United States Patent 10,213,400: A Comprehensive Analysis
Introduction
The United States Patent 10,213,400, assigned to Jazz Pharmaceuticals, is a significant patent in the pharmaceutical industry, particularly in the treatment of narcolepsy and related disorders. This patent is part of a broader portfolio of patents protecting the company's intellectual property related to gamma-hydroxybutyrate (GHB) compositions and their administration methods.
Background
Gamma-hydroxybutyrate, marketed under the brand name Xyrem, is a central nervous system depressant used to treat cataplexy and excessive daytime sleepiness associated with narcolepsy[4].
Patent Overview
Title and Assignee
The patent titled "Gamma-hydroxybutyrate compositions and their use for the treatment of disorders" is assigned to Jazz Pharmaceuticals Ireland Limited.
Filing and Grant History
The patent was granted on February 26, 2019, as part of a continuation of earlier applications, including application No. 15/869,792 filed on January 12, 2018, and application No. 15/343,806 filed on November 4, 2016[1].
Claims and Scope
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover specific compositions of gamma-hydroxybutyrate, methods of administration, and the use of these compositions for treating various disorders.
Dependent Claims
Dependent claims further specify and narrow down the scope of the independent claims, often detailing specific concentrations, administration routes, and patient populations.
Key Claims Analysis
Composition Claims
- The patent claims cover specific formulations of gamma-hydroxybutyrate, including the concentration and pH of the solution, which are critical for its stability and efficacy[5].
Method of Administration Claims
- Claims also cover the method of administering gamma-hydroxybutyrate, including the use of monocarboxylate transporters to enhance absorption[5].
Use Claims
- The patent includes claims for the use of gamma-hydroxybutyrate compositions in treating narcolepsy, cataplexy, and other related sleep disorders[4].
Patent Landscape
Related Patents
The patent 10,213,400 is part of a larger family of patents related to gamma-hydroxybutyrate. Other relevant patents include:
- U.S. Patent Nos. 8,772,306, 9,050,302, 9,486,426, and 10,864,181, which cover various aspects of GHB compositions and their administration[5].
Patent Expiration Dates
- The patent 10,213,400 is estimated to expire in 2033, along with several other related patents, providing a significant period of exclusivity for Jazz Pharmaceuticals[4].
Litigation and Disputes
Infringement Actions
Jazz Pharmaceuticals has been involved in several patent infringement lawsuits to protect its intellectual property. For example, the company has sued Lupin Ltd. and its subsidiaries for submitting an Abbreviated New Drug Application (ANDA) for a generic version of Xywav, alleging infringement of several patents, including the '400 patent[5].
PTAB Decisions
The Patent Trial and Appeal Board (PTAB) has denied institution for inter partes review (IPR) of some of these patents, further solidifying Jazz Pharmaceuticals' patent position[1].
Claim Coverage and Gaps
Claim Coverage Matrix
Using a Claim Coverage Matrix, as described in patent analytics practices, it is possible to categorize and analyze the claims of this patent along with other related patents. This helps in identifying which claims are actively protecting the intellectual property and where gaps or opportunities exist[3].
Scope Concepts
The claims can be categorized by overarching scope concepts, which link similar claims across different patents. This approach helps in filtering, searching, and analyzing large numbers of patent claims efficiently[3].
Impact on Market and Competition
Market Exclusivity
The robust patent portfolio, including the '400 patent, provides Jazz Pharmaceuticals with significant market exclusivity for its GHB-based products. This exclusivity is crucial in maintaining a competitive edge and protecting revenue streams[4].
Generic Challenges
The litigation against generic manufacturers, such as Lupin Ltd., highlights the efforts to prevent generic competition and maintain the exclusivity period. These actions are essential for protecting the company's investment in research and development[5].
Future Directions and Opportunities
New Design Options
The use of claim charts and scope concepts can help identify future design opportunities and potential gaps in current claim coverage. This analytical approach enables the company to explore new avenues of development and strengthen its patent position[3].
International Protection
Ensuring that the patent is protected internationally is crucial for global market dominance. Jazz Pharmaceuticals would need to secure equivalent patents in other jurisdictions to maintain its competitive position worldwide.
Key Takeaways
- Robust Patent Protection: The '400 patent is part of a comprehensive patent portfolio that provides strong protection for Jazz Pharmaceuticals' GHB-based products.
- Litigation and Enforcement: Active litigation against generic manufacturers is essential for maintaining market exclusivity.
- Analytical Tools: Using patent analytics tools like Claim Coverage Matrix and scope concepts helps in managing and optimizing the patent portfolio.
- Future Opportunities: Identifying gaps and opportunities through detailed analysis can guide future research and development.
FAQs
What is the primary use of the gamma-hydroxybutyrate compositions covered by U.S. Patent 10,213,400?
The primary use is for treating narcolepsy, cataplexy, and excessive daytime sleepiness associated with narcolepsy.
How does the patent protect Jazz Pharmaceuticals' market position?
The patent provides market exclusivity by preventing generic competition and protecting the company's investment in research and development.
What is the significance of the Claim Coverage Matrix in patent analytics?
The Claim Coverage Matrix helps in categorizing and analyzing patent claims to identify which claims are actively protecting the intellectual property and where gaps or opportunities exist.
What are the key claims in U.S. Patent 10,213,400?
The key claims cover specific compositions of gamma-hydroxybutyrate, methods of administration, and the use of these compositions for treating various disorders.
When is the estimated expiration date for U.S. Patent 10,213,400?
The estimated expiration date for the patent is in 2033.
Cited Sources
- United States Patent and Trademark Office, "Guidance for Industry: Drug Interaction Studies Study Design, Data Analysis, and Implications for Dosing and Labeling," [PDF].
- FDA, "Patent Listing Disputes," [PDF].
- SLWIP, "Patent Analytics | Intellectual Property Law".
- DrugBank, "Sodium oxybate: Uses, Interactions, Mechanism of Action".
- RPX Corporation, "Case 2:21-cv-14271 Document 1 Filed 07/28/21 Page 1 of 32 PageID".
