United States Patent 8,969,566: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,969,566, 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 field of pharmaceutical chemistry. This patent, assigned to Forest Laboratories Holdings Ltd., pertains to novel compounds and improved methods for their preparation, particularly focusing on the antibacterial agent avibactam.
Background of the Invention
The patent builds upon earlier work disclosed in U.S. Pat. No. 7,112,592, which introduced novel heterocyclic compounds and their salts, along with processes for their preparation and use as antibacterial agents. One of the key compounds is the sodium salt of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide, known as avibactam[1][4].
Scope of the Patent
The scope of U.S. Patent 8,969,566 is broad and encompasses several key areas:
Compounds and Salts
The patent covers the preparation of compounds of Formula (I), specifically trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and its salts. These compounds are crucial in the development of antibacterial agents, particularly in combination with other antibiotics like ceftazidime, as seen in the drug AVYCAZ®[1][4].
Preparation Processes
The patent details improved methods for preparing these heterocyclic compounds. This includes various synthetic routes and conditions that enhance the yield and purity of the final product. These processes are vital for large-scale production and ensuring the consistency of the pharmaceutical product[1][4].
Applications
The compounds and their salts are primarily used as antibacterial agents. Avibactam, in particular, is a beta-lactamase inhibitor that, when combined with other antibiotics, enhances their efficacy against bacteria that produce beta-lactamase enzymes. This makes it a valuable component in treating various bacterial infections[1][5].
Claims of the Patent
The patent includes several claims that define the scope of protection:
Independent Claims
The independent claims focus on the specific compounds, their salts, and the processes for their preparation. For example, Claim 1 describes the compound trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and its salts, while subsequent claims detail various synthetic methods and intermediates involved in the preparation process[4].
Dependent Claims
Dependent claims further specify the conditions, reagents, and steps involved in the synthetic processes. These claims help to narrow down the scope and ensure that the patent covers all aspects of the invention, from the starting materials to the final product[4].
Patent Landscape
The patent landscape surrounding U.S. Patent 8,969,566 is complex and involves several related patents and ongoing legal actions.
Related Patents
This patent is part of a series of related patents, including U.S. Patent Nos. 8,471,025, 8,835,455, 9,284,314, and 9,695,122. These patents collectively cover various aspects of avibactam and its use in pharmaceuticals, including crystalline forms and additional preparation methods[2][5].
Litigation
There are ongoing legal actions related to the infringement of these patents. For instance, AbbVie has filed lawsuits against Fresenius for attempting to manufacture and sell a generic version of AVYCAZ® before the expiration of the patents-in-suit. These lawsuits highlight the importance of these patents in protecting the intellectual property rights of the original inventors and assignees[2][5].
Impact on Innovation and Patent Quality
The scope and claims of U.S. Patent 8,969,566 reflect broader debates on patent quality and scope. The patent's detailed claims and specific processes contribute to the clarity and validity of the patent, which is crucial for maintaining incentives for innovation. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process, indicating better patent quality[3].
Economic and Regulatory Implications
The economic implications of this patent are significant, given the importance of avibactam in the treatment of bacterial infections. The regulatory landscape, particularly the FDA's approval process and the listing of these patents in the Orange Book, further underscores their importance in the pharmaceutical industry[5].
Key Takeaways
- Compounds and Salts: The patent covers the preparation of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and its salts.
- Preparation Processes: Improved synthetic methods are detailed for large-scale production.
- Applications: The compounds are used as antibacterial agents, particularly in combination with other antibiotics.
- Claims: Independent and dependent claims define the scope of protection.
- Patent Landscape: Part of a series of related patents with ongoing litigation over infringement.
- Impact on Innovation: Contributes to clarity and validity, maintaining incentives for innovation.
FAQs
What is the main compound covered by U.S. Patent 8,969,566?
The main compound is trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide, known as avibactam.
What is the primary use of avibactam?
Avibactam is used as a beta-lactamase inhibitor in combination with other antibiotics to treat bacterial infections.
Which company is the assignee of U.S. Patent 8,969,566?
The assignee is Forest Laboratories Holdings Ltd.
What is the significance of the patent in the pharmaceutical industry?
The patent is crucial for the production and use of avibactam in drugs like AVYCAZ®, protecting the intellectual property rights and ensuring the efficacy of the treatment.
Are there any ongoing legal actions related to this patent?
Yes, there are ongoing lawsuits related to patent infringement, particularly against companies attempting to manufacture generic versions of AVYCAZ® before the patent expiration.
Cited Sources
- United States Patent and Trademark Office, "Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof," US Patent 9,284,314, March 15, 2016.
- Insight.RPXcorp, "Case 3:24-cv-06759-ZNQ Document 1 Filed 06/06/24," June 6, 2024.
- Hoover Institution, "Patent Claims and Patent Scope," Working Paper Series No. 16001, August 18, 2016.
- Google Patents, "Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof," US Patent 8,969,566, March 18, 2015.
- Insight.RPXcorp, "in the united states district court," Case 1:24-cv-04914, June 13, 2024.
