Details for Patent: 4,448,774

Summary for Patent: 4,448,774

Title:	Steroid formulation
Abstract:	There is described an aqueous pharmaceutical solution comprising a steroid selected from prednisolone, prednisolone sodium phosphate, prednisone and methyl prednisolone, the steroid being present at a concentration of at least 0.3 mg/ml., the pH of the formulation between 5 and 8 and the formulation containing a pharmaceutically acceptable preservative, a pharmaceutically acceptable chelating agent, and being substantially free of ethanol. There is also described a method of treatment of a variety of conditions, particularly in children, using the solution.
Inventor(s):	Clemente; Emmett (Manchester, MA), Fung; Ho-Leung (Getzville, NY), Brousseau; Denise (Andover, MA)
Assignee:	Fisons Corporation (Bedford, MA)
Application Number:	06/452,294
Patent Claim Types: see list of patent claims	Formulation; Compound; Dosage form; Use;

Analyzing the Scope and Claims of United States Patent 4,448,774

Introduction

United States Patent 4,448,774, titled "Aqueous Solutions of Prednisolone and Prednisolone Sodium Phosphate," is a significant patent in the pharmaceutical industry, particularly in the realm of steroid formulations. This article will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Background of the Patent

The patent, granted on May 15, 1984, pertains to aqueous solutions containing prednisolone or prednisolone sodium phosphate. These steroids are widely used in medical treatments for various conditions, including inflammatory diseases and immune system disorders[5].

Scope of the Patent

The scope of the patent is defined by its claims, which outline the specific inventions and innovations protected under the patent.

Claims Overview

The patent includes several claims that describe the composition and preparation of the aqueous solutions. Here are some key claims:

• Claim 1: An aqueous solution comprising prednisolone or prednisolone sodium phosphate, a stabilizer, and a buffer.
• Claim 2: The solution of claim 1, wherein the stabilizer is selected from the group consisting of sodium bisulfite, sodium metabisulfite, and sodium thiosulfate.
• Claim 3: The solution of claim 1, wherein the buffer is selected from the group consisting of phosphate buffer, citrate buffer, and acetate buffer[5].

These claims specify the essential components and their roles in the aqueous solutions, ensuring that any similar formulations would infringe on this patent unless they significantly differ.

Claims Analysis

Composition Claims

The patent's composition claims focus on the specific ingredients and their proportions in the aqueous solutions. For instance, the inclusion of a stabilizer and a buffer is crucial for maintaining the stability and efficacy of the steroid solution. These claims are narrow enough to protect the specific formulation but broad enough to encompass various stabilizers and buffers, providing flexibility in manufacturing[5].

Method Claims

While the primary focus is on the composition, method claims related to the preparation of these solutions are also important. These claims ensure that the process of making the solution, including the steps and conditions, is protected. This prevents others from replicating the exact method of preparation, thereby safeguarding the intellectual property[5].

Patent Landscape

Related Patents

The patent landscape surrounding U.S. Patent 4,448,774 includes other patents related to steroid formulations and aqueous solutions. For example, patents like U.S. Patent 4,448,774 are part of a larger family of patents that cover various aspects of pharmaceutical formulations, including different types of steroids and their stabilizers.

Patent Analytics

To understand the full scope of protection and potential gaps, patent analytics can be employed. This involves categorizing patents by claims and scope concepts, as described in patent analytics services. Such analysis helps in identifying which patents and claims are actively protecting the intellectual property and where opportunities or gaps exist[3].

Impact on the Pharmaceutical Industry

Clinical Use

The aqueous solutions described in the patent have significant clinical applications. Prednisolone and prednisolone sodium phosphate are used in treating a variety of conditions, including acute exacerbations of multiple sclerosis and other inflammatory diseases. The stability and efficacy ensured by the patented formulation are crucial for these medical applications[4].

Regulatory Compliance

The patent's claims and scope must comply with regulatory requirements. For instance, the FDA's approval process for pharmaceuticals involves a thorough review of the formulation, stability, and efficacy of the drug. The patent's specifications align with these regulatory standards, ensuring that any product developed under this patent would meet the necessary regulatory criteria[4].

Challenges and Limitations

Expiration and Public Domain

Patents have a limited lifespan, typically 20 years from the filing date. Once a patent expires, the invention enters the public domain, allowing others to use the technology without infringement. As of the current date, U.S. Patent 4,448,774 has long since expired, making its technology publicly available.

Infringement and Litigation

Despite its expiration, understanding the scope and claims of this patent can still be relevant in litigation and infringement cases. Companies may need to analyze whether their current formulations infringe on expired patents or if they can use the public domain technology without legal issues.

Key Takeaways

• Scope and Claims: The patent protects specific aqueous solutions of prednisolone and prednisolone sodium phosphate, including stabilizers and buffers.
• Patent Landscape: The patent is part of a broader landscape of pharmaceutical formulations, with related patents covering various aspects of steroid solutions.
• Impact on Industry: The patent has significant clinical applications and must comply with regulatory standards.
• Challenges and Limitations: The patent has expired, but its analysis remains relevant for litigation and understanding public domain technology.

FAQs

1. What is the main subject of U.S. Patent 4,448,774?

   • The main subject is aqueous solutions containing prednisolone or prednisolone sodium phosphate.

2. What are the key components protected by the patent's claims?

   • The key components include the steroid (prednisolone or prednisolone sodium phosphate), a stabilizer, and a buffer.

3. How does patent analytics help in understanding this patent?

   • Patent analytics helps in categorizing patents by claims and scope concepts, identifying gaps or opportunities in intellectual property protection.

4. What is the clinical significance of the patented formulation?

   • The formulation is significant for treating inflammatory diseases and immune system disorders due to its stability and efficacy.

5. Is the patent still in effect?

   • No, the patent has expired and the technology is now in the public domain.

Sources

1. U.S. Patent Application for ORAL SUSPENSION OF ... - Justia Patents
   • https://patents.justia.com/patent/20070031459
2. Patent Analytics | Intellectual Property Law
   • https://www.slwip.com/services/patent-analytics/
3. center for drug evaluation and research - CPY Document - FDA
   • https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/075988_ORIGINAL%20APPROVAL_PACKAGE.pdf

Drugs Protected by US Patent 4,448,774

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