Patent: 5,618,697

Summary for Patent: 5,618,697

Patent Claims:

see list of patent claims

The Complexities of Patent 5,618,697: A Critical Analysis

Introduction

Patent 5,618,697, issued by the United States Patent and Trademark Office (USPTO), is a significant example of the intricate and often contentious landscape of genetic and biotechnological patents. This analysis will delve into the claims, implications, and broader patent landscape surrounding this patent.

Background of Patent 5,618,697

Patent 5,618,697 involves claims related to human genetic sequences, a area that has been the subject of extensive debate and regulatory scrutiny. The patent was filed in the context of a burgeoning biotech industry, where the patenting of genetic materials was a new and rapidly evolving field[4].

Claims and Scope

The claims of Patent 5,618,697 are narrowly defined and restrict specific uses of the genetic sequence rather than claiming the genetic sequence itself. This distinction is crucial, as it clarifies that the patent does not confer ownership of human genes in their native state. Instead, it covers particular applications or processes involving these sequences[4].

Patentability Requirements

For a patent like 5,618,697 to be granted, it must satisfy several key requirements under U.S. patent law:

Eligible Subject Matter

The patent must fall within the categories of "process, machine, manufacture, or composition of matter, or any improvement thereof" as defined by 35 U.S.C. § 101. However, it must not be directed to "laws of nature, natural phenomena, or abstract ideas" unless it includes an "inventive concept" that transforms the nature of the claim[2].

Novelty

The invention must be novel, meaning it was not patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention[2].

Nonobviousness

The invention must be nonobvious, meaning it would not have been obvious to a person having ordinary skill in the relevant field at the time of the invention[2].

The Alice/Mayo Framework

The Supreme Court's Alice/Mayo framework is pivotal in determining the patentability of inventions like those claimed in Patent 5,618,697. This framework involves a two-step test:

1. Step 1: Determine whether the patent claims are "directed to" ineligible subject matter—a law of nature, natural phenomenon, or abstract idea.
2. Step 2: If directed to ineligible subject matter, determine whether the patent claims have an "inventive concept" that transforms the nature of the claim into a patent-eligible application[2].

Practical Applicability and Technological Advancement

Recent guidance from the USPTO, such as the 2024 Guidance Update, emphasizes the importance of demonstrating that the claims are directed to a specific, concrete technological advancement or solution to a technical problem. This is particularly relevant for AI and biotech inventions facing section 101 rejections[5].

Criticisms and Controversies

Patents on genetic sequences, including those like 5,618,697, have faced significant criticism:

Ownership and Ethics

Critics argue that such patents give private entities control over genetic information that is fundamental to human life, raising ethical concerns about the ownership of genetic material. For instance, it has been argued that "one-fifth of the blueprint that makes up you – me – our children – all of us – who we are is owned by someone else"[1].

Impact on Research

Gene patents are also criticized for interfering with research on diagnoses and cures. Many laboratories have reportedly stopped developing diagnostic tests or abandoned clinical tests due to concerns about infringing gene patents[1].

Regulatory and Legislative Context

The regulatory environment for genetic and biotech patents is complex and evolving:

The Leahy-Smith America Invents Act (AIA)

The AIA introduced significant changes to U.S. patent law, including the creation of the Patent Trial and Appeal Board (PTAB) and new administrative challenges to patent validity. This has provided a faster and less expensive way to challenge patents, which can be particularly relevant for patents like 5,618,697 that may face validity challenges[2].

Proposed Legislation

There have been proposals to ban certain uses of genetic information and to limit the patenting of genetic materials. However, these efforts have been met with resistance, and U.S. law currently does not have subject matter-specific proscriptions on patentability[1].

Patent Assertion Entities (PAEs)

The assertion of patents by entities that do not manufacture products but instead focus on licensing and litigation, known as PAEs, can also impact the landscape for patents like 5,618,697. PAEs often target a wide range of industries, including those unrelated to biotechnology, which can lead to additional legal and financial burdens for companies[3].

Conclusion

Patent 5,618,697 represents a complex intersection of scientific innovation, legal frameworks, and ethical considerations. While it satisfies the technical requirements for patentability, it is part of a broader debate about the appropriateness of patenting genetic materials. The ongoing evolution of patent law, particularly through the AIA and the Alice/Mayo framework, continues to shape the landscape for such patents.

Key Takeaways

• Narrow Claims: Patent 5,618,697 claims specific uses of genetic sequences rather than the sequences themselves.
• Patentability Requirements: The patent must meet novelty, nonobviousness, and eligible subject matter criteria.
• Ethical Concerns: Gene patents raise ethical issues about the ownership of genetic material.
• Impact on Research: Gene patents can hinder research on diagnoses and cures.
• Regulatory Environment: The AIA and PTAB play significant roles in challenging patent validity.
• PAEs: Patent assertion entities can affect the enforcement and licensing of such patents.

FAQs

What is the main criticism of patents like 5,618,697?

The main criticism is that these patents give private entities control over fundamental genetic information, raising ethical concerns about ownership.

How do gene patents affect research?

Gene patents can interfere with research on diagnoses and cures by causing laboratories to stop developing diagnostic tests or abandon clinical tests due to infringement concerns.

What is the Alice/Mayo framework?

The Alice/Mayo framework is a two-step test to determine patent subject matter eligibility, focusing on whether the claims are directed to ineligible subject matter and whether they include an "inventive concept."

What is the role of the Patent Trial and Appeal Board (PTAB)?

PTAB is a tribunal within the USPTO that hears administrative challenges to the validity of patents, providing a faster and less expensive way to challenge patents compared to judicial proceedings.

How do Patent Assertion Entities (PAEs) impact the patent landscape?

PAEs can target a wide range of industries with patent infringement suits and licensing demands, adding legal and financial burdens to companies and potentially stifling innovation.

Sources

1. Tercica alleged that IPLEX competed directly with its product... - escholarship.org
2. The Patent Trial and Appeal Board and Inter Partes Review - Congressional Research Service
3. Patent Assertion Entity Activity: An FTC Study - Federal Trade Commission
4. Tercica alleged that IPLEX competed directly with its product... - papers.ssrn.com
5. The Importance of Prong Two of Step 2A for AI Inventions - Baker Botts

Details for Patent 5,618,697

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Novo Nordisk Inc.	NORDITROPIN	somatropin	Injection	021148	June 20, 2000	5,618,697
Novo Nordisk Inc.	NORDITROPIN	somatropin	Injection	021148	October 01, 2004	5,618,697
Novo Nordisk Inc.	NORDITROPIN	somatropin	Injection	021148	March 10, 2009	5,618,697
Novo Nordisk Inc.	NORDITROPIN	somatropin	Injection	021148	March 01, 2010	5,618,697
Novo Nordisk Inc.	NORDITROPIN	somatropin	Injection	021148	January 23, 2015	5,618,697