United States Patent 10,973,836: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,973,836, titled "Methods of treating heart failure with reduced ejection fraction," is a significant patent in the pharmaceutical sector, particularly for the treatment of heart failure. This patent is associated with dapagliflozin, a medication known for its efficacy in managing various health conditions, including type 2 diabetes, chronic kidney disease, and heart failure.
Background on Dapagliflozin
Dapagliflozin, marketed under the brand name Farxiga, is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. It has been approved for several indications, including type 2 diabetes, chronic kidney disease, and heart failure with reduced ejection fraction (HFrEF)[1][4].
Patent Overview
Patent Number and Status
The patent number is US10,973,836B2, and it is currently active. The patent was granted on April 12, 2022, and is set to expire on March 9, 2040[1][4].
Claims and Scope
The patent includes multiple claims that define the methods of treating heart failure with reduced ejection fraction using dapagliflozin. Here are some key aspects of the claims:
- Independent Claims: These are the broadest claims that define the invention. They typically outline the core method of treatment, including the administration of dapagliflozin to patients with heart failure and reduced ejection fraction[1].
- Dependent Claims: These claims are narrower and build upon the independent claims. They may specify particular dosages, patient populations, or additional therapeutic agents used in conjunction with dapagliflozin[1].
Clinical Evidence and Efficacy
The patent references clinical trials, such as the DAPA-HF phase 3 clinical trial, which demonstrated the efficacy of dapagliflozin in reducing worsening heart failure and mortality in patients with HFrEF. This evidence supports the claims made in the patent regarding the therapeutic benefits of dapagliflozin in this patient population[1].
Patent Landscape and Expiration Dates
Composition of Matter and Indication Patents
The patent landscape for dapagliflozin includes a variety of patents covering different aspects such as composition of matter, methods of treatment, and dosage regimens. Key patents include:
- US6515117B2: Expires on October 4, 2025, covering the composition of matter[4].
- US8791077B2: Expires on October 4, 2029, related to methods of treatment for heart failure[4].
Patent Filing Trends
There has been a significant increase in patent filings related to dapagliflozin since 2013, with a notable spike in 2022. This indicates ongoing research and development efforts to expand the therapeutic uses and formulations of dapagliflozin[4].
Key Assignees and Competitors
AstraZeneca is the primary assignee and has filed over 40 patents related to dapagliflozin. Other notable companies involved in patent filings include Sichuan Haisco Pharma, Boehringer, Sun Pharma, Coherus Bioscience, Merck, and Sanofi. This diverse participation highlights the strategic importance of dapagliflozin in the pharmaceutical industry[4].
Evergreening and Patent Abuses
The patent landscape for dapagliflozin, like many other blockbuster drugs, is subject to evergreening tactics. These tactics involve filing multiple patents to extend the exclusivity period of the drug, delaying generic and biosimilar competition. Such practices can result in significant financial losses for healthcare systems, such as Medicare, due to the absence of lower-cost alternatives[5].
Impact on Generic and Biosimilar Competition
The expiration dates of key patents for dapagliflozin will play a crucial role in determining when generic and biosimilar versions can enter the market. The molecule patent for dapagliflozin is set to expire in 2036, but various method of treatment and formulation patents will expire earlier, potentially allowing for earlier generic competition in specific indications[4].
Regulatory and Legal Considerations
Challenges to patents, such as those before the Patent Trial and Appeal Board (PTAB), can impact the exclusivity period of drugs like dapagliflozin. Legislative proposals, such as the PREVAIL Act, could further influence the ability to challenge these patents, affecting the timing of generic and biosimilar market entry[5].
Conclusion
The United States Patent 10,973,836 is a critical component of the broader patent landscape for dapagliflozin, particularly in the context of treating heart failure with reduced ejection fraction. Understanding the scope, claims, and expiration dates of this patent, along with the broader patent landscape, is essential for pharmaceutical companies, regulatory bodies, and healthcare systems.
Key Takeaways
- Patent Scope: The patent covers methods of treating heart failure with reduced ejection fraction using dapagliflozin.
- Clinical Evidence: Supported by clinical trials like DAPA-HF.
- Patent Expiration: Key patents expire between 2025 and 2040.
- Competitors: Multiple pharmaceutical companies are involved in patent filings.
- Evergreening: Tactics to extend exclusivity periods can delay generic competition.
Frequently Asked Questions (FAQs)
1. What is the primary indication covered by US Patent 10,973,836?
The primary indication covered is the treatment of heart failure with reduced ejection fraction using dapagliflozin.
2. When does the molecule patent for dapagliflozin expire?
The molecule patent for dapagliflozin is set to expire in 2036.
3. Which companies are actively filing patents related to dapagliflozin?
AstraZeneca, Sichuan Haisco Pharma, Boehringer, Sun Pharma, Coherus Bioscience, Merck, and Sanofi are among the companies actively filing patents.
4. How do evergreening tactics affect the pharmaceutical market?
Evergreening tactics delay generic and biosimilar competition, resulting in higher costs for healthcare systems and patients.
5. What is the role of the PTAB in challenging pharmaceutical patents?
The PTAB provides a forum for challenging problematic patents, helping to expedite access to lower-cost alternatives by invalidating unjustified patent claims.
Cited Sources:
- US10973836B2 - Methods of treating heart failure with reduced ejection fraction - Google Patents
- Dapagliflozin Tablets - U.S. Food & Drug Administration
- The Ways We've been Measuring Patent Scope are Wrong - Boston University Law
- Farxiga Patent Thicket Patents expiring in 2025 - GreyB
- Using the Inflation Reduction Act to Rein in Patenting Evergreening Abuses - Citizen.org
