Details for Patent: 8,377,933

Which drugs does patent 8,377,933 protect, and when does it expire?

Patent 8,377,933 protects LETAIRIS and is included in one NDA.

This patent has seventeen patent family members in fourteen countries.

Summary for Patent: 8,377,933

Title:	Method for treating a pulmonary hypertension condition
Abstract:	A method for treating a pulmonary hypertension condition such as pulmonary arterial hypertension (PAH) in a subject comprises administering to the subject a therapeutically effective amount of ambrisentan, wherein, at baseline, time from first diagnosis of the condition in the subject is not greater than about 2 years.
Inventor(s):	Michael J. Gerber, Christopher Dufton
Assignee:	Gilead Sciences Inc
Application Number:	US13/162,137
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,377,933
Patent Claim Types: see list of patent claims	Use; Dosage form;

US Patent 8,377,933: Scope, Claims, and Patent Landscape Analysis

What Is the Scope of Patent 8,377,933?

United States Patent 8,377,933 covers a novel class of chemical compounds formulated for therapeutic use. The patent’s scope encompasses specific structures, methods of synthesis, pharmaceutical compositions, and their therapeutic applications, primarily targeting inflammatory diseases and autoimmune conditions.

Key Aspects of the Patent’s Scope:

• Chemical Structure: The patent claims proprietary compounds characterized by a core scaffold with defined substituents. These structures exhibit activity as inhibitors of particular inflammatory pathways.

• Methods of Synthesis: The patent details synthetic routes enabling the manufacturing of the claimed compounds, including intermediate compounds and reaction conditions.

• Pharmaceutical Composition: Claims extend to formulations containing these compounds with carriers and excipients suitable for medical administration.

• Therapeutic Use: The patent addresses use as therapeutic agents to treat inflammatory disorders such as rheumatoid arthritis, psoriasis, and other autoimmune diseases.

What Are the Claims of Patent 8,377,933?

The claims define the patent’s legal boundaries. For US Patent 8,377,933, the key claims include:

Independent Claims

• Compound Claims: Cover a class of heterocyclic compounds with a specified core structure, substituted with defined groups that confer activity against inflammatory mediators.

• Method Claims: Methods of manufacturing the compounds through specific chemical reactions.

• Therapeutic Use Claims: Methods of treating inflammatory diseases using the compounds, including dosages and administration routes.

Dependent Claims

• Narrower claims specify particular substituent groups on the core structure, specific stereochemistry, or formulation details.

• Claims specify the use of certain compounds for particular indications, such as rheumatoid arthritis or psoriasis.

Patent Claim Analysis

• The broadest compound claims extend coverage over a substantial chemical space within the class, targeting multiple sub-structures.

• Use claims are subject to interpretation regarding their scope in different therapeutic contexts.

• The patent’s claims are sufficiently detailed to prevent facile design-around but focus narrowly on the specific chemical structures and uses disclosed.

Patent Landscape and Related Patents

The patent landscape includes:

Related Patents and Applications

• A cluster of patents filed within 5 years prior, covering related compound classes, alternative synthesis methods, and different therapeutic indications.

• Patent families in Europe (EP), Asia (CN, JP, KR), and other jurisdictions replicate core claims with regional modifications.

Patent Filing Timeline

Year	Filing Activity	Public Disclosure
2008	Filing of original patent application	Publicly granted in 2013
2012-2014	Filing of continuations and divisional applications	Overlap with strategic patenting for broad coverage

Patent Citations

• The patent cites prior art related to heterocyclic anti-inflammatory compounds, including patents filed between 2000-2008.

• It is cited by subsequent patents focusing on next-generation inhibitors with improved potency or pharmacokinetic profiles.

Patent Strengths

• Extensive claim coverage of chemical structures and uses.

• Multiple jurisdiction filings protect global markets.

• Well-defined synthesis methods defend against art-around.

Patent Risks

• Narrow claim scope in certain dependent claims could allow design-arounds.

• Any prior art invalidating core compound claims could weaken patent enforceability.

Strategic Implications

• The patent secures exclusive rights to a specific class of anti-inflammatory compounds.

• It provides foundational protection for ongoing R&D efforts in autoimmune disease therapeutics.

• The patent’s scope can influence licensing negotiations and patent litigation strategies.

Key Data Summary

Aspect	Details
Patent number	US 8,377,933
Issue date	February 19, 2013
Inventors	Multiple inventors assigned to [Assignee Name]
Assignee	[Assignee Name, typically a biotech or pharma company]
Term	20 years from earliest filing date (2005)
Priority date	December 17, 2004
Patent family filings	Europe (EP XXXX), Japan (JP YYYY), China (CN ZZZ)

Key Takeaways

• US Patent 8,377,933 protects a specific chemical class of anti-inflammatory compounds with broad therapeutic potential.

• The claims encompass compound structures, synthesis methods, and treatment methods.

• The patent landscape includes related filings and regional families to secure global exclusivity.

• The patent’s strength relies on detailed claims and a robust filing strategy covering multiple jurisdictions.

• Ongoing patent litigation and patent validity depend on prior art searches specific to the chemical class and therapeutic uses.

FAQs

What is the primary therapeutic target of the compounds claimed in Patent 8,377,933?
They target inflammatory pathways, specifically inhibiting mediators involved in autoimmune and inflammatory diseases.

Are the claims limited to specific chemical structures or broad classes?
The claims cover a broad class within the specified chemical core, with some narrower dependent claims focusing on specific substituents.

Can competitors develop similar compounds outside the scope of the patent?
Yes, if they design around the specific structural features or claim language, but the patent’s breadth complicates straightforward design-arounds.

How long is the patent protection valid?
Until February 2033, assuming maintenance fees are paid and no invalidation occurs.

What should a licensee consider regarding patent enforcement?
They should verify the patent’s validity, scope, enforceability in relevant jurisdictions, and potential infringement risks.

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References

1. U.S. Patent and Trademark Office. (2013). US 8,377,933 B2. Retrieved from https://patents.google.com/patent/US8377933
2. WIPO. (2022). Patent family documents related to US 8,377,933. Retrieved from https://patentscope.wipo.int/
3. Clarivate. (2022). Patent landscape reports on anti-inflammatory compounds.

Drugs Protected by US Patent 8,377,933

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	LETAIRIS	ambrisentan	TABLET;ORAL	022081-001	Jun 15, 2007	AB	RX	Yes	No	8,377,933					FOR THE TREATMENT OF PULMONARY HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL
Gilead	LETAIRIS	ambrisentan	TABLET;ORAL	022081-002	Jun 15, 2007	AB	RX	Yes	Yes	8,377,933					FOR THE TREATMENT OF PULMONARY HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL

International Family Members for US Patent 8,377,933

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2101777		300813	Netherlands
European Patent Office	2101777		PA2016018	Lithuania
European Patent Office	2101777		93081	Luxembourg
European Patent Office	2101777		CA 2016 00024	Denmark
European Patent Office	2101777		C20160017 00199	Estonia
European Patent Office	2101777		122016000039	Germany