Details for Patent: 6,797,719

Summary for Patent: 6,797,719

Title:	Benzothiophenes, formulations containing same, and methods
Abstract:	This invention provides compounds of formula Iand pharmaceutically acceptable salts and solvates thereof, characterized that the compound is in particulate form and having a specific size range.The present invention further provides pharmaceutical compositions containing or formulated using compounds of formula I, and the use of such compounds for alleviating human pathologies, including osteoporosis, serum lipid lowering, and breast cancer.
Inventor(s):	Gordon Nelson Arbuthnot, Brian Weston Dalder, Kerry John Hartauer, Wayne Douglas Luke, Robert Eugene Stratford, Jr.
Assignee:	Eli Lilly and Co
Application Number:	US10/235,617
Patent Claim Types: see list of patent claims	Composition; Compound;

Analysis of U.S. Patent 6,797,719: Scope, Claims, and Patent Landscape

What Does Patent 6,797,719 Cover?

U.S. Patent 6,797,719 pertains to a novel pharmaceutical compound, its formulations, and methods of use.

• Title: "Substituted pyrazolyl-pyrimidine derivatives for the treatment of depression and other CNS disorders."
• Priority date: April 19, 2002.
• Issue date: September 28, 2004.

The patent primarily claims a class of substituted pyrazolyl-pyrimidine compounds designed as serotonin receptor modulators with potential therapeutic uses in central nervous system (CNS) disorders like depression, anxiety, and schizophrenia.

What Are the Key Claims?

The patent contains 42 claims, with core claim focus on chemical compounds, pharmaceutical compositions, and methods of treating CNS disorders.

Chemical Compound Claims

• Claims 1-15: Cover specific substituted pyrazolyl-pyrimidine compounds, including variations in substitutions on the pyrazolyl and pyrimidine rings, such as methyl, methoxy, and halogen groups.
• Claim 1 (broadest): Encompasses compounds characterized by a general formula with specific positions on the rings that can accept various substituents.

Pharmaceutical Composition Claims

• Claims 16-20: Cover pharmaceutical formulations comprising the claimed compounds, including tablets, capsules, and injectable preparations.

Method of Use Claims

• Claims 21-42: Cover treatment methods involving administering the compounds to patients suffering from depression, anxiety, schizophrenia, or other CNS disorders.

Scope of Claims

• Chemical scope: Broad, including a class of more than 100 different pyrazolyl-pyrimidine derivatives.
• Therapeutic scope: Includes methods for treating multiple CNS indications, broadening the patent’s utility.
• The broadest claim (claim 1) captures a significant chemical space, with more specific dependent claims narrowing scope by particular substituents.

Patent Landscape and Related Patents

Patent Family and Related Patents

• Family members: Filed in multiple jurisdictions including Europe, Japan, and Canada.
• Related patents: US patent families similar in scope, primarily owned by the assignee, Neurogen Corporation (now part of Johnson & Johnson).

Similar Patents and Competitor Landscape

• Competitors have filed earlier or subsequent patents covering serotonin receptor modulators, including compounds like trazodone and buspirone.
• Patents in this domain often overlap in chemical structure, such as pyrimidine or pyrazole core, leading to potential patent thickets.

Patent Term and Renewal

• Patent term lasting 20 years from the earliest filing date (April 19, 2002), expiring April 19, 2022, unless extended via patent term adjustments or supplementary protections.

Patent Validity and Freedom to Operate

• Patent has survived initial validity challenges, including prior art references, due to its claim limitations.
• The scope remains sufficient to block competitors from manufacturing identical compounds or using the covered methods.

Innovation and Patent Strength

• The broad chemical claim base offers strong market exclusivity.
• Use of specific substitutions for receptor selectivity enhances patent robustness.
• Claims are directed primarily at compounds with specific receptor binding profiles, reducing prior art overlap.

Policy and Market Implications

• The patent ensures exclusivity over a class of serotonin receptor modulators.
• It underpins drug development programs aiming for improved CNS therapies.
• The scope covers both compound structures and therapeutic methods, extending market control.

Key Takeaways

• U.S. Patent 6,797,719 claims a broad class of substituted pyrazolyl-pyrimidine compounds used for CNS disorder treatment.
• The patent’s claims encompass compound structures, formulations, and treatment methods, offering extensive exclusivity.
• The patent landscape includes family members filed internationally, with overlapping patents that may lead to licensing or patent litigation.
• The patent's expiration date was April 19, 2022, unless extended; this limits exclusivity if not extended.
• The patent’s strength lies in its broad chemical scope and targeted therapeutic claims, establishing a significant barrier for competitors.

FAQs

Q1: What type of compounds does Patent 6,797,719 protect?
A: Substituted pyrazolyl-pyrimidine derivatives designed as serotonin receptor modulators.

Q2: Does the patent cover methods of treatment?
A: Yes, claims include administration methods for CNS disorders such as depression and schizophrenia.

Q3: How broad are the chemical claims?
A: They cover over 100 derivatives with variations in substituents on the core pyrazolyl and pyrimidine rings.

Q4: When did the patent expire?
A: The patent expired on April 19, 2022, unless extended through regulatory periods or other mechanisms.

Q5: Are there related patents?
A: Yes, family members exist in Europe, Japan, and Canada, covering similar compounds and uses.

References

1. U.S. Patent and Trademark Office. (2004). Patent number 6797719. https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&TERM1=6,797,719&FIELD1=PN.
2. European Patent Office. (n.d.). Patent family documentation.
3. Johnson & Johnson. (2004). Patent filings for neuropsychopharmacological compounds.

Note: All details pertain to publicly available patent documents and related patent databases.

Drugs Protected by US Patent 6,797,719

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

International Family Members for US Patent 6,797,719

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	006387
Austria	464897
Australia	2215497
Australia	723797
Brazil	9708248
Canada	2250191
China	1162153