Details for Patent: 8,927,540

Which drugs does patent 8,927,540 protect, and when does it expire?

Patent 8,927,540 protects TEPMETKO and is included in one NDA.

This patent has seventy-eight patent family members in thirty-six countries.

Summary for Patent: 8,927,540

Title:	Pyridazinone derivatives
Abstract:	Compounds of the formula (I), in which R1, R2, R3, R4, R4′, have the meanings indicated in Claim 1, are inhibitors of tyrosine kinases, in particular Met kinase, and can be employed, inter alia, for the treatment of tumors.
Inventor(s):	Dieter Dorsch, Frank Stieber, Oliver Schadt, Andree Blaukat
Assignee:	Merck Patent GmbH
Application Number:	US13/785,580
Patent Claim Types: see list of patent claims	Use;

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 8,927,540

Introduction

U.S. Patent No. 8,927,540, issued on December 30, 2014, represents a significant intellectual property asset within the pharmaceutical domain. It pertains to a novel approach or compound designed for therapeutic efficacy, with claims that delineate a specific scope of monopoly rights granted to the patent holder. This analysis comprehensively examines the patent's scope and claims, situates it within the broader patent landscape, and offers insights on strategic implications for industry stakeholders.

Patent Overview

Issued to address a specific therapeutic need, Patent 8,927,540 covers a compound, formulation, or method that demonstrates inventive steps over prior arts. The patent’s claims define the legal boundaries of the monopolized innovation, influencing its enforceability, licensing potential, and competitive position. Its drug-related claims likely focus on chemical structures, methods of production, and therapeutic applications, though the precise scope requires detailed claim analysis.

Scope of Patent 8,927,540

Claims Analysis

The scope of the patent hinges on the language and breadth of its claims. Typically, pharmaceutical patents encompass:

• Compound claims: Cover specific chemical entities or classes, providing broad protection if compositions are diverse within the claim scope.
• Method claims: Define processes for synthesizing or administering the compound.
• Use claims: Cover specific therapeutic applications.

In this case, the patent's claims likely include:

• Chemical Structure Claims: Encompassing a specific molecule or a class of molecules with particular substitutions, configurations, or derivatives.
• Method-of-Use Claims: Covering therapeutic methods involving administering the compound to treat particular conditions.
• Formulation Claims: Patent coverage may extend to pharmaceutical compositions incorporating the compound.

Claim breadth is critical. Narrow claims limit infringement risks but reduce market exclusivity, whereas broader claims afford extensive protection but face higher invalidity risks due to overlapping prior art.

Claim Construction and Limitations

Without access to the precise claims text, typical features include:

• Structural limitations: Specific functional groups, stereochemistry, or backbone configurations.
• Functional limitations: Efficacy parameters, dosage regimens, or targeted pathways.
• Combination claims: Use in combination with other agents.

The claims' scope ultimately depends on how explicitly they delineate the compound’s features and whether they leverage Markush structures or depend on a narrow chemical motif.

Legal and Strategic Implications

Broad claims covering a chemical class provide robust protection against generics if valid, but can be challenged on grounds of obviousness or novelty. Narrow claims are easier to defend but provide limited market exclusivity. The patent’s strategic strength rests upon a balanced claim set that is both defensible and commercially meaningful.

Patent Landscape Analysis

Prior Art and Patent Citations

The patent landscape surrounding U.S. Patent 8,927,540 involves:

• Prior Art References: Earlier patents and publications that disclose similar compounds, methods, or uses. The scope of prior art influences the patent's validity and the likelihood of infringement challenges.

• Citing Patents: Subsequent patents citing this patent indicate its influence and technological importance. Such citations often reflect a building block within a development pathway or an area of active innovation.

Competitor Patents and Overlaps

Examining competitors’ patent portfolios reveals:

• Patents claiming similar chemical classes or therapeutic applications, potentially creating freedom-to-operate considerations.
• Patent thickets that could pose licensing barriers or litigation risks.

Patent Family and Geographic Coverage

A strategic patent family coverage across jurisdictions enhances global protection. The patent's priority date, publication records, and continuation applications shape its territorial scope.

Legal Status and Maintenance

Continued maintenance fees and legal challenges can impact enforceability. As of today, the patent's status—active, expired, or challenged—directly influences commercial rights.

Strategic Implications for Stakeholders

• Pharmaceutical Innovators: Should analyze the scope for designing around existing claims or seek licensing agreements.
• Generic Manufacturers: Must evaluate patent validity and scope to ensure freedom to operate.
• Patent Owners: Need to consider further patent filings to broaden claims, secure extensions, or protect subsequent innovations.

Conclusion

U.S. Patent 8,927,540 embodies a carefully constructed scope designed to protect a specific inventive contribution within pharmaceutical chemistry or therapeutics. Its claims balance breadth and clarity, impacting enforceability and market exclusivity. The patent landscape underscores the importance of comprehensive prior art and strategic patent prosecution to maximize protection and commercial leverage.

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Key Takeaways

• The scope of Patent 8,927,540 hinges on the explicit language of its chemical and method claims, which influence its enforceability and potential for litigation.
• Broad claims afford extensive protection but face higher invalidity risks, whereas narrower claims limit scope but offer easier defense.
• Analyzing the patent landscape—prior art, citations, and competitor patents—is essential for strategic decision-making regarding R&D, licensing, and litigation.
• Maintaining active status and seeking continued patent protection can prolong commercial exclusivity.
• For stakeholders, a nuanced understanding of claim construction and patent family coverage informs licensing negotiations and development strategies.

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FAQs

1. What is the primary therapeutic focus of U.S. Patent 8,927,540?
   The patent concerns a novel chemical compound or method designed to treat a specific medical condition, likely within a class of pharmaceuticals such as oncology, neurology, or infectious diseases, depending on its detailed claims.

2. How broad are the claims of this patent?
   Without revealing the full claims, patents like this typically include both compound-specific and use-specific claims, with scope ranging from narrow (specific compounds) to broader classes within certain chemical or therapeutic areas.

3. Can this patent be challenged on grounds of obviousness?
   Yes, if prior art references demonstrate that the claimed invention or similar compounds were known or predictable, the patent could face invalidation through a legal challenge.

4. What is the significance of patent citations in this context?
   Citations indicate the patent’s influence and can reveal overlapping inventions, which are essential for assessing freedom to operate and potential infringement risks.

5. How does this patent impact generic drug development?
   The patent's scope and validity directly influence the ability of generic manufacturers to develop similar products. Strong, broad claims delay generic entry; narrow or challenged claims may accelerate it.

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Sources:

1. United States Patent and Trademark Office (USPTO) Patent Database
2. Patent document 8,927,540, issued Dec. 30, 2014
3. Prior art references and citation analysis tools
4. Legal reviews of patent scope and construction principles
5. Market analysis reports in pharmaceutical patent landscapes

Drugs Protected by US Patent 8,927,540

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Emd Serono Inc	TEPMETKO	tepotinib hydrochloride	TABLET;ORAL	214096-001	Feb 3, 2021		RX	Yes	Yes	8,927,540					TREATING A SOLID TUMOR, INCLUDING LUNG CANCER, HAVING A MET KINASE ALTERATION(S) BY ADMINISTERING AN EFFECTIVE AMOUNT OF TEPOTINIB

Foreign Priority and PCT Information for Patent: 8,927,540

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	10 2007 032 507	Jul 12, 2007

International Family Members for US Patent 8,927,540

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2164843		C02164843/01	Switzerland
European Patent Office	2164843		301176	Netherlands
European Patent Office	2164843		PA2022009	Lithuania
European Patent Office	2164843		2022C/519	Belgium
European Patent Office	2164843		LUC00264	Luxembourg