United States Patent 9,320,740 B2: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,320,740 B2, titled "Ceftolozane-tazobactam pharmaceutical compositions," is a significant patent in the pharmaceutical industry, particularly in the field of antibiotics. This patent, assigned to Merck Sharp & Dohme Corp., protects the composition and use of ceftolozane and tazobactam, a combination antibiotic used to treat various bacterial infections.
Background and Inventors
The patent was granted on April 26, 2016, to a team of inventors including Joseph Terracciano, Nicole Miller Damour, Chun Jiang, Giovanni Fogliato, Giuseppe Alessandro Donadelli, and Dario Resemini. These inventors, affiliated with Cubist Pharmaceuticals, Inc. and later with Merck Sharp & Dohme Corp., developed novel pharmaceutical compositions of ceftolozane and tazobactam[1].
Patent Scope and Claims
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims are crucial as they delineate what is protected under the patent. Key claims include:
- The pharmaceutical composition comprising ceftolozane and tazobactam.
- Specific formulations and methods of preparation.
- The use of these compositions for treating bacterial infections, including those caused by drug-resistant bacteria like Pseudomonas aeruginosa[1].
Dependent Claims
Dependent claims further specify the details of the independent claims, such as the ratio of ceftolozane to tazobactam, the form of the composition (e.g., lyophilized), and the method of administration. These claims provide a narrower scope but are still protected under the broader independent claims[1].
Claim Language and Patent Scope
The claim language in this patent is detailed and specific, which is important for maintaining clarity and avoiding overly broad claims. Research has shown that narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].
Independent Claim Length and Count
Studies on patent scope metrics suggest that the length and count of independent claims can be indicative of patent scope. In this case, the patent has multiple independent claims, each with a moderate length, indicating a well-defined and specific scope[3].
Patent Landscape and Related Patents
Family of Patents
The patent 9,320,740 B2 is part of a larger family of patents related to ceftolozane and tazobactam. Other patents in this family include US8906898, US8685957, and US8476425, which cover various aspects such as solid forms of ceftolozane, tazobactam arginine compositions, and pharmaceutical compositions[4][5].
Global Dossier and IP5 Offices
Using the Global Dossier service provided by the USPTO, one can access the file histories of related applications from participating IP Offices. This tool helps in understanding the global patent family and the status of related applications across different jurisdictions[2].
Examination Process and Patent Quality
The examination process for this patent, like others, involves a thorough review to ensure the claims are clear, specific, and not overly broad. The USPTO's process tends to narrow the scope of patent claims during examination, which was likely the case here given the detailed and specific nature of the claims[3].
Commercial and Clinical Impact
Zerbaxa (Ceftolozane-Tazobactam)
The pharmaceutical compositions protected by this patent are marketed under the brand name Zerbaxa. Zerbaxa is used to treat complicated urinary tract infections and complicated intra-abdominal infections, among other conditions. The patent protection ensures that only the patent owner can produce and market these specific compositions until the patent expires[4][5].
Patent Expiration Dates
The patents related to Zerbaxa, including US9320740 B2, have expiration dates ranging from 2032 to 2034. This period of exclusivity allows the patent holder to recoup investment in research and development before generic versions can enter the market[4][5].
Industry and Market Implications
The protection offered by this patent is critical for the pharmaceutical industry, as it allows companies to invest in research and development with the assurance of exclusive rights to their inventions. The expiration of these patents will open the market to generic competitors, potentially reducing costs and increasing accessibility of these life-saving antibiotics.
Conclusion
The United States Patent 9,320,740 B2 is a significant patent that protects the composition and use of ceftolozane and tazobactam, a crucial antibiotic combination. The patent's scope and claims are well-defined, ensuring clarity and specificity. The patent landscape, including related patents and global dossier, highlights the comprehensive protection afforded to these pharmaceutical compositions.
Key Takeaways
- Specific Claims: The patent includes detailed and specific claims that define the scope of the invention.
- Examination Process: The USPTO's examination process ensured that the claims were narrowed to maintain clarity and specificity.
- Commercial Impact: The patent protects the exclusive rights to Zerbaxa, a critical antibiotic combination.
- Patent Expiration: The patents related to Zerbaxa will expire between 2032 and 2034, opening the market to generic competitors.
- Industry Implications: The patent protection is essential for pharmaceutical companies to invest in research and development.
Frequently Asked Questions (FAQs)
1. What is the main subject of the United States Patent 9,320,740 B2?
The main subject of this patent is the pharmaceutical composition of ceftolozane and tazobactam, an antibiotic combination used to treat various bacterial infections.
2. Who are the inventors of this patent?
The inventors include Joseph Terracciano, Nicole Miller Damour, Chun Jiang, Giovanni Fogliato, Giuseppe Alessandro Donadelli, and Dario Resemini.
3. What is the significance of the claim language in this patent?
The claim language is detailed and specific, which is important for maintaining clarity and avoiding overly broad claims, thereby ensuring a well-defined scope of the invention.
4. When do the patents related to Zerbaxa expire?
The patents related to Zerbaxa expire between 2032 and 2034.
5. What is the commercial name of the antibiotic protected by this patent?
The commercial name of the antibiotic is Zerbaxa.
Cited Sources:
- United States Patent and Trademark Office, US9320740 B2, April 26, 2016.
- United States Patent and Trademark Office, Search for patents, October 18, 2018.
- Hoover Institution, Patent Claims and Patent Scope, August 18, 2024.
- Pharsight, Zerbaxa patent expiration, November 6, 2024.
- Drugs.com, Generic Zerbaxa Availability, November 6, 2024.
