Understanding the Scope and Claims of United States Patent 7,612,087
Introduction
United States Patent 7,612,087, issued on November 3, 2009, is a significant patent in the pharmaceutical industry, particularly in the realm of antibacterial agents. Here, we will delve into the details of this patent, including its scope, claims, and the broader patent landscape it operates within.
Background of the Invention
The patent in question pertains to novel heterocyclic compounds and their salts, along with processes for preparing these compounds and methods for using them as antibacterial agents. This is part of a larger body of research aimed at developing effective treatments for bacterial infections, which remain a critical health concern globally[1].
Scope of the Patent
The scope of U.S. Patent 7,612,087 encompasses several key areas:
Compounds and Salts
The patent describes novel heterocyclic compounds, including the sodium salt of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3.2.1]octane-2-carboxamide. These compounds are designed to exhibit potent antibacterial activity, making them valuable in the treatment of various bacterial infections[1].
Preparation Processes
The patent details improved methods for preparing these heterocyclic compounds and their salts. These processes are crucial for ensuring the efficient and cost-effective production of these antibacterial agents[1].
Methods of Use
The patent also covers methods for using these compounds as antibacterial agents. This includes their application in treating bacterial infections, which is a critical aspect of their commercial and therapeutic value[1].
Claims of the Patent
The claims of U.S. Patent 7,612,087 are structured to capture the essence of the invention while providing a clear boundary of what is protected under the patent.
Independent Claims
The independent claims typically define the broadest scope of the invention. For this patent, these claims would include the specific chemical structures of the heterocyclic compounds, their salts, and the processes for their preparation[1].
Dependent Claims
Dependent claims further narrow down the scope by specifying particular aspects of the invention, such as specific salts, crystalline forms, or detailed steps in the preparation processes. These claims provide additional protection by covering various embodiments of the invention[1].
Patent Landscape
The patent landscape surrounding U.S. Patent 7,612,087 is complex and dynamic, influenced by several factors:
Related Patents
Other patents, such as U.S. Patents 8,471,025, 8,835,455, 8,969,566, 9,284,314, and 9,695,122, also cover related compounds and processes. These patents, often held by the same assignee (e.g., Allergan), form a protective umbrella around the active ingredient of drugs like Avycaz (ceftazidime and avibactam)[4][5].
Generic Challenges
The expiration dates of these patents are crucial, as they determine when generic versions of the drugs can be introduced to the market. For example, patents related to Avycaz are set to expire in the early 2030s, which could open the door for generic competition[4][5].
Litigation and Enforcement
Patent litigation, such as the case involving Fresenius's proposed generic Avycaz product, highlights the ongoing battles to protect and enforce these patents. These legal actions are essential for maintaining the exclusivity rights of the patent holders[5].
Impact on the Pharmaceutical Industry
The scope and claims of U.S. Patent 7,612,087 have significant implications for the pharmaceutical industry:
Innovation and Investment
The robust patent protection provided by this and related patents is crucial for encouraging innovation and investment in the development of new drugs. The pharmaceutical industry invests billions of dollars in research and development, and strong patent protection is essential for recouping these investments[3].
Generic Competition
The expiration of these patents and the subsequent entry of generic competitors can significantly impact the market dynamics. Generic drugs can reduce costs for consumers but also challenge the revenue streams of the original patent holders[4].
Regulatory Environment
The regulatory environment, including the application of patent disclosure laws such as 35 U.S.C. § 112(a), plays a critical role in defining the scope of patent protection. Recent jurisprudence has made it more challenging to obtain and maintain broad patent claims, particularly in the pharmaceutical and biotechnology industries[3].
Key Takeaways
- Novel Compounds: U.S. Patent 7,612,087 covers novel heterocyclic compounds and their salts with antibacterial properties.
- Preparation Processes: The patent includes detailed methods for preparing these compounds.
- Methods of Use: It outlines the use of these compounds as antibacterial agents.
- Patent Landscape: The patent is part of a broader landscape that includes related patents and ongoing litigation.
- Industry Impact: Strong patent protection is crucial for innovation and investment in the pharmaceutical industry.
FAQs
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What is the main subject of U.S. Patent 7,612,087?
- The main subject is novel heterocyclic compounds and their salts, along with processes for their preparation and use as antibacterial agents.
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Who are the typical assignees of patents related to Avycaz?
- The assignees are often pharmaceutical companies like Allergan.
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When are the patents related to Avycaz set to expire?
- The patents are set to expire in the early 2030s.
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Why is strong patent protection important in the pharmaceutical industry?
- Strong patent protection is essential for encouraging innovation and investment by allowing companies to recoup their research and development costs.
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How does the regulatory environment affect patent claims in the pharmaceutical industry?
- Recent jurisprudence has made it more challenging to obtain and maintain broad patent claims due to stricter application of patent disclosure laws like 35 U.S.C. § 112(a).
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 7,612,087 B2.
- Insight.RPXcorp.com, "Case 3:24-cv-06759-ZNQ Document 1 Filed 06/06/24 Page 1 of 56."
- DigitalCommons@NYLS, "Eviscerating Patent Scope."
- Pharsight.Greyb.com, "Avycaz patent expiration."
- Insight.RPXcorp.com, "in the united states district court."
