Detailed Analysis of the Scope and Claims of United States Patent 10,765,602
Introduction
United States Patent 10,765,602, titled "Medication Delivery Systems and Methods," is a crucial patent in the pharmaceutical industry, particularly for the delivery of medications such as glucagon. This patent, assigned to Eli Lilly and Company, plays a significant role in the protection of intellectual property related to medication delivery systems.
Patent Overview
Issuance and Expiration
The patent was issued on September 8, 2020, and is set to expire on September 23, 2039, which is 20 years from the date of filing, aligning with standard patent duration[2][4].
Assignee and Inventors
The patent is assigned to Eli Lilly and Company, with inventors Jaime Ray Arnett and Andrew Thomas Snow credited for the development of the medication delivery system[2][4].
Scope of the Patent
Medication Delivery System
The patent disclosure relates to a medication delivery system that includes several key components:
- A medication administration device
- A medication contained within the device
- A container defining a cavity that receives the medication administration device
- A cap attached to the container, which seals the medication administration device within the cavity[4].
Key Features
- Actuator Mechanism: The medication administration device includes an actuator that extends from a body and is operable to expel the medication by depressing the actuator into the body.
- Hold Down Members: The cap includes hold down members positioned to bear against the body of the medication administration device, preventing it from moving toward the cap beyond a predetermined distance. This prevents premature discharge of the medication during storage and transport[4].
Purpose and Benefits
The system is designed to maintain the medication administration device and contained medication in a viable condition from the time the device is filled with the medication to its eventual use by a patient. This addresses quality issues such as stability, dosage form, and aerodynamic performance, which are critical for the utility of the dispensed medication[4].
Claims of the Patent
Primary Claims
The patent includes multiple claims that cover various aspects of the medication delivery system:
- Claims related to the structure and function of the medication administration device
- Claims related to the container and cap assembly
- Claims related to the method of using the medication delivery system[4].
Claim Coverage
The claims are categorized into several scope concepts, including:
- The design and functionality of the medication administration device
- The interaction between the device and the container
- The method of sealing and preventing premature discharge
- The overall system for maintaining medication viability during storage and transport[3][4].
Patent Landscape
Related Patents
The patent is part of a broader patent family that includes other patents related to medication delivery systems and formulations. For example, other patents cover nasal powder formulations for treating hypoglycemia and devices for dispensing fluid products[2].
Exclusivities and Generic Launch
The patent, along with other patents and exclusivities granted by the FDA, delays the generic launch of Baqsimi, a drug that utilizes similar delivery systems. The generic launch date for Baqsimi is estimated to be September 23, 2039, aligning with the expiration of this patent[1][2].
International Protection
While this analysis focuses on the U.S. patent, it is important to note that Baqsimi and similar medications are protected by patents in multiple countries. Understanding the global patent landscape is crucial for strategizing market entry and identifying potential generic entry points[1].
Legal Activities and Updates
Maintenance Fees and Changes in Power of Attorney
Recent legal activities include the payment of maintenance fees and changes in power of attorney, which are critical for maintaining the patent's active status. These activities ensure that the patent remains enforceable until its expiration date[1].
Impact on the Pharmaceutical Industry
Innovation and Competition
This patent encourages innovation in medication delivery systems by protecting the intellectual property of companies like Eli Lilly and Company. It also sets a high standard for competitors, who must develop alternative delivery systems that do not infringe on the claims of this patent[3].
Patient Benefits
The medication delivery system described in this patent enhances patient safety and convenience by ensuring that medications are delivered accurately and reliably. This is particularly important for emergency treatments, such as the administration of glucagon for severe hypoglycemia[4].
Conclusion
United States Patent 10,765,602 is a significant intellectual property asset in the pharmaceutical industry, particularly in the field of medication delivery systems. Its scope and claims provide comprehensive protection for the innovative design and functionality of the medication administration device and its associated components.
Key Takeaways
- The patent protects a medication delivery system with a medication administration device, container, and cap.
- The system ensures the viability of the medication during storage and transport.
- The patent expires on September 23, 2039.
- It is part of a broader patent landscape that includes other related patents and exclusivities.
- Recent legal activities include maintenance fees and changes in power of attorney.
Frequently Asked Questions (FAQs)
1. What is the primary focus of United States Patent 10,765,602?
The primary focus is on a medication delivery system that includes a medication administration device, a container, and a cap, designed to maintain the medication's viability during storage and transport.
2. Who are the inventors and assignee of this patent?
The inventors are Jaime Ray Arnett and Andrew Thomas Snow, and the assignee is Eli Lilly and Company.
3. What is the expiration date of this patent?
The patent is set to expire on September 23, 2039.
4. How does this patent impact the generic launch of related drugs?
The patent, along with other patents and FDA-granted exclusivities, delays the generic launch of drugs like Baqsimi until the patent expires.
5. What are the key features of the medication delivery system described in this patent?
Key features include an actuator mechanism, hold down members in the cap, and a container assembly that prevents premature discharge of the medication.
Cited Sources:
- Pharsight: Baqsimi patent expiration.
- Drugs.com: Generic Baqsimi Availability.
- SLWIP: Patent Analytics.
- Google Patents: US10765602B1 - Medication delivery systems and methods.
- PubChem: Medication delivery systems and methods - Patent US-10765602-B1.
