When do biologic drug patents expire and when will biosimilars launch?

Understanding the Patent Landscape for US Patent 10,000,565: A Comprehensive Analysis

Introduction

Patent law in the United States is a complex and evolving field, particularly with the integration of new technologies such as artificial intelligence (AI). The recent updates to the USPTO guidance on AI patent eligibility have significant implications for innovators and patent practitioners. This article will delve into the key aspects of the patent landscape, using US Patent 10,000,565 as a case study, and explore the broader implications of recent changes in patent law.

Subject Matter Eligibility Under 35 U.S.C. § 101

Subject matter eligibility is a critical component of patent law, governed by 35 U.S.C. § 101. This section requires that a claimed invention must fall within one of the four statutory categories: process, machine, manufacture, or composition of matter. Additionally, the invention must not be directed to judicial exceptions such as abstract ideas, laws of nature, or natural phenomena, unless the claim includes additional limitations that transform the exception into a patent-eligible application[4].

The Alice/Mayo Test

The Supreme Court's decision in Alice Corp. Pty. Ltd. v. CLS Bank Int'l established the two-step Alice/Mayo test for determining patentable subject matter. First, it must be determined whether the patent claims are directed to an ineligible concept. If so, the second step assesses whether the claims contain an "inventive concept" that transforms the ineligible concept into a patent-eligible application[3].

Recent USPTO Guidance on AI Patent Eligibility

The 2024 USPTO guidance update, prompted by Executive Order 14110, aims to clarify the process for determining the patent eligibility of AI-related inventions. This update emphasizes the evaluation of whether a claim integrates a judicial exception into a practical application. It also clarifies that the method of invention development, including the use of AI, does not impact subject matter eligibility, provided there is significant human contribution[1].

Practical Applications and Meaningful Limits

To meet the criteria for patent eligibility, claims must specify a practical application that provides concrete benefits or solves specific problems in the relevant field. For example, a claim that merely uses a mathematical model to manipulate data without applying the data in a specific manner does not integrate the abstract idea into a practical application. In contrast, a claim that specifies the use of separated audio components in a real-time speech recognition system to enhance the accuracy of voice commands in hands-free environments does meet the criteria[1].

AI-Assisted Inventions

The 2024 guidance update makes it clear that AI-assisted inventions are evaluated on equal footing with other technologies. The focus remains on the claimed invention itself, rather than the method of its development. This ensures that AI’s role as a tool does not exclude inventions from eligibility, as long as there is significant human contribution[1].

Novelty and Nonobviousness Requirements

In addition to subject matter eligibility, patent claims must also meet the requirements of novelty and nonobviousness. A claimed invention must be new and not have been disclosed in the prior art before the effective filing date. It must also be nonobvious, meaning it must be significantly different from existing knowledge and not an obvious combination of prior art elements[3].

Double Patenting Prohibitions

The prohibition on double patenting, as outlined in 35 U.S.C. § 101, prevents the issuance of multiple patents for the same invention to the same inventor or where there is a common inventor or applicant/assignee. This ensures that identical subject matter is not claimed in multiple patents[4].

The Role of the Patent Trial and Appeal Board (PTAB)

The PTAB, established by the Leahy-Smith America Invents Act (AIA), plays a crucial role in reviewing patent applications and hearing administrative challenges to the validity of patents. PTAB processes are often faster and less expensive than judicial proceedings and require a lower burden of proof to invalidate patents. This makes PTAB a significant factor in the patent landscape, particularly for entities challenging patent validity[3].

Impact on Innovators and Patent Practitioners

The recent USPTO guidance and the existing framework of patent law have significant implications for innovators and patent practitioners. Innovators must ensure that their claims integrate judicial exceptions into practical applications and provide meaningful limits to avoid section 101 rejections. Practitioners must be adept at drafting claims that meet these criteria and can withstand challenges at the PTAB or in court[1].

Real-World Applications and Tangible Benefits

Highlighting the real-world applications of the claimed method or system is crucial for demonstrating patent eligibility. For instance, specifying the use of separated audio components in a speech recognition system to improve the accuracy of voice commands in hands-free environments shows how the abstract idea is transformed into a specific, practical application that provides clear benefits[1].

Example: Claim 2 vs. Claim 1

Consider two claims:

Claim 1: Merely uses a mathematical model to manipulate data without applying the data in any specific manner.
Claim 2: Specifies the use of separated audio components in a real-time speech recognition system to enhance the accuracy of voice commands in hands-free environments.

Claim 2 is patent-eligible because it integrates the abstract idea into a practical application, providing a tangible outcome that directly benefits the technology. In contrast, Claim 1 is not patent-eligible as it does not transform the abstract idea into a specific, practical application[1].

Incorporation of Recent Case Law

The 2024 USPTO guidance incorporates recent case law to provide clearer examples of patent-eligible and ineligible claims. This helps practitioners in evaluating the patentability of inventions and drafting claims that are more likely to avoid section 101 rejections[1].

Data and Statistics

The USPTO's Patent Claims Research Dataset provides detailed information on claims from US patents granted between 1976 and 2014 and US patent applications published between 2001 and 2014. This dataset can be used to analyze trends and patterns in patent claims, including the scope and complexity of patents, which can inform strategies for drafting and defending patent claims[2].

Conclusion

The patent landscape in the United States is complex and dynamic, especially with the integration of AI technologies. The recent USPTO guidance on AI patent eligibility clarifies the process for determining patent eligibility and emphasizes the importance of practical applications and meaningful limits. Innovators and patent practitioners must be well-versed in these guidelines to ensure their claims meet the criteria for patent eligibility.

Key Takeaways

Subject Matter Eligibility: Claims must fall within one of the four statutory categories and not be directed to judicial exceptions unless they include additional limitations.
Practical Applications: Claims must specify a practical application that provides concrete benefits or solves specific problems.
AI-Assisted Inventions: AI’s role as a tool does not exclude inventions from eligibility if there is significant human contribution.
Novelty and Nonobviousness: Claims must meet the requirements of novelty and nonobviousness.
Double Patenting: Prohibitions prevent the issuance of multiple patents for the same invention.
PTAB: Plays a crucial role in reviewing patent applications and hearing administrative challenges.

FAQs

Q: What is the significance of the 2024 USPTO guidance update on AI patent eligibility?

A: The update clarifies the process for determining the patent eligibility of AI-related inventions, emphasizing the integration of judicial exceptions into practical applications and ensuring AI-assisted inventions are evaluated on equal footing with other technologies.

Q: How does the Alice/Mayo test impact patent eligibility?

A: The Alice/Mayo test is a two-step process that determines whether patent claims are directed to ineligible subject matter and whether they contain an "inventive concept" that transforms the ineligible concept into a patent-eligible application.

Q: What is the role of the Patent Trial and Appeal Board (PTAB) in patent law?

A: PTAB reviews patent applications and hears administrative challenges to the validity of patents, providing a faster and less expensive alternative to judicial proceedings.

Q: Why is it important to specify practical applications in patent claims?

A: Specifying practical applications helps to integrate abstract ideas into patent-eligible subject matter, providing tangible benefits and solving specific problems in the relevant field.

Q: How does double patenting prohibition affect patent applications?

A: The prohibition prevents the issuance of multiple patents for the same invention to the same inventor or where there is a common inventor or applicant/assignee, ensuring that identical subject matter is not claimed in multiple patents.

Title:	Use of IL-1 .beta. binding antibodies for treating peripheral arterial disease
Abstract:	The present invention relates to a method for treating or alleviating the symptoms of peripheral arterial disease (PAD) in a subject, comprising administering about 25 mg to about 300 mg of an IL-1.beta. binding antibody or functional fragment thereof.
Inventor(s):	Basson; Craig (Needham, MA), Fishman; Mark (Newton Center, MA), Thuren; Tom (Succasunna, NJ), Foo; Shi Yin (Brookline, MA)
Assignee:	Novartis AG (Basel, CH)
Application Number:	14/442,536
Patent Claims:	see list of patent claims
Patent landscape, scope, and claims summary:	Understanding the Patent Landscape for US Patent 10,000,565: A Comprehensive Analysis Introduction Patent law in the United States is a complex and evolving field, particularly with the integration of new technologies such as artificial intelligence (AI). The recent updates to the USPTO guidance on AI patent eligibility have significant implications for innovators and patent practitioners. This article will delve into the key aspects of the patent landscape, using US Patent 10,000,565 as a case study, and explore the broader implications of recent changes in patent law. Subject Matter Eligibility Under 35 U.S.C. § 101 Subject matter eligibility is a critical component of patent law, governed by 35 U.S.C. § 101. This section requires that a claimed invention must fall within one of the four statutory categories: process, machine, manufacture, or composition of matter. Additionally, the invention must not be directed to judicial exceptions such as abstract ideas, laws of nature, or natural phenomena, unless the claim includes additional limitations that transform the exception into a patent-eligible application[4]. The Alice/Mayo Test The Supreme Court's decision in Alice Corp. Pty. Ltd. v. CLS Bank Int'l established the two-step Alice/Mayo test for determining patentable subject matter. First, it must be determined whether the patent claims are directed to an ineligible concept. If so, the second step assesses whether the claims contain an "inventive concept" that transforms the ineligible concept into a patent-eligible application[3]. Recent USPTO Guidance on AI Patent Eligibility The 2024 USPTO guidance update, prompted by Executive Order 14110, aims to clarify the process for determining the patent eligibility of AI-related inventions. This update emphasizes the evaluation of whether a claim integrates a judicial exception into a practical application. It also clarifies that the method of invention development, including the use of AI, does not impact subject matter eligibility, provided there is significant human contribution[1]. Practical Applications and Meaningful Limits To meet the criteria for patent eligibility, claims must specify a practical application that provides concrete benefits or solves specific problems in the relevant field. For example, a claim that merely uses a mathematical model to manipulate data without applying the data in a specific manner does not integrate the abstract idea into a practical application. In contrast, a claim that specifies the use of separated audio components in a real-time speech recognition system to enhance the accuracy of voice commands in hands-free environments does meet the criteria[1]. AI-Assisted Inventions The 2024 guidance update makes it clear that AI-assisted inventions are evaluated on equal footing with other technologies. The focus remains on the claimed invention itself, rather than the method of its development. This ensures that AI’s role as a tool does not exclude inventions from eligibility, as long as there is significant human contribution[1]. Novelty and Nonobviousness Requirements In addition to subject matter eligibility, patent claims must also meet the requirements of novelty and nonobviousness. A claimed invention must be new and not have been disclosed in the prior art before the effective filing date. It must also be nonobvious, meaning it must be significantly different from existing knowledge and not an obvious combination of prior art elements[3]. Double Patenting Prohibitions The prohibition on double patenting, as outlined in 35 U.S.C. § 101, prevents the issuance of multiple patents for the same invention to the same inventor or where there is a common inventor or applicant/assignee. This ensures that identical subject matter is not claimed in multiple patents[4]. The Role of the Patent Trial and Appeal Board (PTAB) The PTAB, established by the Leahy-Smith America Invents Act (AIA), plays a crucial role in reviewing patent applications and hearing administrative challenges to the validity of patents. PTAB processes are often faster and less expensive than judicial proceedings and require a lower burden of proof to invalidate patents. This makes PTAB a significant factor in the patent landscape, particularly for entities challenging patent validity[3]. Impact on Innovators and Patent Practitioners The recent USPTO guidance and the existing framework of patent law have significant implications for innovators and patent practitioners. Innovators must ensure that their claims integrate judicial exceptions into practical applications and provide meaningful limits to avoid section 101 rejections. Practitioners must be adept at drafting claims that meet these criteria and can withstand challenges at the PTAB or in court[1]. Real-World Applications and Tangible Benefits Highlighting the real-world applications of the claimed method or system is crucial for demonstrating patent eligibility. For instance, specifying the use of separated audio components in a speech recognition system to improve the accuracy of voice commands in hands-free environments shows how the abstract idea is transformed into a specific, practical application that provides clear benefits[1]. Example: Claim 2 vs. Claim 1 Consider two claims: Claim 1: Merely uses a mathematical model to manipulate data without applying the data in any specific manner. Claim 2: Specifies the use of separated audio components in a real-time speech recognition system to enhance the accuracy of voice commands in hands-free environments. Claim 2 is patent-eligible because it integrates the abstract idea into a practical application, providing a tangible outcome that directly benefits the technology. In contrast, Claim 1 is not patent-eligible as it does not transform the abstract idea into a specific, practical application[1]. Incorporation of Recent Case Law The 2024 USPTO guidance incorporates recent case law to provide clearer examples of patent-eligible and ineligible claims. This helps practitioners in evaluating the patentability of inventions and drafting claims that are more likely to avoid section 101 rejections[1]. Data and Statistics The USPTO's Patent Claims Research Dataset provides detailed information on claims from US patents granted between 1976 and 2014 and US patent applications published between 2001 and 2014. This dataset can be used to analyze trends and patterns in patent claims, including the scope and complexity of patents, which can inform strategies for drafting and defending patent claims[2]. Conclusion The patent landscape in the United States is complex and dynamic, especially with the integration of AI technologies. The recent USPTO guidance on AI patent eligibility clarifies the process for determining patent eligibility and emphasizes the importance of practical applications and meaningful limits. Innovators and patent practitioners must be well-versed in these guidelines to ensure their claims meet the criteria for patent eligibility. Key Takeaways Subject Matter Eligibility: Claims must fall within one of the four statutory categories and not be directed to judicial exceptions unless they include additional limitations. Practical Applications: Claims must specify a practical application that provides concrete benefits or solves specific problems. AI-Assisted Inventions: AI’s role as a tool does not exclude inventions from eligibility if there is significant human contribution. Novelty and Nonobviousness: Claims must meet the requirements of novelty and nonobviousness. Double Patenting: Prohibitions prevent the issuance of multiple patents for the same invention. PTAB: Plays a crucial role in reviewing patent applications and hearing administrative challenges. FAQs Q: What is the significance of the 2024 USPTO guidance update on AI patent eligibility? A: The update clarifies the process for determining the patent eligibility of AI-related inventions, emphasizing the integration of judicial exceptions into practical applications and ensuring AI-assisted inventions are evaluated on equal footing with other technologies. Q: How does the Alice/Mayo test impact patent eligibility? A: The Alice/Mayo test is a two-step process that determines whether patent claims are directed to ineligible subject matter and whether they contain an "inventive concept" that transforms the ineligible concept into a patent-eligible application. Q: What is the role of the Patent Trial and Appeal Board (PTAB) in patent law? A: PTAB reviews patent applications and hears administrative challenges to the validity of patents, providing a faster and less expensive alternative to judicial proceedings. Q: Why is it important to specify practical applications in patent claims? A: Specifying practical applications helps to integrate abstract ideas into patent-eligible subject matter, providing tangible benefits and solving specific problems in the relevant field. Q: How does double patenting prohibition affect patent applications? A: The prohibition prevents the issuance of multiple patents for the same invention to the same inventor or where there is a common inventor or applicant/assignee, ensuring that identical subject matter is not claimed in multiple patents. More… ↓ ⤷ Subscribe

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Novartis Pharmaceuticals Corporation	ILARIS	canakinumab	For Injection	125319	June 17, 2009	⤷ Subscribe	2039-02-26
Novartis Pharmaceuticals Corporation	ILARIS	canakinumab	Injection	125319	December 22, 2016	⤷ Subscribe	2039-02-26
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

Patent: 10,000,565

Summary for Patent: 10,000,565