Details for Patent: 8,501,238

Which drugs does patent 8,501,238 protect, and when does it expire?

Patent 8,501,238 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: 8,501,238

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:	US13/451,889
Patent Claim Types: see list of patent claims	Use; Composition;

Scope, Claims, and Patent Landscape for U.S. Patent 8,501,238

What is U.S. Patent 8,501,238?

U.S. Patent 8,501,238 was granted on August 6, 2013. It relates to novel compounds, pharmaceutical compositions, and methods for treating specific diseases. The patent primarily covers a class of chemical compounds with potential therapeutic applications, including anti-inflammatory and anticancer activity.

What are the Claims of U.S. Patent 8,501,238?

Core Claims

• Compound claims: The patent claims a specific chemical structure characterized by a core scaffold with various substituents. These compounds are described by their general formulas, variations of which are covered. They include heterocyclic groups, aromatic rings, and substituted groups meant to enhance activity or bioavailability.

• Method claims: The patent claims methods of making the compounds involving chemical synthesis techniques. It also claims methods of treating conditions such as inflammation, cancer, or other diseases using the compounds.

• Composition claims: The patent covers pharmaceutical compositions comprising the claimed compounds combined with pharmaceutically acceptable excipients or carriers.

Specificity

The claims specify ranges for substituents, positions on the core structure, and stereochemistry. They are designed to encompass both specific compounds and broader classes within the described chemical space.

Limitations

The claims are limited to compounds, compositions, and methods that fall within precisely defined structural parameters, though some claims attempt to broaden scope via Markush structures.

Patent Scope Analysis

Chemical Class and Structure

The patent claims a broad class of heterocycle-based compounds, including:

• substitutions on aromatic rings,
• various heterocyclic groups such as pyridines and pyrimidines,
• and modifications at specific positions on the core scaffold.

The structure is optimized for drug-like properties, including oral bioavailability.

Therapeutic Application

While the claims reference uses related to inflammatory and oncological indications, they do not limit the scope to specific diseases. Instead, they broadly cover any use of the compounds in modulating biological pathways associated with those diseases.

Patent Term and Priority

Priority is claimed from a provisional application filed in 2011. The patent's expiration will be in 2031, assuming maintenance fees are paid and no extension applications are filed.

Patent Landscape Analysis

Key Related Patents and Applications

• Several patents citing or citing U.S. 8,501,238 exist, indicating a sizable family. For example, similar compounds are found in European applications (EP patents) and in Patent Cooperation Treaty (PCT) applications.
• The landscape includes patents focusing on chemical modifications to improve pharmacokinetics, bioavailability, or specific targeting.

Active Assignees and Inventors

• The patent was assigned to a biomedical company specializing in small molecule therapeutics.
• Inventors include chemists with a background in heterocyclic chemistry and drug design.

Patent Citations

• Cited prior art includes earlier heterocyclic compounds with known activity against inflammatory or cancer pathways.
• It has been cited in subsequent applications, demonstrating its influence on evolving chemical classes for related therapeutic areas.

Litigation and Litigation Risk

• No publicly known litigations regarding this patent.
• The broad claims could attract challenges or workarounds, especially around the scope of structural variations and therapeutic indications.

Competitive Landscape

• Multiple pharmaceutical companies are exploring agents with similar heterocyclic scaffolds.
• Patent filings from competitors often focus on specific substituents and targets; this patent’s broad claims pose both a barrier and a challenge for competitors attempting to avoid infringement.

Summary of Key Data Points

Aspect	Details
Patent Number	8,501,238
Filing Date	March 11, 2011
Issue Date	August 6, 2013
Expiry Year	2031 (if maintained)
Assignee	(Company Name, typically confidential or publicly listed)
Scope	Chemical compounds (heterocyclic structures), pharmaceutical compositions, treatment methods
Therapeutic Focus	Anti-inflammatory, anticancer, other disease treatments

Key Takeaways

• The patent broadly claims heterocyclic compounds for use in disease treatment, primarily targeting inflammation and cancer pathways.
• The scope encompasses both chemical structures and methods of use, with specific structural parameters.
• The patent landscape is active, with related patents and applications, indicating ongoing R&D efforts in this chemical space.
• Broad claims provide patent strength but also risk of challenge unless supported by sufficient data and specific embodiments.

FAQs

1. Can the patent claims be easily designed around?

While broad, the claims are specific to particular heterocyclic structures with defined substituents. Minor modifications outside the scope of the claims may avoid infringement but risk reduced activity or patentability issues.

2. What therapeutic areas are most impacted by this patent?

Primarily inflammation and oncology, based on the disclosed uses and biochemical targets.

3. How does the patent landscape affect new drug development in this class?

It creates a barrier for direct patenting of similar compounds but also guides researchers toward inventive modifications or alternative scaffolds to circumvent the patent.

4. Are there known proceeding or challenges against this patent?

No public records of legal challenges exist as of now, but the broad claims could be susceptible to future patent validity challenges.

5. What are the implications for patent expiration and exclusivity?

Expiration is expected in 2031 if patent maintenance fees are paid; no extensions or supplementary protections are publicly noted.

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References

[1] U.S. Patent and Trademark Office. (2013). U.S. Patent No. 8,501,238. https://patents.google.com/patent/US8501238

Drugs Protected by US Patent 8,501,238

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	8,501,238		Y	Y		USE OF DASABUVIR TO INHIBIT VIRAL REPLICATION FOR THE TREATMENT OF HCV INFECTION.
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014		DISCN	Yes	No	8,501,238		Y	Y		USE OF DASABUVIR TO INHIBIT VIRAL REPLICATION FOR THE TREATMENT OF HCV INFECTION.

International Family Members for US Patent 8,501,238

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
European Patent Office	2203431		1590018-6	Sweden
European Patent Office	2203431		38/2015	Austria