United States Patent 5,886,036: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,886,036, titled "Retroviral protease inhibiting compounds," is a significant patent in the field of antiretroviral therapy, particularly for the treatment of HIV. This patent, assigned to Abbott Laboratories, plays a crucial role in the development and commercialization of protease inhibitors, a class of drugs vital for managing HIV/AIDS.
Background and Context
The patent was filed on March 20, 1997, and granted on March 23, 1999. It is part of a broader landscape of patents related to antiretroviral therapies, which have been a focal point of pharmaceutical innovation and legal scrutiny[2].
Scope and Claims
Overview of the Invention
The patent describes and claims compounds that inhibit retroviral proteases, enzymes essential for the replication of retroviruses such as HIV. These compounds are designed to bind to the active site of the protease, thereby inhibiting the virus's ability to replicate.
Specific Claims
The patent includes multiple claims that define the scope of the invention. These claims cover:
- Chemical Compounds: Specific chemical structures and their derivatives that act as protease inhibitors.
- Methods of Use: Methods for treating retroviral infections, particularly HIV, using these compounds.
- Pharmaceutical Compositions: Formulations and compositions that include these protease inhibitors for therapeutic use[2].
Patent Landscape Analysis
Technological Domain
Patent landscape analysis is crucial for understanding the technological domain and competitive landscape. For protease inhibitors like those described in US Patent 5,886,036, this analysis reveals a dense field with numerous patents filed by various entities, including pharmaceutical companies and academic institutions[3].
Key Players
The landscape is dominated by large pharmaceutical corporations, with Abbott Laboratories being a significant player. Universities and research institutions also contribute, though to a lesser extent. The majority of patent filings are in the United States and the European Patent Office, with a high percentage of patent families filing PCT (Patent Cooperation Treaty) applications[1].
Legal Status and Expiry Dates
Understanding the legal status and expected expiry dates of patents is vital for strategic planning. For US Patent 5,886,036, the expiry date would have been around 2017, assuming a standard 20-year term from the filing date. This information is critical for generic drug manufacturers and for assessing market competition[3].
Market Developments and Trends
Patent landscape studies reveal market trends, including mergers and acquisitions, in/out-licensing agreements, and litigation activities. For example, the patent landscape around protease inhibitors has seen significant litigation, such as the case involving Abbott Laboratories and its Norvir (ritonavir) product, which highlights the competitive and legal complexities in this domain[5].
Impact on the Pharmaceutical Industry
Innovation and Competition
Patents like US 5,886,036 drive innovation by protecting intellectual property and encouraging investment in research and development. However, they also create barriers to entry for generic manufacturers, which can impact competition and drug prices.
Regulatory Framework
The FDA plays a crucial role in regulating these patents through the Orange Book, which lists patents associated with approved drug products. This framework ensures that generic manufacturers are aware of the patent landscape and can plan accordingly. For instance, an ANDA (Abbreviated New Drug Application) applicant must identify and challenge relevant Orange Book-listed patents to gain approval[4].
Case Studies and Examples
Abbott Laboratories and Norvir
The case of Abbott Laboratories and its product Norvir (ritonavir) is a notable example. Abbott's assertion of the '036 patent as a defense against claims of monopolization and unfair competition highlights the legal battles that can arise in the pharmaceutical industry. Such cases underscore the importance of patent landscape analysis in navigating these complexities[5].
Industry Expert Insights
Industry experts emphasize the importance of comprehensive patent landscape analysis for strategic decision-making. For example, understanding the patent expiry dates and the legal status of patents can help companies plan for future product launches and licensing agreements.
Statistics and Trends
- Patent Filings: The number of patents filed for protease inhibitors has been significant, with a trend showing increased filings over the years, particularly in the late 1990s and early 2000s[1].
- Geographical Distribution: The majority of these patents are filed in the United States and the European Patent Office, reflecting the global nature of pharmaceutical research and development[1].
Key Takeaways
- Patent Scope and Claims: US Patent 5,886,036 covers specific chemical compounds, methods of use, and pharmaceutical compositions related to protease inhibitors.
- Patent Landscape: The landscape is dominated by large pharmaceutical companies, with significant filings in the US and Europe.
- Legal and Regulatory Impact: Patents influence competition, innovation, and regulatory frameworks, such as the FDA's Orange Book.
- Strategic Importance: Comprehensive patent landscape analysis is crucial for strategic planning, including understanding legal status, expiry dates, and market trends.
FAQs
What is the main subject of US Patent 5,886,036?
The main subject of US Patent 5,886,036 is retroviral protease inhibiting compounds, specifically for the treatment of HIV.
Who is the assignee of US Patent 5,886,036?
The assignee of US Patent 5,886,036 is Abbott Laboratories.
What is the significance of the Orange Book in relation to pharmaceutical patents?
The Orange Book is a publication by the FDA that lists patents associated with approved drug products, helping generic manufacturers navigate the patent landscape and plan for product launches.
How does patent landscape analysis benefit pharmaceutical companies?
Patent landscape analysis provides valuable insights into competitors, market trends, and legal status of patents, aiding in strategic decision-making and minimizing business risks.
What is the typical duration of a patent in the United States?
The typical duration of a patent in the United States is 20 years from the filing date.
Sources
- USPTO issued patents mentioning ritonavir in a patent claim - KEI Online
- US Patent for Retroviral protease inhibiting compounds - Justia Patents
- Navigating Technological Domains with Patent Landscape Analysis - Sagacious Research
- USPTO-FDA Report on Drug Patent and Exclusivity - USPTO
- In re Abbott Laboratories Norvir Anti-Trust Litigation - Casetext
