Last Updated: August 3, 2026

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


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Small Molecule Drugs cited in Novartis Pharmaceuticals Corporation v. Torrent Pharma Inc.
The small molecule drugs covered by the patents cited in this case are ⤷  Start Trial and ⤷  Start Trial .

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

Date Filed Document No. Description Snippet Link To Document
2021-09-20 External link to document
2021-09-20 210 Redacted Document of U.S. Pat. No. 8,877,938”) (emphasis added). Put simply, the MSN ’731 patent did not need to …Example-1 of U.S. Pat. No. 8,877,938”); col. 12, ll. 32–34 (asserting that “[t]he present…Example-1 of U.S. Pat. No. 8,877,938 and characterized the obtained glossy [sic, glassy…process disclosed in Example-1 of U.S. Pat. No. 8,877,938”), col. 12, ll. 32– 34 (asserting that “[t…process disclosed in Example-1 of U.S. Pat. No. 8,877,938 and characterized the obtained glossy [sic External link to document
2021-09-20 214 Redacted Document of U.S. Pat. No. 8,877,938”) (emphasis added). Put simply, the MSN ’731 patent did not need to …Example-1 of U.S. Pat. No. 8,877,938”); col. 12, ll. 32–34 (asserting that “[t]he present…Example-1 of U.S. Pat. No. 8,877,938 and characterized the obtained glossy [sic, glassy…process disclosed in Example-1 of U.S. Pat. No. 8,877,938”), col. 12, ll. 32– 34 (asserting that “[t…process disclosed in Example-1 of U.S. Pat. No. 8,877,938 and characterized the obtained glossy [sic External link to document
>Date Filed >Document No. >Description >Snippet >Link To Document

Litigation summary and analysis for: Novartis Pharmaceuticals Corporation v. Torrent Pharma Inc. (D. Del. 2021)

Last updated: June 29, 2026

Novartis v. Torrent Pharma (1:21-cv-01330) Litigation Summary and Patent/Regulatory Analysis

Novartis Pharmaceuticals Corporation v. Torrent Pharma Inc., case number 1:21-cv-01330, is a Hatch-Waxman patent litigation matter filed in the U.S. District Court (District of New Jersey per docket numbering conventions), with Novartis as plaintiff and Torrent as defendant. The case is litigation over patent rights listed for a Novartis product in the FDA Orange Book tied to a generic or biosimilar-competitive filing by Torrent, typically brought through a Paragraph IV strategy.

Litigation posture and core issues to analyze in this docket class:

  • Validity and infringement challenges: Torrent typically disputes one or more asserted Orange Book patents under 35 U.S.C. § 271 (infringement) and § 282 (invalidity), most often citing anticipation/obviousness and non-infringement based on label/carveout and/or manufacturing process.
  • Relief sought: Novartis seeks an injunction under 35 U.S.C. § 271(e)(4) to bar final FDA approval until patent expiry, plus declaratory relief on infringement/validity.
  • Regulatory trigger: The litigation is tied to FDA review timing and a potential at-risk launch if the court finds the patents invalid or not infringed.

Required: case-specific claims, asserted patents, decision dates, and outcome are not present in the provided input, so a complete and accurate litigation summary cannot be produced.

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