United States Patent 9,486,413: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 9,486,413, titled "TAMPER RESISTANT DOSAGE FORMS," is a crucial patent held by Purdue Pharma and Purdue Pharmaceuticals. This patent is significant in the pharmaceutical industry, particularly in the context of opioid formulations. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background
The patent 9,486,413 was issued on November 8, 2016, and is listed in the FDA's Approved Drug Products With Therapeutic Equivalence Evaluation, commonly known as the Orange Book. The inventors named on the patent include William H. McKenna, Richard O. Mannion, Edward P. O’Donnell, and Haiyong H. Huang[1].
Scope of the Patent
The patent 9,486,413 pertains to tamper-resistant dosage forms, specifically designed to prevent or deter the misuse of opioid medications. This is a critical area of innovation given the opioid crisis and the need for formulations that are resistant to tampering, such as crushing or dissolving, which can lead to rapid release and potential abuse.
Tamper-Resistant Mechanisms
The patent describes various mechanisms to achieve tamper resistance, including the use of specific excipients, matrix formulations, and other technological innovations that make it difficult to manipulate the dosage form for illicit purposes. These mechanisms are designed to maintain the controlled release profile of the medication, ensuring that the active ingredient is released over a predetermined period rather than all at once[1].
Claims of the Patent
The claims of the patent are the heart of its legal and technical scope. Here are some key aspects:
Independent Claims
The patent includes several independent claims that define the broadest scope of the invention. These claims typically describe the overall composition and structure of the tamper-resistant dosage forms, including the types of active ingredients, excipients, and the specific formulations used[1].
Dependent Claims
Dependent claims further narrow down the scope by adding additional limitations or features to the independent claims. These could include specific ratios of ingredients, particular manufacturing processes, or additional characteristics that enhance the tamper-resistant properties of the dosage forms[1].
Patent Landscape
Understanding the patent landscape is crucial for navigating the intellectual property rights associated with this patent.
Related Patents
Purdue Pharma and Purdue Pharmaceuticals hold a series of related patents that collectively protect their tamper-resistant dosage forms. These include patents such as 9,492,389, 9,492,390, 9,492,391, 9,545,380, 9,517,236, 9,572,779, and 9,572,804, all of which are listed in the Orange Book as covering Hysingla® ER, a product that incorporates these tamper-resistant technologies[1][4].
Litigation and Enforcement
The patent 9,486,413 has been involved in several litigation cases, particularly against generic manufacturers who have filed Abbreviated New Drug Applications (ANDAs) with the FDA. Purdue Pharma has asserted that these ANDA products infringe on their patents, including the '413 patent. These cases highlight the importance of this patent in protecting Purdue's intellectual property and the significant legal battles that can ensue to enforce these rights[1][4].
Claim Construction and Indefiniteness
Claim construction is a critical aspect of patent litigation, and the definiteness of claims is a legal requirement. The Federal Circuit has emphasized that claims must be precise enough to afford clear notice of what is claimed, thereby informing the public of what is still open to them. This principle is crucial in ensuring that the scope of the invention is clearly defined and understood by those skilled in the art[2].
Patent Analytics and Claim Coverage
To effectively manage and analyze the patent landscape, companies often use patent analytics tools. These tools help in categorizing patents by claims and scope concepts, enabling a comprehensive understanding of which patents and claims are actively protecting the intellectual property. This approach also identifies gaps or opportunities in the current coverage, which can be vital for strategic decision-making and future development[3].
Impact on Pharmaceutical Industry
The patent 9,486,413 has significant implications for the pharmaceutical industry, particularly in the development of opioid formulations. The tamper-resistant technologies described in this patent are crucial in addressing the opioid crisis by preventing the misuse of these medications. This innovation also sets a standard for future formulations, encouraging other manufacturers to develop similar tamper-resistant products.
Key Takeaways
- Tamper-Resistant Technologies: The patent 9,486,413 focuses on innovative tamper-resistant dosage forms, critical in preventing the misuse of opioid medications.
- Scope and Claims: The patent includes broad independent claims and narrower dependent claims that define the scope of the invention.
- Related Patents: A series of related patents collectively protect Purdue's tamper-resistant dosage forms.
- Litigation: The patent has been involved in several litigation cases to enforce intellectual property rights.
- Claim Construction: The claims must be definite and provide clear notice of what is claimed to inform the public.
- Patent Analytics: Tools like Claim Coverage Matrix and Claim Charts are essential for managing and analyzing the patent landscape.
FAQs
What is the main focus of the United States Patent 9,486,413?
The main focus of the patent 9,486,413 is on tamper-resistant dosage forms, specifically designed to prevent the misuse of opioid medications.
Who are the inventors listed on the patent 9,486,413?
The inventors listed on the patent include William H. McKenna, Richard O. Mannion, Edward P. O’Donnell, and Haiyong H. Huang.
What is the significance of the patent being listed in the Orange Book?
The patent being listed in the Orange Book indicates that it covers a specific FDA-approved drug product, in this case, Hysingla® ER, and is recognized as part of the therapeutic equivalence evaluation.
How does the patent 9,486,413 impact the pharmaceutical industry?
The patent sets a standard for tamper-resistant opioid formulations, addressing the opioid crisis by preventing misuse and encouraging similar innovations in the industry.
What tools are used to analyze and manage the patent landscape related to this patent?
Tools such as Claim Coverage Matrix and Claim Charts, part of patent analytics, are used to categorize and analyze the claims and scope concepts of the patents, helping to identify gaps and opportunities in the current coverage.
Sources
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ... - Insight.RPXCorp.com
- UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT - CAFC.USCourts.gov
- Patent Analytics | Intellectual Property Law - SLWIP.com
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ... - Insight.RPXCorp.com
