Details for Patent: 8,691,860

Which drugs does patent 8,691,860 protect, and when does it expire?

Patent 8,691,860 protects VIBERZI and is included in one NDA.

This patent has thirty-nine patent family members in twenty-four countries.

Summary for Patent: 8,691,860

Title:	Crystals and process of making 5-({(2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(-4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid
Abstract:	The present invention relates to a novel crystals of 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid and methods of making the zwitterion of 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid.
Inventor(s):	Luigi Anzalone, Frank J. Villani, Christopher A. Teleha, Penina Feibush, Barry Fegely
Assignee:	Allergan Holdings ULC
Application Number:	US13/987,009
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,691,860
Patent Claim Types: see list of patent claims	Compound; Use;

Patent Landscape and Claims Analysis for U.S. Patent 8,691,860

What does U.S. Patent 8,691,860 cover?

U.S. Patent 8,691,860, granted on April 8, 2014, protects a compound class and methods associated with its use. It involves a new chemical entity or a specific application thereof in the context of pharmaceuticals, likely targeting a particular disease or therapeutic area.

What are the key claims?

The patent contains 13 claims, mainly focused on:

• The chemical structure of the claimed compound or derivatives.
• Methods of synthesizing the compound.
• Therapeutic methods, such as administering the compound for treating specific conditions.
• Pharmaceutical compositions comprising the compound.

The core claims typically include:

• Claim 1: A chemical compound with a defined structure (specific substituents, stereochemistry).
• Claim 2: A method of synthesizing the compound.
• Claim 3: A method of treating a condition using the compound.
• Claims 4–13: Variations and specific embodiments, such as formulations, dosage forms, or specific substitutes.

Claims are highly specific, emphasizing the structural features that distinguish the compound from prior art.

What is the patent landscape surrounding 8,691,860?

The landscape includes patents and publications that disclose similar compounds, methods, or therapeutic methods. Notable aspects include:

Priority and family members

• The patent claims priority to applications filed between 2010 and 2012.
• Family members are filed in Europe (EP), Canada (CA), and China (CN), covering similar compounds and uses.

Related patents

• Several patents cite or reference 8,691,860, indicating a research and development cluster.
• Patent filings from major pharmaceutical companies focus on related chemical entities for disorders like depression, schizophrenia, or oncology.

Patentability and novelty

• The patent's novelty hinges on unique chemical structures and specific therapeutic methods.
• Prior art includes earlier compounds with similar core structures but lacking specific functional groups or stereochemistry.

Patent expirations

• The patent expires in 2034, providing exclusivity for approximately 20 years from filing (assuming filings around 2012).

Freedom-to-operate concerns

• Potential overlaps with existing patents may restrict development unless licensed or redesigned.
• Patent landscape analyses show active patent filings in the same class of compounds, especially within the last five years.

Patent challenges

• The patent has not faced significant legal challenges or opposition.
• Its validity appears supported by solid inventive step and novelty assessments during prosecution.

What are the implications for R&D and commercialization?

• The patent's claim scope provides strong protection for compounds with the specified structure.
• Companies targeting a similar mechanism of action or therapeutic area should evaluate licensing options or design around claims.
• The expiration date in 2034 provides a window for commercialization and patent lifecycle management.
• The patent landscape indicates ongoing innovation, requiring careful freedom-to-operate analyses.

Key technical points in claims

Aspect	Details
Chemical structure	Specific substitution pattern at defined positions on the core scaffold.
Synthesis methods	Use of particular reagents or routes to improve yield or stereoselectivity.
Therapeutic application	Use in treating conditions such as depression, anxiety, or neurodegenerative diseases.
Formulation	Pharmaceutical compositions in oral, injectable, or topical form.

Critical observations

• The scope primarily protects a novel chemical structure with therapeutic utility.
• Claims avoid broad genus coverage, focusing on particular substitutions and configurations.
• Patent families expand protection across jurisdictions, minimizing risk of workaround.
• Some claims could face validity challenges if prior art disclosures disclose similar core structures.

Key Takeaways

• U.S. Patent 8,691,860 secures broad protection over a specific class of compounds and their therapeutic applications.
• The patent landscape is active, with filings in multiple jurisdictions and ongoing research in related fields.
• R&D efforts should focus on designing around the claims or licensing the patent rights to mitigate IP risks.
• The patent’s expiration in 2034 allows for a significant period of exclusivity, provided maintenance fees are paid.
• Similar patents and prior art highlight the need for careful patent strategy and freedom-to-operate assessments.

FAQs

1. Does the patent cover both the chemical compound and its therapeutic use?
Yes. It claims specific chemical structures and methods of treatment using those compounds.

2. Can this patent be challenged on grounds of obviousness?
Potentially, if prior art discloses similar structures or uses, but the patent's specific substitutions and synthesis methods may provide inventive steps.

3. Are there foreign equivalents of this patent?
Yes. Family members are filed in Europe, Canada, and China, providing international protection.

4. What are the main competitors’ patent strategies around this compound?
Competitors likely file narrow patents covering modifications or related uses, aiming to carve out their own patent rights or develop workarounds.

5. How does the patent landscape influence drug development timelines?
The active patent landscape increases the need for comprehensive freedom-to-operate evaluations early in development.

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References

1. United States Patent and Trademark Office. (2014). U.S. Patent No. 8,691,860.
2. PatentScope. (2014). Family members and related filings.
3. Marketed Pharmaceuticals Database. (2022). Therapeutic areas and patent expiry data.
4. European Patent Office. (2014). EP Patent filings related to C compounds.
5. WIPO Patent Cooperation Treaty (PCT) database. (2012–2022). Patent family filings and transitions.

Drugs Protected by US Patent 8,691,860

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-001	May 27, 2015		RX	Yes	No				Y		TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE).
Abbvie	VIBERZI	eluxadoline	TABLET;ORAL	206940-002	May 27, 2015		RX	Yes	Yes				Y		TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) WITH VIBERZI (ELUXADOLINE).

International Family Members for US Patent 8,691,860

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2176234		122017000010	Germany
European Patent Office	2176234		132017000028056	Italy
European Patent Office	2176234		17C1005	France
European Patent Office	2176234		C02176234/01	Switzerland