United States Patent 9,657,003: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,657,003, issued on May 23, 2017, is a significant patent in the field of pharmaceuticals, particularly focusing on androgen receptor modulating compounds. This patent is assigned to Orion Corporation and involves a series of compounds and methods for treating conditions related to androgen receptor activity.
Inventors and Assignee
The patent was invented by a team of researchers including Gerd Wohlfahrt, Olli Törmäkangas, Harri Salo, Iisa Höglund, Arja Karjalainen, Pia Koivikko, Patrik Holm, Sirpa Rasku, and Anniina Vesalainen. The assignee of the patent is Orion Corporation, a Finnish pharmaceutical company[2].
Patent Scope
The patent covers a broad range of compounds and their pharmaceutically acceptable salts, specifically designed to modulate the activity of the androgen receptor (AR). These compounds are particularly useful in treating conditions such as castration-resistant prostate cancer (CRPC)[1][4].
Compound Formula
The patent discloses compounds of a specific formula (I) and their pharmaceutically acceptable salts. These compounds are characterized by their ability to interact with the androgen receptor, either as agonists or antagonists, depending on the context of their use[2].
Therapeutic Applications
The primary therapeutic application of these compounds is in the treatment of CRPC. The compounds exhibit high to full AR antagonism with minimal agonism, making them effective in inhibiting the proliferation of prostatic cancer cells. Additionally, they have favorable safety profiles and low potential for drug-drug interactions[4].
Claims
The patent includes multiple claims that define the scope of the invention:
Independent Claims
- The patent claims cover the specific chemical structures of the compounds, including their stereochemistry and substituents.
- It also claims compositions comprising these compounds and methods of treating AR-dependent conditions using these compositions[1][2].
Dependent Claims
- Dependent claims further specify the types of substituents, the pharmaceutical formulations, and the methods of administration.
- These claims also include variations in the chemical structure and the therapeutic uses of the compounds[1].
Patent Landscape
The patent landscape surrounding US 9,657,003 is complex and involves several key aspects:
Patent Expiration Dates
- The patent is set to expire on October 27, 2030, which is 20 years from the date of filing, adjusted for any terminal disclaimers or extensions[2].
Related Patents
- This patent is part of a series of patents filed by Orion Corporation, including continuations and divisional applications. For example, it is a continuation of application No. 14/598,973, which is also related to androgen receptor modulating compounds[4].
International Filings
- The patent is part of an international patent family, with filings under the Patent Cooperation Treaty (PCT) and national stage filings in various countries[4].
Patent Quality and Scope
The quality and scope of the patent are critical factors in its validity and enforceability:
Claim Clarity and Breadth
- The patent claims are subject to scrutiny for clarity and breadth. Narrower claims are generally associated with a higher probability of grant and a shorter examination process, while broader claims may face more challenges during the examination process[3].
Examination Process
- The examination process tends to narrow the scope of patent claims, ensuring that the claims are clear and specific. This process is crucial for maintaining patent quality and preventing overly broad or unclear claims[3].
Industry Impact
The impact of this patent on the pharmaceutical industry is significant:
Treatment of CRPC
- The compounds covered by this patent offer new treatment options for CRPC, a condition that is challenging to treat with existing therapies. The effectiveness of these compounds in inhibiting cancer cell proliferation makes them valuable in clinical settings[1][4].
Competitive Landscape
- The patent provides Orion Corporation with exclusive rights to develop and market these compounds, giving the company a competitive edge in the market for CRPC treatments[2].
Future Developments
As the patent approaches its expiration date, several factors will influence its future:
Generic Availability
- After the patent expires, generic versions of the drug may become available, potentially changing the market dynamics and pricing strategies[2].
Continuing Innovation
- Orion Corporation and other pharmaceutical companies may continue to innovate and develop new compounds or formulations, potentially leading to new patents and further advancements in the treatment of AR-dependent conditions[4].
Key Takeaways
- Compound Specificity: The patent covers specific androgen receptor modulating compounds and their pharmaceutically acceptable salts.
- Therapeutic Use: The primary therapeutic application is in treating castration-resistant prostate cancer.
- Patent Expiration: The patent is set to expire on October 27, 2030.
- Industry Impact: The patent provides exclusive rights to Orion Corporation, influencing the competitive landscape for CRPC treatments.
- Future Developments: Generic availability and continuing innovation will shape the future of these compounds.
Frequently Asked Questions
What is the primary therapeutic application of the compounds covered by US 9,657,003?
The primary therapeutic application is in the treatment of castration-resistant prostate cancer (CRPC).
Who is the assignee of the patent US 9,657,003?
The assignee of the patent is Orion Corporation.
When is the patent set to expire?
The patent is set to expire on October 27, 2030.
What are the key characteristics of the compounds covered by this patent?
The compounds exhibit high to full AR antagonism with minimal agonism, have favorable safety profiles, and low potential for drug-drug interactions.
How does the patent landscape influence the development of new treatments for CRPC?
The patent landscape provides exclusive rights to the patent holder, influencing the competitive landscape and encouraging continued innovation in the development of new treatments.
Cited Sources
- US9657003B2 - Androgen receptor modulating compounds - Google Patents
- Generic Nubeqa Availability - Drugs.com
- Patent Claims and Patent Scope - Hoover Institution
- United States Patent - googleapis.com
"Patent scope is one of the important aspects in the debates over 'patent quality.' The purported decrease in patent quality over the past decade or two has supposedly led to granting patents of increased breadth (or 'overly broad' patents), decreased clarity, and questionable validity."[3]
