United States Patent 11,234,976: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,234,976, assigned to Agios Pharmaceuticals, Inc., is a significant patent that protects the drug PYRUKYND and methods related to its use. This article delves into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Title and Abstract
The patent titled "Methods of using pyruvate kinase activators" describes methods for using compounds that activate pyruvate kinase, an enzyme crucial in cellular metabolism[1].
Inventors and Assignee
The inventors include Samuel V. Agresta, Yue Chen, Marvin B. Cohen, Lenny Dang, Charles Kung, Elizabeth A. Merica, Bruce A. Silver, and Hua Yang. The patent is assigned to Agios Pharmaceuticals, Inc., a company based in Cambridge, MA[1].
Application and Patent Details
The patent application number is 15/735,036, and it was granted as part of a larger patent family with twenty-five patent family members in nineteen countries. The PCT application was filed on June 10, 2016, and published on December 15, 2016[1].
Scope of the Patent
Pyruvate Kinase Activators
The patent focuses on the use of pyruvate kinase activators, which are compounds designed to enhance the activity of pyruvate kinase. This enzyme plays a critical role in glycolysis, the process by which cells convert glucose into energy. Activating this enzyme can have therapeutic implications, particularly in treating diseases related to metabolic disorders[1].
Therapeutic Applications
The methods described in the patent involve using these activators to treat various conditions, including those related to pyruvate kinase deficiency. This deficiency can lead to severe anemia and other metabolic issues. The patent outlines specific dosages, administration methods, and potential combinations with other therapies[1].
Claims of the Patent
Claim Types
The patent includes claims related to the use and composition of pyruvate kinase activators. These claims are divided into independent and dependent claims, each detailing specific aspects of the methods and compounds involved[1].
Claim Structure
Each claim is presumed valid independently of the validity of other claims, as per 35 USC 282. This means that even if one claim is invalidated, the others remain valid unless proven otherwise[5].
Patent Landscape
Global Protection
The patent has a significant global footprint with twenty-five patent family members in nineteen countries. This extensive protection ensures that Agios Pharmaceuticals, Inc. has exclusive rights to the use and distribution of PYRUKYND and related methods in multiple jurisdictions[1].
Related Patents and Applications
The patent is part of a larger family of patents related to pyruvate kinase activators. This family includes various national and international patents, all contributing to a robust intellectual property portfolio for Agios Pharmaceuticals, Inc.[1].
Economic and Legal Implications
Market Exclusivity
The patent grants Agios Pharmaceuticals, Inc. market exclusivity for PYRUKYND, allowing the company to monopolize the market for this drug until the patent expires. This exclusivity is crucial for recouping research and development costs and generating revenue[1].
Litigation and Enforcement
The validity of the patent can be challenged through various legal mechanisms. However, the presumption of validity under 35 USC 282 means that any challenger must provide substantial evidence to invalidate the patent. This makes it a formidable barrier against potential infringers[5].
Research and Development
Data and Analytics
The USPTO provides extensive datasets and tools for analyzing patent claims and scope, such as the Patent Claims Research Dataset. This dataset can be used to understand the trends and measurements of patent scope, including those related to pyruvate kinase activators[3].
Collaboration and Consultation
The development of such patents often involves collaboration between academic experts, legal practitioners, and industry stakeholders. For instance, studies like those conducted by ACUS on small claims patent courts highlight the importance of stakeholder input in shaping patent policies and procedures[2].
Public Access and Search Tools
USPTO Resources
The USPTO offers various resources for searching and analyzing patents, including the Public Search Facility, Patent and Trademark Resource Centers (PTRCs), and the Electronic Official Gazette. These tools are essential for understanding the patent landscape and identifying related patents and applications[4].
Global Dossier
The Global Dossier service provides a single portal for accessing file histories of related applications from participating IP Offices. This service is particularly useful for tracking the global patent family of a specific application, such as the one for PYRUKYND[4].
Conclusion and Future Implications
United States Patent 11,234,976 is a critical component of Agios Pharmaceuticals, Inc.'s intellectual property portfolio, providing exclusive rights to PYRUKYND and related methods. The patent's global reach, robust claims, and therapeutic applications make it a significant player in the pharmaceutical industry.
Key Takeaways
- Patent Scope: The patent covers methods of using pyruvate kinase activators, with implications for treating metabolic disorders.
- Global Protection: The patent has twenty-five family members in nineteen countries.
- Economic Implications: Market exclusivity until the patent expires.
- Legal Considerations: Presumption of validity under 35 USC 282.
- Research and Development: Utilization of USPTO datasets and stakeholder collaboration.
FAQs
Q: What is the main focus of United States Patent 11,234,976?
A: The patent focuses on methods of using pyruvate kinase activators, particularly for treating conditions related to pyruvate kinase deficiency.
Q: Who is the assignee of this patent?
A: The patent is assigned to Agios Pharmaceuticals, Inc.
Q: How many patent family members does this patent have globally?
A: The patent has twenty-five patent family members in nineteen countries.
Q: What is the significance of the presumption of validity under 35 USC 282?
A: Each claim of the patent is presumed valid independently of the validity of other claims, making it harder for challengers to invalidate the patent.
Q: What resources are available for searching and analyzing patents related to this one?
A: The USPTO provides resources such as the Public Search Facility, PTRCs, and the Global Dossier service for searching and analyzing patents.
Sources
- DrugPatentWatch: Pharmaceutical drugs covered by patent 11,234,976.
- ACUS: U.S. Patent Small Claims Court.
- USPTO: Patent Claims Research Dataset.
- USPTO: Search for patents.
- US Code: 35 USC 282: Presumption of validity; defenses.
