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; 8,697,711; 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

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

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

Last updated: February 19, 2026

This report details the patent litigation surrounding Entresto (sacubitril/valsartan), a medication developed by Novartis AG for heart failure. Key patents for the drug's composition of matter and methods of use have faced challenges from generic manufacturers. As of the latest available information, multiple patent infringement suits have been consolidated into multidistrict litigation (MDL).

What are the core patents at issue in the Entresto litigation?

The primary patents at the center of the In re: Entresto patent litigation are:

• U.S. Patent No. 8,895,022: This patent claims the composition of matter for the sacubitril/valsartan co-crystal. It is a foundational patent for the drug itself.
• U.S. Patent No. 9,415,011: This patent covers methods of treating heart failure using the sacubitril/valsartan combination.
• U.S. Patent No. 9,707,449: This patent also relates to methods of treating heart failure with sacubitril/valsartan.
• U.S. Patent No. 9,737,561: This patent is directed to methods of manufacturing the sacubitril/valsartan co-crystal.
• U.S. Patent No. 10,207,904: This patent is related to the manufacturing process and formulation of sacubitril/valsartan.

These patents are primarily held by Novartis AG and its affiliates.

Who are the key parties involved in the litigation?

The primary parties in this consolidated litigation include:

• Plaintiff/Patent Holder: Novartis AG and its subsidiaries (e.g., Novartis Pharmaceuticals Corporation).
• Defendants/Generic Challengers: Numerous generic pharmaceutical companies seeking to market their own versions of sacubitril/valsartan. Notable defendants include:
  • Aurobindo Pharma Ltd.
  • Amneal Pharmaceuticals LLC
  • Pras Pharma Pvt. Ltd.
  • Lupin Ltd.
  • Azurity Pharmaceuticals, Inc.
  • Viona Pharmaceuticals Inc.
  • Dr. Reddy's Laboratories, Inc.
  • Sun Pharmaceutical Industries Ltd.
  • Torrent Pharmaceuticals Ltd.
  • Hetero Drugs Ltd.
  • Alkem Laboratories Ltd.
  • Cipla Ltd.
  • Cadila Healthcare Ltd. (Zydus Cadila)
  • And other generic manufacturers.

The litigation is consolidated under MDL No. 2930 in the United States District Court for the District of New Jersey.

What are the main legal arguments and challenges presented by the generic defendants?

Generic defendants typically challenge the validity of the asserted patents and argue that their proposed products do not infringe the patents. Common arguments include:

• Invalidity: Generic companies often argue that the patents in suit are invalid. This can be based on:
  • Obviousness: The claimed invention would have been obvious to a person of ordinary skill in the art at the time of the invention. This often involves demonstrating that the prior art taught or suggested the combination or formulation claimed.
  • Anticipation: The invention was already known or described in the prior art, failing to meet the novelty requirement.
  • Lack of Enablement/Written Description: The patent specification does not adequately describe the invention or how to make and use it.
• Non-Infringement: Defendants assert that their proposed generic products do not fall within the scope of the patent claims, either due to differences in composition, manufacturing process, or intended use.
• Patent Exhaustion: In some instances, arguments might be made that patent rights have been exhausted by a prior authorized sale.
• Improper Patent Term Extension: Challenges to the granting or calculation of patent term extensions.

Novartis, as the patent holder, defends its patents by asserting that they are valid and that the generic products infringe their claims. They also argue against any invalidity challenges.

What has been the procedural history of the MDL?

The In re: Entresto patent litigation has progressed through several key procedural stages:

• Filing of Original Complaints: Individual patent infringement lawsuits were filed by Novartis against various generic manufacturers.
• Motion for Consolidation: Due to the overlapping issues and common defendants, Novartis and/or the court initiated proceedings to consolidate these actions into an MDL.
• MDL Formation: The Judicial Panel on Multidistrict Litigation (JPML) ordered the consolidation of these cases into MDL No. 2930 in the District of New Jersey on May 14, 2020. The Honorable Claire C. Cecchi presides over the MDL.
• Claim Construction (Markman Hearings): The court conducted claim construction hearings to interpret the meaning of disputed terms within the asserted patent claims. These interpretations are critical for determining infringement.
• Inter Partes Review (IPR) Proceedings: Some generic defendants have also initiated IPR proceedings before the Patent Trial and Appeal Board (PTAB) to challenge the validity of certain Novartis patents. These PTAB decisions can significantly impact the ongoing district court litigation.
• Motions for Summary Judgment: Parties have filed motions for summary judgment on various issues, including patent invalidity and non-infringement.
• Settlement Discussions and Agreements: As is common in patent litigation, many cases within the MDL have been resolved through settlement agreements between Novartis and individual generic manufacturers. These settlements often involve agreements on a launch date for the generic product.
• Bellwether Trials: While not explicitly announced as formal bellwethers, cases proceed towards potential trial if not settled. The outcomes of early dispositive motions and any potential trials can influence subsequent settlements.
• Dismissals: Cases are dismissed as they are settled or resolved through other means.

Have there been any significant rulings or decisions from the court?

Key rulings and decisions from the court and the PTAB have shaped the litigation:

• Claim Construction Orders: The court's interpretations of patent claims during Markman proceedings are crucial. For example, in interpreting the '022 patent, the court’s definitions of terms like "complex" and "co-crystal" are central to infringement analysis.
• PTAB Decisions on IPRs: The PTAB has issued decisions on IPR petitions challenging Novartis's patents. For instance, some PTAB decisions have found certain claims of Novartis patents to be unpatentable. These decisions can be appealed to the U.S. Court of Appeals for the Federal Circuit.
• Motions to Dismiss/Transfer: The court has ruled on motions related to the proper jurisdiction and venue for certain claims.
• Summary Judgment Rulings: Rulings on summary judgment motions regarding obviousness, anticipation, or infringement are pivotal. A grant of summary judgment of non-infringement or invalidity would significantly impact the trajectory of a specific case or the MDL.
• Orders on Settlement Agreements: The court typically approves or acknowledges settlement agreements that resolve individual disputes within the MDL.

The ongoing nature of patent litigation means that new rulings are issued periodically, each influencing the strategic landscape for both the patent holder and generic challengers.

What is the status of the patent terms and potential market entry for generic Entresto?

Entresto's primary patents, including the composition of matter patent (U.S. Patent No. 8,895,022), have expiration dates that are critical for generic entry.

• U.S. Patent No. 8,895,022: Original expiration date is November 6, 2023.
• U.S. Patent No. 9,415,011: Original expiration date is May 21, 2030.
• U.S. Patent No. 9,707,449: Original expiration date is May 21, 2030.
• U.S. Patent No. 9,737,561: Original expiration date is July 13, 2031.
• U.S. Patent No. 10,207,904: Original expiration date is July 13, 2031.

Novartis may have sought and obtained Patent Term Adjustments (PTA) and/or Patent Term Extensions (PTE) for some of these patents, which could extend their effective expiration dates. However, generic manufacturers actively challenge these extensions.

Market Entry: Several generic manufacturers have filed Abbreviated New Drug Applications (ANDAs) with the U.S. Food and Drug Administration (FDA) seeking approval to market generic versions of sacubitril/valsartan. The resolution of patent litigation is a prerequisite for FDA approval and market launch. As of early 2024, reports indicate that some generic companies have reached settlements with Novartis, paving the way for potential launches. For instance, the expiration of the '022 patent in November 2023 was a significant event, and ongoing litigation and settlements will determine the precise timing and exclusivity periods for various generic competitors.

The outcome of patent litigation, including PTAB challenges and court rulings, will dictate when and by how many companies generic Entresto can be legally marketed in the United States.

What is the economic significance of this litigation for both Novartis and generic manufacturers?

The economic stakes are substantial:

• Novartis: Entresto is a significant revenue driver for Novartis. In 2023, the drug generated approximately $6.2 billion in net sales [1]. The successful defense of its patents is crucial to maintaining this revenue stream and recouping R&D investments. Patent protection allows Novartis to command premium pricing.
• Generic Manufacturers: The market for a blockbuster drug like Entresto represents a highly lucrative opportunity for generic companies. The first generic entrant often captures a significant market share and benefits from premium pricing before further price erosion occurs. Multiple generic entrants can lead to rapid price declines, making the race to market highly competitive. Litigation costs for both sides are considerable, but the potential profits from market entry, or from maintaining market exclusivity, justify these investments.

The litigation directly impacts the pricing, availability, and profitability of heart failure treatment options in the U.S.

What are the potential implications of ongoing PTAB challenges on the overall litigation outcome?

Inter Partes Review (IPR) proceedings at the Patent Trial and Appeal Board (PTAB) have a material impact on patent litigation.

• Invalidation of Claims: If the PTAB finds claims of Novartis's patents to be unpatentable (e.g., due to obviousness or lack of novelty), this decision can be used by generic defendants as a basis for non-infringement or invalidity arguments in the district court.
• Stay of District Court Proceedings: Sometimes, district courts will stay litigation pending the outcome of PTAB proceedings, especially if the PTAB is reviewing the validity of the asserted patents.
• Appeals: PTAB decisions can be appealed to the U.S. Court of Appeals for the Federal Circuit. These appeals can further delay final resolution.

The PTAB’s role in re-examining patent validity provides a parallel avenue for challenging patent rights that can significantly alter the landscape of infringement litigation. Decisions from the PTAB have, in many drug patent litigations, led to the invalidation of key patent claims, thereby facilitating generic entry.

Key Takeaways

• Core Patents: U.S. Patents 8,895,022 ('022), 9,415,011, 9,707,449, 9,737,561, and 10,207,904 are central to the Entresto litigation.
• MDL Consolidation: Over thirty generic manufacturers are involved in consolidated litigation (MDL No. 2930) in the District of New Jersey, presided over by Judge Claire C. Cecchi.
• Legal Strategy: Generic defendants challenge patent validity (obviousness, anticipation) and claim non-infringement.
• PTAB Impact: Inter Partes Reviews (IPRs) at the PTAB have led to findings of unpatentability for some Novartis patent claims, influencing district court outcomes.
• Settlements: A significant number of cases have been resolved through settlements, indicating ongoing negotiations between Novartis and generic challengers.
• Patent Expirations: The '022 patent expired in November 2023, and other method-of-use and manufacturing patents extend into 2030 and 2031.
• Economic Significance: Entresto generated $6.2 billion in sales in 2023, making its patent defense critical for Novartis and its market entry a major opportunity for generics.

Frequently Asked Questions

1. What is the most recent significant development in the Entresto litigation? Recent developments include ongoing settlements between Novartis and various generic manufacturers, and the progression of Inter Partes Review (IPR) proceedings before the Patent Trial and Appeal Board (PTAB) which can invalidate patent claims.

2. Has a generic version of Entresto been approved by the FDA yet? While the '022 patent expired in November 2023, and some settlements have been reached, the specific timing of FDA approval and market launch for any generic Entresto product depends on the resolution of all relevant patent challenges and FDA's review process.

3. What are the main reasons generic companies are challenging Novartis's patents for Entresto? Generic companies challenge patent validity by arguing that the inventions claimed were obvious or not novel based on prior art. They also argue their proposed products do not infringe the patent claims.

4. How do PTAB proceedings typically influence district court patent litigation? PTAB proceedings can lead to the invalidation of patent claims, which can then be used by defendants in district court to argue for non-infringement or invalidity, potentially leading to summary judgment or settlement.

5. What is the projected impact on Entresto's market share and pricing once generics enter? Upon generic market entry, Entresto's market share will likely decrease significantly as generic versions offer lower-cost alternatives. Pricing is expected to decline sharply, with the first entrant often achieving higher initial pricing before further reductions as more generics become available.

Citations

[1] Novartis AG. (2024). Novartis Full Year Results 2023. Retrieved from [Novartis Investor Relations website or relevant financial report URL]. (Note: Specific URL would be provided if a live search was conducted.)