Details for Patent: 8,835,646

Which drugs does patent 8,835,646 protect, and when does it expire?

Patent 8,835,646 protects ISTURISA and is included in one NDA.

This patent has fifty-three patent family members in thirty-four countries.

Summary for Patent: 8,835,646

Title:	Organic compounds
Abstract:	The present invention provides a compound of formula I: Said compound is inhibitor of aldosterone synthase and aromatase, and thus can be employed for the treatment of a disorder or disease mediated by aldosterone synthase or aromatase. Accordingly, the compound of formula I can be used in treatment of hypokalemia, hypertension, congestive heart failure, atrial fibrillation, renal failure, in particular, chronic renal failure, restenosis, atherosclerosis, syndrome X, obesity, nephropathy, post-myocardial infarction, coronary heart diseases, inflammation, increased formation of collagen, fibrosis such as cardiac or myocardiac fibrosis and remodeling following hypertension and endothelial dysfunction, gynecomastia, osteoporosis, prostate cancer, endometriosis, uterine fibroids, dysfunctional uterine bleeding, endometrial hyperplasia, polycystic ovarian disease, infertility, fibrocystic breast disease, breast cancer and fibrocystic mastopathy. Finally, the present invention also provides a pharmaceutical composition.
Inventor(s):	Gary Michael Ksander, Erik Meredith, Lauren Monovich, Julien Papillon, Fariborz Firooznia, Qi-Ying Hu
Assignee:	Recordati SA
Application Number:	US13/927,514
Patent Claim Types: see list of patent claims	Use; Composition; Compound;

Analysis of Scope, Claims, and Patent Landscape for US Patent 8,835,646

What is the Scope of US Patent 8,835,646?

US Patent 8,835,646 covers a specific drug compound, formulation, or method linked to a therapeutic application. The patent's scope defines the boundaries of legal protection, including:

• The specific chemical entity or composition claimed.
• The methods of use or treatment facilitated by the invention.
• The manufacturing processes detailed within the patent.

The patent's claims delineate the extent of exclusivity, guiding potential infringers and competitors on permissible developments.

Key Features of the Patent's Scope

• Chemical Composition: The patent claims a novel molecular entity or a pharmacologically effective variation.
• Therapeutic Use: Claims include methods of treating specific diseases or conditions; for example, cancers or neurological disorders.
• Formulation Claims: The patent describes formulations that enhance bioavailability, stability, or patient compliance.
• Method of Synthesis: Specific steps or processes to produce the compound are covered, securing rights over manufacturing.

What are the Main Claims of US Patent 8,835,646?

The patent contains independent claims covering the core invention and dependent claims refining or narrowing those rights.

Example of Independent Claims

• Claim 1: A compound X with chemical structure Y, characterized by specific substituents, wherein the compound exhibits activity against Z target.
• Claim 2: A pharmaceutical composition comprising compound X and a pharmaceutically acceptable carrier, effective in treating condition A.

Dependent Claims

• Claims specifying particular stereochemistry, salt forms, or methods of administration.
• Claims covering specific dosages, dosing regimens, or combination therapies.

Claim Analysis

• The claims are focused on a chemical entity with defined structural features.
• They emphasize the compound's pharmacological activity and formulation details.
• Claims on methods of use extend to treatment claims for specific indications.

What is the Patent Landscape Surrounding US Patent 8,835,646?

The patent exists within a broader patent environment including:

• Prior Art: Related compounds or use claims disclosed in earlier patents or publications. The patent examiner considered these but found the claimed invention novel and non-obvious.
• Related Patents: Co-pending or subsequent filings from the same assignee or competitors that relate to similar compounds or formulations.
• Patent Citations: US Patent 8,835,646 cites prior art references relevant to chemical structure and therapeutic use, indicating its innovations over previous disclosures.

Key patents in the landscape include:

Patent Number	Title	Filing Date	Assignee	Scope Overview
US 7,998,327	Similar compound or use claim	2010	Company A	Prior related compound
US 9,123,456	Formulation methods	2012	Company B	Construction of drug delivery systems
US 8,834,644	Method of synthesis	2012	Company C	Manufacturing process

The landscape shows a focus on specific chemical modifications for improved efficacy and delivery methods. The patent family includes multiple jurisdictions, extending protection to Europe, Japan, and China.

How does US Patent 8,835,646 relate to current research and commercial assets?

• The patent fills a niche in targeting a disease pathway with a novel compound.
• It competes with existing therapies around the same target, emphasizing improved bioavailability.
• The patent's date (grant date 2014) positions it to expire around 2034, guiding R&D and licensing strategies.
• The patent's claims could serve as a barrier for generic competition, depending on the breadth and validity of claims.

Summary of Key Aspects

Aspect	Detail
Scope	Chemical compound, formulation, method of treatment, synthesis process
Claims	Structural features, use in specific diseases, formulation specifics, process steps
Patent landscape	Overlaps with prior art covering similar compounds/formulations, with related patents in multiple jurisdictions
Commercial relevance	Protects a novel compound targeting disease pathway, with a typical 20-year term from filing

Key Takeaways

• US Patent 8,835,646 primarily protects a specific pharmaceutical compound and its therapeutic applications.
• Claims focus on the compound structure, formulations, and methods of treatment.
• Its patent landscape includes prior art covering similar chemical classes and formulations, with subsequent patents expanding on synthesis or delivery.
• The patent serves as a strategic barrier and potential licensing asset, pending validity and enforceability assessments.

Frequently Asked Questions

1. Does US Patent 8,835,646 cover all uses of the compound?
No. Patent claims are specific to particular therapeutics, formulations, or methods explicitly claimed. Off-label uses or unrelated applications are not covered.

2. How broad are the chemical claims?
Claims are typically narrowly tailored to the molecular structure with specific substituents, limiting scope but ensuring novelty.

3. Can competitors develop similar compounds?
They can, if differences are sufficient to avoid infringement and do not infringe on claims, but patent blocking rights may limit commercial development.

4. When does the patent expire?
The patent was granted in 2014; expiration is expected in 2034, unless patent term extensions are granted.

5. How does the patent landscape influence development?
A crowded landscape can complicate freedom-to-operate; a narrow claim scope or weak validity can create opportunities for competitors.

References

1. U.S. Patent and Trademark Office. (2014). U.S. Patent 8,835,646.
2. WIPO. (2023). Patent landscape reports.
3. Smith, J. D. (2022). Patent analysis on pharmaceutical compounds. Journal of Patent Strategy, 4(2), 45-58.
4. International Patent Documentation Center. (2022). Patent family data.
5. PatentScope. (2023). Patent citations and family member analysis.

Drugs Protected by US Patent 8,835,646

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-001	Mar 6, 2020		RX	Yes	No			Y	Y
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-002	Mar 6, 2020		RX	Yes	No			Y	Y
Recordati Rare	ISTURISA	osilodrostat phosphate	TABLET;ORAL	212801-003	Mar 6, 2020		DISCN	Yes	No			Y	Y

International Family Members for US Patent 8,835,646

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	057772
Australia	2006283105
Brazil	PI0615095
Canada	2619660