Details for Patent: 9,284,300

Which drugs does patent 9,284,300 protect, and when does it expire?

Patent 9,284,300 protects TEPMETKO and is included in one NDA.

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

Summary for Patent: 9,284,300

Title:	Pyridazinone derivatives
Abstract:	Compounds of formula (I) ##STR00001## and their uses as inhibitors of tyrosine kinases, in particular Met kinase, and their employment in methods 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:	14/496,746
Patent Claim Types: see list of patent claims	Composition; Compound;

Understanding the Scope and Claims of United States Patent 9,284,300

Introduction to Patent 9,284,300

United States Patent 9,284,300, titled "Pyridazinone derivatives," is a significant patent in the pharmaceutical sector, particularly in the field of cancer treatment. This patent, assigned to Merck Patent GmbH, protects a class of compounds that are inhibitors of tyrosine kinases, specifically the Met kinase.

Patent Overview

Issuance and Assignee

The patent was issued on March 15, 2016, to Merck Patent GmbH, a subsidiary of the pharmaceutical giant Merck[2].

Inventors

The inventors listed on this patent include Dieter Dorsch, Frank Stieber, Oliver Schadt, and Andree Blaukat, all of whom have contributed significantly to the development of these pyridazinone derivatives[2].

Claims and Scope

Compound Description

The patent covers compounds of a specific formula, designated as (I), where various substituents (R, R', R'', etc.) have defined meanings. These compounds are identified as inhibitors of tyrosine kinases, with a particular focus on Met kinase, which is implicated in the treatment of tumors[2].

Therapeutic Use

The compounds protected by this patent are employed for the treatment of diseases influenced by the inhibition of Met kinase. This includes various types of cancers where Met kinase activity is a critical factor in tumor growth and progression[2].

Patent Claims

Independent Claims

The patent includes multiple independent claims that define the scope of protection. These claims specify the chemical structure of the compounds, the methods of their synthesis, and their therapeutic applications. For instance, Claim 1 typically outlines the general structure of the pyridazinone derivatives, while subsequent claims may detail specific substituents or methods of use[4].

Dependent Claims

Dependent claims further narrow down the scope by specifying particular aspects of the compounds, such as specific substituents, dosages, or modes of administration. These claims build upon the independent claims to provide a more detailed description of the protected inventions[4].

Patent Expiration

Expiration Date

The patent is set to expire on April 29, 2028. This date marks the end of the exclusive rights granted to Merck Patent GmbH to manufacture, use, and sell these specific pyridazinone derivatives in the United States[2].

Patent Landscape

Related Patents

The patent landscape surrounding US 9,284,300 includes several other patents related to pyridazinone and pyrimidinyl pyridazinone derivatives. For example:

• US 8,329,692: Covers pyrimidinyl pyridazinone derivatives and expires on October 30, 2029[2].
• US 8,580,781: Protects pyridazinone derivatives and expires on May 30, 2028[2].
• US 8,927,540: Also covers pyridazinone derivatives and expires on July 21, 2028[2].

These patents collectively form a robust intellectual property portfolio for Merck, ensuring exclusive rights over a range of compounds and their therapeutic applications.

Impact on Generic Availability

Generic Competition

The expiration of these patents will open the door for generic competition. Once the patents expire, other pharmaceutical companies can develop and market generic versions of these drugs, potentially reducing costs and increasing accessibility for patients[2].

Regulatory and Legal Considerations

FDA Exclusivity

In addition to patent protection, the FDA may grant exclusivity periods that run concurrently with or independently of patent terms. These exclusivity periods can further delay the entry of generic competitors into the market[2].

Patent Litigation

Patent disputes and litigation can also affect the patent landscape. Challenges to the validity of these patents or disputes over infringement can alter the timeline for generic entry and impact the exclusivity period[3].

Conclusion and Key Takeaways

• Patent Protection: US 9,284,300 protects specific pyridazinone derivatives used in cancer treatment, with an expiration date of April 29, 2028.
• Therapeutic Use: The compounds are inhibitors of tyrosine kinases, particularly Met kinase, and are used in treating tumors.
• Related Patents: The patent is part of a broader portfolio including other patents on similar compounds, all set to expire around the same period.
• Generic Competition: The expiration of these patents will allow for generic competition, potentially reducing drug costs and increasing patient access.
• Regulatory Considerations: FDA exclusivity and patent litigation can influence the timing and extent of generic competition.

Key Takeaways

• Exclusive Rights: Merck Patent GmbH holds exclusive rights to manufacture and market these compounds until the patent expires.
• Therapeutic Impact: These compounds are crucial in the treatment of cancers influenced by Met kinase activity.
• Patent Expiration: The patent expires on April 29, 2028, marking the end of exclusive rights.
• Generic Entry: Generic versions can be developed after patent expiration, subject to FDA approval and any remaining exclusivity periods.
• Regulatory and Legal Factors: FDA exclusivity and patent litigation can affect the timing and extent of generic competition.

FAQs

Q1: What is the primary therapeutic use of the compounds protected by US 9,284,300? The compounds are primarily used as inhibitors of tyrosine kinases, specifically Met kinase, for the treatment of tumors.

Q2: Who is the assignee of US 9,284,300? The assignee of US 9,284,300 is Merck Patent GmbH.

Q3: When does the patent expire? The patent expires on April 29, 2028.

Q4: What happens after the patent expires? After the patent expires, other pharmaceutical companies can develop and market generic versions of the drug, subject to FDA approval.

Q5: How do FDA exclusivity periods affect generic competition? FDA exclusivity periods can delay the entry of generic competitors into the market, even after the patent has expired.

Sources

1. Pharsight: Tepmetko patent expiration.
2. Drugs.com: Generic Tepmetko Availability.
3. Hoover Institution: Patent Claims and Patent Scope.
4. Google Patents: US8329692B2 - Pyrimidinyl pyridazinone derivatives.
5. Justia: Andree Blaukat Inventions, Patents and Patent Applications.

Drugs Protected by US Patent 9,284,300

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

Foreign Priority and PCT Information for Patent: 9,284,300

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 9,284,300

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