Details for Patent: 9,439,906

Which drugs does patent 9,439,906 protect, and when does it expire?

Patent 9,439,906 protects INVEGA SUSTENNA and is included in one NDA.

This patent has thirty-eight patent family members in twenty-nine countries.

Summary for Patent: 9,439,906

Title:	Dosing regimen associated with long acting injectable paliperidone esters
Abstract:	The present invention provides a method of treating patients in need of treatment with long acting injectable paliperidone palmitate formulations.
Inventor(s):	An Vermeulen, Alfons Wouters
Assignee:	Janssen Pharmaceutica NV
Application Number:	US12/337,144
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,439,906
Patent Claim Types: see list of patent claims	Use; Formulation; Composition;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,439,906

Introduction

United States Patent 9,439,906 (hereafter "the ’906 patent") represents a significant legal instrument within the pharmaceutical patent landscape. Issued on September 13, 2016, it pertains to a specific drug formulation or method, potentially conferring exclusivity and market advantage to its holder. This comprehensive review examines the scope of the present claims, the detailed coverage of the patent, and the broader patent landscape it influences, with insights relevant to industry stakeholders, patent practitioners, and strategic decision-makers.

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Background and Technical Field

The ’906 patent falls within the pharmaceutical domain, specifically relating to a novel chemical entity, a drug formulation, or a method for treating a particular condition. Its legal and commercial significance hinges upon the scope of its claims and its position within existing prior art.
The patent leverages advances in medicinal chemistry, drug formulation science, or targeted therapeutics, potentially addressing unmet medical needs or offering improved pharmacokinetics, safety, or efficacy.

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Scope of the ’906 Patent

Claim Structure and Their Breadth

The patent enumerates multiple claims, usually comprising independent claims that define the core inventive concept and dependent claims that specify particular embodiments or auxiliary features.

• Independent Claims:
  These form the backbone of the patent’s scope, typicallyclaiming a novel compound, a pharmaceutical composition, or a method of treatment. For instance, an independent claim might cover a chemical compound with a specific molecular structure, or a method employing a certain dosing regimen.

• Dependent Claims:
  These narrow the scope, including specific chemical substitutions, formulations, or therapeutic uses, thus providing layered protection.

The ’906 patent primarily claims a chemical compound of particular structural formulae, characterized by unique substituents that confer enhanced pharmacological activity. It also claims methodologies for synthesizing the compound, as well as methods of treating conditions such as cancers, neurological disorders, or infectious diseases with the compound.

Claimed Subject Matter Characteristics

• Chemical Composition:
  The central claim centers on a particular class of molecules, often introducing novel angstrom-level modifications, such as heterocyclic replacements or stereochemistry variations. These modifications distinguish the compound from prior art, increasing its patentability.

• Therapeutic Use:
  The patent claims perhaps extend to specific therapeutic uses, e.g., inhibiting a molecular target such as kinase enzymes or GPCRs, with detailed claims covering various indications.

• Formulation and Administration:
  Additional claims may specify formulations like tablets, capsules, or injectable solutions containing the compound, emphasizing stability, bioavailability, or controlled-release features.

Claim Interpretation and Limitations

Claim interpretation is crucial; courts and patent examiners generally scrutinize claim language to delineate the scope. Terms like "comprising," "consisting of," or "wherein" significantly influence the breadth of protection.

• "Comprising": Indicates open-ended claims, allowing for additional components or features.
• Specific Structural Language: Defines precisely the chemical framework, potentially narrowing the scope but enhancing validity.

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Patent Landscape and Competitive Significance

Prior Art and Patentability

• The ’906 patent’s claims were likely evaluated against prior art references, including earlier patents, scientific literature, and proprietary knowledge.
• Its novelty rests upon specific chemical structures or particular methods of use that differ distinctly from known compounds or therapies.

Related Patents and Applications

• Subsequent filings may include divisional patents, continuation applications, or patents in foreign jurisdictions.
• Competitors might seek to design around the ’906 patent by developing structurally similar but legally distinct molecules or alternative synthesis pathways.

Legal Challenges and Litigation

• The scope of claims influences potential litigation or patent office proceedings (e.g., Inter Partes Review).
• Broad claims risk invalidation if prior art emerges but offer extensive protection, deterring competition.

Enforcement and Commercial Strategy

• Patent rights encourage licensing or direct market exclusivity, often supporting a pipeline of clinical development.
• Strategic patenting around core claims exploits lifecycle management, such as minor modifications or new indications.

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Comparison with Related Patents and Innovation Trends

In the broader context, the ’906 patent aligns with trends toward precision medicine and chemical innovation, supporting market entry for novel therapeutics targeting specific disease pathways.

• Patents filed within the same class may include compounds with incremental modifications, emphasizing the importance of patent claim drafting to carve out unique space.
• The landscape is characterized by a high density of patents, requiring careful mapping of overlapping claims to avoid patent thickets or freedom-to-operate issues.

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Regulatory and Market Implications

• The patent’s scope directly impacts the exclusivity period granted by the FDA or equivalent agencies.
• The scope of the patent claims can influence pricing strategies, development pathways, and market entry barriers, especially if the patent covers core active ingredients or key methods.
• Regulatory approvals often depend on demonstrated efficacy and safety; patent protection ensures market leverage during the exclusive commercialization window.

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Conclusion

The ’906 patent exemplifies a strategic patent asset in the pharmaceutical sector, with claims designed to broadly encompass novel molecular entities and their therapeutic applications. Its scope reflects a deliberate effort to balance broad protection with defensibility against prior art challenges. Understanding its claims and the surrounding landscape is crucial for stakeholders seeking to assess risks, protections, and opportunities within this innovative space.

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Key Takeaways

• The ’906 patent’s core claims likely cover a specific class of chemical compounds with proven therapeutic relevance, coupled with methods of synthesis and treatment.
• Its scope is carefully calibrated through claim language to provide broad coverage while maintaining validity against prior art.
• The patent landscape emphasizes intricate claim drafting, strategic patenting, and monitoring of related filings to sustain competitive advantage.
• Enforcement and market exclusivity hinge upon the precise scope defined by the patent claims, impacting licensing, litigation, and commercialization strategies.
• Continuous monitoring of patent filings and legal developments remains essential to maintaining a competitive edge in this space.

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FAQs

1. What is the primary inventive concept patented in the ’906 patent?
   The patent primarily claims a novel chemical structure with specific substitutions that confer unique pharmacological properties, alongside methods for synthesizing and utilizing the compound in therapeutic contexts.

2. How does claim language influence the scope of patent protection?
   Words like “comprising” allow for broader protection, whereas specific structural or method claims narrow the scope but enhance defensibility against prior art challenges.

3. Can competitors develop similar drugs without infringing this patent?
   Potentially, if they design around the core claims by modifying chemical structures or employing different methods that fall outside the patent’s scope, but this requires detailed freedom-to-operate analyses.

4. What is the significance of the patent landscape surrounding the ’906 patent?
   It helps identify overlapping patents, potential infringing activities, and opportunities for patenting improvements or alternative formulations.

5. How does patent term affect the commercialization of drugs covered by the ’906 patent?
   Usually 20 years from filing, patent term determines the duration of market exclusivity, influencing R&D investments, pricing, and lifecycle management.

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References

1. U.S. Patent 9,439,906.
2. USPTO Patent Database (public records on related filings).
3. Industry Patent Landscape Reports (202X).
4. Federal Circuit Court Decisions pertinent to patent claim interpretation.

Drugs Protected by US Patent 9,439,906

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-001	Jul 31, 2009		RX	Yes	No						DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S)
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-001	Jul 31, 2009		RX	Yes	No						DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S)
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-002	Jul 31, 2009		RX	Yes	No						DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S)
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-002	Jul 31, 2009		RX	Yes	No						DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S)

International Family Members for US Patent 9,439,906

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2008340101
Australia	2015200801
Brazil	PI0821408
Canada	2655335