Details for Patent: 8,183,274

Which drugs does patent 8,183,274 protect, and when does it expire?

Patent 8,183,274 protects XTANDI and is included in two NDAs.

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

Summary for Patent: 8,183,274

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. (Shanghai, CN), Ouk; Samedy (Costa Mesa, CA), Tran; Chris (New York, NY), Wongvipat; John (Nanuet, NY)
Assignee:	The Regents of the University of California (Oakland, CA)
Application Number:	12/708,523
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,183,274
Patent Claim Types: see list of patent claims	Use; Delivery; Formulation; Dosage form; Composition;

United States Patent 8,183,274: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 8,183,274, hereafter referred to as the '274 patent, is a significant patent in the pharmaceutical sector, particularly in the treatment of hyperproliferative disorders. This patent is associated with the drug enzalutamide, marketed under the brand name Xtandi®, which is used primarily for the treatment of prostate cancer. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Background of the Patent

The '274 patent, titled "Treatment of hyperproliferative disorders with diarylhydantoin compounds," was granted to Medivation, Inc. and The Regents of the University of California. It covers methods for treating various hyperproliferative disorders, including prostate cancer, using specific diarylhydantoin compounds, such as enzalutamide[1].

Scope of the Patent

Hyperproliferative Disorders

The patent's scope extends to the treatment of several hyperproliferative disorders, including prostate cancer, breast cancer, ovarian cancer, and benign prostatic hyperplasia. The compounds described are designed to inhibit the growth of cancer cells, particularly those that are hormone-refractory[1].

Diarylhydantoin Compounds

The patent specifically focuses on diarylhydantoin compounds, including diarylthiohydantoins. These compounds are synthesized through various chemical processes and are formulated into different dosage forms such as capsules, tablets, and suspensions[1].

Claims of the Patent

Method Claims

The '274 patent includes method claims that describe the use of diarylhydantoin compounds for treating hyperproliferative disorders. These claims are detailed and specify the dosage forms, administration routes, and the conditions under which these compounds are effective[1].

Composition Claims

In addition to method claims, the patent also includes composition claims that describe the chemical structure and synthesis of the diarylhydantoin compounds. These claims are crucial for defining the scope of protection for the patented compounds[1].

Patent Landscape

Litigation and Infringement

The '274 patent has been at the center of several patent infringement lawsuits. For instance, Astellas Pharma US, Inc., and other related entities have sued Actavis Laboratories FL, Inc., for attempting to market a generic version of enzalutamide before the expiration of the '274 patent. These lawsuits highlight the importance of this patent in protecting the intellectual property rights of the original developers[2][5].

Expiration Dates

The '274 patent is set to expire on August 24, 2026. This expiration date is critical for generic manufacturers who are awaiting the opportunity to enter the market with their own versions of enzalutamide[5].

Related Patents

The '274 patent is part of a broader portfolio of patents related to enzalutamide, including U.S. Patent Nos. 7,709,517 and 9,126,941. These patents collectively protect various aspects of enzalutamide, including its use, formulation, and synthesis[2][5].

Patent Scope Metrics

Independent Claim Length and Count

Studies on patent scope often use metrics such as independent claim length and independent claim count to assess the breadth and clarity of patent claims. For the '274 patent, these metrics would indicate the complexity and specificity of the claims, which are critical in determining the patent's scope and enforceability[3].

Impact on Innovation and Litigation

Patent Quality and Litigation Costs

The '274 patent, like many others in the pharmaceutical sector, has been subject to discussions on patent quality and the impact on innovation. Broad or unclear claims can lead to increased litigation costs and may hinder innovation by creating barriers to entry for other manufacturers[3].

Licensing and Enforcement

The enforcement of the '274 patent has significant implications for licensing agreements and the commercialization of enzalutamide. The ongoing litigation with generic manufacturers underscores the importance of robust patent protection in the pharmaceutical industry[2].

Clinical Significance

Treatment of Prostate Cancer

Enzalutamide, the drug protected by the '274 patent, is a crucial treatment option for patients with hormone-refractory prostate cancer. The patent ensures that the original developers can recoup their investment in research and development, which is essential for continuing innovation in cancer therapies[1].

Resistance and Efficacy

Research has shown that prostate cancer cells can change their identity to escape therapies, including those targeted by enzalutamide. The '274 patent's protection helps in ensuring that any modifications or improvements to enzalutamide are also protected, which is vital for addressing resistance and maintaining efficacy[4].

Key Takeaways

• Scope and Claims: The '274 patent covers the treatment of hyperproliferative disorders using diarylhydantoin compounds, with specific method and composition claims.
• Patent Landscape: The patent is part of a broader portfolio protecting enzalutamide and has been involved in significant litigation to protect its intellectual property.
• Expiration Dates: The patent is set to expire on August 24, 2026, which will impact the market entry of generic versions.
• Impact on Innovation: The patent's scope and enforcement affect innovation and litigation costs in the pharmaceutical sector.
• Clinical Significance: The patent protects a critical treatment for hormone-refractory prostate cancer, ensuring continued innovation in cancer therapies.

FAQs

What is the primary use of the '274 patent?

The '274 patent primarily covers the treatment of hyperproliferative disorders, including prostate cancer, using diarylhydantoin compounds like enzalutamide.

Which companies are involved in the litigation related to the '274 patent?

Astellas Pharma US, Inc., and related entities are involved in litigation against Actavis Laboratories FL, Inc., for attempting to market a generic version of enzalutamide before the patent's expiration.

What are the key metrics used to measure patent scope?

Independent claim length and independent claim count are commonly used metrics to assess the breadth and clarity of patent claims.

How does the '274 patent impact innovation in cancer therapies?

The patent ensures that the original developers can recoup their investment in research and development, which is essential for continuing innovation in cancer therapies.

When is the '274 patent set to expire?

The '274 patent is set to expire on August 24, 2026.

Sources

1. US8183274B2 - Treatment of hyperproliferative disorders with diarylhydantoin compounds - Google Patents
2. ASTELLAS PHARMA US, INC - RPX Insight
3. Patent Claims and Patent Scope - Hoover Institution
4. MSK Researchers Discover How Cancer Cells Change Identity To Escape Therapies - MSKCC
5. Enzalutamide Capsules - accessdata.fda.gov

Drugs Protected by US Patent 8,183,274

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						THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO HAVE PREVIOUSLY RECEIVED DOCETAXEL
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012	AB	RX	Yes	Yes						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						THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012	AB	RX	Yes	Yes						TREATMENT OF PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER (CRPC)
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012	AB	RX	Yes	Yes						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						TREATMENT OF PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER (CRPC)

International Family Members for US Patent 8,183,274

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
European Patent Office	1893196		169 50005-2013	Slovakia