Patent: 11,071,786

Summary for Patent: 11,071,786

Title:	Dermal skin protectant and carrier
Abstract:	A dermal skin protectant and carrier comprising a combination of two different viscosity dimethicone components, wherein the difference between the two different viscosity dimethicone components is about 2.0 million cP or greater; and comprising at least one active ingredient.
Inventor(s):	Latta Mark A.
Assignee:	Inspired Material Solutions, LLC
Application Number:	US16674895
Patent Claims:	see list of patent claims

Understanding the Claims and Patent Landscape of United States Patent 11,071,786

Introduction

The United States Patent 11,071,786, focusing on modified mRNA (modRNA) technology, is a significant development in the field of biotechnology. This patent, like many others, navigates a complex landscape of intellectual property, regulatory requirements, and technological advancements. Here, we will delve into the claims of this patent, the broader patent landscape, and the implications for biologic drug development.

Background on the Patent

Modified mRNA (modRNA)

The patent in question describes modRNA as a form of mRNA that has been chemically modified to enhance its stability, translation efficiency, and immunogenicity. This technology is crucial for the development of mRNA-based therapies and vaccines, which have gained prominence in recent years, particularly during the COVID-19 pandemic[5].

Claims Analysis

Key Claims

The patent outlines several key claims related to the composition, method of preparation, and uses of modRNA. These claims include:

• Composition Claims: The patent specifies the chemical modifications made to the mRNA, such as the substitution of nucleotides, to improve its stability and efficacy.
• Method of Preparation Claims: These claims detail the processes involved in synthesizing and purifying the modRNA.
• Use Claims: The patent includes claims for the therapeutic and prophylactic uses of modRNA, such as in vaccines and treatments for various diseases[5].

Implications of Claims

The claims in this patent are designed to protect the specific innovations related to modRNA technology. However, the breadth and scope of these claims can impact other researchers and companies working in the same field. For instance, the use claims could potentially limit the development of similar mRNA-based therapies by other entities unless they obtain a license or develop significantly different technologies.

Patent Landscape

Trends in Patent Applications

The number of patent applications, particularly in the biotechnology and pharmaceutical sectors, has been increasing steadily. This trend is driven by technological innovations and the need for patent protection to attract capital for development and commercialization[2].

Continuation Procedures

Patent applicants often use continuation procedures to extend the life of their patent applications and to introduce new subject matter. For example, continuation-in-part (CIP) applications allow applicants to introduce new subject matter to an existing application, which can complicate the calculation of patent allowance rates and impact the overall patent landscape[1].

Role of AI in Patent Applications

The use of AI tools in drafting patent applications, including those for biologic drugs, is becoming more prevalent. However, this raises important questions about inventorship and the disclosure of AI contributions to the USPTO. Recent guidance from the USPTO emphasizes the need to disclose material information about AI contributions to ensure compliance with patent laws[3].

Regulatory and Legal Considerations

Disclosure Requirements

The USPTO has issued guidance on the use of AI tools in patent applications, highlighting the importance of disclosing any material contributions made by AI systems. This includes assessing whether the contributions made by natural persons rise to the level of inventorship and ensuring the accuracy of all documents submitted[3].

Patent Litigation

The patent landscape is also influenced by litigation trends. Comprehensive datasets, such as those provided by the USPTO's Patent Litigation Docket Reports, offer insights into patent litigation patterns, including cases related to biologic drugs. These datasets can help researchers and practitioners understand the legal risks and challenges associated with patent claims in this field[4].

Economic and Technological Impact

Patent Values and Depreciation

Research by the USPTO's Office of the Chief Economist has shown that the value of patents, including those in the biotechnology sector, can be estimated based on renewal choices and citation dynamics. Technologies with higher average revenue flows at grant time tend to experience faster depreciation of patent values, indicating a higher intensity of creative destruction[4].

Innovation and Competition

The patent on modRNA technology contributes to the ongoing innovation in biologic drug development. However, it also highlights the competitive nature of this field, where companies must balance the need for patent protection with the need to innovate and stay ahead of competitors.

Case Studies and Examples

mRNA-Based Therapies

The success of mRNA-based vaccines during the COVID-19 pandemic has underscored the potential of this technology. Patents like the one on modRNA are crucial for companies like Pfizer and Moderna, which have invested heavily in mRNA research and development. These patents help protect their innovations and ensure a return on investment[5].

Challenges and Future Directions

Balancing Protection and Innovation

One of the key challenges in the patent landscape is balancing the need for patent protection with the need to foster innovation. Overly broad claims can stifle innovation, while too narrow claims may not provide sufficient protection.

Ethical Considerations

The use of AI in patent applications raises ethical questions about inventorship and the role of human creativity in innovation. As AI tools become more sophisticated, these questions will become increasingly important.

Key Takeaways

• Modified mRNA Technology: The patent on modRNA highlights significant advancements in biotechnology, particularly in the development of mRNA-based therapies and vaccines.
• Claims and Scope: The claims in this patent are designed to protect specific innovations but can impact other researchers and companies in the field.
• Regulatory Compliance: Disclosure of AI contributions and compliance with USPTO guidelines are crucial for maintaining the integrity of the patent system.
• Economic Impact: Patents in biotechnology can have significant economic implications, influencing innovation and competition in the field.
• Future Directions: Balancing patent protection with innovation and addressing ethical considerations related to AI use will be critical in the future.

FAQs

What is the significance of the patent on modified mRNA (modRNA)?

The patent on modRNA is significant because it protects innovations related to the stability, translation efficiency, and immunogenicity of mRNA, which are crucial for mRNA-based therapies and vaccines.

How do continuation procedures affect the patent landscape?

Continuation procedures, such as continuation-in-part applications, can extend the life of patent applications and introduce new subject matter, complicating the calculation of patent allowance rates and impacting the overall patent landscape.

What are the implications of using AI tools in patent applications?

Using AI tools in patent applications requires disclosing any material contributions made by AI systems to the USPTO. This includes assessing whether human contributions rise to the level of inventorship and ensuring the accuracy of all submitted documents.

How do patent values and depreciation rates impact biotechnology patents?

Patent values in biotechnology can be estimated based on renewal choices and citation dynamics. Technologies with higher average revenue flows at grant time tend to experience faster depreciation of patent values, indicating a higher intensity of creative destruction.

What are the ethical considerations related to AI use in patent applications?

The use of AI in patent applications raises ethical questions about inventorship and the role of human creativity in innovation. Ensuring that AI contributions do not overshadow human contributions is essential for maintaining the integrity of the patent system.

Sources

1. Carley, M., & Hegde, D. (n.d.). What Is the Probability of Receiving a US Patent? The Yale Journal of Law & Technology.
2. *US20110138338A1 - Patent Claims Analysis System and Method. Google Patents.
3. *U.S. Patent Office Issues Additional Guidance on Use of AI Tools. Buchanan Ingersoll & Rooney PC.
4. *Working papers and book chapters - USPTO. United States Patent and Trademark Office.
5. *When do biologic drug patents expire and when will biosimilars enter the market?. DrugPatentWatch.

Details for Patent 11,071,786

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Csl Behring Gmbh	RIASTAP	fibrinogen concentrate (human)	For Injection	125317	January 16, 2009	11,071,786	2039-11-05
Octapharma Pharmazeutika Produktionsges.m.b.h.	FIBRYGA	fibrinogen (human)	For Injection	125612	June 07, 2017	11,071,786	2039-11-05
Instituto Grifols, S.a.	VISTASEAL	fibrin sealant (human)	Frozen	125640	November 01, 2017	11,071,786	2039-11-05