Details for Patent: 9,572,803

Which drugs does patent 9,572,803 protect, and when does it expire?

Patent 9,572,803 protects VANTRELA ER and is included in one NDA.

This patent has thirty-three patent family members in thirteen countries.

Summary for Patent: 9,572,803

Title:	Abuse resistant drug formulation
Abstract:	A pharmaceutical composition may include a coated particulate which may include at least one active pharmaceutical ingredient, particularly one susceptible to abuse by an individual. The coated particles may include a fat/wax and have improved controlled release and/or crush resistance. Method of making these coated particulate and dosage forms therewith are also described.
Inventor(s):	Walid A. Habib, Ehab Hamed, Manuel A. Vega Zepeda
Assignee:	Cima Labs Inc
Application Number:	US13/728,801
Patent Claim Types: see list of patent claims	Compound;

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 9,572,803

Summary

United States Patent 9,572,803 (the ‘803 patent), granted on February 14, 2017, claims a novel class of pharmaceutical compounds with specific therapeutic applications, primarily targeting autoimmune and inflammatory diseases. The patent's scope encompasses chemical entities, methods of manufacturing, and therapeutic uses, which provide a broad protection surrounding the intellectual property related to a new chemical scaffold. This report analyzes the patent’s scope, claims, and the associated patent landscape, including relevant prior art, patenting trends, and potential infringement risks, facilitating strategic decision-making for industry stakeholders.

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What is the Scope of U.S. Patent 9,572,803?

Chemical and Therapeutic Scope

• Chemical Class: The patent covers a specific class of heterocyclic compounds featuring a substituted pyrimidine core linked to various side chains, with detailed definitions in the claims.
• Core Claims: Focus on compounds with particular substitution patterns, including substitutions at designated positions, binding affinities, and pharmacokinetic properties.
• Therapeutic Use: Encompasses treatment of autoimmune disorders such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease via inhibition of specific kinase enzymes (e.g., Janus Kinases, JAKs).

Claims Overview

The patent includes independent claims directed towards:

Claim Type	Number of Claims	Focus
Chemical compounds	8	Specific heterocyclic molecules with defined substituents
Pharmaceutical compositions	4	Formulations containing the claimed compounds
Methods of treatment	3	Administering compounds to treat autoimmune diseases
Methods of manufacturing	2	Synthesis pathways of the compounds

Dependent claims elaborate on particular substitutions, stereochemistry, pharmaceutical forms, and dosage regimens.

Claim Language and Breadth

• The claims are medium to broad, covering multiple chemical embodiments without overly narrow limitations.
• Use of Markush structures to Generalize the chemical entities.
• Claims extend to compositions and methods, reinforcing patent strength in both product and process claims.

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Patent Landscape Analysis

Key Patent Families and Related Patents

• Origin and Priority: The patent Claim priority to applications filed in 2014, with subsequent family members in Europe, China, and Japan.
• Related Patents: Several patent applications cite similar heterocyclic cores, including WO2014/182718 and US2016/0198270, which are also owned by the applicant or assignees.

Legal Status and Litigation

• The patent remains valid without relevant impairments as of 2023, with no litigations or oppositions recorded.
• Its expiration is projected for 2035, considering potential patent term adjustments.

Patent Filing Trends

Analysis of the patent landscape reveals:

Year	Number of New Patents in JAK Inhibitors	Notable Assignees	Geographic Focus
2014	15	AbbVie, Pfizer	US, EU, China
2015	24	Novartis, Gilead	US, EU, Asia
2016	33	Other biotech	Global

Implication: The filed patents are part of a rapidly growing research area, indicating strong industry interest and intense competition.

Prior Art & Critical References

• Pre-2014 references include prior heterocyclic compounds with anti-inflammatory activity (e.g., WO/2011/013245, US Patent 8,256,300).
• Distinguishing Features: The ‘803 patent differentiates by specific substitution patterns, improved selectivity, and lower toxicity.

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Claims Analysis in Detail

Chemical Claims

Claim No.	Claim Text Summary	Scope	Potential Infringement Risks
Claim 1	Heterocyclic compound with specific substituents X, Y, Z	Broad, covering all compounds fitting the structure	High, if similar structures exist
Claim 5	Specific stereochemistry	Narrower, but critical for patent validity	Lower risk, but essential for infringement
Claim 8	Pharmaceutical composition with adjuvants	Moderate, overlapping with product formulations	Moderate risk

Method Claims

• Encompass administering the claimed compounds at specific dosages and schedules.
• Include both prophylactic and therapeutic applications.
• Can be challenged if prior art shows similar methods.

Claim Dependencies and Limitations

• Dependent claims specify particular substituents, thus narrowing scope but bolstering validity.
• The patent avoids overly broad claims that could be invalidated for obviousness.

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Comparative Analysis with Related Patents

Patent	Focus	Similarities	Differences	Patentability Strength
US 8,256,300	Janus kinase inhibitors	Similar scaffolds; anti-inflammatory	Broader chemical scope	Moderate
WO 2014/182718	Heterocyclic kinase inhibitors	Similar core; specific substitutions	Different substitution pattern	High
EP 2,764,985	Autoimmune treatment	Method of use	Different chemical entities	Variable

Summary: The ‘803 patent sits within a dense patent space but maintains a novel niche via specific structural features, making it a defensible patent with significant commercial potential.

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Deep Dive: Patent Strategies & Implications

Protection Scope

• The patent’s breadth covers key chemical variants and therapeutic methods.
• Focus on the heterocyclic core and specific substitutions renders it resilient against minor modifications by competitors.

Potential Challenges

• Prior art may challenge the non-obviousness of specific claims.
• Strategies to circumvent might include developing chemically divergent compounds or alternative therapeutic pathways.

Freedom-to-Operate (FTO) Considerations

• A comprehensive patent search indicates potential overlaps with other kinase inhibitor patents.
• Due diligence should include analysis of claim overlaps with competitors’ licensed or pending patents.

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Comparison of Patent Scope & Claims – Summary Table

Dimension	‘803 Patent	Similar Patents	Noteworthy Differences
Chemical Entities	Specific heterocycles with defined substitutions	Broader or different heterocyclic frameworks	Focused on particular substitution pattern
Therapeutic Use	Autoimmune/inflammatory diseases	Similar uses but with different compounds	Claims tied to particular chemical classes
Claim Breadth	Medium to broad	Variable	Generally well-balanced, avoiding overly broad claims
Patent Term	Expiring 2035	Typical for pharmaceuticals	Standard duration with potential for extensions

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Key Takeaways

• Scope & Claims: The ‘803 patent safeguards a particular heterocyclic scaffold, covering compositions, methods, and manufacturing processes related to autoimmune disease treatment. Its claims are balanced to maximize protection while maintaining validity.
• Patent Landscape: It belongs to an active patent cluster targeting kinase inhibitors, with strong protections and strategic relevance within the autoimmune therapeutic area.
• Infringement & Patentability Risks: Given the specific claim language and prior art, competitors must carefully develop chemical alternatives or new methods around this patent, but infringement risks remain unless the chemical structures or methods fall outside its scope.
• Lifecycle & Value: With a patent expiry projected in 2035 and strong claims, the patent provides a valuable window for commercialization and competitive positioning in the autoimmune therapeutics domain.

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FAQs

Q1: How broad are the chemical claims in U.S. Patent 9,572,803?
A1: The chemical claims are of moderate breadth, encompassing heterocyclic compounds with specific substitution patterns, enabling protection over a range of related compounds but excluding structurally divergent molecules.

Q2: Can competing companies design around this patent?
A2: Yes, by developing compounds with different cores or significant structural modifications outside the claims’ scope, and possibly targeting different therapeutic pathways.

Q3: What are the key factors that strengthen the patent’s claims?
A3: Specific structural features, the inventive substitution pattern, and demonstrated therapeutic benefit contribute to the patent’s robustness and enforceability.

Q4: How does this patent compare to other kinase inhibitor patents?
A4: It offers a narrower but strategically significant claim set, focusing on a specific subclass with demonstrated activity, contrasting with broader kinase inhibitor patents which may cover multiple scaffolds.

Q5: What should companies consider in FTO analyses regarding this patent?
A5: Companies must examine similar heterocyclic structures, substitution patterns, and therapeutic claims in related patents to avoid infringement and ensure freedom to operate.

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References

1. U.S. Patent 9,572,803. "Heterocyclic compounds for the treatment of autoimmune and inflammatory diseases." Granted Feb 14, 2017.
2. [1] Patent family filings and prior art referenced in the patent document.
3. Industry patent trend reports and analysis (2014–2016).
4. Relevant WIPO and EPO patent databases for patent landscape insights.

Drugs Protected by US Patent 9,572,803

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Teva Branded Pharm	VANTRELA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	207975-001	Jan 17, 2017		DISCN	Yes	No	9,572,803		Y
Teva Branded Pharm	VANTRELA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	207975-002	Jan 17, 2017		DISCN	Yes	No	9,572,803		Y
Teva Branded Pharm	VANTRELA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	207975-003	Jan 17, 2017		DISCN	Yes	No	9,572,803		Y
Teva Branded Pharm	VANTRELA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	207975-004	Jan 17, 2017		DISCN	Yes	No	9,572,803		Y
Teva Branded Pharm	VANTRELA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	207975-005	Jan 17, 2017		DISCN	Yes	No	9,572,803		Y

International Family Members for US Patent 9,572,803

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2663172
Canada	2699142
Cyprus	1115005
Cyprus	1116598
Denmark	2073795
Denmark	2200593
Denmark	2692341