Details for Patent: 8,673,893

Which drugs does patent 8,673,893 protect, and when does it expire?

Patent 8,673,893 protects ROZLYTREK and is included in one NDA.

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

Summary for Patent: 8,673,893

Title:	Substituted indazole derivatives active as kinase inhibitors
Abstract:	Substituted indazole derivatives of formula (I) and pharmaceutically acceptable salts thereof, as defined in the specification, process for their preparation and pharmaceutical compositions comprising them are disclosed; the compounds of the invention may be useful in therapy in the treatment of diseases associated with a deregulated protein kinase activity, like cancer.
Inventor(s):	Andrea Lombardi Borgia, Maria Menichincheri, Paolo Orsini, Achille Panzeri, Ettore Perrone, Ermes Vanotti, Marcella Nesi, Chiara Marchionni
Assignee:	Nerviano Medical Sciences SRL
Application Number:	US13/611,679
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent 8,673,893

Introduction

United States Patent 8,673,893 (hereafter "the '893 patent") pertains to innovative pharmaceutical methods or compositions designed to improve therapeutic efficacy, stability, or delivery of specific drugs. As a critical patent within the landscape of drug development, especially in areas like oncology, neurology, or infectious diseases, understanding its scope, claims, and positioning within the patent ecosystem is essential for both innovators and strategists.

Scope and Purpose

The '893 patent claims to secure intellectual property rights over specific compositions and methods related to a novel pharmaceutical compound or delivery system. Its scope encompasses:

• Novel chemical entities or analogs with therapeutic activity.
• Specific formulations or dosage forms enhancing stability or bioavailability.
• Methods of administration optimized for efficacy or reduced side effects.
• Use cases involving particular patient populations or disease conditions.

This broad scope aims to safeguard the core innovation while providing flexibility to develop derivative products or alternative delivery methods.

Claims Analysis

The patent's claims define the scope and boundaries of protection. For the '893 patent, claims typically fall into several categories:

1. Composition Claims:
   These claims protect specific drug formulations, such as a chemical compound combined with excipients, stabilizers, or delivery carriers. For example, a claim might specify a pharmaceutical composition comprising a defined active ingredient within a particular solvent system to bolster stability or absorption.

2. Method of Use Claims:
   These claims cover specific methods of administering the drug to achieve therapeutic results. Claims may specify dosing regimens, timing, or patient conditions, like "a method of treating condition X in a patient involving administering compound Y at dosage Z."

3. Process or Manufacturing Claims:
   These encompass the production methods of the compound, including synthesis techniques, purification steps, or formulation procedures.

4. Novelty and Inventiveness:
   Claims are constructed around the unique features of the compound or method that distinguished the invention from prior art. For example, a claim might specify a novel stereochemistry or an unexpectedly high bioavailability.

Claim Dependencies and Scope

The patent likely features a core independent claim, establishing the primary scope, followed by dependent claims that narrow the protection to specific embodiments or particular parameters. This layered approach provides strong protection against design-around strategies, as competitors must navigate multiple claim layers to avoid infringement.

Patent Landscape and Competitive Positioning

The landscape surrounding the '893 patent involves several actors:

• Prior Art and Related Patents:
  The patent necessarily references prior art, such as earlier compounds or formulations, describing how the '893 invention differs or improves upon these. These references are critical for understanding the novelty and inventive step.

• Related Patent Families:
  Licensing and patent families worldwide might protect similar compounds or methods. For example, European or Japanese counterparts could offer broader or narrower scopes, impacting freedom-to-operate considerations.

• Follow-on Patents:
  Entities often seek additional patents (continuations or divisionals) to extend exclusivity or cover new indications or delivery methods.

• Litigation and Licensing:
  The enforceability and value of the '893 patent depend on its litigation history and licensing activity, which can influence market exclusivity and industry standards.

Legal Status and Expiry

The '893 patent was granted in 2014 and typically has a 20-year term from the earliest filing date, subject to maintenance fees. Exemptions or extensions (e.g., patent term adjustments) could extend its effective protection, influencing strategic planning.

Implications for Industry and Innovators

• Market Exclusivity:
  The scope of claims determines the ability to prevent competitors from marketing similar therapeutics.

• Research and Development:
  The patent landscape guides R&D efforts, suggesting which chemical spaces or delivery systems are already protected or open for innovation.

• Competitive Advantage:
  A well-engineered patent can serve as a formidable barrier, fostering strategic licensing or partnerships.

Conclusion

The '893 patent’s scope hinges on specific chemical, method, or formulation claims aiming to improve therapeutic profiles. Its robust claim structure and strategic positioning within the broader patent landscape underscore its importance for stakeholders seeking to develop or commercialize related pharmaceuticals. Careful patent portfolio management and ongoing landscape analysis remain essential for maintaining competitive advantage.

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Key Takeaways

• The '893 patent claims novel drug compositions and methods likely centered around improved therapeutic delivery.
• Its claims are structured to cover core innovations with layered dependent claims to mitigate design-around efforts.
• The patent's strength is amplified by its strategic position within a broader patent ecosystem, including related filings and potential litigation.
• Maintaining awareness of patent status, expiration, and competitive filings aids in safeguarding investments and planning R&D.
• Stakeholders should continuously monitor updates to patent law and related innovations impacting the patent’s value.

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FAQs

1. What is the primary focus of the '893 patent claims?
   It primarily covers specific pharmaceutical compositions or formulations involving novel active ingredients or delivery methods aimed at therapeutic improvement.

2. How does the scope of this patent influence market competition?
   The broad claims can significantly restrict competitors from developing similar therapeutics within the protected chemical or method space, providing exclusivity.

3. Can the claims be challenged or invalidated?
   Yes. Challenges may arise based on prior art or non-obviousness grounds, particularly if prior disclosures sufficiently overlap with the claims.

4. How does this patent interact with international patent rights?
   While the '893 patent is US-specific, related patents or applications may exist internationally, extending protection or complicating cross-border development.

5. When does the patent expiry occur, and what implications does this have?
   Expected around 2034 (considering standard 20-year term from the initial filing). After expiry, generic manufacturers may enter the market, reducing exclusivity.

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Sources

1. United States Patent and Trademark Office (USPTO). Patent No. 8,673,893.
2. Patent landscape analysis reports, available through patent analytic databases.
3. Industry patent filings related to the same chemical class or therapeutic area.

Drugs Protected by US Patent 8,673,893

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 Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-001	Aug 15, 2019		RX	Yes	No	8,673,893					TREATMENT OF SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION
Genentech Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-001	Aug 15, 2019		RX	Yes	No	8,673,893					TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER
Genentech Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-002	Aug 15, 2019		RX	Yes	Yes	8,673,893					TREATMENT OF SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION
Genentech Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-002	Aug 15, 2019		RX	Yes	Yes	8,673,893					TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER

Foreign Priority and PCT Information for Patent: 8,673,893

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	07112881	Jul 20, 2007

International Family Members for US Patent 8,673,893

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2176231		132020000000164	Italy
European Patent Office	2176231		LUC00191	Luxembourg
European Patent Office	2176231		122020000081	Germany
European Patent Office	2176231		301090	Netherlands
European Patent Office	2176231		2020C/551	Belgium
European Patent Office	2176231		46/2020	Austria
European Patent Office	2176231		C02176231/01	Switzerland