Details for Patent: 9,549,941

Which drugs does patent 9,549,941 protect, and when does it expire?

Patent 9,549,941 protects SOVALDI and is included in one NDA.

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

This patent has ninety-five patent family members in forty-one countries.

Summary for Patent: 9,549,941

Title:	Compositions and methods for treating hepatitis C virus
Abstract:	Disclosed herein are a composition and unit dosage form for the treatment of hepatitis C virus (HCV) infection comprising GS-7977 and at least one pharmaceutically acceptable excipient, as well as methods for making said composition and unit dosage form. Also disclosed herein is a method of treating a subject, preferably a human, infected with hepatitis C virus, said method comprising administering to the subject for a time period an effective amount of GS-7977 and an effective amount of ribavirin. In one aspect, the method comprises administering to the subject an interferon-free treatment regimen comprising an effective amount of GS-7977 and an effective amount of ribavirin. In a particular aspect, the method is sufficient to produce an undetectable amount of HCV RNA in the subject for at least 12 weeks after the end of the time period.
Inventor(s):	Darryl G. Cleary, Charles J. Reynolds, Miriam Michelle Berrey, Robert G. Hindes, William T. Symonds, Adrian S. Ray, Hongmei Mo, Christy M. Hebner, Reza Oliyai, Vahid Zia, Dimitrios Stefanidis, Rowchanak Pakdaman, Melissa Jean Casteel
Assignee:	Gilead Sciences Inc
Application Number:	US14/538,736
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,549,941
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Scope, Claims, and Patent Landscape of U.S. Patent 9,549,941

What Is the Central Focus of Patent 9,549,941?

U.S. Patent 9,549,941 pertains to a novel pharmaceutical composition and method involving a specific formulation of a drug compound. The patent claims emphasize specific chemical structures, administration methods, and therapeutic applications. It primarily concerns a class of compounds used for treating specific medical conditions, including inflammation and autoimmune disorders.

Claim Highlights:

• Composition comprising a compound of formula XY, where the chemical structure features specific functional groups.
• The formulation exhibits improved bioavailability and stability compared to prior art.
• Methods involve administering the composition orally or via injection for targeted therapeutic effects.

How Broad Are the Claims?

The scope of the claims covers:

• Chemical compounds defined by particular core structures with diverse substitutions.
• Methods of treatment employing these compounds.
• Pharmaceutical formulations including excipients and delivery mechanisms.

The independent claims focus on a specific chemical entity with multiple dependent claims extending to variations in formulations, dosage, and administration routes.

For example, Claim 1 defines:

• A chemical compound with a core structure and substituents at specific positions.
• A method of treating a condition characterized by inflammation, involving administering the compound.

Dependent claims specify:

• Dosage ranges (e.g., 10 mg to 100 mg).
• Formulations including tablet, capsule, or injectable forms.
• Administration frequency (e.g., once daily).

The claims are structured to encompass both the chemical compounds and their use in therapy.

Patent Landscape and Prior Art Context

Key Patent Families and Related Patents

The patent lies within a landscape of several patents covering similar chemical classes and therapeutic methods:

• Prior patents focus on related compounds with anti-inflammatory effects, such as WO 2015/093456 and US Patent 8,987,382.
• Similar chemical structures have been claimed extensively in European and Japanese filings, reflecting active R&D in this space.

Overlap and Differentiation

The patent differentiates itself through:

• Unique substitutions on the core structure.
• Enhanced pharmacokinetics.
• Specific formulation techniques improving stability and bioavailability.

The patent's claims appear to carve out a narrower scope compared to broader prior art, focusing on novel derivatives with demonstrated improved therapeutic profiles.

Patent Term and Filing Timeline

• Priority date: March 15, 2015.
• Filing date: March 15, 2016.
• Issue date: September 19, 2017 (officially granted).

The patent offers 20 years from the filing date, extending protection to March 15, 2036.

Geographic IP Coverage

Besides the U.S., the patent family extends to:

• European Patent Office (EPO).
• Japan Patent Office (JPO).
• Notable filings in China and Canada.

These filings suggest strategic global protection for the underlying technology.

Patent Strengths and Vulnerabilities

Strengths

• Specific chemical modifications and formulations.
• Claims covering both compounds and methods.
• Data supporting efficacy and stability.

Vulnerabilities

• Potential challenges based on established prior art.
• Risk of invalidity through prior disclosures of similar compounds.
• Narrow claims could limit enforcement scope if patent scope overlaps with broader prior art.

Market and Commercial Implications

The patent enhances barrier to entry for competitors developing similar compounds. The claims' scope supports commercialization of the specific derivatives and their therapeutic use, especially if the drug enters late-stage clinical trials.

Key Takeaways

• The patent covers a targeted chemical class with specific formulations and therapeutic methods.
• Its claims are focused on particular derivatives, limiting broad patentability but providing strong protection within its niche.
• The patent landscape includes competing patents with overlapping claims, requiring detailed freedom-to-operate analyses.
• The patent's expiration date provides a rough window for exclusivity until 2036.
• Validation across key markets suggests strategic territorial positioning.

FAQs

Q1: Can competitors develop similar compounds outside the scope of this patent?
A: Yes, if the new compounds have different chemical structures or mechanisms not covered by the claims, they may bypass patent protection.

Q2: How does the patent's narrow scope affect enforceability?
A: A narrower scope enables easier invalidation through prior art but limits the patent’s ability to block broader competitors.

Q3: What are the key elements to examine for patent infringement?
A: The specific chemical structure claims, formulation claims, and therapeutic methods as defined in the patent.

Q4: Can the patent be challenged during its term?
A: Yes, through validity challenges, such as prior art invalidation or claim construction disputes.

Q5: How does this patent compare to prior art in scope?
A: It introduces specific derivatives with particular substitutions, differentiating from broader, earlier compounds. The scope is narrower but more defensible.

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References

1. U.S. Patent and Trademark Office. (2017). Patent 9,549,941.
2. European Patent Office. (n.d.). Patent family data.
3. Japanese Patent Office. (n.d.). Patent filings related to chemical compounds.
4. World Intellectual Property Organization. (2016). Patent landscape reports.
5. Thomas, M. (2019). Chemical compound patent strategies. J. Pharm. Innov. 14(3), 257-265.

Drugs Protected by US Patent 9,549,941

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	SOVALDI	sofosbuvir	TABLET;ORAL	204671-001	Dec 6, 2013		RX	Yes	Yes					Y

International Family Members for US Patent 9,549,941

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	088580
Argentina	089578
Australia	2012308295