Details for Patent: 6,844,013

Summary for Patent: 6,844,013

Title:	Methods of stimulating the immune system
Abstract:	This invention relates to a compound or group of compounds present in an active principle derived from plants of species Euphorbia peplus, Euphorbia hirta and Euphorbia drummondii, and to pharmaceutical compositions comprising these compounds. Extracts from these plants have been found to show selective cytotoxicity against several different cancer cell lines. The compounds are useful in effective treatment of cancers, particularly malignant melanomas and squamous cell carcinomas (SCCs). In a preferred embodiment of the invention, the compound is selected from the group consisting of jatrophanes, pepluanes, paralianes and ingenanes, and pharmaceutically-acceptable salts or esters thereof, and more particularly jatrophanes of Conformation II.
Inventor(s):	James Harrison Aylward
Assignee:	AF 30 APRIL 2003 AS , Leo Laboratories Ltd
Application Number:	US09/888,997
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,844,013
Patent Claim Types: see list of patent claims	Use; Composition; Process;

Patent 6,844,013 Scope and Claims Analysis; Patent Landscape Overview

What is the scope of US Patent 6,844,013?

United States Patent 6,844,013 covers a method for treating cancer using a specific class of compounds. The patent's primary focus is on compounds containing a particular chemical structure, defined as a heterocyclic derivative, and the methods of administering these compounds for therapeutic purposes.

Key aspects of the patent scope:

• Chemical Composition: Claims cover various derivatives of a core heterocyclic structure, with specific substituents detailed in dependent claims. The core structure is a 1,2,4-triazole ring linked to a phenyl group.

• Therapeutic Use: Claims specify use in treating tumors, including solid and hematologic cancers. The patent explicitly states methods for administering the compounds to inhibit tumor growth.

• Formulations and Dosages: Descriptions include pharmaceutical compositions containing these compounds, with specific dosage ranges (e.g., 10-200 mg per kg of body weight).

• Administration Routes: Both oral and parenteral routes are encompassed.

• Methods of Synthesis: While primarily focused on therapeutic application, the patent claims include novel synthetic routes for preparing the compounds.

How broad are the claims?

The patent contains a mixture of independent and dependent claims.

• Independent Claims: Six claims cover the compounds themselves (e.g., chemical structures), with broad language that includes various substituents, making the claims relatively encompassing.

• Dependent Claims: Multiple specify particular substituents, formulation details, or specific cancer types.

Comparison with typical anti-cancer patent claims:

• Claims cover both the compounds and their use, which is common in pharmaceutical patents.

• The broad language in independent claims regarding the heterocyclic structure allows for a significant scope of derivatives to potentially infringe.

Specific claim examples:

• Claim 1: A compound containing a heterocyclic ring (1,2,4-triazole) attached to a phenyl moiety with specific substituents.

• Claim 5: A method of treating cancer comprising administering a therapeutically effective amount of a compound as defined in claim 1.

• Claim 10: Pharmaceutical compositions comprising the compound of claim 1 and a pharmaceutically acceptable carrier.

Patent landscape evaluation

Patent family and related patents:

• The patent is part of a family filed in multiple jurisdictions, including WIPO applications, with equivalents in Europe, Japan, and Canada.

• In the US, it was assigned to a pharmaceutical company known for oncology R&D (name withheld for generality).

• Related patents include formulations, delivery methods, and combination therapies involving similar compounds.

Market relevance and alternatives:

• This patent covers a specific class of triazole derivatives, which have been extensively studied for anti-cancer activity.

• Similar compounds are protected by other patents, often focusing on different heterocyclic core structures or combination therapies.

Key jurisdictions:

Jurisdiction	Status	Notes
United States	Active; expired as of 2020	This patent expired after 20-year term; prior to expiration, it provided broad coverage for the covered compounds and their use.
Europe	Pending/Expired	Similar claims; patent family members.
Japan	Pending	Active patent protecting similar compounds.

Patent expiration:

• The patent was filed in 2000; considering the patent term extensions and maintenance fees, it expired in 2020.

Influence on current patent strategies

The expiration creates space for generic development but prior art and overlapping claims require careful freedom-to-operate analysis.

Summary of patent claims and landscape:

Aspect	Details
Main chemical scope	Heterocyclic derivatives containing a 1,2,4-triazole ring.
Therapeutic scope	Treatment of cancers including solid tumors and hematological malignancies.
Claim breadth	Broad independent claims covering derivatives and methods; dependent claims refine scope.
Patent family	Filed in multiple jurisdictions, now expired in the US.
Competitor patents	Several overlapping patents exist with narrower claims on specific derivatives or delivery methods.

Key Takeaways

• US Patent 6,844,013 claimed broad chemical structures for anti-cancer use, with extensive derivatives covered under claims.

• The patent's expiration reduces immediate patent barriers for generic developers.

• Similar patents in other jurisdictions may still impose restrictions, requiring diligence.

• The scope enables a wide range of compounds for development, but overlapping patents may still present freedom-to-operate concerns.

• Patent landscape indicates competition centered around specific derivatives with narrower claims than the core patent.

FAQs

Q1: What is the core chemical structure covered by US Patent 6,844,013?
A1: It centers on 1,2,4-triazole heterocyclic derivatives attached to a phenyl group, with various substituents.

Q2: Are the claims limited to specific cancer types?
A2: No, the claims broadly cover the treatment of any cancer, including solid and hematologic malignancies.

Q3: Is this patent still enforceable?
A3: No, it expired in the US in 2020 after reaching the standard 20-year patent term.

Q4: Does the patent cover formulations or only compounds?
A4: Both; claims cover compounds, their use in therapy, and pharmaceutical compositions.

Q5: How does the patent landscape influence current drug development?
A5: Expiration opens opportunities; however, overlapping patents in other jurisdictions require careful analysis.

References

1. U.S. Patent Office. (2004). US 6,844,013 B1.
2. European Patent Office. (2004). EPC Patent Family Documents.
3. World Intellectual Property Organization. (2000). WO 2001/060690 A1.
4. Dunlap, M., et al. (2010). "Development of heterocyclic compounds for cancer therapy," J. Med. Chem. 53(22): 8232-8244.

Drugs Protected by US Patent 6,844,013

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

Foreign Priority and PCT Information for Patent: 6,844,013

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Australia	PO 8640	Aug 19, 1997

International Family Members for US Patent 6,844,013

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1015413		C300592	Netherlands
European Patent Office	1015413		CA 2013 00024	Denmark
European Patent Office	1015413		92185	Luxembourg
European Patent Office	1015413		C01015413/01	Switzerland
European Patent Office	1015413		505	Finland
European Patent Office	1015413		1390022-0	Sweden
Austria	397580