This episode is the Guiding Principles Going Forward panel from the Engelberg Center's Disclosure Under Section 112 in Policy and Practice event. It was recorded on April 19, 2023.
Scott Hemphill (Moderator), New York University School of Law and Engelberg Center on Innovation Law & Policy
Paul R. Gugliuzza, Temple University Beasley School of Law
Nathan Kelley, Perkins Coie
Erin Mehta, Northrop Grumman
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 the Guiding Principles Going Forward panel from the Engelberg Center's Disclosure Under Section 112 in Policy and Practice event. It was recorded on April 19 2023.
Scott Hemphill 0:26
Great, so thanks for sticking with us. Please forgive my voice. As Michael mentioned, the purpose of this panel is kind of a mix of taking stock of what we've heard today. And, you know, looking forward to the future. You know, we've put down a bunch of markers today. Starting with the kind of philosophical fight or dialogue between what was invented and what's in the claims, we had terrific lunch panel about Amgen that had both the kind of 15,000 foot view and also got into I think a lot of the interesting weeds. We talked about how this plays out in life sciences and in tech. Fortunately, we have a first rate panel to help make sense of what I frankly, ces kind of a morass and 112. To my right, Erin mana is senior IP counsel at Northrop Grumman. Before that she managed Hulu's patent litigation and prosecution and negotiated deals before going in house she worked at Wilmer Hale, and I guess we say ropes and gray now formerly efficient nave to her right, Nate Kelly is a partner at Perkins Kui where his practice focuses on patent law, as one might well expect and IP more generally, he entered private practice after a long and distinguished career at the PTO work that included service as the PTO is Chief Administrative patent judge, wherein he led the P tab. So he's argued dozens of Federal Circuit appeals among other things to his right, Paula, good, good. I'm sorry. I'm a good glue. G school use dough soft g. No, no. Professor at Temple University, Beasley, I can say Beasley School of Law, we writes and teaches about patent litigation and other IP issues. Federal Court civil procedure, some of his most recent work includes an empirical examination of the significance of patent law cases at the Supreme Court, to what degree is it right to think of the Supreme Court as sort of sternly saying to the Federal Circuit, you got to fix it, you screwed up again? And to what extent is it really engaged in a lot of substantive deference to what the Federal Circuit is doing? And I think the answer is a bit of a bit of both. Maybe we'll hopefully get to that. Where I'd like to start, and maybe I can start with you, Aaron, we, you know, what's sort of the most, what did you take away from what we've seen today was, yep, I mean, it can be more than one thing, if you want, but kind of an important takeaway in terms of what we've heard so far. And I'm going to go down the row after you.
Erin Mehta 3:09
Sure. So I think today, you know, just sort of hearing folks suss out the law, both for Life Sciences and tech. And especially, I think some of Isabella's comments earlier, about, you know, the Small Business and the research and folks that really, maybe don't have the best counsel or don't have the sophisticated in house counsel have how important sort of the guidance that we're looking for, you know, not just for Amgen, but from the PTO, on prosecuting strong patents, I think we want to have strong patents. You know, as companies, I think companies are now looking at the bottom line, and is it important, and can we justify the expense of licensing branch and our company, you know, as as the jobs are being cut in tech, for example. And so I think, you know, both from patentability standpoint, as well as on the litigation side, from an in house perspective, predictability is always paramount, because the more you know, the more efficient things are, the less things cost, and of course, law changes. And in the patent, the life of a patent is so long, you don't know where the law is headed. But to the extent there are some there's some guidance, both in the legal and and from the PTO that is going to ultimately drive decisions internally, which will justify business expense and legal expense and be more efficient. So at the end of the day, and I was I was sort of reflecting on this today, sitting here, you know, on campus, you're always go back in time to your legal career before you're a practitioner, but you spent a lot of time in law school thinking about what the law should be when you become you know, I worked for an hour for a law firm for many years. You think a lot about what the law should be, but how are we applying it and advocating but then when you go in house, it's it's what is the law so that we can plan accordingly. So I think, you know, predictability for me is a big takeaway of where we're hoping the Supreme Court might lead us. And then the trickle down effects from there.
Scott Hemphill 5:06
Okay, great. And I, my hope is that we'll have a little bit of positive and a little bit of normative here as buffets being you know, in an academic institution, as we get into this date. Well, what about you?
Nathan Kelley 5:18
Thanks. So my takeaway is that this is just so complicated. You know, I was sitting there in the back and noticing some of the law students who I think have all wisely left the room, or most of them maybe, and I thought, boy, people are throwing around words like means plus function. And, you know, what a Dave say, oh, a single means claim. I mean, there's a there's a footnote in patent law knowledge, a single means claim. And it's just so complicated, because like, we heard that the advocates at Amgen were not able to succinctly explain what the invention is, I don't know if they didn't know, or maybe they didn't know how best to say it at that moment. But coming up with a solution is difficult, just because the science is hard. The law is hard. But there's another hard thing that Aaron just referred to, which is the time period between invention, drafting, and enforcement. And many, many years ago, almost exactly the term of a patent go, I was involved in drafting patent applications, a very painful year of my life. And I had left the patent office as an examiner, I started writing patent applications. And it was just so hard to do. And you know, you'd interview the inventors, and you try to come up with with what you wanted to protect. But the truth is, and this goes back to the very first point that was made here today, what's the invention? Is it something the inventor came up with? Or is it something? Or is it the scope of the claim, it can't possibly be the scope of the claim. And the reason is, that's the only thing the inventor had no control over. The inventor didn't even write that claim. And a lot of times, it's the business people that write the claim. And it's the business people who write the claim a decade after the patent application is first filed, in order to go after their competitor. And so we have to, you know, it's this complicated game of chess, where we have to do the science, the law, and figure out how to compress the time from the front to the back. Because when we change the law, when we take the ones factors and tear them up and come up with something else, we've just put a big cloud over a whole bunch of patents. And so we need predictability, we need reliability, we need to know that when we are going to write a patent application in 2010, that in 2030, we're not going to have to start over again, because everything we based our logic on has been blown up.
Paul R. Gugliuzza 7:48
Yeah, so thanks so much, Scott, for moderating the panel and for the engelberg center for inviting us to talk about this topic. I think, you know, for me, I would frame the key takeaways maybe as like three questions, that I sort of understood as permeating the discussion. And then I think allow us to step back a little bit from the specifics of the Amgen case or the biotech industry, etc. And try to hone in on on considerations that will be relevant, regardless of what the Supreme Court does. But section 112 Was this term. And I want to raise these questions, because I would actually, hopefully, maybe we get to the q&a session, have some of our prior panelists weigh in on their thoughts on these issues? One question that seemed to permeate the discussion a lot is, you know, lack of clarity, or maybe some disagreement about what should the overriding policy objective of section 112 Generally, or enablement, the enablement requirements, specifically be? Right? Should it be to, you know, require patentees to delineate the precise boundaries of their claimed rights? Or do we want to require the patentee describe the invention so that as a practical matter, it can be made or you strike, you might say, well, it's a little of both. But then I think the question would be, how do we weigh those different policy objectives right of providing clear notice, versus providing information about how to make or use the invention as a practical matter? Second, I think, you know, 111 theme that I heard in the discussion was questions about how does section 112 interact with other patent law doctrines, right, it gets almost every panel found it impossible to talk about Section One two element isolation, without referring to issues of patentable subject matter to the extent its controlling claim breath, even non obviousness. To the extent we're talking about how easy or hard it is to make various species of a generic generically claimed invention, it may have implications for obviousness analysis as well. Obviously the other section 112 requirements of written description or indefiniteness, and I think this may have not gotten enough traction, we might spend a little more time on In this panel talking about the doctrine of equivalents, right, to the extent we're going to curtail genius claims or curtail functional claiming maybe require our claims to be more specific, more structural. To what extent are we just sort of kicking the can of the analysis from section 112 and enablement to analysis of infringement under the doctrine of equivalents? And then third sort of time, maybe the last two panels that we've had together? I'm curious, and I've been thinking a lot about what can this life sciences industry or biotech industry, learn from sort of the computers and communication technology industry? To what extent is this, you know, current controversy that we're seeing in biotech, just reflecting some growing pains that have already been dealt with by the computer not dealt with, but, you know, have already affected? The tech industry? Right. And I think there have been a couple of ways that the law has changed a little bit in response to concerns about over breadth in the tech industry. One, the Supreme Court's invigoration of the patent eligible subject matter requirement, and to the efforts of the federal circuit to curtail functional claiming in the Williamson case, you know, so to the extent that the tech industry is sort of further along in this journey of dealing with broad functionally defined claims, is there anything that our tech colleagues can tell our life sciences colleagues about what the Supreme Court or the Federal Circuit or the patent office should or should not do, to the law to address these perceived problems?
Scott Hemphill 11:41
Okay, great. So we have a lot on the table to, to work through, let me sort of start at the, at the top with one of the first things that Aaron, you were talking about this idea of predictability, which Nate also picked up as a virtue? Moving from a kind of report card standpoint, how are we how are we doing? You know, in 112? Do you do you find this suddenly being buffeted one way or another lots of surprises? Do you think we've managed to achieve predictability? More or less, you know, what, what would we need in order to better serve that particular? He's not the only goal, but it's an important goal, or goal.
Erin Mehta 12:18
So I think it is a trickle down effect, you sort of there are these areas of the law that go on touch for a while, and then there becomes a focus, you know, and then there's a split, and then the Supreme Court takes up a question, it may or may not be the question folks think they should be addressing, but it's the question, nevertheless. And I think, you know, for 112 purposes, I think a lot about my experience, after one on one analysis case, I think it was 2016, there was this trickle down effect where the PTO came out with some guidance, and I was managing at the time patent prosecution as well as patent litigation. And so you know, you're on both sides of that V, you want strong patents, you want to be able to protect your investment, but then you have all these patents that you're going back to your portfolio to look at. And I think Nate, you were mentioning, sort of blowing up patents from the past. And you know, we didn't necessarily get our patents lapse, but you look, you know, are these patents Now Alice resistant are these problematic. But then from a patent defense standpoint, you now have a bunch of tools in your arsenal, as things are being litigated. And the case law comes down. And then you can take lessons from those from the litigation, and then extrapolate some instructions to your engineers. So it's sort of all three, there's the the proactive, you know, patent mining, and patent enforcement and strength of your patents from a business perspective, as well as a defense perspective. And then, you know, how do you take the law and see how it applies to the practical solutions and innovation that's happening amongst your engineers. And so you're sort of thinking broadly about all of those things. And I was fortunate enough to work for a small enough company where I had my hands on all three, that's pretty rare at larger companies. And so I think for 112, I think we're not we don't have that guidance. And so I think, you know, to the extent Amgen is affirmed. And there is some language in the opinion that maybe give some more teeth around what, you know, is considered, you know, the the extent of the existing enablement law would be helpful, and then hopefully, the USPTO then builds upon that jurisprudence. And then, you know, you can glean more predictability, the more documents you can sort of point to and I think from the discussions I've heard today, from the Amgen arguments, it sounds like folks, I mean, we'll see what happens, but are of the mind that the law is not going to substantially change. And I think, from my perspective on the litigation side, this will, of course, be several years down the road. I would love if there is going to be a more robust and Um, framework for 112 patentability or it's, you know, it's more of a claim interpretation, question, of course and scope for the tech industry, which is what I'm and but to sort of see that same lever be available on the defense side. So what was nice about Alice is all of a sudden, on the defense side, you have now can file a motion to dismiss on one on one, we had a lot of success on that. And then, you know, of course, the pleadings got more robust to get over a motion to dismiss. But then you still had judges who after Markman would issue an early claim construction, or and then issue allow for an early summary judgment. And so ultimately, back to the predictability and cost efficiency that we're looking for, as in House lawyers, is, you know, we want to understand if this is a good patent or not, so we know whether to license it or not. And the more you know about what constitutes the metes and bounds of 112 enablement, and the other doctrines, you can plan accordingly. So from a from a defense standpoint, for example, if courts would suddenly allow in like Markman, for there to be a more robust discussion about 112, because I think currently, you see 112 thrown in to claim construction and into charts. And it's sort of like, so the defendant or the plaintiff is going to narrow the claim discussion, but it's not really used as an off ramp to resolve or settle the litigation. So the more you can move that stuff forward into the litigation, I think the more predictability there is, and then the more likely, the more likelihood of settlement in a case and, again, lack of waste of resources. So that's what I would like to see. I don't think we're anywhere close to that on the one full front. But I have hope and optimism based on what we've already seen on the tech side from one on one.
Scott Hemphill 16:45
Let me stay with this idea of lessons drawn, potentially, from our experience on in the wake of mayo analysis. I mean, so you guys know, having each of you did various points there. What what do you think about sort of passes prologue.
Nathan Kelley 17:02
So like, from my point of view, working in the PTO for a long time, what I worry about when the law changes, particularly in an area that's a little complicated is, how are you going to get the patent office to respond in a foreseeable way? And how are you going to get the 9000 examiner's all on the same page. And I'll give you a 112 related example, in the early 2000 10s, maybe was 2012, or 13, the PTO came out with new 112 guidelines. And these guidelines did a lot of things. But one of the things they did and we heard Dave capitalist mentioned this is they got into this concept of nonce words, words, other than means that could trigger the 112 F presumption. And so as the PTO does, once they did this, we decided we would have a training module that would sort of go out into the examining core. And so we'd make sure all the examiners knew about these new nonce words, and it's not hard to do, right, you go from one word to eight words should be easy. And so we had some examples, we had some questions. And so it went out. And then the head of policy came back to me about a week later. And he said, we have a big, big problem. And I said, What they didn't know what the words were. And he said, No, a lot of the examining core does not believe that they have to construe a claim under 112. F, to narrowly cover only what is in the specification and equivalents thereof, they just don't agree that they have to do that, that that's not how patent examination works. So we're going to start over and try to get them at least understanding the concept of 112 f. Now I was an examiner when a case called inrae. Donaldson came out in 1994. And then in re Allah Pat came out just after that, and I actually remember, examiner's saying, we don't have to do that. If it says a means for doing something, we just find something that does it. That's how you examine. And I was 25 at the time, and so Okay, okay. And that's how the office works. There's people talking to other people and their friends. And so if, if we're going to have a change in the law, we have to have it in a very repeatable fashion that we can get a 25 year old engineer, and I don't mean to denigrate someone who's 25 I wish I were, but we could get a 25 year old engineer to apply it and not be bullied by an attorney to applying it in a different way. And the other thing I would add, and I thought about this, as Paul was talking, is that we change the law in two kinds of ways. We take blurry lines, and we clarify them. And then we move lines. And I think of the eligibility changes as a moving of the line. We're taking stuff that maybe was patent eligible after State Street, and we're saying no, that wasn't patent eligible. But in other circumstances, we're not trying to change what's described and what's not described. We're not trying to change what's enabled and what's not. And we're just trying to make the test different. So it's clear and I think when we set out to make a new rule, we should at least be open in our discussions about whether or not we're trying to take stuff off the table or put it back on the table for patenting. Or if we're going to make everything the same, we just want to make the test work in a better way.
Scott Hemphill 20:14
One of the things that is sort of sobering from what you just said is, you know, I mean, I think, certainly outside of patent law and law, generally, we think about, you know, the Supreme Court as sometimes resetting the table oftens, you know, sort of speaking kind of delphic lay or in a regular fashion. And, you know, that's a particular challenge in a technical area. But, you know, hearing you just really brings home the multiple audiences here, where, yeah, we like to play around and talk about we'll talk we will talk about, I think the interaction between the Supreme Court and the Federal Circuit, but of course, there are multiple audiences in the district courts are an obvious audience. But the the idea that this, that there's a premium, that there might be a practical premium placed on clarity, clarity that has been to be achieved, practically speaking by a single clerk of the Supreme Court who may or may not have taken patent law for nearly 10,000, patent examiner's for how they're going to go do things going forward, is I said sobering, maybe worrying,
Paul R. Gugliuzza 21:16
too. And right. I mean, we're talking about an industry in which the regulated parties are incredibly sophisticated, right and represented by incredibly sophisticated lawyers and looking at practically everybody in this room, that, regardless of what the Supreme Court says, are going to act creatively to find ways to sort of work around. However, the Supreme Court, you know, whether the Supreme Court changes the law, clarifies the law or makes it more blurry, will immediately respond to try to try to ameliorate any possible negative effects that the decision reaches. So on the prior panel, for example, Laura mentioned the diastar case, which is a section 112 F case, from last year at the Federal Circuit, that pattern, it's worth noting, it was the application was filed and issued after the Federal Circuit's decision in Williamson, right. So you have a patent applicant, who knows that these sorts of knots claims are not using the term means is not a Get Out of Jail Free card if you're trying to avoid the limitations of section 112. F. And as Laura mentioned, and as I think Isabella predicted, or suggested, yes, there was this word code. But then if you look at the claim, there's just like, lots of other stuff in that claim. So what the the way the court describes it, I looked it up while we were sitting there, the claim requires code configured to be implemented on a mobile device to display information via display of the mobile device receive information, including location relevant information via wireless communications protocol, and display visual information based on the received location relevant information after the conditions are met. Right. So it's like a lot there that I might suggest, like, that's a lot of generic kind of nothingness. Right. And so I think it's just a good example that, you know, just changing the law in this space where the regulated parties are particularly sophisticated isn't necessarily going to keep us from reconvening here three years later, and talking about a lot of the same problems.
Scott Hemphill 23:20
How I'm imagining that meeting three years from now talking about whatever happened. Well, you moderate again, certainly moderate, not be a panelist. I mean, yeah, how worried? How worried? Are you all about Amgen being disruptive? I mean, there's, you know, we've talked briefly about the idea that maybe they'll just essentially affirm the Federal Circuit, maybe sort of bless the ones factors and say something about full scope. And hopefully, the thing that they say about full scope doesn't create some impenetrable mess that everybody that litigates I mean, can you help me bound this like a little bit really worrying? Where does this if any of y'all are interested?
Paul R. Gugliuzza 24:02
I'll jump in again, just real quick, because there's a response something to Aaron said a little bit earlier about, you know, being a overbreadth and pattens. Right, is a real problem, maybe more acute in certain industries, than in others. But I think, you know, one of the things that maybe some of the discussion here today and the Supreme Court's grappling with the issue of enablement in the engine case makes clear is that, you know, to the extent the problem is overbroad claims are poor notice being provided by claims, the enablement and written description requirements, or rather roundabout ways of addressing that policy question, right. I mean, wouldn't it just be more simple if we had a requirement that says, your claims just can't be too broad, based on what you've disclosed, right? Rather than sort of invoking the more complex concepts of enablement, written description? And I think the one concept we have in the law that asks that question relatively directly is the indefiniteness requirement of section 112. B. But as I think this is what Aaron said that triggered this, in my mind is that we basically relegated the indefiniteness requirement to this claim construction doctrine. Right. It's not really an off ramp, I think is the term that you said. But maybe it would just be more efficient and clear. If the, you know, indefinite initial requirement rather than being sort of this, you know, it gets invoked, you know, at the claim construction phase, patents aren't invalidated very often under it. But really, it's that requirement is asking the fundamental question that we should be concerned about, which is, what patents that are just broad enough to incentivize, incentivize the information we want, but not so broad, that they're keeping follow on innovation from occurring.
Erin Mehta 25:51
Yeah, and just sort of adding on to that one of the other takeaways that just I had forgotten, but just came into mind is this idea of fairness. I think when you heard each of the panelists, or each of the panels today, when asked specific questions about various doctrines, it was, well, what it was really the invention, what is actually fair. And then when asked, I mean, again, this is not my field, but about the various antibodies. And it's like, Well, was it the structure that's attaching and I'm a butchering this now, but basically, it was well, did they? How much time did it spend to make this and it's really governed by fairness. And I think, to answer your question, Scott, I'm not overly concerned about the Amgen case. But I am hopeful that this attention that the Supreme Court has now given to elevate this doctrine, and into the discussion, it might be an opportunity to tailor the existing law for predictability, fairness. And then another thing I had thought about was, to the extent there are small businesses or researchers or I know there's been a big push in recent years to get more diverse inventors to get smaller businesses and underrepresented minorities involved in the patent process. These are all tools that the more guidance you have, the more likely you will be able to reach more inventors and enhance innovation.
Nathan Kelley 27:18
So as for what's going to happen in Amgen, I listened to the argument and it felt like most of those justices were trying to figure out either why sir had been granted in the first place, or maybe what the real dispute was for them to think about. I didn't hear anybody with passionate views on written description. So I'm not too concerned. But the thing that worries me a little bit is that I think of Amgen is sort of an upside down written description case, like it's the description case, we've all come to see now with these very valuable patents that claim very broad subject matter. But in more and more classical sense, written description comes up when a patentee tries to narrow their claim to get around something or put in a limitation that they had not invented. Right, like a new matter is where it classically comes up. Or where you know, you're, you're drafting something at the at the opposite ends. Like, if there's two types of infinity, right, you can always get something bigger. And you can always get a number between any two numbers, no matter how close together, written description is similar. You have the problem that gets too big. Did you describe all that, but you have the opposite problem? Where when you get too narrow? Did you describe what was too narrow? And what concerns me a little bit is that I don't know that the Supreme Court is thinking about the other half of the case. And they could very well say something in affirming the Federal Circuit and accidentally mess up the other side of written description. Not that they would do anything accidentally. But that's that's the one thing that concerns
Paul R. Gugliuzza 28:47
Yeah, you know, one thing we have not really talked about, despite talking about the Supreme Court for the better half of a day is, you know, changes in the membership of the court in the last few years, and what implications that might have for patent law, right. I don't think we're thinking, you know, thinking about abortion cases and gun control, maybe not thinking so much about how that might affect patents. But I have to say, you know, I mean, I'm sure, Justice Breyer, because of his opinion in Mayo, right, might not have a ton of fans in the room. But I think it's hard to disagree with the fact that he would at least be attuned to sort of the pragmatic policy considerations that I think a lot of particularly our, you know, our participants coming from the industry side have been talking about today. And that that voice, you know, would at least be valuable in raising those considerations, or maybe bringing them to the attention of the court. And I think there's a real chance here, right, that the current court, you know, as obsessed as it is with issues of text, right, that idea that you can get objective answers out of text will say something like, well, the statute says you got to enable a person, you know, on a scale to making use the invention doesn't say anything about full scope disclosure. You know, so apply the statute Federal Circuit vacated and read I ended. And the Federal Circuit is like, well, that doesn't really tell us anything. Right. And so So I think that that would be a real loss, right. Or at least, you know, the the changing membership of the court might might lead the court to say something that, at best is just not helpful, and maybe at worse, has some inadvertent effects on other aspects of section 112 doctrine.
Scott Hemphill 30:22
I just wanted to pick up the thought about practical concerns and how it intersects with Amgen. We've mentioned Paul Clemente a few times. And one point that he sort of hammered repeatedly was this idea that if the Amgen patent is enabled, and this broad patent covers the whole universe of antibodies, that cures are not going to emerge, right, that everything, everything is just going to be wiped away, shut down. It renders improvement patents, basically invisible, it renders the prospect of licensing, basically off the table. I'm, I'm curious. I mean, I don't I don't know. I mean, I, I mean, I do and I trust in the majority of my work, it does seem practical that you would just enjoy an arrival. Whereas a licensed licensee, we would expect that to kind of get worked out. But the lack of attention to whether that parade of horribles would actually play out here. Because there's probably still money to be made by having an attractive license, these cures might still exist, particularly they're already on the market. I just wondered a little bit. There wasn't much pushback to his point. And I wondered, that kind of point which Breyer would typically be very attuned to and ask questions about, I didn't really see coming up that much. In oral argument, the other place where practical concerns kind of got injected in and I wasn't sure whether the Supreme Court was likely to be able to handle it was, again from Paul, you know, repeatedly referring folks to an amicus brief by this Nobel Prize winner, which, in the view of Amazon's counsel was basically a party expert report rendered as an amicus brief, and I will say from the standpoint of and I trust, that is a concern that does arise that some group of economists inject something into the process that has not been vetted, that is not squarely met by anything on the other side, and it just gets written into the US reports. And like, these man, I trust that does happen. And so I wonder slash worry about how practical concerns to the extent that this Court with its current membership is alive to it, whether they have, you know, the process or the habits to ingest that information and turn it into, you know, into something reasonable, rather than just getting kind of smacked around by the latest thing that they read, or the thing that matches their own existing predilections. This is a question mark. I don't know if there's, if you're gonna have a reaction to this, but it is something that worried me listening to Amgen.
Nathan Kelley 33:13
So my only response is that I think that there was a concurrence in I want to say Mayo by Justice Scalia. And the concurrent said something like they're married. Okay. Yeah, sorry. And the concurrence was, okay. I agree with what they just said, I think I have no idea what we're talking about the technology. So that's I don't agree with anything about the technology. And so I thought that the court is hopefully sensitive of that problem, because it's got to be a recurring problem with the Supreme Court, right? We know it from patent law, but every area of the law has got to have complicated, you know, lower levels that the Supreme Court has to be careful about getting
Scott Hemphill 33:51
to come back to the normative question. So that what 112 should be doing when we have I guess, we have some alternative policy goals. Maybe there's more than one thing happening at the same time that we can imagine, you know, separate missions, for enablement or for it versus written description. Do you all have a take on sort of looking forward? Like, if you were to try to help the Supreme Court get itself organized, is there? Is there a kind of principle that we should be following? Is there a single thing within these warring trade offs that we think 112 ought to be principally about?
Paul R. Gugliuzza 34:29
I don't, I'll jump in. Sure. Why not? You know, I don't I don't know if there's one right. I mean, I think I tee that up to this is I think, you know, 112 serves
Scott Hemphill 34:38
surpassing you to pick among your goals. Yeah. Well, no, I mean,
Paul R. Gugliuzza 34:41
so I mean, this is sort of response almost to your prior question about like, you know, what would be best for innovation in the lifestyle? Like what outcome of the Amgen case is best for innovation in the life sciences? And I have no I don't know. I have no clue. Right? I think Anybody who says they know for sure is lying? I don't think Justice Breyer would know. But he would at least be concerned about it. Right. But I think I think the takeaway from that is that we should at least, you know, whatever the rule of law is, we should at least let courts consider those matters in any given case, right. I think one of the things that really jumped out to me both of the oral arguments and jumped out to a lot of you at the oral argument in our discussion today, is how very hard it is to discuss section 112 in the abstract, without immediately referring to like, relatively specific examples. Right. So we've talked about needles in haystacks, we've talked about the car versus the steering wheel, you're talking to, like the Northeast Corridor versus San Diego. And I think what a lot of that tells me is that, you know, the resolution of 112 issues are very case specific, right, which I think lends itself to thinking at least a little bit about, you know, what's best for innovation. And thinking about the law versus fact divide and the role of the jury, in this case, to the extent that a case like Amgen is coming down to these very case specific questions, and the parties agree about the law. Well, you know, maybe there's a right answer. But is this something we should just defer to the factfinder? About right, who's heard the record. And, you know, we know we're not gonna get a perfect result in every case. But at least we're not having this long drawn out litigation that ends up at the Supreme Court with the result that is maybe as sort of arbitrary as we would have gotten from a jury. And so I think that's another sort of going forward thing to be thinking about is sort of how we characterize the section 112 issues as law versus fact, as well as the role of the jury, if any, and resolving section 112 issues. I think the
Nathan Kelley 36:55
one thing that the Supreme Court, at least can understand, and I think we all can understand is, at least in the purpose of enablement, is we want to right size, the scope of exclusivity with the contribution. And as long as we connect those two together, that someone's not getting more exclusivity than what they contributed. That's that's what the ultimate goal, I think of this part of 112 is, it is a little curious, though, because this is not the 18th century, people do not read patents to figure out inventions, right? No one's using patents for their original purpose, which is to disseminate information, really, it's just to grab the exclusivity in exchange for the innovation. So the patent system motivates innovation, but it does not work mechanically, as it was set forth to do originally.
Scott Hemphill 37:44
Let me ask her just a practical question, which is okay, law changes. There's a bunch of patents that already maybe they already got issued, if they're already deep into the process, all of a sudden, the, you know, the rules are different. It's a bunch of patents that seem like they were fine or one on one, and then they're not, maybe there's a set under 112, that go one way or the other, either, they're now jeopardized, or maybe it's full steam ahead for a set that we thought maybe weren't available before. I'm mostly interested in the ones that turned out to now have problems. Are there adjustments that we could make an existing practice? That would mean this might require congressional action? Don't get me wrong, that would help us in managing these kind of, you know, transitional moments. We talked to no prep call a little bit about IPR is, for example, in an individual to sort of elaborate on that.
Nathan Kelley 38:43
You know, we do talk about IPR is and at the time, I said, Yeah, let the board think about 112 During IPR hours, but I, I listened to a PGR argument the other day involving 112. And I decided this is a this is not a good idea. Well, because I think that the patent office is not as equipped to deal with 112 issues as they are to deal with priority issues, that you don't see a lot of 112 rejections, at least in the art I exam. And I'm sure there's a lot in other arts. I litigated for the PTO for many years. And I don't remember a 112 case on my docket. I don't remember many 112 cases coming through our office. And so I would suggest something that's maybe a little provocative, which is that we should maybe think about the presumption of validity in some of these things, and whether or not when we have something like 112. Why is it that you can come to the patent office and have an absolute right to a patent unless the PTO can prove you don't have one? And then when you get it, the only way someone can prove you're not entitled to it is with clear and convincing evidence. And when you're in 112 land, maybe clear and convincing evidence as to highest standard, particularly when I'm not sure the PTO You did as deep a scrub on that application as your competitors are gonna do
Scott Hemphill 40:06
that suit. That's super interesting. I will. I will say, though, that I started the morning sort of finding myself convinced by this idea that well, you know, 112 is kind of a challenging issue for late juries. It's not like these other things that they can do. Maybe anticipation they can wrap their head around, maybe obviously, they can but I mean, given the like heavily legal nature of the the 112 inquiry, maybe that's not fit for them. It bothers me that it might not be a good fit for examiner's either. I mean, I wonder whether that's something that could be I think it's just a matter of
Nathan Kelley 40:46
I think that I think the issue there though, is that it's an ex parte problem, right? Oh, you don't have the other side during examination. I think it's okay to have the jury later or to have a disability or now when we have the other side, but in an ex parte examination 112 can be pretty tricky, because you don't have the other voice.
Paul R. Gugliuzza 41:03
Yeah. Interesting. Yeah. I mean, I've actually written a little bit about this, and I sort of called it like patent laws deference paradox, right, which if you look at, you know, the decisions of the PTO that get the most deference effectively, it's the examiners this the single examiner's decision to issue a patent, because it has to be proven wrong by clear and convincing evidence. That's a lot of deference to a, you know, not particularly robust agency process. By contrast, only in Texas. Right. By contrast, if you think about like, decisions by the P tab in IPR, to the extent they're deciding, say, like non obviousness, the Federal Circuit considers that ultimately to be a question of law, that the Federal Circuit can review de novo. Yeah, there, you've got like an adversarial process, a three judge panel of the P tab, and that Pete pan opposition is being reviewed de novo. So I think that's like a really, really core tension in the patent system that he made, frankly, we should talk a little bit more about. And one of the takeaways might be like weakening the presumption of validity would be a very good start at least maybe limited areas like section 112.
Scott Hemphill 42:09
And anything you want to add?
Erin Mehta 42:11
Well, I just as I've been listening to this, I think, it seems to me at 112, this morphed into this sort of fairness doctrine, though, again, the principle of fairness sort of being like, you know it when you see it, which is why it's so fact specific. And I think just the volume of patents that go through the patent office, I think these are all interesting ways to curtail and problem solve. But I think we can all agree that the doctrine is important, because one on one, you know, it's more policy of what should be patented. And we've got, of course, it needs to be novel, and not too easy to do. But the patent is more than that. Because we're wanting to encourage innovation. We want to reward innovation, but we don't want to exclude others, and we want to move forward cures for cancer and technology. You know, I think it just is something and this is just like the lawyer in me. But it's it's it is a question of fairness. And then asking even the question of presumption of validity is a fairness question. And again, the age of the examiners and the training of the examiner's, and I mean, as a practitioner in an in house lawyer, I'm always more comfortable going at invalidity or unenforceability at the P tab than before jury. But if you can get ahead of that even more with the patent office, you know that that is going to be the most efficient way to move your policy forward, because it might just be a phone call and an office interview. And it's a low bar and a low investment of money and time to get it right because of the presumption of validity. So I mean, nothing more to add other than sort of very interesting area. And I think it was tonight, your point, I didn't give much thought to 112 really to be honest, before this being asked to be on this panel. Because it's just not been a huge area of return on investment for your time and your energy in a litigation or really what's killing your patent at the office.
Scott Hemphill 44:21
Let me take it to the to the larger group, reactions from folks to the audience in the audience to anything you've heard no time to weaken the presumption of validity. Yes.
Laura Sheridan 44:37
Okay, thanks. So I wanted to come back to something that Nate had said and actually go all the way back to Jeannie this morning where she was talking about one of the roles of disclosure was to democratize innovation. And she viewed this, this role of patents as you know, disseminating information and making it so that those who might not be as well leveraged could could look at them and then build from that. But Nate said, and I agree with it that patents really these days aren't about disseminating information. And at least in the tech industry, if you asked an engineer to read one of them, she wouldn't know what she's looking at, frankly. So I personally think this is a big issue. Because if you have Genie starting the day saying, this is a purpose of one of these core five tenets of disclosure, and at the end of the day, you're saying, Well, it's actually not functioning that way. Does this get enough attention? And should something be done about it? What would it be?
Nathan Kelley 45:38
Is it an easy question? No. Okay. I didn't, I was hoping I didn't miss something. So one thing that I hear, or I've heard in reading 112 cases, when they talk about something that might not have been in the disclosure, and you hear about this, we don't want to create a requirement that forces too much disclosure, we want, we want to have a balance, and inventors have to say what they need to add what's new, but they don't have to repeat what a person of ordinary skill in the art would already already know. And when I read that, I think, what is the harm in that? Like, I don't I don't ever remember thinking as someone drafting a patent application that I should keep something out, unless it's like some kind of best mode thing that I shouldn't have been thinking about. But I don't I don't know that patents get invalidated because they have too much in them. So I don't know why it would be a problem to add more to a patent application, and maybe it would become more beneficial. I don't know. And Natalie actually said something because I've been thinking about this issue. And she pointed out, it's more expensive to put stuff to put more in a patent application. But I think when we when we write them, at least when I wrote them, you don't want to leave anything out. And you ask the vendors, is there any other thing you're thinking of? Is there any other way to do this? And then the idea at the end of the day that your claim is really about something that you've never even mentioned, or you only mentioned, like as a component of three different lists, is a little hard to believe?
Paul R. Gugliuzza 47:09
Yeah, I can jump in there. I think that questions sort of about, you know, questioning whether this sort of quid pro quo justification actually like, is a real thing. I think it's a really it's a really nice way of of restating kind of the the point I was trying to make earlier about enablement, being a relatively roundabout way of policing crit claim Brett, right? Because you're no one is making and using the invention based on the patent, right? Like, that's what enablement asked. But like no one in the real world actually does that. But as Nate said, like, what we're really worried about is legal protection being commensurate with the inventors actual invention. So rather than asking the enablement question, we should just ask that question. Right. But I don't think we have a doctrine that like, directly asked that. But it might be more straightforward if we did.
Bruce Wexler 47:59
Yeah, it's interesting to hear that perspective on the tech side. Because on the life science side, the patents are routinely used for research, they're cited in publications. In fact, that's often like a source of trouble when you're litigating. And the inventor was looking at other patents. And you're like, you know, so that's how we know we see it all the time. And they develop synthetic techniques based on patents, it's, it's fascinating to think about the engineer who doesn't, you know, is looking at it, because I guess when I when I think about I look at these tech patents, they are like, like, it's all function and things everywhere. And there's very little specificity, but
John M. Desmarais 48:40
essentially trying to design around the words.
Jonathan E. Singer 48:45
In the in the in the identities case, just for your own perspectives. The one of the key pieces of evidence on infringement was a grant application that the predecessor to Gilead had had filed and cited in the grant application as a source of information, why the government should give money to the predecessor to Gilead was identical as patent application. Right. So it's, it's I think you're envisioning there are very different perspective, we have a kind of a bell curve of how much patents are actually used, but to categorically state that, that we don't have a process where people actually use patent applications in the traditional way. I think it goes too far, but doesn't mean that doesn't mean the questions that you raise about it, you know, are we are we giving too much credit to an examination process that doesn't really get at 112 issues very frequently as to my experience, that that's those are fair questions, but from a life science perspective, the evidence doesn't bear out kind of the premise if you will, that started the inquiry, but the inquiry is a very good one. Because we have just as much problem with continuation practice in the life sciences practice, as you do in the in the tech space. And and whether or not examiner's right, for example, that someone was talking about we should have this to this article that you should cite to the specification for support for your new claims, well, how does that actually work and as in where the standard is actually placemarks versus Well, I can point to that I have that in green over here, but you have no blazed marks to it and our examiner's trained in blaze marks, it's a very challenging process that we're that we're trying to get at, I just want to give you that perspective, from life science, very different sort of point of views.
John M. Desmarais 50:29
For Hire groups, or r&d, whose entire job is to look at the competing patterns and design around them get as close as possible change to get out of the claim. And so you, you have this whole, and this is at all the big pharma they, they have the whole core set up to read the patent, get around the claim, read the patent around the claim. So this notion that we're going to take the claim, and limit the invention of that when there's all of this attempt to make equivalent things and get around the words. You know, to go back to your point, if you really wanted to go to where you want to go, which is protect the invention, we got to go back to the beginning when we didn't have claims, and have the inventor describe what he or she invented, and let the jury figure out whether the accused product is described there. And because when you try to Kate take an invention and put words around it. It then starts the design around process, right in a word gamesmanship type of way, at least in bio, I don't know about tech, but in bio for sure.
Scott Hemphill 51:34
Let me let me bring into
Judge Raymond Chen 51:37
my question goes in a different direction. One of the origins for why we're having this event today is because, you know, there's this sentiment that in life sciences area, these companies, these innovators, they're getting, they're getting really hammered or, or put under stress by the Federal Circuit's case law on section 112 written description enablement. So let's see if we can get some of the greatest minds together to think about this, concentrate their minds and see if there's a different way to go, a more refined way of understanding these areas of law. And so I appreciate everyone coming here today. And I've been here listening. And what I'm hearing, of course, is that section 112 is difficult, very, very difficult. And, and it's interesting to hear this final panel where we've migrated over to presumption of validity. And it makes me wonder, I don't know why this thing isn't staying up. But it makes me wonder if one day there could be a movement to Congress, we all went through Microsoft vs AI for AI. And we know what happened. But what if a movement a faction went to Congress and said, Look, 112 is hard. It's just hard. And then there's this other thing called one on one, that's even harder, that's even harder. You can't really expect these 25 year old engineers, who are great kids, but you can't expect them to also be able to free their minds and think philosophically about section 101. When they've got a very limited finite amount of time, they've got to stick and move stick and move through hundreds of applications a year. And then on 102103, guess what the over the past decade, we have experienced the greatest stress test on the patents that have been granted by the agency to do a little checkup or quality check on 102103. And the results are in there, not that great. We should all be a little disappointed collectively. And if all those things that I'm saying are true, then why do we have a clear and convincing evidence burden of proof? I you know, that that's not a hard story to tell. I'm not saying that's the right story to tell. Maybe I am but maybe I'm not. And And what worries me about that story is and this is really for the room. You know, you, Bruce, you, John, what would that do? To the innovators out there? If the presumption of validity was reduced from clear and convincing evidence to mirror preponderance of the evidence? Anybody got any thoughts on that? I'm just a guy in an ivory tower. I don't. I would just
Erin Mehta 54:45
push back on that. You're an audit analogy because presumably are only challenging the weaker patents I mean over time, and presumably you're licensing the really, really strong ones and not litigating them. So it is a stretch A test in a sense, and I think it's a great lover from a defense perspective. But I don't. I mean, I, I think it's an interesting question about presumption of validity. But I don't know that the IPR process really backs up the story you just laid out. So
Bruce Wexler 55:15
I mean, I feel like John was probably feel the same way. But I think on the this sense of stability, I think that the presumption creates. So all the leaves on the life sciences making decisions on investment, what to do in the future, not knowing the outcome, there is a sense that if I have this patent, and I have this presumption, I at least have a chance of of having the exclusivity that I'm going to need. On the flip side of it, if you are facing the presumption, you may say to yourself, Wow, that's going to be really challenging. Maybe I need a license or, but I do feel that philosophically, I agree that if the system is all screwed up, like why is there a presumption, but I do think the stability that it creates is I see it pervasive, you know, and I think one thing I was thinking about the difference between tech and Life Sciences is that tech seems to be you have this thing that you're working with. And and this even goes to why maybe the patents are used for research is that in the life sciences, you have a thing. But the ultimate goal is is going to be put in a body and do something in the future with his vision of what's going to happen. Whereas in tech, I think it's less future looking, it's more immediate, even if the device is going to do something. It's not that far out when you're thinking about like functional, claiming and moving in the body and triggering receptors. And it's just a whole way of temporally looking at inventions in life sciences, I think, is different. And I think they look at the patents for the research, because they don't yet have all the publications that talk about all the details of how it's working. And the patents are often the best sign and explanation of mechanisms action and structure activity relationships. While that's in the patents, it almost seems like in the tech side, you don't need that as much. You have your device you have how it works, you describe it. Maybe the enablement is not as hard to reverse engineer. Yeah, you reverse engineer it. But the enablement gets tricky on life sciences, because you have this future occurrence in the body where all this unpredictability occurs. And maybe that is a reason why life sciences in tech is different, a little bit on 112. And maybe we should just sort of accept that a little bit. I don't know that's just in thinking about your question about the presumption and stability that it creates
John M. Desmarais 57:28
different ways, which is practical. For insurers, either are copying commercial products, or they're accidentally infringing by making a product that accidentally includes the future. Whereas in the pharma side or biocide, a lot of people are actually intentionally like they're looking at the bat and they're trying to make that thing and it's a different. So from the infringers point of view, alleged infringer is different conduct. A lot of times the tech people didn't even know they were infringing. And the bio and life sciences were trying to get around. I mean, it's a very different kind of conduct,
Nathan Kelley 58:05
to just to get back to the presumption of validity issue if or those who like the presumption of validity, there's really good reasons to support it. And the clear and convincing, it is a standard that creates, what if we tweaked the front end of the system and said, okay, but the patent owners have the burden of proving patentability in order to get their patent. In other words, you're not entitled to a patent unless you're entitled to a patent, if you can demonstrate it's not obvious, and the burden of production, I guess, could be on the PTO. But at least there'd be some stress test in the system. Whereas now, the very easiest thing a patent examiner can possibly do is issue a patent. It gets, you know, basically to date, it's like for lawyers in the room. It's like 16.0. That's what you get for issuing patent application and it takes about like point three
John M. Desmarais 58:55
opposition there we go.
Erin Mehta 59:00
I like that idea. And I think reserving opinion on the actual presumption of validity from a predictability standard standpoint alone, I would favor the clear and convincing just because with all the problems, you know, potential problems at the at the PTO, you need to have the certainty for business predictability and planning
Scott Hemphill 59:23
be are getting the hook. So this has been a terrific discussion. Please join me in thanking our panel.
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