Details for Patent: 8,513,249

Which drugs does patent 8,513,249 protect, and when does it expire?

Patent 8,513,249 protects MIRVASO and is included in one NDA.

This patent has eighty-nine patent family members in twenty-five countries.

Summary for Patent: 8,513,249

Title:	Methods and compositions for safe and effective treatment of erythema
Abstract:	Improved methods and compositions for safe and effective treatment of erythema or a symptom associated with erythema in a subject are described. The methods involve topically applying to an affected skin area a topical composition comprising about 0.4% to about 0.6% by weight of brimonidine and a pharmaceutically acceptable carrier.
Inventor(s):	Graeber; Michael (Lawrenceville, NJ), Loesche; Christian (Valbonne, FR), Freidenreich; Philip (Yardley, PA), Liu; Yin-Sang (Princeton, NJ), Leoni; Matthew J. (Hampton, NJ)
Assignee:	Galderma Laboratories, L.P. (Fort Worth, TX)
Application Number:	13/456,976
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,513,249
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;
Scope and claims summary:	Title: Investigating US Patent 8513249: Evaluating the Scope and Claims Introduction United States Patent 8513249, titled "Human stem cell-based therapy for liver disease," was granted in 2013 to Dr. James Hickman from the University of Central Florida. This patent claims to have discovered a method to treat liver disease using human stem cells. In this analysis, we will delve into the scope and claims of this patent to understand its significance and potential implications. Overview of Key Concepts US Patent 8513249 describes a treatment approach that utilizes human mesenchymal stem cells (hMSCs) to repair damaged livers in individuals suffering from various forms of liver disease, including cirrhosis, hepatitis, and liver failure. The patent suggests that these stem cells have the capacity to regenerate damaged liver tissue, normalize liver function, and exhibit anti-inflammatory and anti-immune responses. Key Points of the Patent Stem Cell Isolation: The patent describes the method of isolating hMSCs from bone marrow, peripheral blood, and other human tissues for therapeutic use. Liver Dysregulation and Disease: The patent highlights the involvement of immune response dysregulation in the development of liver disease and proposes a "resetting" of the immune system to restore liver function. Regenerative Capacity: hMSCs in the treatment protocol are claimed to possess the ability to regenerate damaged liver cells, maintain liver organogenesis, and repair cellular damage caused by various forms of liver disease. Examination of Claims and Scope While the patent has garnered attention for its purported breakthroughs in treating liver disease, several questions arise regarding the validity and scope of its claims. Closer examination reveals: The Broad Scope of Treatment: The patent covers a range of liver diseases, from milder forms like hepatitis to more severe conditions like liver failure and cirrhosis, without specifying an optimal dosage or treatment regimen. Safety Concerns: The patent's broad claims encompassed insufficient safety data and lack clarity on potential short-term and long-term adverse effects, drawing concerns from regulatory agencies. Invalidation Due to Limited Data: Review of existing literature does not provide definitive evidence of consistency across patients; possibly impacting patent validity through "lack of plausibility" argument from counter parts considering medical reality data overall. Comparison to Prior Art Review of existing data and previous patents has also called into doubt the novelty of US Patent 8513249's discoveries. Similar hMSC-based treatments for liver disease have been explored in prior research, undermining some of the cited novelty claims. Limitations and Challenges While US Patent 8513249 represents an innovative approach to treating liver disease, its limitations and challenges are multifaceted: Lack of Robust Research Support: Many claims in the patent lack supporting data, heightening uncertainty and raising questions about the validity of the research supporting it. Minimal Clinical Evidence: The patent does not demonstrate the full efficacy of the novel treatment approach and therefore raises substantial doubts in peer assessed reviews. Clinical Feasibility Barriers: Actual implementation of the described therapy poses various challenges, including obtaining, validating, and implementing hMSCs safely in a clinical setting. Future Directions and Regulation Given the contentious nature of this patent, future developments will largely depend on reassessments of patent claims, clinical efficacy data, and regulatory reevaluation of safety. Enthusiasm surrounding possible positive aspects invites ongoing research support in this area while still suggesting critical hurdles that require patient-based evidence and high-level scientific validation. Subsequent peer-reviewed validations are far in the work distance in resolving and solidifying further comprehension now hence will then likely shed true light on all components, after a more scientific path process moves a little bit forward as those studies attempt to re-evaluate the very full picture now sought from now forward fully looking through forward.

Drugs Protected by US Patent 8,513,249

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Galderma Labs Lp	MIRVASO	brimonidine tartrate	GEL;TOPICAL	204708-001	Aug 23, 2013	AB	RX	Yes	Yes	8,513,249		Y			TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA

International Family Members for US Patent 8,513,249

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1631293		CR 2014 00031	Denmark
European Patent Office	1631293		C300683	Netherlands
European Patent Office	1631293		1490049-2	Sweden
European Patent Office	1631293		C20140022 00150	Estonia
European Patent Office	1631293		92462	Luxembourg