United States Patent 8,568,747: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,568,747, titled "Enalapril compositions," is a significant patent in the pharmaceutical industry, particularly in the development of stable enalapril powder compositions for oral liquid formulations. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of Enalapril
Enalapril is an angiotensin-converting enzyme (ACE) inhibitor used primarily in the treatment of hypertension and heart failure. Its formulation is crucial for ensuring stability and efficacy.
Patent Overview
Publication and Filing Details
The patent, US8568747B1, was published on October 22, 2013, and is assigned to Silvergate Pharmaceuticals, LLC. It was filed on September 14, 2012, as part of the application US13/670,355[1].
Scope of the Patent
Stable Enalapril Powder Compositions
The patent focuses on the development of stable enalapril powder compositions that can be reconstituted into an oral liquid formulation. This is particularly important for pediatric and geriatric patients who may have difficulty swallowing tablets or capsules.
Key Components
The compositions include enalapril maleate, a stabilizer such as mannitol, and other excipients to enhance stability and solubility. The use of mannitol is highlighted as a critical component in maintaining the stability of the enalapril powder[1].
Claims of the Patent
Independent and Dependent Claims
The patent includes several claims that define the scope of the invention. These claims are divided into independent and dependent claims.
- Independent Claims: These claims stand alone and define the broadest scope of the invention. For example, Claim 1 describes a stable powder composition comprising enalapril maleate and a stabilizer[1].
- Dependent Claims: These claims are narrower and depend on the independent claims. They provide additional details or limitations to the independent claims, such as specific ratios of enalapril to stabilizer or the presence of additional excipients[1].
Methods of Use
Reconstitution and Administration
The patent also describes methods of using these enalapril oral liquid formulations. This includes reconstituting the powder with a suitable liquid to form a stable solution that can be administered orally[1].
Patent Landscape
Related Patents
Several other patents are related to the formulation and use of enalapril, including U.S. Patent Nos. 9,669,008, 9,808,442, 10,039,745, and 10,154,987. These patents, also owned by Silvergate Pharmaceuticals, further elaborate on enalapril formulations and their applications[2].
Litigation and Infringement
The patent has been involved in litigation, particularly in the case of Silvergate Pharmaceuticals, LLC vs. Bionpharma Inc. Silvergate alleged that Bionpharma's Abbreviated New Drug Application (ANDA) would infringe on their patents, including the '745 and '987 patents, which are continuations of the '341 application related to the '747 patent[2].
Doctrine of Equivalents
In the litigation, Silvergate contended that Bionpharma's product would infringe under the doctrine of equivalents (DOE), despite not literally infringing the claims. Bionpharma argued against this, citing legal bars such as prosecution history estoppel, disclosure-dedication, and claim vitiation[2].
Impact on the Pharmaceutical Industry
Pediatric and Adult Treatments
The stable enalapril oral liquid formulations described in this patent are significant for treating pediatric and adult patients who require flexible dosing options. This formulation enhances patient compliance and ensures the effective delivery of the medication[2].
Competitive Landscape
The patent landscape around enalapril formulations is competitive, with multiple companies developing similar products. The issuance and enforcement of these patents play a crucial role in protecting intellectual property and market share[2].
Search and Analysis Tools
USPTO Resources
For researchers and practitioners, the United States Patent and Trademark Office (USPTO) provides several tools for searching and analyzing patents, including the Patent Public Search tool, Global Dossier, and Patent and Trademark Resource Centers (PTRCs)[4].
Patent Claims Research Dataset
The USPTO also offers the Patent Claims Research Dataset, which contains detailed information on claims from US patents granted between 1976 and 2014. This dataset can be used to analyze trends and scope measurements in patent claims[3].
Conclusion
The United States Patent 8,568,747 is a pivotal patent in the development of stable enalapril powder compositions for oral liquid formulations. Understanding its scope, claims, and the broader patent landscape is essential for pharmaceutical companies and researchers working in this field.
Key Takeaways
- Stable Formulations: The patent describes stable enalapril powder compositions that can be reconstituted into oral liquid formulations.
- Key Components: Mannitol is a critical stabilizer in these compositions.
- Claims: The patent includes independent and dependent claims defining the scope of the invention.
- Methods of Use: The patent details methods for reconstituting and administering the oral liquid formulations.
- Patent Landscape: The patent is part of a larger landscape involving related patents and litigation.
- Impact: The formulations are crucial for treating pediatric and adult patients, and the patent plays a significant role in protecting intellectual property.
FAQs
What is the primary focus of United States Patent 8,568,747?
The primary focus is on the development of stable enalapril powder compositions for oral liquid formulations.
What is the role of mannitol in the patent?
Mannitol serves as a stabilizer to maintain the stability of the enalapril powder.
Which company owns this patent?
The patent is owned by Silvergate Pharmaceuticals, LLC.
What is the significance of this patent in the pharmaceutical industry?
It provides flexible dosing options for pediatric and adult patients, enhancing patient compliance and ensuring effective medication delivery.
How can one search for related patents and analyze their claims?
One can use USPTO resources such as the Patent Public Search tool, Global Dossier, and the Patent Claims Research Dataset.
Cited Sources
- US8568747B1 - Enalapril compositions - Google Patents
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ... - Silvergate Pharmaceuticals, LLC vs. Bionpharma Inc.
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
