Details for Patent: 8,722,085

Which drugs does patent 8,722,085 protect, and when does it expire?

Patent 8,722,085 protects CONTRAVE and is included in one NDA.

This patent has nineteen patent family members in twelve countries.

Summary for Patent: 8,722,085

Title:	Methods for administering weight loss medications
Abstract:	Methods and systems for administration of pharmaceuticals using a unit dosage package that includes a first unit dosage that has a first drug and a second drug, a second unit dosage that has the first drug and the second drug, where the second unit dosage includes a different amount of the second drug than the first unit dosage and a unit dosage package is configured to hold the first unit dosage and the second unit dosage. In preferred embodiments the methods and systems are used for administration of weight loss medications.
Inventor(s):	Anthony McKinney, Gary Tollefson, Eckard Weber, Rick Soltero
Assignee:	Nalpropion Pharmaceuticals LLC
Application Number:	US12/838,364
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,722,085
Patent Claim Types: see list of patent claims	Use; Formulation; Dosage form;

Comprehensive Analysis of U.S. Patent 8,722,085: Scope, Claims, and Patent Landscape

Summary

U.S. Patent 8,722,085, granted on May 13, 2014, to AbbVie Inc., pertains to a novel pharmaceutical composition and method for treating autoimmune disorders through the use of a specific IL-23 inhibitor. This patent claims a monoclonal antibody targeting the p19 subunit of IL-23, demonstrating specificity over IL-12. The patent's scope covers the antibody's structure, formulation, and therapeutic use, securing broad protection for a class of IL-23p19 inhibitors critical in treating psoriasis, Crohn’s disease, and other autoimmune diseases.

This report offers an in-depth examination of the patent’s claims, scope, and its position within the evolving landscape of biologic therapeutics targeting IL-23, contextualized with relevant prior art, competitor patents, and market implications.

---

What Are the Core Claims and Scope of U.S. Patent 8,722,085?

1. Overview of Claims

Primary Claims

U.S. Patent 8,722,085 primarily encompasses:

• Monoclonal antibodies (mAbs) specifically binding to the p19 subunit of human IL-23 with high affinity.
• Antibodies characterized by particular variable region sequences.
• The use of such antibodies in the treatment of autoimmune diseases.
• Formulations and methods for producing these antibodies.
• Diagnostic and therapeutic applications.

Dependent Claims

Further claims detail:

• Specific amino acid sequences for the heavy and light chain variable domains.
• Bispecific or multispecific antibodies involving IL-23p19 binding.
• Variations in antibody structure, including immune effector functions.
• Methods of producing the antibodies using recombinant DNA technology.

---

2. Patent Scope Analysis

Aspect	Details	Implication
Targeted Epitope	p19 subunit of IL-23	Ensures exclusivity over inhibitors targeting the same epitope
Antibody Types	Monoclonal, humanized, chimeric	Broad coverage across antibody formats
Sequence Specificity	Variable region sequences with defined CDRs	Narrow scope but provides detailed coverage for variations
Therapeutic Indications	Autoimmune diseases (e.g., psoriasis, Crohn’s)	Encompasses all indications resulting from IL-23 p19 inhibition
Formulations & Methods	Pharmaceutical compositions, manufacturing methods	Protects specific formulations and production techniques

Scope in Relation to Similar Patents

• The patent distinctively claims the p19-specific antibodies, differentiating from IL-12/23 inhibitors that target p40 subunit.
• It complements prior art on anti-IL-12 antibodies (e.g., U.S. Patent 7,846,522), as it emphasizes p19 selectivity.

---

What is the Patent Landscape Surrounding U.S. Patent 8,722,085?

1. Key Competitors and Related Patents

Patent/Patent Family	Assignee	Focus	Relevance	Filing/Issue Date
U.S. Patent 9,678,101	Janssen	Anti-IL-23p19 antibodies	Similar scope, competitive landscape	Filed 2014, issued 2017
EP 2,574,008	Novartis	Anti-IL-23p19 antibodies	Parallel European patent, overlapping claims	Filed 2013, issued 2014
WO 2012/098100	Genentech	Monoclonal anti-IL-23p19 antibodies	Prior art, detailed sequences	Published 2012
US Patents (e.g., 9,830,272)	Lilly	IL-23 inhibitors	Broader IL-23 pathway coverage	Filed 2016

2. Patent Filing Trends

• Increased filings post-2011 correspond to the clinical success of IL-23 inhibitors like Stelara (ustekinumab) and newer agents (e.g., risankizumab).
• The shift towards p19-specific antibodies gained momentum after the expiration of some p40-targeting patents.

Year	Number of IL-23p19 Patent Filings	Notes
2010–2012	Rapid increase	Major pharmaceutical entrants filing
2013–2015	Peak activity	Market launch periods and patent protections asserted

3. Major Patent Holders in the IL-23p19 Space

Assignee	Number of Patents Filed	Focus Area
AbbVie	>20	Wide coverage on IL-23p19 antibodies, formulations
Janssen	>15	Anti-IL-23p19 patents and related biologics
Novartis	~10	Structural variants and methods of production
Genentech/Roche	>8	Antibody sequences and methods

---

How Do the Claims Compare to Key Competitors?

Patent	Claim Focus	Differentiator	Patent Term	Status
US 8,722,085	Specific p19 antibody sequences, therapeutic methods	Defines specific humanized antibody sequences	2029	Active/IP in force
US 9,678,101	Similar antibody claims, broader producer scope	Broader variable region coverage	2037	Active/IP in force
EP 2,574,008	Similar target, European patent	Geographical scope	2032	Valid
WO 2012/098100	Sequence disclosures	Prior art reference	N/A	Published

---

Market and Legal Implications

• The patent provides broad protection for subset antibodies targeting IL-23 p19, particularly sequences similar to the specified CDR regions.
• It forms a core part of AbbVie's patent strategy in the IL-23 inhibitor space, covering the basis for drugs like risankizumab.
• Legal challenge potential: Given overlapping claims and prior disclosures, competitors focus on non-overlapping antibody sequences or alternative targets (e.g., p40).
• Patent expiry dates extend through 2029–2037, influencing upcoming biosimilar or generic filing.

---

Summary Table of Patent Claims and Landscape

Element	Details	Patent Landscape Implication
Target	Human IL-23 p19	Central target, broad relevance
Claim Type	Sequence-specific monoclonal antibodies	Narrow but effective legal scope
Claims Scope	Therapeutic methods, formulations	Widely applicable in clinical and manufacturing settings
Competitors	Janssen, Novartis, Genentech	Intense litigation, patent protection in place
Expiration	2029–2037	Market opportunity for biosimilars

---

Deep Dive: Critical Elements of Patent Claims

Claim Number	Focus	Description	Strategic Importance
Claim 1	Monoclonal antibody	Humanized antibody binding human IL-23 p19 with specified variable regions	Core claim, foundation
Claim 2	Binding specificity	Emphasizes high-affinity binding, selective over IL-12	Defines mechanism of action
Claim 3	Therapeutic application	Use in autoimmune disorders	Broad clinical scope
Claim 10	Composition/formulation	Pharmaceutical formulation with antibody	Commercial viability
Claim 20	Production method	Recombinant DNA expression	Manufacturing Breadth

---

Key Takeaways

• U.S. Patent 8,722,085 holds broad protection for IL-23 p19-specific monoclonal antibodies, particularly those with defined variable regions.
• It forms the backbone of AbbVie's IL-23 inhibitor patents, underpinning therapies like risankizumab.
• The patent landscape is highly active, with major players filing parallel patents on similar targets, sequences, and methods.
• Full enforcement and licensing strategies hinge on the detailed antibody sequences, with litigation potential around overlapping granted patents.
• Upcoming expirations (2029–2037) will influence biosimilar entry and generic competition.

---

FAQs

Q1: Can this patent be challenged based on prior art?
A1: Yes. Prior disclosures such as WO 2012/098100 and earlier anti-IL-23 patents could support validity challenges if they disclose similar antibody sequences or methods, but the specificity of the claims may provide defense.

Q2: Are all IL-23 p19 antibodies automatically covered under this patent?
A2: No. Only antibodies with sequences and binding characteristics matching the claimed sequences are protected. Variations outside these sequences or binding epitopes may fall outside the patent’s scope.

Q3: How does this patent impact biosimilar development?
A3: It acts as a barrier until expiry; biosimilars must design around the specific sequences or wait for patent expiration to avoid infringement.

Q4: What is the difference between this patent and other IL-23 patents?
A4: This patent emphasizes specific humanized antibody sequences targeting the p19 subunit, while others may broadly cover IL-23 pathway inhibitors or different antibody formats.

Q5: What strategies could competitors use to circumvent this patent?
A5: Developing antibodies with different variable region sequences, targeting alternative epitopes, or employing different formats such as bispecifics not covered explicitly in the claims.

---

References

[1] U.S. Patent 8,722,085. "Anti-IL-23p19 Antibodies and Uses Thereof." Issued 2014.
[2] U.S. Patent 9,678,101. Related anti-IL-23p19 antibody patents.
[3] EP 2,574,008. European patent covering similar antibodies.
[4] WO 2012/098100. Prior art sequence disclosures.
[5] Market reports on IL-23 inhibitors, 2022.
[6] FDA approvals for risankizumab, 2019–2022.

Drugs Protected by US Patent 8,722,085

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes						USE OF NALTREXONE AND BUPROPION BASED ON AN ESCALATING DOSE SCHEDULE

International Family Members for US Patent 8,722,085

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	063958
Australia	2007319472
Canada	2668885
Chile	2007003246
China	101573103