AccelPro | Intellectual Property Law
AccelPro | Intellectual Property Law
On Best Practices for Biotech Patent Portfolios

On Best Practices for Biotech Patent Portfolios

With Stephen C. Hall, Partner at Wyatt | 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 Stephen C. Hall, Partner at Wyatt.

Hall is a patent attorney and former research and development chemist who specializes in patent creation and drafting patents for biotechnology, medical therapy, physical science and information processing clients.

Hall discusses protecting biotech innovations with patents, keys to portfolio management, what questions practitioners should ask their clients and more.

“Always start with what problem the company is solving: Why has it been difficult in the past for others to solve it? You want to get into the portfolio, what assets are held, and what is it that makes the company valuable, but at the highest level, come up with the message. What problem is being solved?” Hall suggests.

“Another way to look at it, and this is actually a pretty good question to ask yourself as an intellectual property attorney or maybe even as a client: What's different in the field because you're in it; because your company is in it?”

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Interview References:



Neal Ungerleider, Host: From your perspective, what are the most challenging aspects of protecting biotech innovations with patents?

Stephen Hall: One of the first ways that I think about the challenges is going back to a simple triangle that I have in mind: What is it that the client invented? What is it that makes it unique? What is the best way to protect that? If you think about the three edges of that triangle, it's the first one that presents some of the most interesting challenges.

What is it exactly that was invented? Many times in our world of biotech, what's invented can be less predictable. It is more subject to variables than some of the other fields. We see that not only in terms of the client's view of the world and the things that they have to do in light of that variability, but also in some of the rules and regulations that we operate under in the patent law.

Expanding on that a little bit, one good example is that products of nature will often come up. How does one avoid problems of patent ineligibility because it's merely a product of nature? Then, of course, there are things like enablement and the scope of the claims. We see cases that can have just massive scope of claims, especially if functional claiming is used. But in other contexts that tends to come up; it can come up given the variability of life sciences and biotechnology.

NU: What are some of the key elements in a strong and defensible biotech patent portfolio?

SH: One of the key elements begins before you even start putting pen to paper. One of the things that I stress to myself when I'm thinking about how I want to come to work and be there for my clients, and that I share with other people, is the need to understand the client—really see the world through their eyes as much as we can as lawyers. That's probably one of the first things. 

There's an old adage that is sometimes used in business: What do you do that's better, faster, and cheaper? I like to think of it as through biotechnology: What kind of quality is being brought to the marketplace? What extra efficiency is being brought and how is the solution less expensive than traditional ways?

Having a good understanding of that goes a long way as a starting point for the type of portfolio that you mentioned. Right there, that's your mindset. You always want to be thinking about how many different embodiments are there that need to be described, or that can be described in the base application or in the platform.

There always needs to be a very robust disclosure. We always think about the balance and the claims that we're striving for, from as broad and general as possible to the more narrow. The thing to think about in this context is that these portfolios are very large, so you have to start somewhere. 

Often, it's at a platform stage. Where you go from there is the really interesting part: How everything ties back through to that initial platform, if you're talking about a family of patents, can be interesting. 

There are a number of other things we do in thinking about this portfolio that we're trying to build—it's very helpful to think of it like a progression. Sometimes we can get focused on what it is exactly that the client is putting out there to the world. 

Inside of their facilities, there are usually other transition points that happen along the way. Maybe they're taking a raw material and turning it into something else before it's even combined into the finished product. We look for those kinds of ways to say: What else can we try to patent for them? Where else can we find value for this client?

It’s the idea of not leaving something on the table if it's valuable, that, if you're building a more effective series of fences, the components, the transitional states, are also being protected in addition to the methods that go into getting to those components. 

Some other things that we think about are locality, where will you seek to have the patent applications or patents pending? Obviously those are very situational specific decisions, and a lot of strategy and cost goes into that. We usually start from the perspective of “What's the ideal case for you in terms of protecting?,” then we think about the cost, and then we make the business case for it. 

You always want whatever you're doing on the patent side to align with what the business objectives are for the client.


NU: What are some of the things that differentiate biotech and life science patent portfolios from patent portfolios in other fields?

SH: Biotechnology and life sciences areas, these are areas where science can be a little less predictable, in some cases, a lot less predictable. When is it that a protein is actually going to fold into the right confirmation to be functional? What is it that makes a colony of probiotics able to stay alive in one environment? But if you put it into a similar environment, you think it'll have the same result, but it doesn't. 

These are all things that are unique to living organisms that are often the workhorses in biotechnology. What the field does, what the art does, is actually harness nature. That's the way I think about it. Some other fields obviously use the laws of nature; there are mathematical and physical relationships at work. 

What's unique about biotech is that you're having nature and living organisms do the work. You're having them change matter, change the nature of matter, and you're having them assist with analyzing substances or making diagnoses. It's the harnessing of nature that makes it unique. 

In that way, it doesn't always boil down to mathematical relationships, physical relationships, and all these other kinds of things. It really gets back to the point of stressing what it is that makes the client unique in their space.

NU: Besides patents, what other forms of intellectual property protection do you recommend for biotech and life science companies?

SH: Trade secrets are always something very important to consider. Of course, the other two are copyrights and trademarks. I'll go right into what I think is interesting about trade secrets as being the polar opposite in many ways of patents. I usually think of three different words that distinguish the two. 

Distinct patents and trade secrets are distinguishable in terms of disclosure, in terms of the record that's made, and in terms of the ongoing status of these. With disclosure, obviously patents will be disclosed to the world once the patent is issued, if not sooner. 

There's a very public record on patents that's available through the agencies around the world, and through which prosecution occurs. And they're not ongoing, whereas, for trade secrets, it's the exact opposite. You don't want to disclose it. The record has to be done internally if there is to be a record, and it is ongoing and perpetual for as long as it's kept a secret. 

That informs how we approach it with our clients. One of the first questions we ask is, “Can what you're putting out there be reverse engineered?” We're not talking about a trade secret at that point, but there are a lot of things that happen inside of a client's facility that could form viable trade secrets. 

Oftentimes, there's some preparatory stage that's happening, something to prepare the materials that are being used that the public will never see. Those kinds of things can be good subjects around which to talk about trade secrets. One of the big questions I often get from clients is: How do we create a trade secret? Where would you go to find it to look it up? 

It's really an intangible discussion; there's no manual; there's no guidebook. There might be case law on it, but there's nothing akin to the manual on patent examination, the MPEP for that. You have to do what makes the most sense in that situation. Obviously, you want to have some indication of what the trade secret is, and be able to prove that it was owned and how it was protected if the issue ever comes up. 

These can be very valuable and can add to the portfolio of a biotech company if they're interested in being invested in or acquired at some point down the road. They can also be extremely useful in deterring competition, especially with information being as portable as it is today, a lot of care has to go into that.

There are also certain defenses to patent infringement if the company is able to show that it did indeed have the trade secret to the same subject matter as the patent that's being enforced against it.

NU: Do you have any recommendations for working with companies who are looking at fundraising or acquisition?

SH: Always start with what problem the company is solving: Why has it been difficult in the past for others to solve it? I think that's usually a good starting point. Obviously you want to get into what is the portfolio, what assets are held, and what is it that makes the company valuable, but at the highest level, come up with the message. What problem is being solved? 

Another way to look at it, and this is actually a pretty good question to ask yourself as an intellectual property attorney or maybe even as a client: What's different in the field because you're in it; because your company is in it? 

That's one piece of advice. Your company has to have a good appreciation of that, because it's the problem they're solving. It's the way that they set themselves apart from their competition. All that combined with the valuable assets that we help them create as patent attorneys and intellectual property attorneys.

NU: How do international patent laws affect strategy for filing biotech life sciences patents?

SH: Mainly, there are three ways: the support that's required, the costs that go into it, and the procedures that are used in various locations. That's one level of thinking about it. Then you get into the other levels around competition, but let me speak for a moment on those three things. 

Different countries, as your listeners know, will require different levels of support. Some are more strict in terms of the amount of support that is needed. Does it have to specifically be described? Is it something that a person of skill in the art would be able to take from the disclosure? That is one example of how that plays out.

There are different rules on, for example, how you claim a genus and how you support a genus, as opposed to species and that sort of thing. We really think about that in terms of the key markets that our clients are going to go into. 

Cost is another. There's a lot of data on that so we probably don’t need to hit it too hard. Foreign councils can always provide a list of what it costs to file a patent in their jurisdiction. However, you get into things like, how many independent claims can you have in a certain country? 

In the United States, we have it pretty good by comparison to some other countries because you can have a number of independent claims. If you want more than three, you can pay to get more than three. Whereas, in other countries, you must either file a whole lot of divisional applications in that country, or really prioritize what it is they want to protect because they're more strict. That's the cost. 

Then there are other countries that have different procedures, such as how many rejections there can be of an application before it has to go to appeal. Here, as everyone knows, we have requests for continued examination. Some other countries don't allow for that. So you have to think about that in the way you prosecute. 

Those are just some of the procedural things, some of the inherent things that you consider within the patent laws and regulations of other countries.

From there, thinking about strategies in foreign countries, where are you likely to sell the product? Where it is that your competition might be making the product, is another one that innovators in this area are often thinking about. What is the ideal case for where you want to go to protect this? What is the case that makes the most business sense for the particular situation?

NU: What recommendations do you have for clear contract language on ownership of new IP and prerequisites prior to any publication?

SH: Those are good questions that innovators think about very much, particularly in this space. There is the competing desire to protect the innovation, by having the patent application filed before there's a publication on it. 

At other times, it could be a company or a university with a desire to present on this topic if it's a breakthrough at a conference, or to get a publication out there on it. The best advice there is to be very clear in the contract, whatever the contract might be.

It could be a fee for services type agreement between the innovator. Here I'm going to refer to my client as the innovator, and for some other third party who has resources that they can use to help in this situation. So there's going to be some type of contract. 

You want to make sure it has the right language around publication and that everybody's on the same page. You could probably talk to different people and say, “How long is reasonable notice before the publication comes out? Given the technology, how long would it take to prepare the patent application and have that submitted before there's a publication?” That's one thing. 

You don't want there to be surprises. You want everybody to be on the same page and have clear markers on what can be published and what can go into the article or the presentation. Is there a mechanism for removing confidential information? 

A lot of times we see these are very good relationships that have existed for some time. That makes it easier on the front end to have that type of clear language in there. Everybody understands where the different folks are coming from who are trying to work with this technology.

Ownership is obviously another big part. An innovator could come forward and say, “We've got this innovation; we'd like for you to test it; we'd like for you to do something with it, with the capabilities that you have.” 

If something is going to be invented off of that, you definitely want to know how that's going to be treated, if and when that occurs. Who's going to own it? There are different options for doing that. 

You can say it'll be governed by the patent laws in effect in the jurisdiction. In this case, in the United States, the one who conceives of the improvement would be the owner. Other times you can say contractually that if such and such company is paying for the work and there's an improvement on it, then it would be owned by the one paying for the work. 

The main point of all this is just to have good contract language that spells it out, so that it's not ambiguous.


NU: Switching gears over to your career, I understand you worked as a research chemist. What was the transition like from research chemist to patent attorney?

SH: It's been fascinating for me, and I really wouldn't change anything about my career from a high level. I've been practicing law for a little over 30 years. As you alluded to, I graduated with a degree in chemistry, and went to work for industry for a short time before law school. After law school, I went into general litigation. That was the stepping stone.

I was not a patent attorney at the beginning of my career. The type of litigation that I was doing, I would refer to as science based litigation. It was some drug and medical device defense work. I also was with a firm that did medical malpractice, and hospital malpractice defense work for that.

I did those things for about 12 years before I became a patent attorney. What really drew me to patent law was that I've always had a desire to use my science background in my practice. I always had my eye on patent law, because it's the best area in terms of combining the legal knowledge and experience I have with the science background that I have.

My career is a Venn diagram between the legal and the science. I like Venn diagrams. I like things that overlap. The other thing I like is timelines. I like watching how things develop over the course of time. 

Patent law is really cool in that regard, because you see how certain industries develop over time as you review the prior art. It really combines a lot of things that go along with my personality and my interests.

NU: Can you give the AccelPro community an example of a time when a peer helped you with a difficult challenge during your career?

SH: I mentioned earlier that I had this season of my practice before where I was doing medical malpractice defense. 2005 was the year that I decided to take the patent bar and become a registered patent attorney. I was very busy during that time with the medical malpractice cases I had. 

There was one person in particular; he wasn't even in my firm. He represented a particular defendant in some cases that I was also in. So we had co-defendants that we were representing. It just so happened over the course of that time, we spent a pretty fair amount of time either at depositions, sometimes traveling to expert witness deposition in a case somewhere out of town. 

This person showed interest in me taking the Patent Bar. He was aware I was studying really hard. Just the fact that on a couple of occasions, being curious, asking me some questions, what that was like—overall just being genuinely encouraging on that front. 

It made a difference because anybody can take the time to be curious about what another person is up to, what they're about in a particular season of their career, and offer an encouraging word. It takes very little time to do that, but it can have a noticeable impact. 

I'm sitting here talking about it 19 years later. That was a situation where someone gave me some help during a fun time, an exciting time, but also a challenging time while I was getting ready to take that test.

Listen on Apple Podcasts, Spotify and YouTube.

This AccelPro audio transcript has been edited and organized for clarity. This interview was recorded on April 11, 2024.

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AccelPro | Intellectual Property Law
AccelPro | Intellectual Property Law
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