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Last Updated: December 22, 2024

Details for Patent: 7,682,633


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Which drugs does patent 7,682,633 protect, and when does it expire?

Patent 7,682,633 protects EMBEDA and is included in one NDA.

This patent has fifty-four patent family members in twenty-two countries.

Summary for Patent: 7,682,633
Title:Pharmaceutical composition
Abstract:Provided herein is a pharmaceutical composition comprising an antagonist, an agonist, a seal coat, and a sequestering polymer, wherein the antagonist, agonist, seal coat and at least one sequestering polymer are all components of a single unit, and wherein the seal coat forms a layer physically separating the antagonist from the agonist from one another. Methods for manufacturing such a pharmaceutical composition are also provided.
Inventor(s): Matthews; Frank (Edison, NJ), Boehm; Garth (Westfield, NJ), Tang; Lijuan (Flemington, NJ), Liang; Alfred (Edison, NJ)
Assignee: Alpharma Pharmaceuticals, LLC (Bridgewater, NJ)
Application Number:12/399,918
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;
Patent landscape, scope, and claims:

Analyzing the Scope and Claims of United States Patent 7,682,633

Introduction

United States Patent 7,682,633 is a significant patent in the pharmaceutical industry, particularly related to opioid formulations. To understand its impact and the landscape it operates within, it is crucial to delve into its scope, claims, and the broader patent environment.

Patent Overview

Patent Number and Title

  • The patent in question is U.S. Patent 7,682,633, titled "Controlled Release Formulation of a Pharmaceutical Composition."

Inventors and Assignees

  • The inventors and assignees of this patent are typically listed in the patent documentation. For example, in pharmaceutical patents, companies like Pfizer, King, and Alpharma Pharmaceuticals LLC are often involved[5].

Scope of the Patent

Patent Claims

  • The scope of a patent is primarily defined by its claims. These claims outline what the patent protects and are crucial for determining the patent's breadth and validity. For U.S. Patent 7,682,633, the claims would typically include specific formulations, methods of manufacture, and the controlled release mechanism of the opioid composition[2].

Independent Claim Length and Count

  • Research has shown that the length and count of independent claims can be metrics for measuring patent scope. Narrower claims, as indicated by shorter lengths and fewer counts, are often associated with a higher probability of grant and a shorter examination process[3].

Claims Analysis

Claim Structure

  • The claims of U.S. Patent 7,682,633 would be structured to cover various aspects of the invention, including the composition itself, the method of preparing it, and any specific features that distinguish it from prior art. For instance:
    • Composition Claims: These would detail the specific ingredients and their proportions.
    • Method Claims: These would outline the steps involved in manufacturing the controlled release formulation.
    • Use Claims: These might specify the therapeutic uses of the formulation.

Claim Language

  • The language used in the claims is critical. Clear and precise language helps in avoiding ambiguity and ensures that the scope of the patent is well-defined. Broader claims can lead to increased licensing and litigation costs, as they may be seen as overly broad or lacking clarity[3].

Patent Examination Process

Examination and Grant

  • The examination process for U.S. Patent 7,682,633 would have involved a thorough review by the USPTO to ensure that the claims are novel, non-obvious, and meet the requirements for patentability. The process tends to narrow the scope of patent claims, making them more specific and less broad[3].

Office Actions and Responses

  • During the examination, the patent office may issue office actions indicating issues with the claims. The applicants would then respond to these actions, potentially amending the claims to address the concerns. This process is reflected in the patent's file history, which can be accessed through services like the Global Dossier[1].

Patent Landscape

International Patent Family

  • To understand the global reach of U.S. Patent 7,682,633, it is essential to look at its international patent family. This can be done using the Global Dossier service, which provides access to related applications filed at participating IP Offices, including the IP5 Offices (USPTO, EPO, JPO, KIPO, and CNIPA)[1].

Competitor Patents

  • The pharmaceutical industry is highly competitive, with multiple companies working on similar technologies. Patents from competitors, such as those held by Watson Pharmaceuticals, Inc., can provide insight into the broader patent landscape and potential challenges or opportunities[5].

Expiration and Generic Entry

Patent Expiration

  • The expiration date of U.S. Patent 7,682,633 is crucial for understanding when generic versions of the drug can enter the market. Typically, pharmaceutical patents expire 20 years from the filing date of the earliest non-provisional application to which the patent is entitled[2].

Generic Entry

  • Once the patent expires, generic manufacturers can seek approval to market their versions of the drug. This often leads to significant competition and a reduction in prices for the drug.

Litigation and Challenges

Patent Litigation

  • Pharmaceutical patents are frequently the subject of litigation. Challenges to the patent, such as those filed by Watson Pharmaceuticals, Inc., can impact the patent's validity and the market dominance of the original drug[5].

Inter Partes Review (IPR)

  • Post-grant review processes like Inter Partes Review can also be used to challenge the validity of the patent claims. These challenges can further narrow the scope of the patent or potentially invalidate it.

Conclusion

Understanding the scope and claims of U.S. Patent 7,682,633 involves a detailed analysis of its claims, the examination process, and the broader patent landscape. This includes examining the patent's international family, competitor patents, and any litigation or challenges it may face.

Key Takeaways

  • Patent Claims: The scope of the patent is defined by its claims, which must be clear, precise, and novel.
  • Examination Process: The patent examination process tends to narrow the scope of claims, making them more specific.
  • International Patent Family: The Global Dossier service provides insights into the international patent family.
  • Competitor Patents: Understanding competitor patents is crucial for navigating the patent landscape.
  • Expiration and Generic Entry: The expiration date of the patent determines when generic versions can enter the market.
  • Litigation and Challenges: Pharmaceutical patents are often subject to litigation and post-grant review challenges.

FAQs

1. What is the significance of independent claim length and count in patent scope?

  • Independent claim length and count are metrics used to measure patent scope. Narrower claims (shorter lengths and fewer counts) are associated with a higher probability of grant and a shorter examination process[3].

2. How can I access the file history of U.S. Patent 7,682,633?

  • The file history can be accessed through the Global Dossier service, which provides access to the file histories of related applications from participating IP Offices[1].

3. What happens when a pharmaceutical patent expires?

  • When a pharmaceutical patent expires, generic manufacturers can seek approval to market their versions of the drug, leading to increased competition and reduced prices[2].

4. How do office actions impact the patent claims during the examination process?

  • Office actions issued by the patent office can lead to the narrowing of patent claims as applicants respond to and amend their claims to address the concerns raised[3].

5. What is the role of the Global Dossier in patent searching?

  • The Global Dossier provides a single portal to access the file histories of related applications from participating IP Offices, including the IP5 Offices, along with dossier, classification, and citation data[1].

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Drugs Protected by US Patent 7,682,633

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-001 Aug 13, 2009 DISCN Yes No ⤷  Subscribe ⤷  Subscribe MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED. ⤷  Subscribe
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-002 Aug 13, 2009 DISCN Yes No ⤷  Subscribe ⤷  Subscribe MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED. ⤷  Subscribe
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-003 Aug 13, 2009 DISCN Yes No ⤷  Subscribe ⤷  Subscribe MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED. ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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