Understanding the Scope and Claims of United States Patent 8,545,878
Introduction
United States Patent 8,545,878, titled "Capsules containing high doses of levodopa for pulmonary use," is a significant innovation in the field of pharmaceuticals, particularly for the treatment of Parkinson's disease and other neurological disorders. This patent, granted on October 1, 2013, introduces a novel method for delivering high doses of levodopa directly to the lungs, bypassing traditional oral administration.
Background
Levodopa, a precursor to dopamine, is a crucial medication for managing Parkinson's disease. However, oral administration often results in variable bioavailability and side effects due to first-pass metabolism. The invention described in US 8,545,878 addresses these challenges by providing a pulmonary delivery system.
Patent Overview
Inventors and Assignees
The patent was invented by a team of researchers and assigned to a pharmaceutical company. The specific names of the inventors and the assignee are listed in the patent document[4].
Publication and Grant Dates
The patent was published on October 1, 2013, after being filed on December 14, 2012. This timeline reflects the typical process from application to grant[4].
Claims
Independent Claims
The patent includes several independent claims that define the scope of the invention. Here are some key claims:
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Claim 1: This claim describes a capsule containing an inhalable powder composition comprising about 75% by weight of levodopa, along with other components such as a dry powder inhalation excipient. The claim specifies the formulation and the method of delivery[4].
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Claim 2: This claim focuses on the method of preparing the inhalable powder composition, including the steps of mixing levodopa with a dry powder inhalation excipient and filling the mixture into capsules[4].
Dependent Claims
Dependent claims further detail the specifics of the independent claims, such as the types of excipients used, the particle size of the powder, and the method of inhalation.
Detailed Analysis of Claims
Composition of the Capsule
The patent specifies that the capsule contains an inhalable powder composition with a high concentration of levodopa (about 75% by weight). This high dose is critical for achieving therapeutic levels of levodopa in the bloodstream without the need for frequent dosing[4].
Excipients and Formulation
The claims also detail the use of specific excipients, such as dipalmitoylphosphatidylcholine (DPPC), which help in stabilizing the levodopa and enhancing its delivery to the lungs. The formulation ensures that the powder is suitable for inhalation and maximizes the bioavailability of levodopa[4].
Method of Preparation
The method of preparing the inhalable powder involves mixing levodopa with the excipients and then filling the mixture into capsules. This process is designed to ensure uniform distribution of the active ingredient and excipients, which is crucial for consistent dosing[4].
Patent Landscape
Prior Art
The patent landscape for pulmonary delivery of levodopa includes several prior art references that describe different methods and formulations for inhalable drugs. However, US 8,545,878 stands out due to its specific formulation and high dose of levodopa, which addresses the unique challenges of delivering this medication via inhalation[4].
Competing Patents
Other patents in the field focus on different aspects of pulmonary drug delivery, such as different excipients, particle sizes, or delivery devices. For example, some patents may describe inhalable formulations with lower doses of levodopa or different methods of preparation. The uniqueness of US 8,545,878 lies in its high-dose formulation and specific application to Parkinson's disease treatment[5].
Practical Applications
Clinical Benefits
The invention described in US 8,545,878 offers several clinical benefits, including improved bioavailability of levodopa, reduced side effects, and more consistent therapeutic levels. This can lead to better management of Parkinson's disease symptoms and an improved quality of life for patients[4].
Market Impact
The patent has significant market implications as it introduces a novel and potentially more effective treatment option for Parkinson's disease. This can disrupt the existing market for levodopa formulations and provide a competitive advantage to the assignee company.
Legal and Regulatory Considerations
Patent Eligibility
The patent's eligibility is based on its novelty, non-obviousness, and utility. The detailed claims and descriptions ensure that the invention meets these criteria, providing a clear and specific method for delivering high doses of levodopa via inhalation[4].
Exclusivity and Licensing
The patent grants the assignee exclusive rights to manufacture, use, and sell the invention for a specified period. This exclusivity can be leveraged through licensing agreements or partnerships to expand the reach of the product.
Key Takeaways
- High-Dose Formulation: The patent introduces a high-dose levodopa formulation for pulmonary use, addressing the challenges of traditional oral administration.
- Specific Excipients: The use of specific excipients like DPPC enhances the stability and bioavailability of levodopa.
- Clinical Benefits: The invention offers improved bioavailability, reduced side effects, and more consistent therapeutic levels.
- Market Impact: The patent has significant market implications, introducing a novel treatment option for Parkinson's disease.
FAQs
What is the primary innovation of US 8,545,878?
The primary innovation is the development of a high-dose levodopa formulation for pulmonary use, which improves bioavailability and reduces side effects compared to traditional oral administration.
What are the key components of the inhalable powder composition?
The composition includes about 75% by weight of levodopa and specific excipients such as DPPC.
How does the method of preparation ensure uniform distribution of the active ingredient?
The method involves mixing levodopa with excipients and filling the mixture into capsules, ensuring uniform distribution and consistent dosing.
What are the clinical benefits of this invention?
The invention offers improved bioavailability, reduced side effects, and more consistent therapeutic levels of levodopa, leading to better management of Parkinson's disease symptoms.
What is the market impact of this patent?
The patent introduces a novel and potentially more effective treatment option for Parkinson's disease, providing a competitive advantage to the assignee company and potentially disrupting the existing market for levodopa formulations.
Sources
- Google Patents - Capsules containing high doses of levodopa for pulmonary use. US8545878B1.
- PubChem - Capsules containing high doses of levodopa for pulmonary use. US-9393210-B2.
- EPO - HIGH DOSE LEVODOPA CAPSULES FOR PULMONARY USE. EP3815679NWA1.
