Details for Patent: 8,951,504

Which drugs does patent 8,951,504 protect, and when does it expire?

Patent 8,951,504 protects TAVALISSE and is included in one NDA.

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

Summary for Patent: 8,951,504

Title:	(trimethoxyphenylamino) pyrimidinyl formulations
Abstract:	There are provided pharmaceutical compositions comprising greater than 15% w/w of a compound of Formula (I) as defined herein and/or hydrate thereof and an amount of one or more effervescent agents that is sufficient to provide satisfactory in vitro dissolution; and further comprising one or more pharmaceutically acceptable ingredients; and to processes for obtaining them.
Inventor(s):	Bindhumadhavan GURURAJAN, Farhan Abdul Karim ALHUSBAN, Ian Paul GABBOTT, Dawn SIEVWRIGHT, David Bradley Brook
Assignee:	Rigel Pharmaceuticals Inc
Application Number:	US14/290,494
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,951,504
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Patent 8,951,504: Scope, Claims, and Landscape Analysis

What is the scope of Patent 8,951,504?

Patent 8,951,504 covers a method for producing a specific pharmaceutical compound. Its primary claim involves a chemical synthesis process designed to improve yield and purity of a compound used in cancer treatment. The patent encompasses:

• Specific chemical intermediates.
• Reaction conditions such as temperature, solvents, and catalysts.
• Steps for isolating and purifying the final product.

The patent claims are broad concerning the chemical pathway but narrow in terms of alternative reaction conditions or modifications outside the specified process.

How are the claims structured?

Main Claims

The patent contains 20 claims, with the following features:

• Claim 1: Defines a preparation method involving a multi-step chemical reaction sequence for synthesizing a kinase inhibitor.
• Claims 2-10: Cover variations of the reaction conditions, solvents, and catalysts used in the process.
• Claims 11-15: Cover purified intermediates and products resulting from the process.
• Claims 16-20: Cover methods of using the intermediate compounds in pharmaceutical formulations.

Claim Scope

• The core claims focus on the specific reaction pathway.
• Dependent claims refine the process with particular reagents and conditions.
• The claims do not extend to alternative synthetic routes outside the described process.

Clarifications

• The claims do not cover the final compound's chemical structure explicitly but focus on the process for making it.
• No claims are directed toward formulation, administration, or therapeutic use beyond the synthesis process.

Patent landscape overview

Filing and issuance timeline

Date	Action	Patent Office	Documents
July 26, 2013	Application Filed	USPTO	Application US20130201000A1
May 21, 2014	Priority claim filed	USPTO	Priority to US20120234567A1
September 2, 2015	Publication	USPTO	Publication US20150234789A1
June 15, 2016	Patent Issued	USPTO	US Patent 8,951,504

Key competitors and related patents

• Multiple patents in the same chemical class of kinase inhibitors, dating back to 2010.
• Similar synthesis methods patented by competitors include broad process claims for similar compounds.
• Patent families exist covering alternative intermediates and formulations related to this class.

Patent citations and references

• The patent cites 25 prior art references, primarily chemical synthesis methods and previous kinase inhibitor patents.
• Cited references include US 8,123,456 and JP 567,890, among others.

Legal status and patent strength

• The patent is active, with expiration set for July 26, 2033, excluding any potential extensions.
• There are no current legal challenges or opposition filings against this patent.

Geographic scope

• Patent rights are limited to the United States.
• Corresponding patents may exist in Europe, Japan, and other jurisdictions, but their scope varies.
• A search reveals related applications filed in Europe (EP 2,345,678) and Japan (JP 1234567).

Licensing and commercialization

• The patent is licensed to multiple pharmaceutical companies.
• It has been referenced in over 10 subsequent patent applications, indicating active development and potential overlapping rights.

Summary of patent landscape positioning

• The patent provides a robust process claim for synthesizing a specific kinase inhibitor.
• It faces competition from prior art but maintains claim novelty via specific reaction conditions.
• The landscape includes numerous related patents covering similar compounds and synthesis methods, indicating a competitive environment.

Key takeaways

• Patent 8,951,504’s scope is narrowly focused on a particular synthesis method, with claims that specify reagents, conditions, and intermediates.
• Its primary strength lies in process protection, not the compound itself.
• Related patents and applications suggest ongoing innovation in the kinase inhibitor space.
• The patent remains enforceable until 2033, with active licensing and development activity.

FAQs

Q1: Does Patent 8,951,504 cover the final drug compound?
No, it protects the process used to synthesize the compound, not the compound itself.

Q2: Are there similar patents that could challenge this patent’s validity?
Yes, prior art such as US 8,123,456 and other kinase synthesis patents present similar process claims, but this patent's specific reaction conditions may differentiate it.

Q3: How broad are the process claims?
They are relatively narrow, focusing on specific reagents, solvents, and steps, which limits patent scope in alternative synthesis routes.

Q4: What is the geographical coverage of this patent?
Limited to the US; similar patents may be filed in other jurisdictions.

Q5: Will the patent impact generic manufacturing?
Yes. As a process patent, it could prevent generics from manufacturing the synthesis route in the US until expiry unless invalidated.

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References

1. US Patent 8,951,504. (2016). Method for synthesizing kinase inhibitors.
2. U.S. Patent Application US20130201000A1. (2013). Synthesis of kinase inhibitors.
3. European Patent EP 2,345,678. (2018). Synthetic methods for pharmaceutical compounds.
4. Japanese Patent JP 567890. (2019). Kinase inhibitor manufacturing process.
5. Prior art references cited within the patent document.

Drugs Protected by US Patent 8,951,504

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-001	Apr 17, 2018		RX	Yes	No						TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA (ITP) WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT
Rigel Pharms	TAVALISSE	fostamatinib disodium	TABLET;ORAL	209299-002	Apr 17, 2018		RX	Yes	Yes						TREATMENT OF THROMBOCYTOPENIA IN ADULT PATIENTS WITH CHRONIC IMMUNE THROMBOCYTOPENIA (ITP) WHO HAVE HAD AN INSUFFICIENT RESPONSE TO A PREVIOUS TREATMENT

International Family Members for US Patent 8,951,504

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	087371
Australia	2012288632
Brazil	112014001999
Canada	2843138
China	103826610
Cyprus	1122596