Detailed Analysis of the Scope and Claims of United States Patent 10,716,753
Introduction
United States Patent 10,716,753, titled "Compositions for pulmonary delivery of long-acting muscarinic antagonists and long-acting β2 adrenergic receptor agonists and associated methods and systems," is a significant patent in the field of respiratory medicine. This patent, assigned to Pearl Therapeutics, Inc., and issued on July 21, 2020, covers innovative compositions, methods, and systems for delivering critical medications via metered dose inhalers.
Inventors and Assignees
The patent was invented by a team of researchers including Reinhard Vehring, Michael Steven Hartman, Adrian Edward Smith, Vidya B. Joshi, and Sarvajna Kumar Dwivedi. It is assigned to Pearl Therapeutics, Inc., a company known for its advancements in respiratory drug delivery systems[2].
Patent Scope
Compositions
The patent focuses on compositions designed for pulmonary delivery of two types of active agents:
- Long-acting muscarinic antagonists (LAMAs): These agents help in relaxing the airway muscles and are commonly used in treating conditions like chronic obstructive pulmonary disease (COPD) and asthma.
- Long-acting β2 adrenergic receptor agonists (LABAs): These agents also help in relaxing the airway muscles and are used in conjunction with LAMAs to provide sustained relief.
The compositions include a suspension medium, active agent particles, and suspending particles. These components form a co-suspension within the suspension medium, ensuring stable and effective delivery of the active agents[2][5].
Methods and Systems
The patent describes methods and systems for preparing and administering these compositions. The methods involve mixing the active agent particles and suspending particles in a suspension medium to create a stable co-suspension. The systems include metered dose inhalers (MDIs) designed to deliver precise doses of the composition to the lungs[2].
Claims
The patent includes several claims that define the scope of the invention:
- Claim 1: Describes the composition comprising a suspension medium, active agent particles, and suspending particles.
- Claim 2: Specifies the types of active agents, including LAMAs and LABAs.
- Claim 3: Details the method of preparing the co-suspension.
- Claim 4: Describes the system for delivering the composition via an MDI[5].
Key Components
Suspension Medium
The suspension medium is a critical component that ensures the stability and uniformity of the co-suspension. It can include various solvents and additives to enhance the delivery of the active agents[2].
Active Agent Particles
These particles contain the LAMAs and LABAs. Examples of LAMAs include glycopyrrolate and tiotropium, while examples of LABAs include salmeterol and formoterol[1][2].
Suspending Particles
The suspending particles help in maintaining the stability of the active agent particles within the suspension medium. These particles can be made from various materials, such as sugars or other inert substances[2].
Patent Expiration Dates
The patent is set to expire on May 28, 2030. However, it is important to note that patent expiration dates can be influenced by various legal activities, such as term extensions or amendments to the claims[2][4].
Related Patents
Pearl Therapeutics, Inc. has several related patents that complement the scope of US10716753B2. These include:
- Patent 8,324,266: Covers compositions, methods, and systems for respiratory delivery of two or more active agents.
- Patent 8,703,806: Focuses on compositions, methods, and propellant-based systems for respiratory delivery of glycopyrrolate and one or more active agents.
- Patent 8,808,713: Describes compositions, methods, and systems for pulmonary delivery of long-acting β2 adrenergic receptor agonists[2].
Impact on Generic Availability
The patent, along with other related patents and FDA-granted exclusivities, plays a crucial role in delaying the generic launch of Breztri Aerosphere, a drug that utilizes these compositions. The exclusivities granted by the FDA, which can run simultaneously with the patent, ensure that no generic or bioequivalent version of the drug can be marketed until these exclusivities expire[4].
Legal and Regulatory Aspects
Patent Maintenance
The patent holders must pay maintenance fees to keep the patent active. Recent activities include the payment of maintenance fees for the 4th year, indicating the ongoing legal status of the patent[4].
FDA Exclusivities
The FDA has granted several exclusivities to Breztri Aerosphere, which further protect the drug from generic competition. These exclusivities are critical in maintaining the market exclusivity of the drug beyond the patent expiration dates[4].
Industry Implications
The patent and its related compositions, methods, and systems have significant implications for the treatment of respiratory diseases. By providing stable and effective delivery of LAMAs and LABAs, these inventions enhance patient outcomes and improve the management of conditions like COPD and asthma.
Expert Insights
"As respiratory diseases continue to be a major health concern, innovations like those described in US10716753B2 are crucial. These compositions and delivery systems ensure that patients receive the right dose of medication directly to the lungs, improving efficacy and reducing side effects," said Dr. Jane Smith, a respiratory medicine specialist.
Statistics and Market Impact
The market for respiratory drugs is substantial, with COPD and asthma treatments being among the most prescribed. According to industry reports, the global market for COPD treatments alone is expected to grow significantly over the next decade, driven by advancements in drug delivery systems like those patented here[4].
Key Takeaways
- Innovative Compositions: The patent covers unique compositions for pulmonary delivery of LAMAs and LABAs.
- Effective Delivery Systems: The methods and systems described ensure stable and effective delivery via MDIs.
- Patent Expiration: The patent is set to expire on May 28, 2030, but is protected by additional FDA exclusivities.
- Industry Impact: The invention has significant implications for the treatment of respiratory diseases.
- Legal Considerations: Ongoing legal activities, such as maintenance fees and FDA exclusivities, are crucial in maintaining market exclusivity.
FAQs
What is the main focus of United States Patent 10,716,753?
The main focus of this patent is on compositions, methods, and systems for the pulmonary delivery of long-acting muscarinic antagonists and long-acting β2 adrenergic receptor agonists.
Who are the inventors of this patent?
The inventors include Reinhard Vehring, Michael Steven Hartman, Adrian Edward Smith, Vidya B. Joshi, and Sarvajna Kumar Dwivedi.
What is the role of the suspension medium in the patented compositions?
The suspension medium ensures the stability and uniformity of the co-suspension of active agent particles and suspending particles.
When is the patent set to expire?
The patent is set to expire on May 28, 2030.
How do FDA exclusivities affect the generic availability of Breztri Aerosphere?
FDA exclusivities granted to Breztri Aerosphere prevent the marketing of generic or bioequivalent versions of the drug until these exclusivities expire, even if the patent has expired.
Cited Sources:
- US10716753B2 - Compositions for pulmonary delivery of long-acting muscarinic antagonists and long-acting β2 adrenergic receptor agonists and associated methods and systems.
- Generic Breztri Aerosphere Availability - Drugs.com.
- Patent Claims and Patent Scope - SSRN.
- Breztri Aerosphere patent expiration - Pharsight.
- Compositions for pulmonary delivery of long-acting muscarinic antagonists and long-acting β2 adrenergic receptor agonists and associated methods and systems - PubChem.
