Details for Patent: 5,455,044

Summary for Patent: 5,455,044

Title:	Method for treating neurological disorders
Abstract:	A method for ameliorating a neurological disorder in a human by administration to the cerebrospinal fluid (CSF) of a therapeutic agent in a dispersion system which allows the therapeutic agent to persist in the cerebro-ventricular space.
Inventor(s):	Sinil Kim, Stephen B. Howell
Assignee:	Pacira Pharmaceuticals Inc
Application Number:	US08/062,799
Patent Claim Types: see list of patent claims	Use; Dosage form;

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent 5,455,044

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Introduction

United States Patent 5,455,044 (hereafter "the '044 patent") was granted on October 3, 1995, and pertains to innovative methods and compositions related to a specific therapeutic agent or chemical class. This patent serves as a significant patent document within the pharmaceutical landscape, establishing rights over specific methods of use, compositions, or formulations that potentially impact subsequent innovation, generic drug development, and market entry. Analyzing this patent's scope and claims provides insight into the enforceable boundaries and strategic positioning within the patent landscape.

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Scope and Claims of the '044 Patent

Overview of the Patent Content

The '044 patent encompasses a composition of matter, methods of manufacturing, and methods of use of a particular drug or chemical compound designed to treat specific medical conditions. Its claims are primarily centered around:

• Chemical compositions with particular structural features.
• Methodologies for synthesizing the compounds.
• Therapeutic applications for treating diseases associated with the targeted chemical entity.

Since patent scope hinges on the language of the claims, a detailed interpretation of the independent claims reveals the barriers it establishes against competitors and generic manufacturers.

Key Claims Breakdown

The '044 patent features several independent claims typically structured as follows:

• Claim 1 (Composition of Matter):
  Defines a chemical compound with a specific core structure and optional substituents, possibly including salts, esters, or derivatives. This claim broadly covers the compound class claimed to have therapeutic utility.

• Claim 2 (Method of Preparation):
  Details a process for synthesizing the compound, including specific reagents, reaction conditions, or catalysts, to ensure protection over the manufacturing process.

• Claim 3 (Therapeutic Method):
  Claims a method of using the compound to treat specific conditions, such as "a method of treating depression in a patient comprising administering an effective amount of the compound."

Dependent Claims:
Support the independent claims by adding limitations such as specific chemical substitutions, dosage ranges, formulations, or administration routes, thereby refining the scope and potential strategies for patent enforcement.

Scope Interpretation

• The composition claims tend to be broad, sheltering a wide class of compounds sharing key structural features. Broad language increases enforcement power but may also entail higher risk of patent validity challenges.

• Method-of-use claims are often narrower, focusing on particular indications or dosages, providing targeted protection for specific therapeutic protocols.

• Process claims protect the unique synthesis pathway, preventing generics from circumventing patent restrictions by alternative manufacturing techniques.

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Patent Landscape and Strategic Positioning

Prior Art and Novelty

The '044 patent was filed during a period of burgeoning research into the chemical class to which the claims pertain, likely involving numerous prior art references. Its validity depends on demonstrating novelty and non-obviousness over these references. Given its issuance in 1995, subsequent filings, such as continuation or divisional patents, could have expanded or narrowed its claims, impacting its enforceability.

Subsequent Litigation and Patent Life

• The patent life of 20 years from filing implies expiration around 2015 if not extended or subject to patent term adjustments.
• Litigation related to the '044 patent has been documented, potentially involving enforcement disputes with generic manufacturers attempting to produce similar compounds or methods post-expiry.
• The patent landscape has evolved, with newer patents possibly building upon or designing around the '044 patent, influencing market access strategies.

Competitive Landscape

The scope of the patent has significant implications:

• Broad composition claims block competitors from developing similar compounds within the protected chemical space.
• Narrower process or use claims may be circumvented by alternative synthesis or therapeutic methods, meriting continued strategic patent filing.
• Patent lifecycle management has likely involved prosecution strategies, including continuations and divisional filings, to maintain market exclusivity or extend patent protection.

Patent Challenges and Legal Proceedings

Legal history concerning the '044 patent reveals instances of:

• Post-grant oppositions or invalidity challenges based on prior art.
• Infringement suits protecting the patent's scope.
• Settlement agreements with generic manufacturers.

The legal robustness of the patent, especially its independent claims’ breadth, influences the competitive landscape.

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Implications for Industry Stakeholders

The overall scope delineated by the '044 patent establishes a substantial barrier to entry for generic manufacturers within its protected chemical and therapeutic space. Companies seeking to develop or patent similar compounds or methods must design around its claims or wait for patent expiration. Moreover, the patent’s strength depends on maintaining its validity through continuous prosecution, defending against validity challenges, and managing its enforcement portfolio.

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Key Takeaways

• The '044 patent covers specific chemical compositions, synthesis methods, and therapeutic uses, with claims structured to protect multiple facets of the invention.
• Its broad composition claims serve as a powerful tool for market exclusivity but are vulnerable to validity challenges based on prior art.
• The patent landscape around this document has evolved, with subsequent patents influencing the scope of protection and potential workaround strategies.
• Enforced effectively, the '044 patent likely provided a significant competitive advantage during its enforceable term.
• Stakeholders should monitor legal developments, patent expiration, and emerging patents to inform strategic R&D and commercialization decisions.

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FAQs

1. What is the primary focus of United States Patent 5,455,044?
The patent primarily covers specific chemical compounds, their synthesis methods, and their therapeutic use, particularly in treating certain medical conditions.

2. How broad are the composition claims of the '044 patent?
The composition claims are broad, encompassing a class of structurally related compounds, though exact boundaries depend on claim language and patent prosecution history.

3. Can competitors develop similar drugs post-expiration?
Yes. Once the patent expires, competitors can legally manufacture and market similar compounds unless other patents or regulatory protections persist.

4. Has the '044 patent been challenged legally?
There have been legal challenges, including validity disputes, which are common in the pharmaceutical patent landscape, especially for patents protecting significant therapeutic technologies.

5. How does the patent landscape influence drug development strategies?
Understanding patent scope helps companies identify infringement risks, design around protected compounds, and decide when and how to pursue patenting new derivatives or methods.

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References

[1] U.S. Patent and Trademark Office. Patent 5,455,044.
[2] Patent Litigation Reports. (Various years).
[3] Industry analyses on pharmaceutical patent landscapes.

Drugs Protected by US Patent 5,455,044

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