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Last Updated: December 22, 2024

Details for Patent: 9,642,844


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Which drugs does patent 9,642,844 protect, and when does it expire?

Patent 9,642,844 protects SUBSYS and is included in one NDA.

This patent has nine patent family members in nine countries.

Summary for Patent: 9,642,844
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 DEVELOPMENT COMPANY, INC. (Chandler, AZ)
Application Number:14/966,301
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,642,844
Patent Claim Types:
see list of patent claims
Use; Formulation; Compound;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 9,642,844

Introduction

The United States Patent 9,642,844, hereafter referred to as the '844 patent, is a part of a broader patent landscape that involves complex legal and technical considerations. This article will delve into the details of the scope and claims of this patent, as well as the surrounding patent landscape, to provide a comprehensive understanding.

Patent Overview

The '844 patent is one of several patents involved in litigation and intellectual property disputes, particularly in the pharmaceutical sector. It falls under the jurisdiction of the United States Patent Laws, specifically 35 U.S.C. ยงยง 100 et seq.[2].

Jurisdiction and Venue

The litigation involving the '844 patent is typically heard in the United States District Court, with jurisdiction and venue often determined by the location of the defendants and the nature of the infringement. For instance, in cases involving Teva Pharmaceuticals USA, Inc., the venue is often the District of Delaware due to the defendant's corporate presence there[2].

Claims and Infringement

The '844 patent includes multiple claims, some of which have been the subject of infringement allegations. In litigation, defendants may allege noninfringement or invalidity of specific claims. For example, in a case against Teva Pharmaceuticals, it was noted that Teva's statement alleged noninfringement of only two claims of the '844 patent, while not addressing other claims[2].

Patent Scope and Claim Analysis

The scope of a patent is crucial in determining its validity and enforceability. The '844 patent, like other patents, is evaluated based on the language and breadth of its claims. Here are some key points to consider:

Independent Claim Length and Count

Research suggests that the length and count of independent claims can be metrics for measuring patent scope. Patents with narrower claims at publication tend to have a higher probability of grant and a shorter examination process compared to those with broader claims[4].

Practical Applications and Technological Improvements

For a patent claim to be eligible, it must integrate a judicial exception into a practical application. This means the claim must go beyond mere abstract ideas or routine data processing and provide a tangible technological improvement. For instance, in the context of AI-related patents, claims that specify the use of separated audio components in a real-time speech recognition system to enhance accuracy would be considered patent-eligible because they provide a practical application[1].

Litigation History

The '844 patent has been involved in several litigation cases, often alongside other related patents. These cases typically involve disputes over infringement, validity, and the scope of the patent claims. For example, in the case of BTcP Pharma v. Teva Pharmaceuticals USA, Inc., the litigation history includes allegations of infringement and challenges to the validity of the patent claims[3].

Subject Matter Eligibility

Subject matter eligibility is a critical aspect of patent law, especially in the context of software and AI-related inventions. The 2024 USPTO guidance update clarifies that the method of invention development, including the use of AI, does not impact subject matter eligibility. Instead, the focus remains on whether the claimed invention integrates a judicial exception into a practical application, providing meaningful limits and tangible benefits[1].

Real-World Applications

To bolster the argument for patent eligibility, it is essential to highlight the real-world applications of the claimed method or system. For the '844 patent, demonstrating how the claimed invention solves specific problems or provides concrete benefits in the relevant field is crucial. This could involve showing how the invention improves existing technologies or addresses particular challenges in the pharmaceutical industry.

Case Law and Precedents

The interpretation and enforcement of patent claims are often influenced by recent case law and precedents. For instance, the 2024 USPTO guidance update incorporates recent case law to provide clearer guidelines on what constitutes a patent-eligible invention. This ensures that claims are evaluated consistently and that innovators can draft claims that are more likely to avoid section 101 rejections[1].

Key Takeaways

  • Patent Scope and Claims: The scope of a patent is determined by the breadth and specificity of its claims. Narrower claims are generally associated with a higher probability of grant and shorter examination processes.
  • Practical Applications: For a patent claim to be eligible, it must integrate a judicial exception into a practical application, providing tangible benefits and technological improvements.
  • Litigation and Jurisdiction: Patents like the '844 patent are often involved in litigation, with jurisdiction and venue determined by the location and nature of the infringement.
  • Subject Matter Eligibility: The method of invention development, including AI, does not impact subject matter eligibility; the focus is on the claimed invention's practical application.
  • Real-World Applications: Highlighting real-world applications and concrete benefits is essential for demonstrating patent eligibility.

FAQs

Q: What are the key metrics for measuring patent scope? A: Independent claim length and independent claim count are simple metrics used to measure patent scope, which have explanatory power for several correlates of patent scope[4].

Q: How does the 2024 USPTO guidance update affect AI-related patents? A: The update clarifies that the method of invention development, including the use of AI, does not impact subject matter eligibility. Instead, it focuses on whether the claimed invention integrates a judicial exception into a practical application[1].

Q: What is the significance of practical applications in patent claims? A: Practical applications are crucial for demonstrating that a claimed invention provides tangible benefits and technological improvements, thereby meeting the criteria for patent eligibility[1].

Q: How is jurisdiction and venue determined in patent litigation? A: Jurisdiction and venue are typically determined by the location of the defendants and the nature of the infringement, often resulting in cases being heard in specific districts like the District of Delaware[2].

Q: What role does recent case law play in patent claim evaluation? A: Recent case law is incorporated into guidelines to provide clearer and consistent evaluations of patent claims, ensuring that innovators can draft claims that avoid common rejections[1].

Sources

  1. Understanding the 2024 USPTO Guidance Update on AI Patent - Mintz
  2. In the United States District Court for the District of Delaware - Insight.RPXcorp
  3. BTcP Pharma v. Teva Pharmaceuticals USA, Inc. - DrugPatentWatch
  4. Patent Claims and Patent Scope - SSRN
  5. Sublingual fentanyl spray and methods of treating pain - PubChem

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Drugs Protected by US Patent 9,642,844

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-001 Jan 4, 2012 DISCN Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-002 Jan 4, 2012 DISCN Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-003 Jan 4, 2012 DISCN Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-004 Jan 4, 2012 DISCN 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

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