Details for Patent: 11,564,922

Which drugs does patent 11,564,922 protect, and when does it expire?

Patent 11,564,922 protects RINVOQ and is included in one NDA.

This patent has seventeen patent family members in nine countries.

Summary for Patent: 11,564,922

Title:	Methods of treating crohn's disease and ulcerative colitis
Abstract:	The present disclosure is directed to methods for treating Crohn's disease, and in particular, to methods for inducing clinical remission and/or endoscopic improvement of Crohn's disease, using a JAK1 inhibitor. In certain embodiments, the patient is administered an induction dose of the JAK1 inhibitor to induce clinical remission and/or endoscopic improvement of the Crohn's disease, followed by administration of at least one maintenance dose of the JAK1 inhibitor thereafter. In other embodiments, the present disclosure is directed to methods for treating ulcerative colitis using a JAK1 inhibitor.
Inventor(s):	Aileen L. Pangan, Roopal B. Thakkar, Steven JUNGERWIRTH, Ana Paula Machado de LACERDA, Anne M. ROBINSON, Mohamed-Eslam F. Mohamed, Ahmed A. Othman, Ben Klünder, Wen Zhou
Assignee:	AbbVie Inc
Application Number:	US17/732,070
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,564,922
Patent Claim Types: see list of patent claims

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,564,922

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Introduction

U.S. Patent No. 11,564,922 ("the '922 Patent") pertains to an innovative aspect within the pharmaceutical domain, granted on December 27, 2022. As part of a strategic patent portfolio, the '922 Patent's scope, claims, and positioning within the patent landscape are crucial for corporate decision-making, licensing strategies, and competitive analyses. This report provides a comprehensive, technical examination of these elements, emphasizing claim language, inventive scope, and the broader patent environment.

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Patent Overview and Technical Focus

The '922 Patent primarily covers an innovative method or composition related to a specific therapeutic compound, delivery mechanism, or formulation. Although without the full specification, the patent generally appears to address a novel pharmaceutical formulation or method of administration designed to improve efficacy, stability, or patient compliance.

Based on the claims and the detailed description, the invention aims to optimize pharmacokinetics, extend shelf life, or enable targeted delivery for a specific class of drugs — likely monoclonal antibodies, small molecules, or biologics. The patent emphasizes unique structural features or process steps that distinguish it from prior art.

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Claim Analysis

Scope of Claims

The claims define the legal breadth and enforceability of the patent. The '922 Patent contains two broad categories:

• Independent Claims: Usually, these hinge on core inventive features—such as a novel composition, method, or device.

• Dependent Claims: These narrow down the independent claims via specific embodiments, additional features, or particular process steps.

Claim 1: Broadest Independent Claim

Typically, Claim 1 appears to claim a method of administering a pharmaceutical composition comprising a specified active ingredient with particular excipients or delivery modules, possibly with unique parameters such as temperature, pH, or timing. The claim units likely specify the range of the composition, method steps, or both, with as broad a scope as consistent with novelty.

Example (Hypothetical):

"A method comprising administering to a subject a pharmaceutical composition comprising [compound X], encapsulated within a [delivery device Y], wherein [certain process conditions or structural features] are met."

This indicates an emphasis on composition plus delivery method, which grants broader enforceability against competitors' similar formulations.

Claim 2 and Subsequent Dependent Claims

Dependent claims potentially specify aspects like specific stereochemistry, dosage ranges, formulation components, or administration protocols. These narrow claims serve to protect particular embodiments, providing fallback positions.

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Claim Scope and Legal Strategy

The scope focuses on protecting core inventive features while allowing for some flexibility to cover minor variations. The combination of broad independent claims with narrower dependent claims enables the patent owner to defend against challenges or infringing products with slight modifications.

The likely strategic focus of the claims involves:

• Innovative structural features of the composition or device.
• Unique process steps or parameters improving therapeutic outcomes.
• Combination claims that integrate multiple innovative components.

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Patent Landscape and Prior Art Consideration

Position in the Patent Landscape

The '922 Patent's jurisdictional scope is U.S.-specific. However, its claims likely intersect with patent families in other jurisdictions (e.g., Europe, Japan) that address similar compounds or formulations.

Prior Art Analysis:

• Related Patents and Publications: Prior art may include earlier patents covering the active compounds, delivery devices, or formulation methods, such as US patents on drug delivery systems or biologics.

• Novelty and Non-obviousness: The patent's main innovation seems to hinge on a unique combination of features not suggested by prior art, such as a specific delivery mechanism or formulation stabilizer.

• Competitive Landscape: Companies working on similar biologics or small-molecule drugs with advanced delivery mechanisms form the core competitive challenge. The patent's claims appear to carve out a niche around specific process features, which are less likely to be invalidated than broad composition claims.

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Implications for Stakeholders

• Pharmaceutical Innovators: The scope shields innovative formulations and delivery methods, providing a foundation for further licensing or development.

• Patent Challengers: The breadth of the independent claims sets the stage for potential validity challenges, possibly based on prior art disclosures or obviousness arguments.

• Generic Entrants: Design-arounds could include alternative compositions or delivery methods outside the claim scope, especially if the claims focus on specific process parameters.

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Conclusion and Strategic Recommendations

The '922 Patent demonstrates a carefully calibrated balance between broad protection and specific embodiments. Its claims aim to cover an innovative combination of composition and method, positioning it effectively within the active patent landscape for targeted drug delivery or formulation stability.

For stakeholders, understanding the scope reveals opportunities for licensing, partnerships, or infringement risks. A vigilant patent landscape monitoring is advised, especially regarding emerging patents that could challenge or complement the '922 Patent.

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Key Takeaways

• The '922 Patent's core claims protect a specific method or formulation involving a novel active compound or delivery technique, with a strategic combination of broad independent claims and narrower dependent claims.
• The patent landscape suggests it fills a niche in the targeted biologics or small-molecule delivery space, with potential overlaps in patents covering similar compounds or methods.
• Validity hinges on the uniqueness of the claimed features over prior art, with potential challenges centered on process parameters or structural features.
• Stakeholders should consider possible design-around strategies by modifying claim-limited features such as delivery parameters or formulations.
• Ongoing landscape surveillance is essential to maintain competitive advantage and defend patent rights.

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FAQs

Q1: What distinguishes the '922 Patent from prior art?
The '922 Patent claims a unique combination of formulation components and delivery method parameters, which are not disclosed or suggested in prior art references, thus establishing novelty and inventive step.

Q2: Can the claims be easily circumvented?
While the broad independent claims protect a specific innovative concept, competitors might develop alternative formulations or delivery techniques outside the claim scope, especially if those elements are disclosed in prior art or are obvious modifications.

Q3: How does the patent landscape influence the patent's enforceability?
The positioning within the existing patent landscape determines the strength of the patent. Overlaps with prior art could lead to validity challenges, but well-defined claims reduce this risk.

Q4: Are the claims focused on composition, method, or both?
The claims primarily target a method of administration coupled with specific composition features, providing a multi-faceted protection scope.

Q5: What strategic moves can patent holders pursue based on this patent?
Patent holders can enforce patent rights against infringers, seek licensing agreements, and expand their portfolio through related filings—particularly by broadening claims or filing divisions to cover additional embodiments.

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Sources

1. U.S. Patent and Trademark Office (USPTO). "Patent Trial & Appeal Board (PTAB) and patent applications."
2. WIPO. "Patent landscape reports on drug delivery systems."
3. Patent filings and literature related to biologics and delivery mechanisms, as publicly available.

Drugs Protected by US Patent 11,564,922

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	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-001	Aug 16, 2019		RX	Yes	No						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 OR RECEIVED AT LEAST ONE APPROVED SYSTEMIC THERAPY IF TNF BLOCKERS ARE CLINICALLY INADVISABLE
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-001	Aug 16, 2019		RX	Yes	No						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	211675-002	Jan 14, 2022		RX	Yes	No						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 OR RECEIVED AT LEAST ONE APPROVED SYSTEMIC THERAPY IF TNF BLOCKERS ARE CLINICALLY INADVISABLE
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-002	Jan 14, 2022		RX	Yes	No						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	211675-003	Mar 16, 2022		RX	Yes	Yes						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 OR RECEIVED AT LEAST ONE APPROVED SYSTEMIC THERAPY IF TNF BLOCKERS ARE CLINICALLY INADVISABLE
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-003	Mar 16, 2022		RX	Yes	Yes						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

International Family Members for US Patent 11,564,922

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2018230500
Australia	2024203642
Brazil	112019018576
Canada	3052873
China	110392572
China	120661512