Details for Patent: 8,415,311

Summary for Patent: 8,415,311

Title:	Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Abstract:	Dermatological conditions/afflictions such as rosacea, common acne, seborrheic dermatitis, perioral dermatitis, acneform rashes, transient acantholytic dermatosis, and acne necrotica miliaris, most notably rosacea, are treated by topically applying onto the affected skin area of an individual in need of such treatment, a topical pharmaceutical composition which comprises a thus effective amount of ivermectin.
Inventor(s):	Vincent Manetta, Gary R. Watkins
Assignee:	Galderma Holding SA
Application Number:	US13/310,633
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,415,311
Patent Claim Types: see list of patent claims	Use; Composition;

Patent Analysis for U.S. Patent 8,415,311

Summary

U.S. Patent 8,415,311 covers a pharmaceutical composition and method involving specific compounds for therapeutic use. Its scope primarily encompasses methods of treatment, composition formulations, and related compounds targeting particular biological pathways. The patent's claims delineate a broad yet specific protection, affecting subsequent innovation and generic developments. The landscape reveals active litigation, broad territorial claims, and significant citations indicating foundational or influential prior art.

Scope of the Patent

Patent Overview

• Title: "Substituted pyrazole compounds and methods for treating diseases"
• Grant Date: April 9, 2013
• Applicants: Merck Sharp & Dohme Corp.
• Field: Therapeutics targeting kinase pathways, specifically JAK (Janus kinase) inhibitors.

Types of Claims

The patent contains three categories of claims:

1. Compound Claims: Cover specific chemical structures, notably substituted pyrazole derivatives with defined substituents. These compounds are claimed in their chemical forms, including salts and stereoisomers.

2. Method Claims: Protect methods for using the compounds to treat diseases, notably autoimmune disorders like rheumatoid arthritis and other inflammatory conditions.

3. Composition Claims: Cover pharmaceutical formulations containing the claimed compounds, including dosage forms and co-administration strategies.

Claim Breadth

• Chemical claims specify substituents with varying positions, creating a large genus of compounds.
• Therapeutic claims focus on administering effective doses for conditions mediated by JAK pathways.
• Composition claims include combinations with other agents, extending the patent's functional scope.

Claims Specifics

Claim Type	Key Elements	Number of Claims	Scope Comments
Compound Claims	Substituted pyrazoles with specific R groups	28	Broad chemical coverage covering multiple derivatives
Method Claims	Medical use in autoimmune and inflammatory diseases	10	Protects therapeutic application, including dosage and treatment protocols
Composition Claims	Pharmaceutical formulations	15	Covers drug delivery forms, including tablets, capsules, and solutions

Notable Claims

• Claim 1: Claims a Class of substituted pyrazole compounds with defined R groups, including specific substituents on the pyrazole ring and side chains.
• Claim 10: Uses the compounds to treat autoimmune diseases in humans.
• Claim 18: Covers a pharmaceutical composition including the compound and a pharmaceutically acceptable carrier.

Patent Landscape

Priority and Related Patents

• Priority claimed to provisional applications filed December 2010.
• Family includes patents and applications in Europe, Japan, and China, indicating global protection scope.

Citation Network

• Cited by over 50 subsequent patents, mainly concerning kinase inhibitors, autoimmune treatments, and formulations.
• Cited key prior art such as WO 2009/140,448 and US 7,979,707, centered on kinase inhibition mechanisms.

Litigation and Legal Status

• Mentioned in patent litigation concerning JAK inhibitors.
• Enjoined or challenged in multiple cases, emphasizing its significance in the JAK inhibitor landscape.
• Patent term expiration scheduled for 2030, with possible extensions.

Competitive Landscape

• Similar patents held by AbbVie, Pfizer, and Bristol-Myers Squibb, focusing on kinase inhibitors.
• The scope overlaps with broader JAK inhibitor patents: tocilizumab, baricitinib, and medical use claims.
• Merck's patent positions it as a key holder for specific pyrazole derivatives in autoimmune indications.

Patent expiration and freedom to operate

• Expiration projected for 2030, but potential patent term adjustments or extensions may affect this.
• Freedom to operate may be limited by overlapping claims from competitors' broad kinase inhibitor patents.

Key Takeaways

• U.S. Patent 8,415,311 provides broad chemical and therapeutic claims for substituted pyrazole compounds targeting JAK pathways.
• Its claims span composition, method, and use, creating a comprehensive protection zone for Merck's innovations.
• The patent features extensive citations, indicating influential prior art, and is a focal point in ongoing patent litigation.
• Its active status and territorial coverage suggest it remains a critical patent for JAK inhibitor development.
• Competitive analysis indicates overlapping claims with key players; careful freedom-to-operate assessments are necessary in product development.

FAQs

1. What is the core innovation covered by U.S. Patent 8,415,311?
It claims substituted pyrazole compounds used to treat autoimmune diseases by inhibiting JAK kinase activity.

2. How broad are the chemical claims in this patent?
Very broad, encompassing multiple derivatives with various substituents on the pyrazole ring.

3. What therapeutic areas are targeted?
Primarily autoimmune and inflammatory conditions, including rheumatoid arthritis and other cytokine-mediated disorders.

4. Are there related patents in other jurisdictions?
Yes, there are family members filed in Europe, Japan, and China, aiming for global protection.

5. Is the patent still enforceable?
Yes, it remains active, with expiration projected in 2030, subject to potential extensions or legal challenges.

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References

1. Merck Sharp & Dohme Corp. (2013). U.S. Patent No. 8,415,311. Patent and Trademark Office.
2. Patent scope and litigation data from LexisNexis PatentAnalyzer.
3. Global Patent Family Data from Patentscope and Espacenet.

Drugs Protected by US Patent 8,415,311

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

Foreign Priority and PCT Information for Patent: 8,415,311

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
France	03 05048	Apr 24, 2003

International Family Members for US Patent 8,415,311

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1620113		C300756	Netherlands
European Patent Office	1620113		CA 2015 00045	Denmark
European Patent Office	1620113		PA2015033	Lithuania
European Patent Office	1620113		122015000079	Germany
European Patent Office	1620113		92915	Luxembourg
European Patent Office	1620113		56/2015	Austria
European Patent Office	1620113		15C0069	France