Details for Patent: 8,921,357

Which drugs does patent 8,921,357 protect, and when does it expire?

Patent 8,921,357 protects TEPMETKO and is included in one NDA.

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

Summary for Patent: 8,921,357

Title:	Pyridazinone derivatives
Abstract:	Compounds of the formula (I), in which R.sup.1, R.sup.2, R.sup.3, R.sup.4, R.sup.4' 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):	Dorsch; Dieter (Ober-Ramstadt, DE), Stieber; Frank (Heidelberg, DE), Schadt; Oliver (Rodenbach, DE), Blaukat; Andree (Muehltal, DE)
Assignee:	Merck Patent GmbH (Darmstadt, DE)
Application Number:	13/785,471
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Process; Device;

Understanding the Scope and Claims of United States Patent 8,921,357

Introduction

The United States Patent 8,921,357, titled "Pyridazinone derivatives," is a patent that covers a specific class of chemical compounds and their applications. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Patent Overview

Invention Description

The patent 8,921,357 pertains to pyridazinone derivatives, which are compounds used in the inhibition, regulation, and/or modulation of signal transduction by kinases. Kinases are enzymes that play crucial roles in various cellular processes, including signal transduction pathways. The invention involves the synthesis and use of these derivatives for therapeutic purposes, particularly in treating diseases related to kinase activity[4].

Claims

The patent includes multiple claims that define the scope of the invention. Here are some key aspects of the claims:

• Compound Claims: These claims specify the chemical structure of the pyridazinone derivatives, including various substituents and functional groups. For example, the claims might detail the specific arrangement of atoms and functional groups that define the compounds[4].
• Method Claims: These claims describe the methods of using the pyridazinone derivatives, such as their application in treating specific diseases or conditions. This could include dosing regimens, administration routes, and the like[4].
• Use Claims: These claims outline the therapeutic uses of the compounds, such as their efficacy in inhibiting or modulating kinase activity in various disease states[4].

Patent Landscape Analysis

Legal Status

The legal status of the patent is crucial for understanding its current standing and future implications. As of the latest information, the patent 8,921,357 is listed as active but with an expiration date. This status indicates that the patent is still enforceable, but it will eventually expire, allowing generic or other competitors to enter the market[4][5].

Expected Expiry Dates

The expected expiry date of the patent is a critical piece of information for both the patent holder and potential competitors. Knowing this date helps in planning strategies for market entry or the development of alternative compounds. For patent 8,921,357, the expiry date is a key factor in determining the timeline for generic entry and the potential for new innovations in the same therapeutic area[5].

Competitor Analysis

A patent landscape analysis also involves identifying competitors and their activities in the same technological domain. This includes looking at other patents related to kinase inhibitors, mergers and acquisitions, licensing agreements, and litigation activities. For instance, if other companies are developing similar compounds or have patents in the same therapeutic area, this could impact the market dynamics and the competitive landscape[3].

Market Developments and Trends

Mergers and Acquisitions

The pharmaceutical industry is known for its dynamic nature, with frequent mergers and acquisitions. These activities can significantly impact the patent landscape, as companies may acquire or merge to gain control over valuable patents. Understanding these trends can help in predicting future market developments and potential challenges or opportunities[3].

Licensing and Collaboration

Licensing agreements and collaborations are common in the pharmaceutical sector, especially when it comes to patented compounds. Analyzing these agreements can provide insights into how the patent holder is leveraging their intellectual property and how other companies are accessing these technologies[3].

Litigation Activities

Patent litigation is a significant aspect of the pharmaceutical industry. Any ongoing or past litigation related to patent 8,921,357 could affect its enforceability and the overall market strategy. For example, if there are ongoing disputes over patent validity or infringement, this could delay or complicate the entry of generic competitors[3].

Technical Insights

Chemical Structure and Synthesis

The technical details of the patent, such as the chemical structure and synthesis methods of the pyridazinone derivatives, are crucial for understanding the invention's scope. These details help in identifying potential variations or improvements that could be made to the compounds[4].

Therapeutic Applications

The patent's focus on kinase inhibition highlights its therapeutic potential. Understanding the specific kinases targeted and the diseases treated can provide insights into the patent's value and its position within the broader therapeutic landscape[4].

Case Law and Regulatory Implications

Patent Eligibility

While the patent 8,921,357 does not directly involve AI or software-related technologies, the broader context of patent eligibility is relevant. Recent updates from the USPTO, such as those related to AI and software patents, emphasize the importance of integrating judicial exceptions into practical applications. This principle can be applied to chemical patents as well, ensuring that the claimed inventions offer concrete technological improvements[1].

Regulatory Compliance

Compliance with regulatory requirements is essential for any pharmaceutical patent. Ensuring that the patent and its claims align with regulatory standards can facilitate the approval process for drugs based on these compounds. This includes adherence to safety, efficacy, and manufacturing standards set by regulatory bodies like the FDA[4].

Conclusion

The United States Patent 8,921,357 covers a specific class of pyridazinone derivatives with therapeutic applications in kinase inhibition. Understanding the scope and claims of this patent, along with the broader patent landscape, is crucial for both the patent holder and potential competitors.

Key Takeaways

• Patent Scope: The patent covers specific chemical compounds and their therapeutic uses.
• Legal Status: The patent is active but has an expected expiry date.
• Competitor Analysis: Understanding competitors and market trends is essential for strategic planning.
• Technical Insights: The chemical structure and synthesis methods are critical for the invention's scope.
• Regulatory Compliance: Adherence to regulatory standards is necessary for drug approval.

FAQs

Q1: What is the main subject of the United States Patent 8,921,357? The main subject of the patent is pyridazinone derivatives and their use in inhibiting or modulating kinase activity.

Q2: What is the current legal status of the patent? The patent is currently active but has an expected expiry date.

Q3: How does a patent landscape analysis help in understanding this patent? A patent landscape analysis helps in identifying competitors, market trends, and potential risks and opportunities related to the patent.

Q4: What are the key technical aspects of the patent? The key technical aspects include the chemical structure and synthesis methods of the pyridazinone derivatives and their therapeutic applications.

Q5: Why is regulatory compliance important for this patent? Regulatory compliance is important to ensure that any drugs developed based on these compounds meet safety, efficacy, and manufacturing standards set by regulatory bodies.

Sources

1. Understanding the 2024 USPTO Guidance Update on AI Patent - Mintz
2. In re Cellect - United States Court of Appeals for the Federal Circuit
3. Navigating Technological Domains with Patent Landscape Analysis - Sagacious Research
4. US8921357B2 - Pyridazinone derivatives - Google Patents
5. Drugs covered by patent 8,921,357 - Drug Patent Watch

Drugs Protected by US Patent 8,921,357

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			Y	Y

Foreign Priority and PCT Information for Patent: 8,921,357

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 8,921,357

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