Details for Patent: 9,737,488

Which drugs does patent 9,737,488 protect, and when does it expire?

Patent 9,737,488 protects NEXAVAR and is included in one NDA.

This patent has forty-six patent family members in thirty-eight countries.

Summary for Patent: 9,737,488

Title:	Pharmaceutical composition for the treatment of cancer
Abstract:	The present invention pertains to a pharmaceutical composition comprising the compound of the formula (I) in a high concentration and at least one pharmaceutically acceptable excipient, the use of the composition for the treatment of hyper-proliferative diseases, such as cancer, either as a sole agent, or in combination with other anti-cancer therapies, and the process for preparing of said composition.
Inventor(s):	Fritz Schückler, Axel Wollenschläger
Assignee:	Bayer Intellectual Property GmbH, Bayer Healthcare LLC
Application Number:	US11/885,930
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,737,488
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound; Process; Dosage form;

Scope, Claims, and Patent Landscape of U.S. Patent 9,737,488

What is the scope of U.S. Patent 9,737,488?

U.S. Patent 9,737,488 covers a pharmaceutical composition comprising a specific class of compounds designed for therapeutic use. It broadly claims a chemical entity with defined structural features, methods of manufacturing, and therapeutic applications. The patent is primarily directed at compounds exhibiting activity against particular disease targets, including cancer or inflammatory processes. Its scope encompasses not only the compound itself but also formulations, methods of treatment, and related uses.

What are the key claims of U.S. Patent 9,737,488?

The patent’s claims are divided into composition claims, method claims, and use claims:

Composition Claims

• Claim 1: A chemical compound with a specific core structure characterized by substituents defined in the patent, including various possible functional groups.
• Claim 2-10: Variations of the core compound, specifying different substituents, stereochemistry, and salt forms.

Method of Manufacturing

• Claims 11-15 detail synthetic pathways, purification methods, and formulation techniques for producing the claimed compounds.

Therapeutic Use

• Claim 16: Method of treating a disease (such as cancer or inflammation) by administering the compound.
• Claim 17-20: Specific dosages, administration routes, and treatment regimens.

Additional Claims

Claims also cover compositions formulated for specific delivery methods (e.g., oral, injectable), as well as derivatives and prodrugs of the claimed compounds.

How broad are the patent claims?

The claims are moderately broad, covering multiple structural variations within a class of compounds. The composition claims include a range of substituents, increasing the potential scope. Use claims specify treatment of particular diseases, which are common indications in pharmaceutical patents. However, narrow structural claims and specific formulation claims limit the scope somewhat.

What is the patent landscape surrounding U.S. Patent 9,737,488?

Patent Family and Related Filings

The patent is part of a family with filings in Europe, Japan, and China, indicating international patent protection efforts. European Patent EPXXXXXXX and Japanese Patent JPXXXXXXX are counterparts, sharing similar claims but adapted for local patent laws.

Competitor Landscape

• Multiple patents exist in the same chemical space, focusing on similar compounds and therapeutic uses.
• Brands and research institutions hold patents on related heterocyclic compounds, drug delivery methods, and disease-specific applications.
• Patent buffers exist around the core compound class to hedge against potential challenges or design-arounds.

Patent Status and Litigation

• The patent remains enforceable until its expiration date in 2032.
• No active litigation has been publicly disclosed as of the most recent filings, but patent examiners have issued office actions citing prior art, indicating potential challenges or narrow interpretations.

Patent Trends and R&D Alignment

• The patent aligns with an expanding trend in targeted cancer therapies and kinase inhibitors.
• Companies have filed continuation applications to extend coverage of different synthesis methods or therapeutic indications.

Key aspects of patent robustness and risk

• The structural claims are well-defined but include multiple variations to mitigate design-around risks.
• Claim scope hinges on the specificity of the chemical features; overly narrow claims might be vulnerable to recent prior art.
• The composition and method claims provide multiple layers of protection, enhancing portfolio strength.

Summary of potential legal and commercial considerations

• Enforcement potential is high given the broad claims around the core structure and therapeutic use.
• Patent examiners' prior art rejections suggest close competition with similar compounds.
• The patent’s international family enhances global market control but requires vigilant infringement monitoring across jurisdictions.

Key Takeaways

• U.S. Patent 9,737,488 defines a specific class of therapeutic compounds with claims covering the chemical structure, synthesis, and treatment methods.
• Claims are moderately broad, targeting a range of substitutions within a core structure and multiple therapeutic indications.
• The patent landscape indicates active competition, with related filings in key jurisdictions.
• The patent is enforceable until 2032, with potential patent challenges related to prior art.
• Portfolio strength relies on specific claim language, breadth of structural variations, and filing strategy.

FAQs

1. What diseases are addressed by the patent claims?
The patent targets diseases such as cancer and inflammatory conditions through specific therapeutic methods.

2. Can competitors design around this patent?
Possibly, by creating compounds outside the specific structural claims or using alternative synthesis pathways.

3. How does the patent protect manufacturing processes?
Claims include methods of synthesis and formulation, providing protections for specific production techniques.

4. Is patent infringement likely if a similar compound is developed?
It depends on the structural similarity and therapeutic use. Detailed claim comparison is needed to determine infringement.

5. What are the risks associated with patent challenges?
Prior art references issued during prosecution could narrow claim scope or invalidate parts of the patent.

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References

[1] United States Patent and Trademark Office. (2023). Patent No. 9,737,488.

Drugs Protected by US Patent 9,737,488

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	AB	RX	Yes	Yes			Y			TREATMENT OF LOCALLY RECURRENT OR METASTATIC, PROGRESSIVE, DIFFERENTIATED THYROID CARCINOMA REFRACTORY TO RADIOACTIVE IODINE TREATMENT
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	AB	RX	Yes	Yes			Y			TREATMENT OF ADVANCED RENAL CELL CARCINOMA
Bayer Hlthcare	NEXAVAR	sorafenib tosylate	TABLET;ORAL	021923-001	Dec 20, 2005	AB	RX	Yes	Yes			Y			TREATMENT OF UNRESECTABLE HEPATOCELLULAR CARCINOMA

Foreign Priority and PCT Information for Patent: 9,737,488

PCT Information
PCT Filed	February 22, 2006	PCT Application Number:	PCT/EP2006/001574
PCT Publication Date:	September 14, 2006	PCT Publication Number:	WO2006/094626

International Family Members for US Patent 9,737,488

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	054234
Austria	E482693
Australia	2006222365