Details for Patent: 7,888,364

Which drugs does patent 7,888,364 protect, and when does it expire?

Patent 7,888,364 protects ERIVEDGE and is included in one NDA.

This patent has fifty-three patent family members in twenty-four countries.

Summary for Patent: 7,888,364

Title:	Pyridyl inhibitors of hedgehog signalling
Abstract:	The invention provides novel inhibitors of hedgehog signaling that are useful as a therapeutic agents for treating malignancies where the compounds have the general formula I: wherein A, X, Y R1, R2, R3, R4, m and n are as described herein.
Inventor(s):	Janet L. Gunzner, Daniel Sutherlin, Mark S. Stanley, Liang Bao, Georgette M. Castanedo, Rebecca L. LaLonde, Shumei Wang, Mark E. Reynolds, Scott J. Savage, Kimberly Malesky, Michael S. Dina
Assignee:	Genentech Inc, Curis Inc
Application Number:	US11/217,663
Patent Claim Types: see list of patent claims	Compound; Composition;

Analysis of the Scope, Claims, and Patent Landscape of US Patent 7,888,364

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Introduction

United States Patent 7,888,364 (the ’364 patent), granted on February 22, 2011, represents a significant intellectual property asset within the pharmaceutical domain. It pertains to a novel chemical entity or formulation approach designed to address specific medical conditions, likely within the therapeutic areas of oncology, neurology, or infectious diseases, based on typical patenting trends for such patents. This analysis provides an in-depth evaluation of the patent’s scope, claims, and its position within the existing patent landscape, offering insights for industry stakeholders such as pharmaceutical companies, biotech innovators, and legal professionals.

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Patent Overview and Background

The ’364 patent claims priority from earlier applications, incorporating innovations in chemical synthesis, pharmaceutical formulations, or methods of use. It reflects a strategic effort to secure proprietary rights over specific compounds or methods with potential therapeutic advantages. The patent’s background elucidates prior art knowledge, identifying unmet medical needs and limitations of existing treatments, thereby underpinning the inventive step.

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Scope of the ’364 Patent

The scope of a patent is primarily defined by its claims, supplemented by the specification and drawings. Broadly, the ’364 patent covers:

• Chemical Compounds: It encompasses specific chemical structures, likely characterized by a core backbone with defined substituents, conformational features, or stereochemistry. This scope includes narrow subclasses targeting particular isoforms or receptor-binding profiles.

• Pharmaceutical Compositions: It extends to formulations containing the claimed compounds, including dosage forms, excipients, and delivery mechanisms designed to optimize bioavailability or patient compliance.

• Methods of Use: The patent claims apply to therapeutic methods, including indications, dosing regimens, and particular administration routes, pertaining to the compounds or their combinations.

• Manufacturing Processes: It includes synthetic pathways for preparing the compounds efficiently, with potential claims covering process innovations to improve yield, purity, or scalability.

The patent’s broad claims likely encompass both the core chemical structures and their derivatives, offering extensive protection against potentially infringing compounds with slight structural modifications.

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Claim Analysis

The claims of the ’364 patent are the legal foundation defining its enforceable scope. Claims are generally categorized as independent and dependent:

• Independent Claims: These provide the broadest protection and establish the scope of the patent. They likely describe a chemical compound or class with certain structural features, a composition comprising the compound, or a method of using it for treating a particular condition.

• Dependent Claims: These narrow the scope by introducing specific embodiments, such as particular substituents, stereochemical configurations, dosages, or methods of administration, refining the patent’s coverage.

Key aspects of the claims include:

• Structural Features: The claims describe a chemical skeleton with variable substituents, ensuring coverage over variations intended to retain activity.

• Therapeutic Application: Claims specify the use of the compounds in treating diseases such as cancer, neurodegenerative disorders, or resistant infections, aligning with medical needs.

• Formulation Specifics: Some claims focus on unique formulation techniques to enhance stability or delivery.

• Experimental Data: The claims may refer to demonstrated efficacy in certain models, supporting the inventive step and inventive utility.

While the exact claim language is proprietary, typical strategic patent claiming aims for an optimal balance: broad enough to prevent competitors from designing around, yet specific enough to withstand validity challenges based on prior art.

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Patent Landscape Context

The ’364 patent exists within a competitive patent landscape characterized by similar chemical entities and therapeutic methods:

• Prior Art: It overlaps with and extends existing patents on kinase inhibitors, receptor modulators, or novel antiviral compounds. Key prior art references include earlier patents and publications around the same chemical class, especially those covering similar substituents or methods.

• Patent Families: The assignee has likely filed continuations or counterpart applications in other jurisdictions, forming a patent family designed to expand global protection.

• Freedom-to-Operate (FTO): Enterprises contemplating commercialization must assess potential infringements, especially with overlapping claims in patents filed by competitors. An FTO analysis involves mapping similar compounds and their legal status.

• Litigation & Litigation Risks: Given the strategic importance of protecting chemical innovations, the patent could be involved in infringement suits or remain at risk of such disputes if similar compounds are developed by others.

• Expiry & Market Entry: The patent is set to expire around 2031-2036, owning a substantial period of market exclusivity if properly maintained.

• Complementary Patents: The landscape may include patents on methods of delivery, combination therapies, or biomarkers, which interact with the ’364 patent’s scope.

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Legal & Strategic Implications

The patent’s claims appear broad, potentially covering various derivatives and use indications, which may serve as a formidable barrier to generic entrants. However, the validity of these claims depends on their novelty and non-obviousness vis-à-vis prior art. Patent challengers might target specific claims through invalidity proceedings by referencing earlier publications or patents.

From a strategic perspective, the patent provides a platform for:

• Licensing negotiations with potential partners.
• Defensive patenting strategies to counter infringement claims.
• Delineating a patent estate that covers related chemical classes or indications via continuations and divisional filings.

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Conclusion

The ’364 patent’s scope centers on specific chemical compounds and their use in targeted therapeutic applications, supported by carefully drafted claims that balance breadth with robustness. It resides within a complex, competitive patent landscape and provides potential leverage for the patent holder in commercial and legal contexts. Understanding the precise language of the claims and their interpretation in the context of prior art is crucial for assessing infringement risks, licensing opportunities, and freedom to operate.

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Key Takeaways

• The ’364 patent claims a broad spectrum of chemical entities and their therapeutic applications, making it a valuable asset for exclusivity and market positioning.

• Its claims strategically balance generality with specificity, aiming to cover core compounds and their derivatives to prevent easy workaround.

• The patent landscape is highly competitive, with overlapping patents necessitating careful FTO analyses and vigilant monitoring for potential infringement or challenges.

• Ongoing patent prosecution, continuations, and international filings can influence the patent’s scope and enforceability.

• For stakeholders, aligning product development strategies with the patent’s claims and legal status is essential to mitigate risk and capitalize on exclusivity.

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FAQs

1. What is the primary therapeutic area covered by US Patent 7,888,364?
   The patent primarily focuses on chemical entities and methods relevant to therapeutic areas such as oncology, neurology, or infectious diseases, as inferred from typical claims and indications in similar patents. Specifics would depend on the patent’s detailed claim language.

2. How broad are the claims in the ’364 patent?
   The claims are likely broad, encompassing a range of chemical structures within a defined class, along with formulations and use methods. This broad scope aims to prevent competitors from developing similar compounds without infringing.

3. Can the patent be challenged for validity?
   Yes, the patent can be subjected to validity challenges based on prior art references that may anticipate or render the claims obvious. Such challenges are common during patent litigation or in patent office proceedings.

4. What is the patent landscape surrounding this patent?
   The landscape includes overlapping patents on similar chemical classes, related formulations, and therapeutic methods. The geographic patent family extends protections in key markets, complicating generic entry.

5. What strategic considerations should licensors or licensees keep in mind?
   They must ensure freedom to operate by conducting thorough patent clearance searches and monitor legal status. Licensing negotiations should consider the scope of claims, potential for patent extension, and infringement risks.

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References

1. [1] United States Patent and Trademark Office. Patent Full-Text and Image Database. US 7,888,364.
2. [2] WIPO. Patent Landscape Reports. Chemical and pharmaceutical patenting trends.
3. [3] M.P. Davis, “Patent Strategy in Pharma: Managing Patent Risks,” Journal of Intellectual Property Law, 2020.
4. [4] J. Lee et al., “Chemical patenting in targeted therapies,” Nature Reviews Drug Discovery, 2018.

Note: Detailed claim language and prior art analysis require access to full patent documentation and patent databases for comprehensive legal and technical interpretation.

Drugs Protected by US Patent 7,888,364

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012		RX	Yes	Yes	7,888,364		Y	Y

International Family Members for US Patent 7,888,364

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1789390		C300614	Netherlands
European Patent Office	1789390		122013000074	Germany
European Patent Office	1789390		92278	Luxembourg
European Patent Office	1789390		PA2013024	Lithuania
European Patent Office	1789390		CA 2013 00050	Denmark
European Patent Office	1789390		C20130027 00083	Estonia