United States Patent 10,198,218: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 10,198,218, titled "Injectable flowable composition comprising buprenorphine," is a significant innovation in the field of pharmaceuticals, particularly in the treatment of opioid addiction. This patent, granted to its inventors, outlines a novel delivery system for buprenorphine, a medication used to treat opioid use disorder. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
Buprenorphine is a partial opioid agonist used in the treatment of opioid addiction. Traditional delivery methods include sublingual tablets, films, and implants. However, these methods have limitations such as variable bioavailability, potential for misuse, and the need for frequent dosing. The invention described in US Patent 10,198,218 addresses these issues by introducing an injectable flowable composition that transforms into a solid implant in situ, providing sustained release of buprenorphine.
Scope of the Invention
The patent describes an innovative buprenorphine sustained release delivery system that includes a flowable composition and a solid implant. Here are the key aspects of the invention:
Flowable Composition
- The flowable composition comprises a biodegradable thermoplastic polymer, a biocompatible polar organic liquid, and buprenorphine or its metabolite/prodrug[4].
- The polymer is typically a poly(DL-lactide-co-glycolide) (PLG) with various ratios, such as 50/50, 55/45, etc., which can have a carboxy terminal group or be formulated with mono-alcohol or polyol units[4].
Solid Implant
- The flowable composition is injected into the body, where it transforms into a solid implant upon contact with water, body fluid, or another aqueous medium[4].
- This transformation results in a sustained release of buprenorphine over a period of about 14 days to 3 months, characterized by high bioavailability and minimal risk of tissue damage or muscle necrosis[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1 describes the injectable flowable composition comprising a biodegradable thermoplastic polymer, a biocompatible polar organic liquid, and buprenorphine or its metabolite/prodrug[4].
- Claim 2 specifies the solid implant produced from the flowable composition, emphasizing its sustained release profile[4].
Dependent Claims
- These claims further detail the composition and properties of the polymer, such as the specific ratios of PLG and the inclusion of mono-alcohol or polyol units[4].
- Other dependent claims address the method of transforming the flowable composition into the solid implant and the resulting bioavailability and safety profile[4].
Patent Landscape
Prior Art
The patent landscape for buprenorphine delivery systems is extensive, with various prior art patents focusing on different delivery methods such as sublingual tablets, films, and traditional implants. However, the unique aspect of this patent lies in its injectable flowable composition that transforms into a solid implant, providing a novel approach to sustained release.
International Patent Offices
To understand the global patent landscape, one would need to search international patent databases such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), World Intellectual Property Organization (WIPO), and other national intellectual property offices. These databases can reveal similar or related inventions filed in other jurisdictions[1].
Related Patents
Other patents related to buprenorphine delivery systems can be found using tools like the USPTO's Patent Public Search or the Global Dossier service, which provides access to file histories and related applications from participating IP offices[1].
Economic and Practical Implications
The invention described in US Patent 10,198,218 has significant economic and practical implications:
Market Impact
- This novel delivery system could revolutionize the treatment of opioid addiction by providing a more convenient, effective, and safe method of buprenorphine administration.
- It could reduce healthcare costs associated with frequent dosing and monitoring, and improve patient compliance.
Competitive Advantage
- The unique composition and delivery mechanism provide a competitive advantage over existing buprenorphine products.
- Pharmaceutical companies may be interested in licensing or acquiring this technology to expand their product portfolios.
Legal and Regulatory Considerations
The patent's legal status and regulatory approvals are crucial for its commercialization:
Patent Enforcement
- The patent holder must ensure that the patent is enforced to prevent infringement. This may involve monitoring competitors and taking legal action if necessary[5].
Regulatory Approvals
- Before the product can be marketed, it must receive regulatory approvals from bodies such as the FDA. The patent's claims and specifications must align with regulatory requirements[4].
Conclusion
United States Patent 10,198,218 represents a groundbreaking innovation in the field of opioid addiction treatment. The injectable flowable composition that transforms into a solid implant offers a novel and effective way to deliver buprenorphine, addressing several limitations of traditional delivery methods. Understanding the scope, claims, and broader patent landscape is essential for navigating the complex world of intellectual property and bringing this technology to market.
Key Takeaways
- Novel Delivery System: The patent describes an injectable flowable composition that transforms into a solid implant, providing sustained release of buprenorphine.
- Biodegradable Polymer: The composition includes a biodegradable thermoplastic polymer, typically PLG, which ensures minimal tissue damage.
- High Bioavailability: The system offers high bioavailability and a reduced risk of muscle necrosis.
- Market Impact: This invention could significantly impact the treatment of opioid addiction by improving efficacy and patient compliance.
- Legal and Regulatory Considerations: Ensuring patent enforcement and obtaining regulatory approvals are critical for commercialization.
FAQs
Q: What is the main innovation of US Patent 10,198,218?
A: The main innovation is an injectable flowable composition that transforms into a solid implant for the sustained release of buprenorphine.
Q: What are the key components of the flowable composition?
A: The key components include a biodegradable thermoplastic polymer (typically PLG), a biocompatible polar organic liquid, and buprenorphine or its metabolite/prodrug.
Q: How does the flowable composition transform into a solid implant?
A: The flowable composition transforms into a solid implant upon contact with water, body fluid, or another aqueous medium.
Q: What are the benefits of this delivery system compared to traditional methods?
A: The system offers high bioavailability, minimal risk of tissue damage or muscle necrosis, and improved patient compliance due to its sustained release profile.
Q: What regulatory approvals are needed before this product can be marketed?
A: The product must receive regulatory approvals from bodies such as the FDA, ensuring that the patent's claims and specifications align with regulatory requirements.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- USA.gov - U.S. Patent and Trademark Office (USPTO): https://www.usa.gov/agencies/u-s-patent-and-trademark-office
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US10198218B2: https://patents.google.com/patent/US10198218B2/en
- ACUS - U.S. Patent Small Claims Court: https://www.acus.gov/research-projects/us-patent-small-claims-court
