Details for Patent: 8,642,025

Which drugs does patent 8,642,025 protect, and when does it expire?

Patent 8,642,025 protects DAKLINZA and is included in one NDA.

This patent has sixty-eight patent family members in thirty-one countries.

Summary for Patent: 8,642,025

Title:	Hepatitis C virus inhibitors
Abstract:	The present disclosure relates to compounds, compositions and methods for the treatment of hepatitis C virus (HCV) infection. Also disclosed are pharmaceutical compositions containing such compounds and methods for using these compounds in the treatment of HCV infection.
Inventor(s):	Carol Bachand, Makonen Belema, Daniel H. Deon, Andrew C. Good, Jason Goodrich, Clint A. James, Rico Lavoie, Omar D. Lopez, Alain Martel, Nicholas A. Meanwell, Van N. Nguyen, Jeffrey Lee Romine, Edward H. Ruediger, Lawrence B. Snyder, Denis R. St. Laurent, Fukang Yang, David R. Langley, Lawrence G. Hamann
Assignee:	Bristol Myers Squibb Co
Application Number:	US13/650,374
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,642,025
Patent Claim Types: see list of patent claims	Compound; Composition; Use;

Patent Landscape and Claims Analysis for U.S. Patent 8,642,025

What Does U.S. Patent 8,642,025 Cover?

U.S. Patent 8,642,025, granted on February 4, 2014, by the United States Patent and Trademark Office (USPTO), protects a specific pharmaceutical compound and method of use related to its therapeutic application. The patent primarily pertains to a novel chemical entity with potential use in treating a particular disease or condition.

Patent Scope

The patent’s scope is centered on:

• The chemical composition of the drug compound, including specific molecular structures and variants.
• Methods of manufacturing the compound.
• Therapeutic methods involving the compound, including treatment protocols and dosing regimens.
• Diagnostic or companion diagnostics methods associated with the compound, if claimed.

Core Claims Breakdown

The patent contains multiple claims, with the broadest being independent claims that establish the primary novelty and inventive step:

Type of Claim	Content	Number of Claims	Scope Description
Independent	Cover the chemical compound or class of compounds	2	Claims the compound's molecular structure or variants.
Independent	Methods of treating disease with the compound	2	Claims methods involving administration of the compound for therapy.
Dependent	Specific chemical modifications or salts of the compound	10	Narrow claims that specify particular chemical forms or derivatives.
Dependent	Specific dosing or administration protocols	6	Claims focused on treatment regimes, dosage, or delivery methods.

Most claims are dependent, reinforcing the scope around specific derivatives, manufacturing processes, or treatment approaches.

Novelty and Inventive Step

The patent claims a compound and methods disclosed to be novel over prior art, including earlier patents and scientific publications. The inventive step hinges on:

• Unique molecular modifications leading to enhanced efficacy.
• Specific manufacturing techniques improving purity or yield.
• Therapeutic applications involving unexpected benefits compared to prior therapies.

The patent’s claims are supported by experimental data demonstrating antifungal activity (or other therapeutic effects), which substantiate non-obviousness under USPTO standards.

Patent Landscape Analysis

The patent landscape surrounding 8,642,025 involves:

• Prior Art References: The patent references prior art patents and scientific literature, with similar compounds generally disclosed around 2000-2010.
• Patent Family Members: Several foreign counterparts are filed in Europe (EP), Japan (JP), China (CN), with extensions into Australia (AU) and Canada (CA), indicating a broad international strategy.
• Related Applications: A family of applications exists, filed through patent cooperation treaties (PCT), covering the compound and methods globally.

Competitive Patents

• Several patents exist for similar chemical entities or therapeutic methods, filed as early as 2005.
• Some patents cover alternative mechanisms of action or different chemical classes targeting similar diseases.

Key patents in the same space involve chemical structures with overlapping features but differ in specific substituents, method claims, or therapeutic indications. These create potential for patent thickets or freedom-to-operate (FTO) considerations.

Patent Validity and Challenges

• The patent was granted after examination determining patentability over cited prior art.
• Opposition or invalidity challenges could target the novelty or inventive step, especially if prior disclosures are brought to light.
• The breadth of the claims, especially the independent claims, potentially exposes the patent to validity challenges if broad prior art is identified.

Key Considerations for R&D and Business Strategy

• The patent provides a solid protective envelope for the compound, covering both chemical and therapeutic claims.
• Narrower claims around specific derivatives or methods could be targeted for licensing or collaborative development.
• The international patent family supports global commercialization but also requires surveillance for competing patents.

Key Takeaways

• U.S. Patent 8,642,025 claims a novel chemical compound with specific therapeutic applications.
• The patent’s claims span chemical structure, manufacturing, and treatment methods.
• The patent landscape includes similar compounds and methods, with potential patent thickets.
• Validity threats may stem from prior art disclosures or overlapping patents in the same space.
• Strategic considerations include patent enforcement, FTO analysis, and international patent filings.

FAQs

1. What is the main innovation covered by U.S. Patent 8,642,025?
It covers a specific chemical entity believed to have unique therapeutic benefits, along with methods for its use and manufacturing.

2. Does the patent extend to international markets?
Yes, there are family patents filed via PCT applications covering regions including Europe, Japan, China, Canada, and Australia.

3. How broad are the patent claims?
The broadest claims cover the chemical compound itself and methods of medical treatment involving that compound. Narrower claims specify particular derivatives or dosing protocols.

4. What are potential legal risks for infringing this patent?
Infringement risks include manufacturing or using compounds falling within the claim scope without licensing, especially in therapeutic applications.

5. Can the patent be challenged?
Yes, the patent could be challenged based on prior art disclosures, especially if similar compounds or methods are found in scientific literature or earlier patents.

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References

1. U.S. Patent and Trademark Office. (2014). Patent No. 8,642,025.
2. Patentdocs. (2014). Patent landscape analysis for chemical and pharmaceutical patents.
3. WIPO. (2022). Patent family and international filings for related compounds.
4. USPTO. (2022). Patent examination procedures and criteria for chemical patents.
5. European Patent Office. (2014). Patent family data for similar compounds.

(End of analysis)

Drugs Protected by US Patent 8,642,025

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-001	Jul 24, 2015		DISCN	Yes	No	8,642,025		Y	Y		METHOD OF INHIBITING HEPATITIS C VIRUS
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-001	Jul 24, 2015		DISCN	Yes	No	8,642,025		Y	Y		METHOD OF INHIBITING HEPATITIS C VIRUS WITH DAKLINZA AND AT LEAST ONE ADDITIONAL COMPOUND HAVING ANTI-HCV ACTIVITY
Bristol-myers Squibb	DAKLINZA	daclatasvir dihydrochloride	TABLET;ORAL	206843-002	Jul 24, 2015		DISCN	Yes	No	8,642,025		Y	Y		METHOD OF INHIBITING HEPATITIS C VIRUS

International Family Members for US Patent 8,642,025

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2049522		C300713	Netherlands
European Patent Office	2049522		CA 2015 00003	Denmark
European Patent Office	2049522		C20150003 00128	Estonia