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CRISPR Patents Must Be 'Reined In,' Experts Say

NEW YORK (GenomeWeb) – In the battle for the patent rights to CRISPR-Cas9 technology, just about the only thing the two sides seem to agree on is that one of them should be able to control the intellectual property rights arising from the discovery of the genome editing system.

Which side will ultimately receive these rights — the Broad Institute or the University of California, and their respective co-parties — remains unclear. The latest salvo in the battle was launched by the Broad, which filed a brief in October in response to an appeal filed by UC in April to overturn a US Patent and Trademark Office Patent Trial and Appeal Board ruling that would essentially give the Broad control over the key IP estate for companies pursuing targeted genome editing applications in several areas such as gene therapy, drug discovery and development, and ag-bio, which rely on editing in eukaryotic cells.

However, in a new Policy Forum column published today in Science, Duke University law professor Arti Rai and Arizona State University professor Robert Cook-Deegan argued that overly broad CRISPR patents are contrary to the public benefit, and that the courts must rein them in.

The fight over CRISPR patents began in 2012, shortly after UC's Jennifer Doudna and the Broad's Feng Zhang and their colleagues each published papers on their discoveries of CRISPR-Cas9 systems. But in a way, this fight has been brewing for much longer than that, Rai and Cook-Deegan wrote — about 40 years, "since the US Bayh-Dole Act of 1980 invoked patents as a mechanism for promoting commercialization of federally funded research. With the encouragement provided by Bayh-Dole, academic scientists and their research institutions now race in dual competitive domains: the quest for glory in academic research and in the patent sphere."

The problem is that these types of patents fights waste resources as the parties often waste time and money trying to duplicate each other's work and hire lawyers in a bid to acquire broad patents, they added.

In March 2013, the US moved from a "first-to-invent" to a "first-inventor-to-file" system, so patent races from now on will not trigger the expensive legal maneuvers associated with interferences that have gone on with the CRISPR fight, the experts further noted. But that won't eliminate the problem as companies and academic institutions will still race to file first.

"So, the CRISPR wars offer much-needed lessons. A first lesson involves the interplay between patent racing and scientific credit," Rai and Cook-Deegan wrote. "Legal rights can get confused with scientific credit. It is important to get the rules right, not only for the patent system but also for academic science."

The major problem with broad patents is that they can have a chilling effect on downstream innovation. "When granted on broadly useful platform technologies, patents concentrate economic power over essential knowledge and methods," the experts added. "Although some argue that robust ownership rights for intellectual property promote efficient development (either by the owner or by licensees), the weight of evidence suggests that broad knowledge monopolies even in the hands of universities can hinder scientific progress."

For that reason, the law is moving away from broad patents, they noted.

In the end, the best thing that could happen in the CRISPR case would be narrow patents that would prevent anyone from exercising too much control over downstream research, according to Rai and Cook-Deegan. But if broad patents are granted, it would be a good opportunity to improve Bayh-Dole's pro-commercialization safeguards.

"Regulatory improvements that have been suggested in the literature include clarifying government-use rights, extending them to grantees and contractors; recognizing situations in which patenting is not the shortest or best path to widespread application; and simplifying procedures for 'march in' to compel additional licensing when health and safety needs are not being met by those with exclusive rights," the authors wrote.

To this point, none of these proposals have been undertaken by the Department of Commerce, which is responsible for administering Bayh-Dole. The CRISPR patent fight may prove to be the "catalyst for action," they added. "Improvement could prove particularly critical in the event that courts let overly broad rights emerge."