United States Patent 11,142,549: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,142,549, titled "ULTRA-PURE AGONISTS OF GUANYLATE CYCLASE C, METHOD OF MAKING AND USING SAME," was granted on October 12, 2021, to Bausch Health Ireland Limited. This patent is significant in the field of pharmaceuticals, particularly in the development of ultra-pure agonists of guanylate cyclase C (GC-C), an enzyme that plays a crucial role in various physiological processes.
Background and Inventors
The patent was invented by a team of researchers including Kunwar Shailubhai, Audubon, PA; Stephen Comiskey, Doylestown, PA; Rong Feng, Langhorne, PA; Juncai Bai, North Augusta, SC; Ruoping Zhang, North Augusta, SC; Jun Jia, Shanghai; Junfeng Zhou, Shanghai; Qiao Zhao, Shanghai; and Guoqing Zhang, Shanghai. This collaborative effort reflects the global nature of pharmaceutical research and development[1].
Patent Scope and Claims
Invention Overview
The patent covers ultra-pure agonists of guanylate cyclase C, which are crucial for treating various gastrointestinal disorders. The invention includes methods for synthesizing these agonists, ensuring their purity, and their use in therapeutic applications.
Claims Structure
The patent claims are structured to define the scope of the invention clearly. Here are some key aspects:
- Independent Claims: These claims do not reference other claims and define the core invention. For example, claims related to the specific chemical structures of the agonists and their synthesis methods.
- Dependent Claims: These claims build upon the independent claims, providing additional limitations that further define the invention. Examples include claims related to the purification methods and the use of these agonists in specific therapeutic contexts[1].
Claim Limitations
Each claim includes specific limitations that define the invention. These limitations are crucial for determining the scope of the patent and what is protected. For instance, the claims specify the chemical structures of the agonists, the purity levels achieved through the synthesis and purification methods, and the conditions under which these agonists are used therapeutically[1].
Method of Making
The patent describes a detailed method for synthesizing and purifying the GC-C agonists. This includes:
- Synthesis: The method involves the use of specific peptides, such as dicyclized SP-304 or SP-333, and their loading onto an RP-HPLC column.
- Purification: The process involves eluting the peptides with a mixture of acetonitrile and water, pooling qualified fractions, and further purifying them using polymeric adsorbents. The final step includes removing water and alcohol through azeotropic distillation[1].
Using the Agonists
The patent also outlines the therapeutic use of these ultra-pure agonists. This includes their application in treating gastrointestinal disorders, such as constipation and other motility disorders. The claims specify the conditions under which these agonists are effective and safe for use[1].
Patent Landscape
Related Patents
The patent is part of a broader landscape of pharmaceutical patents related to GC-C agonists. Other patents in this family include those related to similar therapeutic agents and methods of synthesis. Understanding the relationships between these patents is crucial for navigating potential issues of obviousness and nonobviousness[4].
Examination and Reexamination
The patent underwent rigorous examination before its grant. The process involved evaluating the novelty, nonobviousness, and enablement of the invention. Any subsequent reexamination would focus on these same criteria, ensuring that the patent remains valid and enforceable[4].
Patent Term and Extensions
The patent term for US 11,142,549 is twenty years from the date of the patent application filing. However, the patent term can be extended under certain circumstances, such as delays due to regulatory review or USPTO procedural failures. This is similar to other patents where such extensions are granted to compensate for time spent in these processes[4].
Enforcement and Litigation
Exclusive Rights
The patent grants its owner, Bausch Health Ireland Limited, exclusive rights to make, use, import, sell, or offer for sale the invention covered by the patent. These rights begin on the date the patent issues and generally expire twenty years from the filing date of the patent application[4].
Infringement
Any infringement of this patent would involve direct or indirect use of the protected invention without permission. This could include induced infringement or contributory infringement, where another party encourages or facilitates the infringement. Litigation related to this patent would be handled in federal district courts or before the International Trade Commission (ITC)[4].
Economic and Research Implications
Research Dataset
The USPTO's Patent Claims Research Dataset provides detailed information on claims from US patents, including those related to pharmaceuticals. This dataset can be used to analyze trends and scope measurements of patents like US 11,142,549, offering insights into the broader patent landscape[3].
Economic Impact
The development and protection of ultra-pure GC-C agonists have significant economic implications. These therapeutic agents can address unmet medical needs, leading to improved patient outcomes and reduced healthcare costs. The patent protection ensures that the innovator can recoup their investment in research and development[3].
Key Takeaways
- Ultra-pure GC-C Agonists: The patent covers the synthesis, purification, and therapeutic use of ultra-pure agonists of guanylate cyclase C.
- Method of Making: The method involves specific synthesis and purification steps to achieve high purity levels.
- Therapeutic Use: The agonists are used in treating gastrointestinal disorders.
- Patent Scope: The claims define the invention clearly, including independent and dependent claims.
- Patent Term and Extensions: The patent term is twenty years from the filing date, with potential extensions for regulatory delays or USPTO procedural failures.
- Enforcement and Litigation: The patent grants exclusive rights, and any infringement would be handled in federal courts or before the ITC.
FAQs
What is the main invention covered by US 11,142,549?
The main invention is the ultra-pure agonists of guanylate cyclase C, including their synthesis, purification, and therapeutic use.
Who are the inventors of this patent?
The inventors include Kunwar Shailubhai, Stephen Comiskey, Rong Feng, Juncai Bai, Ruoping Zhang, Jun Jia, Junfeng Zhou, Qiao Zhao, and Guoqing Zhang.
What is the significance of the purification method in this patent?
The purification method is crucial for achieving high purity levels of the GC-C agonists, which is essential for their therapeutic efficacy and safety.
How long is the patent term for US 11,142,549?
The patent term is twenty years from the date of the patent application filing, with potential extensions for regulatory delays or USPTO procedural failures.
Where can any infringement of this patent be litigated?
Any infringement of this patent can be litigated in federal district courts or before the International Trade Commission (ITC).
Cited Sources
- United States Patent and Trademark Office, "ULTRA-PURE AGONISTS OF GUANYLATE CYCLASE C, METHOD OF MAKING AND USING SAME," US 11,142,549 B2, October 12, 2021.
- United States Court of Appeals for the Federal Circuit, "In re Cellect, LLC," 22-1293, August 28, 2023.
- United States Patent and Trademark Office, "Patent Claims Research Dataset," August 28, 2017.
- Congressional Research Service, "Patent Law: A Handbook for Congress," September 16, 2020.
