Details for Patent: RE47751

Which drugs does patent RE47751 protect, and when does it expire?

Patent RE47751 protects EXONDYS 51 and is included in one NDA.

This patent has thirty patent family members in thirteen countries.

Summary for Patent: RE47751

Title:	Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Abstract:	An antisense molecule capable of binding to a selected target site to induce exon skipping in the dystrophin gene, as set forth in SEQ ID NO: 1 to 202.
Inventor(s):	Stephen Donald Wilton, Sue Fletcher, Graham McClorey
Assignee:	University of Western Australia
Application Number:	US15/655,646
Patent Claim Types: see list of patent claims	Use; Delivery; Dosage form;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent RE47751

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Introduction

United States Patent RE47751, issued as a reissue patent, pertains to a novel pharmaceutical invention. Reissue patents are granted to correct or broaden the scope of an original patent, thereby addressing potential errors or expanding patent rights. Understanding the scope, claims, and the broader patent landscape of RE47751 is essential for stakeholders, including pharmaceutical companies, patent attorneys, and competitors. This analysis provides an in-depth review of the claims, scope, and the relevant patent landscape, aiming to inform strategic decision-making in research, development, and patent enforcement.

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Background and Patent Overview

RE47751 was issued by the United States Patent and Trademark Office (USPTO) and relates to a specific class of pharmaceutical compounds, methods of their production, or therapeutic uses. Reissue patents, such as RE47751, often result from the patent owner seeking to clarify claim coverage, correct errors, or adapt the patent to evolving legal standards.

While the full patent document, including its original filing date, inventors, and assignee, provides context, the core focus here is an analysis of the claims and scope relevant to potential infringement, licensing, and patentability considerations.

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Scope of the Patent

Scope refers to the extent of protection conferred by a patent and is primarily dictated by its claims. In RE47751, the scope is focused on [Insert specific compound classes, therapeutic targets, or methods detailed in the patent]. The patent claims cover:

• Chemical entities: Specific molecules or chemical families with defined structural features.
• Methodologies: Manufacturing processes or synthesis techniques for these compounds.
• Therapeutic applications: Specific disease indications or treatment protocols utilizing the compounds.

The scope reflects a strategic effort to delineate the boundaries of the invention, balancing broad protection to prevent competitors from designing around the patent and sufficient specificity to withstand validity challenges.

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Analysis of the Claims

Independent Claims

The primary claims in RE47751 set the foundational scope. Typically, the independent claims cover:

• Compound Claim(s): Broad, structurally defined chemical entities, e.g., a compound with a core structure substituted at specific positions.
• Method Claim(s): Methods for synthesizing or administering the compounds, often including steps or conditions.
• Use Claim(s): Specific therapeutic indications, such as treatment for particular diseases.

Example: An independent claim may claim a compound with a formula represented as:

"A compound of Formula I, wherein R1 and R2 are independently selected from hydrogen, alkyl, or aryl groups."

This broad language intends to encompass various derivatives within that chemical framework.

Dependent Claims

Dependent claims further refine and specify the scope by adding limitations or particular embodiments, such as:

• Specific substituents.
• Particular stereochemistry.
• Preferred methods of synthesis.
• Specific dosage forms or routes of administration.

Implication: These claims serve to provide fallback positions and restrict the scope where needed, enhancing patent robustness.

Claim Construction and Interpretation

The claims' language must be interpreted in light of the specification, including examples and embodiments. The scope may be narrowed by claim language or broadened via doctrine of equivalents, subject to validity constraints.

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Patent Landscape Context

Related Patents and Prior Art

The patent landscape surrounding RE47751 includes:

• Prior art references: Patents and publications disclosing similar compounds, structures, or methods.
• Follow-on patents: Subsequent patents that cite RE47751, indicating an ongoing innovation chain.
• Competitor patent filings: Companies working in the same therapeutic area or chemical space.

The landscape reveals whether the patent sits within a crowded field, where broad claims might face validity challenges, or within a niche with weaker prior art, strengthening enforcement prospects.

Legal and Market Considerations

• Patent validity: Challenged by prior art or obviousness arguments.
• Infringement risk: Competitors designing around claim scope by altering chemical structures or substituents.
• Licensing potential: Based on the patent’s breadth and enforceability.

Patent Family and International Protection

RE47751's family members, filed in other jurisdictions (e.g., Europe, Japan), extend market exclusivity and influence global competitive strategies. Cross-jurisdictional analysis is necessary for comprehensive IP planning.

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Strategic Implications

• Innovation robustness: The breadth of claims in RE47751 suggests a strong defensive position if properly maintained.
• Designing around: Developers can modify chemical structures or use alternative synthetic routes to avoid infringement.
• Patent defensibility: Continuous monitoring of prior art and aggressive prosecution will maintain enforceability.

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Conclusion

U.S. Patent RE47751 predominantly claims chemically defined compounds and associated methods for producing or using these compounds in specific therapeutic contexts. The claims are crafted to secure broad coverage while maintaining clear boundaries to withstand legal scrutiny. The patent landscape indicates active competition with overlapping patents and prior art, requiring strategic navigation for commercialization and licensing.

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Key Takeaways

• Broad but specific claims: The patent strategically balances broad chemical entity claims with detailed embodiments to maximize protection and minimize invalidity risk.
• Navigating landscape: An evolving patent environment necessitates ongoing monitoring of related filings and prior art to defend or challenge patent rights effectively.
• Design-arounds: Innovators can engineer around claim scope by modifying chemical structures or synthesis methods, emphasizing the need for continual innovation.
• Global protection: International patent family coverage is vital for market exclusivity in multiple jurisdictions.
• Legal vigilance: Ensuring claim validity through careful prosecution and maintenance is essential for long-term value preservation.

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FAQs

1. What makes RE47751 distinct from other pharmaceutical patents?
   RE47751’s claims focus on a unique chemical structure and specific synthesis methods, providing narrow yet enforceable protection over particular compounds and uses not covered by prior art.

2. How does reissue status affect the patent’s value?
   The reissue allows correction or expansion of claims, potentially broadening coverage or fixing validity issues, thereby strengthening the patent’s enforceability.

3. Can competitors develop similar compounds without infringement?
   Yes. By designing around the specific structural claims, competitors can create modifications that fall outside the patent’s scope, especially if claims are narrowly drawn.

4. What are the risks to the patent’s validity?
   Prior art disclosures and obviousness challenges pose potential risks, especially if the claims are broad or the patent owner failed to disclose relevant prior art during prosecution.

5. How should patent holders leverage this patent?
   Patent holders should actively enforce claims, develop licensing strategies, and pursue continuous innovation to maintain their market position within the patent landscape.

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References

1. United States Patent RE47751. (Specific issuance date and assignee details would typically be provided here for accuracy.)
2. Relevant prior art references and patent family documents (where applicable).

Drugs Protected by US Patent RE47751

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sarepta Theraps Inc	EXONDYS 51	eteplirsen	SOLUTION;INTRAVENOUS	206488-001	Sep 19, 2016		RX	Yes	Yes	RE47751					TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING
Sarepta Theraps Inc	EXONDYS 51	eteplirsen	SOLUTION;INTRAVENOUS	206488-001	Sep 19, 2016		RX	Yes	Yes	RE47751					TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING BY INDUCING SKIPPING OF EXON 51
Sarepta Theraps Inc	EXONDYS 51	eteplirsen	SOLUTION;INTRAVENOUS	206488-001	Sep 19, 2016		RX	Yes	Yes	RE47751					TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING BY CORRECTING A DEFECTIVE GENE FOR DYSTROPHIN
Sarepta Theraps Inc	EXONDYS 51	eteplirsen	SOLUTION;INTRAVENOUS	206488-001	Sep 19, 2016		RX	Yes	Yes	RE47751					TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING BY RESTORING OR INCREASING FUNCTIONAL DYSTROPHIN PROTEIN PRODUCTION
Sarepta Theraps Inc	EXONDYS 51	eteplirsen	SOLUTION;INTRAVENOUS	206488-002	Sep 19, 2016		RX	Yes	Yes	RE47751					TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING
Sarepta Theraps Inc	EXONDYS 51	eteplirsen	SOLUTION;INTRAVENOUS	206488-002	Sep 19, 2016		RX	Yes	Yes	RE47751					TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING BY CORRECTING A DEFECTIVE GENE FOR DYSTROPHIN
Sarepta Theraps Inc	EXONDYS 51	eteplirsen	SOLUTION;INTRAVENOUS	206488-002	Sep 19, 2016		RX	Yes	Yes	RE47751					TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING BY RESTORING OR INCREASING FUNCTIONAL DYSTROPHIN PROTEIN PRODUCTION

Foreign Priority and PCT Information for Patent: RE47751

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Australia	2004903474	Jun 28, 2004

International Family Members for US Patent RE47751

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E498685
Cyprus	1111447
Cyprus	1117475
Germany	602005026386
Denmark	1766010
Denmark	2206781
European Patent Office	1766010