United States Patent 8,138,229: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 8,138,229, titled "Compositions and methods of delivery of pharmacological agents," is a significant patent in the pharmaceutical field. This patent, issued to Abraxis Bioscience, LLC, pertains to innovative compositions and methods for delivering pharmacological agents, particularly focusing on the use of albumin as a drug carrier.
Background and Context
The patent was granted on March 20, 2012, and has since been a subject of interest in both the pharmaceutical industry and intellectual property law. The invention described in this patent involves the formulation of pharmaceutical compositions that utilize human serum albumin (HSA) or other albumins as carriers for various pharmacological agents, such as paclitaxel, which is commonly used in cancer treatment[1].
Scope of the Patent
Pharmaceutical Compositions
The patent covers a broad range of pharmaceutical compositions that include a pharmacological agent and a pharmaceutically acceptable carrier, with a particular emphasis on albumin-based formulations. These compositions can be in various forms, including solutions, emulsions, and dispersions. The use of albumin as a carrier enhances the solubility and stability of the pharmacological agents, making them more effective and safer for administration[1].
Methods of Delivery
The patent also describes various methods for delivering these pharmaceutical compositions. These methods include injection, which can be intravenous, intramuscular, or subcutaneous. The invention highlights the importance of the formulation in ensuring the controlled release and targeted delivery of the pharmacological agents, thereby improving therapeutic efficacy and reducing side effects[1].
Claims of the Patent
Independent Claims
The patent includes multiple independent claims that define the scope of the invention. These claims are crucial as they delineate what is considered novel and non-obvious about the invention. For instance, Claim 1 describes a pharmaceutical composition comprising a pharmacological agent, such as paclitaxel, and human serum albumin as a carrier. Other independent claims cover different aspects of the composition and the methods of preparation and administration[1].
Dependent Claims
Dependent claims further specify the details of the independent claims, providing additional limitations and features of the invention. These claims help in narrowing down the scope and ensuring that the patent covers specific embodiments of the invention. For example, dependent claims might specify the concentration of the pharmacological agent, the type of albumin used, or the method of preparing the composition[1].
Patent Landscape and Litigation
Patent Validity and Enforcement
The patent has been subject to various legal challenges and reviews. For instance, the Patent Trial and Appeal Board (PTAB) has reviewed the patent in inter partes review (IPR) proceedings. Despite these challenges, the patent has been upheld, indicating its robustness and the novelty of the invention[2].
Industry Impact
The patent has significant implications for the pharmaceutical industry, particularly in the development of albumin-based drug delivery systems. Companies like Celgene Corporation, which acquired Abraxis Bioscience, have leveraged this technology to develop and market products such as Abraxane, which is an albumin-bound paclitaxel formulation used in the treatment of various cancers[4].
Metrics for Patent Scope
Independent Claim Length and Count
Studies on patent scope, such as those by the Hoover Institution, suggest that metrics like independent claim length (ICL) and independent claim count (ICC) can be used to measure the breadth and clarity of patent claims. For U.S. Patent 8,138,229, these metrics would indicate a moderate to high level of specificity, given the detailed descriptions of the compositions and methods[3].
Challenges and Critiques
Patent Quality and Clarity
There have been broader debates about patent quality and the clarity of claims, especially in the context of pharmaceutical and biotechnology patents. Critics argue that overly broad or unclear claims can hinder innovation by increasing licensing and litigation costs. However, the specific claims in U.S. Patent 8,138,229 are detailed and well-defined, mitigating some of these concerns[3].
Examples and Applications
Abraxane
One of the most notable applications of this patent is Abraxane, an albumin-bound paclitaxel formulation. Abraxane has been approved for the treatment of breast, lung, and pancreatic cancers. The use of albumin as a carrier has improved the solubility of paclitaxel, reducing the need for toxic solvents and enhancing patient safety[1].
Statistics and Market Impact
Market Dominance
The albumin-based drug delivery system patented in U.S. Patent 8,138,229 has contributed significantly to the market success of Abraxane. As of recent years, Abraxane has generated substantial revenue, underscoring the commercial viability and therapeutic impact of the invention.
Clinical Outcomes
Clinical trials and real-world data have shown improved outcomes for patients treated with Abraxane compared to traditional paclitaxel formulations. This includes better response rates and reduced side effects, highlighting the clinical significance of the patented technology[1].
Key Takeaways
- Innovative Formulations: The patent introduces novel pharmaceutical compositions using albumin as a carrier for pharmacological agents.
- Methods of Delivery: It describes various methods for administering these compositions, enhancing therapeutic efficacy.
- Litigation and Validity: The patent has been upheld in legal challenges, affirming its validity and novelty.
- Industry Impact: The technology has been pivotal in the development of successful products like Abraxane.
- Metrics for Scope: The patent's claims are specific and well-defined, indicating a moderate to high level of clarity.
FAQs
What is the primary focus of U.S. Patent 8,138,229?
The primary focus of U.S. Patent 8,138,229 is on pharmaceutical compositions and methods of delivery using albumin as a carrier for pharmacological agents.
What is the significance of using albumin in these compositions?
Using albumin enhances the solubility and stability of the pharmacological agents, making them more effective and safer for administration.
What are some examples of pharmacological agents covered by this patent?
The patent specifically mentions paclitaxel, a common agent used in cancer treatment.
How has this patent impacted the pharmaceutical industry?
The patent has led to the development of successful products like Abraxane, which has improved treatment outcomes for various cancers.
What legal challenges has this patent faced?
The patent has been subject to inter partes review (IPR) proceedings but has been upheld, affirming its validity and novelty.
Sources
- US8138229B2 - Compositions and methods of delivery of pharmacological agents - Google Patents
- UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD - Exparte
- Patent Claims and Patent Scope - Hoover Institution
- Recent Intellectual Property Representations - Quinn Emanuel Urquhart & Sullivan, LLP
