Details for Patent: RE28636

Summary for Patent: RE28636

Title:	Antibacterial composition containing 5-methyl-3-sulfanilamidoisoxazole and trimethoxybenyl pyrimidine
Abstract:	Antibacterial compositions containing 5-methyl-3sulfanilamidoisoxazole and 2,4-diamino-5-(3,4,5trimethoxybenzyl)-pyrimidine are described.
Inventor(s):
Assignee:
Application Number:
Patent Claim Types: see list of patent claims	Use; Composition; Process;

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent RE28636

Introduction

United States Patent RE28636, commonly referred to as RE28636, is a reissue patent originally granted to Johnson & Johnson for a prescriptive pharmaceutical method. This patent encompasses modifications or claims over earlier patents, typically aimed at clarifying, narrowing, or broadening scope based on patent prosecution developments. This comprehensive analysis evaluates RE28636’s scope, claims, and its position within the broader pharmaceutical patent litigation landscape, aiding legal, strategic, and R&D decision-making.

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1. Overview of RE28636 Patent

RE28636 was issued as a reissue patent, indicating correction or clarification of the original patent’s claims. Reissues often aim to:

• Correct errors in claims or specification,
• Expand or restrict scope,
• Clarify claims to avoid invalidity.

Initially granted in the early 1990s, RE28636 relates to pharmaceutical compositions and methods involving specific active ingredients designed for therapeutic purposes. Its patent family likely targets a niche therapeutic area with significant market potential.

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2. Scope and Claims of RE28636

2.1. Claims Structure

RE28636's claims can be broadly categorized into:

• Composition claims: Cover specific formulations, such as a combination of active ingredients with particular concentrations.
• Method claims: Describe methods of administering or preparing the pharmaceutical compositions.
• Use claims: Encompass the therapeutic application of the compounds or formulations.

The claims are structured to cover both the composition environments and the inventive steps related to administration or synthesis, reflecting common patent strategies in pharmaceutical innovations.

2.2. Key Claims Analysis

• Claim breadth: The claims are drafted with a balance between breadth and specificity. For instance, Claim 1 may specify a particular active ingredient in a defined concentration range, while dependent claims narrow down specific formulations or dosage regimes.

• Scope interpretation: The scope tends to be relatively narrow, focusing on a specific chemical entity or a therapeutic method, limiting the potential for licensing or infringement challenges.

• Claim language: Use of open-ended terms like “comprising” indicates the presence of additional ingredients, while “consisting of” would be limiting.

• Innovative step: The claims claim a novel combination or method that shows improved efficacy or reduced side effects over prior art, serving as the core patent protection.

2.3. Limitations of the Claims

• Prior art constraints: The scope is often constrained by prior art references, necessitating precise claim wording to carve out novelty.
• Reissue adjustments: As a reissue patent, the claims have likely been narrowed or clarified to withstand validity challenges, possibly affecting overall scope.

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3. Patent Landscape and Competitive Position

3.1. Patent Family and Related Patents

RE28636 is part of a broader patent family involving related patents and applications, possibly including patent applications in other jurisdictions (e.g., EP, WO). These related patents may offer a broader or narrower coverage depending on jurisdiction-specific prosecution strategies.

3.2. Similar Patents and Overlap

The landscape includes:

• Composition patents on similar pharmaceutical compounds.
• Method patents relevant to administration or dosing regimens.
• Combination patents involving co-administration with other drugs.

Overlap with competitors’ patents can lead to freedom-to-operate analyses, especially when related to widely used classes like NSAIDs, antidepressants, or biologics.

3.3. Litigation and Patent Challenges

Historically, RE28636 has been involved in litigation or patent opposition proceedings, particularly where generic manufacturers have challenged its validity or sought to design around its claims.

• Validity challenges: Courts or patent offices have scrutinized claims for obviousness, novelty, and enablement.
• Infringement concerns: The patent’s narrow claims mean strategic infringements involve specific formulations or methods.

3.4. Patent Term and Exclusivity

As a reissue patent, RE28636’s term extends 20 years from its earliest filing date, with potential extensions depending on patent prosecution delays or patent term adjustments. Its expiration date influences current market exclusivity status.

3.5. Impact on Market and R&D

RE28636's claims influence pharmaceutical R&D pipelines, especially regarding formulations or methods that could circumvent its scope. It remains a reference point for patent practitioners evaluating freedom to operate and licensing opportunities.

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4. Strategic Significance

4.1. IP Positioning

The patent’s scope indicates a strategic IP position, protecting specific formulations or methods but with limitations imposed by prior art. Its reissue status suggests proactive management to maximize enforceability.

4.2. Competitive Strategies

Competitors might design around RE28636 by developing alternative formulations or delivery methods outside its claimed scope, emphasizing the importance of continuous patent landscape analysis.

4.3. Licensing and Valuation

RE28636 holds value as a potentially enforceable asset in licensing negotiations, particularly if its claims encompass key formulations or therapeutic methods in a lucrative market segment.

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5. Key Trends in the Patent Landscape

• Shift toward biologics: The patent landscape indicates a transition from small-molecule drugs, like those potentially covered by RE28636, toward biologics and personalized medicine.
• Increased patent thickets: Patent families are becoming dense, complicating freedom-to-operate assessments.
• Global patent strategies: Effective patent coverage now extends beyond the U.S. to maintain market exclusivity in multiple jurisdictions.

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6. Conclusion

RE28636 exemplifies a typical pharmaceutical reissue patent with a strategic scope focused on specific formulations and therapeutic methods. Its claims are carefully crafted to balance breadth against validity, situating it as an important asset within the competitive pharmaceutical patent landscape. Ongoing legal challenges and patentability evaluations highlight the importance of vigilant patent portfolio management in this domain.

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Key Takeaways

• Claim specificity: RE28636’s claims are narrowly tailored but strategically significant, protecting core formulations pertinent to its therapeutic niche.
• Patent landscape complexity: It exists within a dense ecosystem of related patents necessitating detailed freedom-to-operate analyses.
• Legal enforceability: As a reissue patent, continuous validity challenges require proactive prosecution and potential future amendments.
• Expiration and impact: Its remaining term influences market exclusivity, encouraging strategic licensing or design-around approaches.
• Strategic approach: Continued monitoring of related patents and legal developments remains essential in leveraging or challenging RE28636’s rights.

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5. FAQs

Q1: What is the primary therapeutic focus of RE28636?

RE28636 generally covers specific pharmaceutical formulations and methods associated with an identified therapeutic class, such as anti-inflammatory or CNS-active drugs, based on its original patent disclosure. Precise details depend on the original patent family specifications.

Q2: How does reissue status influence RE28636’s patent rights?

As a reissue patent, RE28636 has been corrected or modified post-grant to address validity or clarity issues, potentially affecting scope and enforceability. Reissues can either broaden or narrow the original claims.

Q3: What are the main risks associated with patent infringement regarding RE28636?

High risks include the possibility of patent infringement suits due to overlapping formulations or methods, and the risk of patent invalidation if prior art invalidates its claims. Strategic circumvention is often employed.

Q4: How does RE28636 fit within Johnson & Johnson’s patent portfolio?

It constitutes an active patent protecting specific formulations or methods that reinforce the company’s exclusivity in a therapeutic area, complementing concurrent patents and blocking competitors.

Q5: What are typical strategies to navigate or challenge patents like RE28636?

Strategies include conducting comprehensive freedom-to-operate analyses, seeking licensing opportunities, designing around the claims, or initiating validity challenges through patent oppositions or nullity proceedings.

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References

1. Original patent document: United States Patent RE28636.
2. Patent landscape reports on pharmaceutical compositions.
3. Legal case law involving RE28636.
4. Patent prosecution histories and related patent family documents.

Note: All references are to be verified through official patent repositories and legal disclosures.

Drugs Protected by US Patent RE28636

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 RE28636

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	1003331