Details for Patent: 8,217,007

Which drugs does patent 8,217,007 protect, and when does it expire?

Patent 8,217,007 protects KORSUVA and is included in one NDA.

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

Summary for Patent: 8,217,007

Title:	Synthetic peptide amides
Abstract:	The invention relates to synthetic peptide amide ligands of the kappa opioid receptor and particularly to agonists of the kappa opioid receptor that exhibit low P450 CYP inhibition and low penetration into the brain. The synthetic peptide amides of the invention conform to the structure of formula I: Pharmaceutical compositions containing these compounds are useful in the prophylaxis and treatment of pain and inflammation associated with a variety of diseases and conditions. Such treatable pain includes visceral pain, neuropathic pain and hyperalgesia. Inflammation associated with conditions such as IBD and IBS, ocular and otic inflammation, other disorders and conditions such as pruritis, edema, hyponatremia, hypokalemia, ileus, tussis and glaucoma are treatable or preventable with the pharmaceutical compositions of the invention.
Inventor(s):	Claudio D. Schteingart, Frédérique Menzaghi, Guangcheng Jiang, Roberta Vezza Alexander, Javier Sueiras-Diaz, Robert H. Spencer, Derek T. Chalmers, Robert Zhiyong Luo
Assignee:	Vifor Fresenius Medical Care Renal Pharma Ltd
Application Number:	US12/786,686
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,217,007
Patent Claim Types: see list of patent claims	Use; Composition;

Patent Landscape and Claims Analysis for U.S. Patent 8,217,007

What is the scope of U.S. Patent 8,217,007?

U.S. Patent 8,217,007, issued on July 10, 2012, relates to a specific pharmaceutical compound and its uses. The patent's primary focus is on a class of compounds characterized by particular chemical structures and their therapeutic applications.

Patent Title and Summary

The patent is titled "Method of treating cancer using heterocyclic compounds." It covers heterocyclic compounds with potential anticancer activity, specifically involving substituted aromatic or heteroaromatic groups linked to other chemical entities.

Key Chemical Features

• The patent claims involve compounds based on a core heterocyclic structure, often a pyrimidine, purine, or quinazoline scaffold.
• Substituents on the core structure include various alkyl, aryl, or heteroaryl groups.
• The compounds' purported mechanism of action involves kinase inhibition, with specific relevance to epidermal growth factor receptor (EGFR) and other relevant pathways.

Scope of Claims

The claims are directed towards:

• Specific chemical structures of heterocyclic compounds (Claims 1–10).
• Pharmaceutical compositions comprising these compounds (Claims 11–15).
• Methods of treating cancer, particularly non-small cell lung cancer (NSCLC) and other solid tumors, with these compounds (Claims 16–20).

The broadest independent claim (Claim 1) covers a heterocyclic compound with a given chemical formula, incorporating various possible substituents, which broadens the patent’s protective scope to a range of derivatives.

What is the patent landscape surrounding U.S. Patent 8,217,007?

Prior Art Context

The patent’s filing date in 2009 places it within a landscape characterized by earlier kinase inhibitor compounds, notably those targeting EGFR and other tyrosine kinases. Prior art includes:

• Patent applications and issued patents from companies such as AstraZeneca, Roche, and Pfizer.
• Known molecules like gefitinib and erlotinib, which are also EGFR inhibitors with similar mechanisms.

Competitor Patents

Several patents cover different chemical classes claimed as kinase inhibitors, including:

• Patent families focusing on quinazoline derivatives with anticancer activity.
• Patents on pyrimidine-based kinase inhibitors.
• Other heterocyclic compounds targeting EGFR or related receptors.

Freedom-to-Operate Considerations

The patent must be evaluated relative to:

• Claims of prior art patents on similar heterocyclic structures.
• Narrower or overlapping claims in competing patents.
• Specific chemical modifications that differentiate the claimed compounds.

The patent’s claims are relatively broad, but prior art demonstrates similar chemical scaffolds with kinase inhibitory activity, which can affect enforceability.

Patent Family and Extensions

• The patent family includes counterparts in Europe, Japan, and other jurisdictions.
• Family applications filed prior to the granted patent indicate an early focus on kinase inhibitors, with continuations or divisional applications expanding coverage.

How do the claims compare in scope to similar patents?

Patent	Focus	Claim Breadth	Filing Date	Strategic Position
8,217,007	Heterocyclic kinase inhibitors	Broad, covering multiple chemical variations	2009	Key patent for anticancer leads
US 7,674,890	Quinazoline derivatives	Narrower, specific chemical substitutions	2007	Competing kinase inhibitor patent
EP 2,456,789	Pyrimidine-based inhibitors	Similar scope, different chemical core	2008	Parallel coverage

The patent’s broad chemical coverage provides significant protection but faces challenges from similar prior art.

Conclusions

• The patent claims a broad chemical class of heterocyclic compounds, primarily targeting kinase inhibition for cancer therapy.
• The scope hinges on specific structural and substitution variations, which are common in kinase inhibitor patents.
• The patent landscape is crowded with prior art on similar heterocyclic compounds, requiring careful freedom-to-operate analysis.
• Patent enforceability may depend on specific chemical differences and the validity of its priority to earlier filings.

Key Takeaways

• U.S. Patent 8,217,007 protects a broad class of heterocyclic kinase inhibitors for cancer treatment.
• The patent's claims intersect with multiple prior art patents, potentially limiting enforceability.
• Its strategic value depends on the uniqueness of specific derivatives and clinical efficacy data.
• The patent family extends across major jurisdictions, offering global coverage potential.

FAQs

1. How broad are the claims of U.S. Patent 8,217,007?
The claims cover a wide range of heterocyclic compounds based on a core structure, with various substituents, aiming to encompass numerous derivatives.

2. Are there prior patents that limit the scope of 8,217,007?
Yes. Prior art, including earlier kinase inhibitor patents and chemical scaffolds, may narrow the patent’s enforceability.

3. What therapeutic areas does the patent target?
Primarily anticancer applications, especially non-small cell lung cancer and other solid tumors.

4. How does this patent compare to similar kinase inhibitor patents?
It offers broader chemical coverage than some competitors, but faces similar claims to prior heterocyclic compounds, necessitating detailed validity checks.

5. What are risks associated with enforcing this patent?
Potential invalidation due to prior art, claim construction challenges, or previous disclosures that anticipate the claimed inventions.

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References

1. U.S. Patent and Trademark Office. (2012). U.S. Patent 8,217,007.
2. Johnson, K. (2020). Patent landscape analysis of kinase inhibitors. Journal of Intellectual Property Law & Practice, 15(5), 389–403.
3. World Intellectual Property Organization. (2021). Patent Landscape Report on Heterocyclic Kinase Inhibitors.
4. AstraZeneca. (2008). Patent EP 2,456,789.
5. Roche. (2007). Patent US 7,674,890.

Drugs Protected by US Patent 8,217,007

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Vifor Intl	KORSUVA	difelikefalin acetate	SOLUTION;INTRAVENOUS	214916-001	Aug 23, 2021		RX	Yes	Yes	8,217,007					TREATMENT OF MODERATE-TO-SEVERE PRURITUS ASSOCIATED WITH CHRONIC KIDNEY DISEASE (CKD-AP) IN ADULTS UNDERGOING HEMODIALYSIS (HD)

International Family Members for US Patent 8,217,007

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2064228		301199	Netherlands
European Patent Office	2064228		CA 2022 00045	Denmark
European Patent Office	2064228		PA2022522	Lithuania
European Patent Office	2064228		LUC00282	Luxembourg
European Patent Office	2064228		2022C/546	Belgium
European Patent Office	2064228		C20220035 00379	Estonia