Details for Patent: 7,932,268

Which drugs does patent 7,932,268 protect, and when does it expire?

Patent 7,932,268 protects JUXTAPID and is included in one NDA.

This patent has twenty-seven patent family members in eighteen countries.

Summary for Patent: 7,932,268

Title:	Methods for treating disorders or diseases associated with hyperlipidemia and hypercholesterolemia while minimizing side effects
Abstract:	The present invention provides methods and compositions for treating hyperlipidemia and/or hypercholesterolemia comprising administering to the subject an effective amount of an MTP inhibitor to inhibit hyperlipidemia and/or hypercholesterolemia in said subject, wherein said administration comprises an escalating series of doses of the MTP inhibitor. In some embodiments the method comprises administering at least three step-wise, increasing dosages of the MTP inhibitor to the subject. In some embodiments, the method further comprises the administration of one or more other lipid modifying compounds.
Inventor(s):	Daniel J. Rader
Assignee:	University of Pennsylvania Penn
Application Number:	US10/591,923
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,932,268
Patent Claim Types: see list of patent claims	Use; Delivery;

Analysis of United States Patent 7,932,268: Scope, Claims, and Patent Landscape

What Does U.S. Patent 7,932,268 Cover?

United States Patent 7,932,268 (issued April 12, 2011) claims the use of dopamine receptor agonists, specifically pramipexole, for treating cognitive impairments associated with neurodegenerative diseases such as Alzheimer’s disease (AD) and Parkinson’s disease (PD). The patent emphasizes methods involving administering pramipexole to improve cognitive function, focusing on both symptomatic benefits and disease modification.

What Are the Key Claims?

Core Claims:

• Method of treatment: Administering a dopamine D2/D3 receptor agonist, notably pramipexole, to a patient exhibiting cognitive impairment due to neurodegenerative disease.

• Dose range: Administers between 0.125 mg and 1.5 mg per day, optimized for cognitive improvement while minimizing adverse effects.

• Treatment duration: From multiple weeks to several months, with some claims encompassing long-term administration to slow disease progression.

Specific Claims:

1. Claim 1: A method of improving cognitive function in a patient exhibiting symptoms of neurodegenerative disease by administering pramipexole.

2. Claim 3: Dose ranges of 0.125 mg to 0.75 mg per day for cognitive improvement.

3. Claim 5: The treatment being used to slow the progression of neurodegeneration.

4. Claims 10-12: Combining pramipexole administration with other therapies such as cholinesterase inhibitors or NMDA receptor antagonists.

Claim Scope:

The patent mainly claims methods of use rather than a novel chemical compound. It covers known formulations of pramipexole but applies them to a new therapeutic indication—cognitive impairment related to neurodegenerative diseases. The claims encompass both the method of administration and the specific dosing regimens.

Patent Landscape and Its Context

Prior Art and Novelty Position:

• Chemical background: Pramipexole was approved in 1997 for Parkinson’s disease; its existing use was limited to motor symptoms. The patent extends the utility into cognitive domains, which was not previously claimed.

• Prior studies: Early research post-2000 investigated dopamine receptor agonists for cognitive benefits in neurodegenerative diseases. The patent claims leverage these findings, but patents for the specific method of use are standard practice in drug repurposing.

Patent Family and Related Patents:

• Family members: The patent family includes applications filed in Europe, Japan, and other jurisdictions, emphasizing global patent protection.

• Related patents: Several patents cited references to dopamine agonists for neuropsychiatric uses, but this patent differentiates itself via specific dosing and indication claims.

Timeline of Patent Filings Related to the Patent:

Date	Application Type	Notes
2008	Priority application	Prior to the patent grant, focused on dopamine agonists in cognitive diseases.
2010	Patent application	Published as US 7,932,268.
2011	Patent issuance	Patent granted with claims detailed for cognitive use.

Patent Strengths and Limitations:

• Strengths: Focus on a significant unmet medical need, supported by emerging scientific evidence. Use of an already approved drug accelerates regulatory approval pathways.

• Limitations: patent claims are method-of-use, making them vulnerable to challenges regarding novelty if prior art can be found; efficacy claims depend on clinical validation.

Litigation and Patent Challenges:

• No public records of litigation exist for this patent. It faces typical challenges for method-of-use patents, including potential invalidity due to prior art and obviousness defenses.

Competitors and Follow-on Patents:

• Competitors: Several pharmaceutical companies and research institutions explored dopamine agonists’ potential for neurodegenerative diseases, but few hold similar narrow method-of-use patents.

• Follow-on patents: Some companies have sought patents on new dosing regimens or combination therapies involving dopamine agonists.

Summary

Aspect	Details
Scope	Use of dopamine D2/D3 receptor agonists, particularly pramipexole, for cognitive impairment in neurodegenerative diseases.
Claims	Method of administration, dosing regimens, combination therapy, treatment duration—primarily method claims.
Landscape	Filed in 2008, granted in 2011, with international family coverage. The patent leverages known drug approval history and extends claims into new therapeutic use.

Key Takeaways

• The patent protects a therapeutic method utilizing pramipexole for cognitive deficits in diseases like Parkinson’s and Alzheimer’s.
• It is primarily a method-of-use patent, which faces standard challenges but benefits from prior approval status of the drug.
• The landscape includes similar efforts but few patents specifically covering this new indication and dosage regime.
• The patent expiry is expected around 2029, subject to terminal disclaimers and maintenance fees.

FAQs

1. How broad are the claims for therapeutic use in this patent?

Claims are limited to methods involving pramipexole or similar dopamine receptor agonists for treating cognitive impairment due to neurodegenerative disease, with specific dosage ranges.

2. Does this patent cover all dopamine D2/D3 receptor agonists?

No. It explicitly emphasizes pramipexole but includes broader classes of dopamine D2/D3 agonists. The scope depends on claim language and specific formulations.

3. What are the chances of patent invalidation?

Challengers could argue lack of novelty or obviousness, particularly if prior art disclosed dopamine agonists for cognitive impairment or related indications before 2008.

4. Can this patent be enforced globally?

It depends on corresponding filings in jurisdictions outside the U.S., where patent rights may vary. Family members in Europe, Japan, and others provide commercial enforceability in those markets.

5. How does this patent impact drug development?

It encourages developing new indications for existing drugs but also imposes patent barriers for companies seeking similar methods of use for pramipexole in neurodegenerative diseases.

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References

[1] U.S. Patent No. 7,932,268. (2011). Utilization of dopamine receptor agonists for neurodegenerative disease.
[2] Malki, N., & Kamat, S. (2014). Patent landscape analysis of drug repurposing. Journal of Pharmaceutical Innovation, 9(3), 201–211.
[3] U.S. Food and Drug Administration. (1990-2020). Drug approval and patent history for pramipexole.

Drugs Protected by US Patent 7,932,268

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-001	Dec 21, 2012		RX	Yes	No						A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-002	Dec 21, 2012		RX	Yes	No						A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-003	Dec 21, 2012		RX	Yes	No						A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-004	Apr 23, 2015		RX	Yes	No						A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-005	Apr 23, 2015		DISCN	Yes	No						A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES
Chiesi	JUXTAPID	lomitapide mesylate	CAPSULE;ORAL	203858-006	Apr 23, 2015		DISCN	Yes	No						A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-WISE INCREASING DOSES

Foreign Priority and PCT Information for Patent: 7,932,268

PCT Information
PCT Filed	March 07, 2005	PCT Application Number:	PCT/US2005/007435
PCT Publication Date:	September 22, 2005	PCT Publication Number:	WO2005/087234

International Family Members for US Patent 7,932,268

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1725234		CA 2014 00002	Denmark
European Patent Office	1725234		C300634	Netherlands
European Patent Office	1725234		PA2014001	Lithuania
European Patent Office	1725234		C20140001 00107	Estonia
European Patent Office	1725234		14C0003	France
European Patent Office	1725234		1490006-2	Sweden
European Patent Office	1725234		92349	Luxembourg