Detailed Analysis of the Scope and Claims of United States Patent 11,077,192
Introduction
United States Patent 11,077,192, titled "Methods for photodynamic therapy," is a significant patent in the field of dermatology and oncology, particularly focusing on the use of 5-aminolevulinic acid (ALA) for photodynamic therapy (PDT). Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
Photodynamic therapy is a treatment that uses a photosensitizing agent, in this case, ALA, and light to target and destroy abnormal cells. ALA is converted into protoporphyrin IX (PpIX) in the cells, which, when exposed to light of a specific wavelength, generates reactive oxygen species that kill the targeted cells[1].
Patent Overview
Inventors and Assignees
The patent was issued to inventors Scott Lundahl and Michael Guttadauro, and assigned to DUSA Pharmaceuticals, Inc.[2].
Issue Date and Expiration
The patent was issued on August 3, 2021, and is set to expire on January 12, 2038[2].
Claims
The patent includes several claims that define the scope of the invention.
Independent Claims
The primary independent claim describes a method of enhancing the penetration of a topical composition of 5-aminolevulinic acid (ALA) into tissue for photodynamic therapy. This method involves:
- Topically applying ALA to a treatment area.
- Covering the treatment area with a low-density polyethylene barrier after the ALA application.
- This barrier is used to minimize transepidermal water loss from the treatment area before light treatment[2][4].
Dependent Claims
Dependent claims further specify the method, including details such as:
- The concentration of ALA in the topical composition.
- The duration for which the treatment area is covered with the barrier.
- The type of light used for the photodynamic therapy[4].
Scope of the Invention
The scope of the patent is narrowly focused on the method of enhancing ALA penetration and its application in photodynamic therapy.
Technical Details
The method involves a specific sequence of steps to ensure optimal penetration of ALA into the tissue. This includes the use of a low-density polyethylene barrier to prevent water loss, which is crucial for maintaining the efficacy of the treatment[2][4].
Clinical Applications
The patent is aimed at improving the treatment of conditions such as actinic keratosis and certain types of skin cancers through more effective photodynamic therapy. The method described can enhance the therapeutic outcomes by ensuring better penetration of the photosensitizing agent into the targeted tissue[1].
Patent Landscape
Related Patents
Several related patents have been issued to DUSA Pharmaceuticals, Inc., all focusing on methods for enhancing the efficacy of photodynamic therapy using ALA. These patents, such as US10357567, US11135293, and US11690914, share similar claims and methods but may vary in specific details or additional steps[2].
Patent Exclusivity
The patent grants exclusive rights to DUSA Pharmaceuticals, Inc., to use and market this specific method of photodynamic therapy. This exclusivity period runs until January 12, 2038, ensuring that the company has a monopoly on this particular method during this time[2].
Generic and Competitor Landscape
As of now, there is no therapeutically equivalent generic version of Levulan Kerastick, the brand name product containing ALA, available in the United States. This lack of generic competition further solidifies the market position of DUSA Pharmaceuticals, Inc., for this specific treatment method[2].
Impact on Innovation and Industry
Innovation
The patent encourages innovation by protecting the intellectual property of the inventors and the company. This protection allows for further research and development in the field of photodynamic therapy, potentially leading to more advanced and effective treatments[3].
Industry Standards
The patent sets a standard for the use of ALA in photodynamic therapy, influencing how other companies and researchers approach similar treatments. The method described can become a benchmark for future developments in this area[4].
Challenges and Critiques
Patent Scope and Clarity
The scope and clarity of patent claims are critical for their validity and enforceability. Narrower claims, as seen in this patent, are generally associated with a higher probability of grant and shorter examination processes. However, broader claims can sometimes lead to disputes over patent scope and validity[3].
Regulatory Compliance
Compliance with regulatory requirements is essential. The patent must align with FDA guidelines and other regulatory standards to ensure that the treatment method is safe and effective for clinical use[2].
Key Takeaways
- Method of Treatment: The patent describes a method for enhancing the penetration of ALA into tissue for photodynamic therapy.
- Barrier Use: The use of a low-density polyethylene barrier is crucial for minimizing transepidermal water loss.
- Clinical Applications: The method is aimed at treating conditions like actinic keratosis and certain skin cancers.
- Patent Exclusivity: The patent grants exclusive rights to DUSA Pharmaceuticals, Inc., until January 12, 2038.
- Impact on Innovation: The patent protects intellectual property, encouraging further research and development in photodynamic therapy.
FAQs
What is the primary claim of United States Patent 11,077,192?
The primary claim involves a method for enhancing the penetration of a topical composition of 5-aminolevulinic acid (ALA) into tissue for photodynamic therapy by using a low-density polyethylene barrier.
Who are the inventors and assignees of the patent?
The inventors are Scott Lundahl and Michael Guttadauro, and the assignee is DUSA Pharmaceuticals, Inc.
What is the expiration date of the patent?
The patent is set to expire on January 12, 2038.
Is there a generic version of Levulan Kerastick available?
No, there is currently no therapeutically equivalent generic version of Levulan Kerastick available in the United States.
What is the significance of using a low-density polyethylene barrier in the method?
The barrier minimizes transepidermal water loss from the treatment area, ensuring better penetration and efficacy of the ALA treatment.
Cited Sources
- DrugBank: Aminolevulinic acid: Uses, Interactions, Mechanism of Action.
- Drugs.com: Generic Levulan Kerastick Availability.
- Hoover Institution: Patent Claims and Patent Scope.
- Google Patents: Methods for photodynamic therapy - US11077192B2.
