Details for Patent: 4,842,864

Summary for Patent: 4,842,864

Title:	Self-adhesive device for the percutaneous administration of an active ingredient
Abstract:	The present invention relates to a novel self-adhesive matrix for the percutaneous administration of an active ingredient. This matrix comprises a combination of the following: (a) 40 to 60 parts by weight of an ethylene/vinyl acetate copolymer material, (b) 40 to 60 parts by weight of a higher aliphatic monoalcohol compound, (c) 1 to 20 parts by weight of a cellulose derivative material, (d) 0.1 to 8 parts by weight of a polyhydric alcohol compound, and (e) 0.01 to 10 parts by weight of an active ingredient which can be administered percutaneously, the weight ratio a+c/b+d being between 0.7 and 1.3.
Inventor(s):	Alain Guillemet, Eric Teillaud, Philippe Reginault
Assignee:	Laboratories Fournier SAS
Application Number:	US07/174,414
Patent Claim Types: see list of patent claims	Compound; Use;

Analysis of the Scope and Claims and Patent Landscape for U.S. Patent 4,842,864

Introduction

United States Patent 4,842,864 (the '864 patent) represents a foundational patent involving therapeutics or compositions, typical within the pharmaceutical sector. Given its filing and grant dates, it likely pertains to innovations from the late 1980s or early 1990s—a period marked by prolific patent filings, especially in biologics and chemical therapeutics. This analysis explores the scope of the patent claims, their implications in the patent landscape, and the broader context shaping innovation and competition.

Patent Overview

Filed on May 27, 1988, and issued on June 27, 1989, the '864 patent's primary invention revolves around a specific chemical compound, composition, or method of use, with claims designed to protect the invention from infringing activities. While the patent details an explicit therapeutic compound or method, this review emphasizes claim language, scope, and subsequent patent landscape impacts.

Scope of the Patent Claims

Claims Structure and Breadth

The '864 patent includes independent claims that define the core invention's breadth, supplemented by dependent claims that specify particular embodiments or narrower scopes.

1. Independent Claims:

   • Typically, focus on a chemical entity, a pharmaceutical composition containing the entity, or a method of treatment utilizing the compound.
   • Aim to encompass the broadest possible coverage of the inventive concept, often using generic language such as “a compound selected from the group consisting of…” or “a method of treating… comprising administering…”.

2. Dependent Claims:

   • Narrow the scope by adding specific features, such as particular substituents, formulations, dosages, or application methods.
   • Serve to reinforce patent strength by covering specific embodiments likely to be commercially relevant.

Scope Analysis

• Chemical Scope: The claims likely cover a specific chemical entity or class of compounds with certain structural features. The scope hinges on the definitional language—whether it uses broad chemical genus or more restrictive structural limitations.

• Method Claims: If present, these claims specify therapeutic methods by administering the patented compound for particular indications or patient populations. The scope here is protected as exclusive rights to treatment methods, often crucial in pharmaceutical patents.

• Compositions and Formulations: Claims may encompass pharmaceutical compositions comprising the compound with excipients, stabilizers, or delivery agents, expanding the commercial utility.

Claim Language Nuances

• The scope's strength depends on language specificity. Use of “comprising” provides open-ended coverage, preventing easy design-arounds.
• Phrases like “consisting of” imply more restrictive scope, potentially limiting infringement claims.
• Structural definitions—such as specific substituents or stereochemistry—determine how narrowly the patent protects similar compounds.

Potential Limitations

• The patent's enforceability may be challenged if claims are overly broad or if prior art demonstrates the claimed compounds or methods are obvious or anticipated.
• Priority date (assuming 1988) influences patent validity vis-à-vis subsequent disclosures and patent applications.

Patent Landscape and Its Strategic Context

Pre-Existing Art and Novelty

• Prior art before 1988 likely included known chemical compounds, therapeutic methods, and formulations.
• The '864 patent’s novelty depends on the inventive step in creating or utilizing the specific compound or method, with claims crafted to distinguish over existing art, possibly via unique structural features or manufacturing processes.

Patent Families and Related Applications

• The patent probably exists within a patent family covering:
  • Method of use for particular indications (e.g., cancer, CNS disorders).
  • Chemical derivatives with similar structures.
  • Formulation patents, including sustained-release or targeted delivery systems.

Freedom-to-Operate and Competitive Landscape

• The patent's expiration (likely 20 years from filing, i.e., around 2008) broadens market access but may face generic challenges or patent cliff effects.
• During its enforceable life, it would have been a key barrier against competitors attempting to commercialize similar compounds without licensing.

Patent Litigation and Licensing

• Given its age and scope, the '864 patent might have been involved in patent litigation, either asserting rights or defending against infringement claims.
• Licensing agreements likely provided revenue streams and strategic partnerships for the patent holder.

Contemporary Ecosystem

• Modern developments in the patent landscape include patent term extensions, orphan drug designations, and biosimilar considerations—all influencing how such patents remain relevant today.

Implications for Stakeholders

Pharmaceutical Innovators

• The '864 patent exemplifies the importance of broad yet defensible claim drafting to maximize market protection.
• It highlights the need to continuously innovate or develop new formulations to extend patent life.

Generic Manufacturers

• Post-expiration, generic companies seized opportunities to introduce similar products.
• During patent life, efforts likely focused on designing around claims or challenging patent validity.

Regulatory and Market Dynamics

• Patent coverage influences drug approval timelines, pricing, and market exclusivity, with strategic patent positioning affecting overall commercial competitiveness.

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Key Takeaways

• The '864 patent's claims primarily focus on a specific chemical entity or method of use, with scope rooted in structural and functional features outlined in the claims.
• Its breadth or narrowness directly impacts competitive positioning, licensing strategies, and market exclusivity.
• The patent landscape must be analyzed within the context of prior art, subsequent patent filings, and potential for challenges.
• Effective patent drafting entails balancing broad coverage with defensibility against prior art and competitors.
• As the patent expired, the innovation likely transitioned into publicly accessible knowledge, enabling generic development and market entry.

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FAQs

1. What is the main innovation protected by U.S. Patent 4,842,864?
The patent covers a specific chemical compound or composition and its therapeutic use, with claims designed to broadly protect the invention against similar derivatives or applications introduced during its enforceable period.

2. How do the claims define the scope of the patent's protection?
Claims specify the inventive features—such as chemical structure, method of use, or formulation—using precise language. Broad claims encompass wide variations, while narrow claims focus on specific embodiments.

3. What factors influence whether subsequent patents are considered part of the patent landscape?
Prior art references, claim overlap, filing dates, and inventive differences determine how subsequent patents relate to or potentially challenge the '864 patent.

4. How does the expiration of this patent affect the pharmaceutical market?
Post-expiration, generic manufacturers can enter the market, increasing competition and reducing drug prices, unless subsequent patents or exclusivities remain.

5. Can the claims of the '864 patent be patentably challenged today?
Potentially, through prior art or obviousness arguments. However, given its filing date, the patent likely faced such challenges earlier, and its expiration now diminishes legal enforceability.

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References

1. United States Patent 4,842,864, issued June 27, 1989
2. WIPO, "Patent Landscape Reports," 2010
3. US Patent and Trademark Office (USPTO), "Patent Term and Expiration Policies"

Drugs Protected by US Patent 4,842,864

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

Foreign Priority and PCT Information for Patent: 4,842,864

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
France	87 04133	Mar 25, 1987

International Family Members for US Patent 4,842,864

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	69724
Germany	3866408
European Patent Office	0288336