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Intrigue and Outdated Rules Complicate Big Biotech Patent Fight

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show that CRISPR/Cas9 could work beyond bacterial cells, does it matter? There is something in patent law called “obviousness.” If someone else invents a vehicle and demonstrates its usefulness on a dirt road, you might not be able to win a patent for a similar vehicle that drives on asphalt.

The beauty of CRISPR/Cas9 as a gene-modification tool is that, to change your target, you only need to change the sequence of the RNA guide that brings the enzyme—the scissors—right to the spot you want to cut. There’s no need to rebuild the scissors.

In other words: What’s the real breakthrough? The claim to invent the basic machinery? Or the claim to invent that machinery in the majority of cells that will matter for research and therapeutic purposes? Overly simple, yes, and of course the science and patent law will require far more complicated arguments. But it’s a good basic question to keep in mind as the fight proceeds.

For those who like a little intrigue in their patent scuffles, there’s also this question: Who submitted an anonymous challenge to the Berkeley group’s patent try in September, soon after Doudna cut ties with Editas? The fight might be governed by old “first to invent” rules, but the new patent rules have also expanded what amounts to a window for public comments. Encouraged by PTO, the comments can last for dozens of pages, and the commenters can remain anonymous.

In PTO-speak, it’s called a “third party relevance submission,” in essence an exhaustive compilation of prior art—examples meant to undermine an inventor’s case for a patent. Someone took pains to point out flaws in more than half of the 155 claims in the Berkeley group’s patent application. Think of it as an anonymous call—a very long call—to a detective that brings attention to alleged skeletons in someone’s closet.

These anonymous submissions are not trivial to produce, and even though new rules make them easier, challengers have to keep a close eye on the timing.

I was curious which other CRISPR-related patent applications have drawn similar challenges. The Zhang/Broad patent never attracted one, according to the PTO records. One application from a group at Lithuania’s Vilnius University did, but otherwise, all other applications I could find either hadn’t attracted a challenge yet, or haven’t had their contents made public (which of course makes a challenge quite difficult).

I would expect more challenges of all stripes to surface, but it’s hard to imagine the field getting bogged down. CRISPR/Cas9 is simply too widespread and too useful. Improvements will emerge at a furious pace, potentially rendering obsolete what’s currently state-of-the-art. Getting CRISPR/Cas9 into cells of all types, using various delivery mechanisms, is one wide-open area.

Another is making the technology more “specific”—hitting the targets it’s supposed to, and avoiding the ones it isn’t. “There still aren’t good ways to measure off-target activity on a genome-wide scale,” says Caribou CSO May. “We still suffer from the ‘looking under the lamppost’ problem,” which means researchers looking for problems can only find them by looking where the “light” is shining.

Still another is to expand CRISPR/Cas9’s limited DNA-cutting repertoire. The technology is limited because the version of Cas9 mainly in use now, borrowed from the bacterium S. pyogenes, only recognizes and snips genes with a certain nucleotide sequence. Cas9 from other bacteria recognize different sequences and might also be therapeutically useful.

Vinod Ranganathan, a researcher in the Johns Hopkins University School of Medicine’s ophthalmology department, says he’s found another way to expand that repertoire. He and colleagues published work this summer in Nature Communications that describes a different method of producing the short strands of guide RNA, giving them the flexibility of ending either with the nucleotide G (guanine) or A (adenine), instead of only with A. That, he says, gives the editing machinery access to more sites along the genome.

As the modifications, improvements, and new ideas accrue, the field’s foundational IP—both Editas’s Bosley and Intellia CEO Nessan Bermingham have described what they’ve licensed in exactly that way—isn’t likely to become obsolete. In RNA interference, Alnylam Pharmaceuticals (NASDAQ: ALNY) about ten years ago sewed up a huge portion of the so-called Tuschl patents and, despite ups and downs, has dominated the field ever since.

Go back further to monoclonal antibodies. As they rose to pre-eminence among biotherapeutics, Genentech squeezed as much value as possible from the Cabilly patents, originally filed in the early 1980s. Protein Design Labs couldn’t bring its own antibody products to market, but its Queen patents were spectacularly lucrative.

How ironic is it, then, that what’s arguably the most important biotech patent fight of the decade could be the last great fight under rules that no longer apply. Who benefits remains to be seen.

“This IP fight is going to burn up a lot of money,” Bermingham says. “It’s worthless if no product gets to the marketplace to help people.”


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2 responses to “Intrigue and Outdated Rules Complicate Big Biotech Patent Fight”

  1. anon says:

    Breakthrough Prize FAILED to honor ACTUAL INVENTOR who truly first harnessed CRISPR-Cas. Feng Zhang. See US Patents 8,945,839; 8,932,814; 8,906,616; 8,895,308; 8,889,418; 8,889,356; 8,871,445; 8,865,406; 8,795,965; 8,771,945 and 8,697,359; allowed US applications 14/226,274 and 14/105,017: EP 2771468; EPA 14170383.5; US 13/842,859; EP 2800811; and US 14/318,933.

    • anon says:

      why are you quoting patents to make a point about first to INVENT? This article was largely about that fact that those patents are being challenged because Zhang WASN’T THE FIRST TO INVENT (allegedly).