Details for Patent: 8,003,673

Which drugs does patent 8,003,673 protect, and when does it expire?

Patent 8,003,673 protects CUBICIN and is included in one NDA.

This patent has three patent family members in three countries.

Summary for Patent: 8,003,673

Title:	Daptomycin for the treatment of biofilm and catheter salvage
Abstract:	Daptomycin can be used for biofilm treatment (particularly central venous catheter salvage for S. epidermidis infected catheters). Catheter salvage with daptomycin shows rapid cidality, activity against stationary phase bacteria, and penetration and activity in biofilms. The present inventions provide formulations, methods, and articles of manufacture useful for biofilm treatment or catheter salvage involving daptomycin. Particular formulations include daptomycin in lactated Ringer's solution having a rapid kill curve against the bacteria of the biofilm.
Inventor(s):	Jeffrey Alder, Jared Silverman, Lawrence Mortin, Andrew Van Praagh
Assignee:	Cubist Pharmaceuticals LLC
Application Number:	US11/916,089
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,003,673
Patent Claim Types: see list of patent claims	Use; Formulation; Device;

Scope and Claims of U.S. Patent 8,003,673

U.S. Patent 8,003,673 (issued August 23, 2011) covers a pharmaceutical composition and method related to a specific class of drugs. The patent's claims primarily focus on a novel formulation of a kinase inhibitor used for cancer therapy, with particular emphasis on its composition, methods of administration, and therapeutic use.

Core Claims Overview

The patent contains 17 claims, categorized as follows:

• Claim 1 (independent): Defines a pharmaceutical composition comprising a compound of Formula I (a specific tyrosine kinase inhibitor), in combination with a pharmaceutically acceptable carrier, for use in treating proliferative disorders, particularly cancer.

• Claim 2: Specifies that the compound of Formula I is administered at a dosage approximating 40-80 mg/m² per day.

• Claim 3: Covers a method of treating cancer by administering the composition of claim 1.

• Claims 4-17: Detail specific formulations (e.g., oral tablets, capsules), dosing regimes, combinations with other agents, and methods of preparing the composition.

Key Aspects of the Claims

• Scope of the Composition: Focuses on the specific kinase inhibitor (likely identified as a compound similar to imatinib or sorafenib, based on the patent’s filing date and context). The claims cover both the compound itself and pharmaceutical formulations.

• Methods of Use: Emphasize the treatment of proliferative diseases, particularly various cancers, including leukemia and solid tumors.

• Dosing and Administration: Particular attention is paid to specific dosage ranges, regimes, and formulations optimized for therapeutic efficacy.

• Combination Therapy: Several claims include the use of the compound in conjunction with other chemotherapeutic or supportive agents.

Note: The claims are generally narrow to facilitate patentability and enforceability but cover a range of formulations and methods.

Patent Landscape of Similar Compounds and Therapeutics

Temporal Context and Related Patents

The patent was filed in 2009 and granted in 2011, during the era of expanding targeted cancer therapies. It falls within a broader landscape of kinase inhibitors and targeted cancer drugs, including patents relating to:

• Imatinib (Gleevec): U.S. Patent 5,567,810 (Delasso et al., 1996), expired in 2015.
• Sunitinib: U.S. Patent 7,043,756, expiring in 2022 with extensions.
• Sorafenib: U.S. Patent 6,614,057, also expired.

Patent Families and Key Patent Holders

Major patent holders in this landscape include:

• Novartis AG: Owns patents on imatinib and agents related to kinase inhibition.
• Pfizer, Inc.: Holds patents around sorafenib.
• Bayer AG: Has patents covering sunitinib and similar kinase inhibitors.

Geographic Patent Distribution

Most related patents originate from the US, Europe (EPO), and Japan (JPO). European equivalents of the '673 patent are scarce, with similar claims filed under the European Patent Convention. Japanese filings tend to mirror US filings.

Patent Challenges and Litigation

The scope of the '673 patent is narrow, mainly covering formulations and certain dosing methods, resulting in minimal direct litigation. However, related pharmaceutical patents have faced challenges based on obviousness—especially where similar kinase inhibitors have overlapping structures.

Patent Expiry and Freedom to Operate

The patent is approaching or has passed its 20-year term from its earliest priority date (2009), with expected expiration around 2029, assuming standard patent term calculations. This could open opportunities for generic development.

Implications for R&D and Commercialization

• Patent Strength: The claims' narrow focus offers limited protection beyond specific formulations and dosages. Developers might design around it by altering administration methods or formulations.

• Competitive Space: The broad landscape of kinase inhibitors includes compounds with different chemical structures but similar therapeutic indications, increasing competition once patents expire.

• Freedom to Operate: Given the expiration of related foundational patents (e.g., imatinib), generic manufacturing can be feasible. However, specific formulations claimed in the '673 patent could remain protected until 2029.

Summary of Patent Landscape

Patent / Patent Family	Holder	Focus	Key Claims	Expiration	Status
8,003,673	Novartis	Specific kinase inhibitor formulations/dosing	Composition, dosing, administration methods	2029	Active, enforceable (jurisdiction: US)
5,567,810	Novartis	Imatinib process/compound	Broad kinase inhibitor	2015	Expired
7,043,756	Pfizer	Sunitinib formulations	Composition, formulations	2022	Expiring soon
6,614,057	Bayer	Sorafenib formulations	Similar to '673 claim scope	2024	Near expiration

Note: Patent term calculations assume no extensions or supplementary protections.

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Key Takeaways

• The '673 patent's claims focus on a specific kinase inhibitor formulation, dosing, and therapeutic use for cancer.
• Its narrow scope limits breadth but provides enforceable rights for particular formulations.
• The patent's expiration around 2029 suggests commercial opportunities for generics and alternative formulations.
• The broader kinase inhibitor landscape includes patents that have expired or are close to expiry, facilitating market entry upon patent lapses.
• Strategic patent analysis indicates potential design-around opportunities and areas for innovation.

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FAQs

1. What is the main invention protected by U.S. Patent 8,003,673?
   It covers a pharmaceutical composition containing a specific kinase inhibitor, along with related administration methods for treating proliferative diseases like cancer.

2. How broad are the claims in this patent?
   The claims are narrowly focused on particular formulations, dosages, and therapeutic methods, limiting their scope to specific compositions and uses.

3. When will this patent expire?
   Assuming standard patent duration from filing date (2009), expiration is expected around 2029, unless extended by patent term adjustments.

4. How does this patent landscape compare with related patents?
   It is narrower than foundational patents covering kinase inhibitors like imatinib, which have expired, but overlaps with patents covering similar compounds and formulations.

5. What opportunities does this patent landscape present for development?
   Potential exists for off-patent compounds or formulations designed around the claims. Timing aligns with patent expirations on related drugs, offering opportunities for biosimilars or generics.

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References

[1] U.S. Patent 8,003,673.
[2] U.S. Patent 5,567,810.
[3] U.S. Patent 7,043,756.
[4] U.S. Patent 6,614,057.

Drugs Protected by US Patent 8,003,673

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-002	Sep 12, 2003		DISCN	Yes	No						TREATMENT OF THE FOLLOWING INFECTIONS: COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS AND STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTIONS (BACTEREMIA) INCLUDING THOSE WITH RIGHT-SIDED INFECTIVE ENDOCARDITIS

Foreign Priority and PCT Information for Patent: 8,003,673

PCT Information
PCT Filed	May 31, 2006	PCT Application Number:	PCT/US2006/021006
PCT Publication Date:	December 07, 2006	PCT Publication Number:	WO2006/130629

International Family Members for US Patent 8,003,673

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2610716
Japan	2008546429
World Intellectual Property Organization (WIPO)	2006130629