Detailed Analysis of the Scope and Claims of United States Patent 8,722,037
Introduction
The United States Patent 8,722,037, titled "X-ray visible drug delivery device," is a significant innovation in the field of contraceptive and hormone replacement therapy. This patent, awarded to Merck Sharp & Dohme B.V., describes a novel device designed for subdermal administration of contraceptive or hormone replacement therapies.
Field of the Invention
The patent pertains to the field of contraception and hormone replacement therapy, focusing on the development of an X-ray visible drug delivery device. This device is designed for subdermal (subcutaneous) administration, ensuring that it can be easily located and monitored using X-ray imaging[1][4].
Device Composition
The device consists of several key components:
- Inert Metal Wire: The core of the device includes an inert metal wire, which can be made of materials such as titanium, certain grades of stainless steel, or gold alloys. Titanium wire is specifically mentioned as a preferred material[1][4].
- Non-Medicated Thermoplastic Polymer Skin: The inert metal wire is covered by a non-medicated thermoplastic polymer skin. This skin does not affect the release of the active pharmaceutical ingredients from the device[1][4].
- Radio-Opaque Element: The inclusion of a radio-opaque element, such as barium sulphate, ensures that the device is visible under X-ray imaging. This is crucial for medical professionals to verify the correct placement and position of the device[1][4].
Claims of the Patent
The patent claims are centered around the unique design and functionality of the X-ray visible drug delivery device. Key claims include:
- The device's ability to deliver contraceptive or hormone replacement therapy subdermally.
- The use of an inert metal wire as part of the device's core.
- The incorporation of a radio-opaque element to ensure X-ray visibility.
- The non-medicated thermoplastic polymer skin covering the core, which does not interfere with the drug release[1][4].
Patent Scope
The scope of the patent is defined by its claims and the detailed description provided. Here are some key aspects:
- Specific Embodiments: The patent includes specific embodiments, such as the use of titanium wire and barium sulphate, which are detailed in the examples section[1][4].
- Broad Applicability: While the patent is specific to subdermal drug delivery devices, it implies a broader applicability in the field of contraceptive and hormone replacement therapies.
- Exclusion of Other Uses: The patent does not cover other types of drug delivery systems or medical devices outside the specified scope, such as brachytherapy seeds[5].
Patent Landscape
The patent landscape surrounding US 8,722,037 involves several key points:
- Related Patents: There are other patents related to the Nexplanon device, such as US9757552, US8888745, and US10821277, which focus on different aspects like applicators and assembly methods[2].
- Exclusivities and Patent Expiration: The Nexplanon device is protected by multiple patents and FDA-granted exclusivities, which delay the launch of generic or bioequivalent versions. The patent for the X-ray visible drug delivery device itself is set to expire in September 2027[2].
- Litigation and Controversies: There have been legal disputes involving Microspherix and Merck regarding patent infringement claims. However, these disputes pertain to different patents and do not directly impact the validity or scope of US 8,722,037[5].
Examples and Preparation Methods
The patent includes detailed examples of how the device is prepared, such as the preparation of a two-layered implant containing barium sulphate in the core. These examples illustrate the manufacturing process and the materials used, further defining the scope of the invention[1].
Impact on Innovation and Competition
The patent's scope and claims have significant implications for innovation and competition in the pharmaceutical and medical device industries. The protection afforded by this patent ensures that Merck maintains a competitive edge in the market for subdermal contraceptive and hormone replacement therapy devices until the patent expires. This can influence the development of similar devices by other companies, as they must navigate around the protected claims to avoid infringement[3].
Metrics for Patent Scope
Studies on patent scope suggest that metrics such as independent claim length and independent claim count can be used to measure the breadth of a patent. In the case of US 8,722,037, the claims are specific and well-defined, indicating a narrower scope that is less likely to be overly broad or ambiguous[3].
Conclusion and Key Takeaways
- Device Design: The patent describes an X-ray visible drug delivery device with a core containing an inert metal wire and a non-medicated thermoplastic polymer skin.
- Radio-Opaque Element: The inclusion of a radio-opaque element like barium sulphate ensures X-ray visibility.
- Patent Scope: The patent's scope is well-defined, focusing on subdermal administration of contraceptive or hormone replacement therapies.
- Patent Landscape: The device is protected by multiple patents and exclusivities, with the current patent set to expire in 2027.
- Impact on Innovation: The patent influences the development of similar devices by other companies, ensuring Merck's competitive edge until the patent expires.
Key Takeaways
- The device is designed for subdermal administration of contraceptive or hormone replacement therapies.
- It includes an inert metal wire and a non-medicated thermoplastic polymer skin.
- The radio-opaque element ensures X-ray visibility.
- The patent is set to expire in September 2027.
- The device is part of a broader patent landscape protecting the Nexplanon system.
Frequently Asked Questions (FAQs)
Q: What is the primary purpose of the device described in US 8,722,037?
A: The primary purpose is for the subdermal administration of contraceptive or hormone replacement therapies.
Q: What materials are used in the core of the device?
A: The core includes an inert metal wire, such as titanium, and a radio-opaque element like barium sulphate.
Q: Why is X-ray visibility important for this device?
A: X-ray visibility ensures that medical professionals can easily locate and verify the correct placement of the device.
Q: When is the patent for this device set to expire?
A: The patent is set to expire in September 2027.
Q: Are there any ongoing legal disputes related to this patent?
A: There have been legal disputes involving Microspherix and Merck, but they pertain to different patents and do not directly impact US 8,722,037.
Cited Sources
- United States Patent and Trademark Office, "X-RAY VISIBLE DRUG DELIVERY DEVICE," US Patent 8,722,037 B2, May 13, 2014.
- Pharsight, "Nexplanon patent expiration," Retrieved from https://pharsight.greyb.com/drug/nexplanon-patent-expiration
- SSRN, "Patent Claims and Patent Scope," Retrieved from https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
- Google Patents, "X-ray visible drug delivery device," US Patent 8,722,037 B2, Retrieved from https://patents.google.com/patent/US8722037B2/en
- RPX Corporation, "Microspherix’s BRACHYTHERAPY PATENT FAMILY," Retrieved from https://insight.rpxcorp.com/litigation_documents/14228257
