United States Patent 10,548,875: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,548,875, titled "Glycopyrrolate salts," is a significant patent in the pharmaceutical industry, particularly in the treatment of hyperhidrosis. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
Patent Overview
The patent, US 10,548,875 B2, was granted to Dermira, Inc. and Rose U, LLC, and it pertains to glycopyrrolate salts, which are used in the treatment of hyperhidrosis. Hyperhidrosis, a condition affecting approximately 8.8 million individuals in the United States, involves excessive sweating[4].
Scope of the Patent
Invention Description
The patent describes various glycopyrrolate salts, including glycopyrrolate tosylate, and their pharmaceutical compositions. These salts are formulated to improve the stability and efficacy of glycopyrrolate, a compound known for its anticholinergic properties. The invention also includes methods for preparing these salts and their use in treating hyperhidrosis[4].
Claims of the Patent
Independent and Dependent Claims
The patent includes several independent and dependent claims. Independent claims define the broad scope of the invention, while dependent claims narrow down the scope by adding specific limitations. For example, Claim 1 describes a pharmaceutical composition comprising a glycopyrrolate salt, while subsequent claims specify different aspects such as the type of salt, the formulation, and the method of administration[4].
Claim Analysis
- Claim 1: This claim is broad and covers a pharmaceutical composition containing a glycopyrrolate salt.
- Dependent Claims: These claims specify various embodiments, such as the type of glycopyrrolate salt (e.g., glycopyrrolate tosylate), the dosage form (e.g., cloth or wipe), and the method of treatment.
Patent Landscape
Related Patents
The patent landscape around US 10,548,875 includes several related patents held by Dermira, Inc. and Rose U, LLC. These patents collectively protect various aspects of glycopyrrolate formulations and their use in treating hyperhidrosis. For instance:
- U.S. Patent Nos. 8,618,160; 8,859,610; 9,259,414; 9,744,105; 10,004,717; 10,052,267; and 10,543,192: These patents, along with US 10,548,875, form a robust portfolio protecting the intellectual property related to glycopyrrolate-based treatments[2][5].
Competitive Landscape
The competitive landscape involves other pharmaceutical companies that may be developing similar treatments for hyperhidrosis. For example, Perrigo Pharma International DAC and Teva Pharmaceuticals, Inc. have been involved in legal disputes with Dermira, Inc. regarding the infringement of these patents. These disputes highlight the competitive nature of the market and the importance of these patents in protecting market share[2][5].
Litigation and Enforcement
Patent Infringement Cases
Dermira, Inc. and Rose U, LLC have been involved in several patent infringement cases to protect their intellectual property. For instance, the case against Perrigo Pharma International DAC involved allegations that Perrigo's submission of an Abbreviated New Drug Application (ANDA) for a glycopyrrolate product infringed on the asserted patents, including US 10,548,875. This case underscores the proactive approach taken by the patent holders to enforce their rights[2].
Impact on the Pharmaceutical Industry
Market Dominance
The robust patent portfolio surrounding glycopyrrolate salts has allowed Dermira, Inc. and Rose U, LLC to maintain a significant market presence in the treatment of hyperhidrosis. Their product, Qbrexza®, which is protected by these patents, has been a leading treatment option, highlighting the importance of intellectual property in pharmaceutical market dominance.
Innovation and Research
The protection afforded by these patents encourages continued innovation and research in the field. By securing exclusive rights to their inventions, companies can invest in further research and development, leading to improved treatments and new products.
Search and Analysis Tools
Patent Databases
For professionals conducting patent searches and analyses, databases such as the USPTO's Patent Public Search, PATENTSCOPE, and the Cooperative Patent Classification (CPC) database are invaluable. These tools allow for full-text searching of patent grants and applications, facilitating comprehensive analysis of patent landscapes[1].
Research Datasets
The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents and applications, which can be used to analyze patent scope and trends. This dataset is particularly useful for understanding the dependency relationships between claims and the overall scope of patents like US 10,548,875[3].
Conclusion and Future Outlook
The United States Patent 10,548,875 is a critical component of a broader patent strategy that protects glycopyrrolate-based treatments for hyperhidrosis. The scope and claims of this patent, along with related patents, form a strong intellectual property barrier that supports market dominance and encourages innovation.
Key Takeaways
- Patent Scope: The patent covers various glycopyrrolate salts and their pharmaceutical compositions.
- Claims Analysis: Independent and dependent claims define the invention's scope and specific embodiments.
- Patent Landscape: The patent is part of a robust portfolio protecting glycopyrrolate-based treatments.
- Litigation and Enforcement: Active enforcement through patent infringement cases protects the intellectual property.
- Industry Impact: The patent portfolio supports market dominance and encourages innovation.
Frequently Asked Questions (FAQs)
What is the main subject of United States Patent 10,548,875?
The main subject of this patent is glycopyrrolate salts and their pharmaceutical compositions for treating hyperhidrosis.
Which companies are involved in the patent infringement cases related to this patent?
Dermira, Inc., Rose U, LLC, Perrigo Pharma International DAC, and Teva Pharmaceuticals, Inc. are involved in these cases.
How does the patent landscape impact the pharmaceutical industry?
The patent landscape allows companies to maintain market dominance, encourages innovation, and protects significant investments in research and development.
What tools are available for conducting patent searches and analyses?
Tools such as the USPTO's Patent Public Search, PATENTSCOPE, and the Cooperative Patent Classification (CPC) database are available for comprehensive patent searches and analyses.
What is the significance of the USPTO's Patent Claims Research Dataset?
This dataset provides detailed information on claims from U.S. patents and applications, helping in the analysis of patent scope and trends.
Cited Sources:
- Clemson University Libraries. Advanced Patent Searching: Overview. Clemson.libguides.com.
- United States District Court for the District of Delaware. Dermira, Inc. and Rose U, LLC v. Perrigo Pharma International DAC. Insight.rpxcorp.com.
- United States Patent and Trademark Office. Patent Claims Research Dataset. USPTO.gov.
- Google Patents. US10548875B2 - Glycopyrrolate salts. Patents.google.com.
- United States District Court for the District of Delaware. Teva Pharmaceuticals, Inc. v. Eli Lilly and Company. Insight.rpxcorp.com.
