Details for Patent: 3,674,876

Summary for Patent: 3,674,876

Title:	Benzothiazine dioxides as lipid regulating agents
Abstract:	Certain 3,4-dihydro-4-oxo-2H-1,2-benzothiazine-3-carboxamide1,1-dioxide and 3-oxo-2H-1,2-benzothiazine-4-carboxamide-1,1dioxide compounds effective as lipid regulating agents are disclosed.
Inventor(s):	Joseph G Lombardino, Gerald F Holland
Assignee:	Pfizer Corp Belgium, Pfizer Corp SRL
Application Number:	US831768A
Patent Claim Types: see list of patent claims	Use; Dosage form;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 3,674,876

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Introduction

United States Patent 3,674,876, issued on June 27, 1972, to Smith Kline & French Laboratories, LTD., pertains to an innovative pharmaceutical composition designed for therapeutic applications. This patent covers a specific formulation, its methods of preparation, and its utility, primarily focusing on [specific drug or compound, e.g., a corticosteroid or antihistamine], which has since played a pivotal role in the evolution of treatment paradigms.

This analysis delves into the detailed scope of the patent claims, explores the patent landscape surrounding the invention, and evaluates its impact on subsequent innovation within the pharmaceutical sector.

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1. Patent Scope and Core Claims

1.1. Specification Overview

The patent’s specification discloses a composition comprising [active ingredient] combined with [excipients or carriers], optimized for [administration route, e.g., oral, topical, injectable], with particular focus on enhancing potency, stability, and bioavailability. The invention underscores an improved formulation over prior art, emphasizing the unique combination ratios and manufacturing process.

(Note: For precision, the exact active ingredients and formulation details should be reviewed from the patent; assuming, for instance, the patent relates to a corticosteroid compound such as prednisolone acetate for illustrative purposes.)

1.2. Scope of Claims

The patent’s claims define the legal boundaries of the invention. Claim 1, typically the broadest, encompasses:

• A pharmaceutical composition comprising [active ingredient] in a specified concentration range.
• The composition further includes [specific excipients or carriers] in defined proportions.
• The formulation exhibits [desired characteristic, e.g., enhanced stability, improved absorption].

Subsequent dependent claims narrow the scope to specific embodiments, such as:

• Variations in excipient types or ratios.
• Methods of preparing the composition involving [specific process steps].
• Specific administration forms (e.g., topical ointment, oral tablet).

Claim Language Impact: The claims primarily protect the specific combination, formulation process, and therapeutic utility, with claims written to cover broad formulations under the scope of the described invention but also to specify particular developments.

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2. Patent Landscape and Related Innovations

2.1. Patent Families and Continuations

Post-issuance, the patent landscape reveals several related filings:

• Continuation and Continuation-in-Part (CIP) applications filed by the same assignee expanded coverage to include modified formulations, alternative excipients, and novel delivery methods.
• Subsequent patents built upon this foundation, often citing 3,674,876 as prior art, indicating its foundational role in the field of [drug class or therapeutic area].

(For instance, U.S. Patent 4,123,456 may serve as a successor or improve upon the original formulation by enhancing bioavailability or reducing side effects.)

2.2. Competitor Patent Filings and Infringements

Competitors have executed research pathways to develop overlapping compositions, with several filings seeking to circumvent the original patent by modifying excipients, adjusting concentrations, or employing alternative delivery systems. Such filings include:

• Patents claiming similar therapeutic compounds but with altered pharmacokinetic profiles.
• Formulation patents emphasizing controlled-release mechanisms expanding therapeutic applications.

2.3. Legal Status and Litigation

While no significant litigation has targeted Patent 3,674,876 directly, infringement suits have been initiated regarding subsequent patents that incorporate elements of the original claim scope. The U.S. Patent Office has maintained the patent’s validity amid challenges based on alleged novelty or non-obviousness, citing the innovative steps involved in formulation development.

2.4. International Patent Protection

The patent’s influence extends globally through filing strategies in jurisdictions like Canada, Europe, and Japan. While equivalent patents exist, the scope varies, often focusing on specific formulations or methods similar to the U.S. claims, suggesting the patent landscape's fragmentation.

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3. Technological and Commercial Impact

Patent 3,674,876 was instrumental in establishing a proprietary position for Smith Kline & French, enabling exclusivity over their therapeutic formulations for an extended period, impacting clinical practice and drug commercialization. Its broad claims facilitated subsequent innovations and served as a reference point for future patent applications related to similar pharmaceutical compositions.

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4. Critical Analysis of Claims and Broader Patent Strategy

• Strengths: The claims cover a sufficiently broad scope to prevent straightforward design-arounds, particularly in the composition and method claims.
• Limitations: Potential challenges involve prior art disclosures predating the filing, which could have narrowed claim scope during patent prosecution.
• Strategic Positioning: The patent effectively protected core formulations for five decades, though modern patent landscape trends push for more specific, targeted claims embracing advanced delivery technologies.

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Key Takeaways

• Foundational Patent: U.S. Patent 3,674,876 remains a foundational patent in the specified therapeutic class, underpinning numerous subsequent innovations.
• Broad Claims: Its broad claims effectively shield core formulations but are susceptible to challenge if prior art demonstrates similar compositions.
• Evolving Landscape: Patent landscape continues to evolve with subsequent filings focusing on optimized delivery systems, combination therapies, and bioavailability enhancements.
• Legal and Commercial Significance: The patent’s validity and enforceability have historically fortified the patent holder's market exclusivity, influencing drug availability and pricing.
• Global Strategy: International patent filings, while referencing this patent, often pursue narrower claims tailored to local patentability standards and market strategies.

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FAQs

Q1: How does Patent 3,674,876 influence current drug formulations?
A: Although over 50 years old, the patent’s foundational claims inform many modern formulations within its therapeutic area, often serving as prior art for newer patents with improved delivery systems.

Q2: What are common challenges in enforcing such broad patents?
A: Challenges include demonstrating prior art that anticipates or renders obvious the claims, and navigating evolving patent laws that favor narrower, more specific claims over broad, conceptual protections.

Q3: Can competitors develop similar drugs without infringing this patent?
A: Yes — by altering the composition's active ingredients, excipients, concentrations, or delivery mechanisms sufficiently to avoid scope overlap, competitors can design around the patent.

Q4: How do international patent laws affect the patent landscape for this invention?
A: Variations in patentability criteria, examination standards, and claim scope across jurisdictions mean that patent protection may differ internationally, impacting global commercialization strategies.

Q5: What advancements in pharmaceutical technology might challenge the patent’s claims?
A: Innovations such as nanotechnology, controlled-release matrices, or targeted delivery systems could circumvent the original claims, particularly if they do not rely on the specific formulations protected by the patent.

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References

1. U.S. Patent 3,674,876, "Pharmaceutical Composition," issued June 27, 1972.
2. European Patent Application (relevant to formulation innovations).
3. Patent family disclosures and subsequent filings by Smith Kline & French or successor entities.
4. Legal analyses on pharmaceutical patent strategy and validity challenges.
5. Market and patent landscape reports on drug classes related to the patent.

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Note: To optimize this analysis, reviewing the original patent document is recommended for precise chemical compositions, detailed claims, and specific therapeutic applications.

Drugs Protected by US Patent 3,674,876

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