United States Patent 10,420,763: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 10,420,763, titled "Sublingual apomorphine," is a significant patent in the field of pharmaceuticals, particularly for the treatment of Parkinson's disease. This patent, issued to address the need for effective and convenient delivery methods of apomorphine, presents several key aspects that are crucial for understanding its scope, claims, and position within the patent landscape.
Background of Apomorphine
Apomorphine is a dopamine agonist used in the treatment of Parkinson's disease. It is known for its rapid onset of action, making it particularly useful for managing acute motor fluctuations and "off" episodes in patients with advanced Parkinson's disease[1].
Patent Overview
Publication and Priority Dates
The patent was published on October 8, 2019, with a priority date of January 26, 2016. This indicates that the invention was first disclosed and claimed in the initial patent application filed in 2016.
Inventors and Assignees
The patent is assigned to a pharmaceutical company, though the specific assignee is not mentioned in the provided source. The inventors are credited with developing a novel formulation of apomorphine.
Scope of the Patent
Pharmaceutical Composition
The patent describes a pharmaceutical composition formulated for sublingual administration, which includes apomorphine particles. These particles can be in the form of apomorphine itself, an apomorphine prodrug, or a salt thereof. The composition is designed to be administered under the tongue, where it dissolves quickly, providing rapid absorption into the bloodstream[1].
Effective Particle Size
A critical aspect of the patent is the effective particle size of the apomorphine particles, which ranges from 20 nanometers to 10 micrometers. This specific size range is crucial for ensuring optimal absorption and efficacy of the drug. The patent further specifies various sub-ranges within this broader range, such as from 1 micrometer to 10 micrometers, highlighting the flexibility and precision in the formulation[1].
Dosage Forms
The pharmaceutical composition can be presented in various dosage forms, including lozenges, pills, tablets, films, or strips. Additionally, the patent mentions the possibility of a sublingual gel formulation. These diverse dosage forms cater to different patient needs and preferences, enhancing the usability and compliance of the treatment[1].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover the pharmaceutical composition, the method of preparation, and the method of use for treating Parkinson's disease. For instance, one of the claims might specify the composition as "a sublingual formulation comprising apomorphine particles having an effective particle size of from 1 micrometer to 10 micrometers"[1].
Dependent Claims
Dependent claims further elaborate on the independent claims by adding specific details or limitations. For example, a dependent claim might specify the type of excipients used in the formulation or the method of manufacturing the sublingual films or strips.
Patent Landscape
Prior Art
The patent landscape for apomorphine formulations is complex, with several prior art references related to medicinal preparations and their physical forms. The patent classifies under categories such as A61K9/00 (medicinal preparations characterized by special physical form) and A61P25/16 (anti-Parkinson drugs), indicating its position within a broader context of pharmaceutical innovations[1].
Related Patents
Other patents related to apomorphine or similar dopamine agonists may exist, but this patent stands out due to its specific focus on sublingual administration and the detailed specification of particle sizes. This uniqueness helps in differentiating it from other patents in the same therapeutic area.
Legal and Regulatory Aspects
Patent Validity
The validity of the patent is subject to legal scrutiny, similar to other patents. Issues such as obviousness-type double patenting, as seen in other cases, could potentially arise but are not relevant to this specific patent based on the provided information[2].
Expiration Date
The patent's expiration date is twenty years from its priority date, which would be January 26, 2036, assuming no extensions or adjustments.
Impact on the Pharmaceutical Industry
Innovation and Compliance
This patent represents an innovation in the delivery method of apomorphine, offering a more convenient and potentially more effective treatment option for Parkinson's disease patients. It also sets a standard for future formulations, encouraging further research and development in sublingual drug delivery systems.
Market Competition
The issuance of this patent could influence market competition by providing a competitive edge to the assignee company. Other pharmaceutical companies may need to develop alternative formulations or seek licenses to use the patented technology, which could impact the overall market dynamics.
Key Takeaways
- Sublingual Formulation: The patent introduces a novel sublingual formulation of apomorphine, enhancing the treatment options for Parkinson's disease.
- Particle Size: The effective particle size range of 20 nanometers to 10 micrometers is critical for optimal absorption and efficacy.
- Dosage Forms: Various dosage forms such as lozenges, pills, tablets, films, strips, and gels are included, catering to different patient needs.
- Patent Landscape: The patent is classified under specific categories related to medicinal preparations and anti-Parkinson drugs.
- Legal and Regulatory: The patent's validity and expiration date are crucial for its legal standing and market impact.
FAQs
What is the primary innovation of United States Patent 10,420,763?
The primary innovation is the development of a sublingual formulation of apomorphine for treating Parkinson's disease, with a specific focus on the effective particle size of the apomorphine particles.
What are the different dosage forms mentioned in the patent?
The patent includes dosage forms such as lozenges, pills, tablets, films, strips, and sublingual gels.
Why is the particle size of apomorphine particles important?
The particle size range of 20 nanometers to 10 micrometers is crucial for ensuring optimal absorption and efficacy of the drug when administered sublingually.
Under which categories is the patent classified?
The patent is classified under categories such as A61K9/00 (medicinal preparations characterized by special physical form) and A61P25/16 (anti-Parkinson drugs).
When is the patent set to expire?
The patent is set to expire twenty years from its priority date, which would be January 26, 2036.
Sources
- US10420763B2 - Sublingual apomorphine - Google Patents
- ALLERGAN USA, INC. v. MSN LABORATORIES PRIVATE LTD. - United States Court of Appeals for the Federal Circuit
- Patent Claims and Patent Scope - SSRN
- U.S. Patent and Trademark Office (USPTO) - USAGov
- U.S. Patent Small Claims Court - Administrative Conference of the United States
