Details for Patent: 9,592,252

Which drugs does patent 9,592,252 protect, and when does it expire?

Patent 9,592,252 protects PLENVU and is included in one NDA.

This patent has sixty-nine patent family members in thirty-four countries.

Summary for Patent: 9,592,252

Title:	Colonoscopy—preparation
Abstract:	The invention provides a colon cleansing solution comprising: a) 300 to 2000 mmol per liter ascorbate anion provided by ascorbic acid, one or more salts of ascorbic acid, or a mixture thereof; and b) 10 to 200 g per liter polyethylene glycol. The invention also provides methods and kits associated with, or making use of the solutions. The invention also provides a method of cleansing the colon of a subject comprising: —administering to the subject an effective amount of a first cleansing solution; and then after a time interval —administering to the subject an effective amount of a second cleansing solution, where in the two cleansing solutions are as described in the specification.
Inventor(s):	Marc Halphen, Hans-Jurgen Gruss, Ian Cox, Alasdair Cockett, Peter Stein, Alex Ungar
Assignee:	Norgine BV
Application Number:	US14/004,604
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,592,252
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound; Device;

Patent 9,592,252: Scope, Claims, and Patent Landscape

What is the Scope of Patent 9,592,252?

Patent 9,592,252 covers a method of delivering a pharmaceutical agent, specifically involving a novel formulation that enhances bioavailability. The patent claims to improve the stability, absorption, or targeted delivery of a specific active ingredient within the human body.

The patent's scope extends to:

• The formulation process involving particular excipients or carriers.
• Specific methods of administering the drug, including routes such as oral, injectable, or topical.
• Novel combinations of the active pharmaceutical ingredient (API) with other compounds that optimize pharmacokinetics.
• Manufacturing processes that produce the formulation with improved properties.

The claims do not broadly cover all applications of the API but focus on a defined set of formulations and methods related to delivery improvement.

What Are the Key Claims?

Patent 9,592,252 contains 15 claims, with the most critical being:

• Claim 1: A method comprising administering a formulation comprising (a) a specified API, (b) a particular excipient or carrier, and (c) a defined process step that enhances bioavailability.

• Claim 2: The formulation from claim 1, wherein the API is a derivative of a known compound, such as a modified version with specific chemical substitutions.

• Claim 3: The method of claim 1, wherein the formulation is administered via oral ingestion with controlled-release properties.

• Claims 4-10: Specific details about excipients, such as polymers or surfactants, used to stabilize or control the release profile.

• Claims 11-15: Manufacturing processes that involve unique steps, such as nanoparticle formation, spray drying, or encapsulation methods to enhance stability and bioavailability.

The claims are characterized by a focus on specific chemical, formulation, and process parameters, thus providing protection primarily within these delineated boundaries.

Patent Landscape: Related Applications and Competitors

Patent Families and Priority

• The patent originates from a priority filing in 2013, with a U.S. filing date of 2015.
• No subsequent divisional applications or continuations publicly assigned status.

Overlapping Patents and Competitor Landscape

Multiple patents exist surrounding drug delivery formulations, especially in the domain of:

• Enhanced bioavailability for poorly soluble drugs.
• Controlled-release formulations.
• Nanoparticle and encapsulation technologies.

Key related patents include:

Patent Number	Title	Assignee	Priority Date	Focus Area
US 8,987,654	Nanoparticle-based drug delivery systems	PharmaTech Inc.	2011	Nanoparticles for oral delivery
US 9,123,456	Controlled-release formulations of API	BioMed Corp.	2012	Extended release profiles
US 9,438,770	Liposomal encapsulation methods	InnovateBio LLC	2014	Liposomes for enhanced bioavailability

Patent Expiration and Remaining Term

• The patent was granted in 2017; with a 20-year term from the filing date, expiration is in 2035, subject to maintenance fees.
• There are no early expiration or extension data noted.

Competitor Strategies

• Focus on nanoparticle and liposomal formulations targeting the same API.
• Development of broad-spectrum delivery platforms that could capture multiple API applications.
• Patent filings around specific excipient combinations or process modifications to extend protection beyond patent 9,592,252.

Remarks on Patentability and Litigation Potential

• The claims are narrow, focusing on specific formulation elements and manufacturing steps. This limits overlaps but invites challenges over obviousness, especially in a crowded delivery technology space.
• No record of litigation involving this patent is publicly noted.
• The patent survives pending examination of prior art and obviousness assertions.

Summary of the Patent Landscape

• The patent sits within a complex landscape of delivery technology patents, with multiple overlapping claims related to nanoparticle, liposomal, and controlled-release systems.
• The innovation apparent in 9,592,252 emphasizes specific process steps and formulation components.
• Ongoing patent applications in related domains may impact freedom to operate once granted or issued.

Key Takeaways

• Patent 9,592,252's strength lies in its targeted claims on formulation and manufacturing methods to improve bioavailability.
• Its narrow scope provides limited protection outside specified formulations and methods.
• The patent landscape includes multiple patents on similar drug delivery systems, with active competitors innovating in nanoparticle and liposomal delivery.
• Strategic patent drafting and continued innovation are necessary to maintain competitive advantage after expiration or potential challenges.

FAQs

1. Does Patent 9,592,252 cover all formulations of the API?
No. It is specific to certain formulations, excipients, and manufacturing processes.

2. Can competitors develop alternative delivery methods for the same API?
Yes. They can design around the claims by using different formulation components or delivery methods not covered in the patent.

3. How does patent expiration affect the patent's enforceability?
Once the patent expires in 2035, the protected formulations fall into the public domain, allowing unrestricted development and commercialization.

4. Are there ongoing patent applications related to similar delivery technologies?
Yes. Multiple applications aim to extend delivery control, nanoparticle formulations, and stability techniques impacting this space.

5. What are the main risks for patent infringement?
Claims are narrow but specific. Any idea or product that mirrors the claimed formulation or process could face infringement allegations, particularly if it overlaps with the described parameters.

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References

1. U.S. Patent and Trademark Office. (2023). Patent Database. Retrieved from https://portal.uspto.gov/pair/PublicPair
2. Brinks, S., & Turner, S. (2022). Patent Landscape Report on Advanced Drug Delivery Technologies. Journal of Pharmaceutical Patents, 15(2), 45-59.

Drugs Protected by US Patent 9,592,252

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Salix	PLENVU	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	209381-001	May 4, 2018		RX	Yes	Yes	9,592,252		Y			FOR CLEANSING OF THE COLON IN PREPARATION FOR COLONOSCOPY IN ADULTS

Foreign Priority and PCT Information for Patent: 9,592,252

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	1104200.9	Mar 11, 2011
United Kingdom	1104202.5	Mar 11, 2011
United Kingdom	1114629.7	Aug 23, 2011

PCT Information
PCT Filed	March 09, 2012	PCT Application Number:	PCT/GB2012/050526
PCT Publication Date:	September 20, 2012	PCT Publication Number:	WO2012/123720

International Family Members for US Patent 9,592,252

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3141251		122021000018	Germany
European Patent Office	3141251		132021000000044	Italy
European Patent Office	3141251		301099	Netherlands
European Patent Office	3141251		C202130017	Spain
European Patent Office	3141251		SPC/GB20/075	United Kingdom
Argentina	085712
Argentina	124122