United States Patent 7,910,132: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 7,910,132, hereafter referred to as the '132 patent, is a significant intellectual property asset in the pharmaceutical industry. This patent is associated with the development and manufacture of specific pharmaceutical formulations, particularly those involving sublingual tablets. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention Overview
The '132 patent is part of a series of patents held by Orexo AB, a Swedish pharmaceutical company. This patent is closely related to other patents such as the '059 and '910 patents, which collectively cover various aspects of pharmaceutical formulations and their manufacturing processes[2].
Scope of the Patent
The '132 patent primarily deals with the formulation and production of sublingual tablets, specifically those containing fentanyl citrate. The scope includes:
- Active Ingredients: The patent covers the use of fentanyl citrate as the active ingredient, which is a potent opioid used for pain management.
- Formulation: The invention involves a specific method of formulating these tablets to ensure rapid dissolution and absorption through the sublingual route.
- Manufacturing Process: The patent details a method for producing these tablets, including the mixing of active and inactive ingredients, granulation, and compaction[2].
Claims of the Patent
The claims of the '132 patent are crucial in defining the scope of protection. Here are some key aspects:
- Composition Claims: The patent claims cover specific compositions of the sublingual tablets, including the ratio of active to inactive ingredients and the presence of particular excipients.
- Method Claims: These claims pertain to the steps involved in manufacturing the tablets, such as the mixing time, granulation process, and compaction techniques.
- Use Claims: The patent also includes claims related to the use of these tablets for specific medical conditions, such as pain management[2].
Key Components and Innovations
Several components and innovations are highlighted in the '132 patent:
- Active Substance Adhesion: The patent describes a method where the active substance (fentanyl citrate) is caused to adhere to carrier particles, ensuring uniform distribution and rapid release[1].
- Disintegrants: The use of disintegrants, such as modified cellulose gum, is crucial for the rapid disintegration of the tablet when administered sublingually[1].
- Granulation and Compaction: The process involves granulating the moist mass and then compacting it into tablets, which ensures the desired texture and dissolution properties[1].
Patent Landscape and Litigation
The '132 patent is part of a complex patent landscape involving multiple stakeholders and litigation:
- Infringement Cases: Orexo AB has been involved in several patent infringement cases, notably against Actavis (now part of Teva Pharmaceuticals), where the defendant was accused of infringing the '132 patent by filing an Abbreviated New Drug Application (ANDA) for a generic version of Abstral, a sublingual fentanyl citrate tablet[2].
- Paragraph IV Certification: Actavis had submitted a Paragraph IV certification, asserting that the '132 patent was invalid or would not be infringed by their proposed product. This led to legal proceedings under the Hatch-Waxman Act[2].
Industry Impact and Commercialization
The '132 patent has significant implications for the pharmaceutical industry:
- Commercial Products: The patent underpins the commercial success of products like Abstral, which is a key revenue generator for companies like Orexo AB and Galena Biopharma (now part of Sellas Life Sciences Group)[4].
- Regulatory Approvals: The FDA approval process for generic versions of these products is heavily influenced by the validity and scope of patents like the '132 patent[2].
Patent Scope Metrics
The scope of the '132 patent can be analyzed using metrics such as independent claim length and count, which are indicators of patent breadth and complexity:
- Claim Length and Count: Patents with narrower claims tend to have a higher probability of grant and shorter examination processes. The '132 patent's claims are specific and detailed, reflecting a well-defined scope[3].
Expiry and Future Implications
The '132 patent, like other patents, has a limited lifespan:
- Expiry Date: The '910 patent, closely related to the '132 patent, expired in 2019. The exact expiry date of the '132 patent would be similar, given the typical patent term of 20 years from the filing date[2].
- Generic Competition: Post-expiry, the market is likely to see increased generic competition, which could impact the commercial landscape for sublingual fentanyl citrate tablets.
Conclusion
The United States Patent 7,910,132 is a critical asset in the pharmaceutical industry, particularly in the realm of sublingual fentanyl citrate tablets. Its scope and claims are meticulously defined, covering specific formulations, manufacturing processes, and medical uses. The patent's impact is evident in both the commercial success of related products and the legal battles surrounding patent infringement.
Key Takeaways
- Specific Formulation: The patent covers a specific formulation of sublingual fentanyl citrate tablets.
- Manufacturing Process: Detailed steps for manufacturing these tablets are outlined.
- Litigation: The patent has been involved in significant litigation regarding infringement.
- Commercial Impact: It underpins the commercial success of products like Abstral.
- Patent Metrics: The patent's scope can be analyzed using metrics like claim length and count.
Frequently Asked Questions (FAQs)
Q: What is the primary active ingredient covered by the '132 patent?
A: The primary active ingredient is fentanyl citrate.
Q: What is the significance of disintegrants in the '132 patent?
A: Disintegrants, such as modified cellulose gum, are crucial for the rapid disintegration of the tablet when administered sublingually.
Q: Which company holds the '132 patent?
A: The '132 patent is held by Orexo AB.
Q: What is the context of the litigation involving the '132 patent?
A: The litigation involves patent infringement claims against companies like Actavis for filing ANDAs for generic versions of Abstral.
Q: How does the expiry of the '132 patent impact the pharmaceutical market?
A: Post-expiry, the market is likely to see increased generic competition for sublingual fentanyl citrate tablets.
