Details for Patent: 10,300,039

Which drugs does patent 10,300,039 protect, and when does it expire?

Patent 10,300,039 protects AURYXIA and is included in one NDA.

This patent has thirty-six patent family members in twelve countries.

Summary for Patent: 10,300,039

Title:	Ferric citrate dosage forms
Abstract:	Disclosed herein are ferric citrate-containing tablets. In various embodiments, the tablets include ferric citrate formulations that meet certain dissolution, tableting and disintegration standards. In various aspects, the tablet formulations can include ferric citrate as the active ingredient and a binder. The formulations also can include a lubricant and/or a disintegrant (which, in some embodiments, can be the same as the binder).
Inventor(s):	Le; Henry Trong (Englewood Cliffs, NJ)
Assignee:	KERYX BIOPHARMACEUTICALS, INC. (Boston, MA)
Application Number:	15/159,008
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,300,039
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Understanding the Scope and Claims of United States Patent 10,300,039: A Detailed Analysis

Introduction

United States Patent 10,300,039, titled "Ferric citrate dosage forms," is a significant patent in the pharmaceutical industry, particularly for the treatment of hyperphosphatemia and iron deficiency anemia. This patent, owned by Keryx Biopharmaceuticals Inc., is part of the broader patent landscape surrounding the drug Auryxia (ferric citrate). Here, we will delve into the scope, claims, and the overall patent landscape associated with this patent.

Patent Overview

Patent Number and Title:

• US 10,300,039: "Ferric citrate dosage forms"

Patent Owner:

• Keryx Biopharmaceuticals Inc.

Patent Expiry:

• The patent is set to expire in July 2030[4].

Scope of the Patent

The scope of US 10,300,039 is centered around the formulation and dosage forms of ferric citrate, a compound used to treat hyperphosphatemia in patients with chronic kidney disease and iron deficiency anemia. Here are some key aspects of the patent's scope:

Therapeutic Uses

• The patent covers the use of ferric citrate as an iron-containing phosphate binder, addressing both hyperphosphatemia and iron deficiency anemia in adults with chronic kidney disease[1].

Dosage Forms

• The patent includes various dosage forms of ferric citrate, such as tablets, capsules, and other oral formulations. These forms are designed to optimize the delivery and absorption of the active ingredient[4].

Claims of the Patent

The claims of a patent are crucial as they define the legal boundaries of what is protected. Here’s a breakdown of the types of claims typically found in such patents:

Independent Claims

• Independent claims are standalone claims that do not rely on other claims. They broadly define the invention and are critical in determining the patent's scope. For US 10,300,039, these claims would likely cover the specific formulations and methods of preparing ferric citrate dosage forms[5].

Dependent Claims

• Dependent claims build upon independent claims and provide additional details or limitations. These claims help to narrow down the scope and provide additional protection for specific aspects of the invention. For example, dependent claims might cover specific tablet sizes, coating materials, or manufacturing processes[5].

Strategic Claim Management

Effective claim management is vital in maximizing the value of a patent. Here are some strategies relevant to US 10,300,039:

Claim Composition

• The initial patent application filing fee in the United States covers up to 3 independent claims and a total of 20 claims. Strategically managing these claims to ensure they utilize the full quota can enhance the patent’s breadth and flexibility without additional costs[5].

Claim Amendments

• During the patent prosecution phase, claims may be amended to align with USPTO requirements. This often involves consolidating multiple dependent claims into fewer, broader independent claims to facilitate application approval. Adding new dependent claims for every canceled claim ensures the patent utilizes its full complement of claims, maximizing its protective scope[5].

Patent Landscape

The patent landscape surrounding US 10,300,039 includes several other patents related to ferric citrate and its uses.

Related Patents

• There are multiple patents filed by Keryx Biopharmaceuticals Inc. that protect various aspects of ferric citrate, including its active ingredient, methods of making, and dosage forms. For example:
  • US 8338642, US 7767851, and US 9328133 have expired, while US 10300039 and US 9387191 remain active until 2030[4].

Patent Expiry and Generic Launch

• The expiry of patents can significantly impact the market. For instance, the expiry of earlier patents related to ferric citrate has opened the door for generic versions. However, the active patents like US 10,300,039 will continue to protect the proprietary formulations until their expiry in 2030[4].

Metrics for Measuring Patent Scope

To understand the scope and quality of a patent like US 10,300,039, researchers often use metrics such as independent claim length and independent claim count.

Independent Claim Length

• Longer independent claims can indicate a more detailed and specific invention, potentially narrowing the scope but increasing clarity[3].

Independent Claim Count

• A higher number of independent claims can suggest a broader scope, but it also increases the complexity and potential for litigation[3].

Impact on Innovation and Commercial Success

The strategic management of claims in patents like US 10,300,039 can have significant implications for innovation and commercial success.

Protection of Intellectual Property

• By ensuring that the patent utilizes its full complement of claims, inventors can secure robust protection for their invention, enhancing its defensive capabilities and value in licensing discussions or infringement disputes[5].

Licensing and Litigation

• Well-managed claims can reduce licensing and litigation costs by providing clear boundaries of what is protected, thus incentivizing further innovation without the burden of overly broad or unclear patents[3].

Key Takeaways

• Patent Scope: US 10,300,039 covers specific formulations and dosage forms of ferric citrate, protecting its use in treating hyperphosphatemia and iron deficiency anemia.
• Claim Management: Strategic claim management is crucial for maximizing the patent’s value, involving the optimal use of independent and dependent claims.
• Patent Landscape: The patent is part of a broader landscape of patents related to ferric citrate, with some patents having expired and others remaining active until 2030.
• Metrics for Patent Scope: Independent claim length and count are important metrics for assessing the scope and quality of the patent.
• Impact on Innovation: Effective claim management can enhance the patent’s protective scope, reduce litigation costs, and incentivize innovation.

FAQs

Q: What is the primary use of ferric citrate covered by US 10,300,039?

• The primary use is as an iron-containing phosphate binder to treat hyperphosphatemia and iron deficiency anemia in adults with chronic kidney disease.

Q: When does the patent US 10,300,039 expire?

• The patent is set to expire in July 2030.

Q: How does strategic claim management impact the value of a patent?

• Strategic claim management can enhance the patent’s breadth and flexibility, maximize its protective scope, and reduce licensing and litigation costs.

Q: What metrics are used to measure the scope of a patent?

• Metrics such as independent claim length and independent claim count are used to measure the scope and quality of a patent.

Q: How does the expiry of related patents affect the market for ferric citrate?

• The expiry of related patents can open the market for generic versions, while active patents continue to protect proprietary formulations until their expiry.

Sources

1. DrugBank: Ferric citrate: Uses, Interactions, Mechanism of Action.
2. USPTO: Patent Claims Research Dataset.
3. SSRN: Patent Claims and Patent Scope.
4. Pharsight: Auryxia patent expiration.
5. Harrity LLP: Maximizing Patent Value: A Strategic Approach to Claim Management.

Drugs Protected by US Patent 10,300,039

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Keryx Biopharms	AURYXIA	ferric citrate	TABLET;ORAL	205874-001	Sep 5, 2014		RX	Yes	Yes	10,300,039					CONTROL OF SERUM PHOSPHORUS LEVELS

International Family Members for US Patent 10,300,039

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2010276242
Brazil	112012001372
Canada	2768656