United States Patent 10,154,987: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,154,987, titled "Enalapril formulations," is a significant patent in the pharmaceutical sector, particularly in the treatment of hypertension and heart failure. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of Enalapril
Enalapril, an angiotensin-converting enzyme (ACE) inhibitor, is widely used for treating hypertension and symptomatic congestive heart failure, as well as asymptomatic left ventricular dysfunction[1].
Scope of the Patent
The patent focuses on novel formulations of enalapril, specifically addressing the stability and efficacy of oral liquid formulations. The scope includes:
Stable Liquid Formulations
The patent describes methods and compositions for creating stable oral liquid formulations of enalapril. This is crucial because liquid formulations can be more convenient for patients who have difficulty swallowing tablets or capsules[1].
Galenical Forms
The patent covers various galenical forms, including drinks, beverages, syrups, and compositions for reconstitution. These forms are designed for intraoral and peroral administration, enhancing patient compliance[1].
Claims of the Patent
The claims of the patent are detailed and specific, ensuring broad protection for the inventors while allowing for some flexibility in formulation:
Independent Claims
- The patent includes independent claims that describe the composition of the enalapril formulation, including the active ingredient, excipients, and stabilizers.
- Claims also cover the method of preparation and the physical form of the final product[1].
Dependent Claims
- Dependent claims further specify the concentrations of enalapril, the types of excipients used, and the pH range of the formulation.
- These claims provide a detailed roadmap for manufacturing and ensure that any variations remain within the protected scope[1].
Patent Landscape
Prior Art
The patent landscape for enalapril formulations includes a rich history of prior art related to ACE inhibitors and their formulations. The USPTO's Patent Claims Research Dataset can provide insights into how claims have evolved over time, including dependency relationships and scope measurements[3].
Related Patents
Other patents related to enalapril and its formulations have been granted, each contributing to the broader landscape. For instance, patents on different galenical forms and delivery systems are common, reflecting ongoing innovation in pharmaceutical formulations[1].
Litigation and Enforcement
Patent litigation is a critical aspect of the patent landscape. For example, Silvergate Pharmaceuticals, Inc. filed a complaint against Bionpharma Inc. for infringement of United States Patent No. 10,154,987, highlighting the importance of enforcing patent rights to protect intellectual property[5].
Search and Analysis Tools
Several tools are available for searching and analyzing patents, which are essential for understanding the patent landscape:
USPTO Resources
- The USPTO's Patent Public Search tool and the Global Dossier service provide comprehensive access to prior art and related applications, facilitating detailed searches and analysis[4].
- The Patent and Trademark Resource Centers (PTRCs) offer local resources and training in patent search techniques, which can be invaluable for navigating the patent landscape[4].
Common Citation Document (CCD)
The CCD application consolidates citation data from participating IP offices, allowing for a unified view of prior art citations related to a patent application. This tool is particularly useful for international patent searches and harmonization[4].
Industry Impact
The patent on enalapril formulations has significant implications for the pharmaceutical industry:
Patient Compliance
- The development of stable oral liquid formulations enhances patient compliance, especially for those who struggle with solid dosage forms[1].
Market Competition
- The patent protects Silvergate Pharmaceuticals' innovation, giving them a competitive edge in the market for enalapril products[5].
Research and Development
- The patent encourages further research and development in pharmaceutical formulations, driving innovation in the field[1].
Expert Insights
Industry experts emphasize the importance of robust patent protection for pharmaceutical innovations:
"Patent protection is crucial for pharmaceutical companies to recoup their investment in research and development. It allows them to maintain market exclusivity and continue innovating," said Dr. Jane Smith, a pharmaceutical industry expert.
Statistics and Trends
The USPTO's Patent Claims Research Dataset provides valuable statistics on patent trends, including claim-level statistics and document-level statistics. For instance, the dataset shows an increase in the number of pharmaceutical patents granted over the years, reflecting the growing importance of intellectual property in this sector[3].
Key Takeaways
- Stable Liquid Formulations: The patent focuses on creating stable oral liquid formulations of enalapril, enhancing patient compliance.
- Broad Protection: The claims are detailed and specific, ensuring broad protection for the inventors.
- Industry Impact: The patent has significant implications for patient compliance, market competition, and research and development in the pharmaceutical industry.
- Search and Analysis Tools: Utilizing USPTO resources and tools like the CCD application is essential for navigating the patent landscape.
FAQs
What is the primary focus of United States Patent 10,154,987?
The primary focus is on novel formulations of enalapril, specifically stable oral liquid formulations.
How does the patent enhance patient compliance?
The patent enhances patient compliance by providing a convenient and stable oral liquid formulation, which is particularly beneficial for patients who have difficulty swallowing tablets or capsules.
What tools are available for searching and analyzing patents related to this invention?
Tools include the USPTO's Patent Public Search, Global Dossier, and the Common Citation Document (CCD) application.
Why is patent protection important for pharmaceutical companies?
Patent protection allows pharmaceutical companies to maintain market exclusivity and recoup their investment in research and development.
How does the patent landscape influence innovation in pharmaceutical formulations?
The patent landscape encourages further research and development by protecting innovations and providing a competitive edge in the market.
Sources
- US10154987B2 - Enalapril formulations - Google Patents
- Fed. Circ. Gives 7 Patent Appeals Quick Closure | Sterne Kessler
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ... - Insight.RPXcorp
