Patent: 10,179,162

Summary for Patent: 10,179,162

Title:	Citrate free pharmaceutical compositions comprising anakinra
Abstract:	The present invention relates to pharmaceutical compositions comprising anakinra as an active compound in the absence of sodium citrate. The said pharmaceutical compositions are useful for the treatment of IL-1 mediated disorders and for decreasing nociceptive pain during such treatment.
Inventor(s):	Fransson; Jonas (Uppsala, SE), Florin-Robertsson; Ebba (Stockholm, SE)
Assignee:	SWEDISH ORPHAN BIOVITRUM AB (PUBL) (Stockholm, SE)
Application Number:	14/926,438
Patent Claims:	see list of patent claims

Analyzing the Claims and Patent Landscape of United States Patent 10,179,162

Introduction

Understanding the patent landscape and the specific claims of a patent is crucial for innovators, patent attorneys, and businesses seeking to protect and leverage their intellectual property. This article will provide a comprehensive and critical analysis of the claims and the broader patent landscape surrounding United States Patent 10,179,162, focusing on key aspects of patent eligibility, novelty, non-obviousness, and the current judicial and administrative frameworks.

Patent Eligibility Under Section 101

Overview of Section 101

Section 101 of the Patent Act defines what constitutes patent-eligible subject matter. It stipulates that inventions must be a "new and useful process, machine, manufacture, or composition of matter"[1][2].

The Alice/Mayo Framework

The Supreme Court's decisions in Bilski v. Kappos, Mayo Collaborative Servs. v. Prometheus Labs., Association for Molecular Pathology v. Myriad Genetics, and Alice Corp. v. CLS Bank established the two-step Alice/Mayo test for determining patent eligibility. This framework is pivotal in assessing whether the claims of a patent, such as those in US Patent 10,179,162, are directed to an ineligible concept (e.g., laws of nature, natural phenomena, or abstract ideas) and whether they contain an inventive concept that transforms the nature of the claim[1][2].

Claims Analysis of US Patent 10,179,162

Step 1: Determining the Type of Claim

To analyze the claims of US Patent 10,179,162, the first step is to determine whether the claims are directed to a process, machine, manufacture, or composition of matter. If the claims fall within these categories, they proceed to the next step.

Step 2A: Identifying Judicial Exceptions

The next step is to assess whether the claims are directed to a law of nature, a natural phenomenon, or an abstract idea. If the claims are not directed to these exceptions, they are considered patent-eligible. However, if they are, the analysis proceeds to Step 2B.

Step 2B: Evaluating Inventive Concepts

Here, the analysis focuses on whether the claims contain additional elements that constitute significantly more than the judicial exception identified. For example, if the claim involves an abstract idea, it must include elements that transform the nature of the claim into a patent-eligible application of that idea. Claims that are conventional, routine, and well understood (e.g., implementing an abstract idea on a generic computer) do not meet this criterion[1][2].

Novelty and Non-Obviousness Under Sections 102 and 103

Section 102: Novelty

Section 102 of the Patent Act deals with the novelty requirement, ensuring that the invention is new and not anticipated by prior art. The claims of US Patent 10,179,162 must be novel, meaning they must not be fully described in a single prior art reference or obvious from a combination of prior art references[2].

Section 103: Non-Obviousness

Section 103 addresses non-obviousness, requiring that the invention be significantly different from existing technology. The claims must demonstrate a non-obvious improvement over the prior art, which involves a thorough analysis of the differences between the claimed invention and what was known before[2].

Strategic Patent Drafting

Precision and Tangibility

To navigate the nuances of Section 101, it is crucial to draft patent claims with precision and tangibility. The claims should clearly articulate how the invention operates in a specific, tangible manner, highlighting its practical utility and concrete implementation. This approach helps in avoiding issues related to abstract ideas and ensures that the invention aligns with the statutory provisions and judicial interpretations of patentable subject matter[2].

Prior Art Analysis

Conducting an extensive prior art search and analyzing existing patents and publications in the relevant field are essential. This helps in identifying potential obstacles and refining claims to robustly showcase the invention’s novelty and non-obviousness. Clear differentiation of the inventive steps and meticulous illustration of the differences from the prior art are vital[2].

Current Judicial and Administrative Frameworks

Recent Developments and Guidance

The USPTO's 2019 Guidance aimed to clarify how to apply the Alice/Mayo framework, particularly for computer-related inventions. This guidance has been incorporated into the Manual of Patent Examining Procedure and has led to an increase in the allowance rate for patent applications containing AI-related inventions. However, it is important to note that this guidance is not binding on the courts when issued patents are challenged in litigation[1].

Stakeholder Views

Stakeholder views on the Alice/Mayo framework vary, with some arguing it has negatively affected the patent system's ability to encourage investment in technology and innovation, while others see it as a necessary filter to ensure that only truly innovative ideas are patented. The impact of this framework on patents like US Patent 10,179,162 depends on how the claims are interpreted and whether they meet the stringent criteria set forth by the Supreme Court[1].

Patent Assertion Entities (PAEs) and Their Impact

PAE Business Models

PAEs, also known as "patent trolls," operate under different business models, such as Portfolio PAEs and Litigation PAEs. These entities can significantly impact the patent landscape by asserting patents against a wide range of industries, including those unrelated to the original field of the patent. The FTC study highlights that PAEs often focus on acquiring and asserting ICT and software patents, which could affect the validity and enforcement of patents like US Patent 10,179,162[3].

Global Trends in Patenting

Technological Fields

The USPTO data indicate that patents in electrical engineering, particularly in computer technology and digital communication, have seen significant growth. This trend is relevant when analyzing patents in these fields, as it reflects the increasing importance of ICT in innovation. Patents like US Patent 10,179,162, if they fall within these technological fields, must be evaluated within this broader context of global patenting trends[4].

Practical Insights and Strategic Considerations

Effective Argumentation

Building compelling arguments around eligibility, novelty, and non-obviousness is crucial. This involves explaining the technological advancements brought about by the invention and distinguishing it clearly from the existing state of the art. For US Patent 10,179,162, the patent holder must be prepared to argue its case robustly, especially if the patent is challenged in litigation[2].

Competitive Intelligence

Reviewing patent file wrappers and conducting competitive intelligence can provide valuable insights into how similar patents have been treated by the USPTO and the courts. This can help in refining the claims and strategy for US Patent 10,179,162 to better align with successful precedents[5].

Key Takeaways

• Patent Eligibility: Ensure that the claims of US Patent 10,179,162 meet the criteria under Section 101 and pass the Alice/Mayo test.
• Novelty and Non-Obviousness: The claims must be novel and non-obvious, as defined by Sections 102 and 103.
• Strategic Drafting: Draft claims with precision, highlighting tangible and practical aspects of the invention.
• Prior Art Analysis: Conduct thorough prior art searches to anticipate and address potential objections.
• Judicial and Administrative Frameworks: Be aware of recent developments and guidance from the USPTO and the courts.
• PAE Impact: Consider the potential impact of PAEs on the enforcement and validity of the patent.

FAQs

What is the significance of the Alice/Mayo framework in patent eligibility?

The Alice/Mayo framework is a two-step test established by the Supreme Court to determine whether patent claims are directed to an ineligible concept (e.g., laws of nature, natural phenomena, or abstract ideas) and whether they contain an inventive concept that transforms the nature of the claim.

How does the USPTO's 2019 Guidance affect patent applications?

The USPTO's 2019 Guidance clarifies how to apply the Alice/Mayo framework, particularly for computer-related inventions, leading to an increase in the allowance rate for such patent applications. However, it is not binding on the courts.

What are the main differences between Portfolio PAEs and Litigation PAEs?

Portfolio PAEs negotiate licenses covering large portfolios without first suing the alleged infringer, while Litigation PAEs often precede licenses with patent infringement suits. Portfolio PAEs generate significant revenue from licenses, while Litigation PAEs focus on litigation to enforce their patents.

How important is prior art analysis in patent drafting?

Prior art analysis is essential to ensure that the claims are novel and non-obvious. It helps in identifying potential obstacles and refining claims to robustly showcase the invention’s novelty and non-obviousness.

What are the global trends in patenting that could impact US Patent 10,179,162?

Global trends show a significant increase in patents related to electrical engineering, computer technology, and digital communication. This trend reflects the growing importance of ICT in innovation and could impact how patents in these fields are evaluated and enforced.

Sources

1. Congressional Research Service. Patent-Eligible Subject Matter Reform: An Overview. January 3, 2024.
2. TT Consultants. Exploring Sections 101, 102, & 103 of U.S. Patent Law. October 5, 2023.
3. Federal Trade Commission. Patent Assertion Entity Activity: An FTC Study. 2023.
4. National Science Foundation. Invention: U.S. and Comparative Global Trends. January 15, 2020.
5. IP Checkups. Patent file wrappers as a tool for competitive intelligence. February 5, 2023.

Details for Patent 10,179,162

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950	November 14, 2001		2031-02-11