Details for Patent: 5,439,686

Summary for Patent: 5,439,686

Title:	Methods for in vivo delivery of substantially water insoluble pharmacologically active agents and compositions useful therefor
Abstract:	In accordance with the present invention, there are provided compositions for the in vivo delivery of substantially water insoluble pharmacologically active agents (such as the anticancer drug taxol) in which the pharmacologically active agent is delivered in a soluble form or in the form of suspended particles. In particular, the soluble form may comprise a solution of pharmacologically active agent in a biocompatible dispersing agent contained within a protein walled shell. Alternatively, the protein walled shell may contain particles of taxol. In another aspect, the suspended form comprises particles of pharmacologically active agent in a biocompatible aqueous liquid.
Inventor(s):	Desai; Neil P. (Los Angeles, CA), Soon-Shiong; Patrick (Los Angeles, CA), Sandford; Paul A. (Los Angeles, CA), Grinstaff; Mark W. (Pasadena, CA), Suslick; Kenneth S. (Champaign, IL)
Assignee:	VivoRx Pharmaceuticals, Inc. (Santa Monica, CA)
Application Number:	08/023,698
Patent Claim Types: see list of patent claims	Composition; Delivery; Formulation; Use;

Understanding the Scope and Claims of United States Patent 5,439,686

Introduction

United States Patent 5,439,686, titled "Methods for in vivo delivery of substantially water insoluble pharmacologically active agents and compositions useful therefor," is a significant patent in the field of pharmaceutical delivery systems. This patent, issued to researchers involved in the development of novel drug delivery methods, is crucial for understanding the intricacies of patent claims, scope, and the broader patent landscape.

Patent Overview

The patent, filed as US08/023,698, was granted on August 8, 1995. It describes methods and compositions for the in vivo delivery of pharmacologically active agents that are substantially water insoluble, such as the anticancer drug taxol (paclitaxel)[4].

Claim Structure

The patent claims are structured to cover both the methods of delivery and the compositions used for these methods.

Independent Claims

• The independent claims define the core inventions, including the specific methods for delivering water-insoluble drugs and the compositions that facilitate this delivery. For example, Claim 1 might describe a method for delivering a pharmacologically active agent using a particular formulation, while Claim 2 might describe the composition itself[4].

Dependent Claims

• Dependent claims further specify the independent claims by adding additional limitations or details. These claims help to narrow down the scope of the invention and provide additional protection against potential infringers.

Scope of the Patent

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

Claim Language

• The claim language is critical in defining what is protected by the patent. In this case, the claims focus on the specific methods and compositions for delivering water-insoluble drugs. The use of terms like "substantially water insoluble pharmacologically active agents" and "in vivo delivery" helps to delineate the scope of the invention[4].

Specification and Description

• The specification provides detailed descriptions of the invention, including examples and preferred embodiments. This section helps to interpret the claims and ensures that the scope of the patent is not overly broad or ambiguous[4].

Patentability Criteria

For a patent to be granted, it must meet several criteria: novelty, nonobviousness, utility, and subject matter eligibility.

Novelty

• The invention must be new and not anticipated by prior art. In the case of US 5,439,686, the novel aspect lies in the specific methods and compositions developed for delivering water-insoluble drugs[4].

Nonobviousness

• The invention must be nonobvious to a person having ordinary skill in the art. The USPTO applies tests such as the "teaching, suggestion, or motivation" (TSM) test to determine if the invention is obvious based on prior art[1].

Utility

• The invention must have a practical application. The delivery of water-insoluble drugs like taxol has significant utility in medical treatment, particularly in cancer therapy[4].

Subject Matter Eligibility

• The invention must fall within the scope of patentable subject matter. It cannot claim "laws of nature, physical phenomena, and abstract ideas" as these are considered part of the public domain[1].

Patent Landscape

The patent landscape surrounding US 5,439,686 includes other related patents and ongoing developments in drug delivery systems.

Related Patents

• Patents like US 5,560,933, which also deal with methods for in vivo delivery of water-insoluble pharmacologically active agents, are part of the broader patent landscape. These patents often build upon or complement the inventions described in US 5,439,686[5].

Litigation and Challenges

• Patents in the pharmaceutical sector are often subject to litigation and challenges. Understanding the litigation history and ongoing legal proceedings related to similar patents, such as those for Abraxane, can provide insights into potential challenges and strategies for navigating the patent landscape[2].

Impact on Innovation

The scope and claims of US 5,439,686 have a significant impact on innovation in the field of pharmaceutical delivery systems.

Encouraging Innovation

• By providing clear and specific claims, the patent encourages further innovation by protecting the intellectual property of the inventors while allowing others to build upon their work[3].

Licensing and Collaboration

• The patent scope can influence licensing agreements and collaborations. Clear and well-defined claims help in negotiating licensing terms and ensuring that all parties understand what is protected and what is not[3].

Expiration and Generic Entry

The patent has expired, which means that the technology described is now in the public domain.

Public Domain

• With the expiration of the patent, the methods and compositions described in US 5,439,686 are no longer protected by patent law. This allows other companies to develop and market similar products without infringing on the original patent[4].

Generic Entry

• The expiration of the patent paves the way for generic versions of the drug delivery system to enter the market. This can lead to increased competition and potentially lower costs for consumers[2].

Key Takeaways

• Specific Claims: The patent claims are specific and focused on methods and compositions for delivering water-insoluble drugs.
• Patentability Criteria: The invention meets the criteria of novelty, nonobviousness, utility, and subject matter eligibility.
• Patent Landscape: The patent is part of a broader landscape that includes related patents and ongoing developments in drug delivery systems.
• Impact on Innovation: The patent encourages innovation by protecting intellectual property and allowing others to build upon the work.
• Expiration: The patent has expired, allowing the technology to enter the public domain and paving the way for generic entry.

FAQs

1. What is the main focus of US Patent 5,439,686?

   • The main focus is on methods and compositions for the in vivo delivery of substantially water-insoluble pharmacologically active agents, such as taxol.

2. What are the key criteria for patentability?

   • The key criteria are novelty, nonobviousness, utility, and subject matter eligibility.

3. How does the patent landscape affect innovation?

   • The patent landscape influences innovation by protecting intellectual property, encouraging further research, and facilitating licensing and collaboration.

4. What happens when a patent expires?

   • When a patent expires, the technology described becomes part of the public domain, allowing others to use and develop similar products without infringing on the original patent.

5. How does the expiration of a patent impact generic drug entry?

   • The expiration of a patent allows generic versions of the drug to enter the market, potentially increasing competition and reducing costs for consumers.

Sources

1. Claiming Nanotechnology: Improving USPTO Efforts at Classifying and Examining Nanotechnology Inventions - Northwestern University School of Law.
2. Abraxane Patent Expiration - Pharsight.
3. Patent Claims and Patent Scope - Hoover Institution.
4. Methods for in vivo delivery of substantially water insoluble pharmacologically active agents and compositions useful therefor - Google Patents.
5. Methods for in vivo delivery of substantially water insoluble pharmacologically active agents and compositions useful therefor - Google Patents.

Drugs Protected by US Patent 5,439,686

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

International Family Members for US Patent 5,439,686

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	0961612		CA 2009 00036	Denmark
European Patent Office	0961612		91613	Luxembourg
European Patent Office	0961612		09C0050	France
European Patent Office	0961612		C00961612/01	Switzerland
European Patent Office	0961612		SZ 41/2009	Austria
European Patent Office	0961612		441	Finland