United States Patent 5,168,062: A Comprehensive and Critical Analysis
Introduction
United States Patent 5,168,062, 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 on November 24, 1992, describes the cloning and utilization of a specific DNA sequence from the human cytomegalovirus (HCMV) to enhance gene expression in human cells.
Background and Context
The patent is part of a series of continuations and improvements on earlier patent applications, reflecting the evolving nature of genetic engineering techniques in the late 20th century. It was developed with support from the National Institute of Allergy and Infectious Diseases under Grant No. AI13526[1][4].
Key Claims and Inventions
Cloning of HCMV Promoter-Regulatory Region
The patent focuses on the cloning of a deoxynucleotide sequence from the HCMV that contains regulatory signals and a promoter. This sequence, known as the HCMV promoter-regulatory region, is crucial for enhancing the expression of adjacent genes in eukaryotic cells of human origin[1][4].
Methodology
The process involves purifying viral DNA from HCMV, digesting it with restriction endonucleases such as XbaI and PstI, and cloning the resulting DNA fragments into bacterial plasmids like pACYC184 and pKH47. The specific clone, pXEP22, is further digested with Sau3A to isolate the pIEPR12 clone, which contains the HCMV promoter-regulatory region[1][4].
Microorganism Transformation
The pIEPR12 plasmid is used to transform bacteria, specifically E. coli C600 RecBC-, resulting in a novel microorganism capable of replicating and propagating the HCMV promoter-regulatory region. This microorganism and the plasmid were deposited at the United States Department of Agriculture Northern Regional Research Center (NRRL)[4].
Scientific Significance
Enhancer Function
The HCMV promoter-regulatory region acts as an enhancer, significantly increasing the transcription of genes in human cells. This is particularly useful in biotechnological applications where high levels of gene expression are required. Enhancers from various animal viruses, such as polyoma virus and adenovirus, have been studied for similar purposes[1][4].
Application in Gene Expression
The isolated DNA sequence can be used to drive the expression of any gene of interest in human cells, making it a valuable tool in genetic engineering, gene therapy, and biotechnology research. The ability to enhance gene expression is critical for various biomedical applications, including the production of therapeutic proteins and the development of gene therapies[1][4].
Patent Landscape and Legal Considerations
Patent Claims
The patent includes product claims and process claims. Product claims cover the use of the HCMV promoter-regulatory region in any context, while process claims protect the methods used to clone and utilize this DNA sequence. These claims are broad, allowing the patent holder to control a wide range of applications involving this specific DNA sequence[3].
Exclusivity and Public Benefit
The 20-year monopoly granted by the patent rewards innovation but must be balanced against public benefit. Full disclosure of the invention is crucial to encourage further innovation and ensure that others can build upon or work around the patented technology once the patent expires[3].
Legal Status
The patent has expired, which means that the technology described is now in the public domain. This allows other researchers and companies to use and build upon the invention without needing permission from the original patent holders[1][4].
Critical Analysis
Innovations and Contributions
The patent represents a significant innovation in genetic engineering by providing a powerful tool for enhancing gene expression in human cells. The detailed methodology and the isolation of the HCMV promoter-regulatory region have contributed substantially to the field of biotechnology.
Limitations and Challenges
One of the challenges with such broad patent claims is the potential to stifle further innovation. Overly broad claims can lead to a monopoly that discourages others from developing similar or improved technologies. Additionally, the complexity of genetic engineering and the ethical considerations surrounding gene patents can pose legal and societal challenges[3].
Ethical and Societal Implications
Gene patents, including those like US 5,168,062, raise ethical questions about the ownership of genetic material and the balance between innovation and public access. The patenting of genetic sequences can impact the availability of genetic resources and the development of new treatments, particularly in areas where access to patented technologies is limited[3].
Industry Impact
Biotechnology and Gene Therapy
The technology described in this patent has been instrumental in the development of various biotechnological products and gene therapies. The ability to enhance gene expression has facilitated the production of therapeutic proteins and the design of gene therapy protocols.
Pharmaceutical and Biomedical Research
The use of the HCMV promoter-regulatory region in pharmaceutical and biomedical research has accelerated the development of new treatments. This includes the creation of vaccines, the production of recombinant proteins, and the advancement of gene therapy techniques.
Key Takeaways
- Cloning and Utilization: The patent describes the cloning and use of the HCMV promoter-regulatory region to enhance gene expression in human cells.
- Methodology: The process involves specific restriction endonucleases and bacterial plasmids to isolate and propagate the DNA sequence.
- Microorganism Transformation: The transformed E. coli microorganism replicates and propagates the HCMV promoter-regulatory region.
- Scientific Significance: The enhancer function of the HCMV promoter-regulatory region is crucial for biotechnological applications.
- Patent Landscape: The patent includes broad product and process claims, which have implications for innovation and public access.
- Legal and Ethical Considerations: The patent's expiration and the ethical implications of gene patents are critical factors in the broader context of genetic engineering.
FAQs
What is the main focus of United States Patent 5,168,062?
The main focus is the cloning and utilization of the human cytomegalovirus (HCMV) immediate-early promoter-regulatory DNA sequence to enhance gene expression in human cells.
How is the HCMV promoter-regulatory region isolated?
The region is isolated through a process involving the purification of viral DNA, digestion with restriction endonucleases like XbaI and PstI, and cloning into bacterial plasmids.
What is the significance of the HCMV promoter-regulatory region?
It acts as an enhancer to significantly increase the transcription of genes in human cells, making it a valuable tool in genetic engineering and biotechnology.
What are the implications of the patent's expiration?
The expiration means that the technology is now in the public domain, allowing others to use and build upon the invention without needing permission from the original patent holders.
What are some of the ethical considerations surrounding gene patents like US 5,168,062?
Gene patents raise questions about the ownership of genetic material, the balance between innovation and public access, and the potential impact on the availability of genetic resources and the development of new treatments.
How has this patent impacted the biotechnology industry?
The patent has facilitated the development of various biotechnological products and gene therapies by providing a powerful tool for enhancing gene expression in human cells.
Cited Sources
- US5385839A - Transfer vectors and microorganisms containing human cytomegalovirus immediate-early promoter-regulatory DNA sequence.
- Case 1:22-cv-00311-WCB Document 414 Filed 03/22/24 Page 1 of ...
- ON THE LEGALITY OF GENE PATENTS - Melbourne Law School.
- US5168062A - Transfer vectors and microorganisms containing human cytomegalovirus immediate-early promoter-regulatory DNA sequence.
