Detailed Analysis of the Scope and Claims of United States Patent 9,486,412
Introduction
The United States Patent 9,486,412, titled "TAMPER RESISTANT DOSAGE FORMS," is a crucial patent held by Purdue Pharma and Purdue Pharmaceuticals, particularly in relation to their product Hysingla® ER (hydrocodone bitartrate). This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Patent Title and Inventors
The patent, titled "TAMPER RESISTANT DOSAGE FORMS," was issued on November 8, 2016, and lists William H. McKenna, Richard O. Mannion, Edward P. O’Donnell, and Haiyong H. Huang as the inventors[3].
Patent Coverage
This patent is listed in the FDA's Approved Drug Products With Therapeutic Equivalence Evaluation (the "Orange Book") as covering Hysingla® ER, a product developed by Purdue Pharma and Purdue Pharmaceuticals[1][3].
Scope of the Patent
Claim Language and Scope
The scope of a patent is often determined by the language of its claims. For the '412 patent, the claims are centered around tamper-resistant dosage forms, specifically designed to deter abuse of opioid medications. The claims include various aspects of the dosage form's composition, structure, and method of manufacture that contribute to its tamper-resistance[3].
Metrics for Measuring Patent Scope
Research suggests that patent scope can be measured using metrics such as independent claim length and independent claim count. These metrics can provide insights into the breadth and clarity of the patent claims. For instance, narrower claims at publication are associated with a higher probability of grant and a shorter examination process, indicating a more focused and potentially stronger patent[2].
Claims Analysis
Claim Structure
The '412 patent includes multiple claims that define the tamper-resistant dosage forms. These claims are structured to cover various embodiments of the invention, including the composition of the dosage form, the process of its manufacture, and the specific features that make it tamper-resistant. Each claim is designed to be as specific as possible to avoid overlap with prior art and to ensure enforceability[3].
Key Claims
- Independent Claims: These claims stand alone and define the invention without reference to other claims. For the '412 patent, independent claims would outline the core aspects of the tamper-resistant dosage forms.
- Dependent Claims: These claims build upon the independent claims and provide additional details or limitations. They help to further define the scope of the invention and can offer additional protection against infringement[3].
Patent Landscape Analysis
Geographical Spread and Saturation
A comprehensive patent landscape analysis involves examining the geographical spread and saturation of patents in the relevant technology area. For the '412 patent, this would include analyzing the global distribution of similar patents related to tamper-resistant dosage forms and assessing the level of saturation in this patent space. High saturation could indicate a competitive and potentially litigious environment[4].
Competitors and New Entrants
Identifying competitors and new entrants in the patent space is crucial. For Purdue Pharma, understanding who else is developing similar tamper-resistant dosage forms can help in strategic decision-making regarding research, development, and litigation. This includes analyzing the patent portfolios of competitors like Alvogen and Actavis, which have been involved in patent infringement disputes with Purdue[1][3].
Time-Slicing and Trends
Time-slicing involves analyzing patent activity over time to identify trends and changes in the technology area. This can reveal whether certain technologies are being abandoned or if new areas are emerging. For the '412 patent, time-slicing could show the evolution of tamper-resistant dosage forms and whether there is a shift towards new technologies or improvements in existing ones[4].
Litigation and Enforcement
Patent Infringement Claims
Purdue Pharma and Purdue Pharmaceuticals have asserted the '412 patent in several litigation cases against companies like Alvogen and Actavis, alleging patent infringement. These cases highlight the importance of the '412 patent in protecting Purdue's intellectual property and the potential harm that infringement could cause to their business[1][3].
Declaratory Judgment
In addition to infringement claims, Purdue has also sought declaratory judgments to clarify the scope of the '412 patent and to prevent future infringement. This approach underscores the proactive stance taken by Purdue to protect their IP rights[3].
Strategic Insights
Decision-Making
A comprehensive patent landscape analysis provides strategic insights that can guide business and R&D decisions. For example, if the patent space for tamper-resistant dosage forms is highly saturated, it may be advisable to pivot to newer inventive spaces or to focus on improving existing technologies rather than pursuing new patents in a crowded area[4].
Counseling and Advice
Attorneys and IP professionals can use the results of a patent landscape analysis to counsel their clients on the potential rewards and risks of entering or continuing to invest in a particular technology area. This includes advising on the likelihood of successful patent prosecution, the potential for litigation, and the competitive landscape[4].
Key Takeaways
- Patent Scope and Claims: The '412 patent's scope is defined by its claims, which are centered around tamper-resistant dosage forms.
- Patent Landscape: Analyzing the geographical spread, saturation, and trends in the patent space helps in strategic decision-making.
- Litigation and Enforcement: The '412 patent has been asserted in several litigation cases, highlighting its importance in protecting Purdue's IP.
- Strategic Insights: A comprehensive patent landscape analysis provides valuable insights for business and R&D decisions.
FAQs
Q: What is the main subject of the United States Patent 9,486,412?
A: The main subject of the United States Patent 9,486,412 is "TAMPER RESISTANT DOSAGE FORMS," specifically related to opioid medications like Hysingla® ER.
Q: Who are the inventors listed on the '412 patent?
A: The inventors listed on the '412 patent are William H. McKenna, Richard O. Mannion, Edward P. O’Donnell, and Haiyong H. Huang.
Q: Why is the '412 patent listed in the FDA's Orange Book?
A: The '412 patent is listed in the FDA's Orange Book because it covers Purdue Pharma's product Hysingla® ER, which is a therapeutic equivalence evaluation.
Q: What metrics can be used to measure the scope of a patent?
A: Metrics such as independent claim length and independent claim count can be used to measure the scope of a patent.
Q: How does a patent landscape analysis help in strategic decision-making?
A: A patent landscape analysis helps by providing insights into the geographical spread, saturation, and trends in the patent space, guiding decisions on research, development, and litigation.
Sources
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ... - Insight.RPXcorp.com
- Patent Claims and Patent Scope - SSRN
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ... - Insight.RPXcorp.com
- Patent Landscape Analysis - Uncovering Strategic Insights - AcclaimIP.com
