Detailed Analysis of the Scope and Claims of United States Patent 10,421,729
Introduction
United States Patent 10,421,729, titled "Microcrystalline diketopiperazine compositions and methods," is a significant patent in the field of pharmaceuticals, particularly in drug delivery systems. This patent, assigned to MannKind Corporation, introduces innovative methods and compositions for microcrystalline diketopiperazine (DKP) particles, which are crucial for pulmonary drug delivery.
Background
Diketopiperazines (DKPs) are cyclic dipeptides that have been explored for their potential in drug delivery due to their stability and biocompatibility. The development of microcrystalline DKP compositions addresses several challenges associated with traditional drug delivery methods, such as the irreversible self-assembly of DKP particles into microparticles.
Patent Overview
Inventors and Assignee
The patent was invented by Bryan R. Wilson, Joseph J. Guarneri, and Marshall L. Grant, and is assigned to MannKind Corporation, a company known for its innovative approaches in drug delivery systems[4].
Issue Date and Expiration
The patent was issued on September 24, 2019, and is set to expire on April 1, 2035[4].
Claims and Scope
Main Claims
The patent primarily claims microcrystalline DKP compositions and methods for their preparation. Here are the key aspects:
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Microcrystal Formation: The patent describes an improved method for producing DKP microcrystals that do not irreversibly self-assemble into microparticles. This is a critical advancement as it allows for more stable and consistent drug delivery particles[1][4].
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Dispersion and Re-formation: The microcrystals can be dispersed by atomization and then re-formed into particles with a spherical shell morphology using spray drying. This process ensures uniform particle size and shape, which is vital for effective pulmonary drug delivery[1][4].
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Incorporation of Active Agents: The method includes incorporating active agents and excipients into the microcrystalline DKP particles through spray drying. This allows for the delivery of a wide range of therapeutic agents, including peptides, proteins, nucleic acids, and small organic molecules[1][4].
Specific Embodiments
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Pulmonary Drug Delivery: The microcrystalline DKP compositions are specifically designed for pulmonary drug delivery. This method leverages the lungs as a primary site for drug absorption, which can enhance the bioavailability and efficacy of the therapeutic agents[1][4].
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Particle Characteristics: The particles produced have defined characteristics, such as a spherical shell morphology, which is crucial for efficient aerosolization and deposition in the lungs[1][4].
Patent Landscape
Related Patents
The patent landscape surrounding DKP compositions and methods is rich with related patents, many of which are also assigned to MannKind Corporation:
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Diketopiperazine Salts for Drug Delivery: Patent 10,130,685 describes drug delivery systems based on diketopiperazine carboxylate salts and microparticles, which can include bioactive agents. This patent complements the methods described in US 10,421,729 by providing additional formulations and methods for DKP-based drug delivery[4].
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Diketopiperazine Microparticles with Defined Specific Surface Areas: Patent 10,772,883 focuses on DKP microparticles with specific surface areas, which can include drugs like insulin. This patent further expands the scope of DKP-based drug delivery systems by specifying particle surface areas[4].
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Treprostinil Administration by Inhalation: While not directly related to DKP compositions, Patent 10,716,793, assigned to United Therapeutics Corporation, discusses the administration of treprostinil via inhalation, which is another example of pulmonary drug delivery. This highlights the broader interest in pulmonary delivery methods within the pharmaceutical industry[4].
Impact on Pharmaceutical Industry
Innovation in Drug Delivery
The patent introduces significant innovations in drug delivery, particularly for pulmonary administration. The ability to produce stable, microcrystalline DKP particles that can be easily aerosolized and delivered to the lungs enhances the efficacy and bioavailability of various therapeutic agents.
Competitive Advantage
MannKind Corporation, with its portfolio of related patents, holds a strong position in the market for DKP-based drug delivery systems. This patent, along with others, provides a competitive advantage by offering unique and effective methods for pulmonary drug delivery.
Legal and Regulatory Considerations
Patent Validity and Scope
The validity and scope of the patent are critical for its enforcement. The patent's claims are specific and well-defined, reducing the likelihood of challenges based on obviousness or lack of novelty. The patent's scope is also protected by the safe harbor provisions under U.S. patent law, similar to those discussed in the context of divisional applications and double patenting[2].
Conclusion
United States Patent 10,421,729 represents a significant advancement in the field of pharmaceutical drug delivery, particularly for pulmonary administration. The patent's claims and scope are well-defined, and its innovations in microcrystalline DKP compositions and methods position MannKind Corporation as a leader in this area. Understanding the patent landscape and the legal and regulatory considerations surrounding this patent is crucial for both the development of new drug delivery systems and the enforcement of intellectual property rights.
Key Takeaways
- Innovative Method: The patent introduces an improved method for producing microcrystalline DKP particles that do not irreversibly self-assemble.
- Pulmonary Drug Delivery: The compositions are specifically designed for pulmonary drug delivery, enhancing the bioavailability and efficacy of therapeutic agents.
- Related Patents: The patent is part of a broader portfolio of related patents held by MannKind Corporation, strengthening their position in DKP-based drug delivery.
- Competitive Advantage: The patent provides a competitive advantage in the pharmaceutical industry by offering unique and effective drug delivery methods.
- Legal and Regulatory Considerations: The patent's validity and scope are protected under U.S. patent law, ensuring its enforcement and the protection of intellectual property rights.
Frequently Asked Questions (FAQs)
What is the main innovation of US Patent 10,421,729?
The main innovation is the method for producing microcrystalline DKP particles that do not irreversibly self-assemble into microparticles, enhancing their stability and effectiveness for pulmonary drug delivery.
Who is the assignee of this patent?
The patent is assigned to MannKind Corporation.
What is the expiration date of this patent?
The patent is set to expire on April 1, 2035.
What types of therapeutic agents can be delivered using this method?
The method allows for the delivery of peptides, proteins, nucleic acids, and small organic molecules.
How do the microcrystals formed in this patent differ from previous methods?
The microcrystals formed in this patent do not irreversibly self-assemble into microparticles, which is a significant improvement over previous methods.
Cited Sources:
- US10421729B2 - Microcrystalline diketopiperazine compositions and methods - Google Patents
- Court of Appeals for the Federal Circuit - held - 2008-03-07
- Patent Claims and Patent Scope - SSRN
- Generic Tyvaso DPI Availability - Drugs.com
