Litigation Details for In re: Entresto (Sacubitril/Valsartan) Patent Litigation (D. Del. 2020)

In re: Entresto (Sacubitril/Valsartan) Patent Litigation (D. Del. 2020)

Docket		Date Filed	2020-03-27
Court	District Court, D. Delaware	Date Terminated	2021-08-30
Cause	35:271 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	Defendant	Referred To	Christopher J. Burke
Patents	10,004,746; 10,010,507; 10,016,435; 10,106,548; 10,125,140; 10,213,386; 10,294,231; 10,294,232; 10,335,462; 7,342,117; 7,468,390; 7,514,444; 7,879,828; 7,982,049; 8,008,309; 8,101,659; 8,404,744; 8,476,284; 8,497,277; 8,563,563; 8,679,069; 8,697,711; 8,703,780; 8,735,403; 8,754,090; 8,754,091; 8,796,331; 8,877,938; 8,952,015; 8,957,079; 8,999,999; 9,125,889; 9,181,257; 9,296,753; 9,388,134; 9,540,382; 9,655,857; 9,713,617; 9,725,455; 9,795,604; 9,801,881; 9,801,883; 9,814,721
Link to Docket	External link to docket

Biologic Drugs cited in In re: Entresto (Sacubitril/Valsartan) Patent Litigation

Details for In re: Entresto (Sacubitril/Valsartan) Patent Litigation (D. Del. 2020)

Date Filed	Document No.	Description	Snippet	Link To Document
2020-03-27	1	Complaint	PageID #: 2 Patent”); 9,655,857 (“the ’857 Patent”); 9,725,455 (“the ’455 Patent”); 10,010,507 (“the ’507… United States Patent Nos. 7,514,444 (“the ’444 Patent”); 8,008,309 (“the ’309 Patent”); 8,476,284 (“…(“the ’284 Patent”); 8,497,277 (“the ’277 Patent”); 8,697,711 (“the ’711 Patent”); 8,735,403 (“the ’403…’403 Patent”); 8,754,090 (“the ’090 Patent”); 8,754,091 (“the ’091 Patent”); 8,952,015 (“the ’015 Patent…507 Patent”); 10,106,548 (“the ’548 Patent”); and 10,125,140 (“the ’140 Patent”).	External link to document
2020-03-27	1057	Proposed Order	pediatric exclusivity for U.S. Patent No. 8,404,744 (“the ’744 patent”) expires on July 14, 2023, which… patent or the ’667 patent] [Noratech’s proposal: if such deposition concerned the ’659 patent or… proposal: the validity of] the ’659 patent or the ’667 patent, (ii) Novartis’s documents concerning…proposal: the validity of] the ’659 patent or the ’667 patent, and (iii) the deposition testimony (including…Asserted Patent. Novartis will produce to Noratech the file history for the ’659 and ’667 patents within	External link to document
2020-03-27	1058	Redacted Document	United States Patent No. 8,101,659 (“the ’659 Patent”), of United Sates Patent No. 8,877,938…the ’938 Patent”), of United States Patent No. 9,388,134 (“the ’134 Patent”), …United States Patent No. 11,058,667 (“the ’667 Patent”), and of United States Patent No. 11,096,918…the ’659 Patent, of the ’938 Patent, of the ’134 Patent, … of the ’667 Patent, and of the ’918 Patent are valid and enforceable. 2. Judgment	External link to document
2020-03-27	1059	Redacted Document	of United States Patent No. 8,101,659 ("the ' 659 Patent"), … of United Sates Patent No. 8,877,938 ("the ' 938 Patent"), of…of United States Patent No. 9,388,134 ("the' 134 Patent"), … ofUnited States Patent No . 11 ,058,667 ("the ' 667 Patent"), and ofUnited… ofUnited States Patent No. 11 ,096,918 ("the ' 918 Patent") are valid and enforceable	External link to document
2020-03-27	1063	Exhibit A-C	21 C.F.R. § 314.95 of U.S. Patent Nos. 7,468,390, 8,101,659, 8,404,744, 8,796,331, 8,877,…strengths, before the expiration of U.S. Patent Nos. 7,468,390, 8,101,659, 8,404,744, 8,796,331, 8,877,… paragraph IV certification are U.S. Patent Nos. 7,468,390, 8,101,659, 8,404,744, 8,796,331, 8,877,… Patent Expiry 7,468,390 Novartis AG 11/27/2023 …to the best of their knowledge, U.S. Patent Nos. 7,468,390, 8,101,659, 8,404,744, 8,796,331, 8,877,938	External link to document
2020-03-27	1099	Opinion	infringement of U.S. Patent 8,877,938 (the “’938 Patent”), 9,388,134 (the “’134 Patent”), 8,101,659 (the “’659 …659 Patent”) and 8,796,331 (the “’331 Patent”). Only the ’659 Patent is at issue in this opinion. The parties… of that patent. (/d.). I held separate trials addressing the ’938 Patent and the ’134 Patent. (D.I. 604…Ciba-Geigy, was issued U.S. Patent No. 5,399,578 (“the ’578 Patent”). (JTX-23). That patent disclosed and claimed…the °659 Patent claims are obvious over EP ’072, the ’996 Patent/Ksander, and the °578 Patent/Diovan®	External link to document

Litigation Summary and Analysis for In re: Entresto (Sacubitril/Valsartan) Patent Litigation

Introduction

The In re: Entresto (Sacubitril/Valsartan) Patent Litigation is a complex and multifaceted case involving patent infringement claims related to Novartis' heart failure drug Entresto, which combines the active ingredients valsartan and sacubitril. Here, we delve into the key aspects of this litigation, including the patent claims, the legal battles, and the recent developments.

Background of the Patent

The U.S. Patent No. 8,101,659 ('659 patent) at the center of this litigation was granted to Novartis and relates to compositions of valsartan and sacubitril, used to treat hypertension and heart failure. The patent's priority date is January 17, 2002, which is crucial for determining the validity of the claims[5].

Generic Manufacturers' Challenge

Several generic drug manufacturers, including MSN Pharmaceuticals, Inc., Hetero USA Inc., and Macleods Pharmaceuticals Ltd., submitted Abbreviated New Drug Applications (ANDAs) to market generic versions of Entresto. This prompted Novartis to file patent infringement lawsuits against these companies, alleging that their generic products would infringe claims 1-4 of the '659 patent[4][5].

District Court Rulings

In the U.S. District Court for the District of Delaware, the case underwent significant scrutiny. The district court initially agreed with Novartis that the term "wherein said [valsartan and sacubitril] are administered in combination" should be given its plain and ordinary meaning. However, the court also found that the claims lacked a written description for the specific complex form of valsartan and sacubitril, which was discovered after the patent's priority date. This led to a determination that the claims were invalid for lack of written description, although they were not found to be invalid for obviousness, lack of enablement, or indefiniteness[1][3].

Appeal to the Federal Circuit

Novartis appealed the district court's decision to the U.S. Court of Appeals for the Federal Circuit (CAFC). The CAFC reversed the district court's finding on the written description requirement. The appellate court held that since the '659 patent does not claim the valsartan-sacubitril complexes specifically, these complexes did not need to be described in the patent. Citing Vas-Cath Inc. v. Mahurkar, the CAFC emphasized that "the invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed"[1][2].

Key Arguments and Findings

• Written Description Requirement: The CAFC clarified that the absence of a description for the complex form of valsartan and sacubitril in the patent does not affect its validity because the claims do not specifically include these complexes. The court rejected MSN's argument that the patent must describe and enable the full scope of the claims, including the later-discovered complexes[1][2].
• Enablement: The district court had found that while the claims were enabled, the lack of description for the complexes was fatal for the written description requirement. However, the CAFC upheld that the enablement was judged as of the priority date and that later discoveries did not invalidate the earlier invention[1][3].
• Claim Construction: The district court's construction of the claims, giving the term "wherein said [valsartan and sacubitril] are administered in combination" its plain and ordinary meaning, was upheld by the CAFC. This construction was crucial as it determined that the accused generic products could infringe the '659 patent claims[1][2].

Impact on Generic Manufacturers

The CAFC's decision is a significant setback for generic manufacturers seeking to market their versions of Entresto. With the '659 patent claims revived, Novartis retains its exclusive rights to the drug until the patent expires on January 15, 2025, with pediatric exclusivity ending on July 15, 2025[4].

Legal and Industry Implications

This case highlights the complexities of patent law, particularly the written description and enablement requirements. It underscores the importance of precise claim construction and the distinction between what is claimed and what is described in the patent specification. For pharmaceutical companies, this decision reinforces the need for meticulous patent drafting and the potential for later discoveries to impact patent validity.

Conclusion

The In re: Entresto (Sacubitril/Valsartan) Patent Litigation is a landmark case that clarifies critical aspects of patent law. The CAFC's decision to revive the '659 patent claims has significant implications for both Novartis and the generic drug manufacturers involved.

Key Takeaways

• The CAFC reversed the district court's finding that certain claims of the '659 patent were invalid for lack of written description.
• The appellate court held that the invention, for purposes of the written description inquiry, is whatever is now claimed.
• The decision emphasizes the importance of precise claim construction and the distinction between what is claimed and what is described in the patent specification.
• The case underscores the potential impact of later discoveries on patent validity.
• The '659 patent remains valid until its expiration on January 15, 2025.

Frequently Asked Questions (FAQs)

Q: What is the main issue in the In re: Entresto (Sacubitril/Valsartan) Patent Litigation? A: The main issue is whether the '659 patent claims for the combination of valsartan and sacubitril are valid, particularly in relation to the written description and enablement requirements.

Q: What was the district court's initial ruling on the '659 patent claims? A: The district court found that the claims lacked a written description for the specific complex form of valsartan and sacubitril, rendering them invalid, but not for obviousness, lack of enablement, or indefiniteness.

Q: How did the CAFC rule on the appeal? A: The CAFC reversed the district court's decision, finding that the '659 patent claims were valid because they did not specifically claim the valsartan-sacubitril complexes.

Q: What is the significance of the CAFC's decision on claim construction? A: The CAFC's decision upheld the plain and ordinary meaning of the term "wherein said [valsartan and sacubitril] are administered in combination," which is crucial for determining infringement.

Q: What are the implications of this decision for generic drug manufacturers? A: The decision prevents generic manufacturers from marketing their versions of Entresto until the '659 patent expires on January 15, 2025.

Cited Sources

1. IP Watchdog - Novartis' Entresto Patent Claims Revived by CAFC
2. United States Court of Appeals for the Federal Circuit - Opinion in Case 23-2218
3. Wiley Law - Wiley Wins High-Profile Drug Patent Case on Behalf of Generic Manufacturer
4. GovInfo - Case 1:20-md-02930-RGA Document 1457
5. Casetext - In re Entresto Sacubitril/Valsartan Patent Litig.