Details for Patent: 9,504,699

Which drugs does patent 9,504,699 protect, and when does it expire?

Patent 9,504,699 protects RAYOS and is included in one NDA.

This patent has thirty patent family members in twenty-seven countries.

Summary for Patent: 9,504,699

Title:	Delayed-release glucocorticoid treatment of rheumatoid disease
Abstract:	The present invention refers to the treatment of a rheumatic disease and/or osteoarthritis by administering a delayed-release dosage form of a glucocorticoid to a subject in need thereof.
Inventor(s):	Schaeffler; Achim (Beerfelden, DE)
Assignee:	HZNP Limited (Hamilton, BM)
Application Number:	14/563,000
Patent Claim Types: see list of patent claims	Use; Dosage form; Formulation;

Analyzing the Scope and Claims of United States Patent 9,504,699

Introduction

United States Patent 9,504,699, titled "Delayed-release glucocorticoid treatment of rheumatoid disease," is a patent that addresses a specific medical treatment for rheumatic diseases and osteoarthritis. To understand the full implications and value of this patent, it is crucial to delve into its scope, claims, and the broader patent landscape.

Patent Overview

Publication Details

• Publication Number: US9504699B2
• Authority: United States
• Prior Art Date: This patent builds upon earlier research and treatments involving glucocorticoids, such as prednisone, which are well-known for their anti-inflammatory properties[4].

Scope of the Patent

The scope of a patent defines the boundaries of what is protected by the patent. For US9504699B2, the scope revolves around the treatment of rheumatic diseases and osteoarthritis using a delayed-release dosage form of a glucocorticoid.

Key Concepts

• Delayed-Release Dosage Form: The patent focuses on a specific formulation that allows for the delayed release of glucocorticoids, which can provide sustained therapeutic effects and potentially reduce side effects associated with immediate release formulations.
• Therapeutic Application: The treatment is aimed at patients suffering from rheumatoid diseases and osteoarthritis, indicating a narrow but significant therapeutic scope.

Claims Analysis

The claims section of a patent is critical as it defines the legal boundaries of the invention. Here’s a breakdown of the claims in US9504699B2:

Independent and Dependent Claims

• Independent Claims: These claims stand alone and define the core invention. For example, Claim 1 might describe the delayed-release dosage form and its composition.
• Dependent Claims: These claims build upon the independent claims and provide additional details or variations. For instance, a dependent claim might specify the type of glucocorticoid used or the method of administration.

Claim Coverage Matrix

To fully understand the claims, a Claim Coverage Matrix can be useful. This matrix categorizes claims by their scope concepts, helping to identify which claims actively protect the intellectual property and where gaps or opportunities exist. For US9504699B2, this would involve mapping the claims to the specific therapeutic applications and dosage forms[3].

Patent Landscape

The patent landscape includes all relevant patents and intellectual property related to the field of the invention.

Competing Patents

• Other patents related to glucocorticoid treatments or delayed-release formulations need to be considered to understand the competitive landscape. For instance, any patents that cover similar therapeutic applications or dosage forms could be relevant.
• Novelty and Non-Obviousness: The patent must demonstrate novelty and non-obviousness over existing prior art. In the case of US9504699B2, the delayed-release aspect and its specific application to rheumatic diseases would need to be distinct from prior art[4].

Patent Analytics

Using patent analytics tools, such as those provided by Schwegman, can help in tracking patents by claims and scope concepts. This involves categorizing patents not only by their claims but also by overarching scope concepts, which can link claims on similar patents. This approach helps in identifying gaps in coverage and future design opportunities[3].

Economic and Strategic Value

The value of a patent can be assessed using various methods: cost, income, and market approaches.

Cost Approach

• This method considers the cost of developing the patent, including research, development, and filing expenses. For a patent like US9504699B2, the cost would include the expenses related to the development of the delayed-release formulation and clinical trials[1].

Income Approach

• This approach evaluates the future benefits provided by the patent, such as royalties, licensing fees, or increased sales due to the patented technology. The income value is the present value of these future benefits over the patent's lifetime[1].

Market Approach

• This method determines the market value by looking at what a willing buyer would pay for a similar asset. For example, the sale of patents by Novell in 2010 for $510,204.08 per patent can provide a benchmark, although the specific value of US9504699B2 would depend on its unique contributions and market demand[1].

Legal and Regulatory Considerations

The legal and regulatory environment is crucial for the enforcement and maintenance of a patent.

Prosecution History

• The prosecution history of a patent, including any challenges or rejections during the application process, can impact its validity and scope. For instance, the case of Hyatt v. Hirshfeld highlights the complexities and challenges that can arise during the patent application process, particularly when dealing with large numbers of claims and amendments[2].

Maintenance and Enforcement

• Maintaining a patent involves paying periodic fees to the USPTO. Enforcement requires monitoring for infringement and taking legal action when necessary. The value of a patent is significantly diminished if it is not properly maintained or enforced.

Key Takeaways

• Scope and Claims: The patent's scope is defined by its therapeutic application and the delayed-release dosage form, with claims that specify the composition and method of administration.
• Patent Landscape: Understanding the competitive landscape through patent analytics is crucial for identifying gaps and opportunities.
• Economic Value: The patent's value can be assessed through cost, income, and market approaches, each providing a different perspective on its worth.
• Legal Considerations: The patent's validity and enforcement depend on its prosecution history and ongoing maintenance.

FAQs

1. What is the primary therapeutic application of US9504699B2?

   • The primary therapeutic application is the treatment of rheumatic diseases and osteoarthritis using a delayed-release glucocorticoid dosage form.

2. How can the claims of US9504699B2 be analyzed?

   • The claims can be analyzed using a Claim Coverage Matrix, which categorizes claims by their scope concepts to identify coverage and gaps.

3. What are the different methods for valuing a patent like US9504699B2?

   • The methods include the cost approach, income approach, and market approach.

4. Why is the prosecution history of a patent important?

   • The prosecution history can impact the patent's validity and scope, as seen in cases like Hyatt v. Hirshfeld.

5. How can patent analytics tools help in managing a patent portfolio?

   • Patent analytics tools help in tracking patents by claims and scope concepts, identifying gaps, and highlighting future design opportunities.

Sources

1. The Value of a Patent - Perpetual Motion Patents
2. HYATT v. HIRSHFELD - Court of Appeals for the Federal Circuit
3. Patent Analytics - Schwegman, Lundberg & Woessner, P.A.
4. US9504699B2 - Google Patents
5. Patent Claims Research Dataset - USPTO

Drugs Protected by US Patent 9,504,699

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-001	Jul 26, 2012		DISCN	Yes	No						TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED-RELEASE 1,2, OR 5MG PREDNISONE TABLET
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-002	Jul 26, 2012		DISCN	Yes	No						TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED-RELEASE 1,2, OR 5MG PREDNISONE TABLET
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-003	Jul 26, 2012		DISCN	Yes	No						TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED-RELEASE 1,2, OR 5MG PREDNISONE TABLET

International Family Members for US Patent 9,504,699

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2007280636
Brazil	PI0717052
Canada	2655682
China	101466385
Cyprus	1113915
Denmark	2049123
Eurasian Patent Organization	015304