Peter Socarras’s father is a doctor, and although he never saw himself destined to enter the same profession, he shared his father’s drive to help others. Combining his own affinity for biology, engineering, and strategic planning, he completed a master’s in biomedical engineering before attending law school and embarking in a career in intellectual property law. That specialty led him to Nevro in 2012.
“When I joined Nevro, I was excited about the unique IP challenges we were facing. But more importantly for me was joining a company that was revolutionizing the pain space, and providing therapy for patients who had few other options available,’’ he recalls. This young company was conducting exciting research for the treatment of chronic pain. Its flagship product, launched stateside in 2015, is an implantable device that electrically stimulates the spinal cord.
Traditional spinal cord stimulation has been around for decades: the concept is to stimulate the spinal cord using small amounts of electricity at about 40–60 pulses per second.
But spinal cord stimulation had really been a therapy of last resort. Applied only when alternatives had been exhausted, the technique traditionally provided about 50 percent pain relief to about 50 percent of patients—often referred to as the “fifty-fifty club.” And when it worked, patients experienced a sensation known as paresthesia—a distinct tingling, buzzing, or pins-and-needles sensation that covered the area of the pain.
“That was really a Sophie’s choice,” explains Socarras. “You get some pain relief, but you have this constant tingling or buzzing sensation, which often served as a constant reminder that you were in pain. So you never really felt ‘normal’ with traditional spinal cord stimulation.”
The Nevro team investigated another approach: a high-frequency application, delivering ten thousand pulses per second to the spinal cord. Previous researchers had been skeptical of using such high-frequency waveforms on the spinal cord, expecting that unwanted side effects would outweigh any possible benefits. According to Socarras, nobody wanted to go there.
“Our founders were really outsiders in the space. They decided to test what others wouldn’t and build equipment that others wouldn’t. That’s the story of innovation, right? You need innovators to go where others won’t go,” he says.
And it was a genuine breakthrough. The team found that with its unique waveform, more patients got significantly better pain relief—to the tune of nearly 70 percent pain relief for 80 percent of patients. Plus, the undesirable paresthesia sensation was entirely eliminated. Patients turned on the device and felt normal again.
Now, Socarras’s team has to make Nevro’s case to the patent ecosystem in order to protect Nevro’s technology and its significant investments in bringing this technology to market. Key to that approach is a distinction between Nevro’s technology and previous spinal cord stimulation products. From research to market, Socarras and Nevro have emphasized that the entire approach—not merely the degree—is different.
“We had to come up with a strategy for getting everyone from investors to the US Patent Office to the district courts to pay attention to Nevro’s story and see the uniqueness in its technology.”
Once Nevro proved its sophisticated technology was superior—even receiving a rare superiority label from the FDA—the competition intensified and followers came knocking on its door. That means, to deliver a return on sizable investments, Socarras and Nevro had to navigate the patent system in a strategic way, protecting research from multiple angles and investing heavily in patent enforcement.
He suggests that the current patent landscape is inadvertently challenging to innovators and investors. He explains, “In an ideal world, an innovator’s patent application would see greater scrutiny at the front end, so as to create greater certainty at the back end. Unfortunately, the system we have is almost exactly the opposite. The reality is that a patent receives its greatest amount of scrutiny at the point in which you try to enforce it.”
Ideally, a single comprehensive patent, obtained through a rigorous application process, would suffice to protect an innovation. It would lock other companies out of the space—freeing innovators from the expense and burden of enforcement. Such an efficient system would encourage investment in further innovations, he says.
At the moment, though, the rules of the game require innovators to take a portfolio approach to protecting innovation. Nevro holds more than 170 patents, and they are exceedingly difficult to enforce due to the expense of litigation.
“We have had the resources to build an IP portfolio and enforce it. But you can imagine that a lot of innovators out there don’t. I think that’s a problem for the system. That takes people out of the game,” he says. “But it’s in the hands of those smaller players that real life-changing innovation takes place.”
Four years since the FDA approved its device for back and leg pain, Nevro is no longer one of the smaller players. As the company pursues additional applications—neck pain, diabetic pain—Socarras is also keeping track of constant changes in the patent system and the case law around it. He’s optimistic about the outlook for Nevro and for patients.
“We’re enforcing our IP. As the market recognizes the importance and superiority of our product, we owe it to our investors to protect our IP. And we’re looking forward to vindicating our efforts and our strategy.”