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Welcome to AccelPro IP Law, where we provide expert interviews and coaching to accelerate your professional development. Today we’re featuring a conversation with Anne Elise Herold Li, Life Sciences Litigation Partner & Co-Chair of Patents at Crowell & Moring.
In this interview, Li discusses the transition from epidemiology (with a sideline as the “Rat Queen” of the New York City Department of Health) to intellectual property law, changes in intellectual property law related to both remote employees and independent contractors, long-term consequences from Amgen vs. Sanofi and more.
One of Li’s primary areas of focus in this conversation is how the increasing number of remote employees working in different states than their main offices requires new approaches to intellectual property concerns.
Listen on Apple Podcasts, Spotify and YouTube.
Interview References:
Anne Li’s Crowell & Moring profile.
3:59 | NY Senate Bill S5640 on Invention Assignments. (2023).
9:45 | Amgen Inc. et al. v. Sanofi et al. No. 21–757. (2023).
TRANSCRIPT
I. INTELLECTUAL PROPERTY, REMOTE EMPLOYEES & CONTRACTORS
Neal Ungerleider, Host: Can you tell us what sort of intellectual property risks exist for companies who work with remote employees and contractors?
Anne Li: I think the principal risk that companies have to deal with now, particularly in the post-pandemic era, is that there are different state laws from where you usually practice. So, for example, if your company is based in New York and you have employees in California or Michigan, you have to understand what the state laws are in all those different states.
There are a lot of new issues that arise that practitioners in-house are not quite equipped for. Unless you're one of those practitioners who's familiar with the laws of all 50 states, you have to start relying a little bit more on outside counsel or 50 State Surveys and gleaning information from where all of your employees reside.
And this is true–and I want to underscore this level of importance–even if the employment contract says, you know, this is governed by the laws of the state of New York. If your employee is sitting in Maryland, for example, you could have a very different interpretation of what those laws are because some of those provisions might be illegal in Maryland.
The same is true for employees who are sitting in Maryland working for a New York company or any other state, which is why this change in the law today that we're going to talk about is so groundbreaking. Attorneys, companies, and practitioners really need to be aware of what's going on in the different states.
NU: What is the change in the New York law?
AL: So most employment contracts, really just about every employment contract ever, has, particularly in the technology space, whether that be software or life sciences–they all have something called IP assignment provisions. Usually those involve language whereby the employee assigns all of their rights, intellectual property that they create, to the employer.
Whether that's patents, trade secrets, knowhow, copyright, trademarks, all of the things, the whole basket is automatically assigned to the employer. Now, there are some states, and New York has just joined these ranks, where that automatic assignment doesn't apply globally. It applies to when you are working for your company.
And for your company is, of course... It's broad and not clearly defined. It's one thing if you're a researcher in a lab and you go in and you mix the things or manipulate the things physically in the lab and you discover something, that's pretty clear, and then if you're writing your discoveries up later that night, that's also pretty clear, right?
The real tricky issue comes for employees who are remote workers or who mix work and play. For example, particularly the software space would be a great example here.
People who code for a living code for their company, but they also code for themselves. They also code recreationally. They also typically don't work regular nine to five business hours. People who have adjusted their work schedules around personal, childcare responsibilities, or a different way of life. They've made it all work for them.
What are their business hours? Those issues are going to be so unclear going forward in New York state especially, and they're going to be hotly contested. So this is going to be an area that's going to be developed. The law, as with all laws, has to get interpreted by the courts.
And so right now there's no moats and bounds on what would be covered by, for the company right now.
NU: And are there any sort of best practices that already exist for companies to mitigate these risks, or is it more of an uncharted territory?
AL: It's a little bit uncharted, but there's certainly a certain amount of risk mitigation that you can take over from your trade secret protection experience. This is where the nexus of my practice and the employment law in IP comes to the fore. For example, even if you have remote employees, something as simple as sending them a company laptop.
Those employees are working on the company's products using the company's equipment and resources and materials. So there's a clear delineation between when you're working for the company versus on your own stuff. So something as simple as having your own laptop that comes from the company and gets returned to the company.
That's just good company hygiene, generally speaking, but particularly in the area of trade secrets and now with employee assignment provisions, that's going to be really critical. Something also a little, I'm not going to say critical, but I'm going to say important is, even if you have employees working odd hours, unusual hours, customized hours, having some kind of memorialization of when they are working for you would be really helpful, right?
So let's say I work from 9 to 12 and then again from 5 to midnight, just understanding that those are generally my regular business hours. That would be really important. And this is going to be a little bit grayer, but some good practice is to have some regular communication between the employee and the manager on what they're working on. For example, I'm trying to solve a particular problem, and that's really taking all of my brain power. This is really for employees who are in the idea creation space. This is really for employees who are scientists or researchers or deep thinkers, and you're really paying for their brain.
But you've got to figure out what problem they're thinking about for you. The sort of joke that comes out from all of my clients a lot is – can I get that shower time, that 15 minutes when you're totally not looking at anything else and no one's distracting you…and I really need your deep thoughts on this issue.
And so that's a critical time frame. The only way to phrase that out – nobody's going to put in my employment agreement: I want your shower time. For God's sake, we'd all be fired, but it would be much more – I need all of your thoughts related to X issue to belong to us. Or you're working on this for us.
If a programmer is trying to figure out how to get Google Maps to anticipate the 5 o'clock change in the traffic pattern so they don't map me through the Holland Tunnel at 4:55, that's a company problem, versus that same software engineer who's coming up with a new app to store recipes. That's not the problem I've hired them to do.
So focusing on your problem, making sure that's clearly communicated, and when one problem is resolved, you make sure you clearly document what the next problem is. That's gonna be important. Using company equipment is gonna be important and getting a clear sense of what their working hours are, and if there's deviation from that, even in the remote environment – it's really helpful to get that clearly documented.
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II. AMGEN V. SANOFI CHANGES
NU: And we were talking in November, 2023 – what are some of the major intellectual property and patent issues in terms of biotech and life sciences that you're seeing right now?
AL: It's obviously the news of the day is the Amgen case that came down from the Supreme Court. It's going to have one of those sea change effects on what constitutes patentable subject matter in the biotech space. It used to be that you could claim an entire class based on a few species in there. We call them species and genus for all of you who remember your high school biology – Philo classifications – but I think what's really the initial impact of that is going to be a whole series of patents are getting invalidated. And so there's going to be like a huge, almost rush to the courthouse to strike these down. People are not going to assert them as much.
Other people are going to try and patent around them. There's going to be a lot more invalidation proceedings. I think it'll be really interesting because this is not a basis on which you can invalidate them in front of the Patent Office, so it has to be at the District Court level. So I think that's sort of the biggest trend right now.
We're seeing a change in how those patents, those granted patents, are being dealt with. The second change is how those sneaky patent lawyers are going to start patenting stuff to get it as broad as possible in light of the Amgen case. So that's also an interesting front that's being developed really right now.
At the USPTO, the patent attorneys are trying to come up with arguments on pending applications. The USPTO is trying to come up with guidance for the examiners on this written description requirement after Amgen, and the examiners are caught in the middle on: we don't exactly have guidance yet, formal guidance – because they have to wait for comments and notice etc., etc.
But I have patents in front of me right now I have to look at. So it's the Wild West right now, on that front, and we'll see that play out over the next, I'd say, for the patenting, probably the next six months to eighteen months. And for the invalidation proceeding, those are going to go out for the next few years, because biotech is big business, and there's a lot of money in it.
That's the news of the day for biotech patenting. But what's also interesting is whether this is going to have the result of moving over more to trade secret protection, right? So this is going to be a whole different class of – oh, I've identified this class of compounds that could work, or I've identified this particular target that if I hit it could work, but I've only disclosed two or three antibodies for that target.
Maybe I'm not going to talk about the target in my patent. I'm going to keep that target secret. I'm just going to talk about the antibodies, right? And say, hey, I've discovered these three things that do this thing. In biotech and pharma that's like the air in the spare, right? You need to make sure if one fails clinical trials, you have the other.
Maybe you'll keep more of your process secret. Maybe you'll keep more of what you're looking at secret. Maybe you'll institute these sorts of protections to make sure that you're not giving away the farm by filing everything in a patent application that actually is not going to be broad enough to cover what you're trying to keep as yours.
NU: The Amgen case – can you tell our listeners the basics?
AL: Sure, so Amgen is an interesting case, because if you don't sit in patent nerdville with me, there are certain things you have to do to get a patent. One of them is: describe your invention with sufficient particularity such that someone else could practice it. Someone who's skilled in the art could pick it up, read it and say – aha, this has advanced my knowledge and I can do this new thing.
It's called a written description requirement. What had traditionally been happening in the biotech space is: you would describe a target, for example: I can create this reaction, pharmaceutical, a therapeutic if I can design an antibody to hit that target. And if it hits that target, I'm going to have this great effect.
That's essentially what these antibody patents are for. But what the Supreme Court came down on with Amgen, is that just because you can envision the target and maybe you've identified 30 antibodies or 60 antibodies, like in the Amgen case, a handful, a certain, not a not insubstantial number, but less than all for sure – is that enough for you to claim and have sufficiently described all antibodies that hit that target in writing?
So basically every key that's going to hit that lock: have you described them all by describing the lock? Maybe. But usually not. So in order for a patentee to claim that they need to have described all of the keys is what the Amgen case essentially says.
And part of the reason for that is if you're trying to avoid infringement – let's say I'm diligently trying to treat the same disease indication and I come up with a class of antibodies that I think might work – the only way I'm gonna know if they hit that target is by designing the antibodies and coming up and figuring them all out and testing them and seeing which one works and screening all the libraries.
So I'd have to go through a huge amount of experimentation to figure out if I'm infringing. So the whole point is that the person who's really trying to do their best and not infringe the patent, shouldn't have to invest all this time and money and effort just to find out that – damn, they're infringing and now they can't recoup all of that time.
So essentially, the patentee is entitled to patent what they have versus all that they could possibly envision. So it's somewhat narrowing on all those antibody patents and biotech, just generally speaking.
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III. FROM EPIDEMIOLOGY TO IP
NU: Can you tell our listeners a little bit about your work and your background?
AL: I came to law via a somewhat circuitous route. I was an epidemiologist before this and did disease outbreak investigation for the New York City Department of Health. I was actually “Rat Queen of New York City,” trademark pending.
Then I became a lawyer and I was really interested in the science and the law, and so I'm a patent lawyer, which is great because I spend so much more of my time doing science than the average lawyer, and I focus on intellectual property law principally in the biotech life sciences space, but I also branch out into other spaces as well.
NU: What is the path from epidemiology to law? What was it like for you?
AL: That's a funny question. And I think post 2020, this is the first time I've ever had to not explain what an epidemiologist is. So thank you for that. So I'll tell you that I was an epidemiologist, and I really liked science and I really liked studying a lot of biology, as you might imagine, but I was trying to decide between getting my PhD and doing something else.
And, actually it was my younger brother who talked me into law, so it's really all his fault. But he was talking to me about law school and what he was studying, and I was asking him a lot of questions and he said, you might actually really like patent law, because you get to study science and you get to study the newest science all the time and the broadest possible focus versus getting your PhD, where you become just the master of a super narrow focus.
And hey, learning new science sounded like a really cool idea to me. So I decided to defer admission to my PhD program. and went to law school and I learned about patent law. And I met a whole bunch of these people who just basically learn about science all day. And I ended up choosing patent law, as you might imagine.
And I've got to say the most amazing thing about doing patent law is that I have had an opportunity to speak to Nobel laureates…to talk to scientists in their field who are so excited about science and so excited to explain it to me that I've learned so much more than I ever would have as a PhD.
The whole breadth of science that I didn't have before. That's my circuitous path.
NU: Do you have any advice for scientists and people from science backgrounds who are entering law school?
AL: Oh my God. If you're a scientist entering law school, I would highly recommend patent law to you first. It's a very small bar. There are just, hysterically, not enough of us.
For IP law, particularly if you're going into biology, biotech, biomechanical engineering – all of those new things – the next frontier of medicine is in that area. And they really need a lot more lawyers who understand this area of law. I personally need a lot more lawyers who understand this area of law.
So it's great. It's interesting. It's very rewarding. And I think that even for engineers – we have a lot of engineers who do IP law with us, obviously. Companies are building things, newest technologies, latest technologies, transistors, and all kinds of little chips and things that I don't know anything about and I can barely use my iPhone, but there's a lot of people who have to patent those sorts of things. And so having those undergraduate degrees in science – if you end up in law school – you are way ahead of the game, and if you are not sure that you want to go to law school, and you are a scientist – there's a hack, okay? There's a little audition period.
A lot of law firms, including mine, hire what are called scientific advisors. So these are people who have usually advanced degrees in a technical field. They come and work for us, and then you make law money, people. And then, you get to advise us on science, you help us with patenting, you help us with litigation.
We are really interested in learning from you, because you've obviously had a much more recent education than we have. We want to learn from you, and this will give you a good chance to see if this is the right career for you. It benefits us because we get to learn from you as well. It's a really great reciprocal relationship.
Some firms will also pay for you to go to law school if you continue to work for them. It's a great way to try it out with very little risk on your part. If you are a scientist, I strongly encourage you to at least call up your friendly local patent lawyer and get a sense of what they're thinking.
NU: Can you give an example of how you've personally relied on peers and not mentors or bosses, both inside and outside your organization, to deal with tough situations that might have come up?
AL: Yes, I literally could not do this job without my peers. I literally rely on my peers for absolutely everything. So if there's a tough situation, if there's a difficult client, I need advice on how to deal with this particular person – I can call my peers and get a good sense on how they dealt with this.
I spend a lot of time relying on – there are not that many women in patent law – I'm not going to lie to you. So I have relied very heavily on the few ladies that are here. Debbie and Shannon and Preetha are my go-to people for advice. They are certainly my peers.
Preetha actually was my associate, but now she's also my partner. It's been helpful to be able to ask how you would handle this particular patent question, how you would deal with this particular client, or how you'd navigate this hurdle in your career. It's not all rainbows and unicorns.
Law is a really tough profession. It's very rewarding, but there is a fair amount of strategy to overcome obstacles, and whether those obstacles are institutional. I don't mean to imply at my firm – I just mean globally speaking, or they're personal and interpersonal conflicts.
Being able to talk to your peers gives you a really good sense on how you're gonna overcome those. If you're talking to a mentor, that person's in power and they have a different perspective. But if you're talking to your peers, they're sitting in a similar or like situation with you and they have likely seen this, or they know someone who's seen this, and they can offer some great advice.
A particular example that comes to mind immediately is, we have some extremely intelligent judges on our bench that we appear in front of. Not many of them are scientists and even fewer of them spend a lot of time on patent law. So being able to turn to a peer who is not a patent lawyer and say, hey, I need to present this to you and I need to make sure you understand the science that I'm talking the law that I'm talking about, even though you're a torts lawyer, would be really helpful because you are most like the judge in this case, right? You've been out of school for the same time. You've seen a lot of different kinds of cases. None of them are my cases. And let me see if this makes sense to you.
And to have that peer come back and say – you're talking at 30,000 feet and I'm at like the top of the hill – I need you to dumb that way down, no, even farther down, no, like I said, way down there, and get this to explain really complicated legal technology and the wedding thereof in plain English is so hard as a patent lawyer, and I think that a skill that is best developed at a place where there are lots of non patent lawyers.
So your peers are golden there. And in fact, if you can wrangle up a junior associate to come and listen as well. They're most like the judges’ clerks, right? The people who've been out of law school just a couple of years. If they get the science, then you know that you're clear and credible.
That's been really helpful to have the peers around for, both at my level, below me, and of course seeking guidance from those above me. But really, it's my peers who've tackled similar problems that everyone has an interesting and different way of doing it.
And actually, I'm going to add one more thing. I know you're going to ask another question, but in case this gets into the interview, I would be remiss if I didn't say – as a woman partner, how I have relied on my peers to navigate being a working mother, woman partner and a working mother, woman associate and how critical my peers have been to me there and how when I was an associate and I had my kids, I had another associate come in and tell me, Anne, you make it all look so easy, this work, this life, the kids, the whole thing. Whereas I felt my life was absolutely on fire. And so I've been very open about challenges that are faced, and as a result, others have felt comfortable being open about challenges that they have faced. And it's really built a whole community of women who are supporting each other through this very difficult time, regardless of what stage of your career you're in. And so I would be remiss if I didn't say that.
NU: Perfect. That was Anne Elise Harold Li. Anne, thank you so much for being here.
AL: Thank you so much for having me.
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This AccelPro audio transcript has been edited and organized for clarity. This interview was recorded on November 13, 2023.
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