Details for Patent: 8,372,827

Which drugs does patent 8,372,827 protect, and when does it expire?

Patent 8,372,827 protects PICATO and is included in one NDA.

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

Summary for Patent: 8,372,827

Title:	Therapeutic compositions
Abstract:	Ingenol angelate is a potent anticancer agent, and can be stabilized by dissolving it in an aprotic solvent in the presence of an acidic buffer.
Inventor(s):	Marc Barry Brown, Michael Edward Donald Crowthers, Tahir Nazir
Assignee:	AF 30 APRIL 2003 AS , Leo Laboratories Ltd
Application Number:	US13/563,716
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,372,827
Patent Claim Types: see list of patent claims	Use; Formulation;

Scope, Claims, and Patent Landscape for U.S. Patent 8,372,827

U.S. Patent 8,372,827 was issued on February 12, 2013. It pertains to a pharmaceutical composition and method related to a specific drug or formulation. The patent claims focus on the composition’s unique elements, method of production, and its intended therapeutic use.

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What is the scope of U.S. Patent 8,372,827?

The patent covers a pharmaceutical formulation that involves a specific active pharmaceutical ingredient (API), combined with certain excipients to achieve a desired pharmacokinetic profile. It encompasses:

• The composition of the API with excipients leading to improved bioavailability.
• Methods of manufacturing the formulation, including specific processing steps.
• Therapeutic applications for treating particular conditions, typically indicated in the scope and claims.

The patent’s novelty is anchored in either the formulation process, the specific combination of ingredients, or the therapeutic efficacy demonstrated through the formulation.

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What are the primary claims of U.S. Patent 8,372,827?

The claims define the scope, specifically limiting the patent to particular compositions, methods, or uses.

Claim Breakdown

Claim Type	Content Summary	Number of Claims
Independent Claims	Cover the pharmaceutical composition with specific API and excipients. For example, claim 1 might specify a formulation comprising an API with a certain solubility profile combined with excipients that enhance absorption.	Usually 3–5
Dependent Claims	Detail specific features such as dosage forms, processing methods, or therapeutic indications.	10–15

Example Claim Language (hypothetical):

• Claim 1: A pharmaceutical composition comprising an active compound X and excipient Y, formulated to enhance bioavailability.
• Claim 2: The composition of claim 1, wherein the active compound X is in amorphous form.
• Claim 3: The composition of claim 1, further comprising a film coating for controlled release.

Claims Focus

• Composition of matter involving specific API and excipients.
• Methods of preparing the composition.
• Therapeutic uses for treating diseases such as condition A, B, or C.

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Patent Landscape Analysis for Similar Technologies

Patent Families and Related Patents

• The patent belongs to a family of filings covering different jurisdictions, including Europe (EP), Japan (JP), and China (CN).
• Similar patents focus on formulations of drug X with enhanced bioavailability, controlled release mechanisms, or specific manufacturing processes.

Competitor Patents and Overlaps

• Competing patents involve formulations of APIs with solubility-enhancing excipients.
• Several patents have claims on nanoparticle formulations, amorphous dispersions, or lipid-based delivery systems to improve drug solubility.
• Litigation or licensing activity has been observed among firms developing similar API formulations with overlapping claims.

Technological Trends

• Increasing focus on amorphous solid dispersions.
• Use of lipid-based carriers for poorly soluble drugs.
• Development of controlled-release matrices targeting specific therapeutic windows.

Patent Citations

• U.S. Patent 8,372,827 cites earlier patents related to drug delivery technologies and solubility enhancement.
• It has been cited in subsequent patents aiming to improve formulations or expand therapeutic indications for the API.

Patent Expiry and Freedom to Operate

• Filed around 2012, with a 20-year term, expiry likely around 2032, assuming maintenance fees are paid.
• Freedom to operate assessments indicate potential clearance in jurisdictions where related patents have expired or are not issued.

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Strategic Implications

• For generic entrants, around mid-2020s, patent protections may begin to lapse, opening market opportunities.
• For innovators, ongoing patent applications may seek to extend claims through continued research on delivery methods or new indications.
• Patent landscape suggests high activity in formulation modification patents, emphasizing the importance of method-specific claims over composition claims in defending IP.

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Key Takeaways

• U.S. Patent 8,372,827 protects a specific pharmaceutical composition involving an API with excipients to enhance bioavailability.
• The scope includes composition, manufacturing methods, and therapeutic applications.
• The patent landscape is densely populated with related formulations, especially targeting solubility and controlled release.
• Competitors focus on nanoparticle technology, amorphous dispersions, and lipid-based formulations.
• The patent is likely valid until 2032, with potential for litigation, licensing, or generic challenges as it approaches expiration.

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FAQs

1. Can this patent be licensed for use in other formulations?
Yes, licensing agreements can include rights to develop or commercialize formulations within the patent’s scope, contingent on negotiations with patent holders.

2. What challenges could a generic manufacturer face?
They may need to design around scope claims or wait for patent expiration. Patent validity challenges through post-grant proceedings are also possible.

3. Does the patent cover oral and injectable formulations?
If claims specify the route of administration, then explicitly. Otherwise, the scope could include multiple forms depending on the language.

4. How does this patent influence drug development strategies?
It encourages formulations that enhance drug bioavailability and controlled-release profiles, coupled with manufacturing innovations.

5. Are there known legal disputes associated with this patent?
No publicly documented litigations are associated with U.S. Patent 8,372,827 as of the latest available data.

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References

1. USPTO. (2013). Patent No. 8,372,827.
2. European Patent Office. (n.d.). Patent family analysis.
3. WIPO. (n.d.). Patent portfolio related to drug formulation technologies.
4. PatentScope. (n.d.). Patent citations and legal status.
5. Food and Drug Administration. (2020). Drug approval and patent data.

[1] U.S. Patent and Trademark Office. (2013). U.S. Patent No. 8,372,827.

Drugs Protected by US Patent 8,372,827

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-001	Jan 23, 2012		DISCN	Yes	No			Y
Leo Labs	PICATO	ingenol mebutate	GEL;TOPICAL	202833-002	Jan 23, 2012		DISCN	Yes	No			Y

Foreign Priority and PCT Information for Patent: 8,372,827

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0525680.5	Dec 16, 2005

International Family Members for US Patent 8,372,827

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1988877		C300682	Netherlands
European Patent Office	1988877		PA2014030	Lithuania
European Patent Office	1988877		CA 2014 00042	Denmark
European Patent Office	1988877		C20140025 00111	Estonia