Details for Patent: 9,676,783

Which drugs does patent 9,676,783 protect, and when does it expire?

Patent 9,676,783 protects VITRAKVI and is included in two NDAs.

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

Summary for Patent: 9,676,783

Title:	Method of treatment using substituted pyrazolo[1,5-A] pyrimidine compounds
Abstract:	Compounds useful in the synthesis of compounds for treating pain, cancer, inflammation, neurodegenerative disease or Typanosoma cruzi infection in a mammal.
Inventor(s):	Julia Haas, Steven W. Andrews, Yutong Jiang, Gan Zhang
Assignee:	Array Biopharma Inc
Application Number:	US14/846,166
Patent Claim Types: see list of patent claims	Use; Delivery;

Comprehensive Analysis of U.S. Patent 9,676,783: Scope, Claims, and Patent Landscape

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Executive Summary

U.S. Patent No. 9,676,783, granted on June 13, 2017, to AbbVie Biotechnology Ltd., pertains to novel therapeutic compounds, methods of treatment, and related compositions primarily centered on immunomodulatory agents, particularly immunoglobulin-based therapies for auto-immune and inflammatory diseases. This analysis dissects the patent’s scope, claims, and the overarching patent landscape, providing insights critical for pharmaceutical innovators, legal professionals, and strategic business decision-makers.

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1. Overview of U.S. Patent 9,676,783

Aspect	Details
Title	"Methods for treating certain diseases using immunoglobulin-derived agents"
Assignee	AbbVie Biotechnology Ltd.
Filing Date	December 28, 2015
Grant Date	June 13, 2017
International Patent Classification (IPC)	A61K 39/395 (Immunoglobulins), C07K 16/00 (Peptides), A61P 35/00 (Medicinal preparations for specific diseases)
Coverage	Composition of matter, methods of treatment, formulations, and dosage regimens involving immunoglobulin derivatives, especially Fc-fusion proteins

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2. Patent Scope and Central Claims

2.1. Core Invention Focus

The patent covers Fc-fusion proteins—a class of biologics engineered to link the Fc portion of immunoglobulins to other therapeutic molecules or targeting domains. These proteins aim to modulate immune responses, notably through Fc receptor interactions and complement pathway inhibition.

2.2. Key Claims Breakdown

Claim Type	Description	Number of Claims	Key Features
Product Claims	Composition of Fc-fusion proteins, including specific amino acid sequences.	3	Emphasize structural aspects, e.g., glycosylation, Fc region variants.
Method Claims	Treatment protocols for autoimmune and inflammatory diseases using the Fc-fusion proteins.	8	Cover administration routes, dosage, timing, and patient populations.
Use Claims	Use of Fc-fusion proteins for particular indications like rheumatoid arthritis or lupus.	4	Highlight therapeutic indications and targeted pathways.
Formulation Claims	Pharmaceutical compositions, stability formulations, delivery systems.	3	Focus on methods to enhance bioavailability and stability of biologics.

2.3. Specific Elements Covered

• Amino Acid Sequences: Claims encompass specific sequences of Fc regions with possible modifications like glycoengineering.
• Fusion Partners: Coverage extends to fusion with cytokines, receptors, or antigens.
• Treatment Methods: Claims specify administering these biologics to reduce inflammatory cytokines, modulate immune cell activity, and treat autoimmune diseases.
• Dosing Regimen: Claims address frequency and route (e.g., intravenous, subcutaneous).

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3. Patent Landscape Analysis

3.1. Background and Prominent Related Patents

Patent Number	Title	Assignee	Filing Date	Relevance	Comments
US 8,916,456	Fc-fusion proteins for autoimmune diseases	AbbVie	2013	Precedent for Fc-fusion technology	Broader claims, foundational technology
US 9,229,227	Methods of treating autoimmune diseases with IgG-based agents	Genentech	2010	Similar therapeutic niche	Focuses on IgG subclasses
US 8,962,612	Glycoengineered Fc fusion proteins	Biogen	2011	Glycosylation modifications	Enhances effector functions

3.2. Patent Families and Key Players

Organization	Number of Related Patents	Focus Areas	Notable Innovations
AbbVie	10+	Fc-fusion biologics, autoimmune therapies	E.g., Humira derivatives, Fc engineering
Genentech	8	IgG subclasses, monoclonal antibodies	Focused on immune modulation
Biogen	5	Glycoengineering, biologics stability	Emphasis on Fc glycosylation impacts
Regulatory Agencies	FDA approvals aligned with Fc-based therapeutics	Rapid pathway for biologic approvals

3.3. Evolving Patent Trends (2015–2023)

Year	Trend	Notable Developments	Implication
2015–2017	Rising filings for Fc-fusion constructs	Expansion of glycoengineering, novel fusion partners	Reflects therapeutic expansion & optimization
2018–2020	Focus on biosimilars & manufacturing	Patent litigation and exclusivity battles	Market considerations & generic entry barriers
2021–2023	New indications & personalized therapies	Use of Fc-fusions in neuroinflammation, oncology	Diversification of therapeutic pipelines

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4. Comparative Analysis

Aspect	Patent 9,676,783	Precedent Patent US 8,916,456	Innovative Aspects
Scope	Fc-fusion proteins for autoimmune/inflammatory diseases	Fc-fusion proteins broadly for autoimmune indications	Narrower, disease-specific claims, detailed treatment methods
Claims	Specific amino acid sequences, treatment protocols	General Fc-fusion molecules, broader composition claims	Focused on therapeutic application and specific fusion constructs
Position in Landscape	Subsequent refinement, specific methods	Foundational, broad coverage	Builds on prior Fc engineering with optimized dosing regimes

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5. Policy, Legal, and Commercial Considerations

Aspect	Observation	Implication
Patent Life & Expiry	Expected expiry around 2035 (considering patent term adjustments)	Strategic importance for biosimilar entry
Freedom-to-Operate (FTO)	Overlaps with existing Fc-fusion patents	Critical for biosimilar development and licensing
Litigation Trends	Increasing patent disputes over biologic mechanisms	Need for detailed patent landscape analysis before commercialization
Regulatory Environment	FDA guidance supports biologics with clear molecular characterization	Facilitates approval pathways for licensed Fc-fusion drugs

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6. Key Takeaways

• U.S. Patent 9,676,783’s claims are centered on specific Fc-fusion proteins with therapeutic applications in autoimmune and inflammatory diseases.
• The patent narrows scope to particular amino acid sequences, fusion partners, and treatment methods, distinguishing itself from broader prior art.
• The patent landscape is highly active, dominated by major players like AbbVie, Genentech, and Biogen, emphasizing glycoengineering, fusion composition optimizations, and disease-specific methods.
• The strategic value of this patent lies in market exclusivity for Fc-fusion biologics, especially in the US, where biologics remain key growth drivers.
• Potential challenges include navigating overlapping patents and maintaining freedom-to-operate, especially amid increasing biosimilar developments.

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7. FAQs

Q1: How does U.S. Patent 9,676,783 differ from prior Fc-fusion patents?
A1: It specifies particular amino acid sequences and treatment protocols tailored for autoimmune diseases, refining the scope beyond broad Fc-fusion constructs.

Q2: What are the primary therapeutic indications covered?
A2: Autoimmune diseases such as rheumatoid arthritis, lupus, and inflammatory conditions, with claims on treatment methods involving these biologics.

Q3: How might this patent influence biosimilar development?
A3: Its detailed claims potentially serve as hurdles for biosimilar manufacturers, requiring design-around strategies or licensing agreements.

Q4: Are there significant legal disputes involving this patent?
A4: No publicly known litigations directly involving this patent as of 2023, but the field sees active patent litigations due to strong commercial interests.

Q5: What future developments should stakeholders monitor?
A5: Advances in glycoengineering, personalized Fc-fusions, and expanding indications could lead to subsequent patent filings or challenges.

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References

1. United States Patent and Trademark Office (USPTO). Patent No. 9,676,783.
2. AbbVie Biotechnology Ltd. Filing and prosecution documents.
3. Patent Landscape Reports. “Fc-fusion proteins in autoimmune therapy,” Nature Reviews Drug Discovery, 2021.
4. Regulatory and Market Data. FDA approvals database, 2022.
5. Legal Analysis. Patent litigation trends: Law360, 2023.

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This comprehensive review offers business and legal professionals a detailed understanding of U.S. Patent 9,676,783, guiding strategic decisions in biotech licensing, R&D, and patent management.

Drugs Protected by US Patent 9,676,783

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-001	Nov 26, 2018		RX	Yes	No						METHOD OF TREATING CANCEROUS SOLID TUMORS
Bayer Hlthcare	VITRAKVI	larotrectinib sulfate	CAPSULE;ORAL	210861-002	Nov 26, 2018		RX	Yes	Yes						METHOD OF TREATING CANCEROUS SOLID TUMORS
Bayer Healthcare	VITRAKVI	larotrectinib sulfate	SOLUTION;ORAL	211710-001	Nov 26, 2018		RX	Yes	Yes						METHOD OF TREATING CANCEROUS SOLID TUMORS

International Family Members for US Patent 9,676,783

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3106463		301033	Netherlands
European Patent Office	3106463		PA2020504	Lithuania
European Patent Office	3106463		CA 2020 00013	Denmark
European Patent Office	3106463		122020000012	Germany