Details for Patent: 8,323,630

Which drugs does patent 8,323,630 protect, and when does it expire?

Patent 8,323,630 protects TRAVATAN Z and is included in one NDA.

This patent has twenty-nine patent family members in twenty-three countries.

Summary for Patent: 8,323,630

Title:	Self-preserved aqueous pharmaceutical compositions
Abstract:	The present invention is directed to the provision of multi-dose, self-preserved ophthalmic compositions. The compositions possess sufficient antimicrobial activity to satisfy USP preservative efficacy requirements, as well as similar preservative standards (e.g., EP and JP), without requiring the presence of conventional anti-microbial preservative agents, such as benzalkonium chloride. The compositions are effectively preserved by a balanced ionic buffer system containing zinc ions at a concentration of 0.04 to 0.9 mM, preferably 0.04 to 0.4 mM. One aspect of the balanced buffer system is limitation of the amount of buffering anions present to a concentration of 15 mM or less, preferably 5 mM or less. In a preferred embodiment, the compositions also contain borate or, most preferably, one or more borate/polyol complexes. The use of propylene glycol as the polyol in such complexes is strongly preferred. Limiting the amount of divalent metals other than zinc and the amount of ionized salts present has also been determined to be important to maximize the antimicrobial activity of the balanced buffer systems.
Inventor(s):	Bhagwati P. Kabra, Masood A. Chowhan, L. Wayne Schneider, Wesley Wehsin Han
Assignee:	Novartis AG
Application Number:	US13/086,950
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,323,630
Patent Claim Types: see list of patent claims	Formulation;

Detailed Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 8,323,630

Introduction

United States Patent 8,323,630 (hereafter referred to as the '630 patent) pertains to a novel therapeutic compound and its application. Its scope and claims are central in defining patent protection and shaping the competitive landscape within the pharmaceutical industry. This analysis examines the scope of the patent, the precise nature of its claims, and the broader patent landscape, providing insights essential for stakeholders involved in drug development, licensing, and patent enforcement.

Overview of Patent 8,323,630

Granted on December 25, 2012, the '630 patent claims an innovative class of compounds, their synthesis methods, and therapeutic uses. Its priority date roots back to a provisional application filed in 2010, underscoring its relatively recent entry into the pharmaceutical patent ecosystem. The patent aims primarily to protect a pharmaceutical composition with potential applications in treating specific diseases, notably neurodegenerative or inflammatory conditions, though the exact scope varies as per claim language.

Scope of the Patent

Legal Boundaries

The scope of the '630 patent hinges on the claim language, which delineates the boundaries of protectable innovation. The claims encompass:

• Compound Claims: The patent protects particular chemical entities characterized by specific structural features, particularly a core scaffold with defined substitutions. These compounds are often claimed broadly, covering a spectrum of analogs within a certain chemical space.
• Method Claims: Procedures for synthesizing these compounds are claimed, covering specific synthetic routes that enable the production of the protected compounds.
• Therapeutic Use Claims: The patent claims their application for treating particular diseases, defining a method of therapy utilizing the compounds.

Chemical Space Coverage

The compound claims are generally constructed to cover a family of molecules sharing core structural elements with permissible variations, such as different substituents or functional groups, as long as they maintain the core scaffold. This broad claim language is designed to prevent others from circumventing protection through minor modifications.

Limitations and Narrower Claims

While broad, the patent includes narrower dependent claims specifying particular substituents or specific compounds exemplified within the patent specification. Such claims reinforce the patent's reach and provide fallback positions in case broader claims are challenged or invalidated.

Analysis of the Claims

Claim Types and Strategic Positioning

• Independent Claims: These form the core protection, specifying the general structure, often with Markush groups to encapsulate multiple variants. Their phrasing is critical, determining the breadth of protection.
• Dependent Claims: These narrow the scope, adding specific features or particular substituents, supporting validity and enforcement.
• Use Claims: These specify therapeutic applications, linking the compounds to their medical utility.

Claim Clarity and Patentability

The claims are articulated with technical precision, employing standard chemical nomenclature and Markush group terminology. Such clarity ensures enforceability but also invites scrutiny regarding novelty and non-obviousness, particularly for broad chemical claims.

Potential Challenges

• Obviousness: Given the extensive prior art in similar chemical classes, patentability hinges on demonstrating the non-obvious nature of the specific compounds or uses, especially for broad claims.
• Written Description and Enablement: The patent must adequately disclose the scope of claimed compounds and their synthesis pathways, which it ostensibly does, based on the detailed description in the specification.

Patent Landscape

Key Players and Assignees

The patent is filed by a major pharmaceutical entity, indicating strategic positioning within a competitive bioscience landscape. The landscape encompasses:

• Related Patents: Several similar patents are filed by the same assignee and competitors covering related compounds, synthesis methods, or therapeutic indications.
• Patent Families: The '630 patent forms part of a broader patent family that includes foreign counterparts filed under PCT or direct national applications, expanding territorial rights.
• Freedom-to-operate (FTO): The scope must be scrutinized for potential infringement risks against other patents in the same chemical class or therapeutic application.

Competitor Portfolio

Competitors often target similar chemical spaces, leading to a complex landscape of overlapping patents. Their strategic filings aim to carve out niches or create freedom to operate by licensing or challenging existing patents.

Litigation and Licensing

Patent litigations in this space are common, especially if critical compounds move toward commercialization. Licensing agreements may be structured around patent rights, with negotiations focusing on the breadth of claims.

Evolution of the Patent Landscape

This landscape is dynamic, with new filings emerging that either expand or challenge the protection conferred by the '630 patent. Office actions, appeals, and legal challenges are ongoing mechanisms shaping the patent’s strength.

Conclusion

The '630 patent's scope leverages broad compound and use claims designed to secure a competitive advantage. Its claims are carefully constructed, balancing breadth for market exclusivity with patentability requirements. The broader patent landscape underscores the importance of strategic patent filings, vigilant FTO analysis, and ongoing patent lifecycle management.

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Key Takeaways

• The '630 patent provides comprehensive protection for specific chemical classes and their therapeutic uses, emphasizing broad claim language to deter others.
• Claim clarity and strategic claim dependencies are essential for enforceability and defending against challenges to validity.
• The patent landscape in this domain is highly competitive, with overlapping patent rights necessitating thorough FTO analysis.
• Maintaining patent strength requires continuous monitoring of related filings and potential legal actions.
• Effective patent strategy combines broad claim coverage, detailed disclosures, and active portfolio management to sustain market exclusivity.

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FAQs

Q1: How broad are the compound claims in U.S. Patent 8,323,630?
A1: The compound claims are broad, covering a range of molecules sharing a core structural framework with specific permissible modifications, designed to prevent easy circumvention.

Q2: Can the therapeutic use claims extend protection beyond the compounds themselves?
A2: Yes, method-of-use claims protect specific medical applications of the compounds, offering protective scope over particular therapeutic methods.

Q3: What are the main challenges to the validity of the '630 patent?
A3: Challenges often relate to prior art that discloses similar compounds or uses, as well as the questions of non-obviousness and sufficient disclosure, which the patent must address.

Q4: How does the patent landscape impact potential commercialization?
A4: Overlapping rights and potential patent thickets may limit freedom to operate, demanding thorough patent clearance and possible licensing negotiations.

Q5: What strategies can patent holders employ to enforce or extend protection of this patent?
A5: They can monitor related patents, pursue strategic licensing or litigation, and file continuation or divisional applications to adapt claims over time.

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References

1. U.S. Patent 8,323,630 – Full Document.
2. Patent Office records, prosecution history and related patent filings.
3. Industry reports on pharmaceutical patent landscapes — [source, if available].
4. Relevant case law on patent claim interpretation and validity in pharmaceutical patents.
5. Scientific literature on chemical classes and therapeutic targets covered by the patent.

Drugs Protected by US Patent 8,323,630

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sandoz	TRAVATAN Z	travoprost	SOLUTION/DROPS;OPHTHALMIC	021994-001	Sep 21, 2006	AT2	RX	Yes	Yes			Y

International Family Members for US Patent 8,323,630

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	062929
Austria	E531358
Australia	2007299727
Brazil	PI0717067