United States Patent 11,319,346: A Detailed Analysis
Introduction
United States Patent 11,319,346 is part of a series of patents related to the formulation and use of guanylate cyclase C (GCC) agonists, which are crucial in the treatment of various gastrointestinal disorders. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
Guanylate cyclase C (GCC) agonists are peptides that activate the GCC receptor, leading to increased levels of cyclic GMP (cGMP), which in turn can help in treating conditions such as constipation and other gastrointestinal motility disorders. The patents associated with these agonists are held by companies like Synergy Pharmaceuticals, Inc., and Bausch Health Ireland Limited[2].
Patent Overview
Title and Inventors
The patent titled "Formulations of guanylate cyclase C agonists and methods of use" was issued on October 12, 2021, to inventors including Shailubhai Kunwar, Comiskey Stephen, Feng Rong, and others. The assignee is Bausch Health Ireland Limited[2].
Claims
The patent includes several claims that define the scope of the invention:
- Claim 1: This claim typically defines the broadest scope of the invention, often describing the formulation of GCC agonist peptides.
- Subsequent Claims: These claims narrow down the invention by specifying particular aspects such as the method of purification, the solvent exchange step, the freeze-drying (lyophilization) step, and the combination with other therapeutic agents[2][5].
Scope of the Invention
Formulations
The patent covers low-dose formulations of GCC agonist peptides. These formulations can be administered alone or in combination with other therapeutic agents, such as inhibitors of cGMP-dependent phosphodiesterase or laxatives. The formulations are designed to enhance the efficacy and stability of the GCC agonists[2][5].
Methods of Use
The methods of use include the administration of these formulations for treating gastrointestinal disorders. The patent specifies that these formulations can be used to treat conditions such as constipation, irritable bowel syndrome, and other motility disorders[2][5].
Patent Landscape
Related Patents
Several patents are related to this invention, including:
- Patent 10,011,637: This patent, issued in 2018, also deals with the purification and use of GCC agonist peptides and is assigned to Synergy Pharmaceuticals, Inc.[2].
- Patent 9,610,321 and 9,616,097: These patents, issued in 2017, cover similar formulations and methods of use for GCC agonist peptides[2].
Patent Expiration Dates
The patent 11,319,346 is set to expire on March 1, 2032. Other related patents have expiration dates ranging from 2028 to 2034, depending on the specific patent and the date of filing[2].
Geographical and Economic Impact
Geographical Distribution
While the patent itself does not specify geographical distribution, the data on patent activity can be analyzed at a county level in the United States. This analysis can show where inventors reside and where the ownership rights are assigned, which can be different locations[1].
Economic Impact
The economic impact of such patents is significant, as they protect the proprietary formulations and methods developed by pharmaceutical companies. This protection allows companies to recoup their investment in research and development and maintain market exclusivity for a period of time[2][4].
Challenges and Limitations
Patent Quality and Compliance
Ensuring the quality and compliance of patents is a critical aspect. The USPTO has developed measures to define patent quality and has set compliance targets to ensure that patents meet statutory requirements[4].
Artificial Priority Patents
One limitation in patent data analysis is the issue of artificial priority patents, which can lead to undercounting of valid patents. This issue is addressed by selecting the first utility patent in the family that was applied for after the artificial priority patent[1].
Industry Expert Insights
Industry experts emphasize the importance of patent claims in defining the scope of protection. The number and complexity of claims can reflect the importance of the patent to the applicant and can influence the cost and strategy of patent filings[3].
Statistics and Trends
- The number of patent claims has been increasing over the years, reflecting the complexity of the subject matter. For example, patents issued in the 1990s had 50% more claims than those issued in the 1970s[3].
- Patent litigation filings have also increased significantly, indicating a more active role in protecting intellectual property[3].
Key Takeaways
- Patent Scope: The patent covers specific formulations and methods of use for GCC agonist peptides.
- Related Patents: Several related patents exist, covering similar aspects of GCC agonist peptides.
- Expiration Dates: The patent expires on March 1, 2032, with related patents expiring between 2028 and 2034.
- Economic Impact: The patent protects proprietary formulations, allowing companies to maintain market exclusivity.
- Challenges: Ensuring patent quality and addressing issues like artificial priority patents are crucial.
FAQs
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What is the primary focus of United States Patent 11,319,346?
- The primary focus is on the formulations of guanylate cyclase C (GCC) agonist peptides and their methods of use.
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Who are the inventors and assignees of this patent?
- The inventors include Shailubhai Kunwar, Comiskey Stephen, Feng Rong, and others. The assignee is Bausch Health Ireland Limited.
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What are the expiration dates of related patents?
- The expiration dates range from January 30, 2028, to June 5, 2034, depending on the specific patent.
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How do these patents impact the pharmaceutical industry?
- These patents protect proprietary formulations, allowing companies to recoup their R&D investments and maintain market exclusivity.
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What challenges are associated with patent data analysis?
- Challenges include ensuring patent quality, addressing artificial priority patents, and managing the complexity of patent claims.
Cited Sources
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NCSES, "Invention, Knowledge Transfer, and Innovation"
- Detailed technical documentation for the data collection and analysis of patent activity in the United States[1].
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Drugs.com, "Generic Trulance Availability"
- Information on the patents related to Trulance, including the GCC agonist peptides[2].
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Santa Clara Computer & High Tech. L.J., "What We Can Learn From Patent Claim Length"
- Analysis of patent claim length and its implications on patent complexity and strategy[3].
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GAO, "Intellectual Property: Patent Office Should Define Quality, Reassess Compliance Targets"
- Recommendations and measures for ensuring patent quality and compliance by the USPTO[4].
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Google Patents, "Formulations of guanylate cyclase C agonists and methods of use"
- Detailed information on the patent 11,319,346, including claims and methods of use[5].
