Details for Patent: 8,415,337

Which drugs does patent 8,415,337 protect, and when does it expire?

Patent 8,415,337 protects NEOPROFEN and is included in one NDA.

Summary for Patent: 8,415,337

Title:	Ibuprofen compositions and methods of making same
Abstract:	The present invention provides an improved ibuprofen lysine pharmaceutical composition and a process for preparing the same.
Inventor(s):	Krishna; Aravind (Skillman, NJ)
Assignee:	Recordati Rare Diseases Inc. (Lebanon, NJ)
Application Number:	13/410,989
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,415,337
Patent Claim Types: see list of patent claims	Composition; Dosage form; Delivery; Formulation;

Analyzing the Scope and Claims of United States Patent 8,415,337

Introduction

United States Patent 8,415,337, titled "Ibuprofen compositions and methods of making same," is a significant patent in the pharmaceutical industry. This patent, granted to a pharmaceutical company, outlines an improved composition and process for preparing ibuprofen lysine, a salt form of the widely used pain reliever ibuprofen. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background of the Patent

The patent 8,415,337 was granted for an improved ibuprofen lysine pharmaceutical composition and the process for preparing it. Ibuprofen lysine is a more soluble form of ibuprofen, which can enhance its bioavailability and efficacy. This invention is crucial for developing more effective pain management treatments.

Scope of the Patent

The scope of a patent defines the boundaries of what is protected by the patent. For U.S. Patent 8,415,337, the scope includes:

Composition Claims

• The patent covers a specific pharmaceutical composition comprising ibuprofen lysine, which is designed to improve the solubility and stability of ibuprofen. This composition can be formulated into various dosage forms such as tablets, capsules, or solutions[2].

Process Claims

• The patent also includes claims related to the method of preparing the ibuprofen lysine composition. This involves specific steps and conditions to ensure the production of a high-quality and consistent product[2].

Claims Analysis

The claims section of a patent is critical as it defines the legal boundaries of the invention.

Independent Claims

• Independent claims are standalone claims that do not depend on other claims. For U.S. Patent 8,415,337, these claims typically describe the composition and the process in broad terms, setting the foundation for the invention[2].

Dependent Claims

• Dependent claims build upon the independent claims and provide more specific details. These claims may include variations in the composition, such as different ratios of ibuprofen to lysine, or specific conditions for the preparation process[2].

Patent Landscape

Understanding the patent landscape is essential for assessing the competitive environment and potential challenges.

Prior Art

• The patent landscape includes prior art, which are existing patents and publications that relate to the same or similar inventions. For ibuprofen lysine, prior art would include other patents and publications related to ibuprofen compositions and their preparation methods. Tools like the USPTO's Patent Public Search and the Common Citation Document (CCD) can help identify relevant prior art[1].

Global Patent Family

• The Global Dossier service provided by the USPTO allows users to view the patent family for a specific application, including related applications filed at participating IP Offices. This helps in understanding the global protection and status of similar inventions[1].

Competitor Patents

• Other pharmaceutical companies may have similar patents or pending applications. Analyzing these patents through databases like the European Patent Office's esp@cenet, the Japan Patent Office, or the World Intellectual Property Organization's PATENTSCOPE can provide insights into the competitive landscape[1].

Legal and Regulatory Aspects

The legal and regulatory environment plays a crucial role in the validity and enforcement of a patent.

Office Actions and Litigation

• Office actions and litigation history, such as those available through the Patent Examination Data System (PEDS) or Law360, can indicate potential challenges to the patent's validity. For example, the PTAB (Patent Trial and Appeal Board) cases related to this patent can provide insights into any legal disputes[1][5].

Compliance with Regulatory Standards

• The patent must comply with regulatory standards set by bodies like the FDA. Ensuring that the composition and process meet these standards is vital for commercialization.

Economic Impact

The economic impact of a patent can be significant, influencing both the company holding the patent and the broader industry.

Market Dominance

• Holding a patent for an improved ibuprofen composition can give the company a competitive edge in the market, potentially leading to increased market share and revenue.

Licensing and Royalties

• The patent can also generate revenue through licensing agreements with other companies. This can be particularly lucrative if the patented composition becomes a standard in the industry.

Conclusion

U.S. Patent 8,415,337 represents a significant advancement in pharmaceutical technology, particularly in the formulation of ibuprofen. Understanding the scope, claims, and the broader patent landscape is crucial for both the patent holder and competitors. This analysis highlights the importance of thorough patent searches, compliance with regulatory standards, and the potential economic benefits of holding such a patent.

Key Takeaways

• Composition and Process: The patent covers an improved ibuprofen lysine composition and its preparation process.
• Claims Analysis: Independent and dependent claims define the legal boundaries of the invention.
• Patent Landscape: Understanding prior art, global patent families, and competitor patents is essential.
• Legal and Regulatory Aspects: Office actions, litigation, and regulatory compliance are critical.
• Economic Impact: The patent can lead to market dominance and generate revenue through licensing.

FAQs

1. What is the main subject of U.S. Patent 8,415,337?

   • The main subject is an improved ibuprofen lysine pharmaceutical composition and the process for preparing it.

2. How can one search for prior art related to this patent?

   • Tools like the USPTO's Patent Public Search, Global Dossier, and the Common Citation Document (CCD) can be used to identify relevant prior art.

3. What databases can be used to analyze the global patent family of this invention?

   • Databases such as the European Patent Office's esp@cenet, the Japan Patent Office, and the World Intellectual Property Organization's PATENTSCOPE can be used.

4. How can one access office actions and litigation history related to this patent?

   • The Patent Examination Data System (PEDS) and legal databases like Law360 provide access to office actions and litigation history.

5. What are the potential economic benefits of holding this patent?

   • The patent can lead to market dominance, increased revenue, and generate income through licensing agreements.

Sources

1. USPTO - Search for patents
2. Unified Patents Portal - US-20130178529-A1
3. USPTO - Patent Claims Research Dataset
4. Duke University Libraries - Finding Patents Online
5. Law360 - U.S. Patent Number 8,415,337

Drugs Protected by US Patent 8,415,337

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	AP	RX	Yes	Yes			Y	Y