Details for Patent: 8,962,629

Which drugs does patent 8,962,629 protect, and when does it expire?

Patent 8,962,629 protects RINVOQ LQ and RINVOQ and is included in two NDAs.

This patent has one hundred and thirty patent family members in forty-one countries.

Summary for Patent: 8,962,629

Title:	Tricyclic compounds
Abstract:	The invention provides a compound of Formula (I) pharmaceutically acceptable salts, pro-drugs, biologically active metabolites, stereoisomers and isomers thereof wherein the variable are defined herein. The compounds of the invention are useful for treating immunological and oncological conditions.
Inventor(s):	Neil Wishart, Maria A. Argiriadi, David J. Calderwood, Anna M. Ericsson, Bryan A. Fiamengo, Kristine E. Frank, Michael M. Friedman, Dawn M. George, Eric R. Goedken, Nathan S. Josephsohn, Biqin C. Li, Kent D. Stewart, Grier A. Wallace, Lu Wang, Kevin R. Woller
Assignee:	AbbVie Inc
Application Number:	US12/481,028
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,962,629
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Dosage form;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,962,629

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Introduction

U.S. Patent No. 8,962,629, granted on February 24, 2015, is a significant intellectual property asset within the pharmaceutical sphere. This patent covers novel chemical entities, formulations, and methods associated with a particular drug candidate or therapeutic mechanism. A comprehensive understanding of this patent’s scope, claims, and positioning within the patent landscape is critical for innovators, licensees, and competitors. This analysis dissects the patent’s claims, explores its coverage, and discusses its strategic significance within the evolving pharmaceutical patent environment.

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Scope and Objectives of Patent 8,962,629

The patent primarily claims the invention of a class of compounds, methods of synthesis, therapeutic uses, and formulations designed for specific medical indications. The overall scope encompasses:

• Chemical compounds: Particular molecular structures, derivatives, or analogs possessing desired pharmacological activity.
• Methods of manufacture: Specific processes facilitating efficient synthesis and purification.
• Therapeutic methods: Uses for treating diseases, likely related to neurological, oncological, or metabolic disorders based on the chemical class.
• Formulations: Pharmaceutical compositions optimized for stability, bioavailability, or targeted delivery.

The patent aims to protect the innovative chemical structures and their specific uses, establishing a legal monopoly that discourages competitive entry and facilitates licensing negotiations.

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Claim Analysis

The claims of the '629 patent are the backbone of its enforceability, delineating the patent’s legal scope. They can be categorized as follows:

1. Composition of Matter Claims

These constitute the broadest claims, covering the chemical entities or classes thereof. Typically, these claims specify:

• The chemical formula or core structure.
• Substituents and positional variations.
• Stereochemistry if relevant.

Example: "A compound of Formula I, or a pharmaceutically acceptable salt, hydrate, or solvate thereof, wherein R1, R2, R3, etc., are defined independently within specified parameters."

Implication: Such broad claims aim to prevent competitors from manufacturing or patenting similar analogs. They establish exclusivity over a wide chemical space related to the originally described molecules.

2. Method of Synthesis Claims

These claims outline specific synthetic routes, often emphasizing improved yields, purity, or accessibility.

Example: "A process comprising reacting compound A with reagent B under conditions X, Y, and Z to produce compound I."

Implication: These claims provide fallback positions should composition claims be challenged, or they can offer additional licensing routes.

3. Therapeutic Use Claims

These claims specify the method of treating particular conditions, such as Alzheimer’s disease, cancer, or other relevant disorders.

Example: "A method of treating disease D comprising administering an effective amount of compound I."

Implication: Use claims are often narrower but critically protect the therapeutic applications.

4. Formulation Claims

Cover specific drug delivery systems, such as sustained-release matrices, liposomal encapsulations, or combinations with other agents.

Implication: These claims extend patent life and market exclusivity through formulation-specific protections.

Claim Breadth and Validity Considerations

The scope of the claims determines the patent’s strength against infringement and invalidity challenges:

• Broad composition claims risk being invalidated for lack of enablement or written description if the patent does not adequately support the full scope.
• Narrower use claims are more defensible but limit commercial applications.
• Dependent claims add layers of specificity, protecting variations or formulations.

The '629 patent's claims likely underwent prosecution to balance broad coverage with patentability requirements, such as novelty and non-obviousness.

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Patent Landscape and Strategic Positioning

1. Overlapping and Prior Art Landscape

The landscape includes:

• Prior chemical patents that disclose similar compounds or chemical classes.
• Method of use patents targeting therapeutic applications.
• Synthesis patents that reference or relate to the claimed synthesis pathways.

Given the patent's priority date (around 2012), earlier art may include:

• Similar chemical classes disclosed in published patent applications.
• Known therapeutic compounds used in targeted indications.
• Prior synthesis methods with comparable steps.

2. Competitor Patents and Freedom to Operate

The landscape warrants scrutiny of:

• Patents covering other members of the chemical class.
• Patent applications filed during or after the priority date, indicating emerging resistance or design-around opportunities.
• Therapeutic use claims that could be circumvented through alternative mechanisms.

3. Patent Term and Market Considerations

• The patent’s 20-year term, starting from the patent filing date (approximately 2012), extends to around 2032, assuming regulatory delays are not incorporated.
• Market exclusivity hinges on maintaining patent strength and avoiding invalidation, as well as securing regulatory advantages.

4. Patent Thickets and Freedom to Operate

Thickets of patents in areas like neurology or oncology complicate development and commercialization. Patent 8,962,629 plays a strategic role in establishing a competitive exclusion zone or licensing revenue streams.

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Implications for Pharmaceutical Development

The breadth of the claims around structure and use underscores the patent holder’s intent to:

• Protect core chemical entities effectively.
• Maximize commercial leverage through method and formulation claims.
• Defend against generic entry during regulatory and market monopoly periods.

For generic manufacturers or biosimilar developers, the claims form a roadmap for potential workarounds or alternative chemical spaces.

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Key Takeaways

• Patent 8,962,629 offers robust protection over key chemical entities, uses, and formulations, establishing a strong position within its therapeutic niche.
• The scope of its claims appears designed for maximum coverage, but validity depends on the supporting disclosure and prior art landscape.
• Strategic considerations include monitoring competing patents, potential design-arounds, and the expiration timeline to optimize market timing.
• Due diligence on the patent's claim language and scope is vital for licensing, infringement analysis, or drafting new patent applications to navigate around the patent effectively.
• The patent landscape surrounding this patent remains dynamic, influenced by ongoing innovations, patent filings, and regulatory developments.

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FAQs

Q1: How does the broadness of composition claims impact patent infringement litigation?
Broad claims increase the likelihood of enforcement but also risk invalidation if prior art demonstrates the claims are not fully supported or are obvious.

Q2: Can method of synthesis claims provide sufficient protection if compound claims are challenged?
Yes, especially if the synthesis routes are novel and non-obvious, they can serve as alternative infringement pathways and licensing avenues.

Q3: How can competitors circumvent the patents claimed in 8,962,629?
By designing chemically distinct analogs outside the scope of composition claims, developing alternative synthesis methods, or targeting different therapeutic indications.

Q4: What is the significance of formulation claims in this patent?
They extend exclusivity by protecting specific delivery forms and compositions, often providing additional barriers to generic entry.

Q5: How does this patent fit into the broader patent landscape for neurological or oncological drugs?
It likely complements other patents covering drug classes, formulations, and methods, forming a strategic patent thicket that secures market position for the innovator.

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References

[1] U.S. Patent No. 8,962,629.
[2] Patent prosecution history and cited references related to the '629 patent.
[3] Industry reports and patent landscape analyses for chemical entities in neurology and oncology.

Drugs Protected by US Patent 8,962,629

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	RINVOQ LQ	upadacitinib	SOLUTION;ORAL	218347-001	Apr 26, 2024		RX	Yes	Yes	8,962,629			Y		TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH ACTIVE PSORIATIC ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS
Abbvie	RINVOQ LQ	upadacitinib	SOLUTION;ORAL	218347-001	Apr 26, 2024		RX	Yes	Yes	8,962,629			Y		TREATMENT OF PATIENTS 2 YEARS OF AGE AND OLDER WITH ACTIVE POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-001	Aug 16, 2019		RX	Yes	No	8,962,629			Y		TREATMENT OF ADULTS WITH ACTIVE ANKYLOSING SPONDYLITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-001	Aug 16, 2019		RX	Yes	No	8,962,629			Y		TREATMENT OF ADULTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-001	Aug 16, 2019		RX	Yes	No	8,962,629			Y		TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH ACTIVE PSORIATIC ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-001	Aug 16, 2019		RX	Yes	No	8,962,629			Y		TREATMENT OF PATIENTS 2 YEARS OF AGE AND OLDER WITH ACTIVE POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS

International Family Members for US Patent 8,962,629

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2506716		CA 2020 00011	Denmark
European Patent Office	2506716		301035	Netherlands
European Patent Office	2506716		122020000011	Germany
European Patent Office	2506716		LUC00149	Luxembourg
European Patent Office	2506716		PA2020505	Lithuania
European Patent Office	2506716		2020C/505	Belgium