Patent: 5,281,661

Summary for Patent: 5,281,661

Title:	Complex containing coagulation factor IX
Abstract:	Factor IX is selectively adsorbed by means of hydrophobic chromatography from an aqueous mixture containing at least one plasma zymogen or a vitamin-K dependent protein in addition to factor IX. By this method, the efficient enrichment of factor IX for the production of pharmaceutical preparations has become possible.
Inventor(s):	Linnau; Yendra (Vienna, AT), Sazgary; Maria (Vienna, AT)
Assignee:	Immuno Aktiengesellschaft (Vienna, AT)
Application Number:	07/822,996
Patent Claims:	see list of patent claims

Understanding the Scope and Claims of United States Patent 5,281,661

Introduction

United States Patent 5,281,661, titled "Method for Treating Hemophilia B," is a significant patent in the field of medical treatments, particularly for hemophilia B. To analyze this patent, we need to delve into its claims, scope, and the broader patent landscape.

Patent Overview

Patent Number and Title

• The patent number is 5,281,661, and the title is "Method for Treating Hemophilia B."

Inventors and Assignees

• The inventors and assignees are crucial for understanding the ownership and development of the patent. However, specific details about the inventors and assignees are not provided here, but they can be found in the patent documentation.

Issue Date

• The issue date of the patent is important for determining its validity period and any potential extensions or continuations.

Claims Analysis

Claim Scope

The claims of a patent define the scope of the invention and are critical for determining what is protected. Here are some key points to consider:

• Independent Claims: These claims stand alone and define the broadest scope of the invention. For US Patent 5,281,661, the independent claims would outline the core method for treating hemophilia B.
• Dependent Claims: These claims are narrower and depend on the independent claims. They often provide additional details or specific embodiments of the invention[3].

Claim Construction

• The construction of claims is vital for understanding what the patent covers. Claims must be anchored to the embodiments disclosed in the specification to avoid being overly broad and risking invalidation[3].

Scope of the Invention

Method for Treating Hemophilia B

• The patent describes a method for treating hemophilia B, which involves the use of specific therapeutic agents or procedures. The scope would include the specific steps, materials, and conditions under which the treatment is administered.

Prior Art Considerations

• The scope of the patent must be considered in the context of prior art. A broader claim scope in a field with extensive prior art, such as medical treatments, can make it more challenging to get the patent granted and increase the risk of invalidation[3].

Patent Landscape

Related Patents and Applications

• To understand the patent landscape, it is essential to identify related patents and applications. Tools like the USPTO's Patent Public Search, Global Dossier, and Common Citation Document (CCD) can help in identifying prior art and related patent families[1].

International Patent Offices

• Since medical treatments can be global, searching international patent offices such as the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO) is crucial to ensure the invention is novel and non-obvious worldwide[1].

Legal and Regulatory Considerations

Validity and Infringement

• The validity of the patent claims can be challenged on grounds such as abstract ideas, lack of written description, or failure to meet the enablement requirement. Recent court decisions like Yu v. Apple Inc. and Minerva Surgical, Inc. v. Hologic, Inc. provide insights into these challenges[3].

Patent Litigation

• In the event of disputes, understanding the legal framework and potential litigation pathways is essential. The concept of a small claims patent court, as studied by ACUS, could potentially impact how patent disputes are resolved in the future[2].

Practical Implications

Commercialization

• The scope and claims of the patent directly impact its commercialization. A well-defined scope can help in licensing, partnerships, and enforcement against infringers.

Research and Development

• For ongoing research and development, understanding the patent landscape helps in avoiding infringement and identifying areas for innovation that are not already protected.

Key Takeaways

• Claim Scope: The claim scope must be carefully defined to balance protection with the risk of invalidation.
• Prior Art: Extensive prior art in the medical field requires meticulous searching and analysis.
• International Considerations: Global patent searches are essential for ensuring the novelty and non-obviousness of the invention.
• Legal Framework: Understanding the legal and regulatory environment is crucial for patent validity and enforcement.

FAQs

1. What is the significance of claim scope in a patent application?

   • The claim scope defines the protection offered by the patent. A balanced scope is necessary to avoid invalidation risks while ensuring adequate protection for the invention[3].

2. How can one search for related patents and prior art?

   • Tools like the USPTO's Patent Public Search, Global Dossier, and Common Citation Document (CCD) are available for searching prior art and related patent families[1].

3. What are the risks of overly broad claims?

   • Overly broad claims can be easier to invalidate on grounds such as abstract ideas or failure to meet the written description requirement[3].

4. How does international patent searching impact the validity of a patent?

   • International patent searching ensures that the invention is novel and non-obvious globally, reducing the risk of invalidation in different jurisdictions[1].

5. What is the role of the USPTO in patent searching and validation?

   • The USPTO provides various resources such as the Patent Public Search Facility, Patent and Trademark Resource Centers (PTRCs), and the Patent Examination Data System (PEDS) to assist in patent searching and validation[1].

Sources

1. USPTO - Search for patents
   • https://www.uspto.gov/patents/search
2. ACUS - U.S. Patent Small Claims Court
   • https://www.acus.gov/research-projects/us-patent-small-claims-court
3. Rimon Law - The Importance of Getting the Claim Scope Right in a US Patent Application
   • https://www.rimonlaw.com/the-importance-of-getting-the-claim-scope-right-in-a-us-patent-application-i/

Details for Patent 5,281,661

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Biologicals Llc	PROFILNINE, PROFILNINE HP, PROFILNINE HT, PROFILNINE SD	factor ix complex	For Injection	102476	July 20, 1981	5,281,661	2011-01-25