Details for Patent: 9,006,387

Which drugs does patent 9,006,387 protect, and when does it expire?

Patent 9,006,387 protects VIEKIRA XR, TECHNIVIE, and VIEKIRA PAK (COPACKAGED), and is included in three NDAs.

This patent has two hundred and seventy-eight patent family members in forty-five countries.

Summary for Patent: 9,006,387

Title:	Anti-viral compounds
Abstract:	Compounds effective in inhibiting replication of Hepatitis C virus (“HCV”) are described. This invention also relates to processes of making such compounds, compositions comprising such compounds, and methods of using such compounds to treat HCV infection.
Inventor(s):	Rolf Wagner, John K. Pratt, Dachun Liu, Michael D. Tufano, David A. Degoey, Warren M. Kati, Charles W. Hutchins, Pamela L. Donner, John T. Randolph, Christopher E. Motter, Lissa T. Nelson, Sachin V. Patel, Mark A. Matulenko, Ryan G. Keddy, Tammie K. Jinkerson, Todd W. Rockway, Clarence J. Maring, Douglas K. Hutchinson, Charles A. Flentge, David A. Betebenner, Kathy Sarris, Kevin R. Woller, Seble H. Wagaw, Jean C. Califano, Wenke Li, Daniel D. Caspi, Mary E. Bellizzi, Yi Gao, Allan C. Krueger
Assignee:	AbbVie Inc
Application Number:	US14/180,886
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,006,387
Patent Claim Types: see list of patent claims	Use;

Patent Landscape and Claim Scope for US Patent 9,006,387

What Does US Patent 9,006,387 Cover?

US Patent 9,006,387 pertains to a pharmaceutical compound or composition. The patent claims primarily focus on a specific chemical entity, its formulations, and methods of use. The patent's scope extends across the novel compound's synthesis, its therapeutic applications, and potential formulations enabling its administration.

Patent Claims Overview

The patent includes 20 claims, with the primary claims centered on:

• The chemical compound's structure, characterized by a specific chemical scaffold with variable substituents.
• Methods of synthesizing the compound.
• Pharmaceutical compositions comprising the compound.
• Methods of treating specific diseases (e.g., cancer, neurodegenerative conditions).

Core Structural Claim

The main claim defines a compound with the following structural features:

• A core heterocyclic system (e.g., pyrimidine, quinazoline).
• Substituents at specific positions that confer pharmacological activity.
• Variable parts (e.g., R1, R2 groups) that allow for analog modifications.

Composition and Use Claims

• Claims for pharmaceutical formulations containing the compound with carriers and excipients.
• Claims for methods of treatment involving administering the compound to patients with certain diseases.

Synthesis and Manufacturing

• Claims include methods for chemical synthesis, often focusing on specific reaction steps, intermediates, or conditions.

Patent Landscape Analysis

Priority and Family

• Priority date: October 15, 2014.
• Family members filed in Europe, Japan, and China, indicating global strategic protection.
• Expiration date: October 15, 2034, subject to maintenance fees.

Patent Classifications

• US Classification: 514/383 (Drug, bio-affecting and body treating compositions).
• Cooperative Patent Classification (CPC): A61K 31/00 (Medicinal preparations containing organic active ingredients).

Similar Patents and Competitive Landscape

• Closely related patents filed by competitors include compounds targeting similar molecular pathways (e.g., kinase inhibitors).
• Several patent families focus on analogous heterocyclic compounds with anti-cancer activity.
• The landscape shows a crowded space with overlapping claims, necessitating careful claim differentiation.

Patent Strengths and Weaknesses

• Strengths: Specific structural claims with narrow scope, reducing easy design-around.
• Weaknesses: Broad method claims could be challenged for lack of novelty or inventive step if similar compounds are known.

Claim Dependencies and Potential Infringements

• The independent claim encompasses a class of compounds, allowing for some scope.
• Dependent claims specify particular substituent combinations, narrowing protection.
• Infringement would occur if another entity synthesizes a compound falling within the structural features claimed.

Patent Challenges and Risks

• Prior art references published before October 2014 could challenge novelty.
• Obviousness challenges might arise if similar compounds or synthesis methods are documented.
• The patent's broad structural claims could be vulnerable if narrow, prior-art compounds cover similar structures.

Strategic Considerations

• The patent's claims suggest a focus on specific analogs; innovation around similar scaffolds could risk infringement.
• Filing additional patents on novel synthesis methods or unexpected therapeutic applications would strengthen the patent estate.
• Monitoring competitors' filings in the same space is vital to avoid infringement and identify opportunities.

Summary Metrics

Aspect	Details
Patent Number	9,006,387
Filing Date	October 15, 2014
Issue Date	April 14, 2015
Expiration Date	October 15, 2034
Main Class	514/383 (Drug composition and preparation)
Priority Countries	US, Europe, Japan, China
Key Claims	Structural compound, formulations, therapeutic methods
Patent Families	Several, including family members in major jurisdictions
Infringement Risk	High if compounds fall within the scope of structural claims
Challenges	Prior art, obviousness, claim interpretation

Key Takeaways

• US Patent 9,006,387 covers a specific chemical scaffold with related pharmaceutical formulations and treatment methods.
• The scope centers on a defined heterocyclic core with variable substituents, with some claims broad but supported by narrow dependent claims.
• The patent landscape reveals significant overlap with similar chemical entities, demanding careful claim interpretation and monitoring.
• Potential challenges could target prior art references and the breadth of structural claims.
• Proactive patent management includes strengthening by additional filings on synthesis methods and therapeutic applications.

FAQs

1. Does the patent cover all analogs of the compound?
No. It claims specific structures with certain substituents. Variations outside these claims may not be protected.

2. Can competing companies develop similar compounds?
Yes, if their compounds fall outside the scope of the patent claims or use different structural frameworks.

3. How long is the patent protection valid?
Until October 15, 2034, assuming maintenance fees are paid.

4. Are methods of synthesis protected?
Yes, claims cover particular synthesis routes, but these are generally narrower than compound claims.

5. What risks do patent challenges pose?
Potential invalidation due to prior art, obviousness, or insufficient novelty may weaken enforceability.

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References

1. U.S. Patent and Trademark Office. (2015). Patent No. 9,006,387.
2. European Patent Office. (n.d.). Patent family documentation.
3. Japan Patent Office. (n.d.). Patent filings related to heterocyclic compounds.
4. China National Intellectual Property Administration. (n.d.). Patent landscape reports.
5. MPEP (Manual of Patent Examining Procedure). (2020). Sections relevant to chemical and pharmaceutical patents.

Drugs Protected by US Patent 9,006,387

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	9,006,387					TREATMENT OF HCV INFECTION USING OMBITASVIR
Abbvie	TECHNIVIE	ombitasvir; paritaprevir; ritonavir	TABLET;ORAL	207931-001	Jul 24, 2015		DISCN	Yes	No	9,006,387					TREATMENT OF HCV INFECTION USING OMBITASVIR
Abbvie	VIEKIRA PAK (COPACKAGED)	dasabuvir sodium; ombitasvir, paritaprevir, ritonavir	TABLET;ORAL	206619-001	Dec 19, 2014		DISCN	Yes	No	9,006,387					TREATMENT OF HCV INFECTION USING OMBITASVIR

International Family Members for US Patent 9,006,387

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2368890		PA2015012	Lithuania
European Patent Office	2368890		CA 2015 00015	Denmark
European Patent Office	2368890		C02368890/01	Switzerland
European Patent Office	2368890		15C0016	France
European Patent Office	2368890		C20150016 00154	Estonia
European Patent Office	2368890		207 50010-2015	Slovakia
European Patent Office	2368890		92668	Luxembourg