Greenberg Traurig Shareholder Chris Bolten is an intellectual property lawyer who works with medical device developers. [Photo courtesy of Greenberg Traurig]
Those device developers have been making headlines with major product launches and deals to sell their businesses to bigger buyers. But the foundation for all that success was laid years ago with the help of IP lawyers like Bolten, who joined Greenberg Traurig this year from Eversheds Sutherland.
J&J, for example, purchased Shockwave for $13 billion just this year. Back when Shockwave’s only employees were its three founders, Bolten did the original due diligence and IP strategy for Sofinnova Partners on their investment in the device developer.
“Shockwave was struggling to raise money because nobody believed in the technology,” Bolten said in an interview with Medical Design & Outsourcing. “… They didn’t have any patents yet, we helped [on the original IP due diligence], and the rest is history.”
Bolten is set to speak on a DeviceTalks West panel with fellow Greenberg Traurig Shareholder Ginger Pigott on Oct. 17 in Santa Clara, California. (Register here.) They (and other panelists yet to be announced) will discuss “Waypoints on the Road to Success,” identifying the major milestones when medtech developers should consult with their IP counsel for key decisions that could affect their ability to secure funding, win regulatory approval and build a business for growth or sale to a strategic buyer.
“If someone’s building a medtech company, one would hope that they know that they have to file patents early on. One thing medtech companies get wrong is they don’t necessarily go to the right IP person early enough,” Bolten said.
While there are lots of IP attorneys out there, it’s key to find one with the right medtech experience, He said. “If you need a prosthetic heart valve, you don’t go to your general practitioner. You want to go to an interventional cardiologist. “Some of the earliest points at which a medtech developer should contact their IP attorney is when they’re identifying an unmet clinical need, defining what success looks like, and building a team, even if it’s just an informal group. And then there’s the first IP filing.
“Once you file that patent application, you’re stuck with it for 20 years,” Bolten said. “Patents last 20 years and you can’t change the original application as filed once you’ve filed it with the patent office. So that’s an important waypoint. Working with someone that knows the field, knows what you can protect and how you should protect it, and how to work with a medtech company, the earlier you do it from an IP perspective, the better.”
How soon is too soon to talk with an IP lawyer about the first filing?
“You have to have identified an unmet clinical need. If you’ve figured out how to solve that, you would want to be talking to an IP attorney and making sure you’re filing as soon as possible, before there is any disclosure outside the company,” Bolten said. “Or if you haven’t formed a company yet, then making sure that you hire the right corporate person to form the company and get your IP filed. The timing of the IP filing can be very fluid. It depends on when you’re ready to do it, but it is something that needs to be looked at early on, certainly before you disclose publicly your inventions and ideally before you’re disclosing it outside of your company circle, even under an NDA.”
Expect scrutiny of your IP when you’re seeking funding from potential investors, who will want to know what kind of patents (and to a lesser degree, trademarks) you have and how many, whether they’ve been granted or are pending.
“If someone’s going to invest money in you, there will be an IP diligence, especially if it’s a substantial amount of money. Are you ready for that investment? You need someone that can help deal with what is going to be important to the investor,” Bolten said. “They’re going to want to look at freedom to operate, the company’s IP, that your agreements — whether they’re your license agreements or your employment agreements — are well in place from an IP perspective, that the company has the rights that they need. Investors will not invest in a company that doesn’t have the IP rights they think they have.”
Successful fundraising then sets a medtech company off toward new waypoints through R&D and testing, regulatory review and commercialization — with pivots and realignments along the way.
“You have to continuously keep in contact with your IP attorney, because you’re going to learn new inventions when you put it in animals,” Bolten said. “Unexpected things will occur, unexpected problems will be identified and you have to solve them — especially if you’re in a new area that nobody’s been in before and they haven’t encountered those problems that need to be solved. That’s where you get great new inventions. As you go into clinicals, as you go into humans, as you do testing of your product and figure out it’s not resilient enough for a five-year implant or whatever it is, how are we going to make this better? There’s always new inventions in this development process, in the clinic, in R&D.”
And with the IPO market “dead” for medtechs right now, Bolten thinks founders ought to build their companies for commercial sustainability.
“Outside of cardiovascular acquisitions aren’t occurring too much until companies are commercial. … Your goal is moving towards commercialization and/or acquisition or a partnership,” he said. “That’s always the end goal.”
These are just a few of the waypoints and the tips Bolten and the rest of his DeviceTalks West panel will discuss — but you can register now to attend this panel and many more in person.
