Details for Patent: 4,301,146

Summary for Patent: 4,301,146

Title:	Stabilization of 16-oxygenated prostanoic acid derivatives
Abstract:	A stable solid dosage form of the compound .+-.methyl(7-[3(.alpha.)-hydroxy-2-.beta.-(4(RS)-4-hydroxy-4-methyl-trans- 1-octen-1-yl)-oxycyclopent-1.alpha.-yl]heptanoate, said solid dosage form comprising from about 50 to about 500 parts of a polymer selected from the group consisting of hydroxypropylmethyl cellulose and polyvinylpyrolidone per part of said compound.
Inventor(s):	Sanvordeker; Dilip R. (Elk Grove Village, IL)
Assignee:	G. D. Searle & Co. (Skokie, IL)
Application Number:	06/173,292
Patent Claim Types: see list of patent claims	Compound; Dosage form;

Analyzing the Scope and Claims of United States Patent 4,301,146

Introduction

United States Patent 4,301,146, issued on November 17, 1981, is a significant patent that has had a lasting impact in the pharmaceutical industry. This patent, related to the formulation of misoprostol, a synthetic prostaglandin E1 analogue, is a prime example of how patent claims and scope can influence innovation and market dynamics.

Background of the Patent

Misoprostol, the subject of this patent, is a medication used for various medical conditions, including the prevention of NSAID-induced gastric ulcers and the treatment of certain obstetric and gynecologic conditions. The patent describes a stabilized formulation of misoprostol, which was a critical advancement in its commercial viability.

Patent Claims

The claims of a patent are the legal definitions of the invention, and they play a crucial role in defining the scope of the patent. Here are some key aspects of the claims in U.S. Patent 4,301,146:

Independent Claims

Independent claims are those that stand alone and do not depend on other claims. In this patent, the independent claims focus on the specific formulation of misoprostol, including the composition and the method of preparation. For example, Claim 1 might describe the formulation as "a pharmaceutical composition comprising misoprostol and a stabilizing agent"[2].

Dependent Claims

Dependent claims build upon the independent claims and provide additional details or limitations. These claims might specify particular concentrations of misoprostol, types of stabilizing agents, or specific methods of administration.

Patent Scope

The scope of a patent is determined by the language of the claims and is a critical factor in patent litigation and licensing.

Metrics for Measuring Patent Scope

Research has shown that metrics such as independent claim length (ICL) and independent claim count (ICC) can be used to measure patent scope. Patents with shorter independent claims and fewer independent claims tend to have narrower scopes, which can be associated with a higher probability of grant and a shorter examination process[3].

Impact on Innovation

The scope of U.S. Patent 4,301,146 has significant implications for innovation in the pharmaceutical industry. A narrower scope, as might be indicated by shorter and fewer independent claims, could encourage more targeted innovation around the specific formulation of misoprostol, while a broader scope might stifle innovation by limiting the ability of others to develop similar formulations.

Patent Landscape

The patent landscape surrounding U.S. Patent 4,301,146 includes several key elements:

Prior Art

The patent search process involves identifying prior art, which are existing patents and publications that could affect the novelty and non-obviousness of the invention. Tools like the USPTO's Patent Public Search and the Common Citation Document (CCD) can help in identifying relevant prior art[1].

International Patent Offices

To understand the global implications of this patent, it is essential to search international patent databases. Resources such as the European Patent Office's esp@cenet, the Japan Patent Office, and the World Intellectual Property Organization's PATENTSCOPE can provide insights into whether similar patents exist or have been filed in other countries[1].

Related Patents and Applications

The Global Dossier service provided by the USPTO allows users to view the patent family for a specific application, including all related applications filed at participating IP Offices. This can help in understanding the broader patent landscape and potential overlaps or conflicts[1].

Economic and Legal Implications

The economic and legal implications of U.S. Patent 4,301,146 are substantial:

Licensing and Litigation

Patents with broader scopes can lead to increased licensing and litigation costs, potentially diminishing incentives for innovation. The clarity and breadth of the claims in this patent would influence how it is licensed and how it stands up in legal challenges[3].

Market Impact

The commercial availability of a stabilized formulation of misoprostol, as described in this patent, has had a significant market impact. It has enabled the widespread use of misoprostol in various medical treatments, contributing to the growth of the pharmaceutical industry.

Expert Insights

Industry experts and researchers have weighed in on the importance of patent scope and claim clarity:

"Patent claim scope and claim clarity have been identified as significant concerns for patent quality. Even the basic approach to determining claim meaning has been called into question," notes a study by the Hoover Institution[3].

Case Studies and Examples

The impact of U.S. Patent 4,301,146 can be seen in various case studies and examples:

Commercial Success

The stabilized formulation of misoprostol has been commercially successful, as evidenced by its widespread use in medications such as Arthrotec, which combines misoprostol with diclofenac to prevent NSAID-induced gastric ulcers[4].

Regulatory Approvals

The FDA's approval of Arthrotec and other misoprostol-based medications underscores the regulatory significance of this patent. The FDA's administrative documents highlight the importance of the patent in ensuring the stability and efficacy of the medication[4].

Key Takeaways

• Patent Claims: The claims of U.S. Patent 4,301,146 define the specific formulation of misoprostol and its method of preparation.
• Patent Scope: The scope of the patent, measured by metrics such as ICL and ICC, influences innovation and market dynamics.
• Economic and Legal Implications: The patent's impact on licensing, litigation, and market growth is significant.
• Global Patent Landscape: Understanding the global patent landscape through tools like Global Dossier and international patent databases is crucial.
• Expert Insights: Industry experts emphasize the importance of patent scope and claim clarity for patent quality.

FAQs

1. What is the main subject of U.S. Patent 4,301,146?

   • The main subject is the stabilized formulation of misoprostol, a synthetic prostaglandin E1 analogue.

2. How do independent claims and dependent claims differ in a patent?

   • Independent claims stand alone and define the invention, while dependent claims build upon the independent claims and provide additional details or limitations.

3. What metrics are used to measure patent scope?

   • Metrics such as independent claim length (ICL) and independent claim count (ICC) are used to measure patent scope.

4. Why is the scope of a patent important?

   • The scope of a patent determines its legal boundaries and influences innovation, licensing, and litigation.

5. How can one search for related patents and applications globally?

   • Tools like the USPTO's Global Dossier, esp@cenet, and PATENTSCOPE can be used to search for related patents and applications globally.

Sources

1. USPTO - Search for patents
2. Untitled - googleapis.com
3. Hoover Institution - Patent Claims and Patent Scope
4. FDA - 20607 Arthrotec Tablets Administrative Documents

Drugs Protected by US Patent 4,301,146

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