United States Patent 9,284,314: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,284,314, titled "Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof," is a significant patent in the pharmaceutical industry. This patent, assigned to Allergan, pertains to the synthesis and preparation of specific heterocyclic compounds, which are crucial in the development of certain antibiotics.
Background
The patent was issued on March 15, 2016, and is part of a series of patents related to the compound trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide, which is a key component in the antibiotic AVYCAZ® (ceftazidime and avibactam)[5].
Scope of the Patent
Overview of the Invention
The patent describes novel processes for preparing heterocyclic compounds, specifically focusing on the synthesis of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and its salts. These compounds are essential for the production of AVYCAZ®, a combination antibiotic used to treat various bacterial infections.
Claim Structure
The patent includes multiple claims that define the scope of the invention. Here are some key aspects:
-
Independent Claims: The patent contains several independent claims that outline the different processes for preparing the heterocyclic compounds. These claims specify the reactants, conditions, and steps involved in the synthesis[4].
-
Dependent Claims: Dependent claims further detail specific aspects of the independent claims, such as variations in reaction conditions, reagents, and purification methods.
-
Use Codes: The patent also includes use codes that specify the approved methods of use for the patented compounds, which are listed in the FDA's Orange Book. This is crucial for generic drug sponsors to understand when and how they can seek FDA approval for generic versions of the drug[1].
Claims Analysis
Claim 1: General Process
Claim 1 describes the general process for preparing the heterocyclic compound, including the reaction of specific starting materials under defined conditions. This claim sets the foundation for the subsequent dependent claims.
Claim 2-5: Specific Processes
Claims 2-5 detail variations of the general process, including different reaction conditions, catalysts, and purification steps. These claims provide a comprehensive coverage of the synthesis methods to ensure broad protection.
Claim 6-10: Salts and Derivatives
Claims 6-10 focus on the preparation of salts and derivatives of the heterocyclic compound. These claims are important as they cover various forms of the compound that may be used in pharmaceutical formulations.
Patent Landscape
Related Patents
The patent 9,284,314 is part of a family of patents related to AVYCAZ®, including U.S. Patent Nos. 8,471,025, 8,835,455, 8,969,566, and 9,695,122. These patents collectively cover different aspects of the compound, such as crystalline forms, processes for preparation, and specific methods of use[5].
Litigation and Enforcement
The patents related to AVYCAZ® have been involved in litigation to protect against generic competition. For instance, Allergan has filed lawsuits against generic drug manufacturers to prevent the early entry of generic versions of AVYCAZ® into the market, citing infringement of the patents listed in the Orange Book[5].
Expiration Dates
The patent 9,284,314 is set to expire on June 15, 2032. This expiration date is critical for generic drug sponsors, as it marks the time when they can potentially seek FDA approval for their generic versions without infringing on the existing patent[5].
Impact on Generic Competition
FDA Approval Process
The listing of these patents in the FDA's Orange Book is a significant barrier for generic drug sponsors. Generic sponsors must file an Abbreviated New Drug Application (ANDA) and certify that the listed patents are invalid or will not be infringed by their product. This process can delay the entry of generic drugs into the market, allowing the brand name drug to maintain market exclusivity for a longer period[1].
Evergreening Strategies
Brand name drug companies often use strategies known as "evergreening" to extend patent protections and delay generic competition. This involves filing additional patents on minor variations or new uses of the existing drug, which can further complicate the generic approval process[1].
Conclusion
United States Patent 9,284,314 is a critical component in the patent landscape surrounding AVYCAZ®, a significant antibiotic in the pharmaceutical market. The patent's claims and scope provide broad protection for the synthesis and preparation of key heterocyclic compounds. Understanding this patent is essential for both brand name and generic drug sponsors navigating the complex regulatory and legal environment of pharmaceuticals.
Key Takeaways
- Patent Scope: The patent covers specific processes for preparing heterocyclic compounds essential for AVYCAZ®.
- Claims Structure: Includes independent and dependent claims detailing various synthesis methods and forms of the compound.
- Patent Landscape: Part of a family of patents protecting AVYCAZ®, with related patents covering crystalline forms, processes, and methods of use.
- Litigation: Involved in litigation to protect against generic competition.
- Expiration Date: Set to expire on June 15, 2032.
- Impact on Generic Competition: Listing in the Orange Book delays generic entry, and evergreening strategies can further extend market exclusivity.
FAQs
What is the main subject of United States Patent 9,284,314?
The main subject is the processes for preparing heterocyclic compounds, specifically trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and its salts.
Who is the assignee of this patent?
The assignee of this patent is Allergan.
What is the significance of this patent in the pharmaceutical industry?
This patent is significant because it protects the synthesis and preparation of a key component in the antibiotic AVYCAZ®, delaying generic competition.
When is the patent set to expire?
The patent is set to expire on June 15, 2032.
How does this patent affect generic drug sponsors?
Generic drug sponsors must navigate the patent landscape by filing ANDAs and certifying that the listed patents are invalid or will not be infringed, which can delay their entry into the market.
Sources
- GAO Report: Stakeholder Views on Improving FDA’s Information on Patents, March 2023.
- Litigation Document: Case 3:24-cv-06759-ZNQ Document 1 Filed 06/06/24.
- Hoover Institution Paper: Patent Claims and Patent Scope.
- US Patent Document: United States Patent 9,284,314.
- Litigation Document: Case 1:24-cv-04914 Document #: 1 Filed: 06/13/24.
