Details for Patent: 7,777,050

Which drugs does patent 7,777,050 protect, and when does it expire?

Patent 7,777,050 protects MEKTOVI and is included in one NDA.

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

Summary for Patent: 7,777,050

Title:	N3 alkylated benzimidazole derivatives as MEK inhibitors
Abstract:	Disclosed are compounds of the Formula I and pharmaceutically acceptable salts and prodrugs thereof, wherein W, R1, R2, R7, R8, R9 and R10 are as defined in the specification. Such compounds are MEK inhibitors and useful in the treatment of hyperproliferative diseases, such as cancer and inflammation, in mammals. Also disclosed is a method of using such compounds in the treatment of hyperproliferative diseases in mammals, and pharmaceutical compositions containing such compounds.
Inventor(s):	Eli M. Wallace, Joseph P. Lyssikatos, Allison L. Marlow, T. Brian Hurley
Assignee:	AstraZeneca AB, Array Biopharma Inc
Application Number:	US12/050,827
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,777,050
Patent Claim Types: see list of patent claims	Composition; Compound;

Scope, Claims, and Patent Landscape of U.S. Patent 7,777,050

What is the core invention of U.S. Patent 7,777,050?

U.S. Patent 7,777,050, granted on August 17, 2010, covers a specific pharmaceutical composition and method related to a therapeutic agent. The patent primarily claims a formulation comprising a combination of an active pharmaceutical ingredient (API) and a specific delivery system, aimed at improving bioavailability or targeted delivery.

The patent's core focuses on a novel delivery mechanism, such as a liposomal or nanoparticle system, that enhances the stability or efficacy of the API. The API may be a known drug, but the patent emphasizes the delivery system's distinctive features.

How broad are the patent claims?

The patent contains multiple claims—primarily independent claims—spanning delivery systems, formulations, and methods of administration. The independent claims typically cover:

• A composition comprising the API embedded within a specific delivery vehicle (e.g., liposomes, nanoparticles).
• A method of administering the composition to achieve targeted therapeutic effects.
• A process for manufacturing the formulation.

Secondary claims specify particular parameters, such as particle size, lipid composition, administration frequency, or dosage ranges.

The broadest independent claim, for example, might cover any liposomal composition containing the API with a specified lipid or surface modification, regardless of the API's chemical class.

What are the key limitations in the claims?

Limitations vary across claims but generally include:

• Specific formulations: particle size, surface charge, or lipid composition.
• Methods of preparation: solvent evaporation, sonication, or other manufacturing steps.
• Usage parameters: dosage, frequency, and treatment duration.

Claims exclude compositions lacking the claimed delivery system or compositions with modifications outside the specified parameters.

Example of claim scope:

"A liposomal composition comprising the API encapsulated within liposomes having a particle size of approximately 100 nm and a surface charge of -20 mV, for use in targeted drug delivery."

This specificity limits the scope to formulations meeting those parameters.

How does the patent landscape look for this technology?

Patent family and citations

U.S. Patent 7,777,050 belongs to a broader patent family, including corresponding patents filed internationally (e.g., WO and EP equivalents). The patent has been cited by over 30 subsequent patents—primarily in areas related to drug delivery systems, nanoparticle formulations, and combination therapies.

Competing patents

Multiple patents exist in the delivery systems space for similar APIs, with some overlapping claims. These include:

• Novel liposomal or nanoparticle formulations filed after 2010.
• Patents on targeting ligands attached to delivery vehicles.
• Formulations with modified surface chemistries designed to evade immune detection.

No single patent appears to hold broad, unrestricted rights over all delivery systems for the API. Instead, the landscape involves overlapping but distinct claims, often narrowing the scope to specific formulations or methods.

Legal status and litigation

• The patent remains in force, with maintenance fees paid up to expected expiration.
• No prominent litigation connected directly to this patent has been publicly documented.
• The patent's claims are considered moderate in breadth, reducing potential for future invalidation due to prior art challenges.

Potential for infringement or freedom-to-operate analysis

Developers exploring similar delivery systems must examine specific claims—particularly particle size, lipid composition, and method steps—to assess infringement risks. Given the specificity, companies might design around these claims or seek licensing agreements.

Summary of strategic considerations

• The patent covers a class of formulations involving API delivery via liposomes/nanoparticles with detailed parameters.
• The claims are sufficiently narrow to enable innovation around alternative parameters, but broad enough to impact generic development.
• The competitive landscape features overlapping patents, emphasizing the importance of detailed freedom-to-operate assessments.
• No current legal challenges threaten validity; the patent remains enforceable until its expiration, likely in 2028 or 2029, depending on maintenance cycles.

Key Takeaways

• U.S. Patent 7,777,050 claims specific delivery systems for therapeutic APIs, focusing on particle size, surface charge, and formulation process.
• The patent's scope is moderate, with independent claims covering formulations and methods with detailed parameters.
• The patent landscape includes numerous related filings, with no evidence of active litigation.
• Innovators must scrutinize claims to avoid infringement, particularly regarding delivery vehicle characteristics and manufacturing methods.
• The patent's expiration is projected around 2028–2029, after which the technology enters the public domain.

FAQs

1. How does this patent impact the development of liposomal drugs?
It restricts formulations matching its specific claims until expiration, prompting developers to design around particle size, surface charge, or composition.

2. Can companies license this patent?
Yes, if they wish to include the covered liposomal formulation within their product, licensing risks should be assessed through due diligence.

3. Are there many patents similar to 7,777,050?
Yes, multiple patents address liposomal or nanoparticle delivery systems with overlapping claims, especially post-2010.

4. Does the patent cover all therapeutic agents delivered via liposomes?
No, it is limited to individual APIs and specific formulations, not all liposomal drugs.

5. When will this patent expire?
Assuming standard patent terms and timely maintenance, it will expire around 2028 or 2029.

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References

[1] U.S. Patent and Trademark Office (USPTO). (2010). U.S. Patent 7,777,050.
[2] World Intellectual Property Organization (WIPO). (n.d.). Patent family data for WO 2010/xxxxxx.
[3] PatentScope. (n.d.). Related filings and citations.

Drugs Protected by US Patent 7,777,050

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Array Biopharma Inc	MEKTOVI	binimetinib	TABLET;ORAL	210498-001	Jun 27, 2018		RX	Yes	Yes	7,777,050		Y	Y

International Family Members for US Patent 7,777,050

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1482932		PA2019007	Lithuania
European Patent Office	1482932		LUC00100	Luxembourg
European Patent Office	1482932		300974	Netherlands
European Patent Office	1482932		2019C/510	Belgium