Detailed Analysis of the Scope and Claims of United States Patent 10,125,149
Introduction to Patent 10,125,149
United States Patent 10,125,149, titled "Synthesis of cephalosporin compounds," is a crucial patent in the pharmaceutical industry, particularly for the antibiotic Zerbaxa, which is a combination of ceftolozane and tazobactam. This patent is held by Merck Sharp & Dohme Corp. and plays a significant role in the production and protection of this antibiotic.
Patent Overview
Issuance and Expiration
- The patent was issued on November 13, 2018, and is set to expire on August 9, 2035[2][4].
Inventors and Assignees
- The inventors listed include David Waller, Gregory Gazda, Zachary Minden, Lisa Barton, and Clifton Leigh, among others. The patent is assigned to Merck Sharp & Dohme Corp.[2][4].
Scope of the Patent
Subject Matter
The patent focuses on methods for the synthesis of cephalosporin antibiotic compounds. Specifically, it describes a palladium-catalyzed coupling reaction used in the synthesis process. This method is critical for producing ceftolozane, a key component of Zerbaxa[4].
Claims
The patent includes several claims that protect various aspects of the synthesis process:
- Method Claims: These claims outline the specific steps and conditions for the palladium-catalyzed coupling reaction.
- Composition Claims: These claims cover the resulting cephalosporin compounds produced through the described synthesis method.
- Process Claims: These claims detail the preparation and use of the solid forms of ceftolozane and tazobactam[4].
Patent Claims Analysis
Independent Claim Length and Count
Research on patent scope suggests that the length and count of independent claims can be indicative of the patent's breadth and complexity. For Patent 10,125,149, the claims are detailed and specific, indicating a focused scope on the synthesis method rather than overly broad claims[3].
Claim Language
The claim language is precise, detailing the chemical reactions and conditions necessary for the synthesis. This precision helps in narrowing down the scope, making it clearer what is protected and what is not[4].
Patent Landscape
Related Patents
Zerbaxa is protected by a suite of patents, each covering different aspects of the drug:
- Solid Forms of Ceftolozane: Patents like US8906898 protect the solid forms of ceftolozane, which are crucial for the drug's formulation[1].
- Tazobactam Arginine Compositions: Patents such as US8476425 and US8685957 cover compositions involving tazobactam, another component of Zerbaxa[1].
- Ceftolozane-Tazobactam Compositions: Patents like US9320740 and US9872353 protect the pharmaceutical compositions of ceftolozane and tazobactam together[2].
Exclusivities and Market Protection
In addition to patent protection, Zerbaxa benefits from exclusivities granted by the FDA. These exclusivities prevent the marketing of generic or bioequivalent versions of Zerbaxa, even if the patents have expired or are set to expire soon. This adds an extra layer of protection, delaying the entry of generics into the market[1].
Impact on Generic Launch
Patent Expiration Dates
The expiration dates of these patents are critical for determining when generic versions of Zerbaxa can be launched. For Patent 10,125,149, the expiration date is August 9, 2035. However, other related patents expire at different times, such as May 15, 2028, and September 7, 2032[1][2].
Legal Activities and Patent Life
The life of a patent can be affected by various legal activities, including the abandonment of a patent, term extensions, or amendments to its claims. Tracking these activities is essential for understanding the potential generic launch timeline[1].
Global Patent Protection
International Patents
Zerbaxa is protected by patents in multiple countries, not just the United States. Understanding the global patent landscape is crucial for identifying markets with weaker patent protection, which could be ideal entry points for generic drugs[1].
Conclusion
United States Patent 10,125,149 is a vital component of the intellectual property portfolio for Zerbaxa, protecting the synthesis method of ceftolozane. The patent's scope is focused on the palladium-catalyzed coupling reaction, and its claims are detailed and specific. The patent landscape for Zerbaxa includes multiple patents and exclusivities that collectively protect the drug from generic competition until the mid-2030s.
Key Takeaways
- Patent Scope: The patent protects the synthesis method of ceftolozane using a palladium-catalyzed coupling reaction.
- Expiration Date: The patent expires on August 9, 2035.
- Related Patents: Zerbaxa is protected by multiple patents covering different aspects of the drug.
- Exclusivities: FDA-granted exclusivities delay the generic launch of Zerbaxa.
- Global Protection: Zerbaxa is protected by patents in multiple countries.
FAQs
What is the main subject matter of Patent 10,125,149?
The main subject matter is the synthesis of cephalosporin antibiotic compounds, specifically using a palladium-catalyzed coupling reaction.
Who is the assignee of Patent 10,125,149?
The assignee is Merck Sharp & Dohme Corp.
When does Patent 10,125,149 expire?
The patent expires on August 9, 2035.
What other protections does Zerbaxa have besides patents?
Zerbaxa benefits from FDA-granted exclusivities that prevent the marketing of generic or bioequivalent versions.
How does the global patent landscape affect the launch of generic Zerbaxa?
The global patent landscape can identify markets with weaker patent protection, which could be ideal entry points for generic drugs.
Cited Sources
- Pharsight: Zerbaxa patent expiration.
- Drugs.com: Generic Zerbaxa Availability.
- Hoover Institution: Patent Claims and Patent Scope.
- Google Patents: Synthesis of cephalosporin compounds.
- Google Patents: Solid forms of ceftolozane and processes for preparing.
