Details for Patent: 9,925,147

Which drugs does patent 9,925,147 protect, and when does it expire?

Patent 9,925,147 protects RAYALDEE and is included in one NDA.

This patent has fifty-two patent family members in fifteen countries.

Summary for Patent: 9,925,147

Title:	Method for treating secondary hyperparathyroidism in CKD
Abstract:	A stable, controlled release formulation for oral dosing of vitamin D compounds is disclosed. The formulation is prepared by incorporating one or more vitamin D compounds into a solid or semi-solid mixture of waxy materials. Oral dosage forms can be prepared by melt-blending the components described herein and filling gelatin capsules with the formulation.
Inventor(s):	Bishop; Charles W. (Miami Beach, FL), Tabash; Samir P. (Whitby, CA), Agudoawu; Sammy A. (Mississauga, CA), White; Jay A. (Newmarket, CA), Messner; Eric J. (Lake Forest, IL), Petkovich; P. Martin (Kingston, CA), Crawford; Keith H. (Lone Tree, CO)
Assignee:	OPKO RENAL, LLC (Miami, FL) OPKO IRELAND GLOBAL HOLDINGS, LIMITED (Grand Cayman, KY)
Application Number:	15/358,065
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound;

Understanding the Scope and Claims of United States Patent 9,925,147: A Comprehensive Analysis

Introduction to Patent 9,925,147

United States Patent 9,925,147, like any other patent, is a complex document that outlines the invention, its scope, and the claims that define the intellectual property protected by the patent. To analyze this patent, we need to delve into several key aspects, including the patent's background, the invention itself, the claims, and the broader patent landscape.

Background of the Patent

Invention Context

To understand the patent, it is crucial to know the context in which the invention was made. This includes the field of technology, the problems the invention solves, and any prior art that influenced the invention. For example, if the patent is related to medical devices, understanding the current state of medical technology and the specific challenges addressed by the invention is essential[4].

Government Interest and Funding

Some patents, especially those in fields like healthcare or technology, may have been developed with government funding or support. For instance, patents granted between 1976 and 2019 often include government interest statements, which can indicate the involvement of agencies like the National Institutes of Health or the Department of Agriculture[1].

The Invention

Description and Details

The patent description provides a detailed explanation of the invention, including its components, how it works, and its advantages over existing solutions. This section is critical for understanding the scope of the invention and what makes it novel and non-obvious.

Drawings and Figures

Patents often include drawings and figures that visually explain the invention. These visual aids can help in understanding the structural and functional aspects of the invention.

Claims Analysis

Types of Claims

Patent claims are the legal definitions of the invention and are categorized into independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims. The number and complexity of claims can affect the patent's scope and validity[3].

Claim Fees and Strategy

The number of claims can also impact the cost of filing and maintaining a patent. In the US, claim fees are charged for each claim in excess of 20 and for each independent claim in excess of 3. Strategically managing the number of claims can help avoid these fees while ensuring the invention is adequately protected[5].

Claim Scope and Breadth

The scope of the claims is a critical factor in determining the patent's validity and enforceability. Broader claims may face challenges during the examination process and could be more susceptible to invalidation due to prior art or obviousness. Narrower claims, while more specific, may offer stronger protection but could limit the invention's applicability[3].

Patent Scope Metrics

Independent Claim Length and Count

Research has shown that metrics such as independent claim length and count can be used to measure patent scope. Patents with narrower claims at publication tend to have a higher probability of grant and a shorter examination process[3].

Forward Citations and Patent Maintenance

The number of forward citations (citations by later patents) and patent maintenance payments can also indicate the scope and impact of the patent. Patents with more forward citations and higher maintenance payments are often seen as more valuable and influential[3].

Patent Landscape and Citations

Prior Art and Citations

Patent citations, both to prior patents and non-patent literature, are essential for establishing the novelty and non-obviousness of the invention. Missing prior art can lead to legal issues, and patent examiners often add references to ensure the prior work is validated[4].

Industry Impact

Understanding the broader patent landscape involves looking at how the patent fits into the existing body of work in its field. This includes analyzing similar patents, industry trends, and the competitive environment.

Legal Considerations

Obviousness and Double Patenting

Patents must pass the test of non-obviousness to be valid. The Federal Circuit has provided guidance on what claims can properly serve as obviousness-type double-patenting references, ensuring that later-filed patents do not unfairly extend the life of earlier patents[2].

Written Description and Enablement

The patent must also meet the requirements of written description and enablement, meaning the patent must clearly describe the invention and enable a person skilled in the art to make and use it. Challenges to these requirements can lead to invalidation of the patent claims[2].

Case Studies and Industry Expert Insights

Real-World Applications

Industry experts often provide insights into how patents like 9,925,147 are applied in real-world scenarios. For example, in the field of medical devices, a patent might be crucial for a company's product line and competitive strategy.

Litigation and Licensing

Patents can be involved in litigation and licensing agreements. Understanding how these legal battles and agreements shape the patent landscape is vital for business professionals looking to leverage patents for market domination.

Key Takeaways

• Patent Claims: The number and scope of claims are critical for defining the invention and determining the patent's validity.
• Government Interest: Government funding can play a significant role in the development of patents, especially in fields like healthcare and technology.
• Patent Scope Metrics: Metrics such as independent claim length and count can help measure the scope and impact of a patent.
• Legal Considerations: Patents must pass tests of non-obviousness, written description, and enablement to be valid.
• Industry Impact: Understanding the broader patent landscape is essential for leveraging patents effectively in business strategies.

FAQs

What is the significance of government interest statements in patents?

Government interest statements indicate that the invention was developed with government funding or support, which can affect the ownership and rights associated with the patent.

How do claim fees impact patent strategy?

Claim fees can significantly affect the cost of filing and maintaining a patent. Strategically managing the number of claims can help avoid these fees while ensuring adequate protection for the invention.

What metrics are used to measure patent scope?

Metrics such as independent claim length and count, forward citations, and patent maintenance payments are used to measure patent scope and impact.

Why are prior art citations important in patents?

Prior art citations are crucial for establishing the novelty and non-obviousness of the invention. Missing prior art can lead to legal issues and challenges to the patent's validity.

How do legal considerations like obviousness and double patenting affect patent validity?

Legal considerations such as obviousness and double patenting are essential for ensuring that patents are valid and do not unfairly extend the life of earlier patents.

References

1. PatentsView Government Interest Results Analysis. PatentsView.
2. Federal Circuit Provides Guidance on What Claims Can Properly Serve as Obviousness-Type Double-Patenting References. WSGR.
3. Patent Claims and Patent Scope. SSRN.
4. A Large-scale Analysis of Patent Citations to HCI Research. Stanford University.
5. Claim fees: how to avoid their payment? - Obtaining an EP Patent. Plass.

Drugs Protected by US Patent 9,925,147

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes	9,925,147		Y			TREATING SECONDARY HYPERPARATHYROIDISM IN CKD WITH SUSTAINED RELEASE CALCIFEDIOL TO REDUCE THE PATIENT'S SERUM PARATHYROID HORMONE LEVEL AND CMAX24HR/C24HR IS REDUCED COMPARED TO BOLUS IV INJECTION AND IMMEDIATE-RELEASE, ORAL DOSING
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes	9,925,147		Y			TREATING SECONDARY HYPERPARATHYROIDISM IN CHRONIC KIDNEY DISEASE WITH SUSTAINED RELEASE 25-HYDROXYVITAMIN D TO REDUCE THE PATIENT'S SERUM PARATHYROID HORMONE LEVEL AND THE SUSTAINED RELEASE IS OVER AT LEAST 10 HOURS
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes	9,925,147		Y			TREATING SECONDARY HYPERPARATHYROIDISM IN CHRONIC KIDNEY DISEASE WITH SUSTAINED RELEASE 25-HYDROXYVITAMIN D TO REDUCE THE PATIENT'S SERUM PARATHYROID HORMONE LEVEL AND CMAX IS REDUCED COMPARED TO BOLUS IV INJECTION AND IMMEDIATE-RELEASE, ORAL DOSING
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes	9,925,147		Y			TREATING SHPT IN CKD WITH SUSTAINED RELEASE CALCIFEDIOL TO REDUCE SERUM PARATHYROID HORMONE LEVEL AND CHANGE IN SERUM CONCENTRATION OF CALCIFEDIOL IN DOSE INTERVAL IS REDUCED COMPARED TO BOLUS IV INJECTION AND IMMEDIATE-RELEASE, ORAL DOSING
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016		RX	Yes	Yes	9,925,147		Y			TREATING SECONDARY HYPERPARATHYROIDISM IN CKD WITH SUSTAINED RELEASE CALCIFEDIOL TO REDUCE THE PATIENT'S SERUM PARATHYROID HORMONE LEVEL AND TMAX IS INCREASED COMPARED TO BOLUS IV INJECTION AND IMMEDIATE-RELEASE, ORAL DOSING

International Family Members for US Patent 9,925,147

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2481400		301085	Netherlands
European Patent Office	2481400		122020000079	Germany
European Patent Office	2481400		CA 2020 00059	Denmark
European Patent Office	2481400		C02481400/01	Switzerland
European Patent Office	2481400		132021000000071	Italy
European Patent Office	2481400		C202130022	Spain