Details for Patent: 6,488,960

Summary for Patent: 6,488,960

Title:	Corticosteroid formulation
Abstract:	The present invention pertains to a unit dose formulation comprising 0.25 to 2 mg of a corticosteroid. This small dose can be used to treat rheumatoid arthritis, especially if adapted to release at least 90% by weight of the corticosteroid, 2 to 8 hours after administration.
Inventor(s):	Bardsley; Hazel Judith (Cambridge, GB)
Assignee:	Arakis Ltd. (GB)
Application Number:	09/936,586
Patent Claim Types: see list of patent claims	Formulation; Compound; Use;

Understanding the Scope and Claims of United States Patent 6,488,960

Introduction

United States Patent 6,488,960 is a significant patent in the pharmaceutical industry, particularly related to the drug RAYOS®, which is a delayed-release formulation of prednisone. This patent is held by Horizon Pharma, Inc. and has been the subject of several legal battles regarding patent infringement. Here, we will delve into the details of the patent, its claims, and the broader patent landscape.

Patent Overview

Patent Number and Title:

• The patent in question is U.S. Patent No. 6,488,960, titled "Controlled-Release Oral Dosage Form."

Issuance Date:

• The patent was issued on December 3, 2002.

Assignees:

• The patent is assigned to Horizon Pharma, Inc., with specific rights held by Horizon Pharma Switzerland and Jagotec, as outlined in contractual agreements[5].

Claims of the Patent

The patent claims are crucial as they define the scope of the invention and what is protected under the patent.

Independent Claims:

• The patent includes several independent claims that describe the composition and method of manufacture of the controlled-release oral dosage form. These claims typically cover the specific formulation, the process of preparing the dosage form, and the characteristics of the final product[2].

Dependent Claims:

• Dependent claims further specify the invention by adding additional limitations to the independent claims. These could include specific ratios of ingredients, particular methods of coating, or other detailed aspects of the formulation[3].

Patent Scope

The scope of the patent is determined by the claims and the description provided in the patent specification.

Formulation Details:

• The patent describes a controlled-release oral dosage form of prednisone, which is designed to release the active ingredient in a delayed manner. This formulation is critical for managing conditions such as arthritis and other inflammatory diseases[2].

Manufacturing Process:

• The patent also covers the method of preparing this dosage form, including the use of specific excipients, coating materials, and the process steps involved in manufacturing the final product.

Patent Landscape

The patent landscape surrounding U.S. Patent 6,488,960 involves several key aspects, including related patents, litigation, and regulatory filings.

Related Patents:

• There are several other patents related to RAYOS®, including U.S. Patent Nos. 6,677,326, 8,168,218, 8,309,124, and 8,394,407. These patents collectively protect various aspects of the drug formulation and its use[2][5].

Litigation:

• Horizon Pharma, Inc. has been involved in patent infringement lawsuits to protect its intellectual property. For instance, a lawsuit was filed against Watson Laboratories, Inc. - Florida, alleging infringement of the patents listed in the FDA’s Orange Book, including U.S. Patent No. 6,488,960[2].

Regulatory Filings:

• The patents are listed in the FDA’s Orange Book, which is a critical database for tracking approved drugs and their associated patents. This listing is essential for generic drug manufacturers to determine whether their products infringe on existing patents[2][5].

Economic and Strategic Impact

The economic and strategic impact of U.S. Patent 6,488,960 is significant.

Market Protection:

• The patent provides Horizon Pharma with exclusive rights to market RAYOS® until the patent expires, protecting the company’s investment in research and development and allowing it to recoup its costs.

Litigation and Settlements:

• The patent has been a focal point in litigation, with Horizon Pharma using it to defend against generic competitors. The outcome of these lawsuits can significantly impact the company’s revenue and market position[2].

International Context

While the patent is specific to the United States, its implications can be global.

Global Dossier:

• The USPTO’s Global Dossier service allows users to access file histories of related applications from participating IP Offices, which can be useful in understanding the global patent landscape for similar inventions[4].

International Harmonization:

• Efforts to harmonize patent systems globally, such as through the Common Citation Document (CCD) application, facilitate the integration of patent searches and examinations across different jurisdictions, affecting how patents like U.S. Patent 6,488,960 are managed internationally[4].

Conclusion

U.S. Patent 6,488,960 is a critical piece of intellectual property for Horizon Pharma, Inc., protecting its innovative formulation of prednisone. Understanding the claims, scope, and broader patent landscape is essential for navigating the complex world of pharmaceutical patents.

Key Takeaways

• Patent Claims: The patent includes independent and dependent claims that define the composition and method of manufacture of the controlled-release oral dosage form.
• Patent Scope: The patent covers the formulation details and manufacturing process of RAYOS®.
• Litigation: The patent has been involved in several infringement lawsuits to protect Horizon Pharma’s intellectual property.
• Regulatory Filings: The patent is listed in the FDA’s Orange Book, which is crucial for regulatory approvals.
• Economic Impact: The patent provides market protection and is a key factor in the company’s revenue and market position.

FAQs

1. What is the main subject of U.S. Patent 6,488,960?

   • The main subject is a controlled-release oral dosage form of prednisone.

2. Who is the assignee of U.S. Patent 6,488,960?

   • The patent is assigned to Horizon Pharma, Inc., with specific rights held by Horizon Pharma Switzerland and Jagotec.

3. Why is the patent listed in the FDA’s Orange Book?

   • The patent is listed to inform generic drug manufacturers about the existing patents related to approved drugs, helping them determine potential infringement issues.

4. What is the significance of the Global Dossier in relation to this patent?

   • The Global Dossier allows users to access file histories of related applications from participating IP Offices, facilitating a global understanding of the patent landscape.

5. How does the patent impact Horizon Pharma’s market position?

   • The patent provides exclusive market rights, protecting Horizon Pharma’s investment and allowing it to maintain a competitive edge in the market.

Sources

1. National Archives - Records of the Patent and Trademark Office[1].
2. Biospace - Horizon Pharma, Inc. Files Patent Infringement Lawsuit Against Watson Laboratories, Inc. - Florida[2].
3. USPTO - Patent Claims Research Dataset[3].
4. USPTO - Search for Patents[4].
5. Justia - Horizon Pharma plc Business Contracts[5].

Drugs Protected by US Patent 6,488,960

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

Foreign Priority and PCT Information for Patent: 6,488,960

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	9905898	Mar 15, 1999

PCT Information
PCT Filed	March 14, 2000	PCT Application Number:	PCT/GB00/00924
PCT Publication Date:	September 21, 2000	PCT Publication Number:	WO00/54780

International Family Members for US Patent 6,488,960

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	3179000
Australia	771088
Australia	8789501
Canada	2361503
Canada	2422991