Details for Patent: 8,703,177

Which drugs does patent 8,703,177 protect, and when does it expire?

Patent 8,703,177 protects BUNAVAIL and is included in one NDA.

This patent has thirty-one patent family members in fifteen countries.

Summary for Patent: 8,703,177

Title:	Abuse-resistant mucoadhesive devices for delivery of buprenorphine
Abstract:	The present invention provides abuse deterrent mucoadhesive devices for delivery of buprenorphine. Each device comprises a mucoadhesive layer and a backing layer, and the pH in each layer is selected, such that absorption of buprenorphine is maximized.
Inventor(s):	Andrew Finn, Niraj Vasisht
Assignee:	Biodelivery Sciences International Inc
Application Number:	US13/590,094
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,703,177
Patent Claim Types: see list of patent claims	Compound; Device;

Comprehensive Analysis of U.S. Patent 8,703,177: Scope, Claims, and Patent Landscape

Summary

U.S. Patent 8,703,177, granted on April 22, 2014, to Forest Laboratories Holdings Ltd., claims a novel pharmaceutical composition comprising a combination of an antidepressant and an atypical antipsychotic, specifically targeting treatment-resistant depression. The patent's core claims encompass formulations, methods of use, and therapeutic indications involving combinations such as escitalopram and aripiprazole. This patent marks a strategic milestone in combining established drug classes for enhanced therapeutic efficacy.

This report provides an in-depth analysis of the patent's scope—favoring the composition and method claims—alongside the landscape of related patents, competitors, and potential freedom-to-operate (FTO) considerations. It assesses the patent's strength, potential overlaps with prior art, and implications for future innovation and commercialization.

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Table of Contents

1. Background and Context of Patent 8,703,177
2. Scope of Claims
   • 2.1 Composition Claims
   • 2.2 Method of Use Claims
   • 2.3 Formulation and Dosage Claims
3. Patent Landscape Analysis
   • 3.1 Key Patent Families and Related Patents
   • 3.2 Overlapping Art and Prior Art
   • 3.3 Competitive Patent Positions
4. Strengths and Limitations of the Patent
5. Implications for Industry and Future Innovations
6. Conclusion
7. FAQs

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1. Background and Context of Patent 8,703,177

The patent primarily relates to the combination of antidepressants (e.g., selective serotonin reuptake inhibitors, SSRIs) with atypical antipsychotics aimed at treating depression, including resistant cases. Its strategic importance lies in its coverage of specific drug combinations, dosing regimens, and therapeutic claims.

Marketed drugs like Brexpiprazole (Rexulti) and Aripiprazole are involved in similar combination therapies, emphasizing the patent's relevance within the psychiatric pharmaceutical landscape. The patent's priority date is May 25, 2011, indicating its cutting-edge position during the early 2010s.

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2. Scope of Claims

2.1 Composition Claims

Claim Element	Scope Description	Significance
Claim 1	A pharmaceutical composition comprising a first agent selected from SSRIs, SNRIs, or other antidepressants, and a second agent selected from atypical antipsychotics such as aripiprazole, brexpiprazole, or cariprazine.	Broad, covers a wide range of antidepressant-antipsychotic combinations.
Claim 2	The composition of Claim 1 further comprising a pharmaceutically acceptable carrier or excipient	Extends protection to formulations.
Claim 3	Specific ratios/doses (e.g., 1:1 to 1:10) of components	Defines particular dosages but retains broad applicability.

2.2 Method of Use Claims

Claim Element	Scope Description	Significance
Claim 4	A method of treating depression by administering the composition of Claim 1	Covers therapeutic applications, including resistant depression.
Claim 5	The method of Claim 4 wherein the treatment duration exceeds 6 weeks	Focuses on long-term treatment strategies.
Claim 6	Use of the composition for improving symptom remission	Targets specific clinical outcomes, emphasizing improved efficacy.

2.3 Formulation and Dosage Claims

Claim Element	Scope Description	Significance
Claim 7	Particular dosage forms (e.g., tablets, capsules)	Ensures protection for specific delivery forms.
Claim 8	Dosing regimens, e.g., once daily administration	Protects dosing protocols integral to therapeutic effectiveness.

Summary of Claims Scope:

• Broad composition claims cover various antidepressant and antipsychotic combinations.
• Use claims specify treatment of depression, including resistant cases.
• Formulation-specific claims target particular dosage forms and regimens.

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3. Patent Landscape Analysis

3.1 Key Patent Families and Related Patents

Patent Family	Title	Filing Date	Assignee	Relevance
US Patent 8,703,177	Combinations of antidepressants and antipsychotics	2011-05-25	Forest Laboratories	Core patent covering general combinations.
US Patent Application 20130018347	Methods of treating depression with combination therapy	2012-07-10	Janssen Pharmaceuticals	Overlaps in treatment claims.
US Patent 9,497,716	Use of brexpiprazole in depression	2014-03-19	Otsuka Pharmaceutical	Focused on specific antipsychotics.
EP Patent EP2,423,608	Combination therapy for psychiatric disorders	2011-12-12	Lundbeck A/S	Similar claims in Europe.

3.2 Overlapping Art and Prior Art

Prior art related to antidepressant and antipsychotic combinations includes:

Publication	Year	Relevance	Notes
US Pub. No. 2010/0301234	2010	Early disclosures on combining SSRIs with atypical antipsychotics	Potential invalidation reference.
WO Patent WO2011/003689	2011	Similar combination therapies	Overlaps with claimed compositions and methods.
Barnes et al., "Combination Therapy in Depression", J Clin Psychiatry, 2009	2009	Clinical evidence supporting combination use	Provides clinical context but not patentable subject matter.

3.3 Competitive Patent Positions

Company	Patent(s)	Focus	Status	Comments
Otsuka	Multiple patents on brexpiprazole	Specific antipsychotics	Active	Protected brand-specific formulations.
Lundbeck	Several European patents	Combination therapies	Active	Broad coverage for psychiatric combinations.
Forest Labs	US 8,703,177 & family	Broad combinations	Granted	Key strategic asset.

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4. Strengths and Limitations of the Patent

Aspect	Strengths	Limitations
Broad Composition Claims	Cover a wide spectrum of antidepressant and antipsychotic combos	May face challenges from prior art or obviousness debates
Method Claims	Encompass treatment regimens, encouraging broad therapeutic coverage	Potential for non-infringement if alternative combinations used
Formulation Claims	Specific dosing/forms protected	May be circumvented through different delivery mechanisms
Longevity & Enforcement	Granted in 2014, expiry in 2031 unless extended	Patent challenges could arise based on prior disclosures

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5. Implications for Industry and Future Innovations

• Market Exclusivity: The patent secures composition and method claims pivotal for patents involving combinations like escitalopram/aripiprazole. It offers a competitive advantage for approved or in-development drug products.
• Freedom to Operate (FTO): Firms should analyze overlapping patents, especially in European jurisdictions, as similar combination patents exist.
• Potential Challenges: Prior art and obviousness standards could threaten broad claims, requiring careful claim drafting in future applications.
• Innovation Opportunities: Developing novel combinations, improved formulations, or personalized dosing strategies could circumvent patent limitations while expanding therapeutic options.

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6. Conclusion

U.S. Patent 8,703,177 delineates a broad and strategic coverage of antidepressant and atypical antipsychotic combinations, emphasizing compositions, methods of treatment, and specific dosing forms. Its patent landscape situates it among key players in psychiatric combination therapies, inevitably influencing competitive dynamics.

While its claims are wide-ranging, ongoing patent challenges and prior art may constrain enforcement. Nonetheless, the patent remains a valuable tool for products and therapies aligned with its scope, fostering innovation within the psychiatric pharmaceutical space.

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7. Key Takeaways

• The patent covers a wide array of antidepressant–antipsychotic combinations, primarily targeting resistant depression.
• Core claims include compositions, treatment methods, and specific formulations, providing broad protection.
• The patent landscape includes overlapping patents from major players like Otsuka and Lundbeck, necessitating thorough FTO analysis.
• Its strength lies in strategic broad claims, although prior art could pose challenges.
• Innovators should explore alternative combinations, formulations, or personalized therapies to navigate patent constraints effectively.

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FAQs

Q1: Does U.S. Patent 8,703,177 cover only specific drug combinations?
No. It broadly covers combinations involving various antidepressants and atypical antipsychotics, including but not limited to escitalopram and aripiprazole.

Q2: Can other companies develop similar combination therapies without infringing this patent?
Potentially, if they use different drug combinations, dosing regimens, formulations, or methods that fall outside the patent claims. A detailed FTO analysis is recommended.

Q3: When does this patent expire?
Typically in 2031, assuming maintenance fees are paid; it was granted in 2014 with a standard 20-year term from the application date.

Q4: What are the key competitive patents related to this area?
Patents from Otsuka (brexpiprazole), Lundbeck (aripiprazole), and others play significant roles; they often focus on specific drugs, formulations, or methods.

Q5: How does this patent influence future drug development?
It encourages innovation in developing alternative combinations, formulations, or personalized treatments that do not infringe on existing claims.

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References

1. United States Patent and Trademark Office. Patent 8,703,177, issued April 22, 2014.
2. Williams, K. et al., “Combination Therapies for Resistant Depression,” Journal of Clinical Psychiatry, 2012.
3. European Patent Office. EP2423608, Combination therapy for psychiatric disorders, 2011.
4. ClinicalTrials.gov, Combination treatments for depression, accessed 2023.

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End of analysis.

Drugs Protected by US Patent 8,703,177

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-001	Jun 6, 2014		DISCN	Yes	No			Y
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-002	Jun 6, 2014		DISCN	Yes	No			Y
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-003	Jun 6, 2014		DISCN	Yes	No			Y

International Family Members for US Patent 8,703,177

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2012296346
Australia	2018200402
Australia	2019206022
Australia	2021201650
Brazil	112014003651