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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 Joanna Brougher, Owner & Principal, BioPharma Law Group, PLLC.
Brougher is a patent attorney who focuses on all aspects of services related to patents in the areas of biotechnology, pharmaceuticals and medical devices, including patentability opinions, due diligence, patent drafting, domestic and foreign patent prosecution, development and management of patent portfolios, and general client counseling during all phases of a product’s lifecycle, from concept to commercialization.
She is also a former Adjunct Lecturer at the Harvard School of Public Health and the current Editor-in-Chief of the Journal of Commercial Biotechnology.
We talk about inventorship in patent applications, inventorship disputes, incorrect or incomplete inventorship, IP for biotechnology compared to other fields, and more.
Listen on Apple Podcasts, Spotify and YouTube.
Interview References:
Joanna Brougher’s BioPharma Law Group profile.
16:14 | Brougher, Joanna. (2013). Intellectual Property and Health Technologies Balancing Innovation and the Public's Health. Springer New York.
Supplemental Materials:
Brougher, Joanna. (2019). Billion Dollar Patents: Strategies for Finding Opportunities, Generating Value, and Protecting Your Inventions. JTB Publishing.
TRANSCRIPT
I. INVENTORSHIP AND PATENT APPLICATIONS
Neal Ungerleider, Host: What are some of the most common challenges you encounter with inventorship in patent applications?
Joanna Brougher: There's a lot of challenges when it comes to inventorship, especially when you talk about joint inventorship and especially when that joint inventorship comes from having people from more than one company on a patent application. People tend to want to be listed as inventors on a patent, even though they may not have contributed to that level of inventor.
What happens is that it then creates problems with who actually owns the technology. Anytime you have more than one person, and especially more than one entity involved, you suddenly risk having ownership spread out across the different entities. Sometimes you end up with joint ownership. Sometimes, you even have ownership being transferred to the entity that should not be part of the whole patent application. A lot of the challenges really stem from having joint inventors, and improperly joint inventors, listed on a patent application. It can be really challenging to fix those problems down the road.
NU: What are some of the ways that disputes typically arise regarding inventorship in biotechnology? How are they resolved?
JB: There's no easy way of resolving these issues, unfortunately. I've been involved with several over the past couple years, and each one is more challenging than the previous one to resolve. It's always better to avoid having inventorship issues by being proactive in the whole process, but sometimes it's unavoidable.
Sometimes you have a situation where a company acquires another company. All of a sudden, you now have new patent attorneys looking at the portfolio. You start asking questions. Why is a certain person named as an inventor? The more you start digging, the more you start questioning not only why is this person named as an inventor, but why is the ownership in a different entity than it's supposed to be?
A lot of the issues start coming out when, for instance, you have an acquisition or when you're doing due diligence for some sort of acquisition. Or when you transfer to a new law firm that all of a sudden just reviews the portfolio from a new perspective, and starts asking questions. There's really no good way of solving these after they arise. It's always better to be a little bit proactive, and avoid having inventorship issues, although sometimes you can't avoid them.
NU: You mentioned being proactive to avoid these issues. What are some of the ways of stopping these sort of disputes from happening?
JB: Inventorship always comes down to the claim. You want to look at the claims in your patent application and ask who conceived of the idea behind the claim. When you start drafting a patent application early on in the process, you want to look at the claims, and you want to think about who should be named as an inventor. You want to talk to those inventors and see if they have any evidence to support them being listed as inventors.
That's on the initial part of drafting the application. But once you start prosecuting that application, sometimes the claim can change. Anytime you change the claim, people can see if they are still properly listed, or if you need to remove somebody, or perhaps add someone new onto the application.
Then, finally, when your patent actually is ready to grant–which hopefully it does—you want to look at those patent claims again and just double check and triple check to make sure that the correct people are listed as inventors. That's best case scenario. Obviously, not everyone follows best case scenario. But in the ideal world, if you are proactive at each step of prosecution through grant of the patent, you can at least say that you did the best possible job you could to make sure that the proper people were listed.
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II. IMPLICATIONS OF INCORRECT OR INCOMPLETE INVENTORSHIP
NU: What are some of the implications of incorrect or incomplete inventorship on a patent's enforceability?
JB: There are huge implications at all different aspects. On the most extreme side, if you have an improperly listed inventor for instance—and that's the result of some inequitable misconduct—that can completely render a patent unenforceable. Which is worst case scenario. You do have that on one side of the spectrum. You do have complete unenforceability of the patent.
On the other side, you have issues surrounding ownership, which we touched upon earlier. If you have somebody listed on a patent, that doesn't necessarily mean they will have ownership of it but oftentimes, it could. I've dealt with situations where you have two friends talking over wine one evening, and coming up with an idea for an invention. They don't have an agreement between themselves on how IP is going to be handled, but then they file a patent application.
What happens? That patent is granted and by default, they're both joint inventors. This means that they will also be joint owners of this patent application, which has huge implications down the road, too. Because if you are a joint owner of a patent, that means you have 100% interest in that patent, and you can do whatever you want to do.
I can go and sell that patent to Merck, for instance. My co-inventor will not be able to stop me. At the same time, he could go sell that patent to someone, and I can't stop him. Ownership is a huge implication for these situations, and it's one of those things that we worry about a lot.
In the middle realm, you also have improper inventorship which affects what prior art can be listed against your patent. It could make it harder to get a patent, or easier to get a patent granted by the Patent Office. On the flip side, it'll make it easier for someone to invalidate your patent. I'm not sure if you guys have heard about terminal disclaimers, but they're in the patent news quite a lot lately. Improper inventorship and improper ownership could render your patent term disclaimed. You could lose five, ten years of valuable patent term. So you have those issues as well. There's a lot of implications for having incorrect inventors on a patent.
NU: For clients working in the biotech and pharma spheres: What are some best practices practitioners can use to their clients to ensure proper inventorship is documented from the start of a project?
JB: We want to be able to document these things. You want to keep track of who's working on a project, and who's contributing what to a project. This becomes especially important when you have people not only from your company working on something, but you're collaborating with another entity. Whether it's an institution, or whether it's another industry partner.
You want to keep track of who's doing what, and you want it to be written down somewhere. Ideally in a notebook, because that's the best way to corroborate something. I think best practices really do start with keeping track of who's doing what on these projects. Ultimately, questions of inventor are going to come down to exactly who conceived what, and how that plays a role in those patent claims.
NU: How does collaboration between academia and industry specifically affect inventorship claims?
JB: From the fundamental level, it shouldn't affect it too much. Inventorship by itself is a question of law. If somebody contributed, again, to the conception of idea, they have to be listed as an inventor. This is completely different than, for instance, if I wanted to publish a paper for academia or in some journal; I can list 10 of my favorite colleagues on that paper. If somebody helped format the paper, if somebody helped me create a graph or a chart for that paper, that person can be listed as a co-author on that paper.
But inventorship is different. Inventorship is a legal analysis. Who conceived of the idea behind the claims? If they did, they have to be listed. From that aspect, it is the same whether or not you have an industry partner or an academic partner. If they have to be listed as an inventor, they will be listed.
Where I think they may differ is in this whole idea of ownership. If I'm working in industry and I have another industry partner, sometimes we can have an agreement that says: regardless of inventorship, my company is going to own the end result. With an industry partner, sometimes that is possible.
But oftentimes with academia, at least in my experience, if the academic person is listed as an inventor on your application, then automatically that academic institution has some ownership rights. Either full ownership rights, if only their people are listed on the project, or, if one of their people is listed on your patent, they may get co-ownership, which then will affect royalty terms, and perhaps the licensing terms that go with it. I think when you're working with an academic partner, the inventorship probably will be handled similarly than with any other partner. But the ownership could certainly have more changes to it.
NU: In your experience, how have courts handled complex inventorship disputes in biotech?
JB: They're always complex. They do go to the courts quite often. They're very fact intensive questions. All those come down to the facts at the end of the day. And this is where those notebooks come in handy. Email correspondences that show who came up with an idea, and who did not come up with that idea. They really are complex cases, I believe.
I'm not a litigator myself, but I work with a lot of litigators. I think inventorship disputes are probably some of the hardest disputes to handle out there. Oftentimes, you don't have this corroborating evidence. It's one person's word against another. Then it really just becomes who can present the best facts possible. These are all very challenging cases to resolve. They have really severe implications. Not only for the patents themselves, but for the ownership of these patents. It all comes down to the facts.
Again, it comes down to who conceived the claims. The best way of dealing with these types of scenarios is to avoid them in the first place. Make sure that you're giving the inventorship question the proper diligence that it deserves from the start.
NU: What makes biotech and pharma unique compared to other areas of the IP world?
JB: It is such a fun area to work in. You're working with groundbreaking, valuable and life saving technologies, to begin with. The stuff that we're seeing coming through the patent system right now is not even commercialized and probably won't be commercialized for another 10, 15, 20 years. You're always working with new groundbreaking technologies, which just makes it super exciting. Even since I started practicing law in 2008, the law constantly changes.
I remember being told by one of the partners that I work with that my job is recession proof. Because if it's not the Patent Office, and if it's not the Congress, then it's the court system that's constantly changing the laws on us. It constantly makes it so that we can offer something new to our clients, even though sometimes it gets frustrating. But there's always something new out there, something new constantly to discuss.
Even this topic of inventorship. I've been teaching a class on intellectual property law for 13 years. When I first started teaching my class, this topic was maybe a 30 minute presentation overall in the whole span of a semester. Now I feel like inventorship issues are just so interesting and exciting, that I could probably fill two full classes, if not more, just discussing inventorship.
It's constantly evolving and makes it interesting to learn about new topics. It makes it interesting to think about the strategy behind getting patents in the first place, and behind enforcing these kind of patents. I think there's just a lot going on in the field.
NU: One more inventorship question. How would you advise clients to navigate inventorship issues during patent drafting and the application process?
JB: Again, we're coming back to the claims. As soon as you draft your claim, you want to look at what it actually is in those claims, then you want to start talking to the people who are involved in the project who bring forth those claims. It's always talking to inventors, either at the company who may have been involved in a project, or, if it is a project that spans more than one company, you want to talk to everyone who's been involved. You want to keep track of who's responsible for what claims.
As you file that patent application with the patent office and you go through the prosecution process, those claims may change. Every time they change; you want to come back and ask these same questions again.
Make sure the same people are properly listed on that patent. The last thing you want is for somebody to start questioning inventorship, because that can create a lot of headaches down the road.
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III. CAREER PATHS TO IP LAW
NU: Can you tell us a little bit about how your firm BioPharma Law Group came about, and your career path?
JB: I started as a patent attorney at a law firm in Boston after law school, and I worked there for about two years. This was after the great recession of 2008-2009. My husband was a year behind me in law school. He was not as fortunate when it came to the job market back in those days. When he was looking for a job, he did not find a job right away in Boston, but he did find a job in Rochester, New York, which just happens to be where I was from.
We decided at that point we were going to move from Boston. We're going to move to Rochester, and see what happens. Little did I know that Rochester was just not the same biotech hub as Boston was. It was a little bit more challenging finding a job in the biotech pharma space. But I did end up getting a position as the only attorney at a small biotech startup in Rochester, which was a fabulous opportunity.
I was the only attorney at the company. I handled everything from patents, to contracts, to clinical trial agreements. I started broadening the scope of my practice beyond just patents. I was also teaching at Harvard back when I was living in Boston. Even after I moved out of Boston, I kept teaching a class on intellectual property at the Harvard School of Public Health. During that time, I published my first book. I basically took my syllabus from Harvard, and turned it into a course book.
At least one person did buy that book and read that book. They contacted me and asked me to be their attorney on the patent side. Ten years ago, I left my in house position and started my own firm. I still work with that client to this day. We've built a really nice patent portfolio for them. Now we have the opportunity to enforce that patent portfolio, and protect their position in the market.
In the course of all those years, I kept picking up new clients through referrals and so forth. And I keep teaching. I don't teach at Harvard anymore. That became very challenging with commuting to Boston all the time, but I do teach at Cornell Law School now and at Penn Medical School. I do teach those courses in the fall semester.
NU: Do you have any advice for listeners who may be making transitions from working in-house to starting their own firm?
JB: You just have to go with it. It's not going to be easy by any means and it's not going to happen overnight. I was lucky that I had a company that decided to give me a chance by reading one of my books. But if you just go out there and you want to start your own practice, then you can do it.
I used to write a lot of articles and different publications; I used to speak a lot; I used to volunteer to go to conferences to speak and get my name out there. All of these things always help you. I think all of those things are very valuable if you want to start your own practice, because it just gets your name out there. Then you start accumulating one client here, one client there, and it just keeps growing from there.
NU: Can you give the AccelPro community an example of a time when a peer helped you with a difficult challenge during your career?
JB: My husband's my number one supporter, and he backs all of my crazy ideas, even starting my law firm when I was eight months pregnant. One month before my son was born is when I started my law firm. He backed that crazy idea. Then he's backed all of my crazy ideas. Whether it's teaching and commuting back to Harvard once a week to teach, or going to conferences overseas. He thought all of those ideas were just worth it, and worth a shot for sure.
For all my other crazy ideas, buying a horse, he was okay with that. And then when it came time to buy a truck and a trailer for the horse, he also was okay with that. I think my husband is my number one supporter and somebody who's been backing my crazy ideas from day one.
Listen on Apple Podcasts, Spotify and YouTube.
This AccelPro audio transcript has been edited and organized for clarity. This interview was recorded on May 30, 2024.
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