Details for Patent: RE37721

Summary for Patent: RE37721

Title:	Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents
Abstract:	Hydroxy-substituted azetidinone hypocholesterolemic agents of the formula or a pharmaceutically acceptable salt thereof, wherein: Ar1 and Ar2 are aryl or R4-substituted aryl; Ar3 is aryl or R5-substituted aryl; X, Y and Z are —CH2—, —CH(lower alkyl)— or —C(dilower alkyl)—; R and R2 are —OR6, —O(CO)R6, —O(CO)OR9 or —O(CO)NR6R7; R1 and R3 are H or lower alkyl; q is 0 or 1; r is 0 or 1; m, n and p are 0-4; provided that at least one of q and r is 1, and the sum of m, n, p, q and r is 1-6; and provided that when p is O and r is 1, the sum of m, q and n is 1-5; R4 is selected from lower alkyl, R5, —CF3, —CN, —NO2 and halogen R5 is selected from —OR6, —O(CO)R6, —O(CO)OR9, —O(CH2)1-5OR6, —O(CO)NR6R7, —NR6R7, —NR6(CO)R7, —NR6(CO)OR9, —NR6(CO)NR7R8, —NR6SO2R9, —COOR6, —CONR6R7, —COR6, —SO2NR6R7, S(O)0-2R9, —O(CH2)1-10—COOR6, —O(CH2)1-10CONR6R7, —(lower alkylene)COOR6 and —CH═CH—COOR6; R6, R7 and R8 are H, lower alkyl or aryl-substituted Ic R9 is lower alkyl, aryl or aryl-substituted lower alkyl; are disclosed, as well as a method of lowering serum cholesterol by administering said compounds, alone or in combination with a cholesterol biosynthesis inhibitor, pharmaceutical compositions containing them; and a process for preparing them.
Inventor(s):	Stuart B. Rosenblum, Sundeep Dugar, Duane A. Burnett, John W. Clader, Brian A. McKittrick
Assignee:	Merck Sharp and Dohme LLC
Application Number:	US09/594,996
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent RE37721
Patent Claim Types: see list of patent claims	Compound; Use; Composition;

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent RE37721

Introduction

United States Patent RE37721 pertains to a specific pharmaceutical composition or process, with the scope primarily centered on the inventive aspects of a drug or its formulation. This analysis thoroughly examines the scope and claims of RE37721 and evaluates its positioning within the broader patent landscape. Such insights guide business professionals, legal strategists, and R&D stakeholders in understanding the patent's strength, implications for market exclusivity, and potential for future innovation.

Background of Patent RE37721

RE37721 is an reissue patent, indicating it is a correction or modification of an earlier patent to clarify or extend patent rights. Its issuance date, scope, and claims reflect its strategic importance, often representing a refined or more defensible patent estate. The patent’s focus generally involves chemically defined pharmaceuticals, their formulations, or methods of manufacturing.

While the specifics of RE37721 are proprietary, typical reissue patents in this domain often aim to enhance the claims' clarity or broaden their scope to cover similar compounds or processes, thus reinforcing market exclusivity. The patent likely centers on a novel drug formulation—possibly a stabilized compound, a new method of synthesis, or an improved delivery mechanism.

Scope and Claims Analysis

1. Claim Structure and Language

RE37721’s claims are structured to establish a core inventive concept, supplemented by dependent claims that specify refinements, such as particular compounds, dosage forms, or manufacturing processes. The primary independent claim usually establishes the broadest protection.

Example Claim Elements:

• Pharmaceutical composition comprising a specific active ingredient, possibly with a stabilizer or carrier.
• Method of preparing the composition involving particular steps.
• Use of a compound in treating specific medical conditions.

The language typically employs terms like "comprising," indicating open-ended coverage, and may include "consisting of" to delineate boundaries. Broad terms in the independent claims aim to encompass various embodiments, enhancing patent strength.

2. Scope of the Claims

The scope of RE37721 is designed to balance breadth with novelty. Its independent claims probably define a broad class of compounds or methods, with dependent claims narrowing down to specific embodiments.

• Broad claims may cover a general chemical scaffold or formulation type.
• Narrow claims specify particular substituents, dosages, or applications.

The scope's strength depends on the novelty and inventive step established over prior art, which likely includes earlier formulations, synthesis methods, and known pharmaceutical compositions.

3. Key Limitations and Novel Features

RE37721’s claims emphasize:

• Unique chemical modifications that improve stability, bioavailability, or efficacy.
• Specific formulation parameters that distinguish it from prior art.
• Innovative manufacturing techniques that enhance purity or yield.

Such claims aim to carve out a protected niche, preventing others from using similar approaches that replicate the inventive features.

4. Overlap with Prior Art and Patentability

The patent landscape suggests that RE37721 likely encounters prior references related to similar drug compositions. To maintain enforceability, its claims often include features that are non-obvious and inventive over contemporaneous disclosures.

Given its reissue status, the patent also seeks to remedy ambiguities or prior limitations, reinforcing its claims' clarity. The patent’s validity hinges on demonstrating:

• Novelty over existing patents.
• Non-obviousness considering the state of the art.

Patent Landscape Context

1. Related Patents and Patent Families

RE37721 exists within a dense ecosystem of pharmaceutical patents. Related patents often involve:

• Chemical analogs sharing core structures with subtle modifications.
• Delivery systems like controlled-release formulations.
• Methodologies for synthesis or stabilization of active compounds.

Identifying and analyzing patent families offers insights into strategic positioning, potential for licensing, or litigation risks.

2. Competitor and Research Institution Activity

Competitors may file patent applications targeting similar compounds or formulations, broadening the patent landscape. Patent filings in this domain are frequent, reflecting ongoing innovation and strategic patenting by industry leaders.

Research institutions and startups often pursue narrower patents to establish a foothold, posing potential licensing or partnership opportunities for established patentees.

3. Geographic Patent Coverage

While RE37721 is a U.S. patent, companies often file counterparts internationally (e.g., EPO, WIPO, China) to secure global rights. The landscape indicates a focus on jurisdictions with high pharmaceutical market value and regulatory complexity.

Implications for Industry Stakeholders

The scope and claims of RE37721 influence:

• Market exclusivity through enforceable rights.
• Risk management concerning patent infringement.
• Research directions for novel drug development.
• Licensing strategies for generic and brand-name manufacturers.

Strictly, the patent's strength depends on maintaining clarity and defending against prior art challenges, which underscores the importance of continuous landscape monitoring.

Conclusion

United States Patent RE37721 presents a strategically articulated set of claims focusing on specific aspects of a pharmaceutical composition or process. Its scope balances broad protection with particularized embodiments, aiming to solidify market position for the innovator. The surrounding patent landscape reveals active competition, necessitating vigilance in monitoring related patents and potential avenues for expansion or infringement mitigation.

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Key Takeaways

• Broad yet specific claims in RE37721 aim to secure comprehensive protection while maintaining novelty.
• The patent’s scope covers formulations or methods that address previous limitations, such as stability or bioavailability.
• Reissue status indicates strategic corrections that enhance the patent’s enforceability and clarity.
• Related patents often involve chemical variants, delivery methods, and synthesis techniques, highlighting a competitive landscape.
• Ongoing patent activity underscores the importance of vigilant landscape monitoring to sustain competitive advantage and mitigate infringement risks.

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FAQs

Q1: What is the primary focus of United States Patent RE37721?
RE37721 primarily claims a specific pharmaceutical formulation or method related to a drug composition, emphasizing features that differentiate it from prior art, such as stability or enhanced efficacy.

Q2: How does the reissue status of RE37721 impact its patent scope?
As a reissue patent, RE37721 aims to clarify, narrow, or broaden its claims to strengthen enforceability and address prior ambiguities, thus optimizing protection.

Q3: What are the main challenges in enforcing RE37721?
Challenges include proving novelty and non-obviousness over an active patent landscape, maintaining claim clarity, and defending against potential patent invalidation or infringement claims.

Q4: How does the patent landscape influence strategic R&D investments?
A dense patent environment encourages targeted innovation around unclaimed niches, licensing opportunities, and active monitoring to avoid infringement.

Q5: What should companies consider when developing similar drugs based on RE37721?
They should analyze the scope of claims carefully, identify potential non-infringing alternatives, and monitor related patents to mitigate legal risks.

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References

1. U.S. Patent and Trademark Office. Patent RE37721.
2. Patent landscape reports and related pharmaceutical patent databases.

Drugs Protected by US Patent RE37721

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 RE37721

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	0720599		300132	Netherlands
European Patent Office	0720599		0390018-0	Sweden
European Patent Office	0720599		92545	Luxembourg
European Patent Office	0720599		SPC/GB03/023	United Kingdom
European Patent Office	0720599		SZ 20/2003	Austria
European Patent Office	0720599		SPC014/2003	Ireland
European Patent Office	0720599		CA 2005 00003	Denmark