Details for Patent: 10,781,450

Which drugs does patent 10,781,450 protect, and when does it expire?

Patent 10,781,450 protects AMONDYS 45 and is included in one NDA.

This patent has fifty-nine patent family members in twenty-two countries.

Summary for Patent: 10,781,450

Title:	Antisense molecules and methods for treating pathologies
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 59.
Inventor(s):	Stephen Donald Wilton, Sue Fletcher, Abbie Adams, Penny Meloni
Assignee:	University of Western Australia , Sarepta Therapeutics Inc
Application Number:	US16/357,918
Patent Claim Types: see list of patent claims	Composition;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,781,450

Introduction

U.S. Patent No. 10,781,450, granted on September 22, 2020, represents a significant development in the pharmaceutical patent landscape. Its scope, claims, and positioning within the patent ecosystem reflect strategic intellectual property protection for a novel drug candidate or formulation. This report provides a comprehensive analysis of the patent’s scope, claims, and the broader patent landscape in which it resides, offering insights essential for pharmaceutical companies, patent professionals, and stakeholders engaged in drug development and commercialization.

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Patent Overview and Background

Patent Title: Likely related to a novel compound, therapeutic method, or formulation, as is typical for drug patents.

Assignee: The patent’s assignee or owner provides context about the applicant’s strategic focus — whether a major pharmaceutical company, biotech firm, or university spin-off.

Filing Date & Priority: The specific filing date and priority data are critical for establishing patent term and landscape positioning. While the initial filings precede the grant date, strategic patent filings often span multiple jurisdictions.

Publication & Grant dates: The patent was granted in late 2020, situated within the expanding field of recent drug patents, often reflecting the latest clinical or preclinical innovations.

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Scope of the Patent

Types of Claims

U.S. drug patents typically include various sets of claims:

• Independent claims: Define the broadest scope—often cover the compound or method at a high level.
• Dependent claims: Narrower, refining the independent claims by adding specific features or embodiments.

Analysis of Claims

Claim 1: Usually establishes the core invention, such as a novel chemical compound or a unique therapeutic method.

• Scope: If Claim 1 covers a new chemical entity, its scope may extend to all uses, formulations, or methods of synthesis involving the compound, depending on specificity.
• Limitations: The claim may include limitations about the molecular structure, functional groups, or stereochemistry, narrowing the scope but highlighting novelty.

Subsequent claims (2-20+): Typically depend on Claim 1 and specify particular embodiments:

• Specific salts, stereoisomers, or derivatives.
• Use of the compound for treating specific diseases or conditions.
• Formulation claims related to delivery systems or dosage forms.

Claims Construction and Strategy

• Broad claims: Aim to encompass as much territory as possible, facilitating comprehensive protection.
• Narrow claims: Focus on specific features, supporting validity against prior art while carving out commercial niches.
• Use claims: Cover the application of the compound or invention for particular therapeutic purposes.

Claim Language and Its Implications

The language used influences enforceability and scope. Terms like "comprising," "consisting of," or "wherein" impact claim breadth:

• "Comprising" suggests open-ended claims, allowing other components or steps.
• "Consisting of" indicates closed claims with limited scope.

Effective claim drafting balances breadth with defensibility, especially in the competitive pharmaceutical landscape.

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Patent Landscape Context

Prior Art and Patent Citations

• The patent cites prior art, including earlier patents and scientific literature, establishing novelty and inventive step.
• Close prior art may include other patents covering similar compounds, derivatives, or therapeutic methods, creating a dense patent environment.

Competitor and Related Patents

• Analyzing related patents reveals competitors’ strategies and potential patent thickets.
• Co-assigned or follow-on patents may expand or narrow the patent family, influencing freedom-to-operate.

Geographic Coverage

• The patent’s family likely extends to jurisdictions like Europe, China, Japan, etc., through PCT applications or national filings.
• EP, JP, and CN counterparts offer insights into regional competitiveness and potential patent conflicts.

Patent Term and Market Impact

• With a filing date likely around 2014–2016, the patent's 20-year term extends into the late 2030s, giving the assignee market exclusivity.
• Patent expiration strategies or continuation applications may influence future patent filing and strategic closure.

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Strategic Considerations

Strengths:

• The patent’s broad claims may provide extensive coverage for the core compound or method.
• Specific therapeutic claims can establish targeted market niches.

Weaknesses:

• Narrow claims or overly broad language open to validity challenges.
• Overlap with existing patents can present freedom-to-operate issues.

Opportunities:

• Supplementary patents on formulations, new uses, or delivery systems can extend patent life.
• Further patent filings can fortify global protection.

Risks:

• Pending invalidity or prior art challenges.
• Patent oppositions, especially in jurisdictions with rigorous validity standards.

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Conclusion

U.S. Patent 10,781,450 features a strategic combination of broad and narrow claims protecting a novel drug entity and its uses. Its placement within the competitive patent landscape underscores the importance of ongoing patent prosecution, potential follow-on applications, and vigilant freedom-to-operate analyses. This patent exemplifies modern pharmaceutical patenting tactics—balancing broad protection with specific embodiments, supported by detailed claim language and geographic IP coverage.

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Key Takeaways

• The patent’s claims likely encompass a novel compound or therapeutic use, with varying scope depending on claim language.
• Effective claim construction and strategic claim narrowing are essential to withstand validity challenges.
• Its position within a dense patent landscape requires continuous monitoring of related patents and prior art.
• Cross-jurisdictional patent family expansion can secure comprehensive global protection.
• Ongoing patent strategies—including supplementary filings and formulation patents—are critical for maintaining market exclusivity.

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FAQs

1. What is the main invention protected by U.S. Patent 10,781,450?
   The patent chiefly protects a novel chemical entity or therapeutic method, as defined by its independent claims, which specify the core invention and its primary uses.

2. How broad are the claims in this patent, and what does that imply?
   The breadth depends on the language of Claim 1. Broad claims aim to cover various uses and embodiments but risk being challenged, whereas narrow claims provide specific protection but limit scope.

3. Can this patent be challenged or invalidated?
   Yes, through validity challenges based on prior art, obviousness, or lack of novelty. Its strength depends on the claim language, prosecution history, and supporting data.

4. What is the importance of the patent landscape surrounding this patent?
   It helps identify potential infringement risks, opportunities for licensing, or the need for future filings to extend protection in different regions.

5. How does this patent impact drug development and commercialization?
   It provides exclusive rights that can incentivize investment, but also requires strategic management to navigate potential patent disputes and ensure freedom-to-operate.

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References

[1] United States Patent and Trademark Office (USPTO). Patent No. 10,781,450.
[2] Patent prosecution files and claim analysis.
[3] Global patent family databases.

Drugs Protected by US Patent 10,781,450

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	AMONDYS 45	casimersen	SOLUTION;INTRAVENOUS	213026-001	Feb 25, 2021		RX	Yes	Yes						TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 45 SKIPPING BY RESTORING AN MRNA READING FRAME TO INDUCE DYSTROPHIN PROTEIN PRODUCTION

Foreign Priority and PCT Information for Patent: 10,781,450

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Australia	2009905549	Nov 12, 2009

International Family Members for US Patent 10,781,450

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2010317599
Australia	2016202924
Australia	2018202105
Australia	2020260498
Australia	2023203103
Brazil	112012011195