United States Patent 9,669,024: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,669,024, hereafter referred to as the '024 patent, is part of a complex patent landscape surrounding pharmaceutical formulations, particularly those related to controlled-release medications. This patent is associated with Purdue Pharma's Hysingla® ER (hydrocodone bitartrate) product. Here, we will delve into the scope, claims, and the broader patent landscape to understand its significance and implications.
Background and Context
Hysingla® ER is a controlled-release formulation of hydrocodone bitartrate, used for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment. The '024 patent is one of several patents listed in the FDA's Orange Book, which covers therapeutic equivalence evaluations for approved drug products[5].
Scope of the Patent
The '024 patent falls under the category of pharmaceutical patents, specifically focusing on controlled-release formulations. It is part of a series of patents that cover various aspects of Hysingla® ER, including its composition, manufacturing process, and delivery mechanism.
Claim Structure
The claims of the '024 patent are structured to protect the specific formulation and delivery system of Hysingla® ER. These claims typically include:
- The composition of the controlled-release formulation.
- The method of manufacturing the formulation.
- The specific characteristics of the delivery system, such as the release profile and the materials used.
Claims Analysis
Independent Claims
Independent claims in the '024 patent define the broadest scope of the invention. These claims are crucial as they set the boundaries of what is considered novel and non-obvious. For example, an independent claim might describe the overall composition of the controlled-release formulation, including the active ingredient (hydrocodone bitartrate), the excipients, and the polymer matrix.
Dependent Claims
Dependent claims further narrow down the scope by adding specific limitations to the independent claims. These could include details such as the ratio of active ingredient to excipients, the method of coating, or the specific polymers used in the matrix.
Patent Landscape
The '024 patent is part of a dense patent landscape involving multiple stakeholders, including Purdue Pharma, Grünenthal, and generic drug manufacturers like Alvogen and Actavis.
Related Patents
Several other patents are closely related to the '024 patent, including:
- 9,669,023: Another patent covering aspects of Hysingla® ER, possibly focusing on different aspects of the formulation or delivery system.
- 9,675,610 and 9,675,611: These patents may cover additional features or variations of the controlled-release formulation.
- 9,682,077: This patent could address specific manufacturing processes or additional components of the Hysingla® ER product[5].
Litigation and Disputes
The '024 patent has been involved in several patent infringement lawsuits. For instance, Purdue Pharma and its affiliates have filed complaints against generic drug manufacturers like Alvogen and Actavis, alleging infringement of various patents, including the '024 patent. These lawsuits highlight the competitive and legally complex environment surrounding pharmaceutical patents[2][5].
Impact on Innovation and Competition
The broad scope and multiple claims of the '024 patent, along with related patents, can significantly impact innovation and competition in the pharmaceutical industry.
Barriers to Entry
The extensive patent coverage around Hysingla® ER can create barriers to entry for generic manufacturers. The need to navigate through a complex web of patents can delay or prevent the launch of generic versions, thereby maintaining the market exclusivity of the branded product.
Innovation Incentives
On the other hand, strong patent protection can incentivize innovation by providing a return on investment for research and development. Companies like Purdue Pharma invest heavily in developing new formulations and delivery systems, and robust patent protection ensures they can recoup these investments.
Regulatory Environment
The '024 patent is listed in the FDA's Orange Book, which is a critical resource for understanding the patent and exclusivity landscape of approved drug products. The Orange Book provides detailed information on patents, exclusivity periods, and therapeutic equivalence evaluations, helping generic manufacturers to plan their entry into the market[4].
Patent Scope Metrics
The scope of the '024 patent can be analyzed using metrics such as independent claim length and count, which are indicators of patent breadth and clarity. Narrower claims, as seen in the examination process, are often associated with a higher probability of grant and shorter examination times. This suggests that the '024 patent, with its specific and detailed claims, has undergone rigorous scrutiny to ensure its validity and enforceability[3].
Conclusion and Implications
The United States Patent 9,669,024 is a significant component of the patent landscape surrounding controlled-release pharmaceutical formulations. Its scope and claims are designed to protect the innovative aspects of Hysingla® ER, ensuring Purdue Pharma's market exclusivity while also incentivizing further innovation in the field.
Key Takeaways
- The '024 patent covers specific aspects of Hysingla® ER, including its composition and delivery system.
- It is part of a broader patent landscape involving multiple related patents.
- The patent has been involved in several litigation cases against generic manufacturers.
- Strong patent protection can both incentivize innovation and create barriers to entry for competitors.
- Regulatory resources like the FDA's Orange Book are crucial for navigating the patent landscape.
Frequently Asked Questions (FAQs)
1. What is the main subject of the United States Patent 9,669,024?
The main subject of the '024 patent is the controlled-release formulation of hydrocodone bitartrate, specifically the Hysingla® ER product.
2. How does the '024 patent fit into the broader patent landscape?
The '024 patent is one of several patents covering various aspects of Hysingla® ER, including composition, manufacturing, and delivery mechanisms.
3. What are the implications of the '024 patent on generic drug manufacturers?
The '024 patent, along with related patents, can create significant barriers to entry for generic manufacturers by requiring them to navigate complex patent infringement issues.
4. How does the FDA's Orange Book relate to the '024 patent?
The FDA's Orange Book lists the '024 patent and provides detailed information on its expiration dates, exclusivity periods, and therapeutic equivalence evaluations, which is crucial for generic manufacturers.
5. What metrics can be used to analyze the scope of the '024 patent?
Metrics such as independent claim length and count can be used to analyze the scope and clarity of the '024 patent, indicating its breadth and validity.
Cited Sources:
- PatentCut - Rolled matrix device having enhanced ability to unroll and method...
- RPX Corporation - IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT...
- Hoover Institution - Patent Claims and Patent Scope
- DrugPatentWatch - Approved Drug Products with Therapeutic Equivalence Evaluations
- RPX Corporation - IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT...
