AccelPro | Intellectual Property Law
AccelPro | Intellectual Property Law
On Patent Eligibility, Diagnostics and Biotech

On Patent Eligibility, Diagnostics and Biotech

With Jeannie Boettler, Partner at Stinson LLP | Interviewed by Neal Ungerleider

Listen on Apple Podcasts, Spotify and YouTube.

Welcome to AccelPro IP Law, where we provide expert interviews and coaching to accelerate your professional development. Today we’re featuring a conversation with Jeannie Boettler, Partner at Stinson LLP.

As a registered patent attorney, Boettler secures and protects intellectual property rights for biotechnology and life sciences companies, including private corporations, universities and government agencies. She blends her experience in life sciences and patent law to prepare and prosecute patent applications and protect clients’ valuable intellectual property assets. She counsels clients on aspects of patentability, invalidity, freedom-to-operate and other due diligence issues.

In this interview, Boettler explores the nuances and emerging changes for patent eligibility in the fields of pharma and biotech. The supplemental materials and episode transcript are available below.

Listen on Apple Podcasts, Spotify and YouTube.

Interview References:

Supplemental Materials:



Neal Ungerleider, Host: Can you give our listeners some background on Stinson and your role there?

Jeannie Boettler: Stinson is an all-practice transactional and litigation law firm. The main offices are in the Midwest. We do have 14 offices that span from New York all the way to Dallas that concentrate most of our offices in Minnesota, Missouri, Colorado; kind of the mid-America landscape.

I am actually in the Intellectual Property department. I have a background in biology, and I started about 20 years ago on the biotech pharma patent prosecution side. So I work with everything from universities to solo practitioners to public companies. Doing anything from when they develop new drugs, new diagnostics. I work with them both in the United States Patent Office and globally to help get their patent or their IP protected. On the patent side, I do a little bit of litigation support when it does come to enforcing or defending their patent rights. But most of my practice is patent prosecution. 

NU: How does patent eligibility impact pharma and biotech?

JB: Yes, so patent eligibility - with all the other requirements for a patent - historically was an extremely low hurdle, right? I mean, under the policy of patent law, we want to progress the sciences. So anything that was useful under the sun, for any purpose, had patent eligibility. Other than natural laws, mental steps, things that already were occurring without human intervention. 

And up until about 2012, it kind of went smoothly. That was never something that I faced in my practice. We didn't try to patent perpetual motion machines and things like that, and it was an easy hurdle to get around if you even saw the hurdle. But back in 2012, the United States Supreme Court took on a case in which they decided to delve into: What does patent eligibility mean?

And for that case, it was a diagnostic treatment kind of thing. Where basically, what they're doing is, the claims wanted the practitioner to administer a drug. And kind of see how the patient's body reacts. And the purpose of that is: How well does the body react to that drug? Is the drug working? Is it doing what we want it to do? Which historically, again, now it's purposeful; useful for a purpose. 

And the Supreme Court said, “You know what? All they're really doing is looking at what the natural body is doing itself. I mean, yes, you administered this treatment. But as far as your claims go, you're just watching what's happening already. That's a natural product. So let's revisit that eligibility.” 

And as courts kind looked at that decision, they decided, “Well, maybe we should look more into what is eligibility. And is it really a low hurdle?” And so in the biotech space, the problems that we're getting are both natural compounds, and it was DNA, if we tried to claim DNA sequences. Any type of nucleic acid sequence, antibodies; are they really things that are happening in nature? Or did somebody do something to make it different, right? And on the diagnostic side is: Really, are you just watching what's happening in the body? If a patient you think has a disease or some type of condition, are you doing more than watching what the body does naturally in response to it? And it pushed that eligibility requirement to be a pretty big hurdle. And where the natural product and DNA sequencing goes, there are ways to kind of overcome that and move on.

We've really seen a lot of pushback in the diagnostic industry. And it's been one of those that, really a diagnostic when you look at the test. You take a sample from a patient that you suspect has some type of disease, you contact it typically with a protein. Like an antibody in their body. And then it lights up, right?

I mean, we send some kind of label and we say “Oh, they have this protein, or they don't have this protein.” And so it detects they have a disease, and diagnoses them with some type of disorder; disease for treatment later on. The biggest hurdle for diagnostics is that: What else could they add to that claim, right? I mean, what kind of man-made step could get around that. And so, I think in the last probably six, seven years; it's really been difficult. The patent office has tried helping. They've given some life science examples - where they give example claims on how they think it could be worded, to get around it.

We've also seen some court cases try to take it on, but it's really been a struggle. And for diagnostic companies, we're almost closing off that industry to patent protection. One of the things that has really been a struggle is examiners are saying, “Well, if you used a novel protein or antibody to detect it that you've made, well, that would be great.

But most diagnostic companies are using antibodies. They don't make antibodies, so they're just using what's available for certain proteins and certain bindings. Another way of trying to get around it is, “Well, add a treatment step.” And so, once you diagnose this subject as actually having the disorder, administer some type of therapy. Again, that does get you around your patent eligibility. 

But the diagnostic company is not typically in the practice of also treating, right? I mean, typically your doctor treats you. Or an urgent care, or a hospital treats you. And so, then you get to the point of when you try to enforce these types of patent, is how much value is the patent worth? Because I can't enforce it against my competitor, because they're not treating, right? 

My competitor in the diagnostic world is coming up with kits that diagnose diseases, so they haven't done every step of my claim. And I can't enforce that claim, unless I wanna sue a doctor as well. Most people, policy-wise, don't want to sue your doctors. And also you don't want to have to try to prove that the doctor has knowingly done this as well.

I have a client, and globally they've looked back on this. And they said, “Maybe this isn't something worth patenting.” Which, I don't know if we want that in the United States. I don't know if we want diagnostic companies, all of a sudden, deciding it's not worth it in the United States to try to get protection. Because then how much effort do they put into the United States market of these tests? So that's one of the big issues.


NU: You mentioned the Supreme Court case that set the stage for all this. What case was that? Can you tell us a little bit about it?

JB: It’s Mayo v. Prometheus. It was the Mayo Clinic. Typically people just call it Mayo. But, it was 2012. And really, it was a little surprising. Because, with the Supreme Court, I am impressed at how well those justices can go across the legal industry and get so caught up on laws and rules and intricacies. Especially in patent law, because they also had to get on biotech knowledge itself, right? 

And they did so well with getting on board with that. And I don't think they intended to close off an industry, but they left it so vague when they were done, right? I mean, the way they really held it is, “We think all you've done is watch something natural happen, and we need something more.” But what's that something more? They keep saying, “Just something more.”

And that's how patent examiners - when they reject your claim - you don't have something more and nobody knows what that would be, right? I mean, except if you administer a treatment or if you do something almost too much. And then it's not really the diagnostic that you're trying to protect.

NU: For diagnostics, what are some of the patent issues that are unique to them as opposed to other parts of the biotech and life sciences fields?

JB: One of the things - I mean for diagnostics - it's usually method claims only. I mean, they can cover their kit when you go to the urgent care and they've got the little swabs that they have for strep or for influenza A or B. Those are all kits that probably have been patented as well, right? And it patents the actual devices to test it. The fluid that's on the device, the protein that's in that fluid, as well as the antibody that they're using. It's the combination of those things. The thing with diagnostic companies is, as great as it is to get a kit patent on that is, it's also very easy to design around.

Again, they're not using novel proteins or novel antibodies. Typically in those kits, they're using what's known. There's not just one antibody. There's millions of antibodies that could function and bind to the same thing in the person's body. And so, unlike other biotech that can reach out and say, “I'm gonna try to get the composition, and I'm gonna try to do this protein. Or this nucleic acid DNA sequence, and I wanna try to get a composition that includes that sequence.”

For a diagnostic company, they really have the method of using their most powerful, the broadest protection they can get. So that way, if their competitor says, “Hey, you know, that's great. I really like how fast, or how efficient, or how accurate that diagnostic is. I wanna use it.” They could license. Or a lot of them could say, “Hey, but all I can do is switch out the antibody, and I can do the same thing.”

So to get something - the method itself - and be broad enough to just detect a certain protein or blood biomarker, and to label it with anything - I mean, you can label it, you get a little broader protection. So again, product companies, pharmaceutical companies, there's not a whole bunch of different ways to protect that method. And then also adding a treatment step. You're doing something that they don't do, their competitors don't do, and you're creating divided infringement. So the patent itself becomes not really commercially viable. It's not really covering what their commercial embodiment is. And they no longer have that leverage of, “Hey, my competitor is now trying to use it, and I can't really stop them from doing it.”, similar to what other biotech industry kind of clients.

NU: What are some of the most important issues when it comes to patents involving DNA sequencing techniques?

JB: So again, not only do you have the patent eligibility problems; because, are they natural products? I mean, our DNA is what it is, but it does mutate naturally. So, how much different does it have to be from what's occurring in human bodies and animal bodies? So any type of living organisms’ body - how much different does it have to be to protect it? The bigger issues we're seeing in the biotech and the nucleic acid, DNA type, patenting process is that you need to have it adequately described and enabled. There are two different requirements adequately described: 1. Saying you've described it in your written application, such that one can envision what you meant by all your terms; 2. And then the second requirement, be an enablement, that you've enabled somebody that has the same skill in the art to repeat that. And make the same product, practice the same method.

The problem with DNA and antibody type patenting applications, right now, is we've heightened that standard as well. So five or six years ago, we had AbbVie v. Janssen Biotech. And in that case, they tried to claim antibodies that functioned a certain way; that bind to a certain protein. And the way they described it is, in their application itself; which includes your claims that we've been talking about that actually identify what you're trying to protect. You also kind of describe around it; you know, describe everything: why you're doing it, how it works, and then what benefit it has. They put in over 300 antibodies that would meet the requirement of their function. Historically, that has been a pretty good amount of description to get the generic antibody that binds to this protein - or, “I want an antibody that functions this way.

And in the AbbVie case, the Supreme Court said, “I know you have 300 antibodies. I'm not sure that's adequately described. They're all structurally pretty similar, so I don't know where the end boundary is. There's a lot of proteins that can function that have completely different structures, and I'm not sure one skilled in the art could envision every single type of antibody.

In one respect, it made it closer to globally how other patent offices in different countries and different regions see this whole “describing your invention”. But it cut off being able to broadly claim these things for companies, right? Just like the diagnostic antibodies; a lot of them are known, the way they function are known, or at least can be routinely experimented on. So if I have to name my specific antibody in my claim, I really didn't get much. Because somebody else can come along and say, “I don't want to give you anything for your effort. I'll just design around it and tweak it a little bit and get my own.” And the court came down saying, “300 is not enough; I don't know what is. There's no set number. I just need to know enough about the functionality, and some type of structure. And I need to know a lot about the structure. But I'm not gonna tell you where that line is. When I was trying to get an antibody, I know I don't wanna protect this one, or even this 300. I wanna protect everything that binds in this area.

And again, I see the policy that the courts were using as that you don't want somebody to monopolize the whole area. The whole idea of patent law is that you're supposed to progress science, right? Company A comes up with a great idea and company B says, “That was a great idea. But look, I can build off of it and get something even better for society.” So the idea behind it was that nobody wants to block off a whole group of antibodies or a whole function. But at the same time, they didn't set forth boundaries of, “How much can you get? Where's the line of what you need?” And so, that's become an issue of, “How valuable can I make my patent for this client?

NU: What are some of the big patent issues right now across different jurisdictions for biotech and life sciences?

JB: So going back to the patent eligibility - one of the biggest things I'm facing with some of my clients that reach globally with their technology and commercial embodiments, is that the patent eligibility standard we now have - and the biotech space for the United States - is extremely different than what we're seeing in Europe, Japan, China, and pretty much every other jurisdiction. A lot of times, companies that are going globally, they'll file a global or international application. And then that gets broken off into the countries. Typically, we like to see prosecution examinations go pretty similarly, right? Similar in scope with the claims, with similar arguments being made. We wanna make sure that we don't step on ourselves as we go across jurisdictions. And somebody can't come in and say, “Hey, you said this in Europe, but then you contradicted yourself in Japan or the United States.” And so we like it going the same way. There's not really an equivalent of what our standard is for eligibility, when you see it globally. Just on a business front, it's extremely uncomfortable to have to tell your global client, “I know university patent protection in every jurisdiction besides the United States. But, what I'm telling you here is, the only way we're going to get it is to add a treatment claim that I know you don't want to add.” 

It's very hard to explain to the client. And they're very sophisticated. They understand what the United States has done, even if they're not based in the United States. But it's still extremely difficult to have to go to business people and say, “I know that everywhere else has allowed this.” So that's been difficult, just for that reason. Again, with the enablement written description, DNA sequencing rules, they have made it more consistent. So I don't think that's been near as a problem, explaining to the global clients that they're getting the same types of pushback in these other countries. So I don't see it quite as much of a business problem.


NU: What was your path to IP law like?

JB: Mine was not the typical career path. I went into biology because I have always been excited about science and math, and I did relatively well going through school. And so from a very early age, I thought I could be a doctor. I wanted to go to med school. I wanted to help people. And my mom told me, “If you're gonna be a doctor, you're gonna have to be sympathetic to people when they get hurt, or when they cry.” And I thought, “Yeah, I know I could do that too.” But as I was going through - especially my undergrad in biology, I took a class: it was a forensic pathology class, and it was the medical examiner in central Missouri. Fantastic. Still my favorite class of all time. Plus true crime was getting to be a big thing, right? I mean, it still is. 

And so I thought, how much fun would it be to be able to be a doctor that doesn't have to have good bedside manner, right? But that can help with law enforcement, crime, trying to put away dangerous people, trying to help solve why things happen as they do. And you also get to see diseases. How did that progress in somebody's body? I could not believe how interesting that class was. I mean, even for some of my friends that took it not in the biology world, it was novel.

So I was like, “Okay, I think I've, I found my career path.” And then I interned with a forensic pathologist and I found out that I don't get to do that right out of med school. They're gonna make me work in a pathology lab. Which is great - but given my undergraduate laboratory experience, I am not the best at lab work.

My mom and dad spent more money on lab equipment that I had destroyed during undergrad tests, than, I think, my textbooks. So it was one of those things: okay, well maybe if I can't be a forensic pathologist, what do I wanna do on that criminal side? And so I started looking at law, because the forensic pathologist that I interned with, she was mentioning that. She's like, “You know, I actually have my law degree as well because I'm deposed so often, and in court.” So we're off to talking about things. It just made sense to get that as well. 

So I said, “You know what? Maybe what I'll do is go to law school. And we'll figure out my path in the med school version, but let's get this done first.” And I just kind of lucked out. The very first week of school, I got to sit by a fellow student whose neighbor was a name partner at an IP boutique (firm) in St. Louis. And so when she heard about my background, she said, “Oh, you probably wanna go into patent law.” And I said, “I don't even know what that is.” So I took a couple classes, and actually this name partner did a night class. And it was amazing. I mean, as much as I love science and the law, patent law gives you that idea to see all the cool things that come out of the lab; all the different things that change. And you get to see why things happen, and you get to do it from the safety of not having to worry about me messing up lab equipment, right?

I span everything from the pharmaceutical world where a new drug is being patented and we're trying to cure some disorder, disease. All the way to consumer hygiene products. I mean, I had a client when I first started out that was in infant care - and so they had diapers, wet wipes. And you thought, “Man, we've had diapers for a long time. What could possibly be happening?” But one of the cool things they did is try to make the diapers more absorbent. We don't want children to have to feel any type of liquid against their body. We also don't want any kind of reaction. But then at the same time, they were noticing that delayed potty training.

So now you have, and I'm sure you've seen the commercial, where they put the designs that come on diapers. Or it has a feeling where the insulation in the diaper itself expands, so it puts a little pressure. My husband laughs because he was like, “So you wanted to cure cancer. You wanted to be a doctor, and now you're making diapers more absorbent.” But you do get to see something different every day from the lab. And it's so cool how technology, how fast these companies are progressing things that we take for granted in everyday life.

NU: Do you have any advice for anyone else from a biology background who's entering law?

JB: It's something that's so exciting with the science background, that I know people think, “Oh, lawyers, that's probably sitting behind a desk or arguing in front of a judge.” And to our litigators, I know they love that too. But it's so interesting to see with your science background, how much law and science can go together. And how you can work on things to help improve our comfort, improve our health, and everything we do. It changes so often. 

I feel like a lot of times one of the drawbacks of being on the prosecution side - I see products right off the lab, right? I get to see it before anybody else has seen it, which is a super cool thought. One of the things that I think would be fun - and if they go to law school, you can always do in litigation - is see how that plays out on the market and see how things go onto the market. And it's really cool scientifically, but how it's valued; how consumers react to it. And then, to try to play off of, why is it so much better than before? 

Because now you have to defend it. I think with a science background, you not only get that technology. You get to keep involved in the science and in the progress. But you get to see it from a commercial side, a business side; you get to see the whole picture. If I stayed in biology and I went into the lab, I only get to see what's in the lab. I don't ever get to see it progress. Same thing when in the university setting. Obviously there are a lot of fish in the biotech side; postdocs and PhDs that decide to go to law school and do this. And they stay in the university for a little bit, but they're in the same lab all the time. And they're going to do a lot of the same things for their whole career. And I'm sure that is probably phenomenal for some people. But you get to see so much more when you go into the law side of it. You get to see so many different types of things, and that makes it exciting everyday.

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This AccelPro audio transcript has been edited and organized for clarity. This interview was recorded on June 30, 2023.

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AccelPro | Intellectual Property Law
AccelPro | Intellectual Property Law
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