United States Patent 8,613,949: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,613,949, titled "Galenical formulations of organic compounds," is a significant patent in the pharmaceutical industry, particularly in the development of oral fixed-dose combinations. This article will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent, filed as US13/063,955, was granted on December 18, 2013. It pertains to pharmaceutical oral fixed-dose combinations, specifically focusing on formulations that include therapeutically effective amounts of certain organic compounds[1].
Scope of the Patent
Therapeutic Compounds
The patent primarily deals with the formulation of oral fixed-dose combinations involving Aliskiren, a renin inhibitor used in the treatment of hypertension, and other therapeutic compounds such as amlodipine, a calcium channel blocker. These combinations are designed to enhance the efficacy and compliance of treatments for cardiovascular diseases[1].
Pharmaceutical Formulations
The scope includes various galenical formulations, which are the physical forms in which the active pharmaceutical ingredients (APIs) are prepared for administration. These formulations involve different methods such as wet granulation, roller compaction, and sieving to ensure optimal drug delivery and stability[1].
Claims of the Patent
Active Ingredients
The patent claims cover specific combinations of Aliskiren and amlodipine, along with other optional therapeutic agents. These claims are detailed and specify the exact amounts and ratios of the active ingredients to ensure therapeutic efficacy[1].
Excipients and Additives
The claims also include various excipients and additives such as microcrystalline cellulose, crospovidone, magnesium stearate, and silicium dioxide. These components are crucial for the formulation's stability, dissolution, and overall performance[1].
Manufacturing Methods
The patent outlines several manufacturing methods, including wet granulation, mixing, and drying processes. These methods are essential for producing consistent and reliable pharmaceutical products[1].
Patent Landscape
Related Patents and Claims
The patent landscape surrounding US8,613,949 involves a network of related patents and claims that protect various aspects of pharmaceutical formulations. For instance, other patents may cover different therapeutic combinations, excipients, or manufacturing techniques. Understanding this landscape is crucial for identifying gaps and opportunities in intellectual property protection[3].
Claim Coverage Matrix
To navigate the complex patent landscape, a Claim Coverage Matrix can be used. This tool categorizes patents by claims and scope concepts, helping to identify which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist. This approach is particularly useful for companies with extensive patent portfolios[3].
Scope Concepts and Claim Charts
The patent claims can be analyzed using scope concepts that link similar claims across different patents. Interactive claim charts generated by software like ClaimScape® can help technical experts, engineers, and management to review patent coverage and identify areas for future design opportunities or gaps in current coverage[3].
Impact on the Pharmaceutical Industry
Compliance and Efficacy
The formulations described in the patent enhance patient compliance by combining multiple therapeutic agents into a single oral dose. This can improve treatment outcomes and reduce the complexity of medication regimens for patients with cardiovascular diseases[1].
Innovation and Development
The patent encourages innovation in pharmaceutical formulation by providing detailed methods and compositions that can be adapted and improved upon. This fosters a competitive environment where companies can develop new and better formulations, driving advancements in the field[1].
Legal and Regulatory Considerations
Patent Expiration and Maintenance
The patent has expired due to fee-related issues, which means that the protected formulations and methods are now in the public domain. However, understanding the original claims and scope is still crucial for companies looking to develop similar or improved formulations without infringing on existing patents[1].
Intellectual Property Strategy
Companies must strategically manage their patent portfolios to ensure that their intellectual property is adequately protected. This involves regular analysis of patent claims, identifying gaps, and updating claim charts to reflect changes in the patent landscape[3].
Key Takeaways
- Therapeutic Combinations: The patent focuses on oral fixed-dose combinations of Aliskiren and amlodipine.
- Formulation Methods: Various manufacturing methods are detailed, including wet granulation and roller compaction.
- Excipients and Additives: Specific excipients and additives are claimed to ensure formulation stability and performance.
- Patent Landscape: Understanding related patents and using tools like Claim Coverage Matrix and claim charts is essential for navigating the patent landscape.
- Impact on Industry: The patent enhances patient compliance and encourages innovation in pharmaceutical formulations.
FAQs
What is the primary focus of United States Patent 8,613,949?
The primary focus of the patent is on pharmaceutical oral fixed-dose combinations, specifically formulations involving Aliskiren and amlodipine.
What are the key components of the formulations described in the patent?
The key components include Aliskiren, amlodipine, and various excipients such as microcrystalline cellulose, crospovidone, and magnesium stearate.
How does the patent impact patient compliance?
The patent enhances patient compliance by combining multiple therapeutic agents into a single oral dose, simplifying medication regimens.
What tools can be used to analyze the patent landscape?
Tools such as Claim Coverage Matrix and interactive claim charts generated by software like ClaimScape® can be used to analyze the patent landscape.
Why is understanding the patent landscape important?
Understanding the patent landscape is crucial for identifying gaps and opportunities in intellectual property protection, ensuring that companies do not infringe on existing patents and can develop new and innovative formulations.
Sources
- US8613949B2 - Galenical formulations of organic compounds - Google Patents
- Galenic formulations of organic compounds - Patent JO-3239-B1 - PubChem
- Patent Analytics | Intellectual Property Law - SLWIP
- US8613949B2 - Galenical formulations of organic compounds - Google Patents (French version)
- WO-2003097098-A1 | Unified Patents - Unified Patents
