United States Patent 9,388,159: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 9,388,159, titled "Substituted diazaspiroalkanes as androgen receptor modulators," is a significant patent in the field of pharmaceuticals, particularly in the development of androgen receptor modulators. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Purpose
This patent, issued to Aragon Pharmaceuticals (now part of Johnson & Johnson), pertains to compounds that act as selective androgen receptor modulators (SARMs). These compounds are crucial in treating conditions related to androgen receptor dysregulation, such as prostate cancer and other hormonal disorders[1].
Scope of the Patent
The patent scope is defined by the claims, which outline the specific compounds and their uses. Here, the scope includes:
Chemical Structure
The patent describes compounds of a specific formula, known as substituted diazaspiroalkanes. These compounds are characterized by their unique chemical structure, which includes various substituents such as aryl, alkyl, alkenyl, and alkynyl groups[1].
Androgen Receptor Modulation
The compounds are designed to selectively bind to the androgen receptor, either as agonists or antagonists, thereby modulating its activity. This modulation is critical for therapeutic applications, particularly in treating conditions like prostate cancer[4].
Claims of the Patent
The claims are the heart of any patent, defining the legal boundaries of the invention.
Independent Claims
The patent includes multiple independent claims that describe the general structure of the compounds and their pharmaceutical compositions. For example, Claim 1 might describe the general formula of the substituted diazaspiroalkanes, while subsequent claims might specify particular substituents or pharmaceutical formulations[1].
Dependent Claims
Dependent claims further narrow down the scope by specifying additional features or limitations. These claims often describe specific embodiments of the compounds, such as particular aryl or alkyl groups, or specific methods of preparation[1].
Pharmaceutical Compositions and Uses
The patent also covers pharmaceutical compositions containing these compounds and their methods of use. This includes formulations for various administration routes, such as oral, injectable, or topical forms[1].
Patent Landscape and Litigation
Understanding the patent landscape is crucial for assessing the patent's strength and potential challenges.
Litigation and Settlements
The patent has been involved in several litigation cases, particularly in the context of Abbreviated New Drug Applications (ANDAs) for generic versions of the drug Erleada® (apalutamide). For instance, Aragon Pharmaceuticals has taken legal action against companies seeking to market generic versions of Erleada® before the patent's expiration[5].
Competing Patents and Technologies
The patent landscape in the field of androgen receptor modulators is complex, with multiple patents covering various aspects of SARMs. Other companies and research institutions have also developed similar compounds, leading to a competitive environment where patent litigation is common[2].
Patent Scope Metrics
Research on patent scope metrics can provide insights into the patent's breadth and clarity.
Independent Claim Length and Count
Studies have shown that narrower claims, measured by independent claim length and count, are associated with a higher probability of grant and a shorter examination process. This suggests that the claims in US 9,388,159, if narrowly defined, would have undergone rigorous examination and are likely to be of high quality[3].
Impact on Innovation and Industry
The patent's impact on innovation and the pharmaceutical industry is significant.
Innovation Incentives
The patent provides exclusive rights to Aragon Pharmaceuticals, which can incentivize further research and development in the field of androgen receptor modulators. However, overly broad patents can sometimes stifle innovation by increasing licensing and litigation costs[3].
Market Dominance
The patent's validity and enforcement play a crucial role in maintaining market dominance for Erleada®. Successful litigation against generic manufacturers helps in delaying market entry of competitors, thereby protecting the patent holder's market share[5].
Key Takeaways
- Specific Chemical Structure: The patent covers substituted diazaspiroalkanes with specific chemical structures.
- Androgen Receptor Modulation: The compounds are designed to modulate androgen receptor activity.
- Pharmaceutical Compositions: The patent includes various pharmaceutical compositions and methods of use.
- Litigation and Settlements: The patent has been involved in several litigation cases related to ANDAs.
- Patent Scope Metrics: Narrower claims are associated with higher grant probabilities and shorter examination processes.
- Impact on Innovation: The patent can both incentivize and potentially stifle innovation depending on its breadth and enforcement.
Frequently Asked Questions (FAQs)
What is the main subject of United States Patent 9,388,159?
The main subject is substituted diazaspiroalkanes as androgen receptor modulators.
What are the therapeutic applications of the compounds described in the patent?
The compounds are primarily used in treating conditions related to androgen receptor dysregulation, such as prostate cancer.
How does the patent landscape affect the enforcement of this patent?
The competitive patent landscape in the field of androgen receptor modulators leads to frequent litigation, particularly against generic manufacturers seeking to market similar products.
What metrics are used to measure the scope of a patent like US 9,388,159?
Metrics such as independent claim length and independent claim count are used to measure patent scope and assess its quality.
How does the patent impact innovation in the pharmaceutical industry?
The patent can incentivize further research by providing exclusive rights, but overly broad claims can increase licensing and litigation costs, potentially stifling innovation.
Cited Sources
- US9388159B2 - Substituted diazaspiroalkanes as androgen receptor modulators - Google Patents
- ANDA Litigation Settlements | Hatch-Waxman - Robins Kaplan LLP
- Patent Claims and Patent Scope - Hoover Institution
- Apalutamide | C21H15F4N5O2S | CID 24872560 - PubChem
- in the united states district court - Insight.RPXcorp
