How Medical Device Intellectual Property Protection Varies by Sector

When developing a product in the medical device space, how does intellectual property (IP) protection work in the private sector versus at an academic institution, like a university? When is a patent needed and when is it not?

In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Neil Thompson, Kevin Buckley, and Stephanie Willerth about intellectual property and why it's important to understand the difference between inventorship and ownership.

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Some highlights of this episode include:

• At a university, Stephanie describes the process that professors and students follow when they have an idea. Before they publish it, if they think they have something novel and meets the definition for a patent, they file a disclosure.

• In the private sector, Kevin describes the publishing, patent, and funding process as being very different. To patent a trade secret, it must be incredibly robust and support a very valuable program. Funding for commercial entities or for-profit companies does not include grant monies.

• On the university side, there is no equivalent to a trade secret but the know-how  in the quest to do research and common sense in licensing agreements. There’s no protection for know-how and only royalties are paid related to patents and in countries where patents are enforced.

• Roles associated with an IP differ depending on the school and its policies and licensing terms. Restrictive conditions are put on IP and licenses because they know they will be negotiated, applied, and sold.

Links:

Patent Cooperation Treaty (PCT)

Creative Destruction Lab (CDL)

Stephanie Willerth on LinkedIn

Neil Thompson

Kevin Buckley

The Greenlight Guru True Quality Virtual Summit

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

Memorable quotes from this episode:

“Do we keep this trade secret or do we patent it? If we’re going to patent it, this better be incredibly robust and it better support some commercial embodiment, some very valuable program. Otherwise, there is no publication.” Kevin Buckley

“Some companies do not want their secret sauce—how they’re making a drug, what the drug is—eventually, drugs will be disclosed and basically hidden in a patent application until they go into clinical trials. When the drug is published.” Kevin Buckley

“If all you have is trade secrets and you don’t have any patents, you’re not going to be seen as valuable.” Neil Thompson

“There’s a big difference between inventorship and ownership.” Kevin Buckley

“It’s a lot different if you make something in your garage or if you spend five years making it in your research lab.” Stephanie Willerth

TRANSCRIPTION

Announcer: Welcome to the Global Medical Device podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Etienne Nichols: Hey, everyone. Welcome back to the Global Medical Device podcast. This is Etienne Nichols, your co- host. And with me today is of course Jon Speer, the host of the Global Medical Device podcast and founder of Greenlight Guru. Also joining us today is Kevin Buckley. He is a patent attorney with a lot of years of experience, a lot of diverse experience, as well as Neil Thompson patent agent with product development experience as well as Stephanie Willerth, CEO of Axolotl and professor in Canada, research chair in biomedical engineering at the University of Victoria. We're really excited to have them today. Let's just go ahead and get started. We're going to be talking about intellectual property and a lot of the different things that come with developing a product in the medical device space, as well as the different things that could be associated with developing that product in the private sector or at a university. I mentioned you all briefly, but Stephanie, if anything I neglected that you'd like to add.

Stephanie Willerth: Yeah. Any place you want us to start out off with? I can talk a little bit about, given my environment as a professor, how IP works and if you're in that sort of environment, you probably have a lot of students and graduate students who listen and oftentimes in academia and I'll admit, I was like this is a graduate student. You vaguely talk about intellectual property and you're very happy writing your grants, doing your research. You're like, why would I want to do this? Academics it's very much publish, give presentations, things like that are the currency that'll get you a faculty position. And so it wasn't until much later on when I was a faculty member that we actually started looking into how you actually get, what is IP? How do you actually start to protect these things in the academic environment? And then now more recently with our startup, it's how do you actually get this once you've got your idea, the university's invested some money in it, how do you get it from the university to your startup?

Etienne Nichols: Yeah, that's a good question. And I'll go to the beginning of what you were talking about and how do we want to start with this? Maybe one of the best ways is you've actually gone through the process of being in academia and then pulling your IP into a company. How did that process go? What did that look like?

Stephanie Willerth: Yeah, so I think and hopefully Kevin and Neil can help on the other side. At the university, what you do when you have an idea, and this is again for students out there and other professors, before you publish it, you have something that you think is going to be novel and meets the definition for a patent, what you do is you file what's called a disclosure. And in this case we have a technology transfer office so we had some really cool technologies we were working on and I guess now that the patent's filed, it was essentially around putting drug releasing particles in bio- ink for 3D printing tissue. Sort of did some background work to see whether or not it was novelble and worth being patented. We kept records of conference publications and things like that to ensure we could meet filing dates. And as I was talking a little bit about in the pre- show, here in Canada, there's actually some really nice granting mechanisms that will cover some of those costs associated with patenting, if you are a professor. There's our equivalent of the National Science Foundation called NSERC has a program called Idea to Innovation. And that brought us in some money to devote to market research as well as file patent costs. And then we more recently got funding from both the Michael Smith Foundation for Health Research and the Pacific Parkinson's Research Institute that are both BC based, as well as our equivalent of the NIH, the CHIR funding. Again, to help offset some of those patenting costs. That's sort of how it starts. And then it sort of goes through the typical. Usually another thing just from an academic perspective, a lot of the provisional patents can actually be, if you've got a draft of your paper with your technology, you can sort of put that in with a cover sheet to sort of mark your territory, claim your spot in line.

Etienne Nichols: Well, Kevin and Neil, what are the things that are kind of standing out as you're hearing this as different than what your process would go through, if you were in the private sector?

Kevin Buckley: Oh, in private, that is very different. Typically there is not a prepublication copy of anything to slap a cover page on and file as a provisional. You can imagine that as a opposed to presenting a lot, publish or perish in the kind of educational institutional context, a lot of this is, do we keep this trade secret or do we patent it? If we're going to patent it, this better be incredibly robust and it better support some commercial embodiment, some very valuable program. Otherwise, there is no publication. And then really the funding source is really very different, not totally different, but very different. You can imagine that a lot of for profit companies are not getting grant funding. I have not seen a commercial entity of any one of our clients get NSF funding, for example, have started with SBIR, STTR funding, but be careful there. A lot of times those grants, even though you're starting off for profit, a lot of that grant funding can't be used for IP. There's a lot of overlap, but totally different motivation to start with. But really the motivation changes once, we represent universities and we have for a long time, but once they license out a technology to a for profit entity, then the motivations become somewhat similar between the academic and the for profit company.

Etienne Nichols: I might just go a little bit upstream of what we're talking about here. You mentioned deciding trade secret versus going ahead and patenting your technology. What are some of the decisions that need to be going through the company's heads when they make that decision?

Kevin Buckley: That's tough and it depends. It's unique really with each company. Some companies do not want their secret sauce, how they're making a drug, what the drug is. Eventually drugs will be disclosed and basically hidden in a patent application until they go into clinical trials when the drug is published or a medical device, they want to keep, for example, the method of manufacturing of the device totally secret, as opposed to what the device does. Something like a kit for diagnosing a certain condition. The part that you patent will be published and your competition will instantaneously know what you're doing and be able to either copy it, work around it or bring it to another country where you don't have patent protection pending. In the commercial aspect of this, you keep trade secret if it's something that you just never want published, you think it's commercially valuable but you patent what you can allow to be published and something that might require something that is still secret, like method of manufacturing, the kit goes on the market, the method of manufacturing it, if it's novel and non- obvious, stays with you and stays off patent but is very valuable. There's a lot of nuance there.

Neil Thompson: I think also another issue to consider when you're deciding trade secret or patent is just the value of the company generally. Typically, if you wanted to sell your company at some point, all you have is trade secrets and you don't have any patents, you're not going to be seen as valuable. Companies oftentimes ensure make that kind of decision. We want to have some patents that people can see to be able to show that we are a valuable company that's worth acquiring.

Jon Speer: And I'm curious on the university side of things, is there an equivalent to a trade secret? It seems like you're not really trying to protect secret per se, in your quest to do research or are you? I guess, I don't know.

Stephanie Willerth: Yeah. Well for us, it's sort of interesting because with our bio- ink formulation, our base one, we had published not the specific version we solved, but anyway. There's knowhow that goes along with making it. It was interesting during the negotiations because technically if you have knowhow, which the university did not like us pointing this out, I have the knowhow, why would we pay? There's no protection on knowhow. What value did it add? Minus the fact that we generated it in my lab. And so that was something we brought up, we were negotiating was that we only wanted to pay royalties on things that were related to our patents and we only also wanted to pay royalties in the countries where the patents were being enforced. Because why should we be paying royalties on things that in countries where we have no patent protection? That didn't logically make sense. I'm not a lawyer, but we tried to use a lot of common sense arguments when working out our licensing agreement. But I do know that schools will often push for deals because they do have the rights to license even though it is on your professor's side, your IP to your company, they will try to drive the best deal for them. But those were some of the things that we pointed out for that. Because it's not protected, people do generate knowhow all the time. It just gets a bit difficult to negotiate that. Or in our case, I think the university was frustrated that they couldn't get more from the company because we were kind of like, well, if it's our knowhow, what benefit does it bring to actually have a license to our knowhow from you? The patent, it makes sense, because that's protected. And in that case, they had actually invested funding into helping us to prosecute the patents, which is something I'm actually curious at with Kevin and Neil. Because if you have a company and I will say, I came from a very lucky position where we had these grant funds so we are in the tens of thousands of dollars of patent costs but it was easier because we had the funding. Of course it was like, well, why wouldn't we patent when we had the funding? Whereas I could see a company you have to decide sort of, is this worth actually putting the money in and actually going through the whole process because as they mentioned, it's a bit of a different thing. Because if you just have a company and I have been jealous of my friends, who've had companies in the past, you don't actually have to publish your work as long as you're selling your product and your board's happy and things like that, but in academia there's much more pressure to actually have your work be public. Then that's where you sort of go down that path. Happy to hear from you guys on that.

Etienne Nichols: Yeah. Kevin, you want to talk to that?

Kevin Buckley: Yeah, it's interesting. And there's a lot of kind of interesting interplay with that right now. You can imagine with the vaccine technology, some of this was developed at university and I believe some of that had federal funding. In the United States, there's something called march in rights. And if the federal government is paying for the research and development, then it can kind of automatically take a license if it wants to and then start just getting it out to people. It's almost like a compulsory license in other countries. That's a really interesting interplay. The other interplay really is in a university when you have a licensee. The technology transfer office will license out the technology to a for profit corporation, that for profit corporation, the licensee, is paying for patent costs a lot. And that can come to hundreds of thousands of dollars depending on the licensee, the technology, the investigator, et cetera. There's a lot at work there. When we're working with university clients and for a little while I was in house at a university, a lot of different considerations went into the value of a certain technology, whether this was going to be a blockbuster, whether this was a foundational technology, how broadly the university wanted to protect it. And so Dr. Willerth mentions, you know, the university or the licensee, isn't willing to take it into Japan, Korea, China, Singapore, et cetera, Then the cost of to the licensee is going to be a lot lower, but the exposure of the technology is going to be a lot lower too. There's just a lot of interplay. I don't know if I answered the question, but there's a lot to be considered when you're working with a university client, as a lawyer, especially when compared to a commercial enterprise.

Jon Speer: Well, I think sort of what I heard or what I was thinking when Stephanie asked, thought that came to my mind is, she and her company, they're fortunate in that they have funds that are allocated specifically for patent protection purposes. But a lot of startups, they don't necessarily have that kind of capital. And if I do have some capital and I'm early stage, what is the strategy from an IP perspective versus getting my product ready to go to market? These things can be, when it comes to spending cash, conflicting with one another.

Kevin Buckley: Yeah. We have this conversation with our startup clients all the time. And this is tough because you have to do proof of concept. You have to eventually get a minimum viable product. You eventually have to talk to VCs, go through due diligence to get more money. There's some element of bootstrapping it. There are pre- seed, seed, angel investors that will put in 10, 20,$30, 000, a lot of which could be spent on IP. But what we typically advise our startup clients to do is try to kick the cost can down the road as far as possible. Like Dr. Willerth suggested, filing a provisional patent application first. Before the technology's really crystallized, you at least get a provisional patent application on file, put one or two claims in there so there's a practical reason for that with respect to going into Europe, but at least get one claim that crystallizes what the invention is, what the concept is. Then we typically recommend at the one year mark, one year after filing provisional, going PCT, patent cooperation treaty. That cost is relative minimal. It's about three grand, maybe less, in government fees, but it kicks the can down the road before you're really choosing what the jurisdictions you want to protect your invention in. That happens at the two and a half year mark from filing your provisional. If in that one year gap period between provisional and non- provisional, you can start doing proof of concept. Instead of everything being prophetic, you're actually making something tangible. You have good, well, let's just say you get any data providing kind of the best configuration of a medical device. If it's made of multiple components, if there's a cloud mechanism associated with the device, you get that worked out. You start doing the research. Hopefully by the time you file the non- provisional, the PCT, you've baked in some of the real world data and real world device, in this case. You've baked that into PCT for relatively low cost and again, you're going to have to bootstrap this somewhat if you don't have money, but it at least kicks the big costs to the 30 month mark, the two and a half year mark, where you have to choose the jurisdictions, US, Europe, Canada. That gets expensive. That's where you're spending tens of thousands of dollars and you don't have to spend it at the beginning. You don't have to spend it at the one year mark, you kick the can down the road.

Jon Speer: Yeah. And thank you for elaborating on that because I think there's a lot of good suggestions and advice that's there for folks listening. But I think the biggest thing is even if you kick that can down the road, you need to build that into your strategy and into your financial spin models too, because two and a half years for most things should be ample enough time to be able to advance the technology, at least to know whether or not you've got something. And of course there's all sorts of pivots and things that can happen, but at least a couple of years, you're buying yourself some time without having the price tag to go with it. But when you get to that two and a half year mark, be ready to put some capital toward that.

Kevin Buckley: Absolutely. And there are a lot of creative things to do as well. For example, if you're working with a contract researcher, a contract manufacturer, sometimes those entities will take equity in your venture and that equity will help pay for some costs. If you're bootstrapping by providing services, in addition to selling and manufacturing a device, those services can bleed into paying IP costs associated with the device. A lot of ways to skin the cat but being creative and baking that into your pitch deck, that is something that will show the sophistication that investors are looking for, as well as potential acquirers or maybe even some highfalutin licensees.

Neil Thompson: You certainly wanted to show that there's some sort of work that you've done on the IP side before you go to these investors, at least file a provisional application before that.

Etienne Nichols: What are some of the different roles associated? When you're talking about a university, maybe it's the professor, maybe it's a different person who's come up with the invention and who owns patents, things like that. What are the different roles associated with the IP? Maybe we can start with Dr. Willerth, if you like.

Stephanie Willerth: Yeah. Well, it honestly varies a lot by the school and this is something again for any students, grad students out there who are working on things, you should check to see what your school's policy is. I trained in the States and now I'm in Canada and I have a very different, well, even in Canada, there's huge diversity in the policy. At the University Victoria, I'm very lucky because we have a creator owned policy. The IP that we generate while working at the university belongs to us. If we work with our tech transfer office who puts in money to start investing in things, then they have a right to a certain percentage of that. But you can at UVic say," I'm going it alone and keep that," but then again, you're on the hook for all of the costs. Other schools, they own the IP that you generate while you're there. And then you're under their licensing terms. I know at Berkeley, they took like the majority of the IP rights. It was very, I wouldn't say difficult. At those schools, you have so many people who are trying to commercialize so many things that I felt like they baked in difficulty because they knew that you're full of ambitious people. You're going to have people who will do whatever. The other thing that I hadn't realized, which might have little bit naive, having trained at places like MIT, WashU and Berkeley, is that oftentimes they put these really restrictive conditions on the IPs and licenses with the idea that they know it's going to be negotiated. And so that they are actually expecting the companies to come back and push back on terms that are restrictive, that they put in initially. UVic is a bit more, because we are smaller school, is a bit more about actually getting our tech transfer out and actually getting people to move things once they've been licensed out into to actually being applied and sold. Our licensing process is a little bit more gentle when we had to license our tech back from Axolotl. As a grad student, again, I would check. Your school has an intellectual property policy, read that, see what would belong to, if you say have a person you're working for, you are graduate student or PI, see if there's any terms. This is where I think pretty sure we talked a bit about conflict of interest. This is something you should also really investigate. I know here with our IP policy, depending on how it is. If the student, even if they worked for me, but didn't use my resources, they could declare that as their own independent IP without me having any access to it. But this does vary by school and each of them have these different types of policies and it actually varies even at our university. Interestingly, the IP policy does also apply to undergraduates, even though it is a union policy that comes from the faculty union. I would just suggest checking on some of those points to ensure that if you do make something, you would have the rights to claim it as your IP and it wouldn't necessarily be the school's. I think that's sort of my little bit of that. As I said, I work extensively with our tech transfer office and so that's who sort of helps you do the initial landscape. See if it's worth being patented, they see a lot of stuff, so they can be really helpful. Other schools have more sophisticated and can help a lot more on the licensing side. Also here in Canada, as well as in schools I've been at at the US, lots of schools, I highly recommend again, if you have an idea going to your entrepreneurship center. Most schools have a little incubator. If you're at fancier schools in the US, a lot of them even have student funds and competitions. I know MIT had an internal entrepreneurship fund that even undergrads could in turn win cash to sort of start their startups with. They also provide a lot of guidance as well. It's sort of where I would say to start, if you have an idea, is to sort of go, especially if you're an undergraduate or graduate student, a lot of people have been there and done that so they can sort of guide you towards a better path or an easier path than some of other people's things.

Jon Speer: Yeah, I might throw in a twist to that, also share a short story. Quite a few years ago, myself and a couple of product designers, really smart, creative guys we were working with, an emergency room physician and the healthcare system was affiliated with a university. He came to us with some problem he was faced with, clinical problem he was faced with and we had come up with a relatively simple, but novel approach or solution to this from a product standpoint. Probably something that was patentable and myself and these two designers, we thought we have ownership of this because it was the thing that we had come up with. But the fact that we were working with the physician in this case, he ended up working with tech transfer and all these sorts of things. And it just wasn't a great experience. I share that story because if you're outside the university or a university affiliated healthcare system, but you're contributing to the IP or to the design of something that may eventually be patented, it could be a little bit tricky to navigate. I don't know if any of you all have dealt with that in any way, shape or form.

Stephanie Willerth: Yeah, well, I have a question, is this because you were under contract? For us, when we were doing like our IP, obviously my graduate students had worked on it and then this might be very benign Canadian BME hippie- ish. And so then we talked about who did what and then divided up the percentages but I could see a situation where the doctor does a disclosure as himself and doesn't actually disclose the other people. I don't know if Kevin has thoughts on how to protect yourself if you're in that situation where you're a contract designer for hire.

Jon Speer: Well, I knew very little about contract law at that point in time and let's just say I didn't have super deep pockets to sue against a large university system. I kind of let it go, but great point. In this case, on the front end, I should have done something differently with respect to ownership of IP. Every contract, every nondisclosure, all these sorts of things, those that are worth it anyway, at least disclose or describe, have a clause that speaks about that. And I think in this case I was a little naive. Didn't appreciate that. I thought, here we are altruistically going to work to solve this problem together and we would share in the ownership of that and so on and so forth. But I think at the end of the day, the physician disclosed the invention to tech transfer and we were really not included as co- inventors with that. But anyway, live and learn.

Stephanie Willerth: No, just as the point for students out there too, if it does look like you are generating novel IP with your supervisor, definitely even as a professor, you've got a lot going on, but this is one of the things that is actually really important, especially if your tech is going to be licensed, what percentage is your idea and you should be getting credit for that. And I know that you are in a weaker position, especially when you're dealing with someone who does pay your salary and have power over your career but it is conversations that are worth having and it's worth fighting for just to protect yourself.

Etienne Nichols: Did you want to add to any of Jon's comments there or his story?

Neil Thompson: I was just going to say that oftentimes when it comes to inventorship, it comes down to the idea, who came up with the idea? But if yours is somebody who put the idea into practice, essentially.

Etienne Nichols: Oh, we lost you.

Neil Thompson: Essentially taking what the person with the brain said and making it something that's tangible, well then typically that's not seen as an invention.

Kevin Buckley: And you should probably add in a couple things too, that there's a big difference between inventorship and ownership and to all the university people, typically being hired by a university requires you to assign your IP to the university and working out the percentages is certainly worthwhile. But the ownership typically will be going to the university, same with contract researchers. If you're under a contract, subcontract, under a federal grant, state grant, even under a nonprofit grant, usually the IP will go to the university and that can be a problem. But this really, you can get into really nuanced discussions here because I've seen employees of universities going from one school to another because the IP policy might be different between school of medicine and school of engineering. Some people might go into a building which was funded by the state versus a building that was not funded by the state so you're not interfering with some state rights in ownership of inventions and so on. The bottom line is, if you're using university resources, you're probably doing work on behalf of the university and you're going to have to assign the IP to the university. If on the other hand, you're in an incubator, for example, in a building that is not owned by the university, there's a colorable argument to say, you weren't using university resources to develop an invention. You didn't need to disclose it to tech transfer. You can bring it to your company, et cetera. You guys, nuance, it's all about nuance. It's all about contract, especially what's in your employment agreement with the university in this context. This can be super challenging. The challenge is not only within the university, but amongst universities. Full disclosure, we represent the regents of the University of California. I've represented WashU in the past, some other, big private research institutes and so on. This can be really challenging. Some people have joint employment with certain institutions, dual appointments. Some people will be spending their summers working at a for profit entity, a large pharmaceutical company, a large medical device company. Really the question is, if you're a professor, a graduate student, an undergraduate, what does your summer work count as? Is it work on behalf of the university? Is it work on behalf of the for profit company? And there's a famous case out there, Stanford V Roche. Roche won. It's something that everybody needs to consider and Jon you're right, it comes down to contract. It really makes sense, no matter what position you are within a university, make sure you're really well versed in some of these considerations. Look at the contracts, look at policies and procedures and by all means, be forthcoming. But certainly know your rights. I think that was a Clash song, wasn't it?

Etienne Nichols: Curious about that. Knowing your rights are there resources? I'm sure there are, if someone is interested or involved in this type of situation, like Jon, what would've you advised Jon, had you been back there and known Jon?

Kevin Buckley: I think going to, so policies and procedures are always available on the website of any university or private research institute and well, that's not true with all research institutes. It's certainly the public universities, you'll find policies and procedures. Ask for them. They gladly advise. At the bigger universities, there is always kind of a liaison between the general counsel's office and tech transfer. That liaison is a really critical asset if you're within the university and my recommendation would be ask the question. You know what you know, you know what you don't know, but the real problem is you don't know what you don't know sometimes. And that's, boy, if you knew that, Jon, my God, to ask the question early on but it's so hard when you don't know what you don't know. You just got to look at the university websites, take advantage of that liaison. They might advise you and trouble spot for you but that's where you should start.

Stephanie Willerth: I was just going to add a few things as someone who's been on the academic side because I think in Jon's case, as we've been talking about, it's a lot different if you make something in your garage or if you spend five years making it in your research lab. And so even for, I work extensively with industry. And so when you start the project, and I've done this with lots of industrial partners, you say," Okay, what IP could we generate out of this?" And what do I want? And what do they want? And honestly, sometimes if things don't match, then it's probably a sign you shouldn't be doing this. I think in Jon's case, it sounded like and this happens a lot, you have a doctor comes to you and you're an engineer and you're like, oh, we just want to help people. But then in this case, it seems like the doctor just went and filed it through the university. Again, if you're just a recent grad, you don't have a tech transfer office. People don't have IP policies. They would go to people like Kevin and say," Well, this is what I might turn into a startup." And then it's just a completely different path for that just in terms of that. And so I think that one of the things for probably good advice for any anybody also life, is having clear expectations, but definitely in all the projects we work on, we always discuss IP, what I would like to keep. And often it works out because a lot of my longstanding collaborations, they're interested in things we aren't. Their IP is more on the bio- printer side, we want the inks. And so it's been easy enough to sort of sort that out. I shouldn't say at the end of the day. IP can get really expensive and so usually if you're protecting, it's something you care a lot about. And so we've just been lucky or maybe it's because we do always talk about, well, what do you want out of this relationship? What do you think? And if this works really well, where do we want to go with this? And sort of having those clear expectations so then you just don't get a surprise when you find out that the doctor who thought was your friend and you guys were going to save all these patients, just filed for the IP without you. And honestly, I've seen this a lot where the doctor files and then thinks everyone else was just the hands. Even if there's not. Whereas being more of as a PhD, as a researcher, I do see my students as active contributors and they helped generate the IP. But again, these are things that it's better to sort of talk about them beforehand than when you're dealing with it. Especially if potentially you're going to be the person in the weaker situation, whether it's a grad student or contractor. Just so you know that you have rights because usually what you see is people taking advantage of the situation, but I'm speaking to some lawyers so they probably know that.

Etienne Nichols: That's right. One person told me that they're called agreements but really they should be called disagreements because you only read them when you disagree on something. I don't know if it's true or not. One question that might be, you could tell me whether or not it's relevant. When I was working at a company, we talked about patents to a certain degree. I was a little outside that conversation. They talked about how there was a concern, there might be, I don't know if they're fence patents, other companies that would come in and patent around our patents. Is that something that you can protect yourself from or maybe a completely different conversation? I don't know. Just any thoughts on that, Kevin or Dr. Willerth or Neil?

Kevin Buckley: Yeah. We work in this space all the time and we colloquially call it the shotgun approach. We try to get as big a scattergram as possible to essentially taint competition from getting into that space. You can imagine that when you're filing a patent application and when it publishes, that becomes prior art to anybody that follows on, your competition. The more broadly you're disclosing the invention, as many alternative embodiments as possible, it gums up your competition as much as possible. And you know where it gets really messy, medical device and pharmaceutical companies, this is just what they do, shotgun. When it's a drug, you claim every single analog, every single indication, you throw the dictionary into the patent application so that you are when this publishes, you're becoming prior art to all of your competition. That is the best way to keep somebody as far away from you as possible when you're going forward. The other way is again, claiming things discreetly as kind of the shotgun approach. If you claim method of manufacturer with the device itself, methods of using the device, if it's a diagnostic, teaching how to use the diagnostic, with 3D printing, how do you claim the ink cartridge and the component as it is used within a broader device and how the stem cells and the ink and what have you are used for providing or used in certain methods. If you're claiming it like that, then Dr. Willerth is excluding as much competition as possible from the get go. And then in a lifecycle management strategy, if there is something novel and non- obvious that goes into version 2.0 of the ink cartridge or the device which prints or what have you, if it's novel and non- obvious, you file yet other patent applications and you have different families which are going to be excluding competition as well. To summarize, shotgun, claim broadly, and then do a lifecycle management strategy whereby you keep patents pending so you can keep excluding the competition using the earliest available priority dates.

Etienne Nichols: That makes sense. I'm sure it gets very specific for every piece of tech that you're working on. Working with a patent attorney, patent agent obviously would make the most sense in those different situations. We're close on time. I want to ask, maybe we can start with Dr. Willerth, any last piece of advice or suggestions you have for someone who may be going through the same process that you went through.

Stephanie Willerth: Oh yeah, for sure. I actually think one of the most exciting things about licensing our technology and spinning off a company has been, especially since it's bio- ink and printing tissues is just seeing how much more science we enabled. And I know sometimes in academia, especially if you're working, some professors are sort of like, oh, industry is sort of a dirty word and making things too commercial. But honestly, some of the stuff we've had to do with QCing our bio- ink, honestly we should have done 10 years ago and it's just made our science a lot better. I also suggest to everyone to just reach out and see the different resources their school has to offer in their incubator. Especially if you're a student who's looking to protect some IP or even if you have questions about what's generated, just because I don't think it gets discussed as much as it could be. And it's always good to know, if you are making something and potentially, entering these competitions and winning money and you want to take things out, there is a great support network. I guess I should also probably give a shout out to, I mentor with Creative Destruction Labs, which I think has now gone global, but there's lots of really cool programs and they actually have a student mentorship program. Definitely I would say there's a lot of resources out there and check in to see what's available where you're at.

Etienne Nichols: Excellent. Thank you. Kevin, do you want to throw something out there? Any last piece of advice?

Neil Thompson: I can throw something out there before Kevin, you can end with him, I suppose. Well, I think it's really important to file a provisional first and it provides you the best amount of protections you can have at least at the point where Kevin mentioned, at the point of just coming up with an idea. As he mentioned also, you have a year to then figure out whether this is something you want to continue on putting money into and just it provides you the best amount of protection. Before you disclose it out, put it out there to people and Dr. Willerth mentioned, especially in academia, they operate in a publisher or perish type of environment, but if this is something you think is novel and not obvious in terms of getting a patent on and you think you can actually commercialize it in some way, file a provisional first.

Etienne Nichols: Kevin, take it away.

Kevin Buckley: Before I became an attorney, I was a biochemist and I really understand both sides of the table and the basic research I performed in immuno-- oncology led to some valuable treatments but here's what I learned. I didn't see this at the time that I was doing the research, there is a well worn path. And as a researcher, you at least have to understand that big pharma, big device, they have a certain way of bringing something to market. It is highly regulated. The funding models are again, well known. Your pitch deck should look a certain way. You should have your provisional patent applications and applications pending in a certain way. And understanding that interface between commercial and basic research and development, is critical for getting some of these things to the market. And while I, as a young, wet haired surfer, doing stuff at the bench, I did not understand that. I think some of the research I was doing wilted on the vine, it was not utilized to treat patients but once I think there's an understanding at least of how to get money to propel these innovations into the clinic and eventually to treat people, that requires at least an understanding of that commercial model to get these things to market. I encourage everybody to at least look at it. I think we're all saying the same thing, whether you want to dive in feet first or head first into that, that's something you have to decide for yourself but there is a model to bring devices to market and I encourage everybody to at least understand that model.

Etienne Nichols: Well, that sounds like a good ending place for me. Thank you all. We really appreciate you being a part of this conversation today. For those of you listening, if you'd like to learn more about Dr. Willerth's company and work that she's doing or Kevin or Neil's and the different companies that they're representing, please check the show notes, get more detailed there. Thank you for listening. You've been listening to the Global Medical Device podcast, powered by Greenlight Guru, the only medical device success platform that can service all your medical device regulatory needs. We encourage you to look that up as well at www.greenlight.guru. All right, thanks everybody.

Kevin Buckley: Thank you, Doctor. Thank you, Jon. Thank you, Etienne.

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