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Last Updated: December 22, 2024

Details for Patent: 8,436,051


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Which drugs does patent 8,436,051 protect, and when does it expire?

Patent 8,436,051 protects CANASA and is included in one NDA.

This patent has thirteen patent family members in twelve countries.

Summary for Patent: 8,436,051
Title:Mesalamine suppository
Abstract: The present invention relates to a mesalamine rectal suppository designed to provide improved comfort of use. One embodiment of the invention is a mesalamine rectal suppository comprising mesalamine and one or more pharmaceutically acceptable excipients, wherein the drug load of the suppository ranges from 35% to 50%. Yet another embodiment of the invention is a mesalamine rectal suppository comprising mesalamine having a tap density ranging from about 600 to about 800 g/L (as measured by USP <616>) and a hard fat having an ascending melting point of 32 to 35.5.degree. C. Yet another embodiment is a mesalamine rectal suppository comprising mesalamine particles and one or more pharmaceutically acceptable excipients, where the mesalamine particles have a surface area of from about 0.1 m.sup.2/g to about 2.8 m.sup.2/g (e.g., from about 0.1 m.sup.2/g to about 1.3 m.sup.2/g). Methods of preparing and methods of treatment with mesalamine suppositories are also provided. The invention further provides a method of determining a dissolution parameter (such as dissolution rate) of a mesalamine rectal suppository, such as a 1 g mesalamine suppository, by measuring its dissolution with USP Apparatus #2 at 40.degree. C. and a paddle rotation speed of 125 rpm in 0.2 M phosphate buffer at a pH of 7.5.
Inventor(s): Gauthier; Carl (Quebec, CA), Dumoulin; Yves (Quebec, CA), Powell; David (Loudon, TN), Moreau; Hugues (Luce, FR)
Assignee: Aptalis Pharma Canada Inc. (Mont-Saint-Hilaire, Quebec, CA)
Application Number:12/639,645
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,436,051
Patent Claim Types:
see list of patent claims
Formulation; Dosage form; Use;
Patent landscape, scope, and claims:

United States Patent 8,436,051: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 8,436,051, hereafter referred to as the '051 patent, is a significant intellectual property asset that warrants a thorough analysis to understand its scope, claims, and the broader patent landscape it operates within. This analysis will delve into the patent's details, its claims, and the context in which it exists.

Patent Overview

Invention Description

The '051 patent pertains to a specific invention related to pharmaceutical formulations. While the exact details of this patent are not provided in the sources, we can infer from similar patents in the pharmaceutical sector that it likely involves a novel formulation, manufacturing process, or application of a pharmaceutical compound.

Classification and Categories

Patents are classified under specific categories to facilitate searching and understanding their scope. For pharmaceutical patents, common classifications include A61K (Preparations for medical, dental, or toilet purposes) under the International Patent Classification (IPC) system[4].

Scope of the Patent

Claims Analysis

The scope of a patent is primarily defined by its claims. These claims outline what the inventor considers to be the novel and non-obvious aspects of the invention. For the '051 patent, the claims would typically include:

  • Independent Claims: These are the broadest claims that define the invention's core aspects.
  • Dependent Claims: These claims are narrower and build upon the independent claims, often adding specific details or limitations.

Research indicates that the scope of patent claims can significantly impact the patent's validity and enforceability. Narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].

Claim Language and Metrics

The language used in patent claims is crucial. Metrics such as independent claim length and independent claim count can provide insights into the patent's scope. These metrics have been shown to have explanatory power for several correlates of patent scope, including patent maintenance payments, forward citations, and the breadth of patent classes[3].

Claims and Patent Scope

Patent Scope Metrics

The scope of the '051 patent can be measured using metrics such as:

  • Independent Claim Length: Longer claims often indicate broader scope but may also suggest ambiguity or overbreadth.
  • Independent Claim Count: A higher number of independent claims can indicate a broader scope but may also complicate the patent's enforceability[3].

Examination Process Impact

The patent examination process can significantly narrow the scope of patent claims. This is evident from studies showing that the examination process tends to reduce claim length and count, making the claims more specific and narrower[3].

Patent Landscape

Global Dossier and International Search

To understand the '051 patent's place in the global patent landscape, tools like the Global Dossier can be invaluable. This service provides access to the file histories of related applications from participating IP Offices, allowing users to see the patent family for a specific application and related citations and classifications[1].

Searchable Databases

Searching international patent databases such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO) can help identify similar patents and prior art. These databases often include machine translations, which can be particularly useful for patents in languages other than English[1].

Litigation and Enforcement

Infringement and Litigation

Patents like the '051 patent can be involved in litigation, particularly if there are allegations of infringement. Litigation documents and court cases can provide insights into how the patent's claims are interpreted and enforced. For example, if the '051 patent is involved in an Abbreviated New Drug Application (ANDA) litigation, it would indicate that the patent is being challenged or defended in the context of generic drug approval[5].

Office Actions and Examination History

The Patent Examination Data System (PEDS) and other resources can provide detailed information on the patent's examination history, including office actions and any changes to the claims during the examination process. This information can be crucial in understanding the patent's validity and the basis for its claims[1].

Key Takeaways

  • Claims Definition: The scope of the '051 patent is primarily defined by its claims, which must be carefully drafted to ensure clarity and enforceability.
  • Metrics for Scope: Metrics such as independent claim length and count can provide insights into the patent's scope and its likelihood of being granted.
  • Global Context: Tools like the Global Dossier and international patent databases are essential for understanding the patent's place in the global landscape.
  • Litigation and Enforcement: The patent's involvement in litigation can reveal how its claims are interpreted and enforced.

FAQs

Q: What is the primary way to determine the scope of a patent?

A: The scope of a patent is primarily determined by its claims, which outline the novel and non-obvious aspects of the invention.

Q: How can the scope of a patent be measured?

A: The scope can be measured using metrics such as independent claim length and independent claim count, which have explanatory power for several correlates of patent scope.

Q: What is the Global Dossier, and how is it useful?

A: The Global Dossier is a service that provides access to the file histories of related applications from participating IP Offices, allowing users to see the patent family for a specific application and related citations and classifications.

Q: Why is the examination process important for patent claims?

A: The examination process tends to narrow the scope of patent claims, making them more specific and narrower, which can affect the patent's validity and enforceability.

Q: How can international patent databases help in understanding a patent's landscape?

A: International patent databases provide access to prior art and similar patents, helping to identify potential conflicts and understand the global context of the patent.

Sources

  1. USPTO - Search for patents: https://www.uspto.gov/patents/search
  2. Insight.rpxcorp.com - Litigation documents: https://insight.rpxcorp.com/litigation_documents/11789844
  3. SSRN - Patent Claims and Patent Scope: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
  4. Google Patents - US8436051B2: https://patents.google.com/patent/US8436051B2/en
  5. Insight.rpxcorp.com - Litigation documents: https://insight.rpxcorp.com/litigation_documents/10151368

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Drugs Protected by US Patent 8,436,051

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Abbvie CANASA mesalamine SUPPOSITORY;RECTAL 021252-002 Nov 5, 2004 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  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

International Family Members for US Patent 8,436,051

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2010339837 ⤷  Subscribe
Canada 2690450 ⤷  Subscribe
Canada 2784772 ⤷  Subscribe
Chile 2012001636 ⤷  Subscribe
China 102970971 ⤷  Subscribe
European Patent Office 2512443 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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