Detailed Analysis of the Scope and Claims of United States Patent 8,445,507
Introduction
The United States Patent 8,445,507, titled "Androgen Receptor Modulator for the Treatment of Prostate Cancer and Androgen Receptor-Associated Diseases," is a significant patent in the field of pharmaceuticals, particularly in the treatment of prostate cancer and other androgen receptor-associated diseases. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Inventors
This patent was issued on May 21, 2013, to the Regents of the University of California as the assignee. The inventors include Michael E. Jung, Charles L. Sawyers, Smedy Oult, Chris Tran, and John Wongvipat[2][4].
Scope of the Patent
The patent covers a hydantoin compound and its use as an androgen receptor modulator. These compounds are designed for the prevention or treatment of hyperproliferative diseases or disorders, with a specific focus on prostate cancer and other diseases associated with androgen receptors[1][4].
Claims of the Patent
The patent includes 31 claims that detail the composition, method of use, and pharmaceutical compositions of the hydantoin compounds. Here are some key aspects of the claims:
- Compound Claims: The patent claims specific hydantoin compounds and their derivatives, which are designed to modulate the androgen receptor. These compounds can be substituted or unsubstituted and may form heterocyclic aromatic or non-aromatic cycles[1][4].
- Pharmaceutical Compositions: Claims include pharmaceutical compositions that contain the hydantoin compounds, either alone or in combination with other active ingredients. These compositions can be in various forms, such as tablets, capsules, or injectable solutions[1][4].
- Methods of Use: The patent claims methods for treating prostate cancer and other androgen receptor-associated diseases using the hydantoin compounds. This includes administering the compounds to patients in need of such treatment[1][4].
Patent Landscape
The patent landscape surrounding US 8,445,507 is complex and involves several related patents and ongoing legal proceedings.
Related Patents
- US 8,802,689: This patent, also related to androgen receptor modulators, was issued on August 12, 2014, and covers similar aspects of treating prostate cancer and androgen receptor-associated diseases[2].
- US 9,388,159: Issued on July 12, 2016, this patent covers substituted diazaspiroalkanes as androgen receptor modulators[2].
- US 9,481,663: Issued on November 1, 2016, this patent pertains to crystalline forms of an androgen receptor modulator[2].
- US 9,987,261: Issued on June 5, 2018, this patent also covers substituted diazaspiroalkanes as androgen receptor modulators[2].
Litigation and Challenges
The patent is part of several ongoing legal proceedings, particularly related to the submission of Abbreviated New Drug Applications (ANDAs) by generic drug manufacturers.
- Infringement Claims: Companies like Sandoz Inc. have submitted ANDAs to the FDA seeking approval to market generic versions of Erleada®, a drug covered by the patents-in-suit, including US 8,445,507. The plaintiffs, including Aragon Pharmaceuticals, Janssen Biotech, and the Regents of the University of California, have alleged infringement of these patents[2][5].
- Paragraph IV Certifications: Defendants in these cases have provided Paragraph IV certifications, which assert the invalidity, unenforceability, or non-infringement of the claims of the patents-in-suit. This has led to extensive litigation to protect the intellectual property rights associated with these patents[2][5].
Impact on Pharmaceutical Industry
The protection and enforcement of US 8,445,507 have significant implications for the pharmaceutical industry.
- Market Exclusivity: The patent ensures market exclusivity for the branded drug Erleada® until the patent expires, protecting the revenue stream for the patent holders. Generic competition can significantly reduce sales and market share once the patent expires[3].
- Research and Development: The ongoing litigation and challenges to these patents highlight the competitive and innovative environment in pharmaceutical research and development. Companies must navigate complex patent landscapes to bring new treatments to market[3].
Key Takeaways
- Compound and Composition: US 8,445,507 covers specific hydantoin compounds and their pharmaceutical compositions for treating prostate cancer and other androgen receptor-associated diseases.
- Claims and Scope: The patent includes detailed claims on the compounds, methods of use, and pharmaceutical compositions.
- Related Patents: The patent is part of a broader portfolio of related patents covering androgen receptor modulators.
- Litigation: Ongoing litigation involves infringement claims and challenges from generic drug manufacturers.
- Industry Impact: The patent protects market exclusivity and influences the competitive landscape in pharmaceutical research and development.
FAQs
Q: What is the main subject of US Patent 8,445,507?
A: The main subject is a hydantoin compound used as an androgen receptor modulator for treating prostate cancer and other androgen receptor-associated diseases.
Q: Who are the inventors of this patent?
A: The inventors include Michael E. Jung, Charles L. Sawyers, Smedy Oult, Chris Tran, and John Wongvipat.
Q: What is the significance of the patent in the pharmaceutical industry?
A: The patent ensures market exclusivity for the branded drug Erleada® and protects the revenue stream for the patent holders until the patent expires.
Q: What are the related patents to US 8,445,507?
A: Related patents include US 8,802,689, US 9,388,159, US 9,481,663, and US 9,987,261, all covering aspects of androgen receptor modulators.
Q: Why is there ongoing litigation related to this patent?
A: The litigation involves generic drug manufacturers submitting ANDAs to market generic versions of Erleada® before the patent expires, leading to infringement claims by the patent holders.
Cited Sources
- United States Patent and Trademark Office: US8445507B2 - Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases[1].
- RPX Corporation: Complaint in the United States District Court for the District of Delaware[2].
- Johnson & Johnson: Form 10-K for Johnson & Johnson filed 02/16/2023[3].
- Google Patents: US8445507B2 - Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases[4].
- RPX Corporation: Complaint in the United States District Court for the District of Delaware[5].
