Details for Patent: 8,541,575

Which drugs does patent 8,541,575 protect, and when does it expire?

Patent 8,541,575 protects BRAFTOVI and is included in one NDA.

This patent has twenty-one patent family members in nineteen countries.

Summary for Patent: 8,541,575

Title:	3,4-diarylpyrazoles as protein kinase inhibitors
Abstract:	3,4-diarylpyrazole derivatives of formula (I) as defined in the specification, and pharmaceutically acceptable salts thereof, process for their preparation and pharmaceutical compositions comprising them are disclosed; the compounds of the invention may be useful, in therapy, in the treatment of diseases associated with a disregulated protein kinase activity, like cancer.
Inventor(s):	Maurizio Pulici, Fabio Zuccotto, Alessandra Badari, Stefano Nuvoloni, Giovanni Cervi, Gabriella Traquandi, Sonia Biondaro, Paolo Trifiro', Chiara Marchionni, Michele Modugno
Assignee:	Lsi Braf Sub LLC , Lsi Financing 1 Designated Activity Co
Application Number:	US13/054,853
Patent Claim Types: see list of patent claims	Use; Composition; Device;

Analysis of U.S. Patent 8,541,575: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 8,541,575?

U.S. Patent 8,541,575, granted on September 24, 2013, covers methods and compositions related to a novel medical use or formulation in the pharmaceutical sector. The patent primarily focuses on a specific chemical compound, its derivatives, and their pharmaceutical applications, particularly in treating or preventing certain medical conditions.

The patent claims revolve around the utilization of a defined chemical structure characterized by particular substituent groups. It encompasses methods of synthesizing these compounds, formulations suitable for administration, and their therapeutic indications.

Key features:

• Defined chemical core with specified substituents.
• Methods for preparing the compounds.
• Pharmaceutical compositions incorporating these compounds.
• Therapeutic use, particularly targeting a specific disease or condition.

What are the main claims of U.S. Patent 8,541,575?

The patent claims are structured to protect multiple aspects of the invention, from the chemical compounds to their medical applications.

Primary Claims:

• Chemical Compound Claims: Claims cover the chemical structure, including specific substitutions on a core scaffold. These claims specify variations that fall within the scope of the patent.

• Method of Synthesis: Claims describe steps to produce the compound, often including specific reagents or reaction conditions.

• Pharmaceutical Composition Claims: Claims related to formulations comprising the compound, such as tablets, capsules, or injectable solutions, along with excipients.

• Therapeutic Use Claims: Claims protect methods of administering the compound to treat or prevent particular diseases or conditions, likely with specific indications detailed in the patent.

Claim Scope and Limitations:

• Claims are specific to particular substituents and derivatives, with some broader claims covering subclasses of compounds.
• The patent may include dependent claims narrowing the scope to specific compounds or formulations.
• The claims are consistent with standards for pharmaceutical patents, balancing broad coverage with specific embodiments.

How does the patent landscape around U.S. Patent 8,541,575 look?

The patent landscape includes prior art, similar patents, and related patent families.

Prior Art

Pre-2013 publications that disclose similar chemical scaffolds or therapeutic applications could challenge the validity or scope. Relevant prior art includes:

• Similar chemical compounds disclosed in patent applications or scientific literature.
• Earlier patents on analogous therapeutic uses.

Related Patents and Patent Families

The patent is part of a portfolio linked to a family of patents covering related compounds or methods. Notable related patents may include:

• U.S. patents citing or citing this patent.
• International counterparts filed under the Patent Cooperation Treaty (PCT), covering similar chemical entities and uses.

Patent Filing Trends

Analysis of filings shows that the applicant maintained their patent family through subsequent jurisdictions, indicating ongoing interest and potential extensions.

Landscape mapping

A patent landscape map reveals clusters around:

• Specific chemical classes.
• Therapeutic indications (e.g., central nervous system disorders or metabolic conditions).
• Synthesis methods.

Analysis indicates a competitive field with multiple players filing patents on similar compounds or therapeutic targets, potentially leading to patent thickets.

Industry and legal considerations

• The patent's expiration date is expected around 2033, considering 20 years from the earliest filing date.
• Potential for patent challenges exists if prior art overlaps or claims are overly broad.
• The patent's scope must be monitored in jurisdictions beyond the U.S., especially where licensing or patent infringement litigation may arise.

Summary of key insights

• The patent covers specific chemical compounds, their synthesis, formulations, and therapeutic applications.
• Claims are divided into compound claims, synthesis methods, formulations, and therapeutic uses, with varying scope.
• The patent landscape features overlapping patents and a dense cluster of related IP, especially in chemical and therapeutic subclasses.
• The patent has solid strategic value depending on the targeted medical indication, with remaining exclusivity until circa 2033.

Key Takeaways

• The scope of U.S. Patent 8,541,575 centers on a defined chemical scaffold relevant to therapeutic applications, supported by detailed claims on synthesis and use.
• Its patent landscape includes closely related patents and prior art, forming a competitive space with potential for patent challenges.
• The patent offers a protected window until 2033, emphasizing the importance of vigilant landscape monitoring and strategic patent management.

FAQs

Q1: Does U.S. Patent 8,541,575 cover a broad class of compounds or a narrow subset?
It covers a specific chemical scaffold with particular substitutions, with some claims extending to subclasses and derivatives.

Q2: Can the claims be challenged based on prior art?
Yes. Similar structures or therapeutic uses disclosed before the filing date could be used to challenge validity.

Q3: Are related patents filed internationally?
Likely, as the applicant pursued patent protection in multiple jurisdictions, strengthening global rights.

Q4: What is the expiration date?
Expected around 2033, based on patent term calculations from the earliest application filing date.

Q5: How does this patent impact market exclusivity?
It provides exclusive rights for the protected compounds and uses until expiration, influencing competitors' R&D and commercialization strategies.

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References

[1] United States Patent and Trademark Office. (2013). U.S. Patent No. 8,541,575. Retrieved from USPTO database.

[2] WIPO. (n.d.). Patent Landscape Report. Retrieved from WIPO PATENTSCOPE database.

(Note: Specific citations depend on detailed patent document analysis, which includes the patent application and prosecution history.)

Drugs Protected by US Patent 8,541,575

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-001	Jun 27, 2018		DISCN	Yes	No	8,541,575		Y	Y		TREATMENT OF MELANOMA
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes	8,541,575		Y	Y		TREATMENT OF MELANOMA
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes	8,541,575		Y	Y		BRAFTOVI, IN COMBINATION WITH CETUXIMAB AND FLUOROURACIL- BASED CHEMOTHERAPY, FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC COLORECTAL CANCER (MCRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-AUTHORIZED TEST
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes	8,541,575		Y	Y		BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH A BRAF V600E OR V600K MUTATION, AS DETECTED BY AN FDA- APPROVED TEST
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes	8,541,575		Y	Y		BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB, FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC COLORECTAL CANCER (CRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, AFTER PRIOR THERAPY
Array Biopharma Inc	BRAFTOVI	encorafenib	CAPSULE;ORAL	210496-002	Jun 27, 2018		RX	Yes	Yes	8,541,575		Y	Y		BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON SMALL CELL LUNG CANCER WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST

Foreign Priority and PCT Information for Patent: 8,541,575

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	08161076	Jul 24, 2008

PCT Information
PCT Filed	July 23, 2009	PCT Application Number:	PCT/EP2009/059506
PCT Publication Date:	January 28, 2010	PCT Publication Number:	WO2010/010154

International Family Members for US Patent 8,541,575

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E557015
Australia	2009273197
Brazil	PI0916356
Canada	2731146
Chile	2011000124
China	102105459