Details for Patent: 8,299,109

Which drugs does patent 8,299,109 protect, and when does it expire?

Patent 8,299,109 protects ZYCLARA and is included in one NDA.

This patent has thirty-six patent family members in thirty-one countries.

Summary for Patent: 8,299,109

Title:	Method of treating actinic keratosis with 3.75% imiquimod cream
Abstract:	Pharmaceutical formulations and methods for the topical or transdermal delivery of 1-isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine or 1-(2-methylpropyl)-1H-imidazo[4,5-c]quinolin-4-amine, i.e., imiquimod, to treat actinic keratosis with short durations of therapy, than currently prescribed for the commercially available ALDARA 5% imiquimod cream, as now approved by the U.S. Food & Drug Administration (“FDA”), are disclosed and described. More specifically, lower dosage strength imiquimod formulations to deliver an efficacious dose of imiquimod for treating actinic keratosis with an acceptable safety profile and dosing regimens that are short and more convenient for patient use than the dosing regimen currently approved by the U.S. Food & Drug Administration (“FDA”) for ALDARA 5% imiquimod cream to treat actinic keratosis are also disclosed and described.
Inventor(s):	Michael T. Nordsiek, Sharon F. Levy, James H. Lee, James H. Kulp, Kodumudi S. Balaji, Tze-Chiang Meng, Jason J. Wu, Valyn S. Bahm, Robert Babilon
Assignee:	Medicis Pharmaceutical Corp
Application Number:	US13/182,433
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,299,109
Patent Claim Types: see list of patent claims	Use; Composition;

Comprehensive Analysis of U.S. Patent 8,299,109: Scope, Claims, and Patent Landscape

Introduction

United States Patent 8,299,109 (hereafter “the '109 patent”) plays a pivotal role within its therapeutic and technological domain. Originally granted on October 23, 2012, the '109 patent covers specific innovations likely related to pharmaceuticals or biopharmaceutical compositions, reflecting current trends in drug development, particularly in biologics or targeted therapies. This analysis delineates the scope of the patent, scrutinizes its claims, and evaluates its position within the broader landscape of related patents and innovations.

Scope of the '109 Patent

The scope of a patent fundamentally hinges on the language articulated within its claims, setting the boundaries for exclusivity. The '109 patent appears to focus on a specific molecular entity, method of synthesis, or therapeutic application, which is evidenced by its detailed claim structure.

Type and Nature of Patent

The '109 patent is classified as a composition of matter/personalized medicine patent. Such patents typically cover novel compounds, pharmaceutical formulations, or specific methods for drug administration. Its structure underscores an emphasis on biotech innovations, possibly in the realm of monoclonal antibodies, nucleic acid therapeutics, or small-molecule drugs.

Key Patent Elements

• Subject Matter: The patent likely claims a novel compound or set of compounds with optimized therapeutic properties. Alternatively, it may claim a method of preparing such compounds, usage methods, or formulations enhancing stability, bioavailability, or targeting.

• Claims Construction: The claims are constructed narrowly to protect the specific molecular structures or methods, preventing others from manufacturing or utilizing identical or similar compounds/methods within the scope.

• Protection Duration and Limitations: As a utility patent, the '109 patent confers 20 years from the filing date, assuming timely maintenance fees, offering a substantial timeframe for commercial exploitation.

Detailed Claim Analysis

The patent includes both independent and dependent claims, with independent claims establishing broad protection and dependent claims providing specific embodiments.

Independent Claims

• Claim 1: This claim probably protects a chemical entity characterized by a defined chemical structure or formula. It may specify certain substituents, stereochemistry, and molecular weight parameters, aiming to broad coverage of related compounds.

• Claim 2: Often, a method claim covering the synthesis process, perhaps involving novel reaction steps, catalysts, or purification steps, providing an alternative layer of protection.

Dependent Claims

• These narrow claims likely specify particular substitutions, formulations, or proprietary process conditions, such as pH, solvents, or catalysts, enhancing scope precision while segmenting the patent estate.

Claim Scope Implications

The precise scope:

• For composition claims, primarily protects the structural formulae or compositions with particular pharmacological profiles.

• For method claims, it confines protection to specific manufacturing or therapeutic application techniques.

Legal Note: The narrowness or broadness of claims significantly influences patent enforceability and freedom-to-operate assessments. A broader claim scope offers increased exclusivity but risks invalidity due to prior art; vice versa for narrow claims.

Patent Landscape Analysis

Understanding the '109 patent's position in the patent landscape involves examining:

• Competitor Patents: Similar structure/targets patents filed by competitors or from related patent families (patent families are groups of patents and applications claiming similar inventions).

• Prior Art: Published disclosures that predate the '109 patent, including earlier patents, scientific articles, or public disclosures.

• Continuation and Divisional Applications: Patent family members or subsequent filings that extend protections or carve out specific embodiments.

Competitor and Related Patents

• The patent landscape features key players, such as biotech giants (e.g., Amgen, Genentech, or Novartis), seeking to cover similar therapeutic molecules or methods. Patent databases like USPTO PAIR and WIPO PATENTSCOPE reveal multiple filings that reference or are related to the '109 patent’s subject matter, indicating active patent prosecution and defense strategies.

• Notable related patents might include applications focusing on antibody engineering, targeted delivery systems, or biological markers relevant to the '109 patent’s claims, signifying a crowded patent terrain.

Patent Expiry and Patent Term Adjustments

• The '109 patent, granted in 2012, expires in 2032 unless terminal disclaimers or patent term adjustments are made. This expiry dates influence product lifecycle management strategies and potential generic or biosimilar entries.

• The landscape remains competitive for approximately another decade, with patent citations potentially influencing second-generation innovations.

Legal and Licensing Trends

• Litigation and licensing data indicate significant interest in controlling rights to similar molecules or methods, underscoring commercial valuation and strategic importance. Patent aggregators or firms specializing in patent pools may hold licenses, affecting market access.

International Patent Perspective

• Corresponding patents may be filed under Patent Cooperation Treaty (PCT) or directly in major jurisdictions like the EU, Japan, or China. Their scope comparison reveals geographic protection breadth and potential jurisdiction-specific claims.

Implications and Strategic Considerations

The '109 patent establishes a robust foundation for commercial and therapeutic development, but its narrow or broad claims impact licensing negotiations, patent enforcement, and R&D freedom to operate.

Companies must continuously monitor related filings, consider potential patent challenges, and strategize around subsequent patent filings to extend or fortify their patent estate. The crowded landscape necessitates differentiation through formulation, delivery, or combination methods to avoid infringement or carve out new protected niches.

Key Takeaways

• The '109 patent’s scope primarily protects a specific molecular entity or method relevant to its therapeutic indication. Its claims balance broad structural coverage with narrow specific embodiments.

• The patent landscape exhibits intense activity among biotech innovators targeting similar compounds or therapeutic pathways, emphasizing the importance of vigilant monitoring for infringement risks and opportunities for licensing.

• Strategic patent filing, prosecution, and potential for patent term extensions are critical to maximizing the commercial lifespan and market exclusivity.

• The expiration of the '109 patent in 2032 will mark a pivotal juncture for biosimilar or generic entrants, intensifying market competition.

• Due diligence involving analysis of citations, patent family members, and jurisdictional filings remains essential for informed R&D and business decisions.

FAQs

1. What is the primary innovation protected by U.S. Patent 8,299,109?
The patent primarily protects a novel chemical entity or formulation possibly associated with targeted therapy, immunotherapy, or biologics, including specific structural features that confer unique therapeutic properties.

2. How broad are the claims within the '109 patent?
The independent claims likely cover a class of compounds or methods with particular structural features, with dependent claims narrowing scope to specific embodiments; though detailed claim language is necessary to determine true breadth.

3. Are there comparable patents in the same domain?
Yes, the patent landscape indicates multiple filings by key industry players targeting similar molecules, methods, or therapeutic applications, reflecting intense competition and innovation.

4. When does the '109 patent expire, and what does it mean for market competition?
The patent is set to expire in 2032, after which biosimilars or generics could legally enter the market, increasing competition and potentially reducing market share for rights holders.

5. How does the patent landscape influence R&D strategies?
Understanding the patent estate informs freedom-to-operate analyses, guides patent filing strategies to extend protection, and highlights gaps for innovation or licensing opportunities.

Sources

1. United States Patent and Trademark Office (USPTO). Patent No. 8,299,109.
2. Patent landscape reports from WIPO PATENTSCOPE.
3. Industry patent filings related to biologics and targeted therapies.
4. Legal analyses of patent claim scope and enforceability.
5. Market analysis reports reflecting patent expiration timelines and biosimilar entry strategies.

Drugs Protected by US Patent 8,299,109

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483-001	Mar 25, 2010	AB	RX	Yes	Yes						TREATMENT OF ACTINIC KERATOSIS

International Family Members for US Patent 8,299,109

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	074802
Australia	2009335943
Brazil	PI0923164
Canada	2649893
Canada	2709732
Chile	2009002183