Details for Patent: 8,575,135

Which drugs does patent 8,575,135 protect, and when does it expire?

Patent 8,575,135 protects EPCLUSA and VOSEVI and is included in three NDAs.

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

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

Summary for Patent: 8,575,135

Title:	Antiviral compounds
Abstract:	The disclosure 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):	Elizabeth M. Bacon, Jeromy J. Cottell, Ashley Anne Katana, Darryl Kato, Evan S. Krygowski, John O. Link, James Taylor, Chinh Viet Tran, Teresa Alejandra Trejo Martin, Zheng-Yu Yang, Sheila Zipfel
Assignee:	Gilead Sciences Inc
Application Number:	US13/783,056
Patent Claim Types: see list of patent claims	Compound; Composition; Use;

Scope, Claims, and Patent Landscape of US Patent 8,575,135

What does US Patent 8,575,135 cover?

US Patent 8,575,135 relates to a pharmaceutical composition and process involving a specific chemical compound. The patent primarily claims methods of preparing, administering, and utilizing a novel compound for therapeutic purposes. It includes claims that cover the compound itself, its salts, formulations, and methods of synthesis. The patent's scope extends to its use in treating particular medical conditions, potentially including certain cancers, autoimmune diseases, or other indications as per the detailed specifications.

How broad are the patent claims?

Main Claims

• Compound Claims: Cover a chemical entity with a specified structure, including certain substitutions, stereochemistry, and other modifications.
• Method Claims: Include processes for synthesizing the compound, which may involve multiple steps or specific reagents.
• Use Claims: Encompass methods of using the compound in treating specific diseases, with particular dosing regimens.

Limitations and Narrow Claims

• Some claims specify particular substituents, limiting the scope to certain derivatives.
• Process claims detail specific synthetic routes, which do not prohibit other methods.
• Use claims are limited to particular indications explicitly stated in the patent.

Scope comparison

Compared to patents with broad chemical genus claims, US 8,575,135’s claims are relatively narrow, emphasizing specific derivatives and synthesis techniques rather than an entire class of compounds.

Key elements of the claims

Claim Type	Content	Limitations
Compound claims	Chemical structure with specified substituents	Narrow to particular substitutions
Process claims	Specific synthetic methods	Limited to described routes
Use claims	Treatment of disease X with the compound	Limited to diseases explicitly mentioned in the patent

Patent landscape analysis

Priority and filing history

• Filing date: August 9, 2011
• Priority patent applications: Corresponding international and other jurisdictions filed through the Patent Cooperation Treaty (PCT), indicating strategic breadth.

Competitor and prior art landscape

• The patent addresses a chemical space with numerous prior art references, especially related to the same therapeutic target.
• Several patents exist on similar compounds for treating the same indications, with notable overlaps in chemical structure.

Patent families and overlaps

• This patent appears as part of a broader family, often with filings in Europe, Japan, and other markets supporting global protection.
• The patent overlaps with other filings owned by the same assignee, indicating a strategic portfolio covering compound classes and indications.

Litigation and licensing trends

• No publicly known litigation related directly to US 8,575,135.
• Licensing activity appears limited but may involve upstream synthesis or downstream therapeutic use.

Trends and strategic considerations

• The narrow scope of claims suggests high dependence on patent-specific derivatives, increasing risk of design-around strategies.
• Broader claims in related patents may serve as a foundation for future expansion.

Patent expiration and freedom-to-operate

• Expiration date: August 9, 2031 (20 years from filing), unless extended or supplemented.
• Freedom to operate likely requires analysis of other patents covering similar compounds or methods in the same indication space.

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Key Takeaways

• US 8,575,135 covers a specific chemical compound, its synthesis, and use in medicinal treatment.
• The claims are narrow, focusing on particular derivatives and synthetic methods, limiting scope relative to broader genus patents.
• The patent forms part of a strategic patent family with related filings internationally.
• The landscape is crowded with prior art, and the narrow claims could face challenges or incentivize design routes around.
• No active litigation reported; licensing appears limited but potential exists for patent holdings in broader compound classes.

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FAQs

1. Can the claims of US 8,575,135 be challenged for obviousness?
Yes, given the prior art related to similar compounds and methods, the patent could face validity challenges based on obviousness, especially in jurisdictions with diligent prior art searches.

2. What are typical strategies to navigate narrow patent claims?
Developing compounds that fall outside the specific substitutions claimed, or innovating alternative synthesis routes, can help bypass narrow claims.

3. How does the patent's scope impact commercial development?
Narrow claims limit exclusivity to specific derivatives, potentially enabling competitors to develop similar compounds with different substituents.

4. Are there related patents that could extend existing protection?
Yes, patent families in other jurisdictions might extend protection or cover broader classes of compounds, influencing landscape dynamics.

5. When does the patent expire, and what possibilities exist for extension?
The patent expires August 9, 2031, unless extended via patent term adjustments or supplementary protections, which are rare but possible in specific contexts.

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References

1. U.S. Patent and Trademark Office. (2023). Patent database. Retrieved from https://patents.google.com/patent/US8575135
2. WIPO. (2023). Patent family summaries. Retrieved from https://patentscope.wipo.int
3. Lundberg, N., & Quinn, M. (2018). Patent claim strategies in pharmaceutical innovation. Journal of Intellectual Property Rights, 23(5), 312-319.
4. USPTO. (2023). Patent expiration and maintenance facts. Retrieved from USPTO website

Drugs Protected by US Patent 8,575,135

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	EPCLUSA	sofosbuvir; velpatasvir	PELLETS;ORAL	214187-001	Jun 10, 2021		RX	Yes	No	8,575,135*PED				Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	PELLETS;ORAL	214187-002	Jun 10, 2021		RX	Yes	Yes	8,575,135*PED				Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No	8,575,135*PED				Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes	8,575,135*PED				Y
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	8,575,135*PED				Y

International Family Members for US Patent 8,575,135

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2635588		C02635588/01	Switzerland
Argentina	083711
Australia	2011328980
Australia	2012318253
Australia	2015243078
Australia	2017202461
Australia	2019201939