United States Patent 11,235,169: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,235,169, titled "Illumination device for photodynamic therapy, method for treating a skin disease and method for operating an illumination device," is a significant innovation in the field of medical technology. This patent, granted to Biofrontera Inc., pertains to an illumination device designed for photodynamic therapy (PDT), a treatment method that uses light to activate a photosensitizer, which then targets and destroys diseased cells.
Patent Overview
Background and Purpose
Photodynamic therapy is a non-invasive treatment used for various skin diseases, including actinic keratosis and certain types of skin cancer. The patent describes an illumination device that enhances the efficacy and safety of PDT by providing a controlled and uniform light source.
Key Components
The illumination device comprises at least one electromagnetic radiation emitting unit, which includes multiple radiation sources, typically light-emitting diodes (LEDs). These LEDs are configured to emit radiation of the same or essentially the same color or peak wavelength, ensuring consistent treatment outcomes[1].
Scope of the Patent
Radiation Sources
- The radiation sources are arranged in a one- or two-dimensional pattern on a radiation source carrier.
- Each radiation source is an optoelectronic component, such as an LED, which may include a semiconductor chip based on III-V compound semiconductor materials like AlGaInN or AlGaInP[1].
Configuration and Arrangement
- The radiation sources are of the same type, material, and manufacturing process to ensure uniformity.
- The distance between adjacent radiation sources within a group is between 5 mm and 40 mm, and the distance between groups is between 20 mm and 80 mm[1].
Angular Adjustment
- The radiation source carriers can be angled relative to each other, with the vertical axes of the carriers being at least 5°, 10°, or 20° apart. This allows for adjustable and targeted illumination[1].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention:
- Claim 1 describes the illumination device with at least one electromagnetic radiation emitting unit.
- Claim 2 specifies the configuration of the radiation sources and their arrangement on the carrier.
- Claim 3 details the method for treating a skin disease using the illumination device[1].
Dependent Claims
Dependent claims further elaborate on the specifics of the invention, including:
- The type and material of the radiation sources.
- The angular adjustment of the radiation source carriers.
- The control mechanisms for moving the radiation source carriers[1].
Patent Landscape
Related Patents and Technologies
The patent landscape in the field of photodynamic therapy and illumination devices is complex and evolving. Other patents, such as those related to advanced LED lamps like the BF-RhodoLED XL, also contribute to the protection and innovation in this area[5].
Competitive Advantage
The listing of this patent in the FDA's Orange Book extends protection for Biofrontera's Ameluz-PDT drug-device combination until October 2040, providing a significant competitive advantage by forestalling generic competition[5].
Legal and Regulatory Aspects
FDA Approval and Orange Book Listing
The FDA's inclusion of the '169 patent in the Orange Book confirms that the patent protects the approved drug-device combination, Ameluz-PDT. This listing is crucial as it prevents generic manufacturers from launching similar products until the patent expires[5].
Patent Litigation and Protection
In the event of a generic product imitating the Ameluz-PDT combination, Biofrontera can file a lawsuit, which would trigger a 30-month stay on the sale of the generic product. This underscores the robust protection afforded by the patent[5].
Operational and Practical Considerations
Method for Operating the Illumination Device
The patent details a method for operating the illumination device, including the adjustment of radiation source carriers to ensure optimal treatment outcomes. This method is crucial for the effective use of the device in clinical settings[1].
Clinical Applications
The device is designed for treating various skin diseases, and its operational methodology ensures that the treatment is both effective and safe. The uniform illumination provided by the device is key to its clinical success[1].
Industry Impact and Future Directions
Innovation in Photodynamic Therapy
The '169 patent represents a significant innovation in photodynamic therapy, enhancing the precision and efficacy of treatments. This technology can lead to better patient outcomes and expanded applications in dermatology and other medical fields.
Market Dominance
Biofrontera's strategic patent portfolio, including the '169 patent, strengthens its market position and competitive advantage. This long-term protection enables the company to invest in further research and development, driving innovation in the field[5].
Key Takeaways
- Uniform Illumination: The patent ensures uniform illumination through the use of LEDs with the same or essentially the same peak wavelength.
- Adjustable Configuration: The radiation source carriers can be angled to provide targeted illumination.
- FDA Approval: The patent's listing in the FDA's Orange Book extends protection for Ameluz-PDT until October 2040.
- Competitive Advantage: The patent portfolio strengthens Biofrontera's market position and prevents generic competition.
- Clinical Applications: The device is designed for treating various skin diseases with enhanced precision and safety.
FAQs
What is the primary purpose of the United States Patent 11,235,169?
The primary purpose of the patent is to describe an illumination device for photodynamic therapy, designed to treat skin diseases with uniform and controlled light.
How are the radiation sources arranged in the illumination device?
The radiation sources are arranged in a one- or two-dimensional pattern on a radiation source carrier, with specific distances between sources and groups to ensure uniform illumination.
What is the significance of the FDA's Orange Book listing for this patent?
The FDA's Orange Book listing confirms that the patent protects the approved drug-device combination, Ameluz-PDT, and extends protection until October 2040, preventing generic competition.
How does the adjustable configuration of the radiation source carriers benefit the treatment?
The adjustable configuration allows for targeted illumination, ensuring that the light is directed precisely at the affected area, enhancing treatment efficacy and safety.
What is the impact of this patent on Biofrontera's market position?
The patent strengthens Biofrontera's market position by providing long-term protection for its Ameluz-PDT drug-device combination, preventing generic competition and enabling further innovation.
Sources
- US11235169B1 - Illumination device for photodynamic therapy, method for treating a skin disease and method for operating an illumination device - Google Patents
- U.S. Patent Small Claims Court - Administrative Conference of the United States
- Patent Claims and Patent Scope - SSRN
- Search for patents - USPTO - United States Patent and Trademark Office
- Biofrontera Inc. Announces FDA Orange Book Listing of U.S. Patent for BF-RhodoLED-XL - GlobeNewswire
