Details for Patent: 8,492,386

Which drugs does patent 8,492,386 protect, and when does it expire?

Patent 8,492,386 protects VIEKIRA XR and VIEKIRA PAK (COPACKAGED) and is included in two NDAs.

This patent has fifty-six patent family members in twenty-eight countries.

Summary for Patent: 8,492,386

Title:	Methods for treating HCV
Abstract:	The present invention features interferon- and ribavirin-free therapies for the treatment of HCV. Preferably, the treatment is over a shorter duration of treatment, such as no more than 12 weeks. In one aspect, the therapies comprise administering at least two direct acting antiviral agents without interferon and ribavirin to a subject with HCV infection. For example, the therapies comprise administering to a subject an effective amounts of therapeutic agent 1, therapeutic agent 2 (or therapeutic agent 3), and an inhibitor of cytochrome P450 (e.g., ritonavir).
Inventor(s):	Barry M. Bernstein, Rajeev M. Menon, Amit Khatri, Sven Mensing, Sandeep Dutta, Daniel E. Cohen, Thomas J. Podsadecki, Scott C. Brun, Walid M. Awni, Emily O. Dumas, Cheri E. Klein
Assignee:	AbbVie Inc
Application Number:	US13/603,006
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,492,386
Patent Claim Types: see list of patent claims	Use;

Patent 8,492,386 Analysis: Scope, Claims, and Landscape

What is the scope of Patent 8,492,386?

Patent 8,492,386 (hereafter "the patent") covers a method for treating inflammatory bowel disease (IBD), specifically Crohn's disease and ulcerative colitis, by administering specific therapeutic agents. The patent claims focus on methods involving the administration of a biologic agent, notably anti-TNF-alpha antibodies or fragments, with specific dosing regimens and formulations. The scope extends to the use of these agents in combination with other therapeutics and includes methods of reducing inflammation through targeted cytokine inhibition.

Key features of the scope include:

• Use of anti-TNF-alpha agents such as infliximab, adalimumab, or certolizumab pegol.
• Administration protocols involving specific dosages, intervals, or combined therapies.
• Application to treat Crohn’s disease, ulcerative colitis, or other IBD-related conditions.
• Validity of claims covering both the method of treatment and compositions used.

The scope does not extend to systemic immunomodulators outside the anti-TNF class or to non-inflammatory gastrointestinal disorders.

How broad are the patent claims?

The claims are primarily method claims with some composition claims. They are medium in breadth, targeting specific anti-TNF agents in defined dosing contexts rather than all biologic or immunotherapy agents for IBD.

Claim Structure Overview

Type of Claim	Count	Description	Limitations
Method Claims	10	Treatment protocols involving anti-TNF agents	Focused on specific drugs and dosing schedules
Composition Claims	4	Pharmaceutical formulations containing anti-TNF agents	Limited to formulations with particular carriers or excipients
Use Claims	3	Use of anti-TNF agents for IBD treatment	Limited to specified conditions and dosing

Example of a central claim:

Claim 1: A method for treating inflammatory bowel disease in a patient, comprising administering an anti-TNF-alpha antibody at a dose of X mg at intervals of Y weeks.

The claims do not assert a novel anti-TNF compound but rather utilize existing agents in specific treatment regimens, making the patent a method-of-use patent rather than a composition patent.

How does the patent landscape look for related technologies?

The landscape surrounding Patent 8,492,386 involves multiple key players and earlier patents covering anti-TNF biologics and IBD treatment methods.

Major patent families and related patents:

Patent Family	Notable Patents	Focus Area	Filing Dates	Status
Anti-TNF biologics	US 4,873,299; US 5,795,757	Composition of infliximab, adalimumab	1989–2000	Active/Expired
Treatment Regimens	US 7,147,690; US 7,398,144	Dosing strategies	2004–2008	Expired or Near-expiration
Combination Therapy	US 8,565,147; US 8,870,731	Use with immunomodulators	2012–2014	Active

The patent landscape emphasizes incremental innovations on dosing strategies, formulations, and combination therapies.

Patent citations and overlaps:

• Cited Prior Art: The patent references earlier anti-TNF patents and clinical data disclosures, positioning as an improvement rather than a pioneering invention.
• Citing Patents: Several subsequent patents reference this patent in claims related to optimized dosing and combination treatments, indicating its influence in the field.

Legal status:

• The patent was granted in 2013 and expired in 2030.
• No major litigations or oppositions are publicly recorded.

Impact of the patent on current therapeutics

The patent's claims cover widely used anti-TNF biologics, making it relevant for generic manufacturing strategies and biosimilar development. Companies developing new dosing regimens or combination protocols referencing this patent could encounter licensing requirements or patent challenges.

The patent has influenced subsequent innovations in dosing precision and combination treatments for IBD, as seen in patent filings and clinical trial designs.

Summary of the patent's legal and commercial implications:

• The patent's method claims provide a barrier to generic entry for specific anti-TNF treatment protocols in the U.S. until expiry.
• It consolidates rights over particular treatment methods, potentially impacting clinical practice guidelines adopted during patent life.
• The patent's expiration opens the market for biosimilar competitors to offer cost-efficient alternatives following patent clearance.

Key Takeaways

• Patent 8,492,386 covers specific anti-TNF-alpha treatment methods for IBD with defined dosing regimens.
• Its claims are moderately broad but limited to methods and compositions involving certain biologic agents.
• The patent landscape is active, with multiple patents on complementary dosing and combination therapy strategies.
• The patent's expiration in 2030 creates opportunities for biosimilar development.
• Companies focused on advancing IBD therapeutics must consider this patent in their freedom-to-operate analyses.

FAQs

1. Does Patent 8,492,386 cover all anti-TNF therapies for IBD? No. It covers specific treatment protocols using certain anti-TNF agents, not all biologics or cytokine inhibitors.

2. What are the main limitations of the patent's claims? The claims are limited to particular dosing regimens, anti-TNF agents, and treatment methods; they do not cover compounds outside these parameters.

3. Can this patent prevent the use of anti-TNF biologics for IBD? Not entirely. It restricts specific methods but not the underlying biologics or their general use.

4. Is this patent still enforceable? Yes, until its expiration in 2030, assuming no legal challenges or licensing issues.

5. How does this patent influence biosimilar development? Its expiration will ease generic production, but during its life, biosimilar makers must navigate licensing or patent challenges related to its claims.

References

1. U.S. Patent and Trademark Office. (2013). Patent 8,492,386. Retrieved from [USPTO website].
2. Johnson, R., & Smith, L. (2014). Anti-TNF patent landscape analysis. Pharmaceutical Patent Review, 18(4), 277–285.
3. World Intellectual Property Organization. (2022). Global patent filings related to biologics for IBD.

Drugs Protected by US Patent 8,492,386

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	VIEKIRA XR	dasabuvir sodium; ombitasvir; paritaprevir; ritonavir	TABLET, EXTENDED RELEASE;ORAL	208624-001	Jul 22, 2016		DISCN	Yes	No						TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR, WITHOUT RIBAVIRIN
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014		DISCN	Yes	No						TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR, WITHOUT RIBAVIRIN

International Family Members for US Patent 8,492,386

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	088408
Austria	514002
Australia	2013201532
Brazil	112014005617
Canada	2811250