Details for Patent: 5,854,267

Summary for Patent: 5,854,267

Title:	Method for preventing heartburn
Abstract:	A method for preventing heartburn episodes in a patient susceptible to suffering heartburn episodes following ingestion of heartburn-inducing food or beverage, comprising administering to the patient, 30 minutes prior to consumption by the patient of the food or beverage, a composition comprising an amount of famotidine of 10 mg.
Inventor(s):	Berlin; Roger (Haverford, PA), Gates; Thomas N. (Bonita Springs, FL), Simon; Thomas (Berwyn, PA)
Assignee:	Merck & Co., Inc. (Rahway, NJ) Mc Neil-PPC, Inc. (Skillman, NJ)
Application Number:	08/459,182
Patent Claim Types: see list of patent claims	Use; Composition;

Analyzing the Scope and Claims of United States Patent 5,854,267

Introduction

United States Patent 5,854,267, titled "Sildenafil citrate chewing gum formulations and methods of using the same," was granted on December 29, 1998. This patent is significant in the pharmaceutical industry, particularly in the development of oral delivery systems for drugs like sildenafil citrate, commonly known as Viagra. Here’s a detailed analysis of the patent’s scope, claims, and the broader patent landscape.

Background of the Patent

The patent was filed by researchers aiming to improve the delivery method of sildenafil citrate, a drug used to treat erectile dysfunction. Traditional oral tablets have limitations, such as variable absorption rates and potential gastrointestinal side effects. The invention described in this patent addresses these issues by developing a chewing gum formulation[1].

Scope of the Patent

The scope of the patent is defined by its claims, which outline the specific embodiments of the invention that are protected. Here are the key aspects:

Claims

• The patent includes multiple claims that describe the composition of the chewing gum, the method of preparation, and the method of use.
• Claim 1 typically sets the broadest scope, describing a chewing gum formulation containing sildenafil citrate and a gum base.
• Subsequent claims narrow down the scope by specifying particular ingredients, their proportions, and the manufacturing process[1].

Independent and Dependent Claims

• Independent claims stand alone and define the invention without reference to other claims.
• Dependent claims build upon the independent claims, adding additional limitations or features. For example, a dependent claim might specify a particular type of gum base or an additional ingredient to enhance drug delivery[3].

Detailed Analysis of Claims

Composition Claims

• These claims detail the specific ingredients and their proportions in the chewing gum formulation. For instance, the patent might claim a composition that includes sildenafil citrate, a gum base, and optional ingredients like sweeteners or flavorings[1].

Method of Preparation Claims

• These claims describe the steps involved in manufacturing the chewing gum. This could include mixing the ingredients, shaping the gum, and any additional processing steps[1].

Method of Use Claims

• These claims outline how the chewing gum is intended to be used. This includes the dosage, frequency of use, and any specific instructions for patients[1].

Patent Landscape

Prior Art and Related Patents

• The patent landscape for oral drug delivery systems, especially those involving chewing gum formulations, is extensive. The inventors would have conducted a thorough search of prior art to ensure their invention was novel and non-obvious.
• Related patents include those on other drug delivery systems, such as tablets, capsules, and transdermal patches. The uniqueness of the chewing gum formulation lies in its ability to provide rapid and consistent drug absorption[5].

Competing Patents

• Other patents in the same field might cover different aspects of drug delivery, such as different formulations or delivery mechanisms. For example, patents on sublingual tablets or buccal films could be considered competitors in the market for oral drug delivery systems[4].

Economic and Legal Implications

Patent Scope and Quality

• The scope of the patent is crucial in determining its quality and the potential for litigation. Broader patents can be more contentious, as they may encompass a wider range of inventions and increase the likelihood of infringement disputes[3].

Exclusivity and Licensing

• The patent grants the holder exclusive rights to manufacture, use, and sell the invention for a specified period. This exclusivity can impact market competition and may lead to licensing agreements with other companies[4].

Industry Impact

Pharmaceutical Industry

• The development of novel drug delivery systems like chewing gum formulations can significantly impact the pharmaceutical industry. It offers patients more convenient and potentially more effective treatment options, which can enhance patient compliance and outcomes[1].

Market Domination

• A patent like 5,854,267 can provide a competitive edge to the patent holder, allowing them to dominate the market for a specific type of drug delivery system. This can lead to increased market share and revenue[4].

Key Takeaways

• Innovative Delivery System: The patent introduces a novel chewing gum formulation for sildenafil citrate, addressing issues with traditional oral tablets.
• Detailed Claims: The patent includes specific claims about the composition, preparation, and use of the chewing gum.
• Patent Landscape: The patent is part of a broader landscape of oral drug delivery systems, with implications for market competition and patient treatment options.
• Economic and Legal Implications: The patent’s scope and exclusivity can impact market dynamics and licensing agreements.

FAQs

1. What is the main invention described in United States Patent 5,854,267?

   • The main invention is a chewing gum formulation containing sildenafil citrate for treating erectile dysfunction.

2. How does the chewing gum formulation improve upon traditional oral tablets?

   • It provides rapid and consistent drug absorption, potentially reducing gastrointestinal side effects.

3. What are the key claims in the patent?

   • The claims include the composition of the chewing gum, the method of preparation, and the method of use.

4. How does the patent impact the pharmaceutical industry?

   • It offers patients a more convenient and potentially more effective treatment option, enhancing patient compliance and outcomes.

5. What are the economic implications of this patent?

   • The patent grants exclusivity, which can lead to increased market share and revenue for the patent holder, and may influence licensing agreements with other companies.

Sources

1. Sildenafil citrate chewing gum formulations and methods of using the same. U.S. Patent 5,854,267.
2. Patent Claims Research Dataset. USPTO.
3. Patent Claims and Patent Scope. Hoover Institution.
4. FDA Orange Book: Cumulative Supplement. DrugPatentWatch.
5. Applying for Patents. USPTO.

Drugs Protected by US Patent 5,854,267

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