United States Patent 9,511,066: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,511,066, titled "Abuse-resistant controlled-release opioid dosage form," is a significant patent in the pharmaceutical industry, particularly in the realm of opioid formulations. This patent, issued to address the growing issue of opioid abuse, introduces a novel dosage form designed to mitigate the risks associated with opioid misuse.
Patent Overview
Publication Number and Authority
The patent number is US9511066B2, and it was issued by the United States Patent and Trademark Office (USPTO)[4].
Invention Description
The patent describes an abuse-resistant, controlled-release opioid dosage form that combines an opioid agonist with an opioid antagonist, such as naloxone. This combination is designed to deter abuse by preventing the euphoric effects typically associated with opioid misuse. The dosage form can be in various pharmaceutical compositions, including tablets, and is engineered to release the opioid agonist in a controlled manner while the opioid antagonist is released either immediately, sustainably, or in a combination of both[4].
Claim Scope
Importance of Claim Scope
The scope of the claims in a patent is crucial for defining the boundaries of the invention and ensuring that the patent is enforceable. A well-defined claim scope must balance between being broad enough to cover the invention's essence and narrow enough to avoid invalidation due to prior art or abstract idea exceptions[3].
Claims in US9511066B2
The claims in this patent are specific to the composition and method of the abuse-resistant opioid dosage form. They include:
- The combination of an opioid agonist (e.g., oxycodone) with an opioid antagonist (e.g., naloxone) in a controlled-release formulation.
- The specific ratios and release profiles of the opioid agonist and antagonist.
- The various pharmaceutical forms the dosage can take, such as tablets, capsules, or other oral formulations[4].
Prior Art and Novelty
Prior Art Considerations
When drafting the claims for this patent, it was essential to consider prior art in the field of opioid formulations. The patent must demonstrate novelty and non-obviousness over existing inventions. The inclusion of naloxone as an opioid antagonist in a controlled-release formulation is a key differentiator from previous opioid dosage forms[4].
Global Patent Landscape
The global patent landscape for opioid formulations is complex, with numerous patents from various countries. For instance, the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO) provide searchable databases that can help identify prior art and similar inventions[1].
Technical Field and Market Impact
Technical Field
The technical field of opioid formulations is highly competitive and rapidly evolving. Patents in this field must navigate the challenges of balancing efficacy with safety and abuse resistance. The use of opioid antagonists like naloxone is a significant advancement in this area[4].
Market Impact
This patent has significant market implications, particularly in the context of the opioid crisis. By providing an abuse-resistant opioid dosage form, it addresses a critical need for safer opioid medications. This innovation can influence pharmaceutical companies to develop similar formulations, potentially reducing the incidence of opioid abuse[4].
Legal Status and Expiration
Legal Status
The legal status of the patent is listed as "Expired - Lifetime," indicating that the patent has reached the end of its term and is no longer in force. However, this does not mean the technology is no longer relevant or protected; it may still be covered by other patents or trade secrets[4].
Expiration and Public Domain
With the patent having expired, the technology described in the patent is now in the public domain. This allows other companies to develop similar products without infringing on the original patent. However, any improvements or new innovations in this area could still be patented[4].
Search and Analysis Tools
USPTO Resources
For conducting a thorough search and analysis of patents like US9511066B2, the USPTO provides several resources, including the Patent Public Search tool, Global Dossier, and the Patent and Trademark Resource Centers (PTRCs). These tools help in identifying prior art, understanding the patent family, and accessing international patent databases[1].
International Databases
International databases such as the European Patent Office's esp@cenet, Japan Patent Office's database, and WIPO's PATENTSCOPE provide comprehensive access to global patent information. These resources are essential for a thorough patent landscape analysis[1].
Claim Validity and Invalidation Risks
Abstract Idea Exception
Claims that are too broad can risk being invalidated under the abstract idea exception, as seen in cases like Yu v. Apple Inc. and Minerva Surgical, Inc. v. Hologic, Inc.. Ensuring that the claims are anchored to the specific embodiments disclosed in the specification is crucial to avoiding such risks[3].
Written Description Requirement
The claims must also meet the written description requirement, meaning they must be supported by the detailed description provided in the patent specification. Failure to meet this requirement can lead to claim invalidation[3].
Industry Expert Insights
Industry experts emphasize the importance of getting the claim scope right to ensure the patent's enforceability and validity. A balanced approach that considers the actual invention, prior art, client budget, and technical field is essential for drafting effective claims[3].
Illustrative Statistics
The impact of opioid abuse is significant, with statistics showing that opioid-related deaths have been a major public health concern. For instance, in 2020, the CDC reported over 91,000 overdose deaths in the United States, with a substantial portion attributed to opioids. Innovations like the abuse-resistant opioid dosage form described in US9511066B2 are critical in addressing this crisis.
Key Takeaways
- Patent Scope and Claims: The patent's claims are specific to the combination of an opioid agonist and antagonist in a controlled-release formulation.
- Prior Art and Novelty: The patent demonstrates novelty over prior art by incorporating naloxone in a controlled-release formulation.
- Market Impact: The patent addresses a critical need for safer opioid medications, influencing the development of similar formulations.
- Legal Status: The patent has expired, placing the technology in the public domain.
- Search and Analysis Tools: Utilizing USPTO resources and international databases is essential for thorough patent landscape analysis.
FAQs
What is the main innovation of US9511066B2?
The main innovation is the combination of an opioid agonist with an opioid antagonist, such as naloxone, in a controlled-release formulation to deter abuse.
Why is the claim scope important in a patent?
The claim scope is crucial for defining the boundaries of the invention, ensuring enforceability, and avoiding invalidation due to prior art or abstract idea exceptions.
How does the patent address the opioid crisis?
The patent addresses the opioid crisis by providing an abuse-resistant opioid dosage form, which reduces the risk of misuse and overdose.
What resources can be used to search and analyze patents like US9511066B2?
Resources include the USPTO's Patent Public Search tool, Global Dossier, PTRCs, and international databases like esp@cenet and PATENTSCOPE.
What are the risks of having overly broad claims in a patent?
Overly broad claims risk being invalidated due to the abstract idea exception or failure to meet the written description requirement.
Cited Sources
- USPTO - Search for patents. Retrieved from https://www.uspto.gov/patents/search
- Google Patents - US8822487B2. Retrieved from https://patents.google.com/patent/US8822487B2/en
- Rimon Law - The Importance of Getting the Claim Scope Right in a US Patent Application. Retrieved from https://www.rimonlaw.com/the-importance-of-getting-the-claim-scope-right-in-a-us-patent-application-i/
- Google Patents - US9511066B2. Retrieved from https://patents.google.com/patent/US9511066B2/en
