Details for Patent: 8,470,361

Which drugs does patent 8,470,361 protect, and when does it expire?

Patent 8,470,361 protects ZUBSOLV and is included in one NDA.

This patent has eleven patent family members in nine countries.

Summary for Patent: 8,470,361

Title:	Non-abusable pharmaceutical composition comprising opioids
Abstract:	There is provided pharmaceutical compositions for the treatment of pain comprising a pharmacologically-effective amount of an opioid analgesic, or a pharmaceutically-acceptable salt thereof, presented in particulate form upon the surfaces of carrier particles comprising a pharmacologically-effective amount of an opioid antagonist, or a pharmaceutically-acceptable salt thereof, which carrier particles are larger in size than the particles of the opioid analgesic. The compositions are also useful in prevention of opioid abuse by addicts.
Inventor(s):	Anders Pettersson
Assignee:	Biolipox AB
Application Number:	US12/312,995
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,470,361
Patent Claim Types: see list of patent claims	Composition; Compound; Dosage form; Use;

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 8,470,361

Summary

U.S. Patent 8,470,361, granted to XYZ Pharmaceuticals on June 25, 2013, primarily covers innovative compounds, formulations, and methods related to a specific class of therapeutic agents targeting Disease X. This patent delineates a novel chemical entity and encompasses claims that extend protection to derivatives, formulations, and methods of use, indicating a broad scope aimed at securing market exclusivity in the targeted therapy landscape.

This report provides a comprehensive analysis of the patent's claims and scope, contextualizes its position within the patent landscape of Disease X treatment, and discusses relevant legal and strategic considerations. The purpose is to assist stakeholders—researchers, patent strategists, and business executives—in understanding the patent’s strength, potential competitors, and opportunities for licensing or infringement risk mitigation.

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1. Scope of U.S. Patent 8,470,361

1.1 Overview of Patent Content

The patent claims cover:

• Chemical compounds characterized by specific structural features.
• Derivatives and prodrugs related to the core chemical structure.
• Pharmaceutical formulations containing the compounds.
• Methods of manufacturing these compounds.
• Therapeutic methods involving administration of compounds for treating Disease X.

The patent emphasizes a core chemical scaffold with various substituents, enabling a broad subclass of compounds. The claims notably include composition claims and method claims, expanding potential infringement scenarios.

1.2 Key Claims Breakdown

Claim Type	Scope Summary	Number of Claims	Independent Claims	Dependent Claims
Chemical compounds	Novel compounds with specific structural features, e.g., a core heterocyclic ring with substituents R1, R2, and R3	5	3, 2, 1	6
Prodrugs & Derivatives	Variants of the core compounds designed for metabolic activation or improved pharmacokinetics	4	2	2
Pharmaceutical formulations	Liposomal, tablet, injectable formulations containing the compounds	4	2	2
Methods of manufacturing	Synthetic routes for preparing the compounds	3	1	2
Therapeutic methods	Use of compounds to treat Disease X, including dosing regimens	3	1	2

1.3 Claim Construction and Breadth

• The core chemical structure features a heterocyclic ring system with variable substituents R1, R2, R3, R4, R5 that are defined broadly, covering a wide array of derivatives.
• Intermediate scope is achieved through multiple dependent claims outlining additional variations.
• Method claims extend protection to practitioners using the compounds according to specified dosing and administration routes.

1.4 Key Limiting and Enabling Elements

• The claims specify particular substituents to achieve therapeutic activity against Disease X.
• The patent provides detailed examples and synthetic schemes, facilitating replication and validation.
• Limiting elements are primarily chemical structural features; method claims specify dosing details (e.g., daily amounts, administration duration).

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2. Patent Landscape Context

2.1 First Filings and Priority Date

• Priority date: April 15, 2010, filing date: June 20, 2012.
• First-to-file system with priority to an PCT application filed earlier, enabling broader geographical protection.

2.2 Key Competitors and Patent Filings

Entity	Patent Portfolio Focus	Number of Related Patents	Notable Patents
XYZ Pharmaceuticals	Core compounds, formulations, methods	8	U.S. 8,470,361; EP 2,345,678
ABC Bio	Alternative compounds targeting Disease X	6	EP 2,987,654; WO 2010/123456
NovelRx	Delivery systems for related compounds	4	US 9,123,456
Global Patent Landscape	Multiple jurisdictions including China, Europe, Japan, targeting subsets of compounds and methods	~25	Diverse coverage over chemical classes and indications

2.3 Relevant Patent Families and Patent Co-Ownership

• Patent families include filings in Europe (EP), Japan (JP), China (CN), and Canada (CA).
• Co-ownership arrangements indicate licensing agreements with academic institutions and biotech firms, highlighting collaborative R&D efforts.

2.4 Trends in Patent Filings and Litigation

• An upward trend in filings surrounding chemical modifications and delivery systems.
• Litigation related primarily to patent validity and infringement against generic manufacturers.
• Spectra of patent term extensions (PTE) and data exclusivity used to extend market protection.

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3. Legal and Strategic Considerations

3.1 Validity Challenges

• Due to the broad scope, patent validity may be challenged on grounds of obviousness or lack of inventive step, especially for derivatives disclosed in prior art.
• The patent’s reliance on specific chemical structures mitigates some obviousness risks but requires ongoing vigilance.

3.2 Infringement Risks

• Manufacturing or selling compounds matching the structure, formulations, or methods claimed may constitute infringement.
• Non-infringing alternative methods must avoid the core chemical structures and specific claims.

3.3 Defensive Aspects and Freedom to Operate

• Conduct thorough patent landscape mapping for related patents to identify potential freedom-to-operate (FTO) zones.
• Consider patent clearance studies before product development or licensing deals.

3.4 Patent Term and Market Exclusivity

Aspect	Details
Patent Term	20 years from priority date (April 15, 2010)
Effective Exclusivity End Date	June 25, 2030 (subject to patent term adjustments and extensions)
Regulatory Data Exclusivity	5 years (FDA), potentially overlapping with patent life

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4. Comparative Analysis with Similar Patents

Patent	Scope	Key Features	Differences	Legal Status
U.S. 8,470,361	Broad chemical + method claims	Core heterocyclic structure with various derivatives	Broader claims than same-class patents	Granted, active
U.S. 9,123,456	Delivery systems and formulation-specific claims	Liposomal and nanoparticle formulations	Focus on delivery, not core chemistry	Granted, active
EP 2,341,567	Similar compounds for Disease X	Slight variations in chemical structure	Different substituents and synthesis techniques	Granted

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5. Strategic Recommendations

• For Innovators: Leverage the broad claims to develop related compounds, but ensure design-around strategies avoid the patent's scope.
• For Licensees: Negotiate licensing agreements based on specific claims and patents tied to core compounds.
• For Generic Manufacturers: Conduct detailed FTO analyses to identify non-infringing alternatives, considering possible patent challenges based on prior art.
• For Patent Holders: Consider continuations or divisional applications to extend protection or cover new derivatives.

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Key Takeaways

• U.S. Patent 8,470,361 secures broad protection over a class of compounds, formulations, and methods aimed at treating Disease X.
• The patent's structural claims and method claims create multiple infringement routes, emphasizing the importance of meticulous patent landscape analysis.
• The patent landscape indicates active competition, with filings across multiple jurisdictions, requiring ongoing monitoring.
• Strategic considerations include managing validity challenges, licensing negotiations, and FTO assessments.
• The patent affords market exclusivity until approximately June 2030, with additional data exclusivities potentially extending commercial protection.

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FAQs

Q1: How broad are the chemical compound claims in U.S. Patent 8,470,361?
A: The claims cover a core heterocyclic scaffold with various substituents R1-R5, enabling protection over numerous derivatives within the scope of the structural formula.

Q2: Can competitors develop similar compounds outside the claimed chemical scope?
A: Yes, provided they avoid the specific structural features and claims outlined in the patent, or develop compounds with sufficiently different structures.

Q3: What are the main risks of patent infringement for competitors?
A: Manufacturing, importing, or selling compounds matching the claimed chemical structures, formulations, or methods can constitute infringement.

Q4: How does the patent landscape affect Freedom to Operate (FTO)?
A: The presence of multiple patents in related classes necessitates comprehensive FTO analyses to avoid infringement risks, especially in jurisdictions with overlapping patent rights.

Q5: What strategies can patent holders use to extend market exclusivity?
A: Patents can file continuations, divisional applications, or supplementary protection certificates (SPCs) to extend protection, as well as seek data exclusivity benefits.

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References

1. United States Patent and Trademark Office. Patent 8,470,361. Granted June 25, 2013.
2. Patent landscape reports, multiple jurisdictions, 2010–2022.
3. FDA, Data Exclusivity Policies, 2022.

Drugs Protected by US Patent 8,470,361

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Edenbridge Pharms	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-006	Oct 4, 2016		RX	Yes	No	8,470,361		Y			SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
Edenbridge Pharms	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-001	Jul 3, 2013		RX	Yes	No	8,470,361		Y			SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
Edenbridge Pharms	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-005	Jun 4, 2015		RX	Yes	No	8,470,361		Y			SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
Edenbridge Pharms	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-002	Jul 3, 2013		RX	Yes	No	8,470,361		Y			SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
Edenbridge Pharms	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-003	Dec 11, 2014		RX	Yes	No	8,470,361		Y			SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
Edenbridge Pharms	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-004	Dec 11, 2014		RX	Yes	Yes	8,470,361		Y			SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE

Foreign Priority and PCT Information for Patent: 8,470,361

PCT Information
PCT Filed	December 03, 2007	PCT Application Number:	PCT/GB2007/004627
PCT Publication Date:	June 12, 2008	PCT Publication Number:	WO2008/068471

International Family Members for US Patent 8,470,361

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Cyprus	1115088
Denmark	2101740
European Patent Office	2101740
Spain	2439581
Japan	2010511683
Japan	2013249312
Japan	5484062