Litigation Details for Novartis Pharmaceuticals Corporation v. Aurobindo Pharma Ltd. (D. Del. 2020)

Novartis Pharmaceuticals Corporation v. Aurobindo Pharma Ltd. (D. Del. 2020)

Docket		Date Filed	2020-10-23
Court	District Court, D. Delaware	Date Terminated
Cause		Assigned To
Jury Demand		Referred To
Patents	10,124,000; 7,314,938; 7,745,460; 7,790,743; 7,928,122; 8,084,047; 8,168,655; 8,367,701; 8,592,450; 8,927,574; 9,085,553; 9,216,174; 9,353,088; 9,447,077; 9,890,141
Link to Docket	External link to docket

Details for Novartis Pharmaceuticals Corporation v. Aurobindo Pharma Ltd. (D. Del. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-10-23				External link to document
2020-10-23	1	Complaint	,174 (“the ’174 patent”); U.S. Patent No. 10,124,000 (“the ’000 patent”); U.S. Patent No. 8,084,047 (…of U.S. Patent No. 7,314,938 (“the ’938 patent”); U.S. Patent No. 7,745,460 (“the ’460 patent”); U.S.…U.S. Patent No. 7,790,743 (“the ’743 patent”); U.S. Patent No. 7,928,122 (“the ’122 patent”); U.S. Patent… (“the ’047 patent”); U.S. Patent No. 8,592,450 (“the ’450 patent”); U.S. Patent No. …8,168,655 (“the ’655 patent”); U.S. Patent No. 8,367,701 (“the ’701 patent”); U.S. Patent No. 9,447,077 (	External link to document
2020-10-23	3	ANDA Form	November 5, 2024 10,124,000 November 5,… Date of Expiration of Patents: U.S. Patent No. …. SUPPLEMENTAL INFORMATION FOR PATENT CASES INVOLVING AN ABBREVIATED NEW DRUG	External link to document

Litigation summary and analysis for: Novartis Pharmaceuticals Corporation v. Aurobindo Pharma Ltd. (D. Del. 2020)

Here is a summary and analysis of the patent litigation Novartis Pharmaceuticals Corporation v. Aurobindo Pharma Ltd. et al (Case No. 1:20-cv-01426) in the U.S. District Court for the District of Delaware:

Key Details:

• Filed: October 23, 2020
• Closed: March 27, 2023
• Judge: Gregory B. Williams
• Plaintiff: Novartis Pharmaceuticals Corporation
• Defendants: Aurobindo Pharma Ltd. and 3 other defendants
• Cause of Action: Patent infringement
• Patents-in-Suit: 16 patents
• Market Sector: Biotech and Pharma

Summary: This was an ANDA litigation brought by Novartis against generic drug manufacturers seeking to market generic versions of Novartis's drug Entresto (sacubitril/valsartan). Novartis alleged infringement of 16 patents related to Entresto.

Key Developments:

• The case was part of a multi-district litigation (MDL) concerning Entresto patents.
• Novartis filed suit after receiving Paragraph IV certifications from the defendants challenging the validity of Novartis's patents.
• The litigation lasted about 2.5 years before being resolved, likely through settlement agreements.
• As an ANDA case, the main issues were likely patent validity and infringement based on the defendants' proposed generic products.

Analysis:

• The large number of patents-in-suit (16) suggests Novartis has built a significant patent portfolio around Entresto to protect its market exclusivity.
• The relatively long litigation duration of 886 days indicates this was a complex case with substantial discovery and motion practice.
• The case ending in early 2023 likely means Novartis was able to delay generic entry for several years after Entresto's initial approval in 2015.
• As part of an MDL, this case was coordinated with other similar lawsuits against different generic manufacturers.
• The resolution was likely a settlement allowing generic entry on agreed terms, which is common in ANDA litigation.

This case demonstrates the complex patent disputes that often arise between brand and generic drug companies as generics seek to enter the market. Novartis appears to have successfully leveraged its patent portfolio to protect Entresto's exclusivity for a significant period.