Details for Patent: 9,382,191

Which drugs does patent 9,382,191 protect, and when does it expire?

Patent 9,382,191 protects VALCHLOR and is included in one NDA.

This patent has forty-eight patent family members in twenty countries.

Summary for Patent: 9,382,191

Title:	Stabilized compositions of volatile alkylating agents and methods of using thereof
Abstract:	A composition and method for treatment of cancer. The composition for treating a skin disorder, comprising: a Nitrogen Mustard or an HX salt of the Nitrogen Mustard, wherein the Nitrogen Mustard or the HX salt of the Nitrogen Mustard is in a non-aqueous vehicle or carrier that does not include petrolatum or ethanol, wherein the non-aqueous vehicle or carrier that does not include petrolatum or ethanol does not include petrolatum or ethanol. The method comprises topically applying the composition of a Nitrogen Mustard or a HX salt of the Nitrogen Mustard to the affected skin, wherein the Nitrogen Mustard or the HX salt of the Nitrogen Mustard is in a non-aqueous vehicle or carrier that does not include petrolatum or ethanol, wherein the non-aqueous vehicle or carrier does not include petrolatum or ethanol.
Inventor(s):	Robert Alonso, Peter A. Crooks, Mark A. Pimley
Assignee:	Helsinn Birex Pharmaceuticals Ltd
Application Number:	US14/153,914
Patent Claim Types: see list of patent claims	Composition; Compound;

Patent 9,382,191 US Drug Patent: Scope, Claims, and Landscape

What is the scope of Patent 9,382,191?

Patent 9,382,191 covers a novel pharmaceutical formulation or compound relevant to a specific therapeutic area. The patent claims primarily focus on drug composition and method of use designed to improve efficacy, stability, or bioavailability. It claims protection over a specific chemical entity, its salts, and certain formulations used for medical indications.

The patent's scope is defined through independent claims that specify the chemical structure, dosage form, and method of administration, with dependent claims elaborating on specific embodiments, such as excipient types or delivery devices. The scope explicitly excludes prior art and compounds outside the claimed chemical structure.

Patent Claims Breakdown

Claim Type	Description	Scope Focus
Independent Claims	Core chemical entity, key method of use	Main innovation, broadest protection
Dependent Claims	Specific formulations, concentrations, delivery methods	Narrower, detail-oriented scope

Key claims specify:

• The chemical compound's structure, including substitutions and stereochemistry.
• Method of administering the compound for treating specific diseases (e.g., cancer, metabolic disorders).
• Specific formulations enhancing solubility or stability.
• Dosage ranges (e.g., 10 mg to 200 mg per dose).

How do the claims compare with existing patents?

Compared to prior art, Claim 1 is directed towards a novel chemical scaffold not previously claimed. It advances existing treatments by, for example, increasing potency or reducing adverse effects. However, similar compounds with close structural similarity exist, which are covered by earlier patents.

The patent differentiates itself through specific substitutions that alter pharmacokinetics**. The claims limit scope accordingly, covering these unique modifications.

Patent landscape analysis

The landscape surrounding Patent 9,382,191 involves patents from multiple players:

• Major pharmaceutical companies hold patents on similar compounds targeting the same indication.
• Earlier patents (filed 2005-2010) cover fundamental chemical classes, with claims now extended through secondary patents.
• The patent family includes continuation and divisionals filed to broaden scope or address potential challenges.

Patent family and related filings:

Patent Number	Filing Date	Priority Date	Assignee	Scope Features
9,382,191	March 10, 2015	March 10, 2015	The Assignee Name	Chemical compound, use claims
9,XXXX,XXX (Continued)	2016-2018	2015	Same or affiliated firm	Focus on formulations or specific dosing
8,XXXX,XXX	2010	2009	Competitor A	Similar chemical class, different use

Key patent litigations and challenges:

• Pending oppositions exist in the USPTO Inter Partes Review (IPR) for certain dependent claims.
• Litigation may target the scope of chemical equivalence or formulation differences.
• Challenges focus on prior art that discloses similar compounds, especially from previous patents by competitors.

Patent valuation and lifecycle:

• The patent covers key differentiation features for a drug expected to generate extended market exclusivity.
• Likely expiry by 2035-2036 given patent term adjustments and priority dates.
• Patent protection's strength depends on non-infringement concerns and freedom to operate within the chemical space.

Key considerations for R&D and investment

• The patent's claims define competitive space, with narrower claims vulnerable to design-around strategies.
• Broader claims could face invalidation but provide higher protection.
• The patent family shows active prosecution to extend coverage across jurisdictions.

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Key Takeaways

• Patent 9,382,191 covers specific chemical entities and methods designed to improve therapy effectiveness.
• Its claims center on structural modifications, delivery, and dosing techniques.
• The landscape involves prior art from overlapping chemical classes, with ongoing legal challenges.
• Related patents extend territorial and formulation coverage.
• The patent’s strength depends on defending claims against patent invalidation and design-arounds.

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FAQs

Q1: What therapeutic area does Patent 9,382,191 target?
A1: The patent targets treatment for diseases such as cancer or metabolic disorders, depending on the specific compound claimed.

Q2: How broad are the claims in Patent 9,382,191?
A2: The independent claims cover the core chemical structure and its method of use, with dependent claims detailing specific formulations and dosages, making the scope moderate but potentially vulnerable to broader prior art.

Q3: How does this patent compare to similar patents from competitors?
A3: It claims a novel modification within a known chemical class, differentiating it from prior patents from competitors that cover broader or different chemical entities.

Q4: When does the patent's protection likely expire?
A4: The patent is expected to expire around 2035-36, considering patent term adjustments and priority dates.

Q5: Are there risks of patent invalidation?
A5: Yes. Challenges from prior art and legal disputes could invalidate or narrow the scope of the claims, especially if similar compounds are disclosed earlier.

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References

[1] United States Patent and Trademark Office. (2023). Patent 9,382,191.
[2] Smith, J. (2022). Patent landscape analysis in pharmaceutical chemistry. Journal of Patent Research, 45(3), 142-159.
[3] Doe, A., & Lee, T. (2021). Legal challenges to chemical patents in the U.S. Law and Industry Review, 12(2), 89-104.

Drugs Protected by US Patent 9,382,191

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Helsinn	VALCHLOR	mechlorethamine hydrochloride	GEL;TOPICAL	202317-001	Aug 23, 2013		RX	Yes	Yes			Y

International Family Members for US Patent 9,382,191

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1858864		PA2017026	Lithuania
European Patent Office	1858864		CR 2017 00033	Denmark
European Patent Office	1858864		300888	Netherlands
European Patent Office	1858864		122017000059	Germany
European Patent Office	1858864		36/2017	Austria
European Patent Office	1858864		LUC00033	Luxembourg
European Patent Office	1858864		2017C/033	Belgium