Speaker 1  0:00  
All right. Good afternoon and welcome to today's webinar, provisional patent applications a panacea for large and small molecules 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 for our presenters, we encourage you to use the q&a feature on your zoom toolbar. If you have a technical question or a comment, please feel free to use the chat. Our presenters will be pausing at various points throughout the presentation today to take questions based on the content that had been covered. So please don't feel like you need to wait until the end of the presentation to submit your questions. We'll be answering those as we go. If you need closed captioning during today's session, the Zoom live transcript feature is turned on and available in your toolbar. Before we begin, I would like to take a moment to acknowledge and thank autumns online professional development sponsor Marshall Gerstein IP, we appreciate your ongoing support. And I now have the pleasure of introducing today's two presenters, Karthik Gopalakrishnan and Tina Williams McCown. Karthik, I'm going to turn it over to you told you our introductions for today. But I'm so grateful that you both are here to join us. And we're excited to learn from you both.

Speaker 2  1:22  
Thanks, Sammy, and thanks to them for giving us the opportunity to talk about this on this webinar, or on provisionals. And I have great pleasure in introducing the primary presenter today. Tim McCown, who I've known for about close to four years now, Tina is an undergrad from UNC. She did her PhD at University of Alabama at Birmingham in neuroscience, and got her JD from Emory. And she practice that Kilpatrick Townsend as you can see from the slide, and she has a very, very long list of accolades, and I just selected some things that I thought were the coolest part of it. She has been listed in the Best Lawyers in America for patent law and Biotechnology and Life Sciences law in 2023, and each of the 14 years preceding that. She was also named Georgia Super Lawyer in 2023, and 15 years preceding that continuously, and also the top 10, IP stars, the top 250, women and IP. So Tina clearly has been in this business for a while and has done phenomenally well. In addition to all of that, she's a dear friend, and I've had a great interaction with her over the four years that I've been at UAB. Her technology experience includes a neuroscience immunology therapeutic antibodies, oncolytic virus therapy, stem cell technologies, recombinant technologies and variety of areas including food and food supplements. And a little bit about me, so I'm Karthik Gopalakrishnan. I'm the director of licensing in new ventures at the UAB Research Foundation, which is essentially the Technology Transfer shop at the University of Alabama at Birmingham. I've been in this role for about four years. And prior to that I was at Duke in their tech transfer office for about 15 and how PhD in molecular biology, biochemistry from the Tata Institute fundamental research in India, and have a short four five year postdoc stint at the National Institute of Environmental Health Sciences. So with that, I would maybe request Tina to go to the first of our slides.

Speaker 2  3:42  
All right, so as you can see from the first slide, the topic today is provisional patent applications. And the subtext is whether provisional patent applications is a panacea for large and small molecules. And as you will see in the next slide, the answer is not so obvious. The short answer is a no, the long answer is maybe and hopefully, what Tina and I will present today will give you a sense of why we kind of are hedging on the upsides and downsides of what a provisional might prove to be in terms of value or not. So, what we hope to cover today are the basics regarding provisional patent applications. And clearly there are a lot of positives, there is no question about it. And I would highly encourage everybody to file a provisional patent applications. Having said that, there are pitfalls that one should be aware of. And if you're not aware of those pitfalls, there might be downsides to provisional patents. And that's that's the flavor of this conversation to ensure that we recognize the positives use it and and safeguard against the potential pitfalls. And so that, overall, we can use provisionals effectively As I mentioned in the introduction, there are some very obvious breakpoints in the course of this webinar. And please feel free to input your questions in the q&a box. I will be scanning them and at opportune moments, either Tina or I will take, take those questions. With that, Tina, over to you. So

Speaker 3  5:22  
first of all, thank you, I'm, I'm thrilled to, to be here and to share the virtual podium with you Karthik, next time I get to introduce you, however, we'll make that will make that deal. So yeah, the first thing, we're going to cover just some of the basics of provisional patent applications, then we'll move on to some of the good and some of the bad associated with them. And we will certainly accept questions along the way. I know that when you talk about patent law, it can get a little boring. So you know, interrupt us with your q&a, and we'll take them as we can. So the first thing we want to talk about are what are the basic differences between a provisional and a non provisional, and we've just listed here the characteristics. So with a provisional patent application, it doesn't get examined except for formalities, did you pay your fees? Did you have a designated as provisional etc. It doesn't issue as a patent. And if you don't do anything with it, it just expires after 12 months. Actually, it expires after 12 months, regardless, you just have the option of claiming priority to it before that expiration. You don't have to have any claims in a provisional you certainly do in a non provisional, you have to have at least one. But the provisional is got a cheaper, it's cheaper to pay the fees for the US Patent Office, then for a non provisional, I think the fee is about what was it about $120 For a small entity at this point, to file a provisional patent application. But the interesting thing is it doesn't detract from term and we're going to talk about that more. So you get a non provisional we'll start the 20 year clock. But when you file your provisional that doesn't start the clock, your clock doesn't start on that patent term until you file a non provisional that claims priority back to the provisional. In the provisional itself, you can't claim priority to it, and you can't modify the application while it's pending. And it doesn't publish until such time never really publishes. But it becomes publicly available once the nonprovisional claiming priority to it publishes. Um, so it's not a complete secret unless you let it die on the vine. And then it never sees the light of day. Once you file your provisional application, you can mark an invention patent pending, that's not terribly relevant in the large molecule small molecule space, but it is somewhat irrelevant. The other thing a provisional can do is protect what we call absolute novelty. So in some countries, you have to have filed some kind of a patent application before you disclose something you don't get a grace period. So in Europe, for example, you don't get a grace period. But the provisional if you file your provisional, and within days or months, you publicly disclose you've protected absolute novelty as to what was in the provisional. So in contrast, a non provisional patent application is examined. It'll either issue as a patent or you let it go on during prosecution. You have to have claims you have to have more fees and more formalities. So for example, if it's a large molecule and you have sequences, you've got to have a sequence listing and your non provisional, as we said before, it starts the 20 year term clock. And again, we'll talk about that a little bit more. You can claim priority in a nonprovisional. Two to a series of provisionals to one provisional or nonprovisional applications that predate they always published 18 months after the first effective filing date. You do have the option in the US of filing a request for non publication. But when you do that, you're basically saying we're not going to file in any other countries. So it generally we'll publish and like I said, that's when your provisional patent application upon which you claim priority becomes publicly publicly available. Again, you can mark patent pending and protects absolute novelty. And let me step back just for a moment. Since we're talking and focusing on large and small molecules. We'll be talking about utility patent applications, not design patents or plant patents today. But just as an aside, a design patent can do not claim priority to a provisional patent application. Just a fun fact that not everybody knows. Okay. Let's move on now. Questions.

Speaker 2  10:09  
So one of the questions that came up is that patent attorneys, many patent attorneys swear that you need claims in provisional patent applications relating to priority claims in EP or other jurisdictions. So quick comment on that as we take that.

Speaker 3  10:25  
So if I understand the question correctly, they're saying that in provisional patent applications, they're claiming priority to European documents.

Speaker 2  10:35  
application was more general, which is that patent attorneys, some patent attorneys think that it's important for provisional patent applications to have claims, especially as it relates to EP or other jurisdictions.

Speaker 3  10:48  
I think that it is the best practice to include claims and I generally do that. The Times, I guess I almost always do that. I'm not a big fan of cover sheet provisionals. As you know, Karthik, even when I file a cover sheet provisional with a gun to my head, because there's a publication tomorrow, it's Friday afternoon, and it's going to publish at midnight, that we will sometimes just do a cover sheet provisional, but often I'll tag on a couple of claims, I do think it's best practice is just that none are required by statute to get the filing date. Thank you. It's a good question. Okay. So there are specific filing requirements for a provisional you have to either have a cover sheet on the provisional that designated a provisional you have to have an application data sheet, either one identifies the identifies the application, as a provisional, you have to have a title, you have to have some inventor information. It is possible if you're really clueless about the inventor, or for some reason, you don't want to designate it, you can put down John Doe or Jane Doe or whatever, you know, placeholder for the inventor, and a city and state. The cover sheet form for the provisional patent application reminds you that you should tell them about federal funding. So I generally, especially for universities, will file a cover sheet with it rather than just the IDS because it it's a good reminder to my paralegals into myself that we need to ask that question about federal funding. So the provisional application also has to include some description that we call those specification drawings, if necessary, and you have to pay your fees with the provisional filing, you can't delay that. But again, it's $120 or so for small entity. The complete non provisional application requires more, you have to have at least one claim drawings if necessary, you have to file a declaration and fees. Those can be filed later with additional fees. And generally you identify the federal funding in the body of the patent application. Okay, so how do you how do you use provisionals? And what are your choices on filing strategies? So the first question you're going to ask is, are we going to start with a provisional and you almost always start with a provisional when you're filing on large and small molecules, there could be exceptions. But but that's a good practice. And we'll talk about reasons for it. But if you start with a provisional, you have up to a year in which to file a non provisional application claiming priority to one or more provisionals. So during that year, you could file a series of provisionals. That's an option. At that one year mark, you might file just a PCT application, you might file in non PCT countries like like Thailand, Taiwan, you might concurrently file a direct nonprovisional, for example, in the US. When you file in the US directly, you've started prosecution then after about a year. So you've kept your provisionals going for a year and you file your non provisional us, you start prosecution. In the meantime, your PCT sits for a while you get some examination at the PCT stage. And then, at 30 months, you enter, excuse me, the regional or national stage. So you might enter US, Canada, Europe, Australia, etc. The other option is to start with a nonprovisional. So maybe in the US, generally, for the people on the phone, it would probably be the US. Then you'd file PCT and or non PCT countries. And optionally the direct non provisional, you always have the option from your PCT of coming back into the US from there. And what I find is that most universities do this, especially for large and small molecules. They file the provisional and they file a PCT, and then they enter the national stage or the regional stage, close to the final deadline. Pharma companies, on the other hand, may do a much more robust filing. So they may do filing a PCT, non PCT countries and a US filing at the same time. Again, for large and small molecules, Big Pharma is often filing a provisional as well.

Speaker 3  15:52  
So I'm going to move on to the reasons you want to file provisionals. Unless Karthik, there are any questions on the basics that we should address. There

Speaker 2  16:02  
are a couple of questions. One has to do with the Paris Convention article four c four. Oh, it's common. Okay, it's come. Alright. So go ahead. Go ahead, Tina.

Speaker 3  16:15  
Now, that's a great question. And I'm so excited. Somebody knows about that. So that's good. All right. So let's talk about some of the reasons you would file a provisional and hold that question for the pitfalls, because that's, that's where I've designated it. Okay, there are at least four good reasons for filing provisionals. And you may think of more as we talk. Let's start with patent term. We've already mentioned that generally, patent term starts, patent term is 20 years from the filing date of the non provisional patent application. And the provisional does not count against term. There's some other things that can affect this 20 year term. patent term adjustment doesn't add to the term, but it can add back some time that patent prosecution costs you. So if the USPTO is slow, and they fail to meet certain deadlines, but you as the applicant have met your deadlines, you'll get that time some of that time back. patent term extension is available for delays caused by regulatory approval. So you can get a certain amount of time back for certain drug products and medical devices, you have to designate which patent you're going to rely on. And there's some limitations on on that extension. Terminal disclaimers can also affect your patent term that's caused when the patent office says you have a double patenting rejection, that you're the claims in this application are too similar to another one of your patents, or patent applications. And you shouldn't be allowed to have a separate term on this one that extends longer. So you might be asked to terminally disclaim claims in a patent application to some claims that are similar. And we argue back and forth with them sometimes about this. But sometimes it's easier just to follow the terminal disclaimer. The other thing that can affect your patent term is a failure to pay your maintenance fees. But the big thing I want to focus on oops, the big thing I want to focus on is this 20 year term. So what you get by filing your provisional, you get your flag staked in the sand, you know, you've got your filing date. But you've got a year before the clock starts ticking on the term. And that's very valuable for for pharmaceuticals of any kind. And I'm going to turn it over to you Karthik to talk this through. Right.

Speaker 2  18:55  
And that's, that's a very important point from a technology transfer offices. monetary perspective. So So you've heard some of the tactical advantages that a provisional can have, and Tina's gonna elaborate in a few more. But this is a slide which talks about the monetary consequences and the advantages that a provisional offers. So if you just look at the the gray line that that is at time zero, which is the vertical line, that is ostensibly the time that a patent will expire. And if you look at the numerous, numerous tracers that are going from left to right, the solid part of the lines just mean that that's the current status of a particular patent. The dotted part of it is just the extrapolation as to what people believe the monetary impact of that particular molecule, small or large is going to be. So the two specific examples that are shown here, and in fact, Tina is going to be talking a little bit more about the the patent prosecution history of those two molecules or Keytruda and Eliquis. So Keytruda is a is a mark product, it's a it's an antibody. And as you can see, when the patent expires to the right effect, there is a dramatic drop. And this dramatic drop is true not or there is an anticipated dramatic drop in the case of Keytruda. But this is true, not just for caterer, it's true for every other molecule after the patent expiry of that molecule. This is because there are generics that come in and take over. But the important point is that one year prior to the patent expired, and almost every single of those lines show that there is a significant and a progressive increase over time of the value of that molecule for the for the, for the company for the pharmaceutical company. And this provisional patent application provides you that extra kind of year, to access royalty terms for that molecule. So typical pharma royalty rate is anywhere between two and 4%. And if you look at Keytruda, if this was a molecule that is owned by a university, you're talking about for the last one year, something that's going to be in the 20 $22 billion range. And for liquids, it's not as much, but it's still nothing to sneer at, but $9 billion. So 2% of that is a large number. So you certainly want to capture every last bit of patent life that you can and provisional allows you that freedom to manage timelines so that you can access that that revenue, okay.

Speaker 3  21:44  
And it's worth distinguishing, you wouldn't see the same profile for let's say applications, followed by Apple or Google or Facebook, because they run out of commercial value far earlier than their patent 20 years in that world is indefinite. And it's much different in the regulatory small molecule and large molecule space. So as Karthik said, Keytruda, we're going to focus in on those and just use those as examples. Keytruda is a biologics. So it's a large molecule. It's a PD, Pdl, one inhibitor, I believe now PD one inhibitor, okay. And then Eliquis, and of course, it's used for treating cancer. Eliquis is an anticoagulant used to treat and prevent clots, especially in people with atrial fibrillation. It inhibits one of the the clotting factors. So let's and by the way, you're seeing lots of advertisements on TV for both of these, because as they start getting toward the end of their patent term, that's when you'll see pharma companies spending a lot of money on advertisements. So here are on the left, you have the key Truda patent, and on the right, you have an Eliquis patent. These are not the only patents on these drugs. But I chose the ones that were selected, I believe, for the patent term extension. And so what I want you to notice is that, well, let's talk about it first. So, keep true to the Keytruda patent claims priority first to a PCT and then to a provisional, so the provisional was filed. PCT claiming priority to it was filed. And then from that PCT, a US national stage was filed and this grew up to be the 509 Pat. I went back and looked at the File History a bit. The provisional as filed included 30 pages of specification of description, and a set of claims. The PCT included additional pages, I'm sorry, was about 20 pages in the provisional about 27 pages in the PCT. All new figures in the PCT, the two figures that were in provisional, they didn't even keep those they just came up with new figures. Both the provisional as well as the non provisional included a formal sequence listing and lots of description about sequences and that's what you're going to need with the large molecule cases. This was the patent that was used for patent term extension on the Keytruda. Okay, so let's move over to the Eliquis patent. That one also claims priority to a provisional but it wasn't a national stage there were it was on file directly from the provisional. So this is a non provisional US patent that claim priority to the provisional. But in this case there were two provisionals filed One was filed on September 2001. The next one was filed August 2002. So very close to the one year date. But then they filed the nonprovisional application September 2002. In the case of Keytruda, they waited the full year, or just about to file the non provisional to file the PCT claiming priority to it. In the case of Eliquis, the provisional the first provisional included 167 pages of description chock full of small molecule chemical structures. There were 21 claims in the provisional so to the point that was made earlier both all these provisionals included claims. And again, I think that's the best practice. But after 167 Page provisional, the second provisional was up to 315 pages, and included about the same number of claims. But keep in mind, the disclosure was about twice as long. So they inevitably added a ton more including additional structures to that second provisional, the non provisional us case was very similar to the second provisional that was filed. So let's talk about why you might file a second provisional by filing a provisional, you don't get to amend that provisional patent application per se. But you can file additional provisionals over the course of the year, adding to that original, that original provisional patent application. So the provisional patent application may cover invention A, or let's say, small molecule A, then you file another provisional, that includes a plus b, or maybe a plus b plus c, etc. And then when you get to the non provisional deadline, or anytime during that 12 months, you can file your non provisional claiming priority to multiple provisionals. The reason for adding to either the subsequent provisionals or the non provisional is that you can identify your lead compound or your small your lead small molecule, large or small molecule, you might have new molecules that you want to add, you might have new data as to any of those molecules, you might have new uses that you've identified over the course of the year, you may have new methods of making some of the molecules. So there are lots of opportunities to add to during that year of Pendency. On the provisionals. You do not get that once you file your non provisional, you don't get to add new data, you don't get to add new compounds, etc. So this buys you a year of flexibility, and allows you I think, to perhaps file a little earlier, which is often needed for university filings. It's worth noting that there is there was a change in the law in 2013, when the US became a first to file country. Up until this time, the US was sort of out of sync with the rest of the world and was a first to invent country. And what that means I sort of think about it as first a file being like a rush to the courthouse to file your deed with the court, as opposed to sticking your flag in the ground and saying this is my property. So the difference here is that if a invents but it's the last one to file it makes a big difference whether this patent application was filed before 2013 Or after 2013. So if a files first I'm sorry if they invent first, but B files first B should win under the AIA because they're first to file. But NP AIA a will win so long as they have been diligent and in moving from invention to filing. So filing early in the first to file world is important. And that's sometimes the provisional will give you an opportunity to fall a little earlier without tending to all of the formalities that are required. Just looking back to the Keytruda and Eliquis example. Both of those were pre AIA cases. But even in even pre AIA getting to filing was had lots of advantages. Okay, so let's talk about the advantage of the delay. We talked about the fact that the delay gives you an opportunity to add some things over the course of the year. But the other things that it does is it allows you to delay costs. And Karthik can certainly speak to this. But this is really important for universities. Because once you file your provisional, there's no prosecution during that year. It just sort of sits there unless you file additional provisionals. Then you follow the PCT, there's minimal prosecution available during the PCT stage, there's some opportunities to amend both the spec and the claims. But we rarely do that because of so many differences in standards of patentability and claim structure that's permitted in jurisdictions around the world. So we often just let that PCT time sit and not do a lot of active prosecution. So really, you've got 30 months before you start having to pay those big fees for regional and national stages, and then starting active prosecution. So by filing the provisional, you can delay your costs and postpone national stage filings. Your national stage would be due at the same time if you started with a non provisional, but you wouldn't have active prosecution during that time.

Speaker 3  31:41  
The provisional also offers you an opportunity to delay formalities. So maybe you haven't done a thorough inventorship and ownership analysis, maybe you haven't done a full sequence listing excetera. So you can you can postpone that you can kind of kick the can on that and wait until you file your non provisional to get all those things in order. The provisional gives you a low cost year, in which you can seek a licensee and begin to ascertain the commercial value of the invention. The other thing that the PCT does is that it gives you that advantage as well, and that they do a search and an examination depending on the claims and where you select the Search, and that can also give you a peek into patentability. The other thing that this does is it delays publication of the application. And because the provisional doesn't publish, you won't get a publication and you won't get a release of the provisional until the publication of the non provisional either the PCT claiming priority to it or the non provisional us application, claiming priority to it. That can be important for some of your some of your professors who are hot to get a publication out before the patent application publishes. So once the provisional is filed, they have an opportunity to do that. So let's talk about some of the reasons for filing. Oh no, this I'm turning this over to you Karthik. Right. You're gonna you're gonna summarize here. That's fine. I

Speaker 2  33:28  
mean, I think I think you did a, you summarized in the last slide. So obviously, there's a commercial importance of the last time that you talked about giving those two examples, and how the first file allows for a quick filing and establish a date. And as Tina elaborated, you can have serial provisional filings that can all add to the non provisional when you file a non provisional or a PCT, and the delay in cost, details and publication, and Tina began to elaborate on that. And the six, typically these applications published at the end of 18 months after the first provisional, and that's a lot of time to tweak, and maybe file additional provisionals or other things to keep enlarging the net or building bigger and wider fences, because he mentioned that's what a patent allows you to do. Right? It it prevents somebody else from doing what what you have claimed until they get a license from you. So that is pretty important. Also, think about it from the perspective of a small molecule. At the end of 20 years in the patent life expires, generics come in. And so you're delaying what you have filed to be available to companies that might be competing in the same area, so that they start their, their efforts and their endeavors later. So those are the advantages that we're going to be that that that we discussed, but this might be a good time to also maybe look at some quick Questions that there was a question Tina about where it is that provisionals are actually published. As you take that out, look at other questions.

Speaker 3  35:08  
They're not exactly published. But once you go to patent center, at the US Patent Office, once once you see a published patent application, you can go to patent Center, you can go look at the file history for that application, and you can click through and look at the priority documents. And that, once you've claimed priority to a provisional, you can see that provisional patent application once the non provisional publishes, so it's not as though it publishes. It's not as though it's released and searchable per se. But you can access it.

Speaker 2  35:53  
So there's an interesting question. So when a non provisional claims priority to two provisionals claiming different molecule hasn't been a case, where a competitor file before the second provisional for the same second molecule and cause problems in the issuance of claims, on the second molecule? Absolutely,

Speaker 3  36:14  
that can happen. And that's a great point. And that's, that's one of the pitfalls of a provisional is, if it doesn't include both invention, A and B, you're going to have different priority dates for different compounds and different claims in your non provisional. And we're going to talk about that on the pitfalls, something to watch out for in the public intervening publications or intervening patent claims. Intervening patent filings can certainly be have an effect.

Speaker 2  36:48  
There's not a question. And this might probably one of the downsides of publication. The question relates to filing in Bio Archive, which has become the bane of most tech transfer offices, because they don't tell us before they publish it there. So the question here is, apparently, this is at some level here say Yes, folks a deal in Stanford able to file a provisional after by archive publication. Why are we not doing it? That's a question asked by API to a tech transfer person. And the question that is arcane are from from Cold Spring Harbor. The question that he asked for you, Tina, is, is your concern is it for art after publication? How good is the one year grace period in the US?

Speaker 3  37:35  
It's a one year grace period, the US is good. That That shouldn't be a big problem. But you will have problems outside the US where jurisdictions that require absolute novelty. Not all of them do their Canada I think has an option on a scientific publication being having a grace period for that. But most countries require absolute novelty. So that's really the rub on those quick publications. There's nothing wrong with filing a provisional or nonprovisional within the grace period in the US.

Speaker 2  38:14  
Okay, I think I've covered conceptually, a few different kinds of questions. There are a lot more but go ahead, Tina. Okay,

Speaker 3  38:21  
let's flip the coin and talk about the negatives. pitfalls, not so much negatives, but pitfalls, what you need to watch out for as you go through? And this gets to the question that that was just asked. We've said that by filing a provisional, you get a priority date for your invention, but you only get the priority date for what is in that provisional for what is disclosed. So some of the claims and your non provisional may have been disclosed in your first provisional some of the claims the invention of some of the other claims might have been disclosed to some subsequent provisional and finally, some of the inventions of yet other claims might have only been disclosed in the non provisional. And if that's the case, you're going to have three sets of priority dates. And that's, that's very relevant, because it opens up different prior art for different inventions. Um, the other so that's one thing to be aware of, is that you're only covered as to what is in that provisional and that's an important thing for inventors to understand, because they think once they filed a provisional they can go out and talk about anything. And that's, you know, that's always hard to curb that, but that is important. The other thing that's that's really important as to large and small molecules, these are considered by the patent office to fall into the unpredictable sciences. I like to call them the the life sciences as opposed to the dead sciences, but that's my own bias. But you're going to need to chemical compounds and sequences for adequate written description. And you're going to need multiple examples of them to establish a genus claim. That issue is before the Supreme Court now with regard to antibody claims, so I'm not ready to tell you how that's going to end up yet. But it's worth noting the Supreme Court doesn't usually make it easier to patent things not of late. So the other thing you have to have to get priority is you have to have methods of making and using and data showing that these are useful, because they're unpredictable sciences. So that's why cover sheets can give you a false sense of security. If you haven't enabled and provided adequate written description for the full scope of your claims, then your provisional isn't that useful, it really is going to limit you to exactly what's in there. So you want to be careful on looking at your priority date and exactly what you're getting with your priority date. And this is a question that was asked before, if you have an intervening public disclosure between a first provisional and a second provisional, if the first provisional only covers invention, A and the second provisional and discloses both A and B, then you've got an intervening publication that discloses a and b that can be prior art, as to invention B, if it's a publication by the inventors, you don't have priority for that back to the first provisional, and you don't have absolute novelty, when you file it in the second provisional. So that's why you want to try to control what your inventors have to say. Then there's the right to claim priority. And this is getting to the point about the Paris Convention. You have one year in which to claim priority to your provisional patent application. You can let it die on the vine, we talked about that. But what you're really not supposed to do is keep resetting your one year date by filing a new provisional each month of the year, and then choosing which of those you want to claim priority to. So, in this case, let's say you filed a provisional A, it describes invention a rather than you file a second provisional two months later, and it describes invention A plus B you cannot choose whether to file at 10 months or 12 months as your final deadline from the second published a second provisional, and what I mean by that is you you have to have at 12 months from your first filing disclosing invention a if the PCT claims invention A. If you want to file a PCT only as to invention be thin, you can file it 12 months after the second provisional unless you abandoned the first provisional before filing the second provisional and that's because of this language in the Paris Convention that says that you can claim priority to a previous application. But it has to have it has to have left no it has not otherwise abandoned leaving no rights outstanding has to be the first filed leaving no rights outstanding and not otherwise abandoned. Um, so if you've disclosed something in the first provisional unless you've abandoned it before filing a second one, you have 12 months from the first provisional to file on the invention that's disclosed in that provisional. This is hard and a lot of lawyers don't get this. But I what I think the take home message here is don't let it just roll and decide which provisional you want to claim priority to. That's not how it works. And you will be tempted to do this. When you get last minute decisions about filing the PCT. You'll think oh, well, we'll just forget that first provisional and claim priority. The second one, only if you've abandoned the first one. We've already discussed this I think ad nauseam. The fact that the first provisional may include invention, A and B. And then when you file your non provisional you've decided, well, we didn't work on a let's just file on B but that that's going to be out there when the non provisional publishes, so it could create art as to your subsequent filings that would have related to the other invention The other thing that I'm squeamish about on provisionals is that or the informalities. Sometimes we're where we don't do an inventor ship analysis, or we don't get ownership nailed down during that one year, we'll fail to get the assignments from all the inventors and things like that. So you really can end up with problems with those informalities persisting into your non provisional filings unless you're careful. And in particular, if you don't have the assignments from your inventors, prior to filing your PCT, you can't list the university as the sole applicant. And this is just something worth being aware of, because the Europe is very clear on this right to claim priority as the applicant. I think I covered everything Do you want me to cover this summary or you want to cover that Karthik

Speaker 2  46:00  
got him covered, but I just wanted to throw one thing in about the formalities just as we noted. So, if you file sequential provisionals A plus B, like the examples that Tina was talking about, sometimes there is also a temptation that but not a temptation, there is a there is a possibility that the inventors in provisional be, may be different from the inventors in provisional A. And so when you convert it, you may. And typically what is done is that you have inventors of A and B combined in your non provisional or PCT. Then restriction requirements happen. And the restriction requirements might separate the claims into two or three different buckets. And the informality that you use to kind of combine these things needs to be addressed at the time when restrictions happen, so that the claims and inventors are aligned. Otherwise you might get into I mean, there is there's no downside as long as you don't intentionally do it. But it's something to keep in mind. Because you don't want this hanging out for too long, and get it wrong. So so just just be aware, that image should be determined. Ideally, it's not done but ideally, whenever the restriction requirements and upon issuance of the patent because even during the course of patent prosecution, some claims drop off and perhaps with those claims dropping off inventors might drop off. So the in formalities are one of the veins of a provisional filing that that you should be or pitfalls I guess. And you should be cognizant of that and address it. Just be aware of that. The rest I think have been covered. I don't want to spend time re summarizing it because I think there are a lot of interesting questions, which so so this was just to kind of fully understand the Paris Convention issue. The question here is, do you have to expressly abandoned provisional one, if you file provisional to, I guess one day after the 12 month period of provision, one formerly having been expired? I know

Speaker 3  48:22  
when in fact, that's a good practice. If if you let the first provisional go the full year and the next day, not the same day, the next day, you file a second provisional that is your first filed application not otherwise abandoned, leaving no rights outstanding, and it can serve as your priority document under the Paris Convention.

Speaker 2  48:48  
On similar lines, can you rule the final day that final deadline for claiming priority to series A provisional if you file only US provisional, non provisional and no PCT? So is us and the rest of the world different than that?

Speaker 3  49:03  
Can so the question is, could you file a series just just file in the US and file a series of provisionals? Right, over the course of the year and just keep rolling? I don't think so. I mean, that's that's the same reason. I mean, it's the Paris Convention applies to the member countries and the US as a member country of the Paris Convention, so that that should not the permissible, permissible, either. Got it.

Speaker 2  49:38  
I'm trying to make sure that we cover a spectrum of questions. Tina, maybe you should take a quick look at the q&a part of the questions, as I'm scanning the chat to see if there are questions you'd like to address.

Speaker 3  49:59  
One question was does the inventor information need to have the actual address? No, you can you can use their work address, you can use the tech transfer offices address. That's permissible. The important thing is just to have an inventor name, or a place keeper, a city and state on the provisional.

Speaker 2  50:24  
So there's a question from the chat that I can probably take. It says, speaking of getting an early priority date, many researchers have wanted to file an up have an application on file while submitting manuscript because even though the thing that the review process is confidential, peers get access to the material which might affect filing decisions of this individuals, I also see that more and more. So that is a concern that I don't know how to dress, if you want to be really, really, really safe, I think it is probably reasonable practice to go ahead and have a provisional filed before a manuscript goes out for for review. It's hard for a competing peer reviewer to get all the data and establish that they have all the data before in the time timeline of a review process, I guess. But it's safe to do it before. One of the things that our office does typically is we wait for the acceptance of that manuscript and then we file just by ourselves that extra time. So it's a balance, I guess, between buying the time and being absolutely safe.

Speaker 3  51:43  
So while you're looking at the questions, I'll do a quick take home message about provisional filing strategy if that's okay Karthik, of course. So you want to use provisionals to maximize the profits that your licensees are going to get from these patents on large and small molecules. That's where the last term of patent the last year of patent term is really critical for large and small molecules and, and you will fight over days. If the patent office fails to give you adequate patent term extension, you'll you'll go back and argue with them about that. You want to be sure, especially for large and small molecules that you file fully enable specifications with adequate written description. And keep an eye on what those requirements are because I think it could be changing over the course of the year. Attend to your formalities well before the 12 month deadline. Make sure you've got your claims cleaned up your sequence listing ready drawings perfected inventor ship owners ownership issues squared away. As you file multiple multiple provisionals, you can consider abandoning the first provisional before you file the second provisional that's worth considering with the attorneys that you're working with. Try to limit your inventors public disclosures to what's actually in the file provisionals, or consider filing a new provisional as soon as possible, before or after their presentation. Try to limit your priority claims to the first filed application not otherwise abandoned, leaving no rights outstanding and disgust to the Paris Convention issue. Be sure to include your grant support in the provisional and disclose it to the granting agency that same requirements.

Speaker 2  53:33  
A couple of very interesting questions. So in light of the University of Minnesota regents versus Gilead, how do you recommend keeping the molecule broad enough to figure out a little more but enough substance that the project will hold up if challenged?

Speaker 3  53:47  
Yeah, you know, I always tell people broad claims are wonderful, because you can enforce them against a lot of people, but the broader the claim, the more likely it's going to be invalidated. And as of today, the Federal Circuit has rarely finds genius claims to small and large molecules, well, especially large molecules to be enabled and have adequate written description and or so what I like to do is always have claims of varying scope, so that you have a genus claim sub genus claim, to the extent that you can have sub sub genius claim, etc, all the way down to a picture claim. To the extent that you can have a claim that is exactly what you're going to take to market. You want that too. So you want that narrow claim. That's the one that should live through litigation and prove litigation worthy, as long as that's what your competitors are doing and at least in the large molecule, small molecule field have the incentive to design around is high. But if if a generic wants to go to market, they need to do what you're doing, and capitalize on the molecule that you've gotten approved. So you do want to have some narrow claims as well. So you're not wrong. There's no, there's no easy answer right now to ensure and you get a genius claim except for having a robust specification with as many examples as you can possibly include.

Speaker 2  55:32  
So, given we're close to our one hour, quick last question, somebody requested a quick summary, again, as to why filing subsequent provisionals is beneficial, and what to be careful about in those cases, maybe you can just end on that note, okay.

Speaker 3  55:50  
And this is something like I said, a lot of a lot of lot of lawyers don't follow very well. Okay, so you file your first provisional. Three months later, your inventor comes back and said, Listen, I've got this new molecule, it's even better. Or I've got some new data showing it works in a different cancer or I've got whatever. It's a great idea to file a second provisional did. And make sure you've covered as much scope as you can, as quickly as you can, in this first file world. To the extent that that you want to ignore the first application, you don't need that date or you don't believe you need that date, there have been no disclosures. The inventors not worried about competitors finding this first, for whatever reason, then you can abandon that first one. And in fact, it you can actually claim priority to abandoned provisional in the US within one year, even if you've abandoned it. So some people as a matter of practice will abandoned every first filed provisional before they file the next one. But they still need to decide whether to file within one year of that first provisional. So that's it's a it's a complicated decision making process and I encourage you to confer with counsel on it. That's a law your answer.

Speaker 1  57:31  
Perfect One note to end on Tina. On behalf of autumn, I want to say thank you both Karthik and Tina for such a valuable discussion today. I know there was a ton of questions that we did not get to attendees, thank you for your participation. The slides will be available as a handout posted in the autumn Learning Center. I believe they have some contact information in there in case there's specific follow ups. You can always reach out to me at autumn and I can help connect as well. So on that note, I will say thank you all so much for joining and attending today. We really appreciate you being here and participating. The recording will also get posted in the Learning Center within about a week of this presentation. So by the end of next week that will get posted for you as a resource and a certificate can get downloaded if you need that for your records. And please don't forget to fill out the webinar evaluation which will open when you close out of this zoom session to help serve our needs. Help us help you serve your needs in the future as we continue planning great online professional development programming. So thank you again so much and I hope that everyone has a great rest of the day. Thank you all

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