United States Patent 8,835,488: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,835,488, titled "Opioid receptor ligands and methods of using and making same," is a significant patent in the field of pharmaceuticals, particularly in the treatment of pain and related disorders. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
The patent, granted on September 16, 2014, describes compounds that act as opioid receptor ligands. These ligands are designed to interact with opioid receptors, which are crucial in the management of pain and other related conditions[1].
Scope of the Patent
Overview of Opioid Receptor Ligands
The patent focuses on the development and use of opioid receptor ligands, which are molecules that bind to opioid receptors. These receptors are key targets in the treatment of pain, as they play a significant role in the body's natural pain relief mechanisms.
Specific Compounds
The patent details various chemical compounds that can act as opioid receptor ligands. These compounds include a range of heterocyclic and other organic molecules, each with specific structural features that enhance their binding affinity to opioid receptors[1].
Therapeutic Applications
The primary therapeutic application of these ligands is in the treatment of pain. The patent also mentions potential uses in managing other conditions associated with opioid receptor activity, such as constipation and other gastrointestinal disorders[1].
Claims of the Patent
Composition of Matter Claims
The patent includes claims related to the composition of matter, specifically the chemical structures of the opioid receptor ligands. These claims define the specific molecules and their derivatives that are covered under the patent[1].
Method of Use Claims
In addition to the composition of matter claims, the patent also includes method of use claims. These claims outline the specific ways in which the opioid receptor ligands can be used, including their administration routes and dosages for treating pain and other conditions[1].
Pharmaceutical Compositions
The patent claims also cover pharmaceutical compositions that include these opioid receptor ligands. This includes formulations such as tablets, capsules, and injectables, as well as the excipients and other components used in these formulations[1].
Patent Landscape
Prior Art and Related Patents
The patent landscape in the field of opioid receptor ligands is extensive. Prior art includes numerous patents and publications related to opioid receptor modulators and their therapeutic applications. The USPTO's Patent Public Search tool and other international patent databases can be used to identify related patents and assess the novelty and non-obviousness of the claimed inventions[4].
International Patent Filings
The invention described in US Patent 8,835,488 may also have been filed in other jurisdictions. Tools like the Global Dossier and the Common Citation Document (CCD) can help in identifying related international patent applications and assessing the global patent family[4].
Competing Technologies
Other technologies and patents in the field of pain management and opioid receptor modulation are relevant. These include non-opioid analgesics and alternative approaches to pain treatment, which can impact the market and therapeutic landscape for the patented compounds[1].
Methods of Making the Compounds
Synthesis Processes
The patent details various methods for synthesizing the opioid receptor ligands. These methods include substitution reactions, chromatography analysis, and other chemical processes necessary for producing the desired compounds[1].
Dosage Forms
The patent also describes different dosage forms in which these compounds can be administered. This includes solid dosage forms like tablets and capsules, as well as liquid formulations such as injectables[1].
Potential Impact and Market
Therapeutic Impact
The compounds described in the patent have the potential to significantly impact pain management by providing new and potentially more effective opioid receptor ligands. This could lead to improved patient outcomes and reduced side effects compared to existing treatments.
Market Competition
The market for pain management is highly competitive, with numerous existing treatments and ongoing research into new therapies. The patented compounds must compete with other opioid and non-opioid analgesics, which could affect their market penetration and adoption[1].
Regulatory Considerations
FDA Approval
For these compounds to be used clinically, they must undergo rigorous testing and receive approval from regulatory bodies such as the FDA. The patent term extension process, as seen in other pharmaceutical patents, may also be relevant to extend the exclusivity period for these compounds[5].
Conclusion
United States Patent 8,835,488 represents a significant advancement in the field of opioid receptor ligands and pain management. Understanding the scope, claims, and broader patent landscape is crucial for navigating the complex environment of pharmaceutical innovation.
Key Takeaways
- Opioid Receptor Ligands: The patent describes specific compounds that act as opioid receptor ligands for pain management.
- Therapeutic Applications: The compounds are primarily for treating pain but also have potential uses in managing other conditions.
- Claims: The patent includes composition of matter, method of use, and pharmaceutical composition claims.
- Patent Landscape: The patent is part of a larger landscape that includes prior art, international filings, and competing technologies.
- Synthesis and Dosage Forms: Detailed methods for synthesizing and formulating the compounds are provided.
- Regulatory Considerations: FDA approval and potential patent term extensions are critical for clinical use.
FAQs
What are opioid receptor ligands?
Opioid receptor ligands are molecules that bind to opioid receptors, which are key targets in pain management.
What is the primary therapeutic application of the compounds described in US Patent 8,835,488?
The primary therapeutic application is the treatment of pain.
How do the compounds described in the patent differ from existing treatments?
The compounds may offer improved efficacy and reduced side effects compared to existing opioid and non-opioid analgesics.
What regulatory steps must the compounds undergo before clinical use?
The compounds must undergo rigorous testing and receive FDA approval before they can be used clinically.
How can one search for related patents in the field of opioid receptor ligands?
Tools such as the USPTO's Patent Public Search, Global Dossier, and Common Citation Document can be used to search for related patents.
Sources
- US8835488B2 - Opioid receptor ligands and methods of using and making same - Google Patents
- US8835488B2 - Opioid receptor ligands and methods of using and making same - Google Patents (German version)
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- Food and Drug Administration CDER, Office of Regulatory Policy - Regulations.gov