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Patent: 5,385,839


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Summary for Patent: 5,385,839
Title: Transfer vectors and microorganisms containing human cytomegalovirus immediate-early promoter regulatory DNA sequence
Abstract:The cloning of a eucaryotic promoter-regulatory region that functions preferentially in human cells is disclosed. The invention is exemplified by the cloning of a section of the human cytomegalovirus genome comprising a DNA sequence with regulatory and promoter signals and an initiation site for RNA synthesis. The fragment, termed the human cytomegalovirus (HCMV) promoter-regulatory sequence, was obtained from purified HCMV DNA.
Inventor(s): Stinski; Mark F. (Iowa City, IA)
Assignee: University of Iowa Research Foundation (Iowa City, IA)
Application Number:07/900,056
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive Analysis of United States Patent 5,385,839: Transfer Vectors and Microorganisms Containing Human Cytomegalovirus Immediate-Early Promoter-Regulatory DNA Sequence

Introduction

United States Patent 5,385,839, titled "Transfer vectors and microorganisms containing human cytomegalovirus immediate-early promoter-regulatory DNA sequence," is a significant patent in the field of genetic engineering and biotechnology. This patent, issued to inventors who utilized government support, revolves around the cloning and utilization of specific DNA sequences from the human cytomegalovirus (HCMV) to enhance gene expression in human cells.

Background and Context

The HCMV immediate-early promoter-regulatory region is crucial for initiating transcription in human cells. This region is highly transcribed immediately after viral infection, making it an attractive candidate for enhancing gene expression in various biotechnological applications[1][4].

Key Claims of the Patent

Cloning of HCMV Promoter-Regulatory Region

The patent describes the cloning of a DNA fragment containing the HCMV immediate-early promoter-regulatory region. This fragment is obtained from the HCMV genome and is known for its strong transcriptional activity in human cells[1][4].

Method of Cloning

The method involves purifying viral DNA from HCMV, digesting it with the restriction endonuclease XbaI, and cloning the resulting XbaI DNA fragments into bacterial plasmid pACYC184. Further subcloning and digestion with other restriction enzymes like PstI and Sau3A are used to isolate specific clones with the desired promoter-regulatory region[1][4].

Application in Human Cells

The cloned DNA sequence is designed to enhance the expression of adjacent genes in eukaryotic cells of human origin. This is achieved by providing a strong promoter-regulatory region that is recognized preferentially by human cell factors involved in transcription by RNA polymerase II[1][4].

Patent Landscape Analysis

Geographical Spread

The geographical spread of this technology is primarily within the United States, given the patent's issuance and the involvement of U.S. research institutions and biotechnology companies. However, the application of this technology can be global, as genetic engineering techniques are widely used across different countries[3].

Saturation of Patent Space

The patent space related to viral promoters and genetic engineering is highly saturated. numerous patents exist for various viral promoters and their applications in biotechnology. This saturation indicates a competitive and well-explored field, where new innovations must offer significant improvements or novel applications to stand out[3].

Competitors and New Entrants

Key players in this field include biotechnology companies and research institutions that have developed similar technologies using different viral promoters. New entrants would need to demonstrate unique advantages or applications of their technologies to compete effectively[3].

Time-Slicing and Trends

Over time, there has been a continuous evolution in the use of viral promoters for gene expression. The trend has shifted towards more specific and efficient promoters, and there is an increasing focus on safety and regulatory compliance. Time-slicing analysis would show a gradual increase in the sophistication of these technologies and a broader range of applications[3].

Strategic Insights

Opportunities and Challenges

The patent offers opportunities for enhancing gene expression in various biotechnological applications, including gene therapy, vaccine development, and production of therapeutic proteins. However, the highly saturated patent space and stringent regulatory requirements pose significant challenges for new entrants and ongoing research[3].

Alternative Technologies

Given the saturation in this patent space, researchers and companies may explore alternative technologies, such as using different viral promoters or non-viral gene delivery methods. A comprehensive patent landscape analysis can help identify underappreciated niche areas and potential pivot points for innovation[3].

Regulatory and Legal Considerations

Patent Term and Extensions

The patent has expired, but the process of patent term extensions, as seen in related patents, highlights the complexities and opportunities for extending the life of a patent through regulatory review periods and other mechanisms[2][5].

Government Support and Rights

The invention was made with government support, which grants the government certain rights in the invention. This aspect is crucial for understanding the legal and financial implications of such patents[1].

Impact on Biotechnology

Enhanced Gene Expression

The HCMV immediate-early promoter-regulatory region has been widely used to enhance gene expression in human cells. This has significant implications for various biotechnological applications, including the production of therapeutic proteins and the development of gene therapies[1][4].

Vaccine Development

The strong transcriptional activity of this promoter-regulatory region makes it an attractive candidate for vaccine development, where high levels of antigen expression are often required[1].

Conclusion

United States Patent 5,385,839 is a foundational patent in the field of genetic engineering, particularly in the use of viral promoters to enhance gene expression. Understanding the claims, methods, and the broader patent landscape is crucial for navigating this highly competitive and saturated field.

Key Takeaways

  • The patent involves the cloning of the HCMV immediate-early promoter-regulatory region to enhance gene expression in human cells.
  • The method includes specific steps of DNA purification, digestion, and cloning into bacterial plasmids.
  • The patent space is highly saturated, with numerous competitors and a need for innovative approaches.
  • Regulatory and legal considerations, including government support and patent term extensions, are important.
  • The technology has significant implications for biotechnology, including gene therapy, vaccine development, and therapeutic protein production.

Frequently Asked Questions (FAQs)

What is the significance of the HCMV immediate-early promoter-regulatory region?

The HCMV immediate-early promoter-regulatory region is significant because it is highly transcribed in human cells immediately after infection, making it a strong candidate for enhancing gene expression in various biotechnological applications.

How is the HCMV promoter-regulatory region cloned?

The cloning involves purifying viral DNA from HCMV, digesting it with restriction endonucleases like XbaI, and cloning the resulting fragments into bacterial plasmids.

What are the potential applications of this technology?

The technology has potential applications in gene therapy, vaccine development, and the production of therapeutic proteins, among others.

Why is the patent space for viral promoters highly saturated?

The patent space is highly saturated due to the extensive research and development in genetic engineering and biotechnology, leading to numerous existing patents and a competitive environment.

What are the regulatory considerations for patents like US 5,385,839?

Regulatory considerations include the potential for patent term extensions based on regulatory review periods and the implications of government support in the invention process.

Cited Sources

  1. US5385839A - Transfer vectors and microorganisms containing human cytomegalovirus immediate-early promoter-regulatory DNA sequence - Google Patents
  2. JUN I 0 2014 - Regulations.gov - Patent No.: 7,612,182
  3. Patent Landscape Analysis - Uncovering Strategic Insights - AcclaimIP
  4. US5168062A - Transfer vectors and microorganisms containing human cytomegalovirus immediate-early promoter-regulatory DNA sequence - Google Patents
  5. JUN I 0 2014 - Regulations.gov - Patent No.: 7,291,721

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Details for Patent 5,385,839

ApplicantTradenameBiologic IngredientDosage FormBLAApproval DatePatent No.Expiredate
Biogen Inc. TYSABRI natalizumab Injection 125104 November 23, 2004 5,385,839 2005-01-30
>Applicant>Tradename>Biologic Ingredient>Dosage Form>BLA>Approval Date>Patent No.>Expiredate
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