Litigation Details for Novartis Pharmaceuticals Corporation v. Torrent Pharma Inc. (D. Del. 2019)

Novartis Pharmaceuticals Corporation v. Torrent Pharma Inc. (D. Del. 2019)

Docket		Date Filed	2019-10-17
Court	District Court, D. Delaware	Date Terminated	2024-09-06
Cause	35:271 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	None	Referred To
Parties	TEVA PHARMACEUTICAL INDUSTRIES LTD.
Patents	7,468,390; 8,101,659; 8,404,744; 8,796,331; 8,877,938; 9,388,134
Attorneys	Scott A. Cunning , II
Firms	KL Gates LLP
Link to Docket	External link to docket

Details for Novartis Pharmaceuticals Corporation v. Torrent Pharma Inc. (D. Del. 2019)

Date Filed	Document No.	Description	Snippet	Link To Document
2019-10-17				External link to document
2019-10-17	59	Patent/Trademark Report to Commissioner	the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) US 7,468,390 B2 ;US 8,404,744 …HOLDER OF PATENT OR TRADEMARK TRADEMARK NO. OR TRADEMARK 1 7,468,390 …following G Trademarks or G✔ Patents. ( G the patent action involves 35 U.S.C. § 292.): DOCKET…Laboratories Ltd., et al. PATENT OR DATE OF PATENT … G Other Pleading PATENT OR DATE OF PATENT	External link to document
2019-10-17	598	Stipulation-General (See Motion List for Stipulation to Extend Time)	Order Regarding Post-Trial Briefing for U.S. Patent No. 8,796,331 by Novartis Pharmaceuticals Corporation.… 17 October 2019 1:19-cv-01979 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2019-10-17	601	Order	Order Regarding Post-Trial Briefing for U.S. Patent No. 8,796,331. Signed by Judge Richard G. Andrews on 11… 17 October 2019 1:19-cv-01979 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2019-10-17	628	Post Trial Brief	Suzhou) Co., Ltd.'s Infringement of U.S. Patent Nos. 8,877,938 and 9,388,134, by Novartis Pharmaceuticals… 17 October 2019 1:19-cv-01979 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2019-10-17	657	Redacted Document	Appeal No. 23-2218, involving U.S. Patent No. 8,101,659 (“the ’659 Patent”). …2023 opinion invalidating U.S. Patent No. 8,101,659 (“the ’659 Patent”) (MDL No. 20-2930-RGA, D.I. 1099… 2023 opinion invalidating U.S. Patent No. 8,101,659 (“the ’659 Patent”) (MDL No. 20- 2930-RGA, D.I.…infringement of several of Novartis’s patents including the ’659 Patent, based on Torrent’s filing of an…involving the same patents under the caption In re Entresto (Sacubitril/Valsartan) Patent Litigation, MDL	External link to document
2019-10-17	662	Order	2023 opinion invalidating U.S. Patent No. 8,101,659 (“the ’659 Patent”) (MDL No. 20-2930-RGA, D.I. … ) In re Entresto (Sacubitril/Valsartan) Patent ) MDL No. 20-2930-RGA Litigation …RGA, D.I. 646), and (2) the July 21, 2023 ’659 Patent Judgment (MDL No. 20-2930-RGA, D.I. 1120; C.A. … 17 October 2019 1:19-cv-01979 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Novartis Pharmaceuticals Corporation v. Torrent Pharma Inc.: A Comprehensive Litigation Summary and Analysis

Background

The litigation between Novartis Pharmaceuticals Corporation and Torrent Pharma Inc., among other defendants, revolves around patent infringement claims related to Novartis's drug Entresto® (sacubitril/valsartan). This case is part of a multi-district litigation in the United States District Court for the District of Delaware[2][3].

Patents in Dispute

The patents at the center of this litigation include U.S. Patent 8,877,938, 9,388,134, 8,101,659, and 8,796,331. However, the primary focus has been on the '659 Patent, which pertains to compositions of valsartan and sacubitril used to treat hypertension and heart failure[2][3].

Claims and Infringement

Novartis alleged that the defendants, including Torrent Pharma Inc., infringed claims 1-4 of the '659 Patent by submitting Abbreviated New Drug Applications (ANDAs) for generic versions of Entresto®. The defendants stipulated to infringement but argued that the claims were invalid due to obviousness and lack of an adequate written description and enablement[2][3].

Obviousness Determinations

The court addressed the defendants' arguments on obviousness, particularly focusing on whether a person of ordinary skill in the art (POSA) would have been motivated to combine valsartan (an angiotensin receptor blocker) and sacubitril (a neprilysin inhibitor). The defendants, such as MSN Pharmaceuticals, argued that such a combination was obvious based on prior art references. However, the court rejected these arguments, finding that the defendants failed to provide clear and convincing evidence that a POSA would have been motivated to pursue this specific combination. The court noted that the "obvious-to-try" theory relied on impermissible hindsight, given the numerous potential drug combinations for treating heart failure and hypertension[3].

Written Description and Enablement

The court also examined whether the '659 Patent provided an adequate written description and enabled the claimed inventions. MSN argued that the patent must enable and describe the full scope of the claims, including the physical combination and complex of valsartan and sacubitril. Novartis countered that the patent sufficiently described and enabled the claimed compositions. The court ultimately affirmed the district court's determination that the claims were not invalid due to lack of written description or enablement[3].

Appeal and Outcomes

Novartis appealed the district court's decisions, and the Federal Circuit reviewed the determinations. The Federal Circuit reversed the district court's finding that the claims lacked an adequate written description but affirmed the determinations that the claims were not invalid as either non-enabled or obvious. Several defendants, including Hetero USA Inc. and Torrent Pharmaceuticals Ltd., settled their disputes with Novartis during the appeal process[3].

Key Takeaways

• Patent Validity: The '659 Patent was found valid against challenges of obviousness, lack of written description, and lack of enablement.
• Infringement: Defendants stipulated to infringement of the '659 Patent claims.
• Court Decisions: The Federal Circuit affirmed the district court's obviousness and enablement determinations but reversed the written description finding.
• Settlements: Several defendants settled their disputes with Novartis during the appeal.

FAQs

Q: What is the main drug at the center of the litigation between Novartis and Torrent Pharma Inc.?

A: The main drug is Entresto® (sacubitril/valsartan), used to treat hypertension and heart failure.

Q: Which patents are primarily involved in this litigation?

A: The primary patents include U.S. Patent 8,877,938, 9,388,134, 8,101,659, and 8,796,331, with a focus on the '659 Patent.

Q: What was the outcome of the obviousness challenge by the defendants?

A: The court rejected the defendants' obviousness arguments, finding that they failed to provide clear and convincing evidence that a POSA would have been motivated to combine valsartan and sacubitril.

Q: Did the court find any issues with the written description and enablement of the '659 Patent?

A: The Federal Circuit reversed the district court's finding that the claims lacked an adequate written description but affirmed that the claims were not invalid due to lack of enablement.

Q: Which defendants settled their disputes with Novartis during the appeal?

A: Hetero USA Inc., Hetero Labs Limited, and Torrent Pharmaceuticals Ltd. settled their disputes with Novartis during the appeal process.

Sources

1. Novartis AG v. Torrent Pharmaceuticals Limited, 853 F.3d 1316 (Fed. Cir. 2017)
2. In re Entresto Sacubitril/Valsartan Patent Litig., United States District Court, D. Delaware, MDL 20-2930-RGA (D. Del. Jul. 7, 2023)
3. NOVARTIS PHARMACEUTICALS CORPORATION v. TORRENT PHARMA INC., Case: 23-2218, Document: 106, Page: 1, Filed: 01/10/2025
4. NOVARTIS PHARMACEUTICALS CORPORATION v. TORRENT PHARMA INC., Case: 23-2219, Document: 19, Page: 1, Filed: 09/03/2024