Speaker 1 0:29 Hello and good afternoon and welcome to today's webinar, medical devices, patent law and the FDA regulatory process presented by Autumn. My name is Sammy Spiegel, autumns professional development manager and I will be your staff host for today. All lines have been muted to ensure high quality audio and today's session is being recorded. If you have a question during the presentation, please submit your question through the chat or the q&a feature. Should you need closed captioning during today's session, the Zoom transcript feature is turned on and available on your toolbar. If you need to expand your view in the autumn Learning Center, there is an option to expand your window that will allow you to see the screen bigger and ask us all the toolbar features. Before we begin, I would like to take a moment and acknowledge and thank autumns online professional development sponsor Marshall Gerstein IP, we appreciate your ongoing support. I now have the pleasure of introducing you to today's presenter. Tonya Shapiro bar is senior patent counsel with 12 years of patent law experience working in the areas of medical devices, biotechnology and pharmaceuticals. She provides Patent and Trademark counseling and portfolio management and provides opinions regarding patentability, freedom to operate infringement and validity. Tonya works with a variety of medical device and biotechnology clients, including fortune 500 companies, midsize and startup companies and university clients. She has authored a number of publications and given presentations on issues relating to the life sciences IP. Welcome, Tanya, we're so excited to learn from you today. And I will now pass it over to you to get started. Speaker 2 2:10 Thank you. So let me just let me just share my screen. Speaker 1 2:25 Um, oh, sorry. Okay, sorry. I know the bounce between these two screen shares is always tricky. Unknown Speaker 2:33 All right. Is that working? Not Speaker 1 2:35 yet. Oh, I see. Oh, it might be a pop up window. There we go. Okay, perfect. Speaker 2 2:43 All right. Well, thank you, everyone, for having me today. I'm excited to discuss medical devices and the interplay between patent law and the FDA regulatory process. So hopefully, this is going to be helpful to all of you. And you know, if you have questions during my presentation, feel free to type it in the chat box, and Sammy can interrupt me, or if you want, we'll have time for questions at the end. All right. So here's an overview of what we're going to talk about today, we're going to start by talking about the typical organizational approach to FDA, and patent law issues within universities and companies that that do medical device innovation. We're going to talk about the FDA approval process. We're going to talk about the 510 K clearance, which is one particular type of FDA approval process. And the one we'll be focusing on here, and the intersection of patent law issues with that particular path of FDA approval, we're also going to touch on a newer method of getting medical devices approved, and that's called the de novo pathway to FDA approval. And we'll talk about patent issues that that touch on that particular pathway. And then we'll kind of draw some conclusions at the end. So interestingly, most companies and universities that are involved in medical device innovation, handle FDA regulatory compliance and the protection of IP rights as to largely independent processes. And as we'll see, this is not really a good thing. But it's just the way things are done. Run in both both medical device companies and universities. Even sophisticated organizations prepare and file regulatory submissions, but often fail to consider the impact that those submissions have on their or may have on their IP portfolios. For example, information related to clinical safety and efficacy, or competitor devices may in fact, be material to patentability. In addition, statements made in regulatory submissions may detrimentally impact patent validity and enforceability. So with this dynamic in mind, let's talk more about the interplay between patent law and the FDA regulatory process. So this is a little chart that I put together of different pathways to FDA approval for medical devices. So under the Food, Drug, and Cosmetic Act, medical devices fall into one of three classifications. Class One is for low risk devices that require only what's referred to as general controls to ensure safety and effectiveness. So this includes devices that are not used in supporting or sustaining human life or in preventing the impairment of human health. So examples of class one devices might be bandages, tongue depressors, manual, stethoscopes, non electric wheelchairs, those type of low risk devices. Class Two is for devices presenting an intermediate level of risk and these devices may require a bit more to provide reasonable assurances of safety and effectiveness. So an example of a class two device might be a CT scanner or an infusion pump or a catheter, blood pressure cuff syringe, those types of intermediate risk devices. And then class three is for devices that pose the highest level of risk. So just devices that are for use in supporting or sustaining human life or preventing impairment of human health. So examples of class three devices would be pacemakers, or any implantable device, deep brain stimulators, ventilators, defibrillators, those types of life sustaining devices. So class three devices require pre market approval, or PMA, which is a rigorous and costly and time consuming process. Well, well, class one or class two devices can be cleared by the FDA in a more abbreviated process that is permitted under Section 510 K Of The Food, Drug and Cosmetic Act. And in fact, most medical devices, as I said, are cleared through the 510 K pathway. So later, we'll touch on a third option that de novo pathway as I as I mentioned, and this can be used for the approval of novel medical devices that for one reason or another are not eligible for 510 K approval and they're fought for by default, they're categorized as class three. Speaker 2 8:45 So just briefly, we'll talk about pre market approval PMA, for class three medical devices and as I said, it's a cumbersome, costly, time consuming process. It's required for devices that are used in sport supporting or sustaining human life and in preventing the impairment of human health, or devices that present a potentially unreasonable risk of injury or illness. So the PMA route generally involves the submission of a device description and indications marketing and manufacturing information, reference to pertinent performance standards, preclinical and clinical investigatory studies, and proposed labeling. And FDA may very well require additional supplemental submission submissions up beyond all of this. So overall, this this is a process that takes years the 510 K clearance process, which is what we're going to focus on here is referred to as also referred to as premarket notification. And it's abbreviated compared to The PMA process and it uses slightly different terminology. For example, in the PMA process, the applicant submits the device for approval to the FDA. And then the FDA approves the device but but here under 510 K, what happens is or the terminology that's used is that the, the applicant notifies the FDA and the FDA clears the device for sale. So some of this tech terminology kind of gets tricky, but well, we'll we'll get through it. So the 510 K notification generally needs to be made at least 90 days prior to product launch. And in comparison, a PMA review by the FDA is is supposed to take no longer than 180 days by statute, but yet, in reality, it's often delayed much longer. So under the 510 K clearance process, an applicant notifies the FDA of a new device and asserts a substantial equivalence, and we'll talk about what that means in a minute. The applicant then, hopefully receives a letter from the FDA finding that the new device is substantially equivalent to the predicate device. And we'll also talk about what a predicate device is in a second. And once the FDA clears the device, then the applicant can mark it and offer it for sale in the US. Speaker 2 11:39 So let's talk about what substantial equivalence is. substantial equivalence to a predicate device means in in the context of a 510 K submission. When an applicant notifies the FDA of their intent to market a new medical device under the 510 K process, the applicant first needs to identify a predicate device, which is a legally marketed equivalent device. And the predicate device can be one of the applicants own devices or a competitors device, then the applicant needs to provide details showing that their new device is substantially equivalent to the predicate device. So from the FDA perspective, the key to substantial equivalence is being able to demonstrate that the new device is at least as safe and at least as effective as the existing marketed predicate device. Speaker 2 12:48 So according to the FDA device is substantially equivalent if in comparison to a predicate device, the new device either has the same intended use in the same technological characteristics as the predicate. And we'll talk about what technological characteristics are to inside or the device needs to have the same intended use and different technological characteristics. But in that case, the information submitted to the FDA cannot raise any new questions of safety and effectiveness. So in other words, the, the new device must be at least as safe and effective as the predicate. So when we talk about intended use, this is pretty straightforward, and it includes a general description of diseases or conditions that the device will diagnose, treat, prevent, care or mitigate, including a description of the patient population where that's appropriate. And remember, for intended use, the intended use must be the same for the new device and the predicate device in order to qualify for 510 K clearance. And when we talk about technological characteristics, those are defined as including aspects such as design, material selection, chemical composition or energy source. For example, if a new device has the same technological characteristics as the predicate, a summary of those technological characteristics is typically included in the 510 K submission. However, if the device has different technological characteristics than the selected predicate device, which which is allowed, then the 510 K submission must show the technological characteristics of the of how the technological characteristics of the device compare to the legally marketed predicate device. And that's often done in some sort of a chart form. Speaker 2 15:15 So now we'll talk about how the 510 K clearance pathway can intersect with patent law. And there are at least two aspects of patent law that are involved. First, a medical device developer needs to consider the impact of regulatory regulatory submissions on patentability, as well as the validity of any result resulting in patents. So for example, equivalence assertions, made in the context of safety and efficacy may indirectly in implicate the equivalence from a perspective of novelty or obviousness under patent law. Secondly, the medical device developer needs to consider whether 510 K submissions can include factual statements that may point the way for a competitor to challenge or to allege infringement by the applicant or for a competitor to evade infringement using the applicants own admission, it's. So let's first talk about patentability. And in particularly the novelty requirements. As you all under Section 102, a person shall be entitled to a patent unless the claimed invention was patented, described in a printed publication, or in public use on sale or otherwise available to the public before the effective filing date of the claimed invention. And as you also know, in the US, there's a one year grace period between public disclosure and filing of the patent application. This is not true, however, in most foreign jurisdictions. So it is important to understand that when a medical device is cleared via the 510 K pathway, the FDA decision, and the 510 K summary will be published on the FDA website by the fifth day of the following month. So this becomes public information. And it includes statements related to substantial equivalence, intended use technological characteristics, all of which may use be made, may be used by a patent examiner, or third parties as prior art. And when this information becomes public, it also of course, starts the one year clock ticking for the US grace period. In addition, Speaker 1 17:53 keep going on you we have a question before you move to the next slide. Okay. Speaker 2 17:57 Yeah. And so in addition, there may be FOIA requests that are made and this too can can serve as prior art. Got Go ahead. Yeah, Speaker 1 18:09 so the question that was just submitted says, how does a company prove safety and efficacy of their new device for a 510 K submission? Speaker 2 18:20 What so well, we'll, we'll get into that a little bit, but it safety and efficacy has to you have to start with the predicate device. And, and and identify a predicate device. And then let's go back for a couple of slides here hold on. So substantial equivalence to prove, you know, safety and efficacy, you need the same intended use and different the same technological characteristics or different characteristics with with at least this safe and effective. So, safety and effective effectiveness are going to be proved based on clinical data and trials. Great, thank you. Sure. So, okay. So the key takeaway here and really, throughout this presentation, is that you need to file at least a provisional patent application prior to submitting a 510 K notification, or at least prior to the publication of the 510 K notification. Otherwise, you risk your own 510 K notification being used as prior art against you when it during patent prosecution. Speaker 2 19:43 So moving on to the impact of 510 K submissions on patentability from an obviousness standpoint. As you all know, section 103 requires that a claimed invention must not have been obvious to a person of ordinary skill in the art Before the effective filing date of the patent application obviousness of course involves using various references to piece together the elements of a patent claim, or patent application claim. And often when making an obviousness rejection, all that a patent examiner is missing is the motivation to combine these various references. And so where can that motivation be found? Well, it's possible that the motivation to combine references can be found in an applicant's own 510 K notification, which is kind of scary. For example, the 510 K notification, including information related to claims of substantial equivalence could inadvertently provide evidence of an expectation of success if certain references are combined. So an applicant might be tempted to disclose only what's necessary to demonstrate equivalence from a safety and efficacy perspective. But the applicant has an obligation of candor to the FDA, just like there's an obligation of candor to disclose references that are material to patentability to the PTL. But as you all know, so that so the applicant cannot omit any potentially patentable features if they're related in any way to safety and efficacy, even if this might provide motivation in an obviousness analysis. Another thing to consider in terms of obviousness is that you need only one predicate device. Applicants often rely on multiple predicate devices, perhaps in hopes of having a better chance of getting FDA clearance. But in fact, claiming substantial equivalence to multiple predicate devices can create unnecessary IP risks without obtaining any regulatory benefit. So the key takeaways from an obviousness standpoint are again to file a patent application before submitting a 510 K notification, or at least before the publication. Additionally, 510 k applicants should avoid making overbroad statements of equivalence that go beyond safety and efficacy. So for example, they mean that a device is identical to the predicate device. And remember that only one predicate devices needed and it should be carefully chosen with patentability. So here's one case law example of inner play between the 510 K process and patentability. This is a case from the Western District of Pennsylvania in 2000 Sunrise Medical versus intercept corporation. In this case, Sunrise sued sued AirSep for patent infringement and AirSep and challenged the validity of sunrises patent based on sunrises by 10k assertion of substantial equivalence between its patented device and the prior art and in this case, the patented device was in an electronic oxygen conserving device for respiratory patients who needed therapeutic oxygen. So specifically, sunrises 510 K notification stated that its device was a fundamentally repackaged version of the predicate device in the event stated that the two devices were identical in terms of specifications and performance. However, the 510 K notification emphasize similarities in the dosage methodology that was used in conjunction with these devices, as opposed to similarities in the devices themselves. So the court ultimately disregarded the 510 K, which was good for sunrise stating that the sole purpose was to demonstrate equivalence safety and efficacy as as opposed to patentability. Importantly, the court noted that the substantial equivalence assertion focused on methodology, whereas the patent claims were directed to the actual device or system. So what this case shows is, is the importance of carefully wording in a substantial equivalence assertion to limit its scope to safety and efficacy and also that the accompanying mean factual assertions can either help or hurt depending on whether they are focused towards or away from the claims the patent claims. So here the substantial equivalence assertion helps because it is focused on methodology. And that was not the subject matter of the patent claims, the claims were directed towards the device and the system. Speaker 2 25:33 So, we saw how 510 K submissions can affect patentability, and now we'll talk about how they can affect the infringement as well. It turns out that statements in a 510 K submission can come back to bite you long after a device has been cleared by the FDA and patented, and the way that they come back is in the form of patent infringement suit. 510 K submissions can be used as evidence of direct or indirect infringement, and they can also play a role in ultimate into alternative theories of infringement and methods of determining damages. Similar to patentability, 510 case, substantial equivalence, but sell does not admit patent infringement. Because substantial equivalence and patent infringement are two fundamentally different inquiries. For substantial equivalence a comparison of a product to a predicate device is performed. And for patent infringement, an element by element comparison of the patent claims to the accused product is performed. So historically, in patent infringement suits, courts have been wary of the risk of confusing juries with 510 case substantial equivalence assertions since it's often difficult enough for juries to understand infringement proceedings and what needs to be proven in that context. However, supporting factual statements made in 510 case, omissions can and have been used in infringement cases. In particular, the technological characteristics which we discussed, are part of the substantial equivalence determination may support or refute in arrangement. So, for example, in US surgical Corporation versus hospital products International, the court noted that beyond beyond a generalized substantial equivalence assertion, the defendant also stated that both devices utilize the same type of disposable cartridges which you will realize similar staples similar anvil similar staple line configurations in the same tissue joining methods. So statements like these can really provide a roadmap that a patentee can use to support a claim of pattern Bridgman. On the other hand, in the University of Florida versus ortho Vita, the Court considered a technical chart that was part of the 510 K notification. That noted a marked difference between the clear product and the predicate device, and this helped to refute the infringement claim. Speaker 2 28:40 Some of you may have heard of the doctrine of equivalents, which is an infringement analysis that uses the function way result test for determining infringement. So basically, an accused infringing device is doesn't literally range each and every claim element of a patented device. But it nevertheless performs substantially the same function and substantially the same way to obtain substantially the same result that can be used to help establish infringement infringement. So courts amuse 510 K submissions to show functional equivalence. So for example, in this car bar case, the court noted that although the actual 510 K filing is irrelevant, because it is controlled by a different regulatory scheme, the fact that Barr did not retest its catheter, as indicated in its 510 K submission was probative of functional equivalence. Courts can also use 510 K information in assessing damages in patent infringement cases. So willful infringement, which can be With up to triple damages and an award of attorneys fees is determined using a Totality of the Circumstances Test. And you can see how a 510 K filing could be viewed as an admission of knowledge of a predicate device, which may be patented, and how this might be considered a circumstance in a willful infringement analysis. So the key takeaway here is really that patent counsel should be aware of the contents of FDA submissions, particularly the technological characteristics portion of the 510 K submission with respect to potential infringement considerations down the road Speaker 2 30:57 Okay, so back to the chart that I showed earlier. You might recall I mentioned a third FDA approval pathway for medical devices the de novo pathway, and this is for novel devices for which there are is no substantially equivalent triad kit. So they are classified as Class three, but would other Be wise be class one or class two. The de novo pathway has become more popular over recent years with the development of new technologies that don't necessarily align with existing device classifications. For example, digital health devices that incorporate AI technologies are a good candidate for this de novo pathway. So situation in which in Africa might consider going to de novo route is if they have a new device that is not substantially equivalent to a predicate kit, class one or class two device or for which no predicate device exists. And in this case, their device will automatically be slotted as a new class three device. But if they don't want to go through the rigorous PMA process that we discussed earlier than they might want to avoid it, bye, bye, attempted to go the de novo route. And they did de novo process provides a pathway to classify these novel medical devices, which again would otherwise be class three, due to lack of substantial equivalence as a class one or class two device. Importantly, if a device is approved under the donor mobile pathway, the device can then serve as a predicate device for future 510 K submissions. So in a way, it creates a new type of predicate device. But patent issues can arise in the context of de novo approval as well. For example, I mean, could it could it be a conflict of interest for a newly approved denoble device to serve as a predicate for a follow on 510 K device? Likely Yes, and we'll see why the the the FDA recently began asking denoble manufacturers to propose their devices, special controls used to determine substantial equivalence and again, the terminology it is kind of loose here and changes, but special controls are really performance standards, which you know, overlap somewhat with some of the previous terminology we've been using. The special controls need to include a reasonable assurance of safety and efficacy. And they likely overlap with the core technological characteristics such as material design energy source, which are likely also protected by the de novo man of manufacturers patent. So, this can really lead to a catch 22 situation and which follow on 510 K applicants face a fatal choice and they can admit to the same technological characteristics and therefore risk patent infringement or they can admit to different technological characteristics and therefore risk not being considered substantially equivalent and not being cleared under the 510 K pathway. So as a result, anti competitive de novo manufacture yours could potentially take advantage of a catch 22 like this for for 510 K follow ons. Here's some examples. Both had a self pitying air conduction air conduction hearing aid that was received de novo classification in 2018. The special controls included a directional sensitivity as a core feature. And not surprisingly directional sensitivity was also claimed as a key element in the patent that issued on the same product. Tandem diabetes care had a insulin pump that received de novo classification in 2019. Its special controls included chip sharing information between the pump and digitally connected controls. And again, not surprisingly, wireless communication means that the pumps are claimed in the corresponding patterns. Speaker 2 36:11 So as I mentioned, the de novo pathway could encourage anti competitive patent strategies. And if the FDA is asking de novo manufacturers to propose their own special controls that will be used in future substantial equivalence determinations, they should carefully review whether the proposed special controls are necessary from a safety and efficacy standpoint, in order to prevent this potential anti competitive behavior. Speaker 2 36:49 Such as sum up the interplay of FDA approval via any of the pathways that we talked about and and patent protection for medical devices, there needs to be better communication between patent counsel and FDA counsel, there needs to be coordination on the timing of the FDA submissions, and patent filings. And patent counsel should review the contents of FDA submissions and perhaps vice versa, to avoid potential problems in the future. So that is the end of my presentation. And I would be happy to take questions as well as I'd love to hear about how your institutions handle regulatory approval and whether or not there is any coordination between the the FDA filings and Speaker 1 37:46 thank you so much, Tonya, attendees, please feel free to submit questions into the chat or the q&a, we do have time. You can also use the raise hand feature if you would like to ask a question out loud or share any of your experiences. Tanya, while we wait for some questions to come through. I know we talked in a lot of detail with lots of great takeaways throughout each section. But are there some key things that you want to make sure our attendees remember when they've you know, headed back to their desk, and they're digesting and thinking about all of this information in the coming days? Speaker 2 38:24 Yes. And Sammy, you're gonna make these slides available? Okay, Unknown Speaker 38:28 yep. slides will be available as a handout to everyone. I yeah, Speaker 2 38:31 I would say that, you know, again, it's, it's strange, but but there's just a lack of communication between the FDA approval process and the patent process. And, you know, I've I've not run into, in my experience, I've not run into issues that were directly related, but I have had clients who have been late in the patent team, late to the patentee process, and they've had, you know, they were well into the FDA process that, you know, didn't end up impacting their patentability. But other things, because of their missed timing, like their prior publications ended up serving as prior art against them. So I would view the FDA submissions, as I mean, they are they can be prior art, they will be published. And it that's something that a lot of people just aren't aware of, or don't, you know, don't realize, and so it's important to keep that in mind. And to, particularly to to make sure you have a provisional patent on file prior to any type of FDA submission. Speaker 1 39:49 Great, thank you. Our first question that came in states are their attorneys in the legal field that specialize in both patent law and FDA. Law, are these practice areas traditionally kept separate, traditionally Speaker 2 40:03 separate. Okay. Good question. I'm gonna Speaker 1 40:10 give us a few minutes before I close this out any other, like pitfalls that you've seen that tech transfer offices may have experienced are lessons learned? That would be good to keep in mind when folks are going down this path? Yeah, I Speaker 2 40:25 mean, when I, when I see invention disclosure, sometimes I, I see it because a large part of my practice does focus on medical devices. And, and a lot of times I see, you know, I work with individual. When I work with in university clients, a lot of times the inventors or individual physicians, and I've seen them, you know, have these invention disclosures where they have, you know, they identify predicate devices. And, and often they have a whole big list of them and and, you know, as we said, you only need one, and having more than one is not going to be helpful from from a regulatory perspective, and it could be harmful from from a patent perspective. So I know that, you know that that's a common thing that I see in these invention disclosures. Speaker 1 41:31 Okay, well, I know this was a lot for our attendees to digest. There's a lot of technical information throughout the presentation. So I'm sure if questions do come up along the way, once you've sat with it for a bit. You can reach out to myself here at autumn or Titania, and we'd be happy to answer any specific individual questions. So we can give it another minute or so if anyone does have any lightbulbs. But while we wait to see that, I will just make a couple of announcements. As a reminder, a recording of this session will be available in the autumn Learning Center along with the presentation slide handouts, those will also be available through your mind autumn account. If you have questions about accessing any of those resources, please feel free to reach out to me directly. And it usually takes about a week or so to get everything posted up online. So you'll be on the lookout for that in the coming days. And then a certificate can also get accessed from the Learning Center if you need one of those for your attendance today. And we ask that you please don't forget to complete the webinar evaluation which will open up when you close out of this session as well as be sent in a reminder email tomorrow to help us serve your needs in the future. And I think that's all of the housekeeping comments that I had. Oh and perfect timing. We just had a question come through. So this last question was how does de novo submissions requirements differ from PMA Speaker 2 43:02 didn't know, well, de novo is is a lot more abbreviated than PMA, it doesn't require that it's less time consuming, less, less costly, less rigorous. It's kind of like an alternative. shortcut. If you remember that chart that I showed earlier. It it's definitely if an applicant has a choice between going through the the the PMA process and going through the de novo process, if they qualify for de novo, meaning that their device is not a high risk device, then, you know, most likely the applicant would want to choose the de novo pathway. So de novo is is for devices that that are you know, eligible under class one URL that, you know, are lower intermediate risk risk. So class one and class two devices, but simply aren't categorized that way because they don't have a predicate device and and cannot be they are not eligible for the 510 K mat. Excellent. All right. Well, Speaker 1 44:18 I think that that brings us home for this afternoon. So Tanya, thank you so much for sharing your knowledge and experience with us. This was such an informative presentation. And I know, on behalf of our attendees, we're really grateful that you took the time to join us today and attendees. Thank you all so much for being here and participating and asking great questions. And if anyone has any additional follow up notes, we'll be here for a minute. Otherwise, I hope that everyone has a great rest of the afternoon and week ahead. Thank you. Thank you Transcribed by https://otter.ai