Understanding the Scope and Claims of United States Patent 9,708,371
Introduction
United States Patent 9,708,371, titled "Treatments for Gastrointestinal Disorders," is a significant patent granted to Ironwood Pharmaceuticals, Inc. This patent involves the use of peptides and other agents that activate the guanylate cyclase C (GC-C) receptor, a key target in treating gastrointestinal disorders. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape.
Inventors and Assignee
The patent was invented by Marco Kessler, Angelika Fretzen, Hong Zhao, Robert Solinga, and Vladimir Volchenok, and is assigned to Ironwood Pharmaceuticals, Inc., based in Cambridge, MA[1].
Patent Issue and Application Details
The patent was issued on July 18, 2017, with the application filed on August 17, 2012. It is part of a larger series of patents related to gastrointestinal treatments, reflecting the ongoing research and development in this area[1].
Claims Overview
The patent includes 28 claims that describe various aspects of the invention, including the peptides, compositions, and methods for treating gastrointestinal disorders. Here are some key types of claims:
Independent Claims
Independent claims define the core invention and are not dependent on other claims. For example, Claim 1 might describe a specific peptide sequence that activates the GC-C receptor, while Claim 2 could describe a composition containing this peptide[1].
Dependent Claims
Dependent claims build upon the independent claims and provide additional details or variations. These claims might specify different dosages, modes of administration, or specific gastrointestinal disorders treated by the invention[1].
Scope of the Patent
The scope of the patent is crucial as it defines the boundaries of what is protected. Here are some metrics and considerations:
Independent Claim Length and Count
Research has shown that the length and count of independent claims can be indicative of the patent's scope. Narrower claims, as measured by shorter lengths and fewer counts, are often associated with a higher probability of grant and a shorter examination process[3].
Patent Scope Metrics
The USPTO's Patent Claims Research Dataset provides tools to analyze patent scope, including metrics such as claim length and claim count. These metrics can help in understanding how the scope of the patent was refined during the examination process[2][5].
Examination Process
The examination process for this patent would have involved a detailed review by the USPTO to ensure that the claims are clear, novel, and non-obvious. The process tends to narrow the scope of patent claims, especially when the examination duration is longer. This is evident from studies showing that narrower claims at publication are associated with a higher grant probability and shorter examination times[3].
Related Patents and Prior Art
The patent cites several prior art documents, including other patents related to gastrointestinal treatments and the use of peptides. For example, patents such as US 5,654,278 A and US 6,068,850 A are referenced, indicating a rich landscape of prior research in this area[1].
Economic and Legal Implications
The patent's scope and claims have significant economic and legal implications. For instance, the patent's exclusivity period, which includes maintenance fees and potential litigation, affects the market entry of generic or bioequivalent versions of the drug. The FDA's grant of exclusivities to Linzess, a drug related to this patent, further delays the generic launch, highlighting the patent's economic impact[4].
Maintenance Fees and Litigation
The patent's maintenance fees, which are paid periodically to keep the patent in force, are an indicator of its ongoing relevance. Payments such as those made in 2021 and 2022 for the 12th and 8th years, respectively, show that the patent remains active and potentially litigated[4].
Industry Impact
The activation of the GC-C receptor by peptides has been a significant area of research in treating gastrointestinal disorders. This patent contributes to the body of knowledge and therapeutic options available, impacting both the medical community and pharmaceutical industry.
Key Takeaways
- Inventors and Assignee: The patent was invented by a team of researchers and assigned to Ironwood Pharmaceuticals, Inc.
- Claims: The patent includes 28 claims detailing peptides, compositions, and methods for treating gastrointestinal disorders.
- Scope: The scope is defined by independent and dependent claims, with narrower claims often associated with a higher grant probability.
- Examination Process: The patent underwent a detailed examination process, likely resulting in narrowed claims.
- Economic and Legal Implications: The patent affects market exclusivity and generic drug entry, with ongoing maintenance fees and potential litigation.
FAQs
Q: What is the main subject of United States Patent 9,708,371?
A: The patent focuses on treatments for gastrointestinal disorders using peptides and other agents that activate the guanylate cyclase C (GC-C) receptor.
Q: Who are the inventors of this patent?
A: The inventors are Marco Kessler, Angelika Fretzen, Hong Zhao, Robert Solinga, and Vladimir Volchenok.
Q: What is the significance of the patent's claims?
A: The claims define the protected invention, including specific peptides, compositions, and treatment methods, and are crucial for understanding the patent's scope.
Q: How does the patent's scope affect its economic implications?
A: The patent's scope influences market exclusivity, delaying the entry of generic or bioequivalent versions of the drug, and involves ongoing maintenance fees and potential litigation.
Q: What datasets can be used to analyze the scope of this patent?
A: The USPTO's Patent Claims Research Dataset provides detailed information on claims and can be used to analyze the scope and other metrics related to the patent[2][5].
Sources
- United States Patent and Trademark Office. US9708371 B2: Treatments for Gastrointestinal Disorders. July 18, 2017.
- USPTO. Patent Claims Research Dataset. August 28, 2017.
- Marco, Alan C., Sarnoff, Joshua D., and deGrazia, Charles. Patent Claims and Patent Scope. Hoover Institution, January 2016.
- Pharsight - GreyB. Linzess patent expiration. Retrieved December 22, 2024.
- USPTO. Patent and patent application Claims data (Stata (.dta) and MS Excel (.csv)). Retrieved December 22, 2024.
