Discretionary denials at the Patent Trial and Appeal Board (PTAB) of the US Patent and Trademark Office (USPTO), the CRISPR patent landscape and 35 US Code §101 are top of mind for Eldora Ellison, director at Sterne Kessler Goldstein & Fox.

On October 27, Ellison provided her thoughts on a range of topics, including life sciences trends and diversity and inclusion in the legal profession, during an LSPN Connect interview.

Ellison, who serves as a director in Sterne Kessler’s biotechnology and chemical, and trial and appellate practice groups, is also the lead patent strategist on CRISPR-Cas9 matters for the University of California.

Earlier in October, French microbiologist Emmanuelle Charpentier and US biochemist Jennifer Doudna (professor of chemistry at the University of California, Berkeley) jointly won the Nobel Prize in chemistry for their seminal work on CRISPR.

While Ellison cannot talk about the long-running dispute between the university and the Broad Institute of MIT and Harvard University, she does speak more generally about the CRISPR landscape.

“When our firm was first brought in, the University of California was still trying to develop the technology and obtain patents. Now it has more than 30 issued patents,” says Ellison.

She adds: “The patents involved in the ongoing interference cover basic platform technology. As more entities undertake more research on the technology, there will be refinements, just as in any other field.”

Ellison predicts that we’re likely to see more innovations being developed and more patents being granted. Entities interested in working on the technology will need to be careful to navigate the IP in this growing and complex field.

Trends on the horizon

Looking ahead, Ellison hopes “legislators can reform section 101 so we can provide adequate patent protection in the diagnostics space”.

Section 101 sets out that “any new and useful process, machine, manufacture, or composition of matter” is patent-eligible, but judicial exceptions prohibit patent claims directed to a law of nature, a natural phenomenon or an abstract idea.

Ellison adds: “As with anything in the patent system, we want to keep the scientists motivated and to promote innovation as the patent system is designed to do.

“Unfortunately, section 101 is not quite living up to the job it needs to do.”

On the PTAB front, Ellison notes that a lot of discretionary denials are being seen, particularly in cases where the same arguments have been made previously.

“Lately, we’ve seen the board deny trial when district court litigation is so far advanced that in the PTAB’s mind, it may not be efficient for the board to institute trial,” she explains.

From Ellison’s perspective, one of the most important things for stakeholders is having some degree of predictability.

The America Invents Act was enacted in 2012 in an effort to give stakeholders the ability to challenge patents outside of district court litigation, says Ellison.

“If we have some sense of predictability around whether a trial will be instituted, then companies can make their business decisions as to whether it makes sense for them to move forward with a given proceeding,” she adds.

In October, the USPTO published a request for comments on the board’s discretion to institute trials.

COVID-19 and diversity

Ellison also describes the impact the COVID-19 pandemic is having on Sterne Kessler and the level of diversity and inclusion in the legal profession.

Applauding the firm’s IT team, she says Sterne Kessler was able to transition to home working quickly and almost seamlessly.

“This makes us think about life in the future post-COVID and wonder what that’s going to look like. Now that we see that we can have the entire firm working remotely, how much of the firm do we need to have work on site going forward?

“There are some whole departments that we think can work remotely indefinitely,” she says.

“With some of our back-office operations, we don’t see the need for them to be on site.”

On diversity and inclusion, Ellison noted that she’s seen some positive responses from the legal industry to the Black Lives Matter movement.

“It’s refreshing. It’s unfortunate that it’s taken so long, but silver linings probably come out of every situation and I try to find them,” she says. “A number of companies and institutions have made an active effort to insist upon diversity in their choice of counsel.”

Ellison has seen some specific outreaches by entities trying to change the way they’ve been doing things, and not go with default choices they’ve made in the past.

“The fact that there’s more discussion about it and more efforts to hire, retain and train people is a step in the right direction for everyone’s benefit,” she concludes.

Image: Shutterstock.com / NASA images