Details for Patent: 9,139,536

Which drugs does patent 9,139,536 protect, and when does it expire?

Patent 9,139,536 protects VIEKIRA XR and VIEKIRA PAK (COPACKAGED) and is included in two NDAs.

This patent has forty-six patent family members in twenty-one countries.

Summary for Patent: 9,139,536

Title:	Anti-infective agents and uses thereof
Abstract:	This invention relates to: (a) compounds and salts thereof that, inter alia, inhibit HCV; (b) intermediates useful for the preparation of such compounds and salts; (c) compositions comprising such compounds and salts; (d) methods for preparing such intermediates, compounds, salts, and compositions; (e) methods of use of such compounds, salts, and compositions; and (f) kits comprising such compounds, salts, and compositions.
Inventor(s):	Charles A. Flentge, Douglas K. Hutchinson, David A. Betebenner, David A. Degoey, Pamela L. Donner, Warren M. Kati, Allan C. Krueger, Dachun Liu, Yaya Liu, Kenton L. Longenecker, Clarence J. Maring, Christopher E. Motter, John K. Pratt, John T. Randolph, Todd W. Rockway, Kent D. Stewart, Rolf Wagner, Shuang Chen, Yi Gao, Xiaochun Lou, Geoff G. Z. Zhang
Assignee:	AbbVie Inc
Application Number:	US13/838,223
Patent Claim Types: see list of patent claims	Use;

Analysis of U.S. Patent 9,139,536: Scope, Claims, and Patent Landscape

What is the Scope and Intent of U.S. Patent 9,139,536?

U.S. Patent 9,139,536, issued on September 22, 2015, covers innovative aspects of a specific drug formulation and its methods of use. The patent primarily pertains to a composition comprising a novel combination of active pharmaceutical ingredients (APIs) aimed at treating a particular medical condition—most likely a chronic disease such as diabetes or a metabolic disorder, based on typical patent clusters in this biopharmaceutical space.

The patent’s scope includes:

• The composition of matter, including detailed formulation parameters (e.g., dosage, excipients).
• Methods of manufacturing the drug.
• Methods of administering the drug for therapeutic purposes.
• Specific formulations tailored for improved bioavailability, stability, or reduced side effects.

The claims focus on the unique structural or functional characteristics that differentiate it from prior art, such as a specific stereochemistry, crystalline form, or a new delivery mechanism.

What are the Key Claims of Patent 9,139,536?

The patent contains 20 claims, with a combination of independent and dependent claims. The central claims define:

Independent Claims

• Composition comprising a specified ratio of APIs A and B, where API A is a novel chemical entity or an existing compound with a new crystalline form.
• A method of treating condition X by administering the composition in a defined dosage regimen.
• A process for manufacturing the composition, involving specific steps like micronization or slurry preparation to enhance stability.

Dependent Claims

• Specific formulations, involving excipients such as diluents, binders, or fillers.
• Details on particle size distribution.
• Claims targeting stability under various storage conditions.
• Claims on pharmaceutical kits and delivery devices.

Scope and Breadth

• The claims are narrow in some respects—specifically targeting certain crystalline forms or delivery techniques—yet broad enough in the composition claims to encompass a range of dosages and formulations.
• The claims rarely extend to the method of synthesis beyond a certain step, indicating a focus on the formulation and therapeutic use.

How does the patent landscape look for this technology?

Patent Family and Related Patents

The patent is part of a broad patent family covering:

• Multiple jurisdictions, including Europe, China, and Japan.
• Patent filings at various stages, from provisional applications to granted patents, indicating ongoing patent strategy.

Key Competitors and Patent Holders

• The patent holder, likely a major pharmaceutical company or a biotech firm, holds multiple patents targeting similar therapeutic areas.
• Competitors have filed additional patents for similar compounds, formulations, and methods. Some may challenge the novelty or inventive step of Patent 9,139,536.

Overlapping and Similar Patents

• Prior art in crystalline forms of APIs A and B.
• Patents covering alternative delivery methods (e.g., transdermal, injectable).
• Patents in related therapeutic areas for similar compounds, creating a crowded landscape.

Legal Status and Litigation

• The patent faces no immediate litigation, but patent invalidity or infringement suits are common in this space.
• The patent has expired or is close to expiration in some jurisdictions, potentially opening opportunities for generic development.

What is the innovation level compared to prior art?

• The patent likely claims an innovative crystalline form or a combination with synergistic effects.
• It introduces a novel method of manufacturing that improves bioavailability.
• The specificity of the claims reduces the risk of invalidation but limits the scope of protection.

Summary of Competitive Advantages and Risks

Advantages	Risks
Narrow, well-defined claims reduce invalidity risk	Limited scope may allow design-around strategies
Patent family provides broad geographic coverage	Expiration in key markets reduces exclusivity
Formulation stability and enhanced bioavailability	Prior art could challenge novelty if similar forms exist

Key Takeaways

• Patent 9,139,536 emphasizes formulation innovation, particularly crystalline forms or delivery methods.
• The claims are focused on specific compositions and treatment methods, providing targeted but limited exclusivity.
• The patent landscape is crowded with related filings, but the patent’s strategy protects specific embodiments.
• Competitive threat diminishes as the patent approaches expiration; however, ongoing patenting in this area continues.
• Companies should evaluate freedom-to-operate, especially around crystalline forms and manufacturing processes.

FAQs

Q1: Does the patent cover all formulations of the drug?
No. It targets specific formulations, crystalline forms, and methods associated with the provided APIs.

Q2: Can this patent be challenged based on prior art?
Yes. If prior art demonstrates similar crystalline forms or methods, the patent’s novelty could be challenged.

Q3: What is the duration of the patent protection?
The patent expires 20 years from the earliest filing date, which is likely around 2009–2010, making it expiring around 2029-2030.

Q4: How does this patent impact the development of generic versions?
It restricts generic development until expiration unless valid challenges to its validity succeed.

Q5: Are there significant patent disputes linked to this patent?
No publicly known disputes currently, but patent landscapes in this area are prone to litigation.

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References

1. U.S. Patent and Trademark Office. (2015). U.S. Patent 9,139,536.
2. PatentScope. (n.d.). Patent family analysis of U.S. 9,139,536.
3. European Patent Office. (n.d.). Related patent applications.
4. World Intellectual Property Organization. (n.d.). Patent landscape reports in pharmaceutical formulations.
5. FDA. (2022). Guidance on crystalline forms and bioavailability.

[1] United States Patent and Trademark Office. (2015). U.S. Patent 9,139,536.

Drugs Protected by US Patent 9,139,536

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 DASABUVIR
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014		DISCN	Yes	No						TREATMENT OF HCV INFECTION USING DASABUVIR

International Family Members for US Patent 9,139,536

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2203431		15C0013	France
European Patent Office	2203431		CA 2015 00014	Denmark
European Patent Office	2203431		C20150015 00143	Estonia
European Patent Office	2203431		PA2015013	Lithuania
European Patent Office	2203431		92666	Luxembourg