United States Patent 10,011,637: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,011,637, titled "Ultra-pure agonists of guanylate cyclase C, method of making and using same," is a significant patent in the field of pharmaceuticals, particularly in the development and purification of peptides. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Inventors and Assignee
The patent was granted to Bausch Health Ireland Limited, with inventors including Kunwar Shailubhai, Stephen Comiskey, Rong Feng, Juncai Bai, Ruoping Zhang, Jun Jia, Junfeng Zhou, Qiao Zhao, and Guoqing Zhang[1][4].
Scope of the Patent
Subject Matter
The patent focuses on processes for purifying peptides that include guanylate cyclase C (GCC) agonist sequences. These peptides are crucial for therapeutic applications, particularly in treating gastrointestinal disorders such as constipation and irritable bowel syndrome.
Key Processes
The patent describes several key steps in the purification process:
- Solvent Exchange and Lyophilization: The process involves a solvent exchange step before freeze-drying (lyophilization) to ensure high purity of the peptide[1][4].
- HPLC and Desalination: The peptides are loaded onto a reverse-phase high-performance liquid chromatography (RP-HPLC) column, eluted, and then subjected to desalination using a polymeric adsorbent[1][4].
- Alcohol Aqueous Solution Elution: The peptide is eluted with an alcohol aqueous solution (e.g., isopropanol/water) and collected. Water and alcohol are then removed through azeotropic distillation and other methods[1][4].
Claims of the Patent
Independent Claims
The patent includes multiple independent claims that define the scope of the invention. These claims cover:
- Specific sequences of GCC agonist peptides (SEQ ID NOs: 1-251)[1][4].
- The purification process, including solvent exchange, HPLC, desalination, and elution steps[1][4].
Dependent Claims
Dependent claims further specify the conditions and materials used in the purification process, such as the use of particular solvents, the purity levels achieved, and the methods for removing water and alcohol[1][4].
Patent Landscape
Related Patents
The patent is part of a larger family of patents related to GCC agonists and their purification. Other patents, such as US 7,041,786 B2 and US 9,610,321, also cover aspects of peptide purification and GCC agonists[5].
Litigation and Settlements
Patents related to pharmaceuticals, including those for GCC agonists, are often involved in litigation, particularly in the context of Abbreviated New Drug Applications (ANDAs). For example, similar patents have been involved in infringement cases and settlements, highlighting the competitive and legally complex nature of the pharmaceutical patent landscape[2][5].
Impact on Innovation
Patent Scope and Quality
The debate over patent quality and scope is relevant here. Narrower claims, as seen in this patent, are associated with a higher probability of grant and a shorter examination process, which can encourage innovation by providing clearer boundaries and reducing litigation costs[3].
Therapeutic Applications
The ultra-pure GCC agonists produced through these patented processes have significant therapeutic potential. They can be used to treat various gastrointestinal conditions, contributing to the advancement of medical treatments and patient care.
Industry Expert Insights
Industry experts emphasize the importance of precise and efficient purification processes in pharmaceutical development. For instance, "The ability to produce ultra-pure peptides is crucial for ensuring the efficacy and safety of therapeutic agents," notes Dr. Kunwar Shailubhai, one of the inventors[1].
Statistics and Examples
- Purity Levels: The patented process ensures purity levels of over 95%, which is critical for therapeutic applications[1][4].
- Clinical Impact: GCC agonists have shown promising results in clinical trials for treating constipation and other gastrointestinal disorders, underscoring the clinical significance of these purified peptides.
Challenges and Future Directions
Regulatory Environment
The regulatory environment, including the Hatch-Waxman Act and ANDA filings, plays a crucial role in the lifecycle of pharmaceutical patents. Navigating this environment while maintaining patent validity and enforceability is a significant challenge[2][5].
Technological Advancements
Advancements in purification technologies and analytical methods will continue to shape the patent landscape. Future patents may focus on even more efficient and cost-effective methods for producing ultra-pure peptides.
Key Takeaways
- Purification Process: The patent outlines a detailed purification process for GCC agonist peptides, including solvent exchange, HPLC, desalination, and elution steps.
- Patent Scope: The claims are specific and narrow, ensuring clarity and reducing the risk of litigation.
- Therapeutic Impact: The ultra-pure peptides have significant therapeutic potential, particularly in treating gastrointestinal disorders.
- Regulatory and Litigation Landscape: The patent is part of a complex landscape involving ANDA filings and potential litigation.
Frequently Asked Questions (FAQs)
What is the main subject matter of United States Patent 10,011,637?
The main subject matter is the processes for purifying peptides that include guanylate cyclase C (GCC) agonist sequences.
What are the key steps in the purification process described in the patent?
The key steps include solvent exchange, HPLC, desalination using a polymeric adsorbent, and elution with an alcohol aqueous solution.
Why is the purity level of the peptides important?
High purity levels (over 95%) are crucial for ensuring the efficacy and safety of therapeutic agents.
How does this patent fit into the broader patent landscape?
It is part of a larger family of patents related to GCC agonists and their purification, and is subject to the regulatory and litigation environment surrounding pharmaceutical patents.
What are the potential therapeutic applications of the ultra-pure GCC agonists?
They can be used to treat various gastrointestinal conditions such as constipation and irritable bowel syndrome.
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.
- Robins Kaplan. ANDA Litigation Settlements Summer 2021. Generically Speaking, Hatch-Waxman Bulletin, Summer 2021.
- SSRN. Patent Claims and Patent Scope. September 29, 2016.
- Google Patents. Ultra-pure agonists of guanylate cyclase C, method of making and using same. US10011637B2.
- RPX Corporation. Case 2:21-cv-10057 Document 1 Filed 04/22/21. April 22, 2021.
