EPISODE 8 – Staking Your IP Claim

In this episode, Gregory Bernabeo, Patent Attorney and Partner at FisherBroyles, covers intellectual property ground rules and special topics in the medtech space. 

Greg and Dan discuss:

• Why a patent isn’t what (exactly) what you thought
• Is my medtech innovation patentable?
• Are patents valuable if I can’t afford to litigate?
• Can medtech innovators protect their IP rights and publish their research?
• What’s important when selecting a patent attorney for my medtech project?

Episode Transcript

Dan Henrich:                     Hey Greg, thanks so much for coming in today to talk with us about IP and patent issues regarding medtech.

Greg Bernabeo:                My pleasure to be here. Yeah.

Dan Henrich:                     Before we get started, maybe you can just tell us a bit about who you are, your background, your position and the firm that you work at.

Greg Bernabeo:                Sure. Be Happy to do that. Well, thanks for having me today. I’m glad to be here to talk to you about these questions and issues today in intellectual property. It’s where I spend my time. I’m an intellectual property attorney, a patent attorney by trade. I’ve been practicing for over 20 years. I work as a partner at the law firm of FisherBroyles and my core of my expertise is patent prosecution.

Greg Bernabeo:                I’m a mechanical engineer by training, but my technologies span mechanical, electrical mechanical, computer hardware and software and is a very good fit for a lot of what we see in the medical device space.

Dan Henrich:                     Well, I’m so glad to have somebody who has both an engineering background and an IP background to talk with us about these things. So why don’t we jump in here and just start by talking a little bit about what a patent is in theory and in application. I think people conventionally think of a patent as a stamp of approval from the government to commercialize a particular product or technology, that’s not quite correct, right?

Greg Bernabeo:                Not quite.

Dan Henrich:                     Tell us your take.

Greg Bernabeo:                What is a patent? A patent is a grant from the government of course, and they’re territorial. A US patent has application in the United States. It gives you legal rights in the United States, specifically the right to exclude others from making, using, selling, offering for sale or importing into the United States the patented product or making use of a patented process. So ultimately it’s a right to exclude others, not a right to practice.

Greg Bernabeo:                And I think in some ways, this is maybe the least intuitive part of patent law, but the idea is that you can have an improvement to something that is patent worthy and yet someone may have a prior patent that’s broad enough to keep you from practicing your invention. And so there are slightly different analysis for determining whether what you have is patentable versus whether you have a right as they might say, to practice it, to use it.

Dan Henrich:                     Gotcha. Okay. And what about the various types of patents? I hear this is a utility patent, this is a design patent, this is a provisional patent. Can you talk to us a little bit about what the different aspects of it are?

Greg Bernabeo:                Sure. Absolutely. In this context, in the medical device field that we’re really talking about two different types of patents. Utility and design. So design covers the ornamental aspects of an article of manufacture. That’s the language in our law. The ornamental aspects are essentially how the product looks. Utility patent is really the other type of patent. The second type. Utility patent covers not particularly the way something looks, but more so how it is structured or how it works or maybe a process and how the process is used.

Greg Bernabeo:                It’s more about typically structure and functionality than appearance. And in a lot of ways a utility patent can be much broader than a design patent. A provisional is a utility patent concept. A provisional is not strictly speaking of patent, it’s a patent application. It’s a first step down the road towards utility patent protection. 

Dan Henrich:                     What are the elements that I have to demonstrate in order for my application to be granted?

Greg Bernabeo:                Essentially, what you have is new. It’s thinking about it a very high level, but the legal test are utility, novelty and non-obviousness. So what does that mean? Well, there’s a lot that we could probably talk about on that front, but it’s probably enough to say for any kind of device product that has a physical structure, utility is very unlikely to be a bar that you can’t overcome.

Greg Bernabeo:                In the field of medical devices, I think you’re a lot less likely to have the typical problem with respect to utility. You can almost put that off to the side. What you really need to be thinking about is novelty and non-obviousness. Novelty means your device is new. Nobody’s done it before, doesn’t mean not on the market. It means nobody’s done it before typically from a structural sense, and that means no one in the US, no one in the rest of the world. It’s a global standard as to whether your product is new, your invention is new.

Greg Bernabeo:                Non-obvious means maybe nobody’s ever done it before, so maybe it’s novel, but non-obvious means different enough from what someone has done before. If what you’ve developed is new and different than what anyone has done before, but it’s all such a minor and trivial variation that it’s a mirror obvious variation of what has gone before, patent law’s not going to give you a patent, but if you’ve made enough of a step away from what’s already been done before, then you can demonstrate that your development is not only novel but also non-obvious and that you’re entitled to a patent.

Dan Henrich:                     Okay. What about what is and isn’t patentable? For instance, if I’m a surgeon and I invent a new surgical technique that no one has used before, can I protect that for my institution or for my practice?

Greg Bernabeo:                Yeah, that’s a good question. I think sometimes you see different answers to this question, but my answer to this question is, yes those techniques are patentable. A surgical technique or method of treatment type of claim is generally speaking patentable. Generally, they’re not enforceable in the US against a surgeon or a doctor. Usually you find that those claims are somewhat disfavored because the thinking is, “Well, we’re not going to be able to enforce this method claim against the person who’s going to be carrying out the method, the person who’s providing the treatment.”

Greg Bernabeo:                But the truth of the matter is elsewhere in the world, methods of treatment are in some ways a little bit more patentable. And even here in the US there are reasons to have those claims. And one of the reasons is that a medical device manufacturer may be pursued because they’re contributing to or inducing infringement of the method claim by providing a device that can be used in the infringing method.

Greg Bernabeo:                It serves a strategic purpose, but to the extent people say those claims are in lay persons term invalid or you can’t get those claims, I think what they’re really referring to is you can’t enforce them against the practitioner because the public policy of making sure that you’re treated properly with the right treatment when you need it outweighs the patent interest. Nobody wants your doc running off for a patent license in the middle of your procedure.

Dan Henrich:                     Okay. All right. Can you maybe just take us quickly through the typical patent process? There’s a lot of terms that we hear. Freedom to operate, prior art, patent prosecution, request for continued examination, patent maintenance. Can you just take us through the process and explain where the main terms come into play?

Greg Bernabeo:                Sure, absolutely. The way I’d put those terms together is that you might normally start with a freedom to operate search or study or non-infringement study. What this generally means is non-infringement typically you know the patent and you want and determine if I make the product I intend to make, am I going to infringe this patent and hopefully you can come to a non-infringement conclusion. That might be one of your earliest steps.

Greg Bernabeo:                Freedom to operate search is generally a little bit of a broader term, meaning you’re looking at the field of patents more broadly and you’re trying to determine whether there are any patents out there that might be problematic for you, and when you find one you might do an infringement analysis and hopefully come to a non-infringement conclusion. So those terms are about understanding the rights of others before you move forward with your own rights or your own product.

Greg Bernabeo:                And when you’re looking at those patents that already exist before you came along, you’re looking at the prior art. That’s the term we use, the prior art, you might say the state of the art. You’re looking to a body of knowledge that predates you and it’s against the prior art that the novelty and non-obviousness of your invention will be determined. So you’re going to compare what you’ve developed to the prior art.

Greg Bernabeo:                When you start your own process, you’re trying to advance the ball with your own intellectual property rights, one of your first steps might be a patentability study. So you might go out, look at those patents and determine, regardless of whether you may infringe them and there’s freedom to operate, you might look at whether what you have is different enough that you’re entitled to your own patent, determine whether what you have is patentable. Then you may file an application and that’s where the patent prosecution process really begins.

Greg Bernabeo:                Patent prosecution is a little bit of an unfamiliar term. Prosecution used in an unconventional sense for most people, but what it really means is the process of applying for the patent and the back and forth communication with the patent office where you might say you’re negotiating the scope of your rights under the eventual patent, and so that starts with a patent application or a patent filing. And during the patent prosecution process, typically the patent office makes rejections and the attorney and patent applicant make responses to overcome those rejections. And if you’re successful at the end, you get a notice of allowance, which means the claims you’ve negotiated that define the scope of your rights have been approved and your patent is going to issue.

Greg Bernabeo:                And so when your patent issues, you get an actual physical hard copy with a nice seal on it and that is the paper documentation of your patent rights and it’s an issued patent. Along the way, you might have to go through multiple rounds of patent prosecution and you only get so many for your filing fee. And so they might at some point say, “We’ve given you as much review as you’re entitled to for your filing fee,” and you might have to request continued examination, which is more about the fee for continuing prosecution than it is about other requests.

Greg Bernabeo:                You pay the patent office to keep going. You get to your notice of allowance, your patent issues and post issuance. After the patent has issued, you have to pay maintenance fees in the US to keep it in force. And those are due in the US basically every four years after patent issuance.

Dan Henrich:                     The typical term for a utility patent as 20 years, is that correct?

Greg Bernabeo:                It is 20 years and it’s under the newer laws. It used to be 17 years, but under the newer laws it’s 20 years, but those 20 years are no longer measured from issuance. They’re 20 years measured from filing, but there are actually term extensions that are available for various reasons.

Dan Henrich:                     Okay. This is a question that came up was we were thinking through, what’s particular to medtech about this conversation we’re having. You’re going through this patent prosecution process with the US PTO, the Patent and Trademark Office, and you’re trying to convince them of the novelty of your idea. But many of the clients that we’re dealing with, and I’m guessing many of the clients you’re dealing with are going to take a 510(k) approval pathway through the FDA.

Dan Henrich:                     To do that, they have to then turn around and convince a separate federal agency that basically what they’re doing is not new, that it’s safety and efficacy, essentially how it works is the same as a product that’s already on the market or maybe a host of other products and they’re going to cite that as a predicate. Do those claims ever come into conflict your world?

Greg Bernabeo:                Well, I should start by saying I’m a patent attorney and not an FDA regulatory attorney. And so there may be FDA regulatory attorneys that are closer to that issue than I am, but I would say I haven’t seen that problem. I think what the best answer to that question is, is that the purpose and focus in meaning of same as the predicate device for safety and efficacy, it’s really a different analysis than what we’re talking about. We’re talking about novelty in the patent context.

Greg Bernabeo:                I think the FDA is really more focused on the impact to the patient and very often in the patent process. We’re not nearly focused as much on impact on the patient as we are on things like structural differences. I think the structure could be different and the impact to the patient could still be the same.

Dan Henrich:                     Okay. All right, well let’s talk a little bit about how your patent informs the rest of your business strategy. So if your patent is pending, you have filed the application. What protections do you have for your IP? Is it done at that point? Do you have to be worried about your intellectual property if you’ve got a good solid application that’s currently being prosecuted?

Greg Bernabeo:                A couple of answers to that question. Patent application is important for any inventor. It’s an important step because it can prevent the loss of your patent opportunity or the loss of your patent rights because you have only a limited window of opportunity in which to pursue patent protection. When you have something that’s new, it’s not new forever. And ultimately, if you sit on that development too long, your own work can be used against you in determining whether what you have is new in certain circumstances.

Greg Bernabeo:                Filing an application is important because then you are more free to go and talk to those potential commercialization partners because you’ve captured your IP in an application. At the same time, you’re not done, definitely you’re at the first step along the path towards an issued patent to having filed your application and you have not yet enforceable rights. You have inchoate rights. You have rights that are not yet mature. So you’ve captured your intellectual property, which is important because then you can more freely go out and talk to these commercialization partners without losing your patent opportunity.

Greg Bernabeo:                But you don’t have something that you can use at that moment to stop someone else from making or using your development. You need to advance the application through the issuance to have that enforceable right where you could actually sue someone and get a judgment that would pay you royalties or an injunction that would preclude them from practicing.

Dan Henrich:                     It’s still then probably very important if you’re having conversations in any detail with commercialization partners, potential investors or vendors that you have a non-disclosure agreement in place prior to getting into any confidential details. Is that correct?

Greg Bernabeo:                Absolutely. That’s getting a non-disclosure agreement in place is important for a couple of reasons. It’s not a substitution in any way for your patent rights, but it complements them and so by proceeding in a way such that you have a confidentiality agreement in place first, it’s supports your efforts in not disclosing your invention before you’ve filed your patent application or even afterwards.

Greg Bernabeo:                And it also creates an immediate contractual obligation on the other party, but you can hold them responsible to in terms of not using or commercializing or disclosing your technology, and that’s great because it’s an immediate contractual obligation when you do not yet have IP rights that you can use because you don’t yet have an issued patent. So it can provide you some measure of protection of a certain sort before you have patent right type protection.

Dan Henrich:                     A lot of our clients come from academic backgrounds, that might be part of a large research hospital or university health system and in those academic environments a lot of your progress is measured by how much you publish.

Dan Henrich:                     Publishing, there’s an emphasis on publishing research, but if that’s research that you’re hoping to commercialize, does that ever come into conflict and how should you try and negotiate that in terms of making sure that your IP is protected?

Greg Bernabeo:                Yes. This is definitely something that comes up quite often because there is pressure to publish and get it out in the hands of the public as soon as possible. That objective works in a lot of ways, contrary to the objective of the patent applicant, which is really keep it secret until you file the patent application. So really what you need to do or we do as attorneys working with our inventors who are sometimes faculty, we make sure that they understand that we can work best together when we coordinate our efforts.

Greg Bernabeo:                There is a way to play the game such that they can go ahead and publish and you can still file a patent application at least in the US, but you might trade all of your international rights for that publication. You’ll lose those international patent opportunities. The best answer to that question is why don’t we work together from the earliest point so that we can get a patent application on file for you before you publish a publication that might work against you and not every publication necessarily does.

Greg Bernabeo:                When the applicants or the professors or inventors are doing their job as well as they can and we’re doing our job as well as we can, we’re working hand in hand so we understand what’s going to be published and when, so we can build an IP strategy around that. My view is always that IP plays a supporting role for the business or the university or the applicants. And so we have to find a way to conduct ourselves that fits with the objectives, not to reshape the business processes so that it’s convenient for the IP process.

Greg Bernabeo:                So we play a supporting role and we try to tailor how we do and when we do what we do, so that supports what people want to do anyway. But we can only do that when we’re working together really from the early stages.

Dan Henrich:                     Okay. So what about the flip side of the equation where maybe an inventor is in a different environment where they know that there are competitors working to solve the same problem and they don’t want to tip their hand by filing a patent application which will become public. They don’t want to let their competitors know the approach that they’re taking to the problem. Does it ever make sense to hold off on filing?

Greg Bernabeo:                Yes, it can make sense to hold off a bit, but it’s very dangerous with respect to your patent opportunity, especially under the newer and relatively recent in the timeline of patent system laws that are first to file laws because if your competitor publishes before you file you’re out of luck really, your patent opportunity evaporates. The other part of my answer to your question is that, when you file your application will not necessarily be published and it certainly won’t be published immediately.

Greg Bernabeo:                In the normal course of events, you file a provisional or a non provisional application and the first publication is 18 months later. So you’ve got at least 18 months, even if you’re going the route of making it available through the patent process as soon as possible. If you are willing to limit your rights to the US only and not pursue foreign rights, which is not always the case, but it’s sometimes the case, you can actually file your application and never have it published as an application, it will publish only when you have an issued patent, only at the very end of the process.

Greg Bernabeo:                So at that point, your competitor may learn of what you’re doing, but you’ve already have your IP rights in hand. You’re a little more vulnerable when they see your publication and you don’t yet have your rights in hand and they can learn from what you’re doing and perhaps even make use of it for your patent issues. But so there are different ways to address those concerns.

Dan Henrich:                     Okay. We’ve talked about a patent has really a means of not so much as a license to commercialize or that you necessarily have the ability to commercialize an idea, but you have the right to block someone else from commercializing whatever piece of the process you have patent rights to. That all makes sense, but for a startup company almost every one of them is running on limited cash. They have a limited runway and they cannot in most cases afford to litigate against a competitor who’s infringing on their patent rights, especially if it’s a large competitor with deep pockets.

Dan Henrich:                     In that case, my question is what’s the real value of a patent if you’re in that environment where you might go through the patent application process and pay your fees and pay your attorney and at the end of the day you have a patent, but you can’t afford to defend?

Greg Bernabeo:                Again, a few answers to that question. So when you file your patent application, you’re not going to have a patent immediately. So not going to be suing immediately, but you have to capture your rights immediately or almost immediately because that’s the way the patent system works. There’s only so much you can do and keep your patent opportunity before you file a patent application. So the patent model really is file early.

Greg Bernabeo:                If startups had their choice, they would develop something, commercialize like crazy, see it’s worth a fortune, then take a little bit of that and put it in patent process. Unfortunately, that’s not the way it works. And the reason for that is the objective and in our constitution is to essentially accelerate the progress of science. So the model is, come up with something, just put it in the hands of the scientific community essentially as soon as possible so that the scientific community can learn from it and grow.

Greg Bernabeo:                That’s the reason why you can’t just sit on it. Part of the reason why you can’t just sit on it and then come back and do the patent process later. Patent process is really one that needs to be addressed very early on in order to keep that window of opportunity open.

Greg Bernabeo:                The other part of my answer is that you can do something short of litigating. Well, even before I give you that part, if you have a good position, you can find litigation finance companies that have business models of even particularly in the IP space, financing litigation and taking a piece of the recovery. So that’s another reason why, even if you don’t have all the money in your pocket, it may still make sense.

Greg Bernabeo:                You can also do something short of litigation. Sometimes something can be resolved by a demand letter, and you certainly don’t need the same budget you need for litigation to do that.

Dan Henrich:                     Like a cease and desist-

Greg Bernabeo:                Like a cease and desist letter. Exactly. And there can be some pretty stiff penalties for a competitor that knows that they’re violating your patent and continuing to do so. And that puts pressure on settlement even when you’re in the demand letter context. And you may have to go further to get there, but still there are reasons that someone who receives a demand letter may want to pay some close attention, particularly if they’re a big player.

Greg Bernabeo:                Another reason is that, if you don’t pursue those rights early on, that window of opportunity closes and it’s lost forever. And another reason is that by capturing that IP and establishing even an inchoate right, even you don’t have an issued patent yet, you have an application that has value. And so you can attract partners, commercialization partners, potential licensees, you can leverage or sell the patent application at least procedurally. And it has value as of the time it’s captured in.

Greg Bernabeo:                The one that maybe comes into play most often is that it’s part of a portfolio or part of a package that is a startup’s value really. It’s part of a startup and it can be used to attract capital into the startup, and oftentimes that is a motivator for a startup to want to capture their own IP. It may be that an investment in IP handling it in a diligent and thoughtful way and demonstrating that the startup has the wherewithal to execute in development and documentation and the patent process is a little bit confidence inspiring, that there will be further innovation and even the first one isn’t fully funded, there’s something there.

Greg Bernabeo:                And a lot of times IP does take somewhat of a meandering, or maybe it’s fair to say an iterative path, and so that there are not only a development, but there are also follow on developments that can be captured. So all of that weighs in favor of capturing what you have, and you have to do it in a thoughtful and strategically meaningful way, but I think the decision process is really not, if I don’t have enough millions of dollars to litigate then I shouldn’t file because there are a lot of other paths that don’t lead directly to litigation.

Dan Henrich:                     As someone who advises startups in terms of their IP strategy, do you ever take that iterative approach to say, “Okay, well this is what you need to demonstrate is patentable for your next round of funding. Let’s worry about claims, 2 through 10, further down the road after you have more capital.”

Greg Bernabeo:                Yes. Essentially, yes. There are a couple of ways to do that. One of the ways may be to file on a first application that has a scope that you’re able to pursue now even if you have to put some stuff on the back-burner. Putting it on the back-burner does have some risks. You can also file a broader application with the intention that it may be broader than what you can handle in a single application, but at least you’ve captured it and you can put it on the back.

Greg Bernabeo:                Back-burner meaning you can divide the application essentially into parts and pursue one part now and the rest of the parts later. And yet by making your filing, you’ve established an early priority date. You’ve captured it and essentially gotten a place in line at the patent office or in the state of the art, so that you could come back and pick it up later.

Greg Bernabeo:                So there are a couple of different ways that you can play that game so that you may have IP but limited resources and there are ways to plan for taking off a comfortably sized chunk and dealing with it sooner and deferring some of the rest. There are also procedural opportunities to try to take the slow path towards patent protection.

Dan Henrich:                     Okay. Let’s keep with that idea of a medtech startup that’s has a limited amount of cash. They’re looking to stay lean. Are there steps that, especially if someone is technically inclined, like an engineer, inventor or something like that, are there steps those folks can take ahead of engaging an attorney or a firm to prosecute their patent application to do preliminary work?

Dan Henrich:                     Is it worth spending time on Google patents or going through the US PTO database to try to do a solo prior art search or whatever? What can folks do to try to be in the best position they can when it’s time to bring on someone like yourself?

Greg Bernabeo:                I think the question is really focused at the very small end of the startup. Correct me if I’m wrong, but if we have someone who’s maybe thinking about striking out on with a med tech development in a startup mode, is there something they can do to begin to get the ball rolling? I think maybe one of the best piece of advice there is, yes, there are.

Greg Bernabeo:                And one of the best things you can likely do for yourself is make sure that you have a clear articulation of the development. And so before you see an attorney that will allow things to proceed much more efficiently. And so if you can prepare some text or description or even PowerPoint slides and drawings that would be fantastic. Even hand sketches can be very useful, but what typically is most helpful is a careful consideration of what the development is, why it’s being developed and how it works in a way that communicates it well in documentation.

Greg Bernabeo:                That usually works best. You don’t have to have it, but if you went to promote efficiency, that probably helps. And the exercise of preparing those documents on the inventors part is worth something in and of itself in that it forces them to think carefully about, “What do I have? Why do I think it’s novel?” Even in the absence of the prior art that can be very useful.

Greg Bernabeo:                Doing their own search can also be useful. That said, everything you find and touch need to keep track of because in the application process we’ll need to disclose things that are relevant to the determination of whether or not what you have is new and so the inventor will have an obligation, the attorney will have an obligation. And so a reasonably focused search can be helpful. Even better would be a patent attorney’s patentability search. And the reason for that is poking around on Google patents and doing word searches or poking around in the patent office website and doing web searches is not the same way that a patent attorney would typically search for a patentability search. We focus using a subject matter based and indexed classification system that categorize a subject matter in a way that is really independent or not so dependent of any particular words.

Greg Bernabeo:                Doing a word search is different than a classified subject matter search. So we can tend to get better results. But doing some searching on the inventors part I think is a valuable step and preparing drawings, I would say yes, that’s worthwhile, although any drawings that are prepared will be very helpful. Well done drawings as you might get from a Smithwise or someone else would be very helpful. I think what should be kept in mind is that very often those drawings will not ultimately be used in at least a formal patent application, they may be used in a provisional, but in a formal patent application, there are strict and varied drawing requirements that the patent office has.

Greg Bernabeo:                So it’s very unlikely that a lay person is going to produce drawings that are going to comply with the way the patent office wants to see it, but in terms of communicating it to the patent attorney, that can be very, very effective and they’re often sufficient. They’re often sufficient for at least a provisional application where those drawing rules are not applied in the same way.

Dan Henrich:                     We talked a little bit then about when the right time to begin the patent process then. You alluded to something earlier about the change, I believe it’s the American Invents Act set, the change from a first to invent to a first to file system.

Greg Bernabeo:                Yes, that’s right.

Dan Henrich:                     In light of that change, how important are keeping good records, lab notebooks, documenting the timeline of your development and all that sort of thing?

Greg Bernabeo:                I think you’re asking that question is the role of lab notebooks has changed somewhat with the coming of the America Invents Act, which did change us to a first to file system. So the American Invents Act has to some extent created a race to the patent office in a way that it didn’t really exist before. Because under the old system, the first to invent system, someone who filed later would not necessarily be a problem for you as the applicant if you were the first to invent because the determinations were made by who was first to invent.

Greg Bernabeo:                Now, the system doesn’t work that way anymore. It’s first to file, it’s first inventor to file. It’s really what it is, but someone else can pose a problem for you in terms of getting your own patent rights if you are not the first to file. Lab notebooks used to be used or the importance of lab notebooks in the patent prosecution process used to be use them to show that you were first to invent. So for a newly filed application, you’re not going to use a lab notebook to do that anymore because it’s not relevant in the way it was in the past.

Greg Bernabeo:                That said lab notebooks are still important and they’ve always been used for purposes other than preparing a declaration to show that you were first to invent as part of the patent prosecution process. It can be used for fundamental documentation to show that you are in fact an inventor, it can be used maybe to document something that ultimately is a trade secret, it can be used for a number of different purposes.

Greg Bernabeo:                The other thing that it’s more likely to be used for under the American Invents Act is to show that something is your own work and not derivation, it’s not derived from somebody else, which is a concept that’s more central to the American Invents Act. It’s a newer concept. I would say the answer to that question is they’re still very important. There’s no reason to discontinue any keeping have lab notebooks. In the patent prosecution process, they won’t be used in the same way that they’ve always been used, but they should still be kept.

Dan Henrich:                     Okay. This is a question that comes up fairly often, I would say with our clients at Smithwise. Many of our clients are perhaps clinicians or that’s the origin of an idea and so they are the original inventor, but then many of those folks go out and they hire a firm like Smithwise or an engineering firm to develop that concept further and those people are often gonna get involved prior to the patent application being filed.

Dan Henrich:                     Who needs to be listed on the application as an inventor? And is there a distinction between inventorship and ownership even if you’re going to sign the IP rights over?

Greg Bernabeo:                That’s a great question. This fundamental question of who’s an inventor comes up in a lot of different context and it comes up pretty often. Absolutely, inventorship and ownership are two entirely … Well, they’re two separate concepts certainly. And the question of who is an inventor it’s really a fact question. It’s governed by certain legal principles, but the question when you’re thinking about inventorship is who are those people who actually conceived of the invention? Who created it? Without regard to, are they in my company or somebody else’s company?

Greg Bernabeo:                The inquiry is just who contributed? Who contributed to the creation? Ownership is handled separately from inventorship. Ownership may be governed by contract or by whim. You may choose to assign it to someone without an obligation. And typically when a party like Smithwise is engaged to contract with inventors to do some development work, in my experience, it’s not uncommon that there will be ownership provisions in there sometimes.

Greg Bernabeo:                Ownership provisions in there and sometimes it will provide that ownership will be in the hiring party. And so ownership would be handled by an assignment document where the actual inventors sign a document saying, “I’m transferring my rights over to a company.” They’re two entirely separate issues. You absolutely need to not allow ownership to interfere with the inventorship determination.

Greg Bernabeo:                Identifying the inventors properly is very important for the integrity of the patent. Under certain circumstances when you’ve improperly named the inventors, it can be grounds for holding the patent unenforceable. It can be invalid essentially.

Dan Henrich:                     If you had advice to give, an inventor who knows that they need IP help, how would you advise them to go about finding a firm or finding an attorney or an agent to assist them with their application? What should be their criteria and what should their process look like from your perspective?

Greg Bernabeo:                Well, it’s definitely important to shop around because not all attorneys or all firms are equal. You need to find someone that you’re certainly that you’re comfortable with. I think what you should be shopping for is someone who has, I’ll say the right experience, but what does that mean? There are certainly going to be good patent attorneys at firms of all different types, small, medium, large, but what I think you’re looking for when you’re looking for a patent attorney in this space is someone with the right technical background.

Greg Bernabeo:                If you’ve developed something that’s a chemical development, you’re going to want a patent attorney with a chemistry background ’cause they’re going to best understand what your development is and how to present it. If you develop something that’s more electrical, maybe you need an electrical engineer, maybe software, you want someone who’s familiar with software, if it’s mechanical, you want a mechanical engineer.

Greg Bernabeo:                Although many of us because the projects are so intertwined with mechanical, electrical and software aspects you find that we practice and really across all those fields. But fundamentally you’re looking for a good technical match between your patent attorney and what you’ve developed. So you wouldn’t want a biotech patent attorney, you’d really want an engineer who’s familiar with the issues, if you have engineering in your device. That’s one of the first things I’d look for.

Greg Bernabeo:                Another thing I’d look for is experience in the medtech space. I think that’s also very important. Perhaps secondary to making sure you find the right technical match, but can be very important in ways that go beyond just the pure patent prosecution process. Also, want to think about the firm and how the services will be delivered and make sure that you have a good fit there as well. So again, not all law firms are the same. Not all attorneys are the same. You need to find someone you’re comfortable with.

Dan Henrich:                    You alluded to this earlier a little bit, but can you just tell us when would you say is the right time to involve a patent attorney or an IP firm for the first time? Is it when you have a napkin sketch, should you have a functional prototype? When should you go have that first consultation meeting with a patent attorney?

Greg Bernabeo:                I think it’s never too soon to have that initial consultation. I know that I’m always happy to talk to inventors or companies, startups even before they’re really ready to engage me. And the reason for that is, as we mentioned earlier, there’s a limited window of opportunity to pursue patent protection. Typically, in that first meeting we’re thinking about have any activities already taken place that could compromise patent rights? If so, when did they happen? What’s a critical date that we need to monitor?

Greg Bernabeo:                Or if something hasn’t already occurred or at least having a conversation about the fact that there is a limited window of opportunity and making sure that they understand what they should be keeping their eye on in terms of activities so that they can proceed in a cautious and thoughtful way that will preserve their rights and meet their goals. And so I think it’s never too early to have that initial consultation.

Greg Bernabeo:                Sometimes I find that I have an initial consultation, I get the client oriented in terms of thinking about what they should keep their eye on to preserve their IP rights. But I tell them, “You’re probably not going to need me until you get a little bit further along in articulating your ideas.” You don’t need to engage me. You don’t need to hire me until we get a little bit further along. Sometimes, if I feel that way, I certainly say it, but I think from the client’s perspective or from the medtech companies perspective, med device companies perspective, it’s never too early to have that conversation because time ultimately is working against you and you’d hate to find that you just missed your window of opportunity.

Greg Bernabeo:                You’d rather know about it and then you can decide whether to take advantage of it or not, but at least you can do it knowingly so it’s never too soon.

Dan Henrich:                     Sure. It seems like that initial conversation will be pretty important for a company that has just started to put together what is their IP strategy and how does it tie in when they’re presenting to investors, they would probably want to be able to say, “We’ve had preliminary conversations. This is our plan for when we’re going to file a patent if we haven’t already.”

Greg Bernabeo:                Absolutely. Absolutely. That can be very confidence inspiring and it demonstrates IP savvy and I think it can only be well received. Personally, I’m always happy to have that initial consultation at no charge.

Dan Henrich:                     Great. Well, we’ll make sure to post your contact information on the blog when we put this episode up.

Dan Henrich:                     Great. Thanks so much. I really appreciate.

Greg Bernabeo:                Thanks you. I love talking about these topics.

Dan Henrich:                     All right. Thanks.

Greg Bernabeo:                Thank you.