None of these dates are included.

When could generic launch become permissible?

That requires:

• Whether patents were found invalid or not infringed
• Whether a settlement triggered an agreed launch date
• Whether any remaining patents stayed on the Orange Book
  No such details are provided.

Did Novartis and MSN settle, and what settlement terms matter for generic entry?

Short answer: No settlement agreement terms or entry commitments are provided.

Did the settlement include a stipulated “treat as” date or launch date?

No.

Were there covenants not to sue, dismissal with prejudice, or stipulated judgment terms?

No.

How strong is Novartis’s patent estate in this dispute?

Short answer: Strength cannot be assessed without the asserted patents, their filing/priority chain, remaining life, claim scope, and known validity/infringement arguments.

What is the expected expiration landscape?

Not computable from the prompt.

Are there related litigations or family patents?

Not computable from the prompt.

What Orange Book status applies to this case?

Short answer: The prompt does not name the drug, NDA, ANDA reference number, or the Orange Book entries.

Is the case tied to NCE exclusivity, 505(b)(2 exclusivity, or 3/5-year exclusivity?

Not provided.

Which listed patents were certified as paragraph IV?

Not provided.

How do other Novartis competitors typically challenge the same patent estate?

Short answer: No competitor names, parallel Hatch-Waxman cases, or co-defendants are provided. The competitive landscape cannot be generated.

Are there biosimilar risks in this matter?

This docket number suggests small molecule Hatch-Waxman, but without the product identity, biologic/biosimilar relevance cannot be concluded.

Business impact: what does 1:21-cv-00870 mean for MSN’s ANDA timing and revenue exposure?

Short answer: Business impact cannot be quantified without:

• The NDA/ANDA product identity
• The patent and expiration schedule
• Whether a stay remains in effect
• Whether settlement permits earlier launch
• Market size and forecast
  None of those inputs are included.

Key Takeaways

• 1:21-cv-00870 is a Novartis v. MSN Pharmaceuticals Hatch-Waxman patent litigation filed in 2021, but the prompt does not supply the asserted patents, procedural events, current status, or settlement/judgment terms needed to produce a litigation summary that stands up for business or legal use.
• A reliable analysis of generic entry timing, 30-month stay impact, Orange Book risk, and patent strength cannot be completed without docket-specific details.

FAQs

1) What does “1:21-cv-00870” indicate procedurally?
It indicates a U.S. District Court civil case filed in 2021, commonly used in Hatch-Waxman matters involving paragraph IV certifications.

2) Does this case involve a preliminary injunction or only damages?
The prompt does not provide the requested procedural history.

3) Which patents are asserted in Novartis v. MSN?
The prompt does not list the asserted patent numbers.

4) How does this case affect MSN’s ability to launch its generic?
Without settlement or judgment and without patent identity, launch timing cannot be derived.

5) What is the Orange Book drug and NDA/ANDA connection?
The drug identity is not included, so Orange Book mapping cannot be performed.

References

1. U.S. District Court docket, Novartis Pharmaceuticals Corporation v. MSN Pharmaceuticals Inc., 1:21-cv-00870. (Source identifier provided in prompt only.)