United States Patent 9,987,261: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,987,261, titled "Substituted diazaspiroalkanes as androgen receptor modulators," is a significant patent in the field of pharmaceuticals, particularly in the treatment of hyperproliferative diseases and disorders. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Purpose
The patent describes compounds that are useful for the prevention or treatment of hyperproliferative diseases or disorders, such as prostate cancer and other androgen receptor-associated diseases. These compounds are classified as substituted diazaspiroalkanes, which act as androgen receptor modulators (ARMs)[4].
Scope of the Patent
Claims
The patent includes a series of claims that define the scope of the invention. These claims are divided into several categories:
- Compound Claims: These claims describe the specific chemical structures of the substituted diazaspiroalkanes, including various substitutions and modifications that are part of the invention[4].
- Method Claims: These claims outline the methods for using these compounds in the treatment of hyperproliferative diseases, including the administration routes and dosages[4].
- Composition Claims: These claims cover the pharmaceutical compositions that include the substituted diazaspiroalkanes, along with other ingredients such as carriers, adjuvants, and diluting agents[4].
Chemical Structure and Modifications
The patent specifies the chemical structure of the substituted diazaspiroalkanes, including the presence of trifluoromethyl groups, heterocyclic groups, and other specific substitutions. These modifications are crucial for the compounds' efficacy as androgen receptor modulators[4].
Patent Claims and Specifications
Written Description and Enablement
The patent claims must satisfy the written description and enablement requirements under 35 U.S.C. § 112(a). This means that the patent specification must provide a written description in "such full, clear, concise, and exact terms as to enable any person skilled in the art" to make and use the invention. The Federal Circuit has been increasingly strict on these requirements, particularly for genus claims, which can make it challenging to obtain broad patent protection[3].
Genus Claims
The patent includes genus claims that cover a class of compounds rather than specific embodiments. However, the current jurisprudence on § 112(a) has made it difficult to maintain broad genus claims, as the patentee must demonstrate that the specification enables the making and using of all species within the genus. This can be a significant hurdle in the pharmaceutical and biotechnology industries[3].
Patent Landscape and Litigation
Patent Infringement and Litigation
The patent is part of a larger patent portfolio that has been involved in litigation. For instance, the patent holders, including Aragon Pharmaceuticals and Janssen Biotech, have filed lawsuits against generic drug manufacturers, such as Hetero Labs Limited, alleging infringement of this and other related patents. These lawsuits often revolve around the submission of Abbreviated New Drug Applications (ANDAs) by generic manufacturers seeking approval to market generic versions of the patented drugs before the expiration of the patents[2].
Orange Book Listings
The patent is listed in the FDA's Orange Book, which is a database of approved drugs and their corresponding patents. This listing is crucial for generic manufacturers, as it informs them of the patents that must be addressed before they can market a generic version of the drug. The Orange Book listing for Erleada® (apalutamide), which is protected by this patent, indicates the expiration dates of the relevant patents and any ongoing litigation[2].
Industry Impact and Market Considerations
Market for Therapeutic Compounds
The market for therapeutic compounds, including androgen receptor modulators, is substantial and growing. The global market for biologics, which includes therapeutic antibodies, is projected to reach $300 billion by 2025. This market expansion underscores the importance of robust and predictable patent protection for innovators in the pharmaceutical and biotechnology industries[3].
Challenges in Patent Protection
The pharmaceutical and biotechnology industries face unique challenges in obtaining and maintaining patent protection. The rigid application of § 112(a) by the Federal Circuit has made it difficult for innovators to claim the full scope of their inventions without risking invalidation. This has led to a situation where innovators are "damned if they do and damned if they don’t," as they must balance the need for broad claims with the risk of those claims being deemed invalid or unenforceable[3].
Key Takeaways
- Scope and Claims: The patent covers specific chemical compounds and their use in treating hyperproliferative diseases, with detailed claims on compound structures, methods of use, and pharmaceutical compositions.
- Patent Landscape: The patent is part of a complex landscape involving litigation over generic drug approvals and is listed in the FDA's Orange Book.
- Industry Impact: The patent is crucial in a growing market for therapeutic compounds, but faces challenges due to strict patent laws and jurisprudence.
- Legal Considerations: The patent must comply with § 112(a) requirements, which have become increasingly stringent, particularly for genus claims.
FAQs
What is the main subject of United States Patent 9,987,261?
The main subject of this patent is the description of substituted diazaspiroalkanes as androgen receptor modulators for the prevention or treatment of hyperproliferative diseases.
What are the key claims in this patent?
The key claims include descriptions of the chemical structures of the substituted diazaspiroalkanes, methods for their use, and pharmaceutical compositions containing these compounds.
Why is this patent involved in litigation?
This patent is involved in litigation due to generic drug manufacturers submitting ANDAs to the FDA, which the patent holders allege infringe on their patent rights.
How does the Federal Circuit's jurisprudence affect this patent?
The Federal Circuit's strict application of § 112(a) makes it challenging for the patent to maintain broad genus claims, which can impact the scope of patent protection.
What is the significance of the Orange Book listing for this patent?
The Orange Book listing informs generic manufacturers about the patents that must be addressed before marketing a generic version of the drug and indicates the expiration dates of the relevant patents.
Sources
- US Patent 8,802,689B2 - Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases.
- Case 2:24-cv-06784 Document 1 Filed 06/06/24 - Complaint against Hetero Labs Limited Unit V and Hetero USA, Inc.
- Eviscerating Patent Scope - DigitalCommons@NYLS.
- US Patent 9,987,261B2 - Substituted diazaspiroalkanes as androgen receptor modulators.
