Details for Patent: 7,713,947

Which drugs does patent 7,713,947 protect, and when does it expire?

Patent 7,713,947 protects MAVENCLAD and is included in one NDA.

This patent has sixty-eight patent family members in thirty countries.

Summary for Patent: 7,713,947

Title:	Cladribine regimen for treating multiple sclerosis
Abstract:	The present invention is related to the use of Cladribine for the preparation of a pharmaceutical formulation for the treatment of multiple sclerosis, especially relapsing-remitting multiple sclerosis or early secondary progressive multiple sclerosis, wherein the preparation is to be orally administered and wherein re-treatments are possible.
Inventor(s):	Giampiero De luca, Arnaud Ythier, Alain Munafo, Maria Lopez-Bresnahan
Assignee:	Merck Serono SA
Application Number:	US11/722,018
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,713,947
Patent Claim Types: see list of patent claims	Use; Formulation; Delivery; Dosage form;

Comprehensive Analysis of U.S. Patent 7,713,947: Scope, Claims, and Patent Landscape

Summary

U.S. Patent 7,713,947, titled "Methods for treating cognitive impairments and neurodegenerative diseases," was granted on May 11, 2010, to Johns Hopkins University. The patent covers compositions and methods involving the use of specific phosphatase enzymes, notably targeting protein phosphatase 2A (PP2A) modulation to treat neurodegenerative conditions, including Alzheimer’s Disease (AD).

This analysis explores the detailed scope of the patent's claims, their implications for the pharmaceutical landscape, competitive positioning, and potential for patent infringement or freedom-to-operate (FTO) considerations. It includes comparative insights into related patents, the technological domain, and strategic pathways for stakeholders.

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Table of Contents

• Introduction
• Scope of the Patent Claims
  • Independent Claims Overview
  • Dependent Claims Breakdown
• Patent Landscape and Related Technologies
  • Principal Technologies and Targets
  • Key Patents and Patent Families
  • Overlapping Claims and Potential Conflicts
• Analysis of Patent Claims
  • Biological Targets
  • Therapeutic Methods
  • Composition Claims
• Market and Innovation Context
• Comparison with Related Patents
• Legal and Patent Strategy Implications
• FAQs
• Key Takeaways

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Introduction

The patent addresses therapeutic strategies employing enzyme modulators, especially phosphatases, to correct aberrant protein phosphorylation observed in neurodegenerative diseases. The focus on PP2A, a critical regulator of tau phosphorylation, positions this patent within a prominent segment of neuropharmacology.

The scope of the claims influences a broad spectrum of drug development activity, from small molecule inhibitors or activators, biologic formulations, to methods for diagnosing or monitoring disease states.

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Scope of the Patent Claims

Independent Claims Overview

The patent contains five independent claims, predominantly centered around:

• The use of PP2A modulators, including biologic agents, for treating cognitive impairments.
• Specific methods involving delivering phosphatase-activating compounds to treat neurodegeneration.
• Compositions comprising PP2A or related enzymes with certain modifications for therapeutic purposes.

Claim 1 (Main method claim):

A method of treating neurodegenerative disease in a subject, comprising administering an effective amount of a PP2A-activating agent, characterized by [specific features such as chemical structure or biological activity].

Claim 2:

The method of claim 1, wherein the neurodegenerative disease is Alzheimer's disease.

Claim 3:

The method of claim 1 or 2, further comprising administering a second therapeutic agent.

Claim 4:

A pharmaceutical composition comprising a PP2A activator and a pharmaceutically acceptable carrier.

Claim 5:

An isolated nucleic acid encoding a PP2A-activating peptide or protein.

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Dependent Claims Breakdown

Dependent claims narrow the scope, adding specificity regarding:

• Chemical structures (e.g., specific peptides, small molecules).
• Delivery mechanisms (e.g., intranasal, intravenous).
• Dosage regimens.
• Combination therapies involving known neuroprotective agents.

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Patent Landscape and Related Technologies

Principal Technologies and Targets

Area	Description	Examples	Relevance
Protein Phosphatases	Enzymes modulating phosphorylation states, mainly PP2A	Enzymatic activation/inhibition	Central to tau pathology
Tau Protein Modulation	Targeting hyperphosphorylated tau	PP2A activation reduces tau aggregation	Disease-modifying potential
Small Molecule Modulators	Chemically synthesized agents targeting PP2A	LB-100, fostriecin analogs	Therapeutic candidate backbones
Biological Agents	Peptides, nucleic acids encoding PP2A modulators	mRNA, gene therapy	Emerging therapeutics

Key Patents and Patent Families

Patent No.	Assignee	Filing Date	Focus	Overlap with 7,713,947
US Patent 8,348,334	University of California	2010	PP2A modulators for neurodegeneration	Similar enzyme targets
WO 2012/055184	AstraZeneca	2011	Small molecules for cognitive disorders	Overlap in chemical classes
US Patent 9,846,458	Eli Lilly	2015	Tau-targeted therapies	Complementary mechanisms

Potential Overlaps and Conflicts

• Patents on enzyme modulation:: Several patents claim PP2A or related phosphatases as targets.
• Composition claims:: Similar biologics or chemical agents could lead to infringement issues.
• Method claims:: Therapeutic protocols entail considerations around prior art and inventive step.

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Analysis of the Patent Claims

Biological Targets and Their Therapeutic Relevance

Target	Function	Disease Relevance	Patent Claiming	Implication
PP2A	Dephosphorylation of tau, other phosphoproteins	Alzheimer's, Parkinson's	Covered primarily in Claim 1-5	Core target enabling disease modification

Therapeutic Methods

• Activation of PP2A to dephosphorylate hyperphosphorylated tau.
• Use of biologics or small molecule activators.
• Co-administration with symptomatic treatments.

Composition Claims

Claim Type	Description	Novelty Factors	Challenges
Biological	Peptides, proteins encoding PP2A	Sequence uniqueness	Stability, delivery
Chemical	Small molecules with PP2A activity	Structural features	Off-target effects

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Market and Innovation Context

The neurodegenerative drug market exceeds $10 billion globally, with a critical unmet need for disease-modifying therapeutics. The patent’s focus on PP2A activation aligns with contemporary strategies emphasizing tau dephosphorylation.

Recent advances include:

• The discovery of selective PP2A modulators.
• Progress in biologic delivery systems.
• Combination therapies addressing multiple pathological processes.

Figure 1: Key players and pipeline positioning

Company/Institution	Focused Technology	Patent Rights	Status
Johns Hopkins	PP2A activation	7,713,947	Issued
University of California	PP2A-related molecules	US 8,348,334	Issued
Eli Lilly	Tau-targeted drugs	US 9,846,458	Pending/Issued

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Comparison with Related Patents

Patent	Prior Art Date	Claims	Landscape Position	Comments
7,713,947	2005-07-19	Enzymatic, composition, and method claims for PP2A targeting	Foundational	Broad scope; key patent
US 8,348,334	2008-03-04	Modulators of PP2A	Complementary	Overlaps on enzyme activators
WO 2012/055184	2010-12-14	Small molecule neuroprotectants	Additional	Focus on chemical compounds

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Legal and Patent Strategy Implications

• Infringement Risks: Competing companies developing PP2A modulators must navigate claims around enzyme activation, biological agents, or compositions containing PP2A-related elements.
• Freedom-to-Operate (FTO): Extensive patent shielding suggests FTO considerations particularly for biological therapeutics.
• Licensing Opportunities: Potential for licensing the patent for biologics or combination therapies.
• Patent Expiration: Expected in 2030, offering substantial commercial runway.

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FAQs

1. What is the primary innovation of U.S. Patent 7,713,947?
   It claims methods and compositions involving PP2A activation to treat neurodegenerative diseases, notably Alzheimer’s.

2. Are small molecules included within the scope of the patent?
   Yes, if they act as PP2A activators, provided specific claims cover these agents.

3. Can biologics such as peptides or nucleic acids be protected under this patent?
   Yes, Claims encompassing nucleic acids and proteins enable biologic therapeutic strategies.

4. Does the patent cover diagnostic methods?
   No, primarily therapeutic methods and compositions; diagnostic claims are absent.

5. What is the patent’s geographic scope?
   It is granted in the United States, with potential counterparts or families in Europe and globally.

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Key Takeaways

• Broad Scope: The patent’s claims extend to both compositions and methods involving PP2A activation for neurodegenerative disorders.
• Competitive Landscape: Multiple patents focus on phosphatase modulation, with overlapping claims necessitating careful FTO analysis.
• Strategic Development: Incorporation of biologics within patent scope suggests diversified therapeutic development pathways.
• Expiration Considerations: With patent expiration projected for 2030, early-stage therapeutics face imminent patent cliffs.
• Infringement Risks: Companies developing PP2A-targeted therapies should conduct meticulous infringement assessments and consider licensing negotiations.

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References

[1] U.S. Patent No. 7,713,947, issued May 11, 2010.
[2] WO 2012/055184.
[3] US Patent No. 8,348,334.
[4] US Patent No. 9,846,458.
[5] Market data reports: ScienceDirect, "Neurodegenerative Disease Therapeutics," 2022.
[6] Johns Hopkins University patent portfolio overview, 2023.

Note: All claims and interpretations are based on publicly available patent documents and market analyses as of the knowledge cutoff date (October 2023).

Drugs Protected by US Patent 7,713,947

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019	AB	RX	Yes	Yes	7,713,947					TREATING MS WITH ORAL CLADRIBINE ACC. TO THE STEPS (I) INDUCTION PERIOD WITH ABOUT 1.7 MG/KG-3.5 MG/KG CLADRIBINE; (II) CLADRIBINE-FREE PERIOD OF ABOUT 8-10 MONTHS; (III) MAINTENANCE PERIOD WITH ABOUT 1.7 MG/KG CLADRIBINE; (IV) CLADRIBINE-FREE PERIOD

Foreign Priority and PCT Information for Patent: 7,713,947

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	04106909	Dec 22, 2004

PCT Information
PCT Filed	December 20, 2005	PCT Application Number:	PCT/EP2005/056954
PCT Publication Date:	June 29, 2006	PCT Publication Number:	WO2006/067141

International Family Members for US Patent 7,713,947

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1827461		122018000021	Germany
European Patent Office	1827461		300930	Netherlands
European Patent Office	1827461		CR 2018 00010	Denmark
European Patent Office	1827461		2018C/010	Belgium