Editas Medicine, a start up medical biotech company, has raised more than $160 million prior to an eventual IPO to support its mission to develop a novel gene editing therapy to treat diseases. Unfortunately for Editas, the technology upon which it bases that therapy is now the subject of a patent dispute. Editas licensed that technology, which is formally known as “clustered regularly interspaced short palindromic repeats” or “CRISPR”, from a team of scientists affiliated with Harvard and MIT. A rival group of scientists from the University of California, however, have also laid claim to ownership of the technology. The rival ownership claims are now playing out before the United States Patent Office.
The competing ownership claims are driven, in major part, by recent changes in the U.S. Patent law, which now recognizes the first entity to file a patent application as the owner of the technology over the first to create the invention. The University of California team filed its patent application immediately before this law went into effect, and the MIT/Harvard team filed their application shortly thereafter.
Editas and other companies that sought to license the CRISPR technology stand to lose billions in revenue if their licensing rights to use that technology are deemed to be invalid. Apart from valuations and licensing rights, this situation raises two other issues that are relevant to the world of advanced gene therapy.
First, this technology can provide dramatic benefits to cure diseases. From a policy perspective, should the control of this technology be limited only to entities that can afford the billions of dollars that will be sought for license rights? Is there a public policy that extends those rights beyond a small group of entities who seek to control it?
Second, gene therapy brings to mind some of the worst examples of eugenics and population control. Ethicists continually warn of the slippery slope presented by gene therapy. If man can rearrange a person’s gene’s to ward off diseases, how else might that therapy be used?
Biotech and medical industry managers are not expected to have immediate answers to either of these questions. They need to remain aware of the challenges posed by gene therapy technologies and to have the foresight to manage those challenges when they arise in their own corporate environments.
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