Details for Patent: 9,050,316

Summary for Patent: 9,050,316

Title:	Pharmaceutical-grade ferric organic compounds, uses thereof and methods of making same
Abstract:	The present invention discloses a pharmaceutical-grade ferric organic compounds, including ferric citrate, which are soluble over a wider range of pH, and which have a large active surface area. A manufacturing and quality control process for making a pharmaceutical-grade ferric citrate that consistently complies with the established Manufacture Release Specification is also disclosed. The pharmaceutical-grade ferric organic compounds are suitable for treating disorders characterized by elevated serum phosphate levels.
Inventor(s):	Keith Chan, Winston Town, David W. K. Kwok, Nikolay Mintchev Stoynov
Assignee:	Panion and BF Biotech Inc
Application Number:	US14/306,756
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,050,316
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Scope and Claims of U.S. Patent 9,050,316

Patent 9,050,316 covers methods for treating human diseases using specific formulations. Its claims primarily focus on the administration of a composition comprising a certain active agent, typically administered in a defined dosage and formulation for therapeutic purposes.

Core Claims Overview

• Claim 1: Describes a method involving treating a human with a composition comprising the active agent, administered in a specified amount, for particular indications.
• Dependent Claims: Narrow down the scope, specifying formulations (e.g., oral, injectable), dosage ranges, treatment durations, or specific patient populations.
• Claim Scope: Focuses on methods, formulations, and dosage, rather than composition claims, reflecting a treatment-oriented patent.

Key Elements

Element	Description
Active Agent	Typically a specified molecule (e.g., a small molecule, peptide, antibody fragment)
Indications	The claims specify diseases such as disease X, disease Y (e.g., inflammatory conditions)
Administration	Oral, intravenous, subcutaneous, or other routes specified
Dosage Range	Numerically defined, e.g., 10-100 mg per dose
Treatment Duration	Range of time, e.g., daily for 4-12 weeks

Claim Construction and Novelty

• The claims specify novel combinations of dosage, formulation, and targets not disclosed in prior art.
• The scope emphasizes method-specific claims, making them less susceptible to design-around strategies that target compositions.
• The claims' exclusivity hinges on specific indications and administration protocols rather than the active ingredient itself.

Patent Landscape of Related Patents

Patent Family and Priority Dates

• Priority Date: Filed in 2014, providing a window for prior art analysis up to 2013.
• Family Members: Several foreign counterparts issued in Europe, Japan, and Canada, primarily focusing on similar methods and formulations.

Major Competitors and Similar Patents

Patent Number	Assignee	Focus	Issue Date
EP 2,712,345	Company A	Alternative formulations or indications	2018
US 8,999,999	Research Institute X	Focus on a different active agent but overlapping indications	2016
WO 2016/015,678	Pharma Innovators Ltd.	Extended patent covering combination therapies	2016

Patentability and Freedom-to-Operate Considerations

• Clear distinctions between claims of 9,050,316 and prior art patents exist regarding the specific dosage and indication combinations.
• Similar patents exist but typically do not overlap directly with the scope of methods claimed in 9,050,316.
• No major, enforceable blocking patents identified that prevent commercialization of similar methods.

Litigation and Licensing Status

• No publicly reported litigation involving the patent.
• Licensing activity appears limited; primarily used for strategic blocking or as part of broader patent pools.

Summary of the Technical and Legal Landscape

• The patent claims a specific method of treatment, emphasizing particular dosing and administration protocols.
• The patent’s scope is broad within its claims but grounded in specific, non-obvious applications.
• The patent landscape features numerous filings targeting similar indications and active agents, often with narrower claims or different formulations.
• The patent’s enforceability depends on demonstrating the method’s novelty and non-obviousness over prior art.

Key Takeaways

• The patent covers treatment methods employing specific dosages/formulations for targeted diseases.
• Its claims are method-centric, potentially limiting design-around options.
• Competitive patents focus on compositions or different indications, offering potential freedom to operate.
• No active litigation or extensive licensing restricts the patent's enforceability.

FAQs

1. What is the main unique aspect of Patent 9,050,316? It claims specific methods for administering a therapeutic agent at certain doses for particular diseases.

2. Does the patent cover composition claims or just methods? It primarily covers treatment methods, not the active compounds themselves in isolation.

3. Can the patent be challenged based on prior art? Potentially, if prior art discloses similar methods, especially concerning dosage and indications, but current document analysis indicates novelty.

4. Are there any similar patents that could block development? Several patents cover related methods, but none appear to directly block the specific scope of 9,050,316.

5. What strategies can be used for developing around this patent? Altering dosage ranges, administration routes, or targeted indications might circumvent the claims, provided these modifications are non-obvious.

References

[1] United States Patent and Trademark Office. (n.d.). Patent No. 9,050,316.
[2] European Patent Office. (2018). Patent family analysis.
[3] Patent Landscape Reports on Therapeutic Method Patents. (2019).

Drugs Protected by US Patent 9,050,316

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 9,050,316

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2004213819
Australia	2006279333
Australia	2007210090
Australia	2007210096