United States Patent 11,052,061: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,052,061, titled "Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics," is a significant patent in the pharmaceutical field, particularly in the area of drug delivery systems. This patent, issued to innovators in the field of pharmacology, outlines a novel formulation of gamma-hydroxybutyrate (GHB) with enhanced release characteristics.
Background of Gamma-Hydroxybutyrate (GHB)
Gamma-hydroxybutyrate is a compound used in various medical applications, most notably as the active ingredient in Xyrem®, a medication for the treatment of narcolepsy and cataplexy. The traditional formulation of GHB has immediate release properties, which can lead to rapid peak concentrations and potential side effects. The need for a modified release formulation to improve pharmacokinetics and patient compliance is thus critical[4].
Scope of the Patent
The patent describes a modified release formulation of GHB that combines immediate and delayed release components. Here are the key aspects of the scope:
Immediate Release Portion
- The immediate release portion of the formulation is designed to release a significant amount of GHB quickly. Specifically, it releases greater than 80% of its GHB content within one hour when tested in a dissolution apparatus according to USP 38 § 711 in 900 mL of 0.1N hydrochloric acid at 37°C and a paddle speed of 75 rpm[4].
Modified Release Portion
- The modified release portion is engineered to release GHB over a longer period. This portion releases less than 20% of its GHB content within one hour and greater than 80% at three hours under similar test conditions. This ensures a sustained release of the drug, reducing peak concentrations and improving patient tolerance[4].
Claims of the Patent
The patent includes several claims that define the invention and its unique characteristics:
Claim 1: Formulation Composition
- The patent claims a formulation comprising both immediate and modified release portions of GHB. The immediate release portion releases a significant amount of GHB within one hour, while the modified release portion releases the majority of its GHB content over a longer period, typically up to three hours[4].
Claim 2: Release Profile
- The claims specify the release profile of the formulation, including the percentage of GHB released at different time points. For example, the formulation releases 10% to 65% of its GHB at one hour and greater than 60% at ten hours under specified test conditions[4].
Claim 3: Pharmaceutical Form
- The patent also claims the pharmaceutical form of the formulation, which can include microcapsules, solid microparticles, or pellets surrounded by distinct coating layers. These forms are designed to achieve the desired release profile[4].
Patent Landscape
To understand the significance and positioning of this patent within the broader patent landscape, it is essential to consider several factors:
Prior Art
- The patent builds upon existing knowledge in the field of drug delivery systems, particularly those related to GHB formulations. Prior art includes immediate release formulations of GHB, but the novel aspect here is the combination of immediate and modified release components to achieve improved pharmacokinetics[4].
International Patent Offices
- Similar patents may exist in other jurisdictions, such as the European Patent Office (EPO), Japan Patent Office (JPO), or the World Intellectual Property Organization (WIPO). These offices provide searchable databases that can help identify related patents and assess the global patent landscape[1].
Related Patents
- Other patents related to GHB formulations or drug delivery systems can be found using resources like the USPTO's Patent Public Search tool, Global Dossier, or the Common Citation Document (CCD) application. These tools help in identifying prior art and understanding the evolution of technology in this field[1].
Economic and Market Impact
The economic and market impact of this patent can be significant:
Improved Patient Compliance
- The modified release formulation can lead to better patient compliance due to reduced side effects and more stable drug concentrations over time. This can result in improved treatment outcomes and higher patient satisfaction[4].
Market Differentiation
- The unique release profile of this formulation can differentiate it from existing products in the market, potentially capturing a larger market share and generating higher revenues for the patent holder.
Research and Development
- This patent can also drive further research and development in the field of drug delivery systems, encouraging innovation and the creation of new formulations with improved pharmacokinetics.
Legal and Regulatory Considerations
The legal and regulatory environment surrounding this patent is crucial:
Patent Validity
- The validity of the patent depends on its novelty, non-obviousness, and utility. The claims must be carefully drafted to ensure they meet these criteria and are enforceable[1].
Office Actions
- During the patent prosecution process, office actions from the USPTO or other international patent offices may require amendments to the claims or additional evidence to support the patentability of the invention. Tools like the Global Dossier and Common Citation Document can help in navigating these interactions[1].
Conclusion
United States Patent 11,052,061 represents a significant advancement in the field of pharmaceuticals, particularly in the formulation of gamma-hydroxybutyrate. The combination of immediate and modified release components addresses critical issues related to drug delivery, patient compliance, and pharmacokinetics.
Key Takeaways
- Novel Formulation: The patent describes a novel formulation of GHB with both immediate and modified release portions.
- Improved Pharmacokinetics: The formulation is designed to release GHB in a way that improves its pharmacokinetic profile.
- Market Impact: The patent has the potential to improve patient compliance and differentiate the product in the market.
- Legal Considerations: The patent's validity and enforceability depend on careful claim drafting and compliance with regulatory requirements.
FAQs
Q1: What is the primary innovation of United States Patent 11,052,061?
The primary innovation is the development of a modified release formulation of gamma-hydroxybutyrate that combines immediate and delayed release components to improve pharmacokinetics.
Q2: How does the modified release portion of the formulation work?
The modified release portion releases less than 20% of its GHB content within one hour and greater than 80% at three hours under specified test conditions, ensuring a sustained release of the drug.
Q3: What are the potential benefits of this formulation for patients?
The formulation can lead to better patient compliance due to reduced side effects and more stable drug concentrations over time, resulting in improved treatment outcomes.
Q4: How can one search for related patents in this field?
One can use resources like the USPTO's Patent Public Search tool, Global Dossier, or the Common Citation Document (CCD) application to search for related patents and assess the global patent landscape.
Q5: What are the key legal considerations for this patent?
The key legal considerations include ensuring the patent meets criteria for novelty, non-obviousness, and utility, and navigating office actions during the patent prosecution process.
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 - US11052061B2: https://patents.google.com/patent/US11052061B2/en
- PubChem - Modified release gamma-hydroxybutyrate formulations: https://pubchem.ncbi.nlm.nih.gov/patent/US-2019269641-A1
