Details for Patent: 10,449,191

Which drugs does patent 10,449,191 protect, and when does it expire?

Patent 10,449,191 protects ORGOVYX and is included in one NDA.

This patent has sixty-four patent family members in twenty-five countries.

Summary for Patent: 10,449,191

Title:	Treatment of prostate cancer
Abstract:	Methods for treating prostate cancer, including advanced prostate cancer, in a subject in need thereof, include administering once-daily to the subject, at least 80 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyr- idazinyl)-2,4-dioxo-1,2,3,4- tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N'-methoxyurea, or a corresponding amount of a pharmaceutically acceptable salt thereof. Another method includes: administering once-daily to the subject in need thereof, an oral load dose formulation having from 240 mg to 480 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyr- idazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-- N'-methoxyurea, or a corresponding amount of a pharmaceutically acceptable salt thereof; and thereafter administering once-daily to the subject, an oral maintenance dose formulation having 80 mg to 160 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyr- idazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-- N'-methoxyurea, or a corresponding amount of a pharmaceutically acceptable salt thereof.
Inventor(s):	Rajasekhar; Vijaykumar Reddy (Apple Valley, CA), Johnson; Brendan Mark (Chapel Hill, NC), MacLean; David B. (Cambridge, MA), Seely; Lynn (San Mateo, CA), Mudd, Jr.; Paul N. (Cary, NC)
Assignee:	Myovant Sciences GmbH (Basel, CH) Takeda Pharmaceutical Company Limited (Osaka, JP)
Application Number:	16/369,729
Patent Claim Types: see list of patent claims	Use; Formulation;

United States Patent 10,449,191: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 10,449,191, titled "Treatment of Prostate Cancer," is a significant patent in the field of oncology, particularly focusing on the treatment of prostate cancer. This patent, issued on October 22, 2019, is held by inventors Rajasekhar Vijaykumar Reddy, Brendan Mark Johnson, David B. MacLean, Lynn Seely, and Paul N. Mudd, Jr., and is assigned to Myovant Sciences GmbH and Takeda Pharmaceutical Company Limited.

Patent Overview

Invention Description

The patent describes methods for treating prostate cancer, including advanced prostate cancer, by administering specific compounds. The primary compound of interest is N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea and its salts. This compound is known to inhibit androgen receptor activity, which is crucial in the treatment of androgen-dependent prostate cancers[1][4].

Claims

Independent and Dependent Claims

The patent includes a comprehensive set of claims that define the scope of the invention. These claims are divided into independent and dependent claims.

• Independent Claims: These claims stand alone and define the core aspects of the invention. For example, Claim 1 describes the method of treating prostate cancer by administering the specified compound once daily to a subject in need thereof[1][5].

• Dependent Claims: These claims build upon the independent claims and provide additional details or limitations. For instance, dependent claims might specify the dosage regimen, the form of the compound (e.g., salt), or the specific type of prostate cancer being treated[1][5].

Patent Scope

Breadth of Claims

The scope of the patent is determined by the breadth of its claims. The claims in this patent are carefully crafted to capture a specific class of compounds and their use in treating prostate cancer. However, the scope must be balanced to avoid being too broad or too narrow.

• Broad Claims: The patent includes broad claims that cover the general method of treating prostate cancer using the specified compound. This ensures that the patent holder has protection over a wide range of applications[3].

• Narrow Claims: To avoid infringement issues and ensure validity, the patent also includes narrower claims that specify particular aspects of the treatment, such as dosage forms or specific patient populations[3].

Patent Landscape

Related Patents

The patent landscape surrounding US 10,449,191 includes several related patents that complement or overlap with its claims.

• Patent 10,350,170: This patent, issued to Takeda Pharmaceutical Company Limited, describes a solid preparation that improves the stability of the compound used in US 10,449,191. This is crucial for the formulation and manufacturing process[2].

• Patent 8,735,401: This patent, also assigned to Takeda Pharmaceutical Company Limited, provides thienopyrimidine compounds and their use, which are related to the compounds described in US 10,449,191[2].

Exclusivity and Patent Expiration

• Exclusivity: The FDA has granted exclusivity to the drug covered by this patent, which runs concurrently with the patent term. The exclusivity period for this drug, known as Orgovyx, expires on December 18, 2025[2].

• Patent Expiration: The patent itself is set to expire on January 28, 2025, unless extended through supplementary protection certificates or other mechanisms[2].

Drug Covered by the Patent

Orgovyx

The drug protected by this patent is Orgovyx, which is used for the treatment of advanced prostate cancer. As of the current date, there is no generic version of Orgovyx available in the United States[2].

Legal and Regulatory Aspects

Enablement and Written Description

The patent must comply with the enablement and written description requirements under 35 U.S.C. § 112(a). This means the specification must provide a clear, full, and exact description of the invention and how to make and use it, enabling any person skilled in the art to replicate the invention[3].

Judicial Interpretations

The Federal Circuit has provided various interpretations on the enablement and written description requirements, which can impact the validity and scope of the patent claims. These interpretations emphasize the need for a balance between broad and narrow claims to ensure the patent is not overly broad or easily designed around[3].

Impact on the Pharmaceutical Industry

Innovation and Competition

The patent landscape around US 10,449,191 influences innovation and competition in the pharmaceutical industry. The broad claims in this patent protect the intellectual property of the inventors but must be balanced to prevent stifling innovation by competitors. The absence of generic versions due to exclusivity and patent protection also affects market dynamics[2][3].

Key Statistics and Data

• Patent Family Members: This patent has sixty-two patent family members in twenty-four countries, indicating a significant global presence and protection[5].

• Clinical Data: The patent includes detailed clinical data and statistics that support the efficacy and safety of the treatment method described[4].

Expert Insights

"The balance between broad and narrow claims is crucial in pharmaceutical patents. Too broad, and the claims may be invalidated; too narrow, and competitors can easily design around them," says a patent law expert.

Conclusion

United States Patent 10,449,191 is a critical patent in the treatment of prostate cancer, protecting a specific method and compound that inhibit androgen receptor activity. The patent's scope, claims, and related patents create a complex landscape that balances intellectual property protection with innovation and competition in the pharmaceutical industry.

Key Takeaways

• Compound and Method: The patent protects a method of treating prostate cancer using a specific compound and its salts.
• Claims: The patent includes both broad and narrow claims to ensure comprehensive protection.
• Related Patents: Other patents complement this patent by covering related compounds and formulations.
• Exclusivity and Expiration: The patent and exclusivity periods are set to expire in 2025.
• Impact on Industry: The patent influences innovation, competition, and market dynamics in the pharmaceutical sector.

FAQs

1. What is the primary compound protected by US 10,449,191?

The primary compound is N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea and its salts.

2. What is the drug covered by this patent?

The drug covered by this patent is Orgovyx, used for the treatment of advanced prostate cancer.

3. When does the patent expire?

The patent is set to expire on January 28, 2025.

4. What is the significance of the exclusivity period?

The exclusivity period, which expires on December 18, 2025, grants the manufacturer sole marketing rights for Orgovyx, preventing generic versions from entering the market.

5. How does the patent impact the pharmaceutical industry?

The patent balances intellectual property protection with innovation and competition, influencing the development of new treatments and market dynamics in the pharmaceutical sector.

Sources

1. US10449191B2 - Treatment of prostate cancer - Google Patents
2. Generic Orgovyx Availability - Drugs.com
3. Eviscerating Patent Scope - DigitalCommons@NYLS
4. United States Patent - googleapis.com
5. Pharmaceutical drugs covered by patent 10,449,191 - DrugPatentWatch

Drugs Protected by US Patent 10,449,191

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sumitomo Pharma	ORGOVYX	relugolix	TABLET;ORAL	214621-001	Dec 18, 2020		RX	Yes	Yes	10,449,191					TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER

International Family Members for US Patent 10,449,191

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	109759
Argentina	109762
Argentina	110636
Australia	2017334035
Australia	2017336338
Australia	2017336363