You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

Details for Patent: 8,287,903


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 8,287,903
Title:Orally effective methylphenidate extended release powder and aqueous suspension product
Abstract: An oral methylphenidate powder which is reconstitutable into a final oral aqueous sustained release formulation containing at least about 50%, or at least about 80% by weight water based on the total weight of the suspension, is provided. The powder is a blend containing a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and a water soluble buffering agent such that upon formed into an aqueous liquid formulation, the formulation has a pH in the range of about 3.5 to about 5, or about 4 to about 4.5. Following administration of a single dose of the oral aqueous methylphenidate suspension, a therapeutically effective amount of methylphenidate is reached in less than one hour and the composition provides a twelve-hour extended release profile.
Inventor(s): Mehta; Ketan (Cranbury, NJ), Tu; Yu-Hsing (West Windsor, NJ), Perumal; Ashok (Edison, NJ)
Assignee: Tris Pharma Inc (Monmouth Junction, NJ)
Application Number:13/244,706
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,287,903
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form; Formulation;
Patent landscape, scope, and claims:

United States Patent 8,287,903: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

Understanding the scope and claims of a patent is crucial for inventors, businesses, and legal professionals. This article provides a detailed analysis of United States Patent 8,287,903, focusing on its scope, claims, and the broader patent landscape.

Patent Overview

United States Patent 8,287,903, hereafter referred to as the '903 patent, is associated with pharmaceutical inventions, specifically related to extended-release formulations. To understand its scope and claims, it is essential to delve into the patent's background and technical details.

Patent Claims

The '903 patent includes multiple claims that define the scope of the invention. These claims are categorized into independent and dependent claims.

Independent Claims

Independent claims are the broadest claims in a patent and define the core invention. For the '903 patent, these claims typically involve the composition and method of manufacture of the extended-release formulation. For example, an independent claim might describe a specific formulation of a drug, such as methylphenidate, and the process by which it is prepared to achieve extended release[2].

Dependent Claims

Dependent claims narrow down the scope of the independent claims by adding additional limitations. These claims often specify particular aspects of the invention, such as the dosage form, the type of excipients used, or specific manufacturing steps. Dependent claims help to further define the invention and can provide additional protection against infringement[2].

Scope of the Patent

The scope of the '903 patent is determined by the language of its claims. Here are some key aspects that define its scope:

Technical Details

The patent likely includes detailed descriptions of the chemical composition, the extended-release mechanism, and the manufacturing process. This includes the type of active ingredients, excipients, and any specific conditions required for the formulation[2].

Novelty and Non-Obviousness

To be granted, the '903 patent must have met the criteria of novelty and non-obviousness. This means that the invention must be new and not obvious to a person of ordinary skill in the relevant field. The patent office would have evaluated these criteria during the examination process[4].

Patent Landscape

The patent landscape surrounding the '903 patent involves several key elements:

Related Patents

Other patents related to extended-release formulations, particularly those involving similar active ingredients or manufacturing processes, are part of the broader patent landscape. For instance, patents like the '544 patent and '545 patent, also owned by Tris Pharma, Inc., may share similarities or complement the '903 patent[2].

International Patent Filings

The '903 patent may have corresponding international filings under the Patent Cooperation Treaty (PCT) or in various national patent offices. Tools like PATENTSCOPE and the European Patent Office's esp@cenet database can provide access to these international filings[1][4].

Litigation and Enforcement

Patents like the '903 patent are often involved in litigation, particularly in the pharmaceutical industry where generic versions of drugs are common. For example, Tris Pharma, Inc. has been involved in patent infringement cases related to their extended-release formulations, highlighting the importance of patent enforcement[2].

Search and Analysis Tools

To analyze the '903 patent and its place in the patent landscape, several tools and resources are available:

USPTO Patent Public Search

The USPTO's Patent Public Search tool allows for comprehensive searching of U.S. patents and published applications. This tool can be used to find prior art, related patents, and to analyze the claims and scope of the '903 patent[4].

Global Dossier

The Global Dossier service provides access to file histories of related applications from participating IP offices, which can help in understanding the international aspects of the '903 patent and its family members[4].

Cooperative Patent Classification (CPC)

The CPC database can be used to classify the '903 patent and find other patents within the same classification scheme, aiding in a broader analysis of the patent landscape[1].

Metrics for Measuring Patent Scope

Research has shown that metrics such as independent claim length and independent claim count can be used to measure patent scope. Narrower claims, as measured by these metrics, are often associated with a higher probability of grant and a shorter examination process[3].

Impact on Innovation

The scope and claims of the '903 patent can influence innovation in the pharmaceutical industry. Broad patents can sometimes stifle innovation by increasing licensing and litigation costs, while narrower, well-defined patents can encourage further innovation by providing clear boundaries[3].

Key Takeaways

  • Patent Claims: The '903 patent includes independent and dependent claims that define its scope and protect the invention.
  • Scope: The patent's scope is determined by its claims, which include technical details of the extended-release formulation.
  • Patent Landscape: The patent is part of a broader landscape involving related patents, international filings, and potential litigation.
  • Search and Analysis Tools: Tools like the USPTO's Patent Public Search, Global Dossier, and CPC database are essential for analyzing the patent.
  • Metrics for Patent Scope: Metrics such as independent claim length and count can help in understanding the patent's scope and its impact on innovation.

FAQs

Q: What is the main subject of United States Patent 8,287,903?

A: The main subject of the '903 patent is related to extended-release pharmaceutical formulations, specifically involving drugs like methylphenidate.

Q: How do independent and dependent claims differ in a patent?

A: Independent claims define the broadest scope of the invention, while dependent claims narrow down the scope by adding additional limitations.

Q: What tools can be used to search and analyze the '903 patent?

A: Tools such as the USPTO's Patent Public Search, Global Dossier, and the Cooperative Patent Classification (CPC) database can be used.

Q: Why is the scope of a patent important?

A: The scope of a patent determines what is protected and what can be considered an infringement, which is crucial for legal and business strategies.

Q: How can metrics like independent claim length and count help in patent analysis?

A: These metrics can help measure the scope of a patent and predict its likelihood of grant and the length of the examination process.

Sources

  1. Clemson University Libraries, "Research and Course Guides: Patent Searching, Advanced: Overview," May 23, 2024.
  2. McCarter & English, LLP, "First Amended Complaint," Case 2:20-cv-05212-KM-ESK, Document 114, Filed September 16, 2021.
  3. SSRN, "Patent Claims and Patent Scope," September 29, 2016.
  4. United States Patent and Trademark Office, "Search for Patents," October 18, 2018.

More… ↓

⤷  Subscribe


Drugs Protected by US Patent 8,287,903

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Nextwave QUILLIVANT XR methylphenidate hydrochloride FOR SUSPENSION, EXTENDED RELEASE;ORAL 202100-001 Sep 27, 2012 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Nextwave Pharms QUILLICHEW ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE, CHEWABLE;ORAL 207960-001 Dec 4, 2015 RX Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Nextwave Pharms QUILLICHEW ER methylphenidate hydrochloride TABLET, EXTENDED RELEASE, CHEWABLE;ORAL 207960-002 Dec 4, 2015 RX Yes No ⤷  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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.