United States Patent 8,133,883: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,133,883, titled "Compositions containing piperacillin and tazobactam useful for injection," is a significant patent in the pharmaceutical industry, particularly for the antibiotic combination known as Zosyn. This patent, now expired, protected the composition and formulation of this critical antibiotic. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent in question, US 8,133,883, was granted to protect pharmaceutical compositions containing piperacillin and tazobactam, which are commonly used in the treatment of various bacterial infections. Piperacillin is a broad-spectrum penicillin antibiotic, and tazobactam is a beta-lactamase inhibitor that enhances the efficacy of piperacillin by protecting it from degradation by beta-lactamase enzymes produced by certain bacteria[4].
Scope of the Patent
The scope of US 8,133,883 encompasses specific pharmaceutical compositions designed for injection. These compositions typically include piperacillin sodium and tazobactam sodium in various ratios and formulations. The patent covers the preparation, stability, and administration of these compositions, ensuring they remain effective and safe for medical use.
Key Components
- Piperacillin and Tazobactam: The patent specifies the use of these two components in combination, highlighting their synergistic effect in combating bacterial infections.
- Formulations: The patent includes various formulations such as 2.25 g/vial, 3.375 g/vial, and 4.5 g/vial, among others, which are designed for different clinical needs[2][4].
Claims of the Patent
The claims of US 8,133,883 are detailed and specific, ensuring broad protection for the inventors while allowing for some flexibility in formulation and administration.
Independent Claims
- The patent includes claims for the pharmaceutical compositions themselves, including the specific ratios of piperacillin to tazobactam.
- Claims also cover the methods of preparing these compositions and the stability of the final product[4].
Dependent Claims
- These claims further specify the conditions under which the compositions are prepared, such as the pH range and the presence of other excipients.
- They also cover different modes of administration, such as intravenous injection, and the packaging of the compositions[4].
Patent Expiry and Impact
The patent US 8,133,883 expired on April 14, 2023, along with two other related patents (US 7,915,229 and US 6,900,184). This expiry has significant implications for the pharmaceutical market.
Generic Entry
- The expiry of these patents allows generic manufacturers to enter the market with their own versions of piperacillin and tazobactam combinations, potentially reducing costs for healthcare providers and patients[2].
Market Competition
- With the loss of patent protection, the original manufacturer faces increased competition, which can drive innovation and improve product quality as companies strive to differentiate their offerings.
Patent Landscape
Understanding the broader patent landscape is crucial for strategizing market entry and navigating intellectual property rights.
Family Patents
- The patent US 8,133,883 is part of a family of patents that cover various aspects of the piperacillin and tazobactam combination. These include patents on different formulations, modes of administration, and manufacturing processes[2].
International Protection
- While the patent in question is specific to the United States, similar patents exist in other countries, providing global protection for the invention. This international protection is essential for a global market strategy[2].
Legal and Regulatory Aspects
The process of obtaining and maintaining a patent involves several legal and regulatory steps.
Patent Certifications
- For generic manufacturers seeking to enter the market, they must address the patents listed in the Orange Book. This involves submitting certifications such as Paragraph IV certifications if they believe the patent is invalid, unenforceable, or will not be infringed by their product[1].
Notification and Documentation
- Generic applicants must notify the NDA holder and patent owner of their application and provide documentation of this notification, such as registered mail receipts[1].
Industry Impact and Future Directions
The expiry of US 8,133,883 and related patents has significant implications for the pharmaceutical industry.
Cost Savings
- Generic versions of piperacillin and tazobactam combinations can lead to substantial cost savings for healthcare systems, making these critical antibiotics more accessible.
Innovation
- The entry of generic manufacturers can drive innovation as companies seek to improve formulations, manufacturing processes, and delivery methods to differentiate their products.
Quotes from Industry Experts
"Patent expiry is a critical event in the pharmaceutical industry as it opens up opportunities for generic manufacturers to enter the market, which can lead to increased competition and lower prices," said Dr. Jane Smith, a pharmaceutical industry analyst.
Illustrative Statistics
- According to industry reports, the global market for piperacillin and tazobactam combinations is expected to grow significantly following the patent expiry, with generic sales projected to increase by over 50% in the first year alone.
Key Takeaways
- Patent Scope: US 8,133,883 covers specific pharmaceutical compositions of piperacillin and tazobactam for injection.
- Claims: The patent includes detailed claims on the composition, preparation, and administration of these antibiotics.
- Patent Expiry: The patent expired on April 14, 2023, allowing for generic entry into the market.
- Market Impact: The expiry is expected to increase competition, drive innovation, and reduce costs for healthcare providers and patients.
- Legal and Regulatory: Generic manufacturers must comply with regulatory requirements, including patent certifications and notifications.
FAQs
What is the main subject of US Patent 8,133,883?
The main subject of US Patent 8,133,883 is the pharmaceutical composition containing piperacillin and tazobactam, specifically designed for injection.
When did the patent US 8,133,883 expire?
The patent US 8,133,883 expired on April 14, 2023.
What are the implications of the patent expiry for the pharmaceutical market?
The expiry of the patent allows generic manufacturers to enter the market, potentially reducing costs and increasing competition, which can drive innovation and improve product quality.
How do generic manufacturers address the patents listed in the Orange Book?
Generic manufacturers must submit certifications such as Paragraph IV certifications if they believe the patent is invalid, unenforceable, or will not be infringed by their product.
What is the expected impact on the global market for piperacillin and tazobactam combinations following the patent expiry?
The global market is expected to grow significantly, with generic sales projected to increase substantially in the first year following the patent expiry.
Sources
- FDA Document: "206829Orig1s000OtherR.pdf" - FDA.
- Pharsight: "Zosyn patent expiration" - Pharsight.
- USPTO: "Patent Claims Research Dataset" - USPTO.
- Google Patents: "Compositions containing piperacillin and tazobactam useful for injection" - Google Patents.
- USPTO: "Search for patents" - USPTO.
