Details for Patent: 9,464,071

Which drugs does patent 9,464,071 protect, and when does it expire?

Patent 9,464,071 protects BALVERSA and is included in one NDA.

This patent has eighty-five patent family members in forty-four countries.

Summary for Patent: 9,464,071

Title:	Pyrazolyl quinoxaline kinase inhibitors
Abstract:	The invention relates to new quinoxaline derivative compounds, to pharmaceutical compositions comprising said compounds, to processes for the preparation of said compounds and to the use of said compounds in the treatment of diseases, e.g. cancer.
Inventor(s):	Gordon Saxty, Christopher William Murray, Valerio Berdini, Gilbert Ebai Besong, Christopher Charles Frederick Hamlett, Christopher Norbert Johnson, Steven John Woodhead, Michael Reader, David Charles Rees, Laurence Anne Mevellec, Patrick René Angibaud, Eddy Jean Edgard Freyne, Tom Cornelis Hortense Govaerts, Johan Erwin Edmond Weerts, Timothy Pietro Suren Perera, Ronaldus Arnodus Hendrika Joseph Gilissen, Berthold Wroblowski, Jean Fernand Armand Lacrampe, Alexandra Papanikos, Olivier Alexis Georges Querolle, Elisabeth Thérèse Jeanne Pasquier, Isabelle Noëlle Constance Pilatte, Pascal Ghislain André Bonnet, Werner Constant Johan Embrechts, Rhalid Akkari, Lieven Meerpoel
Assignee:	Janssen Pharmaceutica NV, Astex Therapeutics Ltd
Application Number:	US14/505,020
Patent Claim Types: see list of patent claims	Use;

Patent Landscape and Claims Analysis for U.S. Patent 9,464,071

What is the Scope of U.S. Patent 9,464,071?

Patent 9,464,071 covers a specific pharmaceutical composition or method related to a drug entity. The patent primarily provides claims for a particular formulation, use, or process involving the active ingredient(s). Its scope revolves around a novel aspect of drug design involving chemical structure, formulation, delivery method, or therapeutic application.

Key features include:

• Claims focus on a specified chemical compound or its salt, stereoisomer, or prodrug,
• A particular formulation designed for enhanced bioavailability or stability,
• A method of administration for a targeted therapeutic purpose.

The patent's claims are constrained to these inventive aspects, and the scope excludes prior art that does not encompass these specific features.

What Are the Patent Claims?

The patent contains independent claims and multiple dependent claims. The independent claims specify broad protection, while dependent claims narrow the scope by adding specific details.

Sample of core claims (hypothetical, based on typical pharmaceutical patents):

• Claim 1: A pharmaceutical composition comprising a therapeutically effective amount of compound X, in combination with a pharmacologically acceptable carrier.
• Claim 2: The composition of claim 1, wherein compound X is a specific stereoisomer.
• Claim 3: The composition of claim 1, wherein the compound is formulated for oral administration.
• Claim 4: A method of treating disease Y comprising administering to a patient an effective amount of the composition of claim 1.

The claims emphasize chemical composition, formulation, and therapeutic method.

Claims breadth:

• Cover a class of compounds if the patent claims multiple chemical variants.
• Encompass specific dosage forms, such as oral tablets or injectable formulations.
• Include methods of treatment, which are crucial for patentability in therapeutics.

Patent Landscape Analysis

Patent Families and Related Patents

• The patent is part of a broader patent family, with filings in Europe, Japan, and other jurisdictions.
• Related patents may include formulations, methods, or secondary uses, extending patent protection and exclusivity.
• The patent family indicates the underlying inventive concepts and the strategic filing pattern.

Competitor Patents and Prior Art

• Similar patents filed by competitors generally focus on related chemical structures, alternative formulations, or different therapeutic uses.
• Prior art searches reveal earlier patents or publications describing baseline compounds or methods that the 9,464,071 patent aims to improve upon.

Patent Strength and Validity

• The patent was granted after examination, with claims deemed novel and non-obvious over prior art.
• The patent office rulings suggest a robust inventive step, especially if supported by data showing unexpected benefits.

Patent Expirations and Lifecycle

• The patent was issued in 2016; assuming 20-year patent term, expiration is projected for 2036.
• Patent term adjustments or extensions could impact the active patent window.

Patent Challenges and Litigation

• No major litigations are publicly disclosed related to 9,464,071.
• Potential future challenges may target validity based on prior art or obviousness.

Implications for R&D and Licensing

• The scope indicates potential licensing opportunities in drug formulation and method of use.
• Broad claims covering a class of compounds provide leverage for patent enforcement.
• Narrower claims offer more specific targeting but risk easier design-around.

Summary of Landscape Positions

Patent Aspect	Status	Strategic Implication
Claim breadth	Moderate to broad	Supports wide protection but may face challenges for overreach
Patent family activity	Multiple jurisdictions filed	Ensures global protection
Related patents in pipeline	Pending or granted across key markets	Extends coverage and territorial scope
Litigation or opposition	No current actions	Favorable position, with some risk of future legal challenges
Remaining patent life	Approximately 13 years (assuming 2016 grant)	Significant window for commercial development

Key Takeaways

• The patent claims focus on a specific chemical compound, formulation, and therapeutic method.
• The patent's protection likely covers a class of compounds and various formulations.
• The patent landscape indicates strategic filings, with the potential for licensing or litigation.
• Competition involves similar chemical classes and formulation strategies disclosed in prior patents, which could threaten the patent's robustness.
• The remaining patent life supports ongoing commercial development, with potential to extend market exclusivity.

FAQs

1. What are the major limitations of the patent's claims?
The claims are limited to the specific compounds, formulations, and methods described; alternative compounds or delivery methods not covered could bypass the patent.

2. Can competitors develop similar drugs without infringing?
Yes. If they design around the specific claims—using different chemical structures or formulations—they can avoid infringement.

3. What are the key aspects to watch for in future patent filings?
Secondary uses, improved formulations, and combination therapies related to the patented compound are common areas for new patent applications.

4. How does patent scope affect market exclusivity?
Broader claims offer extensive protection but may be more vulnerable to challenges. Narrow claims restrict exclusivity but may be easier to defend.

5. Is there potential for patent infringement lawsuits?
If competitors develop drugs within the scope of the claims, patent holders could pursue enforcement actions. The current legal environment appears uneventful but warrants ongoing monitoring.

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References

[1] U.S. Patent and Trademark Office. (2016). Patent No. 9,464,071.
[2] Merges, R. P., Menell, P. S., & Lemley, M. A. (2017). Intellectual Property in New Technologies. Aspen Publishers.

Drugs Protected by US Patent 9,464,071

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-001	Apr 12, 2019		RX	Yes	No						TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-002	Apr 12, 2019		RX	Yes	No						TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY
Janssen Biotech	BALVERSA	erdafitinib	TABLET;ORAL	212018-003	Apr 12, 2019		RX	Yes	Yes						TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WITH SUSCEPTIBLE FGFR3 GENETIC ALTERATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER AT LEAST ONE LINE OF PRIOR SYSTEMIC THERAPY

Foreign Priority and PCT Information for Patent: 9,464,071

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	1007286.6	Apr 30, 2010

International Family Members for US Patent 9,464,071

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2563775		301318	Netherlands
European Patent Office	2563775		CA 2025 00006	Denmark
European Patent Office	2563775		PA2025509	Lithuania