United States Patent 11,058,667: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,058,667, assigned to Novartis AG, is a crucial patent protecting the drug Entresto, a combination of sacubitril and valsartan used for the treatment of heart failure. This patent is part of a complex patent landscape that has significant implications for the pharmaceutical industry, particularly in the context of generic drug approvals and patent litigation.
Patent Overview
Title and Abstract
The patent is titled "Sacubitril-valsartan dosage regimen for treating heart failure" and relates to specific dosage regimens of sacubitril and valsartan for treating heart failure in patients[1].
Inventors and Assignee
The inventors listed are Adel Remond Rizkala, Victor Chengwei Shi, and Fabian Chen, with Novartis AG as the assignee[1].
Patent Claims
The patent includes claims related to the use and dosage regimens of the sacubitril-valsartan combination. These claims are critical in defining the scope of protection for Entresto, particularly in terms of method-of-use patents[1].
Patent Claims and Scope
Method-of-Use Patents
The patent specifically covers dosage regimens for treating heart failure, which falls under method-of-use patents. These patents protect the way a drug is used rather than the drug itself, providing a layer of protection that extends beyond the expiration of composition-of-matter patents[5].
Dosage Regimen
The patent details specific dosing schedules and regimens for the administration of sacubitril and valsartan, which are essential for the effective treatment of heart failure. This specificity is a key aspect of the patent's claims and distinguishes it from other patents related to Entresto[1].
Patent Expiration and Protection
Expiration Date
The patent is set to expire on May 9, 2036, which is one of the later expiration dates among the Entresto-related patents. This extended protection period is significant for Novartis, as it delays the entry of generic competitors into the market[4].
International Protection
The patent has sixteen patent family members in fourteen countries, indicating a broad international protection strategy by Novartis. This global coverage ensures that the intellectual property rights for Entresto are safeguarded in multiple jurisdictions[1].
Patent Litigation and Challenges
In re Entresto (Sacubitril/Valsartan) Patent Litigation
This patent has been at the center of several litigation cases, particularly involving generic drug manufacturers seeking to market their own versions of Entresto. In one notable case, Novartis prevailed against defendants who sought declaratory judgments on the validity of several Entresto-related patents, including the '667 patent. The court ruled that the defendants lacked standing to seek declaratory relief because they had not submitted paragraph IV notice letters for these patents[2].
Hatch-Waxman Act Implications
The litigation highlights the complexities of the Hatch-Waxman Act, which governs the approval process for generic drugs. The act requires ANDA applicants to submit paragraph IV certifications challenging the validity of listed patents or section viii statements certifying that they do not seek to market the drug for use-cases covered by the patent. Novartis's success in these cases has been based on the argument that the Hatch-Waxman statute bars declaratory judgment counterclaims unless the ANDA applicant has filed the necessary paragraph IV certifications[2].
Impact on Generic Drug Approvals
Abbreviated New Drug Applications (ANDAs)
The '667 patent, along with other Entresto-related patents, hinders generic entry into the market. ANDA applicants must either challenge the validity of these patents through paragraph IV certifications or carve out the patented use-cases from their generic drug labels using section viii statements. This process ensures that generic versions of Entresto cannot be marketed for the same use-cases protected by Novartis's patents until the patents expire[5].
FDA Approval Process
The FDA's Orange Book lists active pharmaceutical patents, including method-of-use patents like the '667 patent. Generic drug manufacturers must navigate this regulatory landscape carefully to avoid infringement. The FDA's approval process for ANDAs involves ensuring that the generic drug is pharmaceutical equivalent, labeled for the same conditions of use, and bioequivalent to the reference drug, while also complying with patent-related requirements[5].
Financial and Market Implications
Revenue Protection
The extended patent protection provided by the '667 patent and other related patents has allowed Novartis to maintain significant revenue from Entresto sales. As of recent reports, Novartis has generated over $10.5 billion in revenue from Entresto in the United States alone, highlighting the financial importance of these patents[5].
Market Dominance
The patent landscape surrounding Entresto has enabled Novartis to maintain market dominance in the heart failure treatment segment. The absence of generic competition due to these patents has allowed Novartis to continue its market leadership and maintain its guidance and mid-term outlook without significant disruption[4].
Key Takeaways
- Patent Scope: The '667 patent specifically covers dosage regimens for treating heart failure with sacubitril and valsartan.
- Expiration: The patent expires on May 9, 2036, providing extended protection.
- International Protection: The patent has broad international coverage across fourteen countries.
- Litigation: Novartis has successfully defended this patent in litigation, leveraging the Hatch-Waxman Act.
- Generic Drug Approvals: The patent hinders generic entry by requiring ANDA applicants to navigate complex regulatory and patent challenges.
- Financial Implications: The patent protection has allowed Novartis to generate significant revenue from Entresto sales.
FAQs
Q: What is the main subject of United States Patent 11,058,667?
A: The patent relates to specific dosage regimens of sacubitril and valsartan for treating heart failure in patients.
Q: Who is the assignee of this patent?
A: The assignee of this patent is Novartis AG.
Q: What is the expiration date of this patent?
A: The patent is set to expire on May 9, 2036.
Q: How has this patent impacted generic drug approvals?
A: The patent has hindered generic entry by requiring ANDA applicants to either challenge its validity or carve out the patented use-cases from their generic drug labels.
Q: What financial implications does this patent have for Novartis?
A: The patent has allowed Novartis to maintain significant revenue from Entresto sales, generating over $10.5 billion in the United States alone.
Sources
- Drug Patent Watch - Summary for Patent: 11,058,667
- Robins Kaplan - In re Entresto (Sacubitril/Valsartan) Patent Litigation
- FDA - ANDA 213748 ANDA APPROVAL MSN Pharmaceuticals Inc.
- Novartis - Novartis will appeal to U.S. Court of Appeals to uphold validity of Entresto combination patent
- GovInfo - Case 1:24-cv-02234-DLF Document 23 Filed 08/13/24 Page 1 of 15
