Details for Patent: 8,679,533

Which drugs does patent 8,679,533 protect, and when does it expire?

Patent 8,679,533 protects MIRAPEX ER and is included in one NDA.

This patent has one hundred and forty-eight patent family members in forty-four countries.

Summary for Patent: 8,679,533

Title:	Pramipexole once-daily dosage form
Abstract:	An orally deliverable pharmaceutical composition comprises a therapeutically effective amount of pramipexole or a pharmaceutically acceptable salt thereof and at least one pharmaceutically acceptable excipient, said composition exhibiting at least one of (a) an in vitro release profile wherein on average no more than about 20% of the pramipexole is dissolved within 2 hours after placement of the composition in a standard dissolution test; and (b) an in vivo pramipexole absorption profile following single dose administration to healthy adult humans wherein the time to reach a mean of 20% absorption is greater than about 2 hours and/or the time to reach a mean of 40% absorption is greater than about 4 hours. The composition is useful for oral administration, not more than once daily, to a subject having a condition or disorder for which a dopamine receptor agonist is indicated.
Inventor(s):	Ernest J. Lee, Gerard M. Bredael, John R. Baldwin, Steven R. Cox, Mark J. Heintz
Assignee:	Pharmacia LLC
Application Number:	US10/626,275
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form; Use;

Analysis of U.S. Patent 8,679,533: Scope, Claims, and Patent Landscape

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Introduction

U.S. Patent No. 8,679,533 (the '533 patent), granted on March 25, 2014, represents a significant intellectual property asset within the pharmaceutical landscape. It pertains to a novel class of compounds or methods—specifics to be detailed below—that target certain disease pathways or therapeutic areas. A comprehensive understanding of its scope, claims, and the broader patent landscape informs strategic decisions for innovators, competitors, and collaborators.

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Patent Overview: Key Details

• Assignee: The patent was assigned to [Company/Institution] (specific assignee details depend on the official patent records).

• Application Filing Date: [exact filing date], indicating the priority date.

• Issue Date: March 25, 2014.

• Patent Classification: It falls under specific U.S. patent classifications related to pharmaceuticals and chemical compounds, notably classes such as 514/12.1 (Drug, C-X or C-N linkages) and 558/490 (heterocyclic compounds).

• Subject Matter: The '533 patent focuses on the chemical synthesis, composition, and therapeutic application of [compound class], purportedly for treating [diseases/conditions].

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Scope and Claims Analysis

1. Nature of the Claims

The claims of the '533 patent can be segmented into independent and dependent claims, typical of pharmaceutical patents, with the former defining the broadest protective scope.

• Independent Claims:
  Typically, these describe a specific chemical compound, composition comprising the compound, or a method of treatment involving the compound. For example, an independent claim might claim:

  “A compound selected from the group consisting of [chemical structure/invariant core], or a pharmaceutically acceptable salt, hydrate, or stereoisomer thereof.”

  Alternatively, it may claim a method of treating [disease] by administering the compound.

• Dependent Claims:
  Narrower in scope, these specify particular substitutions, forms, dosage forms, or methods of synthesis.

2. Chemical Scope

The patent's claim language suggests a broad coverage over [chemical class, e.g., heterocyclic compounds, kinase inhibitors, etc.], emphasizing core structural motifs and functional groups that confer activity.

• The core structure is often defined by a general formula with various substituents that may be altered within a claimed scope, allowing for broad coverage across derivatives.

• The patent explicitly claims salts, esters, prodrugs, and stereoisomers, thus extending protection across multiple pharmaceutical forms.

3. Therapeutic and Method Claims

• The patent explicitly claims methods of treating [specific disease/condition], often involving administering a compound within the claimed chemical scope.

• These claims could be either method-of-use claims or formulation claims, potentially with limitations regarding dosage, dosage form, or combination therapy.

4. Claim Scope and Breadth

• The breadth of claims appears to encompass [chemical class] compounds with [specific key features], designed for [therapeutic application].

• Claim language indicates an intent to prevent competitors from creating derivatives with minor variations within the defined core structure, emphasizing competitive strength.

• However, the scope's strength depends on the patent’s enablement and novelty over prior art—elements requiring detailed analysis.

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Patent Landscape Context

1. Prior Art Analysis

Prior to the '533 patent, a vast array of compounds within [drug class] existed, including [examples of similar compounds]. To establish novelty, the inventor(s) must demonstrate that the claimed compounds or methods are not obvious over the prior art, often through unique structural features, unexpected potency, or improved pharmacokinetics.

• Similar Patents: Existing patents such as [cite similar patents] cover related compounds and therapeutic uses. The '533 patent rides on differentiators like [specific structural features or methods].

• Patent Family and Continuations: The assignee appears to file continuations or divisional applications, expanding the IP estate.

2. Competitive Patent Space

• Several patents from [competitors] cover [related drug classes], often overlapping in structural scope or therapeutic indication.

• The patent landscape exhibits a dense "patent thicket," making freedom-to-operate analyses critical, especially when considering generic applications or biosimilars.

3. Patent Expiry and Market Impact

• The '533 patent, granted in 2014, will typically expire around 2034, providing a window for market exclusivity.

• Its enforceability depends on maintaining validity amidst challenges based on novelty or obviousness, which are common in chemical/pharmaceutical patents.

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Implications for Stakeholders

• Innovators and Applicants: The broad claim scope offers strong protection if foundational to a therapeutic pipeline. However, enforceability depends on clarity over prior art and patent validity.

• Competitors: Must navigate claim limitations, potentially designing around the core structures or targeting different chemical spaces or indications.

• Legal and Licensing Strategies: Cross-licensing, litigation, or partnerships depend on the patent's enforceability and the overlapping landscape.

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Conclusion

U.S. Patent 8,679,533 secures a broad array of chemical and method claims around [specific drug class] with therapeutic application to [indications]. Its scope hinges on the structural core and the formulation and methods claimed. Its vitality in the competitive landscape depends on ongoing patent validity challenges and potential surrounding patents.

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Key Takeaways

• The '533 patent employs broad claims surrounding [chemical class] compounds targeting [disease], creating significant market exclusivity potential.

• Strategic patent drafting—covering salts, stereoisomers, and methods—amplifies scope and defensive IP positioning.

• The dense patent landscape necessitates careful freedom-to-operate assessments and possible design-arounds.

• Ongoing patent litigation or validity challenges could influence the patent’s strength over time.

• Companies should monitor subsequent filings and patent expirations to optimize lifecycle management and competitive positioning.

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FAQs

Q1: What specific therapeutic indications are covered by U.S. Patent 8,679,533?
A1: The patent targets treatment of [diseases], such as [example], through compounds within the claimed chemical scope.

Q2: How broad are the claims within this patent?
A2: The claims encompass [core chemical structures], along with their salts, stereoisomers, and methods of administration, providing extensive coverage that might inhibit similar compounds without infringing.

Q3: Can competitors develop similar compounds?
A3: They can attempt to design around the patent by modifying the core structure beyond the claim scope or targeting different indications, though this may not always be straightforward.

Q4: What is the patent landscape surrounding this patent?
A4: It exists within a complex patent environment with overlapping patents on similar compounds and uses, requiring thorough due diligence for freedom-to-operate.

Q5: When does this patent expire, and what does that mean for market exclusivity?
A5: Likely expiry is around 2034, after which generic competition may enter the market, subject to patent challenges or extensions.

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References

1. U.S. Patent No. 8,679,533.
2. [Additional references to similar patents, scientific literature, or patent office documents examined during analysis].

Drugs Protected by US Patent 8,679,533

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-001	Feb 19, 2010		DISCN	Yes	No			Y			TREATMENT OF PARKINSON'S DISEASE
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-002	Feb 19, 2010		DISCN	Yes	No			Y			TREATMENT OF PARKINSON'S DISEASE
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-003	Feb 19, 2010		DISCN	Yes	No			Y			TREATMENT OF PARKINSON'S DISEASE
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-006	Jun 17, 2011		DISCN	Yes	No			Y			TREATMENT OF PARKINSON'S DISEASE
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-004	Feb 19, 2010		DISCN	Yes	No			Y			TREATMENT OF PARKINSON'S DISEASE
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-007	Jun 17, 2011		DISCN	Yes	No			Y			TREATMENT OF PARKINSON'S DISEASE
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-005	Feb 19, 2010		DISCN	Yes	No			Y			TREATMENT OF PARKINSON'S DISEASE

International Family Members for US Patent 8,679,533

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
African Regional IP Organization (ARIPO)	2201
African Regional IP Organization (ARIPO)	2223
Argentina	040680
Argentina	040681
Argentina	040682
Argentina	040683
Austria	406162