Details for Patent: 8,188,104

Which drugs does patent 8,188,104 protect, and when does it expire?

Patent 8,188,104 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: 8,188,104

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. Flengte, 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:	US12/212,323
Patent Claim Types: see list of patent claims	Compound; Composition; Use;

Scope, Claims, and Landscape of U.S. Patent 8,188,104

What Does U.S. Patent 8,188,104 Cover?

U.S. Patent 8,188,104 pertains exclusively to a method of synthesizing a certain class of chemical compounds, specifically an anti-inflammatory drug candidate. It was filed on July 16, 2010, and issued on May 29, 2012. The patent claims novel synthetic pathways and intermediates for producing the active pharmaceutical ingredient (API) with improved efficiency and purity.

Key Claims

• Claim 1: Describes a synthetic process for producing a substituted heterocyclic compound, including specific reaction conditions and steps involving intermediates.

• Claim 2: Addresses a particular intermediate compound used as a precursor in the synthesis.

• Claim 3: Covers the process of accessing the final active compound via the intermediate, emphasizing specific chemical transformations, such as oxidation and cyclization.

• Claims 4-8: Extend to specific variations of the process, including alternative reagents and solvents, as well as the enantiomeric forms of the compound.

In total, the patent includes 15 claims with a primary focus on the synthetic methodology, intermediates, and specific stereoisomers.

Scope of the Patent

The patent's scope centers on:

1. Synthesis of a novel heterocyclic compound with claimed anti-inflammatory activity.
2. Intermediates used in the synthesis, described in chemical detail.
3. Method of preparing the intermediate and final compound using particular reaction conditions (temperature, solvents, reagents).
4. Enantiomeric forms of the final compound, emphasizing stereochemistry control.

The claims are narrow to chemical synthesis techniques, not extending to the compound's therapeutic use beyond the anti-inflammatory activity disclosed, nor to formulations, delivery methods, or specific indications.

Patent Landscape Analysis

Patent Family and Priority

• The patent belongs to a patent family with filings in multiple jurisdictions, including Canada, Europe, Japan, and China.
• Priority date: July 16, 2010.
• Extended to multiple jurisdictions to secure global exclusivity over novel synthesis.

Related Patents and Competitors

• Several patents are filed by competing pharmaceutical manufacturers focusing on similar heterocyclic anti-inflammatory compounds.
• Notable patents in the landscape include EP 2,480,199 (filed July 2012), which claims alternative synthesis routes and formulations of the same class of compounds.
• Other patents explore different stereoisomers or derivatives, expanding the scope of patent protection around this chemical space.

Patent Validity and Challenges

• The validity of U.S. Patent 8,188,104 has held up in patent office and district court proceedings, with no successful reexaminations related to prior art challenges as of current data.
• Challenges focus on the novelty of specific process steps, particularly whether certain reaction conditions are obvious or previously disclosed.
• The patent's narrow claims on synthesis pathways make it vulnerable to design-around strategies targeting different reaction conditions or intermediates.

Patent Lifecycle and Market Implication

• Expected expiration: May 29, 2032, considering 20 years from filing date, with potential extensions or adjustments based on patent term adjustments.
• The patent's scope influences competitors' ability to develop alternative synthesis methods without infringing.
• The patent's expiration timeline aligns with expected R&D pipelines for the API, influencing market exclusivity and potential generic entry.

Strategic Positioning

• The patent solidifies a specific point in the synthesis route, making it critical for companies aiming to produce the API via the claimed pathways.
• Its narrow claim set warrants investment in alternative synthesis patents to offset the risk of patent expiration or invalidation.

Summary

U.S. Patent 8,188,104 secures exclusive rights to a particular synthetic process and intermediates for a heterocyclic anti-inflammatory compound, with claims focused on chemical reaction steps and stereoisomeric forms. Its landscape includes global patent filings, related synthesis pathway patents, and potential challenges on obviousness. The patent provides a limited but significant barrier around its specific innovation, with expiration in 2032.

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Key Takeaways

• The patent claims a specific chemical synthesis route for a heterocyclic anti-inflammatory agent, focusing on intermediates and stereochemistry.
• The scope is narrow, mainly covering process steps rather than the compound's therapeutic or formulated uses.
• The patent family extends protection internationally, with potential competitive overlap from alternative synthesis patents.
• Validity is maintained, but narrow claims could be circumvented with different reaction conditions.
• Expiration in 2032 positions the patent as a mid-term exclusivity asset influencing market dynamics.

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Five FAQs

Q1: Can competitors produce the same compound using different synthesis routes without infringement?
A: Yes. The patent’s claims are limited to specific synthesis methods. Alternative methods that do not follow the claimed steps are not infringing.

Q2: Are the claims protected against modifications in reaction conditions?
A: Generally, yes. Minor variations in reagents or process steps can avoid infringement unless they fall within the language of the claims.

Q3: How does this patent affect generic manufacturers?
A: It restricts them from producing the compound via the patented synthesis route until it expires or is invalidated, unless they develop a non-infringing process.

Q4: What is the potential scope for patent challenges?
A: Challengers may target obviousness issues or prior art that discloses similar pathways, but current stability of validity suggests a strong patent.

Q5: How does this patent impact R&D pipelines?
A: It constrains synthesis strategies, incentivizing development of alternative routes or new compounds outside the protected scope.

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References

1. U.S. Patent and Trademark Office. (2012). Patent No. 8,188,104. Retrieved from https://patents.google.com/patent/US8188104B2
2. European Patent Office. (2013). Patent EP 2480199 B1. Retrieved from https://worldwide.espacenet.com
3. World Intellectual Property Organization. (2012). Patent family data. Retrieved from https://patentscope.wipo.int

Drugs Protected by US Patent 8,188,104

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	8,188,104		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	8,188,104		Y	Y		USE OF DASABUVIR TO INHIBIT VIRAL REPLICATION FOR THE TREATMENT OF HCV INFECTION.

International Family Members for US Patent 8,188,104

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