United States Patent 7,862,833: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,862,833, issued on January 4, 2011, is a significant patent in the pharmaceutical industry, particularly in the realm of oral opiate dosage forms. This patent, held by Cephalon, Inc., pertains to effervescent oral opiate dosage forms and methods of administering opiates. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Context
The patent in question is part of a series of patents related to the drug FENTORA®, a fentanyl buccal tablet used for the management of breakthrough pain in cancer patients. The issuance of this patent was crucial in the context of the Hatch-Waxman Act, which governs the relationship between pioneer drug manufacturers and generic drug manufacturers[2].
Scope of the Patent
Invention Overview
The patent describes the use of effervescence as a penetration enhancer to influence oral drug absorption. This innovation involves the creation of effervescent oral opiate dosage forms that enhance the absorption of fentanyl, a potent opioid analgesic. The dosage forms include various components such as bicarbonate and carbonate, which react to produce carbon dioxide gas, facilitating the rapid absorption of the drug through the mucosal tissues[4].
Key Components
- Effervescence: The patent highlights the role of effervescence in enhancing drug absorption. The reaction between bicarbonate and carbonate produces carbon dioxide, which aids in the rapid dissolution and absorption of the drug.
- Dosage Forms: The invention includes various dosage forms such as tablets, lozenges, and films, designed to release the opioid in a controlled manner.
- Excipients: The patent lists several excipients, including disintegrants, lubricants, and binding agents, which are crucial for the stability and efficacy of the dosage forms[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims are critical in determining the patent's validity and infringement.
- Claim 1: This claim describes the effervescent oral opiate dosage form comprising fentanyl and an effervescent agent.
- Claim 2: This claim specifies the method of administering the dosage form, emphasizing the role of effervescence in enhancing absorption[4].
Dependent Claims
Dependent claims further narrow down the scope by adding specific details to the independent claims. For example, dependent claims might specify the type of effervescent agent, the dosage form's composition, or the method of manufacture.
Patent Landscape
Global Dossier and International Implications
The patent is part of a larger global patent family, accessible through the Global Dossier service provided by the USPTO. This service allows users to view the file histories of related applications from participating IP Offices, including the IP5 Offices (the United States, Japan, Korea, China, and Europe)[1].
Common Citation Document (CCD)
The CCD application consolidates prior art citations from all participating offices for the family members of a patent application. This helps in visualizing search results for the same invention produced by several offices on a single page, which is particularly useful for patents like 7,862,833 that have international implications[1].
Litigation and Regulatory Context
Hatch-Waxman Act
The patent was listed in the Orange Book by Cephalon, which is a critical step under the Hatch-Waxman Act. This act requires pioneer drug manufacturers to list patents covering their approved drugs and for generic manufacturers to certify whether these patents are invalid or not infringed upon. The litigation surrounding this patent, such as the case involving Sandoz, highlights the complexities and the importance of accurate patent listing and certification processes[2].
Paragraph IV Certification
The generic manufacturer's Paragraph IV certification is a key aspect of the Hatch-Waxman Act. This certification allows generic manufacturers to challenge the validity or non-infringement of listed patents. The case law surrounding this patent shows how critical it is for both pioneer and generic manufacturers to adhere to these regulatory requirements to avoid legal complications[2].
Patent Scope and Quality
Metrics for Measuring Patent Scope
Research on patent scope suggests that metrics such as independent claim length and independent claim count can be used to measure the breadth of a patent. Narrower claims, as seen in the examination process of this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Examination Process
The examination process for this patent likely involved narrowing the scope of the claims to ensure clarity and validity. This process is crucial in maintaining the quality of patents and preventing overly broad claims that could stifle innovation[3].
Key Takeaways
- Effervescent Technology: The patent introduces a novel use of effervescence to enhance oral drug absorption, particularly for opioids.
- Regulatory Compliance: Accurate listing and certification of patents under the Hatch-Waxman Act are crucial to avoid legal disputes.
- Global Implications: The patent is part of a global patent family, accessible through services like the Global Dossier.
- Patent Scope: The scope of the patent is defined by its claims, with narrower claims often resulting from the examination process.
FAQs
What is the main innovation described in United States Patent 7,862,833?
The main innovation is the use of effervescence as a penetration enhancer to influence oral drug absorption, particularly for fentanyl.
How does the Hatch-Waxman Act impact this patent?
The Hatch-Waxman Act requires the pioneer drug manufacturer to list the patent in the Orange Book and for generic manufacturers to certify whether the patent is invalid or not infringed upon.
What is the role of the Global Dossier in relation to this patent?
The Global Dossier provides access to the file histories of related applications from participating IP Offices, allowing users to view the patent family and related documentation.
How are the claims of this patent structured?
The patent includes independent claims that define the scope of the invention and dependent claims that further narrow down the scope by adding specific details.
What metrics can be used to measure the scope of a patent like 7,862,833?
Metrics such as independent claim length and independent claim count can be used to measure the breadth and quality of a patent.
Sources
- USPTO: Search for patents - USPTO.
- District of Delaware: MEMORANDUM ORDER - District of Delaware.
- SSRN: Patent Claims and Patent Scope.
- Google Patents: US7862833B2 - Effervescent oral opiate dosage forms and methods of administering opiates.
- GovInfo: Case 1:11-cv-01152-SLR Document 65 Filed 09/06/12.
