Understanding the Scope and Claims of United States Patent 9,980,961
Introduction
United States Patent 9,980,961, titled "Pyruvate kinase activators for use in therapy," is a significant patent in the pharmaceutical sector, particularly in the field of metabolic disorders. This patent, assigned to Agios Pharmaceuticals, Inc., protects a class of compounds that activate pyruvate kinase, an enzyme crucial in cellular metabolism.
Patent Overview
- Title: Pyruvate kinase activators for use in therapy
- Inventors: Shin-San Michael Su and Lenny Dang
- Assignee: Agios Pharmaceuticals, Inc.
- Application Number: 15/583,412
- Approval Date: The patent was granted after the application was filed on May 1, 2017[1][5].
Abstract and Background
The patent describes methods for using compounds that activate pyruvate kinase, an enzyme involved in the final step of glycolysis. Pyruvate kinase deficiency is associated with various metabolic disorders, and activating this enzyme can have therapeutic benefits. The abstract outlines the importance of these activators in treating conditions related to pyruvate kinase deficiency.
Claims
The patent includes several claims that define the scope of protection for the invention. Here are some key aspects of the claims:
- Compound Claims: The patent claims cover specific chemical compounds that activate pyruvate kinase. These compounds are defined by their structural formulas and functional groups[1].
- Method Claims: The patent also claims methods for using these compounds in therapy, including the treatment of pyruvate kinase deficiency and other related metabolic disorders.
- Use Claims: Claims are made for the use of these compounds in various therapeutic applications, highlighting their potential in medical treatment[1].
Patent Family and International Protection
- Global Coverage: The patent has forty-seven patent family members in twenty-six countries, indicating a broad international protection strategy. This includes patents in Australia, Brazil, and other jurisdictions[1].
- Supplementary Protection Certificates (SPCs): In some countries, the patent is further protected by SPCs, which extend the patent term beyond the standard 20 years from the filing date.
Expiration and Generic Entry
- Patent Expiration: The estimated expiration dates for the patent vary by country but generally fall around the mid-2030s, considering the standard patent term and any potential extensions.
- Generic Entry: After the patent expires, generic versions of the protected compounds can enter the market, potentially reducing costs and increasing accessibility for patients.
Therapeutic Applications
The compounds protected by this patent have significant therapeutic potential, particularly in treating pyruvate kinase deficiency and related metabolic disorders. Here are some key therapeutic applications:
- Pyruvate Kinase Deficiency: The primary focus is on treating this genetic disorder, which affects the production of pyruvate kinase, leading to hemolytic anemia and other complications.
- Other Metabolic Disorders: The activators may also be useful in treating other metabolic conditions where pyruvate kinase activity is compromised.
Market Impact
- PYRUKYND: The patent protects PYRUKYND, a drug that has been approved for use in therapy. This drug is part of a new class of treatments that target metabolic pathways at the molecular level.
- Competitive Landscape: The protection offered by this patent gives Agios Pharmaceuticals a competitive edge in the market for metabolic disorder treatments, allowing them to exclusively market and sell PYRUKYND and related compounds.
Research and Development
- Continuation Applications: The patent is part of a series of applications, including continuation applications that further refine and expand the scope of the original invention[5].
- Clinical Trials: The development of these compounds involves extensive clinical trials to ensure safety and efficacy, which are critical for regulatory approval.
Regulatory Approval
- NDA Approval: The patent is included in one New Drug Application (NDA), indicating that the drug has undergone rigorous regulatory scrutiny and has been approved for use by regulatory bodies such as the FDA[1].
Economic and Legal Implications
- Patent Scope Measurements: The scope of this patent, like others, can be analyzed using datasets and tools provided by the USPTO, such as the Patent Claims Research Dataset. This helps in understanding the breadth and depth of patent protection[3].
- Litigation and Licensing: The patent's broad protection can lead to potential litigation if other companies attempt to develop similar compounds. It also opens avenues for licensing agreements, allowing other companies to use the protected technology under certain conditions.
Global Patent Landscape
- International Search Tools: To navigate the global patent landscape, tools like the Global Dossier and Common Citation Document (CCD) are invaluable. These tools help in identifying related applications and prior art across different jurisdictions[4].
- Foreign Patent Databases: Access to databases from international intellectual property offices, such as the European Patent Office (EPO) and the World Intellectual Property Organization (WIPO), is crucial for a comprehensive patent search[4].
Conclusion
United States Patent 9,980,961 is a pivotal patent in the field of metabolic disorder treatments, offering significant protection for pyruvate kinase activators. Understanding its scope, claims, and international protection is essential for both the pharmaceutical industry and researchers.
Key Takeaways
- Patent Protection: The patent protects specific compounds and methods for activating pyruvate kinase.
- Therapeutic Applications: It has significant therapeutic potential for treating pyruvate kinase deficiency and other metabolic disorders.
- Global Coverage: The patent has broad international protection across 26 countries.
- Regulatory Approval: It is included in one NDA and has been approved for use in therapy.
- Economic and Legal Implications: The patent's scope can be analyzed using USPTO datasets, and it has implications for litigation and licensing.
FAQs
Q: What is the main subject of United States Patent 9,980,961?
A: The main subject is pyruvate kinase activators for use in therapy.
Q: Who are the inventors of this patent?
A: The inventors are Shin-San Michael Su and Lenny Dang.
Q: Which company is assigned this patent?
A: The patent is assigned to Agios Pharmaceuticals, Inc.
Q: What is the estimated expiration date of this patent?
A: The estimated expiration dates vary by country but generally fall around the mid-2030s.
Q: What is the therapeutic potential of the compounds protected by this patent?
A: The compounds have significant therapeutic potential for treating pyruvate kinase deficiency and other related metabolic disorders.
Sources
- Drug Patent Watch - Summary for Patent: 9,980,961
- Unified Patents Portal - US-5965559-A
- USPTO - Patent Claims Research Dataset
- USPTO - Search for patents
- Justia Patents - US Patent Application for PYRUVATE KINASE ACTIVATORS FOR ...
