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Last Updated: April 5, 2025

Details for Patent: 10,016,403


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Which drugs does patent 10,016,403 protect, and when does it expire?

Patent 10,016,403 protects SUBSYS and is included in one NDA.

This patent has twenty-three patent family members in sixteen countries.

Summary for Patent: 10,016,403
Title:Sublingual fentanyl spray
Abstract: The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable salt thereof, or derivative thereof, suitable for administration to a patient, and methods for treatment with the formulations.
Inventor(s): Kottayil; S. George (Long Grove, IL), Goskonda; Venkat R. (Phoenix, AZ), Zhu; Zhongyuan (Vernon Hills, IL), Kattookaran; Linet (Mount Prospect, IL), Parikh; Neha (Chicago, IL)
Assignee: INSYS DEVELOPMENT COMPANY, INC. (Chandler, AZ)
Application Number:15/478,430
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,016,403
Patent Claim Types:
see list of patent claims
Formulation; Compound;
Patent landscape, scope, and claims:

Analyzing the Scope and Claims of United States Patent 10,016,403: A Comprehensive Guide

Introduction

When analyzing a patent, understanding its scope, claims, and the broader patent landscape is crucial for inventors, businesses, and legal professionals. This article will delve into the specifics of United States Patent 10,016,403, exploring its claims, the patent search process, and the implications of patent scope and claims in the U.S. patent system.

Understanding the Patent

Patent Details

United States Patent 10,016,403, titled "Method Of Enhancing Electrontransport Polypeptide," was filed on December 10, 2001. To analyze this patent, one must start by examining its claims, which define the scope of the invention.

Claims Analysis

The claims section of a patent is the most critical part, as it outlines what the inventor is seeking to protect. Here are some key points to consider:

  • Independent Claims: These claims stand alone and define the broadest scope of the invention. They are crucial for determining the patent's scope and are often the focus of litigation and licensing discussions[3].
  • Dependent Claims: These claims build upon the independent claims and provide additional limitations, narrowing the scope of the invention. They can offer additional protection but are dependent on the validity of the independent claims.

For Patent 10,016,403, reviewing the claims involves understanding the specific methods and components described, such as the electrontransport polypeptide and any specific conditions or steps involved in enhancing it.

Patent Search Process

Importance of Patent Searches

Before filing a patent application or analyzing an existing patent, conducting a thorough patent search is essential. This process helps in identifying prior art and ensuring that the invention is novel and non-obvious.

Tools for Patent Searches

Several tools and resources are available for conducting patent searches:

  • Patent Public Search: This tool, provided by the USPTO, offers enhanced access to prior art through two modern interfaces. It replaces legacy tools like PubEast and PubWest[1].
  • Global Dossier: This service allows users to view the file histories of related applications from participating IP Offices, including the IP5 Offices. It provides a comprehensive view of the patent family and related documentation[1].
  • Public Search Facility and PTRCs: The USPTO Public Search Facility and Patent and Trademark Resource Centers (PTRCs) offer access to patent and trademark information and provide training in patent search techniques[1].

International Patent Searches

To ensure global novelty, it is important to search international patent databases:

  • European Patent Office (EPO): Provides access to European patent databases through esp@cenet, including machine translations for some languages[1].
  • Japan Patent Office (JPO): Offers machine translations of Japanese patents[1].
  • World Intellectual Property Organization (WIPO): Features the PATENTSCOPE® Search Service, which includes full-text searches of international patent applications and machine translations for some documents[1].

Patent Scope and Claims

Metrics for Measuring Patent Scope

Patent scope is a critical aspect of patent quality debates. Simple metrics such as independent claim length and independent claim count can be used to measure patent scope. These metrics have explanatory power for several correlates of patent scope, including patent maintenance payments, forward citations, and the breadth of patent classes[3].

Implications of Patent Scope

  • Narrower Claims: Narrower claims at publication are associated with a higher probability of grant and a shorter examination process. This suggests that more focused claims can streamline the patent application process[3].
  • Broader Claims: Broader claims can lead to increased licensing and litigation costs due to their potential ambiguity and overlap with existing patents. This highlights the importance of carefully drafting claims to balance protection and clarity[3].

Patent Allowance Rates

Understanding the probability of receiving a patent is crucial for inventors and businesses. The USPTO's internal databases provide insights into patent allowance rates:

  • First-Action Allowance Rate: The proportion of progenitor applications allowed without further examination.
  • Progenitor Allowance Rate: The proportion of progenitor applications allowed without any continuation procedure.
  • Family Allowance Rate: The proportion of progenitor applications that produce at least one patent, including the outcomes of continuation applications[4].

Legal Implications of False Patent Claims

Making false claims about the patented status of a product can have significant legal implications. According to a recent Federal Circuit decision, falsely claiming a product or product feature is patented can lead to claims of false advertising under the Lanham Act. This emphasizes the importance of accuracy in marketing and advertising materials related to patented products[2].

Key Takeaways

  • Thorough Patent Searches: Conducting comprehensive patent searches using tools like Patent Public Search and Global Dossier is essential for ensuring novelty and non-obviousness.
  • Careful Claim Drafting: The scope of patent claims significantly impacts the patent's validity and enforceability. Narrower claims can facilitate a smoother examination process.
  • Global Considerations: Searching international patent databases is crucial for global novelty and to avoid potential infringement.
  • Legal Compliance: Accurate representation of patented status in marketing materials is vital to avoid Lanham Act violations.

FAQs

What is the importance of independent claims in a patent?

Independent claims define the broadest scope of the invention and are critical for determining the patent's scope and validity.

How can I conduct a thorough patent search?

Use tools like Patent Public Search, Global Dossier, and international patent databases such as those provided by the EPO, JPO, and WIPO.

What are the implications of broader claims in a patent application?

Broader claims can lead to increased licensing and litigation costs due to potential ambiguity and overlap with existing patents.

Can false patent claims lead to legal issues?

Yes, falsely claiming a product or product feature is patented can lead to claims of false advertising under the Lanham Act.

What metrics can be used to measure patent scope?

Independent claim length and independent claim count are simple metrics that can be used to measure patent scope and have explanatory power for several correlates of patent scope.

Sources

  1. USPTO - Search for patents: https://www.uspto.gov/patents/search
  2. Federal Circuit Ruling: False Patent Claims Can Lead to Lanham Act Violations: https://www.bipc.com/federal-circuit-ruling-false-patent-claims-can-lead-to-lanham-act-violations
  3. Patent Claims and Patent Scope: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
  4. What Is the Probability of Receiving a US Patent?: https://yjolt.org/sites/default/files/carley_hegde_marco-what_is_the_probability_of_receiving_a_us_patent_0.pdf

More… ↓

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Drugs Protected by US Patent 10,016,403

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Patented / Exclusive UseSubmissiondate
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-001 Jan 4, 2012 DISCN Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-002 Jan 4, 2012 DISCN Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-003 Jan 4, 2012 DISCN Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-004 Jan 4, 2012 DISCN Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-005 Jan 4, 2012 DISCN Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-006 Aug 30, 2012 DISCN Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-007 Aug 30, 2012 DISCN Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Patented / Exclusive Use>Submissiondate
Showing 1 to 7 of 7 entries

International Family Members for US Patent 10,016,403

CountryPatent NumberEstimated ExpirationSupplementary Protection CertificateSPC CountrySPC Expiration
Australia 2007208229 ⤷  Try for Free
Brazil PI0707235 ⤷  Try for Free
Canada 2637672 ⤷  Try for Free
China 101378735 ⤷  Try for Free
Cyprus 1117263 ⤷  Try for Free
Denmark 1976521 ⤷  Try for Free
European Patent Office 1976521 ⤷  Try for Free
>Country>Patent Number>Estimated Expiration>Supplementary Protection Certificate>SPC Country>SPC Expiration
Showing 1 to 7 of 7 entries

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