Details for Patent: 9,126,941

Which drugs does patent 9,126,941 protect, and when does it expire?

Patent 9,126,941 protects XTANDI and is included in two NDAs.

This patent has one hundred and thirty-seven patent family members in twenty-eight countries.

Summary for Patent: 9,126,941

Title:	Treatment of hyperproliferative disorders with diarylhydantoin compounds
Abstract:	The present invention relates to diarylhydantoin compounds, including diarylthiohydantoins, and methods for synthesizing them and using them in the treatment of hormone refractory prostate cancer.
Inventor(s):	Sawyers; Charles L. (New York, NY), Jung; Michael E. (Los Angeles, CA), Chen; Charlie D. (Los Angeles, CA), Ouk; Samedy (Los Angeles, CA), Tran; Chris (New York, NY), Wongvipat; John (Nanuet, NY)
Assignee:	The Regents of the University of California (Oakland, CA)
Application Number:	13/448,964
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,126,941
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

United States Patent 9,126,941: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 9,126,941, titled "Treatment of hyperproliferative disorders with diarylhydantoin compounds," is a significant patent in the field of pharmaceuticals, particularly in the treatment of cancer and other hyperproliferative disorders. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background of the Patent

The patent, filed under the application number US13/448,964, was granted on September 8, 2015. It pertains to diarylhydantoin compounds, including diarylthiohydantoins, and their methods of synthesis and use in treating hyperproliferative disorders such as cancer[1][4].

Scope of the Patent

The scope of the patent is defined by its claims, which outline the specific inventions and methods that are protected. Here, the patent covers:

• Diarylhydantoin Compounds: The patent describes various diarylhydantoin compounds, including diarylthiohydantoins, which are synthesized through specific chemical reactions.
• Methods of Synthesis: Detailed methods for synthesizing these compounds are provided, including the use of specific reagents and conditions.
• Therapeutic Uses: The patent claims the use of these compounds in the treatment of hyperproliferative disorders, which include various types of cancer and other proliferative diseases[1][4].

Claims of the Patent

The claims of the patent are crucial as they define the boundaries of what is protected. Here are some key aspects:

• Independent Claims: These claims define the broadest scope of the invention. For example, Claim 1 might describe a specific diarylhydantoin compound, while subsequent claims might describe specific methods of synthesis or therapeutic uses.
• Dependent Claims: These claims narrow down the scope by adding additional limitations to the independent claims. For instance, a dependent claim might specify a particular method of synthesizing a compound or a specific dosage regimen for treatment[1][4].

Importance of Claim Scope

The scope of the claims is critical in patent law. A common misconception is that broader claims are always better, but this is not the case. Broader claims can be more difficult to get granted and are easier to invalidate due to issues such as the abstract idea exception or failure to meet the written description requirement[3].

Patent Landscape

The patent landscape surrounding US 9,126,941 involves several key factors:

• Prior Art: The patent must be novel and non-obvious over prior art. The presence of prior art in the field of diarylhydantoin compounds and their therapeutic uses could affect the validity and enforceability of the patent[1][4].
• Competitor Patents: Other patents in the same field could pose challenges or opportunities for collaboration. For example, patents related to similar therapeutic compounds or methods might require careful analysis to avoid infringement[2][5].
• Litigation and Settlements: Patents in the pharmaceutical industry are often subject to litigation, particularly when generic manufacturers seek to enter the market. The validity and enforceability of the patent claims can be tested in court, as seen in various ANDA (Abbreviated New Drug Application) litigation cases[2][5].

Litigation and Enforcement

The enforcement of US 9,126,941 would involve ensuring that no other entity infringes on the protected claims. This could involve monitoring generic drug applications and taking legal action if necessary. For instance, if a generic manufacturer files an ANDA that infringes on the valid claims of this patent, the patent holder could seek an injunction to prevent the generic product from entering the market[2][5].

Economic and Social Impact

The economic and social impact of this patent is significant. By protecting the invention, the patent holder can recoup investment in research and development, which can lead to further innovation. However, it also means that generic versions of the drug may not be available until the patent expires, potentially affecting the affordability and accessibility of the treatment.

Key Takeaways

• Specific Claims: The patent's claims are specific to diarylhydantoin compounds and their therapeutic uses.
• Synthesis Methods: Detailed methods of synthesis are provided.
• Therapeutic Applications: The compounds are used in treating hyperproliferative disorders.
• Patent Landscape: The patent must navigate prior art, competitor patents, and potential litigation.
• Economic Impact: The patent affects the availability and affordability of the treatment.

FAQs

What are diarylhydantoin compounds?

Diarylhydantoin compounds, including diarylthiohydantoins, are a class of chemical compounds used in the treatment of hyperproliferative disorders such as cancer.

What is the significance of US 9,126,941 in the pharmaceutical industry?

This patent is significant because it protects specific compounds and methods used in cancer treatment, allowing the patent holder to recoup investment in research and development.

How do broader claims affect the validity of a patent?

Broader claims can be more difficult to get granted and are easier to invalidate due to issues such as the abstract idea exception or failure to meet the written description requirement.

What is the role of ANDA litigation in patent enforcement?

ANDA litigation involves generic manufacturers seeking to enter the market with a generic version of a patented drug. The patent holder can seek an injunction to prevent infringement if the generic product infringes on valid claims.

How does the patent landscape affect the enforcement of US 9,126,941?

The patent landscape, including prior art and competitor patents, must be carefully navigated to ensure the validity and enforceability of the patent claims.

Sources

1. US9126941B2 - Treatment of hyperproliferative disorders with diarylhydantoin compounds - Google Patents
2. ANDA Litigation Settlements - Robins Kaplan LLP Law Firm
3. The Importance of Getting the Claim Scope Right in a US Patent Application - Rimon Law
4. US20120295944A1 - Treatment of hyperproliferative disorders with diarylhydantoin compounds - Google Patents
5. ANDA Litigation Settlements - Robins Kaplan LLP Law Firm

Drugs Protected by US Patent 9,126,941

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012	AB	RX	Yes	Yes	9,126,941					TREATMENT OF PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER (CRPC)
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012	AB	RX	Yes	Yes	9,126,941					THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (CRPC).
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012	AB	RX	Yes	Yes	9,126,941					THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012	AB	RX	Yes	Yes	9,126,941					TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (NMCSPC) WITH BIOCHEMICAL RECURRENCE (BCR) AT HIGH RISK FOR METASTASIS
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-001	Aug 4, 2020		RX	Yes	No	9,126,941					THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER

International Family Members for US Patent 9,126,941

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1893196		C300632	Netherlands
European Patent Office	1893196		CA 2013 00065	Denmark
European Patent Office	1893196		PA2013029	Lithuania
European Patent Office	1893196		1390060-0	Sweden
European Patent Office	1893196		C20130036 00106	Estonia