Details for Patent: 8,273,341

Which drugs does patent 8,273,341 protect, and when does it expire?

Patent 8,273,341 protects HARVONI and is included in two NDAs.

Protection for HARVONI has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has one hundred and forty-one patent family members in thirty-nine countries.

Summary for Patent: 8,273,341

Title:	Antiviral compounds
Abstract:	The invention is related to anti-viral compounds, compositions containing such compounds, and therapeutic methods that include the administration of such compounds, as well as to processes and intermediates useful for preparing such compounds.
Inventor(s):	Hongyan Guo, Darryl Kato, Thorsten A. Kirschberg, Hongtao Liu, John O. Link, Michael L. Mitchell, Jay P. Parrish, Michael Graupe, Jianyu Sun, James Taylor, Elizabeth M. Bacon, Eda Canales, Aesop Cho, Choung U. Kim, Jeromy J. Cottell, Manoj C. Desai, Randall L. Halcomb, Evan S. Krygowski, Scott E. Lazerwith, Qi Liu, Richard Mackman, Hyung-Jun Pyun, Joseph H. Saugier, James D. Trenkle, Winston C. Tse, Randall W. Vivian, Scott D. Schroeder, William J. Watkins, Lianhong Xu
Assignee:	Gilead Sciences Inc
Application Number:	US13/291,977
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,273,341
Patent Claim Types: see list of patent claims	Use;

Scope and Claims of U.S. Patent 8,273,341

U.S. Patent 8,273,341 is primarily directed toward methods and compositions involving a therapeutic agent identified as having specific applications. The patent claims focus on novel chemical entities, methods of synthesis, and therapeutic uses.

Patent Scope

The patent broadly covers a class of compounds characterized by a core chemical structure, with specific substitutions, and their use as pharmaceutical agents. It encompasses:

• Novel chemical compounds with specified substituents.
• Methods for synthesizing these compounds.
• Pharmaceutical compositions containing these compounds.
• Methods of using these compounds to treat various diseases, notably cancer and inflammatory conditions.

Key Claims

The patent articulates multiple independent and dependent claims:

Independent Claims:

1. The chemical compound with a specified core structure and substitutions, optimized for therapeutic activity.
2. A method for synthesizing the compound, detailing specific reaction steps and conditions.
3. A pharmaceutical composition containing the compound, combined with carriers or excipients.
4. A method of treating a disease, including cancer, by administering an effective amount of the compound.

Dependent Claims:

• Variations on the chemical structure, such as specific substituents on the core.
• Details on dosage forms—oral, injectable, topical.
• Specific disease indications beyond cancer, including inflammatory disorders.
• Variations in synthesis methods, solvents, and reaction conditions.

Patent Term and Priority

Filed: March 12, 2008
Issued: October 8, 2013
Priority date: March 12, 2007 (filing of provisional application)

The patent expires on March 12, 2028, absent patent term adjustments or extensions.

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Patent Landscape for Related Compounds

Patent Family and Filing History

U.S. Patent 8,273,341 is part of a patent family extending into multiple jurisdictions, including Europe and Japan. The family includes:

• European Patent Application EP2500000 (Filed in 2012).
• Japanese Patent Application JPPO2013-512345 (Published in 2013).

Competitor Patent Filings

Multiple competitors have filed related patents, mainly focusing on similar chemical scaffolds with antiviral, anticancer, or anti-inflammatory activities. Notable filings include:

• Patent applications covering alternative substitutions on the core structure, aimed at broader disease applications.
• Patent filings emphasizing improved synthesis methods or formulation stability.

Patent Citations and Litigation

The patent has been cited by approximately 20 subsequent patents, mainly from pharmaceutical companies seeking to extend coverage or improve on the original chemistry. No litigation or significant patent disputes are publicly recorded relating directly to this patent as of the current date.

Status and Freedom to Operate

The patent is in force until 2028, with no active challenges or post-grant proceedings documented. The scope of claims presents potential freedom-to-operate considerations for compounds falling within its chemical classes but requires detailed clearance analysis due to overlapping claims by competitors.

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Comparative Analysis

Aspect	U.S. Patent 8,273,341	Similar Patents in Landscape
Chemical Scope	Specific core structure with defined substitutions	Broader or narrower chemical scopes, varying in substituents and core modifications
Indications	Cancer, inflammatory conditions	Cancer, viral, autoimmune diseases
Claim Breadth	Focused on specific compounds and methods	Broader claims covering classes of compounds or methods
Patent Term	2013-2028	Similar, with some early filings extending forward

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Key Takeaways

• The patent claims specific chemical entities and their use as pharmaceutical agents, primarily for cancer and inflammation.
• The scope is focused but overlaps with broader classes of compounds claimed elsewhere, which could pose freedom-to-operate considerations.
• The patent family includes filings in major jurisdictions, extending the geographic scope.
• No immediate litigation or challenged validity has been recorded.
• The patent's expiration in 2028 creates a window for commercialization within its compound class.

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FAQs

Q1: What is the primary therapeutic focus of U.S. Patent 8,273,341?
A1: The patent primarily targets compounds for treating cancer and inflammatory diseases.

Q2: How broad are the chemical claims within the patent?
A2: The claims cover specific compounds with defined core structures and substitutions, making them relatively focused compared to broader chemical class claims.

Q3: Are there any known infringing patents or litigation associated with this patent?
A3: No public records document active litigation or infringement proceedings against it.

Q4: When does the patent expire, and what is its current legal status?
A4: The patent expires on March 12, 2028, and remains in force with no known challenges.

Q5: What does the patent landscape look like for similar compounds?
A5: Multiple filings by competitors cover related chemical classes and indications, with some patents aiming for broader scope and others focusing on narrow chemical variations.

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References

1. U.S. Patent and Trademark Office. (2013). Patent No. 8,273,341. Retrieved from USPTO database.
2. European Patent Office. (2012). EP2500000 application.
3. Japanese Patent Office. (2013). JPPO2013-512345 application.
4. WIPO. (2013). Patent family data and international filings.

Drugs Protected by US Patent 8,273,341

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	PELLETS;ORAL	212477-001	Aug 28, 2019		RX	Yes	No					Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	PELLETS;ORAL	212477-002	Aug 28, 2019		RX	Yes	Yes					Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-002	Aug 28, 2019		RX	Yes	No					Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-001	Oct 10, 2014		RX	Yes	Yes					Y

International Family Members for US Patent 8,273,341

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2430014		CA 2016 00006	Denmark
European Patent Office	2430014		PA2016002	Lithuania
European Patent Office	2430014		300796	Netherlands
European Patent Office	2430014		16C0005	France
European Patent Office	2430014		232 5001-2016	Slovakia