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Last Updated: December 26, 2024

Details for Patent: 8,324,281


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Which drugs does patent 8,324,281 protect, and when does it expire?

Patent 8,324,281 protects NEVANAC and is included in one NDA.

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

Summary for Patent: 8,324,281
Title:Topical nepafenac formulations
Abstract: Topical suspension compositions of nepafenac are disclosed. The compositions are especially suitable for topical ophthalmic administration.
Inventor(s): Wong; Warren (Fort Worth, TX)
Assignee: Novartis AG (Basel, CH)
Application Number:13/253,648
Patent Claim Types:
see list of patent claims
Composition;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of U.S. Patents: A Detailed Analysis

Introduction

Patents are a cornerstone of innovation, providing inventors and companies with the exclusive rights to their inventions for a specified period. The U.S. patent system, managed by the U.S. Patent and Trademark Office (USPTO), is complex and involves various aspects such as patent scope, claim construction, and the broader patent landscape. This article will delve into the details of patent scope, claims, and the overall patent landscape, using the context of U.S. Patent 8,324,281 as a reference point.

Patent Scope and Quality

The scope of a patent is a critical aspect that determines the breadth of protection it offers. Research has shown that patent scope can be measured using metrics such as independent claim length and independent claim count[3].

  • Metrics for Patent Scope: Studies have validated these metrics by showing they have explanatory power for several correlates of patent scope, including patent maintenance payments, forward citations, the breadth of patent classes, and novelty. Narrower claims at publication are associated with a higher probability of grant and a shorter examination process than broader claims[3].

Claim Construction and Validity

Claim construction is a crucial step in the patent process, as it defines the boundaries of what is protected by the patent.

  • Legal Framework: Claim construction is a question of law that receives de novo review on appeal. The claims must inform those skilled in the art with reasonable certainty, and independent claims must be consistent with other independent claims, though they do not have to be mutually exclusive[2].

  • Validity Challenges: Patents are accompanied by a presumption of validity, but this can be challenged through various mechanisms such as inter partes review (IPR) petitions. For instance, in the case of VASCULAR SOLUTIONS LLC v. MEDTRONIC, INC., the Patent Trial and Appeal Board (PTAB) determined some claims unpatentable while others remained valid[2].

The U.S. Patent Landscape

The U.S. patent landscape is diverse and dynamic, with various industries and entities contributing to the patent ecosystem.

  • Patent Activity: In 2018, the USPTO awarded 309,000 utility patents, with businesses receiving the majority (85%) of these patents. The computer and electronics manufacturing industry was particularly active, receiving nearly 30,000 patents and reporting the highest level of domestic R&D performance[1].

  • Technology Areas: Patents are classified into broad technology areas such as electrical engineering, mechanical engineering, and others. The number of electrical engineering patents more than doubled between 2000 and 2018, driven significantly by advancements in information and communication technologies (ICT)[1].

Patent Trends and Innovations

The patent landscape is constantly evolving, reflecting technological advancements and changing market needs.

  • Industry-Specific Trends: High R&D industries tend to have high rates of patenting. For example, the computer systems design and related services industry shows relatively high levels of U.S. patenting, even if they do not always outspend other industries in R&D[1].

  • Global Comparisons: The USPTO's patent data can be compared internationally using the World Intellectual Property Organization (WIPO) classification system. This allows for a comprehensive analysis of global trends in patenting[1].

Challenges and Controversies

The patent system faces several challenges and controversies, including debates over patent quality and the need for reform.

  • Patent Quality Debates: There is ongoing debate about the quality of patents, with some arguing that patents have become overly broad and less clear, leading to increased licensing and litigation costs. This has sparked discussions about how to measure and improve patent quality[3].

  • Small Claims Patent Court: There have been proposals and studies on the feasibility of a small claims patent court to address the high costs associated with patent litigation. This initiative aims to provide a more accessible and cost-effective way for small entities to resolve patent disputes[5].

Case Study: U.S. Patent 8,324,281

While the specific details of U.S. Patent 8,324,281 are not provided here, understanding its scope and claims would involve analyzing the patent's claim language, the technology area it belongs to, and any legal challenges it may have faced.

  • Claim Analysis: The scope of the patent would be determined by the independent claims and their length. Narrower claims generally have a higher probability of being granted and face fewer challenges during the examination process[3].

  • Technology Area: The patent would be classified under one of the broad technology areas defined by the USPTO and WIPO. This classification helps in understanding the broader trends and innovations within that technology area[1].

Key Takeaways

  • Patent Scope Metrics: Independent claim length and count are useful metrics for measuring patent scope and predicting the likelihood of patent grant and examination duration.
  • Claim Construction: Claim construction is a legal process that defines the boundaries of patent protection and is subject to de novo review on appeal.
  • U.S. Patent Trends: The U.S. patent landscape is dominated by businesses, particularly in the computer and electronics manufacturing industry, with significant contributions from ICT advancements.
  • Challenges and Reforms: The patent system faces challenges related to patent quality and litigation costs, with proposals for reforms such as a small claims patent court.

FAQs

1. What are the key metrics for measuring patent scope? Independent claim length and independent claim count are two simple yet effective metrics for measuring patent scope. These metrics have explanatory power for several correlates of patent scope, including patent maintenance payments and forward citations[3].

2. How is claim construction determined in patent law? Claim construction is a question of law that receives de novo review on appeal. It involves interpreting the claim language to define the boundaries of what is protected by the patent, ensuring that the claims inform those skilled in the art with reasonable certainty[2].

3. Which industries are most active in patenting in the U.S.? The computer and electronics manufacturing industry is one of the most active in patenting, receiving nearly 30,000 patents in 2017 and reporting the highest level of domestic R&D performance[1].

4. What is the role of the World Intellectual Property Organization (WIPO) in patent classification? WIPO provides a classification system that allows for the aggregation of patent data into broad technology areas. This system facilitates international comparisons of patent trends and innovations[1].

5. Why is there a need for a small claims patent court? The need for a small claims patent court arises from the high costs associated with patent litigation, which can be prohibitive for small entities. A small claims court would provide a more accessible and cost-effective way to resolve patent disputes[5].

Cited Sources

  1. NCSES, "Invention: U.S. and Comparative Global Trends," January 15, 2020.
  2. CAFC, "VASCULAR SOLUTIONS LLC v. MEDTRONIC, INC.," September 16, 2024.
  3. SSRN, "Patent Claims and Patent Scope," September 29, 2016.
  4. YJOLT, "What Is the Probability of Receiving a US Patent?"
  5. ACUS, "U.S. Patent Small Claims Court," April 28, 2022.

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Drugs Protected by US Patent 8,324,281

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Harrow Eye NEVANAC nepafenac SUSPENSION/DROPS;OPHTHALMIC 021862-001 Aug 19, 2005 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 8,324,281

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 052252 ⤷  Subscribe
Austria E476200 ⤷  Subscribe
Australia 2005311738 ⤷  Subscribe
Brazil PI0518904 ⤷  Subscribe
Canada 2586807 ⤷  Subscribe
China 101068573 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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