Engelberg Center Live!

Section 112: Section 112 in the Life Sciences

Episode Summary

This episode is the Section 112 in the Life Sciences panel from the Engelberg Center's Disclosure Under Section 112 in Policy and Practice event. It was recorded on April 19, 2023.

Episode Notes

Bruce Wexler (Moderator), Paul Hastings 

Henry Hadad, Bristol-Myers Squibb 

Amy Nelson, Office of the Solicitor, U.S. Patent and Trademark Office

E. Joshua Rosenkranz, Orrick

Episode Transcription

Announcer  0:00  

Welcome to Engelberg Center Live!, a collection of audio from events held by the Engelberg Center on Innovation Law and Policy at NYU Law. This episode is a Section 112 in the Life Sciences panel from the Engelberg Center's Disclosure Under Section 112 in Policy and Practice event, it was recorded on April 19 2023.


Bruce Wexler  0:26  

All right, I guess we'll get started. I was a great panel on Amgen Sanofi. So I guess. Should we do some introductions are Mike Mike was Mike, do you have introductions? Do you want to just quickly just go down the line and introduce yourself? Sure.


Henry Hadad  0:46  

So my name is Henry had I'm the chief intellectual property counsel for Bristol Myers Squibb. I'm speaking as an individual today, not on behalf of the company. But I will note that we were involved with adjudicate case against my friend Josh here.


Amy Nelson  1:00  

Amy. Yeah. Amy Nelson. I'm the Senior Counsel for patent policy and litigation in the office of solicitor at the patent office. I'm also speaking on my personal capacity, I was involved with the Amgen case, in the government's the government's brief in the Amgen case. And so I'm speaking on my own behalf.


Josh Rosencrantz  1:22  

I'm Josh Rosencrantz. I had the Supreme Court and Appellate Group had or I actually argued, I think the only reason I'm here is they argued both Juno and identical, I don't think I have a personal capacity. Because I mean, all of these cases on behalf of clients.


Bruce Wexler  1:40  

Okay, great. And we'll get to those slides that I use at the beginning, if you could just I'm not going to use them right now. But there's one slide that I didn't get to that I want to call up in a bit. So if you could just get those, I don't know where the slide person is. Michael, maybe you could just I don't need it right now. But okay, so I want to go back to this question about the needle in the haystack. Because I found that fascinating. And maybe we could just start there actually, you know, one of the things that I struggle with in thinking about these issues on full scope of enablement, which, which, which I have a lot of thoughts about in terms of the kinds of cases and what it means to look at the full scope of enablement. But isn't it you know, if you have any open ended claim, or really any claim at all, isn't it logically the case that there are sort of infinite embodiments in every patent claim, except, for example, maybe a chemical claim to one molecule, or genus or something. But in other words, if you claim, let's say, a chair, right, and you don't exclude a chair made out of water, that's an embodiment that doesn't work. If you have, and I have this all the time with you have a method of treatment using a drug, you can dream up endless versions of the treatment that don't work. If you have a claim to a range that says 50 to 100. And I challenge you to say did you enable, or it's, you know, two to 10. And I challenge you and say did you enable 3.14159 to whatever three, six, like did you enable that embodiment? The answer's no. So within every claim, there are endless embodiments that can't be made and won't work. It's a fact. So how do you distinguish? And so that grows out the haystack, in a sense, but that's not what we're talking about, right? When we think about a claim and sort of concrete enough embodiments that are sort of thought about and deliberate. But what I am seeing in practice, and I'm seeing it in Markman hearings and this and that, is people are hypothesizing and listen, body wants to create and look for things that won't work. And then they and they actually will try to get those incorporated into a Markman construction that says, including that, which does, you know, it doesn't work. So so if we accept that 112 cares about which it does, the needles, and how many needles and the relationship to the haystack, if we accept that that's fat, which we know it is, how do you when you move to this full scope of enablement test? How do you not run headlong into the fact that there are infinite embodiments most of the time, many of which don't work? Henry, you're nodding. So I'll go to you. Okay, well, alright.


Henry Hadad  4:35  

So I was going to ask a question to the prior panel, about how burden of proof plays into all this. And it's related, in a way because clearly, someone's skilled in the art of making chairs will know that you don't use water to make a chair right. There are certain parameters that a skilled artisan would have, and know this these are the fertile air areas to work in. And these are the ones I shouldn't be working in. And that comes down to the level of skill in the art, predictability, art, etc. Sounds a lot like one's doesn't it. But when you cut off the ones analysis and say your claim is broad, show me why you every embodiment works, you will inevitably fail, right? So that can't be, that can't be the test. If you're applying ones, you should be applying it in a way where the burden of proof remains on the infringer, you've got a granted patent. by clear and convincing evidence, you need to show that there are things that just vast swaths of patented area that just don't work, and it's completely unpredictable, what works and what doesn't work. I mean, that was what I would think that you should have the burden on the alleged infringer to show that under the way I understand the law.


Amy Nelson  5:54  

Yeah, no, I was gonna say like, I think that, you know, when you leave the patent office, and you have a claim, and I think the Federal Circuit's talked about, it was like a plot of land, and you have your plot of land. And maybe in front of the examiner, it looks like, okay, you've got a number of examples, it looks like maybe you've got, you know, a good representation, but then you get out, and you're in the real world. And you're, you know, it kind of comes with a, you know, buyer beware tag on it. And you get out into the real world. And you're in the middle of litigation with an infringer. And the finisher comes in and says, Well, you know, actually I have this thing maybe falls within the scope of the claim. But it's like, completely different, or it's, it's much better, and really, very different from what you've claimed. And so really what you've claimed, and what you've shown is really over in this little corner of that plot of land, and I have something that's really very different. So I think like, what it matters when you get into district court litigation, what the infringer didn't competitors are doing. And we saw that in cases like the, you know, the Curan case where there's like, the patent owner has the murine antibodies, and then suddenly, we see this infringer who's developed humanized antibodies, and they're just like, hugely different and better. And it's like, no, you can't claim those you didn't, you didn't disclose them. And you shouldn't get the rights to exclude people from doing that.


Bruce Wexler  7:14  

So where do you land on this full scope being a test that is workable, as saying everything in the full scope needs to work? And if not, how do you get around? What's the alternative? Yeah, so


Speaker 5  7:26  

So I really like judge Chen's analogy to the needle in the haystack. And I think in both identities, and you know, we talked about a needle in a hay field. And that's what these cases are turning on. On 112. It's, it's really three factors, essentially, that that are deciding these cases as a matter of law. And for enablement. Maybe there's a fourth. The first is just the sheer magnitude of the universe that's described by the structural claims, the this the structural components of the claims. The second is, what proportion of those claimed, excuse me, what proportion of that universe performs the function that is described in the in the claims, and those two are really critical. In the cases where they're being decided, as a matter of law, it is a tiny, tiny proportion of them. The third is, how easy is it to predict which of those needles will perform the role described by the function? And then for enablement, as the previous panel talked a lot about, you've got the added? You know, how many things do you have to test and, and make and test? In order to figure out the answer to those first three questions. I don't think those cases are revolving around someone hypothesizing a chair made out of water, those cases are revolving around the fact that someone is claiming something. They don't actually have it. And it would take years or generations to to figure out the full scope in and so, to my mind, the answer to the question about full scope just revolves around those three or four basic inquiries. When you've invented when you've figured out enough to have to be deemed to have invented the full scope. You get to claim the full scope. And when you've only figured out a small piece of it, you get to claim the small piece of it.


Bruce Wexler  9:46  

You said you have something Henry? Yeah,


Henry Hadad  9:47  

yeah. So I, of course agree that a research plan isn't enough to patent right you can't say I aspire to create a perpetual motion machine or cold fusion and get a patent. That is clear. I'm on the flip side, we also don't want to create a system where you only get to patent exactly what you make. Because there's many made or points the point earlier than it would be very easy to design around pioneering inventions. One of the areas, I think, is why we have this issue in the biologic space, is that a lot of this law was created in the small molecule in the chemistry area. At a time when it was indeed exactly what Judge Chen said, a needle in a haystack, you wanted to say, a Cox two inhibitor for treating, you know, a certain condition. That's the Rochester case, and you didn't know what that structure would possibly be, it could have been anything, okay. And that was ultimately found to violate 112. In chemistry, biology is a very different animal, yet the same type of laws being an approach is being taken, which is the scientists and really, we haven't just not a scientist here, right. And we really shouldn't be speaking to them, the scientists would say you have a target, you know, that blocking and neutralizing that target, will have a desired effect on a disease, what whatever the number of antibodies that will do, that doesn't really matter, because I'm going to generate antibodies, I'm gonna identify those antibodies. And at some point in distant future, I'll probably sequence of to see what the structure is, but I don't really care. I just want to know it binds and it neutralizes and now I'm going to find the optimal one. It's not a needle in a haystack. It's relatively something that scientists will try. And then the question becomes back to my earlier point, who should the burden beyond? And should it be on the infringer to say, by clear and convincing evidence, it wouldn't be routine? It wouldn't be routine, it would it would be predictable or wouldn't be versus simply saying it's abroad claim you shouldn't get a patent on that.


Bruce Wexler  11:43  

Okay, so if I mean, I'm going to ask him his questions, because I want to take what Josh said, which I understand was that in a functional claim, step one is to figure out what's the breadth of the structure that corresponds to the function step two, is to look at that and compare it to the disclosure, I get that the law that corresponds to that process is also being used to generate sort of broad claims scope, asking the question of what is covered by the claim, in general. And for virtually every claim I because it's happening in terms of treatments in terms of ranges in terms of words that have functional connotation, like cheer, or what have you. It's happening out there and it it goes hand in hand with this full scope test. Because if you have a test that says, I'm going to figure out the full scope, and then ask compare that to this disclosure, that same test will be used to look at the literal full scope, regardless of the kind of claim. So the question now is, is there a sort of more granular test for a functional claim? Where Step one is to simply look at what is the structure that corresponds to the function? And then look at full scope corresponding to that? And is that a viable path forward to avoid the problem? The other problem, which is everybody just taking a claim, saying it's giant and you haven't enabled every possible embodiment? Amy, what do you think?


Amy Nelson  13:13  

If I, if I understand your question, I mean, I think there's certainly opportunities in in most of these technologies to put structure into your claim and to get a reasonable scope. So you know, even with the even with the NW claims issue in in Amgen and Sanofi their earlier claims, actually claimed the cdr and those, they just claimed the CDRs. And anything else could be anything. So when in fact, they already were had some scope to them. And so, you know, antibodies are a little trickier, because they're more unpredictable than probably anything else in the life sciences. But I think routinely, in most of the life sciences, there's a way to claim structure and claim it with some sort of breath to combine structure and function, whether it's like, and to account for those sort of fungible changes that can be made, and not go so far as to include the things that are actually very different that perform the same function. So I mean, I think in most it's worked pretty well. I think in like nucleic acid molecules, for example, you have a consensus sequence, you can claim that you can claim things with that consensus sequence, that's the important conserved region that does the work and performs the function and you can get things that have that consensus sequence and so you get some breath. Antibodies are a little trickier, but I think there might even be ways to get some sort of scope within like the CDRs, which are obviously the part of the molecule that's important. Yeah, they just


Speaker 5  14:38  

I know this, this whole notion of two bodies of law, one for antibodies, or whatever you call them large molecules or biologics and another body of law for everything else. It just, it doesn't resonate with me. I mean, the we litigated Juno and identical Some in exactly the same way because the law was the same. And there isn't a separate body of law for biologics. And you know, one lesson that I heard from the Supreme Court from the Amgen argument, which is I think, a useful point here is, you know, if there's going if one is going to propose a different test for large molecules or for biologics, precisely because they are so unpredictable, and it's the unpredictability that makes them fail the test. That's that's the job for Congress, not for not for the Federal Circuit or the Supreme Court. And I just I don't get why the same exact sentence with the same exact criteria would apply differently to one category of inventions.


Henry Hadad  15:52  

I don't think anyone's saying there should be two different bodies of law. I'm certainly saying the law should be applied. And if law is the law, then we should look at things and Josh even mentioned it as to predictability are things routine, what is the relevant level of skill in the art, we shouldn't truncate that analysis just by saying the claim is broad, therefore, it lacks enablement, or prove to me why it's enabled, it should be the rigorous application of wands


Bruce Wexler  16:19  

is part of the problem. I was thinking about this, as we were hearing discussion earlier today, part of the issue that in the mechanical space, the words that are being used are often functional in nature, a lever, a cloche, these are, these are structures, but they have function sort of built into them to tell you what they are. In the chemical Arts where you have a compound, there's very little room when you specify a compound for that sort of functional play. So that's why I think you use geniuses, because you have a list of all the different chemical structures, if I say, three carbons and two oxygens, I mean, there's not really much function around that. So in the chemical arts, you go out to geniuses or lists of compounds to sort of broaden out your area around the concepts of function in biotechnology, you could do it with homology, or this or that, but the more common way to do it is really about the biological function, which is driving the larger sense of what's happening. So to Josh's point, is it not that there's different bodies of law, but that the subject matter itself is often being described in different ways? Henry, I agree. Okay, Josh, what do you think about that, that this is really an artifact of the nature of what you have to do to get protection beyond just the actual specific form?


Speaker 5  17:45  

So? I'm not sure because I Well, I'm not sure I understand the question. So let me let me give my answer. And then you can tell me if I'm answering the question started, let me give you the answer. And you can tell me whether I'm answering your question. It is certainly true in the chemical realm, that one can provide a structure with all sorts of variables. And that may or may not present written description problems. I've got a case right now where there's no functional claiming, but there's a written description challenge. And I've been so accustomed to litigating cases in the functional realm, that I'm not even sure I understand how 112 works in that in this particular realm, because you can literally identify everything that is claimed to work. And in fact, in that case, everything that you put at the X, Y, Z variables does perform the function for which the compound was created. So that happens, they're also in smaller molecules, functional claims that are that don't just that aren't described by variables, they just say, in this variable, you will do something that works. And I think that's what the antibody claims do. That's what the claims did. In identical acts. It's I think it's when what you're doing is attaching a function, but you haven't figured out what in the world actually performs that function. That's why I struggle with your question. If it's like, you could put a halogen here, but if not, maybe it's a hydrogen on an organic molecule. I don't think that there's a big problem. Yes, it performs a function, but it's it's pretty notable what substituents would satisfy that. In in the cases in which the Federal Circuit has overridden the jury. That's not what's going on. You they I mean, they've the inventor literally has no idea what is actually going to satisfy the function and if they did, they would have written it down and claimed it.


Bruce Wexler  19:58  

So let me go back in History again, the slide in re Swinehart 1971. This is the case where the CCPA, the predecessor, the Federal Circuit wrestled with this very question. Ought there be functional claims? And they came out on the side that there should be that there's nothing per se wrong with defining something by what it does rather than what it is. But what's fascinating about this case, was that they recognized step one was, as a matter of claim drafting in principle, the law allows for a functional claim that was a debate, should they be functional claims you have means plus function, you know, the should the law does the law that it 52 Act allow for functional claims? The answer is yes. But they said it can raise two big problems potentially. One is indefiniteness, and one is enablement. That's right there in Swinehart. And they said, there's basically two problems two ways these claims can go down. And indefiniteness and that case wasn't that big a deal, because they kind of had a good sense of what was meant by the function, but enablement, was the one they really talked about. And they said, the claim is so broad that it causes the claim to have a potential scope of protection. Beyond that, which is justified by the specification disclosure, legitimate concern often probably exist, therefore, whether the scope of protection defined thereby is warranted by the scope of enablement indicated and provided by the description contained in the spec that sounds very familiar. So in allowing for these functional claims, they noted the fear that I think Josh and everybody's been talking about, so it does seem like there's something to functional claims. And in that case, they went on to actually analyze how broad is this function based on the number of structures and kinds of structures that are within the function? But so so is are we at the place now, where we're revisiting Swinehart, where we're where people are arguing, you know, what the patent law has means plus function. And you could say, a means to accomplish a function, you can have multiple functions to Amy's point, you can have a function that, but you need some structure, are we at the point now, we're defining a claim by what it does, should be rejected? Sure.


Henry Hadad  22:23  

I'd like to go back to sort of principles of why we are even having this discussion in the first place. So I'm not gonna get it yesterday, you're gonna get a yes, but it may take a bit. We want to encourage innovation and cutting edge pioneering innovation. Quite often, when you're talking about those very early discoveries, Bruce, you're talking about research institutions, small business, small companies, occasionally larger companies like Bristol Myers Squibb. And you also want them to publish on that, right? So if we tell them that you can't get a patent, which isn't easily designed around? What do they do? Do they just publish? Well, maybe they will, maybe they won't. But a lot of them really rely on licensing income to fund their r&d. So what is one to do? Perhaps you hold on to it for a while? Well, another possibility is you just start making routine examples. Let's just generate examples. I think Jonathan's example, you come up with a novel steering wheel, let's say that's some medical innovation, but let's call a steering wheel. And you claimed it as part of a car. And you, you had a Chevy around? Do you have to actually then put it in a Cadillac or in a Mazda Rottie? Or in a Hyundai to protect those things? Or can you just say a car, once you put it in the Chevy? What are we encouraging research institutions to do to sit there doing rote experimentation? Are you saying go find an IQ score for cancer? So when I think about the danger of saying that some type of functional leeway is not going to be permissible, and that we're not going to look at the level of skill in the art, we're not going to look at what was routine and conventional, or maybe it wasn't routine and conventional, but at the very least it should be fully investigated on the record. And the appropriate burden of proof should be applied. And maybe a patent is is deserved, or maybe it isn't, but it shouldn't be you have a broad claim, maybe you won the Nobel Prize, but you're not going to get a patent.


Bruce Wexler  24:36  

So functional, claiming Should we go the other way? And Swinehart


Unknown Speaker  24:41  

I have an answer, but they really want to


Amy Nelson  24:43  

Well, I mean, I think functional claiming is is appropriate when you know in the in the right circumstance. And so when they're when you have disclosed enough examples that you've really covered the field that I think it's probably it's, it should be absolutely fine. I query two, when we talk about pioneering inventions, what is a pioneering invention? Because science occurs incrementally. And a lot of times, the next logical leap is pretty clear to multiple people in the industry. And they're all trying to do it. And I think just because you're the first one to get the patent office doesn't mean, you're really a pioneer. But But that said, I think, you know, and oftentimes, you come in with a disclosure, that's not all that robust either. So if your disclosure doesn't, doesn't match with, you know, the breadth of the function, then I think that that's a problem.


Speaker 5  25:37  

So, so, two pieces, one, one is the answer on Swinehart. And then this innovation theme, which Henry and I have made a cottage industry out of debating. I have no problem with functional claiming, I don't think the Federal Circuit has a problem with functional claiming, in fact, I think functional claiming is, is as a practical matter quite necessary. There are constraints, what you what you claim has to be, you know, definite, it's got to be sufficiently described and enabled, it's got to satisfy the other patentability requirements. And I think of 112. This is what I think Swinehart is saying 112 in those other doctrines, but 112 in particular, is a really important constraint on overreach and it goes back to the point I was making earlier about, claim what you invented, but don't claim more than then, then you get a patent on what you invented. But you don't get a patent on anything broader. Henry, and I've debated innovation quite a bit in and I see the Federal Circuit's 112 jurisprudence as being motivated very much by your desire to encourage innovation, I think the cases are rewarding innovation. It also worries that patents are claiming too broadly. And that inhibits innovation. I mean, I think in this context, where the Federal Circuit is saying is really what I was saying, you say you invented something great, tell us what you invented, and you get a claim on that. And I think the Juno case is a really great example of how overclaiming has its own dangers to inhibiting innovation. I mean, think about what the inventors did in June Oh, Judge Moore set it from the bench, oh, my goodness, this invention cured cancer. And you're saying that you had what was essentially a blocking patent on it. The inventors had these were they was recalled cars. As Jonathan pointed out, the inventors had literally two species of things that could plug in. And it was the thing that performed that mean, that actually performed the function. But they taught the public nothing at all about them. And on that basis, they claimed a monopoly on every single car that would fit on that backbone. Now, meanwhile, they were never able to bring a therapy to market using the structure that they invented. Sloan Kettering couldn't do it. Juno couldn't do it, only kite did it. And in a world where you can claim everything, and people are making smart decisions about what to invest in. And those smart decisions can be completely scuttled by a blocking pattern. That invention would never have been brought about.


Henry Hadad  28:44  

Yes, you had to bring up June if he kite. You know, it's a sore subject. Josh, I wanted that this to be the discussion about the Supreme Court. And I know we I didn't realize that I you know, that's it's a funny case, right? Because here is a patent, where, let's say there's three components of the car. The first two were the sort of the invent of pieces, right? They were the points of novelty. The third piece was the binding element. The binding element was actually in the public domain, that concept of binding elements, making those binding elements creating those binding elements was already out there. We didn't invent it. I mean, Sloan Kettering did it wasn't our invention. So, you know, where was the robust discussion of how much information in the patent versus how much would be within the level of skill in the art and the knowledge? Yes, there might have been only a couple of examples, but again, are we going to ask Sloan Kettering scientists to go out and keep on making new binding elements? Are we going to ask them to keep on trying to cure cancer? Right, and what is wrong with saying to a fast follower, a copyist a willful infringer, in this case? Pay your fair share? We're not going to join you clearly because there's no competing product on the market. In fact, in the medical arts like this, innovators rarely see conjunction It's but pay your fair share. You know, I that will inspire Sloan Kettering to do more work because then they get revenue back.


Speaker 5  30:08  

So I don't know how this goes to this question about pioneering inventions that that I imagined we'll get to so in you raise the topic it's just another aspect of this debate that that I've never really understood. In no other area of patent law, do you get to say I discovered a target. And now I'm now going to claim anything that binds to the target without regard to what disease is being cured. And what's being proposed is just a is the big because it's supposedly so routine to do. And by the way, it took 18 years for anyone to figure out how to do it with Sloan Kettering this pattern. Because it's supposedly so routine, we're now going to make an exception for antibodies. You know, that's what was discovered, you know, the this target and something that binds to the target or in these antibody conversations that we're going to have just the target itself. That's, that's a law of nature. I mean, that's, that's a discovery. That's not something for which you get a patent. And I'll just, I, my, my dad was a cancer research scientist, he trained at Sloan Kettering, he was driven by the desire to identify targets and figure out what binds to them. And he wasn't doing it for the money, the basic research is going to get done in the patent rewards loose, who actually found the the particular species that work, not those who found the mechanism by which it works.


Bruce Wexler  32:01  

So So let me ask this, then let me pose a hypothetical. Suppose you know, we see what's going on now with Alzheimer's in the debate about antibodies targeting plaque to reduce the plaque to help with Alzheimer's. Suppose, hypothetically, someone discovered the cascade that actually led to Alzheimer's in some part of the brain, or even another part of the body, they unlocked this thing that no one can fully understand. They unlocked it, and all you have to do is inhibit that that enzyme or whatever it is, and you will cure Alzheimer's, right. And now that was incredibly hard, as we know, and does in this is Henry's sort of hypothetical, designing an antibody requires that it targets that. And you can teach how to do that. But all the different permutations of the bottom part of the antibody, whatever it is, people can routinely create those. So what I want as my invention is the antibody that has the thing that matches the big discovery I made that will then cure Alzheimer's. So my effect is curing Alzheimer's, we're not talking about just targeting treatment, we're actually a treatment. We're talking about a discovery of how to do it. And we've given the key structure that achieves that. But recognizing we're defining it functionally. Now, under Swinehart, you may say, Well, let's look at all the structures that accomplish that and Henry saying, let's just figure out how routine it is to get there. But I think what Amy and others have said as well. But that's just a lot, a lot of things. And you haven't actually elucidated all the different things, right. So in that hypothetical AMI, is that okay? To claim any antibody, let's say that targets this particular enzyme and cures all time, you know, if


Amy Nelson  33:51  

all antibodies were fungible, and they all worked exactly the same way. And they all did the exact same thing that might be. But the reality is they aren't I mean, and that's what we've learned with antibody Therapeutics is they aren't like all. So you're taking on


Bruce Wexler  34:07  

Henry's sort of point that it's routine to just make a whole slew of different antibodies that all do it by set by saying just as matter of science, it's not true that there's lots and lots of ways that it won't work.


Amy Nelson  34:17  

I think we've seen that in cases like that, that enemies don't all come out the same. They don't all work. They all worked. And so


Bruce Wexler  34:23  

then that goes to Juan's and undue experimentation. And we're back to sort of a well


Amy Nelson  34:26  

and so and and also, I think, like, when you're starting to claim something where you've basically taught, you're basically following basic research methods to get to your whatever it is you disclose, and then you're telling others to go back. And what you're telling them to do is go back and basically do what you just did. That doesn't seem like really providing much of a disclosure that's assisting anybody else that doesn't seem like you're doing your quid pro quo because it's allowing you to basically vote in somebody else's go back and do more experimentation just like you did to get more. Unlike for example, if you disclose this once for the antibody, someone can like take that they have a shortcut they can make that they can make that with recombinant DNA, recombinant DNA techniques, and they can get it, you know, instantly. So I guess there's there's that I think plays into so that the fact of like, yes, we can say, oh, it's routine, but it's a lot of experimentation, and we're basically doing what you just did,


Bruce Wexler  35:21  

can I just go to Josh, because you're, I think you're gonna support, I want to just stay on the counter side from the extract. So assuming it is very, you know, there is some experimentation, and there are things that fail. And as a matter of science, if I'm the inventor of this, and I want real patent protection for this pioneering, I mean, it is pioneering discovery. If I just claim the structure of that antibody, even though there were things that may not work, there's still a lot of different things that will do the same thing, right? So how do I invest? How do I protect the investment to go along with bringing this thing to market, when someone can just change the antibody to a different one and not infringe on my patent Josh?


Speaker 5  36:07  

Similarly, I just want to make sure I understand the hypothetical you've, you've discovered a target, or you discovered a target and a really robust structure, the vast majority of appendages to which will work.


Bruce Wexler  36:22  

So I will concede, I made up this hypothetical as we were thinking about today's discussion, but I will try to do my best to further give more facts. So you have discovered a target that unlocks the key to Alzheimer's disease, like for example, we saw with the plaques and how they're trying to take out the plaques, but there's a lot of debate whether that actually is curing the disease, right? That's a lot of issues. But imagine that hypothetical where you come up with something not that clear with the plaques, and it unlocks the disease. So so you get the target, and then making an antibody is not that hard to target it. And yes, there are some antibodies, that won't work. But there's a lot that would, right. And so if I claim the particular antibody I made, right, I'm going to people are going to design around, if I claim five antibodies, they'll design around. So the way to have my investment towards this incredible discovery is really I need something broader. And I've been there when people have asked me about antibody


Speaker 5  37:23  

matches. So light, my answer is you've used the word discovery in your hypothetical five times. Patent law does not reward discoveries of basic scientific principles, what you've just described, is a natural process that has the s has been discovered. And it took a lot of work to discover. But that's not what patent law rewards. Patent Law rewards the thing that was invented. If you invent neck, if you invented an antibody, and it took just a few days, because just about any technique of developing an antibody would work now that you found the target, then you can claim that antibody and I think it would be interesting to ask whether, you know, someone then reverse engineers, the antibody, and changes whatever it is a few nucleotides or amino acids in the antibody and in, in maybe there's a doctrine of equivalents argument, which I think Swinehart also refers to, by but if all you've done is made the basic discovery, which will then take other people decades to figure out exactly what what antibody,


Bruce Wexler  38:42  

medical, you create an antibody, it works, okay, but you just don't want to limit your claim to that antibody because someone else can just make another antibody. And your investment goes to crap. Excuse me.


Speaker 5  38:52  

Yeah. Yeah, no, I think I mean, in the investment is, it took you no time at all to create that antibody. Now you're bringing an antibody to market? Right? Yeah. I think I think patent law does not reward the, you know, the invention of the antibody beyond that antibody itself. And your protection is getting to market first making the the best possible one, because in then it'll work the better than anything else, and potentially doctrine of equivalents.


Bruce Wexler  39:26  

Well, what about 35 USC 103, patentability shall not be negated by the manner in which the invention was made. Right. And you're not dealing with the


Speaker 5  39:35  

manner in which the invention was very, you're talking about a different dimension.


Bruce Wexler  39:39  

Henry Ford ended up you know, first off,


Henry Hadad  39:41  

I want to say I agree with largely what Amy had to say in his much that if it's not easy to make the antibody if there are real obstacles to making the antibody, then by all means, that should be on the record, and that should be shown why it doesn't meet 112. What we're talking about here is just the full Hold on negation of that inquiry because the claim is quite broad. And we don't need even need to show evidence to that degree. Now, to your hypothetical, to your hypothetical, that is one of the potentially the most game changing innovations in the world, right? Even back in 1988, in the Hypertech, the monoclonal they said, you can actually get an antibody if you identify a novel target. I know that's been modified since then. Right. But the point is, is I agree, Bruce, that if you limit them to the specific antibody, people are not going to license it, right. They're just going to say, Ah, thank you very much. I will take your novel target, and that one antibody that you made, I will avoid it. And I will just generate any one of a number of other functional antibodies. And Josh also talked about if it takes decades to do, it may take decades, or it may take a day. But we need to actually fully explore that on the record to see if it's fully enabled or not. It would be my view.


Bruce Wexler  40:57  

And, Amy, would that be would you have a problem showing non obviousness if the fact that I discovered this amazing problem, make a solution to it, but the actual process of making the solution is not hard. Would you face an obviousness problem, then? Because how do you defend the complexity of making the antibody? If that's all you get to talk about?


Amy Nelson  41:19  

I don't think he would have an obviousness problem. I mean,


Bruce Wexler  41:23  

so then we need the problem that we solve, doesn't that take us back to square one, which is not be part of the event?


Amy Nelson  41:29  

I mean, I think I should say, maybe it's a combination of both. I mean, I think there's, you know, I think there's probably depending on how broadly you claim. Yeah, if it's just brought the claiming, inhibiting this this target, then maybe there's an obviousness problem. But on the other hand, if you're if you're claiming to get the narrow you're playing becomes and I think you'll get away from obviousness, you may face 112. I mean, I think the two works pretty nicely together to sort of get you to the appropriate scope.


Speaker 5  41:58  

Yeah, maybe maybe I'm misunderstanding the hypothetical. And I know it's been it's been on the move, but if has it? Yeah, no, more and more facts of him. So I'm not a Supreme Court justice. So I've just got you understand the stuff better. He's doing what he would do, if I wasn't, but So if what you discovered was this target, you then overnight, find an antibody that binds to it, you can get certainly get a patent on that antibody. If it's then sequenced in somebody's eye. So somebody sequences it and then does a minor tweak that doesn't change the structure, then I think you've got an easy DLP issue. If what has happened is someone has taken that basic fundamental discovery of a law of nature, and found completely separately developed another antibody that also took them 24 hours. Yeah, right. I don't think your patent blocks that totally separate antibody, which presumably has a completely different structure,


Bruce Wexler  43:06  

I guess I'm more asking about incentive to innovate. In other words, if you if you are limited to the form, and we know that it's easy to make alternatives, then there's very little incentive to do the investment to bring it to market. If you can go broader, you may have a patent problem. Right. And so and the reason I'm asking this is because these are real hypotheticals not on, not on, not on this. But I have been confronted with hypotheticals as more of a litigator, but by people who are looking to build portfolios, who said to me, what do I do here? Like, how do I, how can I get a patent? That's going to help me with what I want to do? If I can't get the functional antibody, but I get the specific structure? And then that's going to be useless? What's the answer? And I'm just wondering if the Supreme Court's Amgen case or all of it is going to impact that in any way?


Unknown Speaker  43:59  

Amgen definitely won't.


Amy Nelson  44:02  

I mean, I think you can get a functional antibody if until somebody shows you that you really have an invent, you haven't invented like the best, or there's others out there that are much different, or, you know, and then then you're probably be stuck. So like I said, I think you might be able to, assuming you show enough disclosure, and enough maybe examples, I think you might you might be able to like walk out of the patent office with a claim a functional claim. But you know, if you get into the world, and you find other other, you know, competitors who have developed something that's very different and happens to fall within your claim, are much better, or somehow works operates differently than I think. I think that then then it shows that maybe you didn't you hadn't disclosed that your kids pleasure wasn't.


Bruce Wexler  44:46  

I've seen attempts to use the function to define in other words, someone says this is the function and it works. And someone says, Well, that's an example of something that doesn't work. And the counter is well, but that doesn't meet the claim. It's not within the scope. because it doesn't work is that and that's sort of been rejected as an argument, because the scope is the scope and you can't circumscribe the function by saying it's only that which works, it sort of begs the question of finding what doesn't work. What do you think about that? Should that be revisited? Should that be? Should you be allowed to try to narrow the scope by pointing to what the function is, and using that, to argue it's limited to things that work?


Speaker 5  45:26  

I'm puzzled by your, by your choice of words, narrowing the scope, the function narrows the scope, right? Right. So you do you've defined your claim in a way, that narrows it to things that work.


Bruce Wexler  45:39  

So that means you have a small group of things that work so your full scope of the claim is now narrow. And when people point to things that don't work, to show that there's a breadth of unpredictability, you can discount those and say, well, but they're not within my claim.


Speaker 5  45:54  

No, you can't under 112 law, you can't discount those because those go to the unpredictability, and and the mismatch between the structure and the huge universe of things that satisfy the structure, and the tiny needles in the haystack. So the


Bruce Wexler  46:13  

answer is that you have this small scope that works. There's a large universe, that doesn't work. And you have to figure out from that what gets you to the finish?


Speaker 5  46:19  

And sometimes you can I mean, Europe is a great example. I mean, it's a it's a chemical structure, it was it was hugely studied, they had whatever it was a hundreds of species that they described, and they could they could find a functional, I think it was, yeah, it was defined functionally.


Henry Hadad  46:38  

In there. My brother in law has a farm in Virginia. And you wouldn't want to claim it, as you know, it has a house on it, and it has rocks, and it has a lake like the a pond and, you know, road, but there's also area of pasture. Right, you should be able to say, a 20 acre farm or a 25 acre farm, without having to say except for the road, except for the pond, because people skilled in the art would know there's going to be structures on on the land. So again, it comes down to those skilled in the art saying, I know kind of what neighborhood I should be in. I should be in the northeast, I shouldn't be in San Diego.


Bruce Wexler  47:17  

And we're running close to one, I want to take some questions. But as our last question, maybe before I open up to the floor. Do you feel that there's a trend now to a shift towards, you know, we saw the debate in the law between the philosophy that we saw, you know, that there's an invention that exists apart from the patent? And we're going to give room to that invention? Versus we're going to very be very strict to what's claimed? And we're going to be very focused on that. And that's been a debate in the patent law. Do you think there's any sort of pendulum movement? Do you feel that all the different doctrines of patent law are showing a dramatic swing one way or the other? Or is it just a swing? And I just, if we could just go down the line and get your sense on that. And I'll open it up to questions.


Henry Hadad  48:00  

Going to start? Sure. Okay. So since I started practicing a bunch of your students, I think, right, just in case you wonder whether this is relevant to your practice. The wants case we've been discussing came out during my first year in law school, I was still talking about it. So


Unknown Speaker  48:17  

that was like six years ago.


Henry Hadad  48:22  

Late started. So I think there's definitely been a shift toward a more strict and draconian application of 112. I think when I started out, Gentry gallery, route shag, there was a gatekeeping function of written description, which was you invented this, when you filed the case, you shouldn't try to change it into something else. 10 years down the road by continuation practice. That's what description was about. Since then, in our yard and regions case, it kind of morphed into sort of super enablement. But that's a discussion for another day. At the same time, enablement was kind of languishing for a while, right, it kind of gets people spending time in written description, but in the last maybe eight to 10 years, enablement has now taken on this whole new, robust application. And now with the Supreme Court, you know, based on the oral argument, it seems like more likely than not, either things won't change, or they may change mod modestly. Maybe there'll be some recognition that the cumulative effort of the full scope isn't really it's about the effort of indeed, each individual embodiment, which seems like some of the justices were focusing on, but you have this tightening constraint on 112, while at the same time 103 and 102 are still there. Right? So in the old world, the more the more advanced the technology, the more likely you're gonna get a prior art issue, but the less likely you're going to get 112. Now, even as the technology advances, you're still gonna have 112 issues, but you still have priority issues at the same time. I feel like it's putting are innovators in a difficult position? And I think I doubt the pendulum will swing back in the near term.


Amy Nelson  50:08  

Anyway. Um, yeah, I mean, I think Lilly, Lilly did change the law, I guess in terms of written description. I do think that the reason why wands, or at least how I can reconcile ones and with the later cases is that we moved into the area of antibody therapeutics, which is like a completely brand new field. And I think the court recognize that it needed to exercise some caution in that field, that it was very, you know, unpredictable. And they were seeing competitors getting kind of different, different different results. I also think that we'll we'll see what happens with with the, with the Supreme Court here, but it could have been a positive effect, maybe on one one on one jurisprudence, because there's been a lot of there's been a lot of stress petitions have gone to the to the Supreme Court saying, look, the Federal Circuit's conflict in one on one with 112. And I think the Supreme Court's a little bit a little reluctant to trust, I guess, you know, the the Federal Circuit and the courts to enforce 112. But maybe if it thinks oh, they really are enforcing 112. It's possible, they could let you know, lighten up a little on one on one. So I think we could get some benefit there. But yeah, I mean, I I'm not sure that I think the science has changed. And I'm not sure I see as much of a big change, as maybe Henry does. But you know, I think it's just the sciences. They are the Court has recognized how unpredictable some of these arts are, and the amount of experimentations required, and it's decided that, you know, there's been overreach by some of the patent owners.


Speaker 5  51:44  

It's a I think, all so many of these doctrines really revolve around the set of questions that you've been asking, you know, the quid pro quo point and the match between what you invented and what you've claimed. I agree with Henry 112 law has definitely expanded. I mean, I just, I think about some of the quote unquote, pioneering patents like Kabili. I just I don't think would survive under current doctrine. And I agree with Amy, that there are other doctrines that have this one contract, it might be used.


Bruce Wexler  52:25  

Anyway, questions? Yeah, Brendon?


Speaker 6  52:29  

Well, first of all, what a great panel. And thanks, everybody. The first panel was great. And this one, it's really hard to say they were just great. And, and there's been a lot of time this conundrum of functional planning. And, you know, I'm thinking of the client that comes in the door and say, come back to the hedge stack and say, Well, you want to hop on a needle? Or do you want a patent on on a haystack, and they're all gonna stay, say, you know, on the haystack, and so we tell them that the, the, you can claim up as broadly as you can to the prior art, you can claim it all the way up to the prior art. And and then you have to enable it, you have to enable everything that you claim, and they say that everybody comes back and says the same thing. You know, let's say it's a device, they say, well, the device pulls the suture through this particular tunnel, no one's no one's no one's done that operation before. I wanted device for poor pulling the suture for the tunnel. And the story or in your case, I want the I want the antibody I want anything that binds to that anybody? No one's done it before. I'm up, but, uh, you know, and so. And you say that, so like, I tell him, Well, you gotta enable the full scope you mentioned, but it's an only one. So that's, I guess the question. I mean, what do you tell people to say, if they say I invented this function? And I want the whole scope of this claim? And everyone's saying, No, it's got to match. It's got to match. It's got to match according to what you enable. What is the debt is it only wants? Is there some, you know? Yeah, it's much to my chagrin, I'm most still dealing with needles, you know, like, with these guys, you know, I feel like the money is in the haystack after the fact, you know, but I'm just wondering what what sort of, if this test other than one's from for exactly that for matching the scope of enablement, before the fat to the


Henry Hadad  54:33  

I'll give it give it a try. First off, in a few months, we'll probably be called now the Amgen test. But we'll see. We'll see. If I was counseling, let's say research institutions reason why a bunch of research institutions filed amicus briefs in this case and the general case they're, they're concerned about this as well. You would you would have to say to them, you came up with something which was groundbreaking. You've made one or to actual embodiments, which, you know, let's say an antibody that blocks and neutralizes, go back in and make a whole bunch more, and then cross your fingers that in 15 years when this is litigated, the standard hasn't moved even further away from where you are, that's the best. And then maybe we'll get that licensing revenue want early because somebody like me will say, it's worth a gamble, let's license it. Or maybe I'll just litigate it instead. Because I think maybe the one to 112 will win the day. So it's a bit of a tough spot for these innovators, I think.


Unknown Speaker  55:35  

But But I think that, oh, sorry. I mean, you know, I'm finished. And then it was,


Amy Nelson  55:38  

well, I was just gonna say, um, you know, I think Amgen to some extent, was trying to do that, like, by sequencing a whole bunch of them to sort of, you know, I really think they really only had a couple that they worked hard with figuring out the crystal structure, we really got to, you know, tested and found out that they worked in humans. But But the other thing I was gonna say, you know, the, some of the other companies on the other side provided an amicus briefs where they were talking about the importance of having multiple, multiple companies working in the industry, and because they potentially you get better, you better molecules, because it's just so unpredictable. They're different indications that they might have. And I think there was one other thing that they talked about, but any event, like there's a huge benefit to our because patient populations are different. And so there is like some benefit to having multiple companies working in, in a field like, you know, antibody therapeutics, just because of, you know, there's a lot of opportunity, but there's also a lot of disappointments. And even one of I think it was one of the companies Pfizer, I think they there's, you know, when it's clinical trials, and was a complete disaster. So, you know, just having one company with all the rights might not be the best result in terms of like helping, you know, innovation.


Unknown Speaker  56:58  

Yeah, that's the hope.


Announcer  57:01  

Sorry. Okay. That's it. Yeah. So


Speaker 5  57:05  

that's the point I was alluding to on the other side of innovation, making sure that there's the room for others to go ahead and invest without feeling like the profits will either either they'll be blocked or the profits will be siphoned off, but I do I have a few drafting tips for your for your friend or client, the inventor that would match that least help match to the 112 jurisprudence. First is try to try to identify as many working examples as possible. Second, is considered starting out narrow and then broadening I get the sense that most scientists like your hypothetical friend starts out broad and then never gets to the narrow talk to him about what other devices or compounds are next on the drawing board for them to be designing and why and then explain the patent why you how you think this works and and why it works. Because that is an important indication of your of the inventor sense of the predictability. And then during prosecution, just keep checking in with your scientists about where they are headed.


Bruce Wexler  58:22  

Okay, well, we're out of time. Thank you. Thank you, everybody, for attention. Thank you to the panel. And thank you to NYU. Thanks so much.


Announcer  58:38  

The Engelberg Center Live! podcast is a production of the Engelberg Center on Innovation, Law and Policy at NYU Law and is released under a Creative Commons Attribution 4.0 International license. Our theme music is by Jessica Batke and is licensed under a Creative Commons Attribution 4.0 International license