Details for Patent: 7,763,615

Which drugs does patent 7,763,615 protect, and when does it expire?

Patent 7,763,615 protects ZEPZELCA and is included in one NDA.

This patent has thirty-two patent family members in twenty-three countries.

Summary for Patent: 7,763,615

Title:	Ecteinascidin analogs for use as antitumour agents
Abstract:	Derivatives of ecteinascidin 736 of general formula (I) wherein the groups R1, R2, R3, R4 and R5 are each independently selected from the group consisting of H, OH, OR′, SH, SR′, SOR′, SO2R′, C(═O)R′, C(═O)OR′, NO2, NH2, NHR′, N(R′)2, NHC(O)R′, CN, halogen, ═O, substituted or unsubstituted C1-C25 alkyl, substituted or unsubstituted C2-C18 alkenyl, substituted or unsubstituted C2-C18 alkynyl, substituted or unsubstituted aryl, substituted or unsubstituted heterocyclic; wherein X is independently selected of OR′, CN, (═O), or H; wherein each of the R′ groups is independently selected from the group consisting of H, OH, NO2, NH2, SH, CN, halogen, ═O, C(═O)H, C(═O)CH3, CO2H, substituted or unsubstituted C1-C25 alkyl, substituted or unsubstituted C2-C18 alkenyl, substituted or unsubstituted C2-C18 alkynyl, substituted or unsubstituted aryl; wherein m is 0, 1 or 2; and wherein n is 0, 1, 2, 3, or 4, and their use as antitumoral agent.
Inventor(s):	Pilar Gallego, Carmen Cuevas, Simon Munt, Ignacio Manzanares, Valentin Martinez
Assignee:	Pharmamar SA
Application Number:	US10/485,536
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,763,615
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 7,763,615

Introduction

U.S. Patent No. 7,763,615, granted on July 27, 2010, represents a significant intellectual property asset within the pharmaceutical landscape. It pertains to innovative formulations or methods associated with a specific drug or therapeutic area. A comprehensive understanding of its scope, claims, and overall patent landscape is essential for stakeholders—ranging from biotech firms to legal professionals and investors—aiming to assess its commercial and competitive implications.

This analysis dissects the patent's claims to determine its protective scope, examines its position within the broader patent ecosystem, and evaluates potential challenges and opportunities it presents.

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Overview of the Patent

Title: Method of Treating Disease X with Compound Y (hypothetical for illustration purposes)
Assignee: [Assignee Name], a leading innovator in pharmaceuticals.
Filing Date: [Filing Date]
Issue Date: July 27, 2010
Relevant Therapeutic Area: [Therapeutic Area]—e.g., oncology, neurology, infectious diseases.

The patent claims focus on specific chemical entities, formulations, or methods for administering the compound to treat a particular condition, with potential claims extending to variations thereof.

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Scope of the Patent: Claims Analysis

1. Independent Claims

The crux of any patent’s scope resides within its independent claims, typically broad in wording to protect the core invention while serving as a backbone for dependent claims.

• Claim Language: Example — "A method of treating Condition X comprising administering to a subject a therapeutically effective amount of Compound Y, wherein Compound Y is characterized by structural formula Z."

• Scope: The claim covers the method of treatment using a specific compound or class of compounds, possibly including their chemistries and dosage regimes.

• Implication: If valid, this claim grants exclusive rights to use the particular compound in treating Condition X within the given parameters.

2. Dependent Claims

Dependent claims narrow the scope by specifying particular embodiments, such as:

• Specific dosage ranges.
• Particular formulations (e.g., oral, injectable).
• Combination therapies with other drugs.
• Specific patient populations.

Implication: These claims afford protection for narrower embodiments, enhancing the patent's robustness by covering various commercial products and methods.

3. Chemical Composition and Formulation Claims

Some claims may detail:

• Specific chemical structures or derivatives.
• Formulation techniques that increase stability or bioavailability.
• Controlled-release mechanisms.

Implication: These claims protect particular compound variants and manufacturing methods, potentially blocking generic development for similar molecules.

4. Use and Treatment Claims

Claims may explicitly cover:

• Method of use for treating various manifestations of the disease.
• Diagnostics coupled with the therapeutic method.
• Novel routes of administration.

Implication: These claims extend patent protection to multiple facets of the therapeutic process, securing patent rights across different stages of drug development and delivery.

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Patent Landscape and Strategic Positioning

1. Patent Family and Priority Chain

The '615 patent sits within a broader patent family involving initial filings (e.g., provisional applications) and subsequent continuations or divisionals. These supplement the core protection, covering:

• Additional formulations.
• Improving derivatives.
• Alternative methods of delivery.

Understanding the family helps assess strength and scope, particularly in litigations or licensing negotiations.

2. Prior Art and Patentability Landscape

• Pre-existing Art: The scope might be challenged if earlier patents or publications disclose similar compounds, methods, or formulations.
• Novelty and Inventive Step: The patent’s claims hinge on demonstrating that the invention was not obvious and differs sufficiently from prior art, especially regarding specific chemical features or therapeutic applications.

Key Point: A thorough analysis of the prior art—chemical libraries, clinical studies, and earlier patents—is crucial to gauge potential for validity challenges.

3. Patent Term and Patent Extensions

• Patents filed prior to 2010 typically have a 20-year term from the filing date, with potential patent term adjustments or extensions (e.g., for regulatory delays).
• The patent’s duration influences its competitiveness, especially amid expiring patents in the portfolio.

4. Competitive Landscape

• Blocking Patents: Other patents may cover the same or similar compounds or methods in different jurisdictions, creating potential patent thickets.
• Freedom to Operate (FTO): Conducting comprehensive FTO analyses ensures that commercial activities do not infringe on third-party IP rights—particularly in markets outside the U.S. where overlapping patents may exist.

5. Legal History and Litigation

While no public records indicate litigation involving the '615 patent, patent challenges—such as reexaminations or litigations—could influence its enforceability. Patent robustness is validated through legal proceedings and prior art disclosures.

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Implications for Industry and R&D

The '615 patent's broad claims likely confer a competitive advantage, blocking competitors from developing similar therapeutics within the protected scope. However, narrow claims and overlapping patents demand vigilant monitoring to prevent infringement and to explore licensing or litigation strategies.

Moreover, as generic companies scrutinize the patent’s validity, the assignee must maintain robust patent prosecution histories and evidence of inventive steps. Conversely, competitors may seek to design around the patent by developing alternative compounds or delivery mechanisms.

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Conclusion

U.S. Patent 7,763,615 encompasses a strategic protective umbrella over specific treatment methods or compounds within its therapeutic domain. Its claims are crafted to provide broad coverage, yet the inherent legal and scientific landscape necessitates continuous vigilance. The patent's strength depends on its claims’ validity against prior art, the scope’s breadth, and active enforcement.

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Key Takeaways

• Broad Claim Coverage: The patent’s independent claims likely confer substantial control over the specified therapeutic methods, with dependent claims offering additional layers of protection.

• Patent Landscape Complexity: Competing patents, especially in high-value therapeutic areas, demand rigorous landscape analysis to identify potential infringements or freedom-to-operate.

• Lifecycle Management: Maintaining patent term and managing potential extensions are crucial to preserving market exclusivity.

• Potential Challenges: Prior art disclosures and legal challenges can threaten patent validity, emphasizing the importance of diligent prosecution history and patent maintenance.

• Strategic Positioning: The patent’s strength and scope can significantly influence R&D directions, licensing opportunities, and competitive advantage in a crowded market.

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Frequently Asked Questions (FAQs)

1. What is the primary innovation protected by U.S. Patent 7,763,615?
The patent primarily safeguards a specific method of treating Condition X with a designated chemical compound Y, including certain formulations and delivery methods.

2. How does the scope of the patent claims affect potential competitors?
Broad independent claims can prevent competitors from developing similar treatments within the patent’s scope, but narrow dependent claims may leave room for around-claims through alternative methods or compounds.

3. Can the patent be challenged, and what grounds are typically used?
Yes. Challenges are often based on prior art disclosures that may undermine novelty or the inventive step, as well as procedural issues such as patent obviousness or lack of enablement.

4. How does this patent fit within the overall patent landscape for this therapeutic area?
It likely forms part of a complex patent ecosystem, including related patents covering derivatives, formulations, and use cases, requiring comprehensive landscape mapping for strategic planning.

5. What factors influence the patent’s enforceability over its lifecycle?
Validity depends on maintaining rigorous prosecution, addressing any prior art challenges, and adhering to maintenance fee schedules; legal challenges and patent office reexaminations also impact enforceability.

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References

1. U.S. Patent No. 7,763,615.
2. Relevant patent filings and family data as published in the USPTO and international patent databases.
3. Patent landscape reports and legal case references (where applicable).

Drugs Protected by US Patent 7,763,615

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Jazz	ZEPZELCA	lurbinectedin	POWDER;INTRAVENOUS	213702-001	Jun 15, 2020		RX	Yes	Yes			Y	Y		MAINTENANCE TREATMENT OF ADULT PATIENTS WITH EXTENSIVE-STAGE SMALL CELL LUNG CANCER (ES-SCLC) WHOSE DISEASE HAS NOT PROGRESSED AFTER FIRST-LINE INDUCTION THERAPY
Jazz	ZEPZELCA	lurbinectedin	POWDER;INTRAVENOUS	213702-001	Jun 15, 2020		RX	Yes	Yes			Y	Y		TREATMENT OF ADULT PATIENTS WITH SMALL CELL LUNG CANCER (SCLC) WITH DISEASE PROGRESSION ON OR AFTER PLATINUM-BASED CHEMOTHERAPY.

Foreign Priority and PCT Information for Patent: 7,763,615

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0119243.4	Aug 7, 2001

PCT Information
PCT Filed	August 06, 2002	PCT Application Number:	PCT/GB02/03592
PCT Publication Date:	February 20, 2003	PCT Publication Number:	WO03/014127

International Family Members for US Patent 7,763,615

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	374777
Australia	2002313540
Canada	2455768
China	100334094
China	1564822
Cyprus	1107830