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Questions Remain on Legal Implications of Gene Editing

A great deal of attention has been paid to CRISPR technology in recent years. The most discussed CRISPR technology, CRISPR/Cas9, promises to speed up genetic research and allow precise, inexpensive editing of plant and animal DNA. CRISPR/Cas9 is an improvement over previous genome editing technologies. It allows a user to target a precise location in plant or animal DNA to add, delete or replace a gene without leaving any “foreign” DNA, such as DNA from plasmids using previous genome editing technologies.

The rapid adoption of CRISPR/Cas9 is unsurprising given its significant advantages over its predecessors, most notably its ease of use, inexpensive cost, lack of “foreign” genetic-material introduction, and ability to target precise locations in prokaryotic and eukaryotic DNA.

The ability to make such edits quickly, reliably and inexpensively creates many scientific and commercial opportunities. Aside from the general benefits in accelerating research into plant and animal DNA, the immediate practical applications of rapid genomic sequencing and editing include medicine—for example, the development of vaccines and cancer-fighting technologies, the engineering of new antimicrobial agents and the treatment of human and animal diseases—and agriculture and environment, with CRISPR/Cas9’s potential to increase crop yields and livestock breeding rates and control disease-carrying insects and pests.

With the the rapid development and adoption of CRISPR technology, many legal questions have arisen and remain unanswered, including:

Regulatory

  • Will CRISPR-edited products be subject to the same regulatory framework as products modified using traditional genome editing? For example, the U.S. Department of Agriculture has recently indicated it will not regulate CRISPR-edited crops.
  • How will the biosecurity of CRISPR-developed organisms be maintained? What containment mechanisms should be utilized to prevent premature or unauthorized release of these organisms? When does the Biological and Toxin Weapons Convention apply to CRISPR-developed organisms?

Liability

  • What are the limitations for using CRISPR/Cas9 for genome editing in plants? Can it be used for gene drives in plants and the development of sterile seeds?
  • What are the limitations for using CRISPR/Cas9 in animals? Can it be used to modify human germ cells and embryos or modify animal cells to develop organs suitable for transplantation into humans?
  • How will patients receiving treatment using CRISPR-developed products be educated to secure informed consent for clinical use and research trials? If the technology fails, who is responsible?
  • Once released into the environment, how will CRISPR-developed products be tracked? What measures can be taken to mitigate a premature or unauthorized release of CRISPR-edited organisms?
  • How will liability for damages caused by CRISPR-edited organisms be addressed through legislation and the courts?

Intellectual Property

  • What is the current state of CRISPR intellectual property ownership? How do academic, nonprofit and commercial entities license CRISPR/Cas9 for use in genome editing? For example, non-exclusive licenses may be obtained for use of CRISPR/Cas9 for editing plant and animal DNA.
  • Non-exclusive licenses for use of CRISPR/Cas9 technology currently do not include its use for gene therapy. Is it possible to obtain a license to use CRISPR/Cas9 for gene therapy?
  • Are new CRISPR technologies being developed? Are new CRISPR technologies available for licensing, or will they be soon?
  • How will the patent office treat CRISPR-developed products? How can patent-eligibility issues be navigated for CRISPR-developed products?

International

  • What international standards are applicable for safe and ethical use of CRISPR technology? For example, how will the Universal Declaration on the Human Genome and Human Rights, the Universal Declaration on Bioethics and Human Rights and the Universal Declaration of Human Rights affect use of CRISPR/Cas9 technology?
  • How will international standards evolve based on increased use and development of CRISPR/Cas9 products?
As CRISPR technology is rapidly adopted for genome editing, the laws and regulations regarding the technology are rapidly evolving as well. Many legal issues must be considered when developing a set of best practices to address the intellectual property, ethical, regulatory, security and liability issues surrounding CRISPR-edited organisms. ●
Jean Dickman
Jean Dickman
Jean represents numerous national and international clients, including several Fortune 500 pharmaceutical corporations, start-up biotechnology and pharmaceutical companies and major U.S. universities. Jean regularly counsels these clients in all aspects of intellectual property, with an emphasis on strategic patent portfolio development and procurement, patent infringement and validity analysis, due diligence analysis of intellectual patent portfolios as a part of mergers and acquisitions, and intellectual property licensing in a variety of technologies.
2019-04-19T21:08:42+00:00October 1st, 2018|