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Last Updated: April 11, 2025

Details for Patent: 8,835,459


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Which drugs does patent 8,835,459 protect, and when does it expire?

Patent 8,835,459 protects SUBSYS and is included in one NDA.

This patent has nine patent family members in nine countries.

Summary for Patent: 8,835,459
Title:Sublingual fentanyl spray
Abstract: The present invention is directed to sublingual formulations containing fentanyl, a pharmaceutically acceptable sale 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 Therapeutics, Inc. (Phoenix, AZ)
Application Number:13/895,111
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,835,459
Patent Claim Types:
see list of patent claims
Formulation; Compound;
Patent landscape, scope, and claims:

Analyzing the Scope and Claims of United States Patent 8,835,459: A Comprehensive Guide

Introduction

Understanding the scope and claims of a patent is crucial for both the patent holder and potential infringers. This article delves into the analysis of United States Patent 8,835,459, exploring its claims, scope, and the broader patent landscape.

Patent Overview

United States Patent 8,835,459, hereafter referred to as the '459 patent, is a patent that has been granted by the United States Patent and Trademark Office (USPTO). To analyze this patent, we need to look at its background, claims, and the technological area it covers.

Background and Technological Area

The '459 patent is typically associated with a specific technological field, such as software, hardware, or a particular industry. Understanding this context is essential for grasping the patent's relevance and impact. For example, if the patent pertains to image sensors, as seen in the Cellect case, it would involve claims related to devices comprising these sensors[1].

Claims Analysis

Independent and Dependent Claims

Each patent includes independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims. The '459 patent's claims would be analyzed to determine what is specifically protected under the patent.

Claim Scope and Coverage

The scope of the claims determines the extent of the patent's protection. A Claim Coverage Matrix, as described in patent analytics, can help categorize these claims by their scope concepts, making it easier to understand which aspects of the technology are protected[3].

Patent Landscape

Related Patents and Family Members

The '459 patent may be part of a larger patent family, including continuations, continuations-in-part, and divisional patents. Understanding these relationships is crucial, as seen in the Cellect case where multiple patents were interrelated and claimed priority from a single application[1].

Patent Term Adjustment (PTA) and Expiration

Patents can receive Patent Term Adjustments (PTA) due to USPTO delays during prosecution. This adjustment affects the patent's expiration date. Ensuring that the '459 patent's PTA, if any, is correctly calculated is vital for determining its current status and potential expiration date[1].

Obviousness-Type Double Patenting (ODP)

ODP is a critical issue in patent law, particularly for patents within the same family. If the '459 patent is part of a family where other patents have been granted, an ODP analysis may be necessary to ensure that the claims do not overlap in a way that renders them unpatentable[1].

Post-Grant Proceedings

The Leahy-Smith America Invents Act (AIA) introduced several post-grant proceedings, including Inter Partes Review (IPR) and Post-Grant Review (PGR), which can challenge the validity of granted patents. Understanding these proceedings is essential for managing and defending the '459 patent[4].

Inter Partes Review (IPR)

IPR is a common mechanism for challenging patent validity. If the '459 patent is challenged through an IPR, the Patent Trial and Appeal Board (PTAB) would review the patent's claims for validity based on prior art and other grounds[4].

Claim Charts and Patent Analytics

Using tools like ClaimScape® software, patent holders can generate interactive claim charts to review patent coverage. These charts help in identifying gaps in current coverage and highlighting future design opportunities. This analytical approach ensures that the '459 patent's claims are aligned with the company's current and future technological directions[3].

Economic and Strategic Implications

Value Assessment

The value of the '459 patent can be assessed based on its current and potential future impact on the company. High-value claims are those that protect core technologies, while medium and low-value claims may indicate future directions or areas that might not be worth maintaining[3].

Litigation and Enforcement

If the '459 patent is involved in litigation, understanding its claims and scope is crucial for both the plaintiff and defendant. The patent's validity and infringement claims would be scrutinized in court, and any weaknesses in the claims could impact the outcome of the litigation[5].

Expert Review and Collaboration

Collaboration with technical experts, engineers, and management is essential for accurately analyzing the '459 patent's claims. This collaborative approach ensures that the patent's coverage is thoroughly understood and aligned with the company's strategic goals[3].

Updating and Maintaining Patent Coverage

As new patents are filed or as technological developments evolve, the claim charts and coverage analysis should be updated. This ongoing process helps in maintaining robust patent protection and identifying new design opportunities[3].

Key Takeaways

  • Claims Analysis: Understand the independent and dependent claims to determine the scope of protection.
  • Patent Landscape: Identify related patents and family members to assess the broader patent context.
  • ODP Analysis: Ensure that the patent does not suffer from obviousness-type double patenting issues.
  • Post-Grant Proceedings: Be aware of potential challenges through IPR or PGR.
  • Patent Analytics: Use tools like ClaimScape® to analyze and update claim coverage.
  • Strategic Implications: Assess the economic and strategic value of the patent claims.

Frequently Asked Questions (FAQs)

What is the importance of analyzing the claims of a patent?

Analyzing the claims of a patent is crucial because it defines the scope of protection and determines what is legally protected under the patent.

How does Patent Term Adjustment (PTA) affect a patent's expiration date?

PTA adjusts the patent's expiration date due to delays during the prosecution process, ensuring that the patent holder receives the full term of protection.

What is Obviousness-Type Double Patenting (ODP), and why is it important?

ODP is a doctrine that prevents the same inventor from receiving multiple patents for the same invention. It is important to ensure that patents within the same family do not overlap in a way that renders them unpatentable.

What role does the Patent Trial and Appeal Board (PTAB) play in post-grant proceedings?

PTAB is responsible for hearing administrative challenges to the validity of patents, including Inter Partes Review (IPR) and Post-Grant Review (PGR), to determine whether the patent claims are valid.

How can patent analytics tools like ClaimScape® help in managing patent claims?

Patent analytics tools like ClaimScape® help in categorizing and analyzing patent claims, identifying gaps in coverage, and highlighting future design opportunities, making it easier to manage and maintain robust patent protection.

Cited Sources:

  1. In re Cellect - United States Court of Appeals for the Federal Circuit
  2. Update: IPRs Involving Biotech and Pharmaceutical Patents
  3. Patent Analytics | Intellectual Property Law
  4. The Patent Trial and Appeal Board and Inter Partes Review
  5. 35 USC 282: Presumption of validity; defenses

More… ↓

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Drugs Protected by US Patent 8,835,459

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 202788-003 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 202788-006 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 5 of 5 entries

International Family Members for US Patent 8,835,459

CountryPatent NumberEstimated ExpirationSupplementary Protection CertificateSPC CountrySPC Expiration
Australia 2008282743 ⤷  Try for Free
Canada 2698749 ⤷  Try for Free
Denmark 2180844 ⤷  Try for Free
European Patent Office 2180844 ⤷  Try for Free
Spain 2668366 ⤷  Try for Free
>Country>Patent Number>Estimated Expiration>Supplementary Protection Certificate>SPC Country>SPC Expiration
Showing 1 to 5 of 5 entries

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