New Gene-Editing Technology Whets Appetites In Health, Food Industry, Fuels Patent Fights

A new discovery allowing easier and swifter genome editing, considered by some as a major game changer in the field of biology, is opening doors to new technological wonders in many areas, such as medicines and agriculture. Yesterday, the United States Patent and Trademark Office issued a ruling on a case where two US university laboratories both claimed the invention of a genome editing technique. The USPTO decided that the two universities had made distinct discoveries. In Europe, patents from both universities on the technology are also challenged at the European Patent Office.

At the heart of the battle: the Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR), a barbaric name for the neophyte gene-editing technology, making it easier and swifter to modify specific DNA in the genomes of organisms, from plants to animals, and in particular its variant CRISPR-Cas9.

On 15 February, the USPTO issued a ruling [pdf] in a case opposing the Broad Institute, Massachusetts Institute of Technology and Harvard University, and University of California on patents for a CRISPR-Cas9 system. CRISPR-Cas9 “is a combination of protein and ribonucleic acid 17 (“RNA”) that can alter the genetic sequence of an organism,” according to the ruling.

The University of California (Jennifer Doudna and Emmanuelle Charpentier) was the first of the two parties to apply for a patent on the technology, but the Broad Institute (Feng Zhang) was the first to be granted patents at the USPTO. The ruling means that the Broad Institute patents will stand, according to sources.

The USPTO in the ruling said both parties claim CRISPR-Cas9 systems and methods of using them, though none of their claims are identical. The patent office found that the Broad Institute “provided sufficient evidence to show that its claims, which are all limited to CRISPR-Cas9 systems in a eukaryotic environment, are not drawn to the same invention as UC’s [University of California] claims, which are all directed to CRISPR-Cas9 systems not restricted to any environment.”

The USPTO ruling concluded that “there is no interference-in-fact between the parties’ claims.” It also states that, “A determination of no interference-in-fact deprives UC of standing to raise other challenges against Broad’s claims in this proceeding.”

The ruling includes a list of the respective involved applications and patents of the Broad Institute, and the University of California (Appendix).

In a 15 February article, Nature said that at a press conference soon after the decision was issued, University of California attorney Lynn Pasahow “said the team had not yet decided whether it would appeal the patent judges’ decision.”

The article also underlined that the “The patent battle was unusually fierce given that inventors on both sides worked for academic institutions, and their inability to settle the case before moving to an interference proceeding surprised some.”

According to Northeastern University, gene editing is not a new field of science, but CRISPR “vastly outperforms its expensive and inefficient predecessors.” The university, in its January article, underlined the multi-million dollar prospect of the technology.

“Only those who get the first seat at the table will be able to reap the benefits that CRISPR promises; there is no time to wait for the patent system to catch up,” it said. “The CRISPR patent dispute highlights a trend in the biotechnology industry that contravenes the theoretical framework of the patent system: ‘move first and sort out the licensing later.’”

The dispute also “sheds light on the difficulty of maintaining pace with the rapid advancements of biotechnology and the need for companies to have the first bite of the apple,” it added.

Unstoppable Progress Amid Concerns

Despite some concerns voiced as the CRISPR technologies were used when they were discovered, swift progress is being made. At the end of January, according to Phys.org, a web-based science, research and technology news service, tuberculosis-resistant cows were developed for the first time using CRISPR technology.

In 2015, a Nature article said, “CRISPR is causing a major upheaval in biomedical research. Unlike other gene-editing methods, it is cheap, quick and easy to use, and it has swept through labs around the world as a result.”

However, the article noted, “some scientists are worried that the field’s breakneck pace leaves little time for addressing the ethical and safety concerns such experiments can raise.” The article cited the fact that scientists used CRISPR to engineer human embryos in 2015, generating “heated debate over whether and how CRISPR should be used to make heritable changes to the human genome.” Other scientists worried about the potential consequences on ecosystems of this technology, the article said.

Licensing Agreements with Monsanto, DuPont

According to a 15 February article published by Sciencemag.org, the Broad Institute and the University of California “have given birth to companies that have licensed the technology for multiple – and in many cases overlapping – applications in human therapeutics, agriculture, and industry.” These include CRISPR Therapeutics, Editas Medicine, and Caribou Biosciences. The article provides an interesting diagram of interactions between researchers, fields of applications, and companies.

In January, Monsanto announced it had reached “a new global licensing agreement with the Broad Institute of MIT and Harvard for the use of the novel CRISPR-Cpf1 genome-editing technology in agriculture.” CRISPR-Cpf1, according to the release, “is an exciting advance in genome-editing technology, because it has potential to be a simpler and more precise tool for making targeted improvements in a cell’s DNA when compared to the CRISPR-Cas9 system.”

In 2015, Caribou Biosciences (originally started by Doudna) and DuPont jointly announced the formation of a strategic alliance. “This multi-faceted agreement includes the cross-licensing of key intellectual property, a research collaboration, and financial investments by DuPont in Caribou, a developer of CRISPR-Cas technologies,” the release said.

CRIPR Patents Challenged at the EPO

Meanwhile, according to a European Patent Office source, the Broad Institute had been granted seven CRISPR-related patents at the EPO as of October 2016, all of which are subject to opposition by up to nine parties. Some 69 patent applications have been filed at the EPO in relation to CRISPR-Cas methods.

According to the source, many of those applications are related to medical applications, some of them to the food area.

For example, the first granted patent (EP2771468) has a list of nine opponents, among which CRISPR Therapeutics AG, and Novozymes. The patent is being opposed for numerous reasons of technical and legal nature, the source said.

“As is normal in opposition proceedings, the opponents request revocation of the patent. A summons to oral proceedings may be expected to be sent within the next few months, and a decision may ensue within a month of the oral proceedings taking place, so within a year or so,” the source added.

The University of California with Doudna, Charpentier, and others as inventors, has a pending application (EP 13793997) on a CRISPR patent, which has not been yet granted, the EPO said. Several anonymous third parties have submitted observations in the form of letters asserting that the invention is not patentable for technical and legal reasons, the source said.

According to the EPO, the USPTO ruling “will not affect proceedings before the EPO, which will take independent decisions for each application.”

 

Image Credits: Flickr – Richard Ricchiardi – Human Genome Project