Speaker 1  0:00  
Okay, good afternoon. Welcome to protecting trade secrets disclosed to the FDA presented by aadam. My name is Holly Lundgren autumns online professional development manager and I'll 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 for the speaker, we encourage you to use the q&a feature rather than the chat feature. If you have a technical question or comment, please feel free to use the chat feature for that. Today's session may be eligible for CLE credit. Throughout the webinar, you'll see pop up surveys that are simply asking for a yes or no answer. If you do not intend to apply for CLE credit, you may simply dismiss the poll. If you do intend to apply for CLE credit, you must answer the question as it is answered. Each poll will be left up for about 20 seconds. For more information about CLE eligibility for this session, or for what states have already pre approved this program, please contact me at h lundergan at autumn dotnet. I would like to take a moment to acknowledge and thank autumns 2020, online professional development sponsors. We appreciate the ongoing support. And now I'll introduce today's speaker, Sharon Syntyche is a partner in the firm Marshall Gerstein and Borun. clients seeking to obtain and protect worldwide patent rights for all type of biotech innovation can benefit from the education and experience of Sharon on their behalf. She combines expertise in all aspects of patent prosecution, with technical insight gained from her graduate research and tumor cell biology. She also counsels clients in Portfolio Management, and provides opinions on patent validity, patented foreseeability, and freedom to operate issues. Dr. Cynthia obtained her JD from the John Marshall Law School in January 22,004. And previously, she earned a BS in Biology from Bradley University, and a PhD in tumor cell biology from Northwestern University. At this time, I'll go ahead and turn it over to our distinguished speaker. Welcome, Sharon.

Speaker 2  2:10  
Thank you, Holly. It's good to be here. I'm going to just share my screen. Okay. There we go. All right. So as Holly mentioned, I'm going to discuss trade secrets today protecting trade secrets disclosed in to the FDA. I'm going to start with a primer on trade secret law and discuss how trade secret protection is different from pet differs from patent protection. And then I'll go on to to talk about the disclosures to the FDA. And then I'll end it with some thoughts and considerations for when your licensing, trade secret rights in combination with patent rights. So we'll start off talking about what is a trade secret. So what is protectable as a trade secret, and that's can be any information, any type of information, it does not have to be information that's patentable. It can be a formula and algorithm, devices methods. In the biotech field, which I practice, many times it's methods of manufacturing or production or purifying compositions or biologics, or assays, like quality control assays and things like that. This information has to be commercially valuable and not generally known. And it must be the subject of reasonable efforts. To maintain the efforts that are reasonable under the circumstances to maintain its secrecy, the key is that this information is kept secret and must be must intentionally be kept secret from the public. The term commercially valuable means that the information must have economic independent economic value, this an economic value can be either actual or potential that derives from the fact that the information is not generally known to the public. commercially valuable can also be that when it this information does get disclosed or a person learns of this information that it then has, it's economically valuable once people learn about this information. So this slide compares, compare compares the patent rights versus trade secret rights, and is sure most people know that patent rights are right to exclude others from making and using a I'm there information. And this information is published and provided to the public. And the fact that something is a patent, a third party cannot use it unless you're given a license to use this. However, a trade secret is a right to sue someone who is misappropriated. The trade secret misappropriation means that the information had to be obtained through an improper manner. So there must be some wrongful doing. There must be some wrongdoing. And there's the owner of the trade secret has no rights against people, or a person who independently develops a reverse engineers or obtains the information. So there if someone comes across this information in an innocent way, you won't will not have a right to sue for misappropriation, whereas in a patent right. There is no you know, if they develop this information on their own, but you have a patent on the information, you can sue for patent infringement. The time of a patent protection is limited, whereas trade secret protection is has no time limit and it's made, the right is maintained. As long as information is kept secret. It's effective, the trade secret right is effective immediately, as long as once you determine that the information is has economic value, and that it is kept secret, it the right begins. And there are no formal filing requirements and no process no examination process, no. You know, Pat, no requirements that on the information, no qualifying a court quirements on the trade secrets other than economic value. So up to case having a obtaining a trade secret, right. As far as it'll, it's a pretty low cost intellectual property, right. Whereas on the other hand patents, in addition to being limited in time, they also have, they're also it takes a long time to get a patent usually about you know, at least three years, if not longer. And there are formal filing requirements. There are, you know, there's requirements, whether something can actually be can actually be granted is actually patentable subject matter. And it's also in all these things. Obtaining a patent right is, is costly compared especially compared to a trade secret which the only cost are really in maintaining the secrecy of the trade secret. So most, you know, trade secret law is, is common law, which allows for remedies for trade secret misappropriation. And the there is the Uniform Trade Secrets Act, which was completed by the Uniform Law Commission in 1979, amended in 1985. And it was approved by the ADA ABA. This the UTSA is an effort to codify the common laws throughout the country and provide clarification of the rights and remedies. So there is a understanding of what protection people have, or you would have to protect your trade secrets across across the country. This was a created also to eliminate these uncertainties created by the common law. This Act has been has been enacted by most of the states, including the Virgin Islands and Puerto Rico, that has the slide is a little out of date, because you can see New York, Massachusetts and Rhode Island have introduced the bill but have not enacted it or the the map says it has not been enacted, but actually it has the UTSA has been enacted in Massachusetts at this point. Um, North Carolina has a law that's very similar to the Uniform Trade Secrets Act. So they have not they have not enacted the actual UTSA. There is also a federal law protecting trade secrets and this is relatively new. It was signed into law in 2016. And it creates the Defend Trade Secrets Act DTSA creates a federal private and civil cause of action for trade secret misappropriation. Again, it's a means to provide a uniform statute to be applied nationwide in federal court and gives American companies federal jurisdiction to for remedy for remedies for trade secret misappropriation. In order for a trade secret rights are claimed to be brought in federal court, the trade secret must relate to a product or service used in or intended for us in interstate or foreign commerce. And this law does not preempt existing state laws. Some of the interesting things of this, the DTSA is that it does have a seizure seizure provision, and it does have immunity provisions for whistleblowers relating to disclosing trade secrets. So when you compare the UTSA versus the DTSA, one of the differences is in the definition of what a trade secret is. In my first slide, when I talked when I mentioned and described the definition of a trade secret, I used the UTSA definition, the DTSA has a more narrow definition of trade secret, it defines that the information the all forms and types of financial business, scientific, technical, economic, or engineering information, so it has these identifiers on the types of information that can be considered a trade secret, whereas the Uniform Trade Secrets Act really says any type of information that has the that has the economic value. And the another main difference is that the owner of the information must take a reasonable measure to keep that information secret under the DTSA. And the UTSA does not define who must undertake the efforts to maintain the secrecy.

Speaker 2  12:01  
And this is a few more comparisons between the UTSA and the DTSA they both have the same definition of misappropriation, they have slightly different now, as I mentioned earlier misappropriation is the is you know an improper method obtain an improper way of obtaining the trade secret information. And both acts define what a proper means of obtaining the trade secret information. So these are real ways or defenses for people who, you know, have obtained the information. And so the UTSA This is proper means as independent invention, reverse engineering, Discovery under license from the owner observation of the item or information in public or it's in the published literature. And the DTSA has kind of a more general definition. You know, specifically says reverse engineering, and then also states and independent derivation or any other lawful means of acquisition. So it kind of gives us a broader net of how you have proper means for obtaining the the information. They both have three years. Three year statute of limitations. And one of the big one of the provisions that's a big difference in the DTSA is that it provides an ex parte seizure remedy to be applied in extraordinary circumstances. There is no seizure remedy in the etsa. But otherwise, the remedies under both acts are very similar, which would include actual damages, injunctions, reasonable royalties, attorney fees, and ex ex ex exemplary damages. So I have been mentioning and talking a bit about what is missing what misappropriation. So I just wanted to add a slide in on what actually is misappropriation, and that is the acquisition or disclosure of a trade secret by another. Who knows or has reason to know that the trade secret was acquired by improper means, and so improper means can include many things that bribery, misrepresentation, breach inducement of a breach of duty to maintain secrecy, espionage. So, you know, there's a broad there are many things that can be constitute misappropriation. And then as I mentioned in the last slide, you know, there are the acts actually to provide clarification say what could be is actually considered proper means as well. So you're, in many times you're going to get an information you're good a invention, disclosure statement and or form from your, from your scientists or clients. And the question is whether this if you should protect this information as using by filing a patent application, or you should keep this information as a trade secret. And this slide here just takes you down a few of the things to consider a checklist, if you will, will think of one when you're considering what type of intellectual property protection you should have on this information. And the first question to consider is, is the information patentable? Now, it has to be patentable subject matter, under 101, which, you know, might be an easy way to determine if something is going to be you're going to protect as a patent through a patent application or a trade secret. And then also, is it novel and non obvious? So do you meet the requirements under the statute for something to be patentable? And if it does, the next thing I would consider is what is the breadth of the claims you can you can obtain? Is it going to be something narrow? Is it going to be some the the claims that you obtain? Is it going to have the actual patented device or patent claim? Is that going to have economic or commercial value? Or is it going to be something too narrow and someone can reverse engineer around it pretty easily? The other question, the next question to consider is how you would know if someone's infringing especially on these methods of production, or assays that might be kept secret, you know, that your competitors might do and you might have no idea that they're doing or can and can you prove that someone is actually carrying out these methods or infringing? So if you're a patent claim, as a lot of, you know, limitations that are hard to prove, you know, it might be something you want to keep as a trade secret, rather than rather have it as a patent protection. Another thing to consider is, would the early disclosure, the patent app, have the information in the patent application says you'll even get a disclosure before the patent grants. Or the public will have the information before the patent grabs, well, that give a competitive give a competitor leg up, you know, you know, starting early before you actually even have your patent claims. Give them time to reverse engineer or to work around your invention if it's an if so maybe it's better to keep the information secret. And on the flip side, if you have a device or something that's when you when it's out and being sold, is it easy to ascertain your trade secret information by looking at and examining the commercial product. And if so, then those are things that maybe you should file a patent, but consider filing a patent application on because the information would be out there anyway, even if it's not, you know, by someone examining the commercial product. And the third thing to think of or the lab side, the last thing to think about, or one of the other additional things to think about is how easy it is to keep this information secret. You know, the trade secret law requires reasonable efforts to keep this information secret. So if it's something that's difficult, like I said, it can be examined, and people know what it is. If if you know if your inventors are or your scientists are turning over quickly, and it might be difficult to keep this information secret, and you might want to file a patent application to protect the information. So the take home here is you need to compare the extent of the patent protection you can obtain. So the scope and your ability to enforce the patent if if you know someone's infringing, versus the value, the value you gave to the competitor by providing the full disclosure because your patent specification needs to teach someone how to make and use your invention or your information. So that disclosure is going to give someone with much of a leg up compared to the amount of protection you're going to get from your patent claims. You know, you may want to protect it as a trade secret. So it's a balance between the risk of giving out all of that information and how much protection you will actually get from your from your past claims. So that jumps into started talking about the risks of choosing a trait so so you have your Pat As you have your information, you decide it's not something you want to protect as a patent. And what are the risks of deciding to protect it as a trade secret? In addition to you know, we started off the talk discussing the variations in law of trade, trade secret law between you know, that there is some between the states, it's common law, protection, in addition to the two acts, but taken to another level, this is that level of trade secret protection is going to vary significantly, could vary significantly from country to country. So, you know, if you're going to, you know, you have to think about in where this information would need to be protected, and it will does the other cut, do foreign countries have the same amount of protection as for trade secrets as the US and under patent law, it's, you know, there's, it's probably more consistent between countries where compared to trade secret law. You don't have if you use trade secret protection, you have no right to exclude someone else who independently develops the trade secret. I mentioned that in the earlier slides. But I think, you know, it's definitely a risk because if someone does just obtains the information on their own, you can't, you don't have a remedy for suing for misappropriation if there's no wrongdoing, whereas, you know, the patent protection, if you have a, you know, if you have a patent no matter what they cannot make or use your invention.

Speaker 2  21:51  
So, so the third party actually, you know, independently develops the trade secret information, the information that you're keeping secret, and they get a patent on the information, they can exclude you from using their patent information. So that's a big risk that someone else is going to be able to patent or patent your information that you've been keeping secret. There is a prior use defense that you can use. And it is going to depend on the timing and application of the prior use. In order if you're going to get that defense or get, that's going to be a winning defense. But so but that is a risk that you're taking by keeping something as a trade secret. And then the last thing to think about is what are the reasonable efforts to maintain the secrecy if it's difficult to restrict employees, or to restrict access after employees have left the company or if you have a high employee turnover, that adds to your risk of trade secret misappropriation. And also, when you're providing this information to people outside versus in through an agreement, such as a nondisclosure agreement, or a confidentiality agreement, you have to think about those contract provisions. And whether that the risk of those trades that the trade secret is actually being disclosed, that could be considered disclosed through those agreements. There have been a couple of cases in the United in the US that have said that exploration of the expiration date of an NDA might lead to an inadvertent loss of a trade secret protection. So when the NDA expires, is there an app is does that obligation to keep that trade secret secret by the person who's learned it? Does that extend after the expiration of the NDA? So that's something to think about in your agreements that, you know, when you're if there's a time limit on the NDA is that reasonable? Are the the people who've learned your trade secret information through that agreement, actually now have access to disclose it? And that's an important thing to think about when you're adding trade secret information to agreements or disclosing it for under non disclosure agreements. So how do you keep what are some ways to maintain the secrecy of the trade secret at least to have these reasonable efforts? If someone says hey, I'm my when I if you're making a claim for misappropriation and then the defendant says, hey, you know, this stuff is this information is out there and the owners not keeping it secret. So one thing is to keep a log of individuals who have access to them automation, and strip strictly limit access of information to employees who have a need to know need to know the information. And then also put procedures in place to require that your third party vendors keep the information confidential, and to limit access to only third parties. People as a third party vendor who actually have to have access, so you have to really think about what what you're putting into those contracts, when you're giving access to other to other parties, for electronic communications are around the information you want to encrypt all those. Sure. There's many ways to do that these days. And, and then of physical documents, if there are some, you need to make sure that they're all labeled highly confidential, trade, secret restricted access, and you have to identify all information as you want to move for sufficient to identify the information as a trade secret. So people know that this is something that's that shouldn't be passed on. Okay, so trade secret. We've mentioned earlier, some of the remedies, I just want to walk through those again, injunctions, criminal prosecution, compensatory damages, unjust enrichment, attorney fees, enhanced damages, you can get a exclusion order under the ITC. And then I mentioned the seizure, you can get ex parte seizures under the DTSA. So when we're talking about the risks and the advantages between trade secrets and patents, This slide compares the trade secret remedies versus the patent remedies. And I know I've said this a couple times, but again, only the people, only those who misappropriate, the trade secret can be liable. Instead of having anyone who just uses the information, so there's that requirement of wrongdoing again. And then injunctions, which is something that, you know, is one of the remedies, you have to think about for a trades under trade secret, if an injunction is actually something that will be commercially effective, because once the information is out in the public, you can't bring it back in, right? It can't, you can stop someone from infringing your patent through an injunction from selling your good, but once information is out there, you can't you can't bring get the information back in so, whether you know depend on the facts, whether an injunction is a viable remedy where it Patents You have to literally infringe every element of the claim and sometimes four methods say a method of treatment claims that are you know, that are common in bio biological or bio bio patents and pharma patents, they you know, you have to one party has to carry out actually has to literally a fringe every element of the claim. So, but for trade secret misappropriation, you know, you don't have that literal infringement requirement, you can have proof of misappropriation can be you know, circumstantial evidence and it does not require a showing that all elements of the information are copied or disclosed. And it doesn't have to actually even be identical substantial similarity or derivation is sufficient to establish can be sufficient to establish misappropriation. So there's a little bit broader, I mean, you have the requirement of wrongdoing to sue for misappropriation, but you have a you know, there's some broader there is some some, you might have broad a broader amount of actions that can help you prove misappropriation. And you can have unjust enrichment as a possible remedy for trade secrets, misappropriation, whereas patent law, there is no unjust enrichment remedy. So that's one other things to consider. So now you've decided you wanted to keep your information secret. So let's consider when you file your submission so that says this is a by biologic or or a keeping information about a biologic or pharmaceutical composition secret, as a trade secret, such as your methods of producing or pure We're fine. And if you want to think about you know what will happen if what you disclose this information to the FDA is still being kept secret. So, the FDA may may share nonpublic information on its own initiative or in response to a FOIA request. Under a FOIA request, any person has a right to access federal agency records, unless that information falls under one of the FOIA exemptions. And add one of the FOIA exemptions exemption for is an exemption for trade secrets. And then the other one of the other exemptions that might play a role here is privileged communications within or between agencies. So the FDA also is allowed to disclose not the nonpublic information to state and local counterparts as part of cooperative law enforcement or regulatory efforts if certain conditions are met. So the trade secrets under exempt under exemption for trade secrets will include both commercial and financial information that is confidential and privileged. And the purpose of this is to protect the financial interest of the information owner and to prevent competitive harm. Exemption five is the privilege communications between between agencies is to protect deliberative process privilege, Attorney work party privilege,

Speaker 2  31:49  
and to protect your attorney client privilege in things that have been submitted to the FDA. So so it feels like as we talk about trade secrets is always have to consider what the definition is, is it's kind of it's it varies between, you know, different laws. So under the FDA statutes, a trade secret may consist of any commercial, the valuable plan, Formula process or device that is used in making preparing compounding, or processing of the trade commodities. And that has to be related to the end product of either innovation or substantial effort. So what does that mean? There must be a direct relationship between the trade secret and the productive process, the process that the process of the biologic or pharmaceutical agent, that's, that's, you know, that you're looking for marketing approval. This definition of trade secret is actually something more than economic value, it has to have that relationship between, you know, it can be really any, any of those specifically listed types of information, as long as there's that direct relationship between the production process, and there's also the commercial and financial information that can be considered a trade secret, that this information is something that's privileged or privileged or confidential. And that I think I mentioned in the last slide as well, that this information if disclosed, is what caused, you know, financial harm. And then also data and information submitted or developed to the FDA. Okay, yeah, and it's not in this information for a trade secret must not be available for public disclosure.

Speaker 2  34:08  
So, so how do you take advantage of this, the trade secret acts are one of the exemptions. In your in order to avoid being disclosed, using a FOIA request, so what you need to do, you have to identify the trade secret information within your FDA submission. This can be done at either the time of filing your FDA submission or at a reasonable time thereafter. Something to consider is to think about where you want to put this information within the submission. Some of the documents are more likely to be disclosed than others. So you might want to put it in something that isn't going to be requested by, you know, requested by the public. And The FDA may release a trade secret. And they may, even though you've marked something as a trade secret, they may release it to the public, if they believe that trade secret designation to be frivolous. So if you take your submission and you mark everything as trade secret can't be disclosed can't be disclosed. You know, the sky is falling type of attitude. The FCA can say, well, you know, you just everything can't be isn't, isn't falling within the exception, and they may disclose your information. The other key here is that things that you mark as a trade as trade secrets, you need to have reason that that keep this information as a trade secret. And that and when I walked through the FOIA requests, you'll see why that is information is important, but you can't, you need to have an argument ready, and why this information is something that you that it needs to be kept secret. In addition, on the flip side, the FDA may designate information as confidential as well and decide that they don't think this this is something that should be disclosed through a FOIA request. So here it is that the flowchart that I had mentioned about what happens when to respond to a FOIA request. So the FDA receives a FOIA request for information. And then they look at the information and determine if that information is falls under one of the exemptions. If it does, then your exemption, the the request is denied, the requester can file an administrative appeal to try to get the information. And that would move forward from there. If the FDA looks at the information that requests and determines that the information is not exempt, the FDA will send a notice of plan disclosure to the owner of the information. The owner then has only five working days to object to the notice. So this is why it's important at that at that point in your response to your FOIA to the notice of the FOIA request, you need to explain why this information is a trade secret. So that's why I think it's important to have when you mark things as a trade secrets important to have your arguments ready or have an idea of why this information to be kept has to be kept secret. Because you know, once you get that request, you have five days for a response. And that's, you know, it's not enough time to come up with elaborate arguments or, you know, it's good to have this ready to go in case someone does ask for the information. And then the FDA will look at your response. And then they will disclose the information unless the there's a court order to prohibit the release.

Speaker 2  37:58  
So in 2018, the FDA also had a program a Tete had a pilot program to increase transparency. And that was, they were going to put some of the information in the clinical study reports, make it available to the public on their website. And this pilot program was a response to the stakeholders request for greater transparency in the drug approval process, and more access to usable information. I think part of it is that, you know, there's so much information that goes into so many documents related to market approval of a drug. So it's kind of it's hard for to obtain that information in a usable fashion. So the goal of the pilot program was to determine if disclosing certain information, improve the public asset access to the drug approval process. And in particular, they were going they were disclosing portions of the clinical study reports, after the approval of an NDA. And so they were testing the process to select and post particular CSR information on a public website. And then they would provide also efficacy and safety information on the drugs at FDA site. And this and as I mentioned, this information was supposed to be more user friendly. And the key is to make, you know, to make information more practical and user friendly to key collaborators, such as medical researchers, drug developers, and and the other members of the public. And so they so they they've conducted the study for like two years and it was concluded this March. But I think it was still important for I wanted to still include it in this in this in this webinar, because I think it's still, the FDA gained some information out of this that they're going to take forward. And it still relates to disclosing your information in your NDA, in your approval in your, in your FDA submissions to the public. I think there's good news here. So this is this slide was an example of one of they the first one that they had, they, the first drug on the in the pilot program that they use to take some of the clinical study reports and publish them on the website was for your lead your ER leader, I'm gonna screw that up. But um, so one of the approved drugs, and this is an example of how it looked on their website. And they and then they absorb sorry, one more step on that. They also took, they were also in addition to the clinical study reports, they were also thinking of taking some of the complete response letters, and putting them on the website as well. There's a lot of information and a lot of these letters. So release of all of it would have been burdensome. So they were part of the pilot program is just just Turman, which part of the CLR, these letters contain clinical safety and efficacy of Bo, that would, that could have significant public health value and decide deciding what what parts of the information these letters and this in the in the reports that they would want to put on the website. So they have learned, they did learn some, the FDA did learn some best practices that they want, they're going to try to apply to future efforts to increase transparency. So it's a goal of the FDA to to continue to increase transparency in the drug approval process. Excuse me. This pilot program determine there's significant inefficiencies and having multiregional disclosure requirements, which relate often to identical clinical data summaries. So there's a lot of overlap, that they wanted to streamline the process more, and they identified a potential approach that could facilitate a harmonized system for disclosing the study report. So they still the FDA still sees value in disclosing the clinical study reports to the public and having it available. They're just working on the best way to do so. And the one, they're what they have proposed at this point is creating an international library that's available online, which would have parts of these parts of the clinical study reports available to the public. That should be standardized. And also, probably the best part of this is that it would be voluntary. So the sponsor could have a choice of committing to use the international library system and will have a, you know, would have some say in what would actually be available to the public. So that's so well, it's giving information to the public, you this drug sponsor will have some role in deciding what to put in it if they want to actually they if they want to, if they want to volunteer that information to the public, there will be a still an on they also considered an on demand system, where the public can request study reports of interest and the sponsor would then prepare the report. So this is this if this information was provided in a, you know, a letter from the FDA, so it wasn't they didn't have that much detail what that would mean out yet. Because it was only in March. But that you know, it seems to me that on the on demand system, if someone uses that to get information, they would the sponsor would have the ability to provide that information and you know, and have some control over what's turned over to to the pond the public request instead of a FOIA requests, which is you know, short and make someone turn it around really quickly. You're trying to shut it down. So maybe people would not use the on demand if they you know, they were some you know, they were adversarial and when might want to use the FOIA request to move you know, to make it go faster. But this is a system that the FDA is trying to put that is considering putting a practice in process based on their pilot program And then there are a few other ways the FDA discloses your information to the public, they cannot disclose trade secret information to states without, or states or government or the government, the state governments without express written authorization from the owner or the submitter. So again, if you have something marked as a trade secret, they're going to need either authorization to turn it over. However, confidential commercial information can be disclosed without the owners authorization, if it's in the interest of public health. And the other disclosure the FDA might could make is they do have an agreement with the EMA to share lists of inspection reports of facilities. So there is some talk between the market regulatory agencies, at least in Europe and the US and maybe even other countries. So that's what the FDA is telling other agencies could disclose some of your information. And then the other thing, and one thing to also think about is that, you know, you're not most likely, the drug sponsor is not just applying for approval in the US there is going to be in other countries as well. So some of your trade secret information, you know, given to other countries, we it's not as might not be as clear as how it's being, how it's being treated. So that's another thought when you have trade secrets in your your market regulatory submissions, how it's how it's actually being kept secret in other countries.

Speaker 2  46:58  
Okay, so, to some practice tips, when you're thinking about your FDA FDA approvals, you want to review your submissions and identify materials that should be exempt from the FOIA requests. Again, I mentioned in the last slide, just to repeat it, I wouldn't, you know, you don't want to mark everything. And make sure be prepared to provide a basis for why that information is valuable and should be kept secret. And I suggest conducting periodic reviews of the submissions. As the process goes on to determine if their information remains a trade secret after submission. I have this bullet point to review past CRF clinical study reports and the clinical response letters to determine when information is confidential. This might not be as important now that the FDA is not valance not submitting this information without the sponsor approval at this point. And the pilot program is no longer ongoing. And this this last bullet point is kind of a little bit of a it's a little different than what we've just been talking about. But if you're a defendant, so someone has claimed that you have misappropriated a trade secret, one way relating to, you know, a drug or something that's in the process of being FDA approved, you could submit a FOIA request to to the FDA to try to obtain the information that you allegedly misappropriated. So if it comes back through a FOIA request, you have a defense that it's not that information is not a trade secret. So if if if something comes, you know, the FDA can, finds it not exempt and responds to the FOIA request, you know, it's likely it's not a trade secret. And this induces a response from the FDA to act on the exemption, you know, act on the information to say if it's an exempt or not. And FOIA cases usually are resolved at summary judgment, so a court may rule that there's no trade secret before them for misappropriation trial. So if you're put in that position, and you know you're the defendant, it's something to consider and try to see if you can obtain the information on your own. Okay, I want to end the talk with some licensing considerations. When you actually have your you have your trade secret rights, and maybe you have a hybrid license between you can have a trade secret license, or a hybrid license that has both patent and trademark rights in the agreement. So a trade secret license is an agreement where the IP He owner grants a licensee permission to use some or all of the secret information, the license holder retain full title and all ownership associated with the trade secret. But there's a risk that the licensee who obtains the information will not keep it secret. However, there is a benefit of because, you know, you'll have additional rights. And this allows you to maximize your royalties on the trade secret. Like trade secret licenses can be exclusive or non exclusive. And the right to use the trade secret can be limited to a defined period of time. And a license can be revoked if the licensee fails to comply with the terms of the agreement. So it's important to conduct periodic reviews to determine if the information that you're defining as a trade secret remains a trade secret after submission or or execution of the license. So again, the same you know, as we talked for what are trade secrets, a license can be anything that is a value, the formulations assays, this is from a biologic biological pharma perspective, your manufacturing methods. And it's advised that the licensee who is going to obtain the trade secret should also sign a nondisclosure agreement. And that NDA should clearly define the information is the trade secret. And it should limit the disclosures to purpose to purposes agreed upon by both parties. By signing the by signing this NDA the licensee expressly accepts a duty to preserve the secrecy of information. That's a key that you know that that licensee is going to keep the information secret. And as I mentioned earlier, if a license, you know, there are case there's case law that if the NDA expires, there's you know, you have to make sure that that duty to keep the information secret does not expire with the NDA, it can keep going. This allowed, you know, when you're when trade secrets are part of the license, there's kind of this black box of information, no one really knows what's in it, but you're expecting the you know, the licensee to say, Okay, I'm going to, I'm going to pay I'm going to agree to accept this. And but I don't know what the information is. So there's a due diligence period, where the parties, the licensee at least needs to learn what is in this information that they're going to be some of the rights that they are going to accept and pay for in the agreement. So those are things to consider about this black box of information. So if you're the trade secret owner, what should you think about when you're about to divulge the contents of your blackbox, or the secret information, you'll want to put a restriction on the use of that information. As I mentioned earlier, you also want to restrict who can view the information. And the party of the light, you know, on the other side who's actually getting access to the information, you want to limit that. And you want to limit the amount of time that they have to actually examine or have actual access to the information. And then also, you want to think about how much you can charge the licensee the potential licensee to view this information to learn about it. And then on the other side, if you're the trade secret recipient, you want to look into the black box, what should you consider and then again, you should think about these, what restrictions you're willing to accept. And on before the restrictions you have before the execution of the license, and then restrictions of use of the information after after the after the execution of the license. And then what happens? What happens if you look at this information and then determine it's actually in the public domain? You have to think about what are the ramifications of that, and then how much you're willing to pay to look into this black box of trade secret information. And then I think one thing to consider about the hybrid license so a license that is going to transfer both the rights of a patent and trade secrets in one agreement. Royalties in the US royalties cannot be paid on for patent rights. If the patent is not enforced. However, a trade secret as we mentioned early on that trade secret rights are indefinite. It's going to you're going to have this intellectual property right as long as the information was kept secret. So there is no expert. There's no definite expiration date. And so therefore, royalties on a trade secret can extend longer than those for patent rights. So how you have to think about how how you're going to structure the royalties and payments based on these different rights in your agreement, and a couple of different ways you can options that are these are some options, I'm sure there's more. But you could separate the patent, you could have two separate agreements for patent rights and trade secret rights. You could do an initial lump sum payment for trade secrets, you can clearly differentiate between patents and trade secret rights. You could have separate allocations for each of the rights, you can do a decrease in the royalties after the patent expires. Grant a royalty free license to the pens or another option is to grant a trade secret license without patent license. So similar to having a similar as separate or trade secret agreements. Oh, wow, I've been talking for a long time. So that's the end of my presentation. I'll open it up to any questions.

Speaker 1  56:17  
Thanks, Sharon. We did get a couple of questions early on, I think you actually ended up covering them?

Unknown Speaker  56:22  
Oh, I'm sorry. No, it's great. It's not that good at zoom. Perfect.

Speaker 1  56:28  
I'm going to just ask them, maybe they can be reviewed briefly. Since somebody did ask. If somebody is found to be in breach of trade, secret protection, how do you take back the knowledge once it's been released?

Speaker 2  56:43  
I think that's one of the difficult things. Once that information is out there, if it can't be taken back, I think you can only try to make yourself hold on the remedies. And maybe get some damages. But I don't think you can ever get the information from not being out there, you might be able to stop them from further disclosing. But you really can't. Once it's out there, you can't get it back in, which is one of the risks of trade secret protection.

Unknown Speaker  57:17  
You're out tally, you're on mute.

Speaker 1  57:21  
Thank you. Okay, so what is considered reasonable effort to limit access to trade secrets.

Speaker 2  57:30  
Um, so I think it's reasonable efforts are to keep it from, you want to limit the amount of people who can have access to information and have if it's electronic? Well, one is to keep a log, so you know, who has access to the information, you want to limit the amount of people who can get to the information. And for electronic information, you know, there's probably tons of different ways to encrypt it and keep it control. I was just talking to about setting up data data rooms for clients, with my with our IT department and, you know, you can have these links that access to a data room that only that owns the link is only valid for a certain amount of time, you know, you can prohibit people from downloading the information, they can only view it while in the, you know, within the data room. So that's just an example of ways you can keep things, you know, keep things secure, trying to get people not to be able to download, you know, keeping, keep prohibiting people from downloading or sharing and things like that. For paper, which is the old way, you would mark everything. Again, it wouldn't be something that, you know, and try to get people you know, so if it is copied, it has a big watermark on it that says this is not supposed to be copied and for, you know, trade secret information, but I think probably everyone's moved to the electronic format. So you'll need to, you know, there's there's probably many different ways electronically, you can keep the access restricted.

Speaker 1  59:05  
Great, thank you might just have one more question that's come in to those listening. If you have any questions, enter them now. We're, we just have one more question to go and then we'll probably close out so now's your chance. Okay, the last question I have so far, Sharon is how do you how specifically do you indicate what is a trade secret when disclosing to the FDA? And why wouldn't you just mark everything you submit as trade secret?

Speaker 2  59:32  
Think I mean, I actually I will admit, I don't know exactly how you mark it as a trade secret. You might think you might need to redact it. You'd have to I'm sorry, I did. You'd have to check on how to do it. Exactly. But I think the problem with marking everything a trade secret is that they the FDA can look at your designations as frivolous and and decide that it's not actually a trade suit is not actually something that should be have secret and then disclose it through the FOIA request. So, you know, if you mark everything, they're gonna say, Well, you're not being very careful on what, there's no way that all this information has to be kept secret. So you know, we're going to not, you know, we're going to disclose any of it. There we have that we're not going to keep it. We're not going to take your designation seriously, and we're going to disclose it. So that is, you know, that's, I think that's why you want to be careful on the things that you just did. You actually mark as a as a trade secret. I hope that answered the question.

Speaker 1  1:00:41  
Great. Thank you. That is all the questions we have. So do you have any parting thoughts, Sharon? Otherwise, I'll just go ahead and close this out.

Speaker 2  1:00:50  
No, I think I think I've talked a lot. But thank you, everyone. And I hope I hope you learned something from this talk.

Speaker 1  1:00:58  
Great. On behalf of autumn, I want to thank you, Sharon for this informative discussion. There was a lot of information there. It's really great. And I also want to thank everybody who attended today, we hope you found some really good information and some takeaways. Just a reminder, a recording of this webinar will be available for viewing I was in just a few days of today's event. Access to that recording is included in your registration. Visit the autumn website to view the recording or you could also purchase a past webinar you might have missed. If you have any questions about submitting for CLE credits, please contact me directly and I'll help you through it. It is a new thing that we're offering CLE for webinars. So I'll work with you on that. When you close out there will be a pop up evaluation. Please complete that that really helps us out. And with that I will go ahead and conclude our program for today. Thanks so much for joining us and have a great afternoon.

Unknown Speaker  1:01:52  
Thank you

Transcribed by https://otter.ai