As technological innovation continues to prompt evolution across the life sciences landscape, the biotechnology sector is seeing rapid growth that is igniting industry competition and, with it, litigation. And with steep patent cliffs looming, financing decreasing, and regulatory action ramping up, it is important to understand where potential complications may lie for major players in the space for the remainder of 2023 and beyond.
An Academic’s Perspective
To examine what is to come in the biotechnology industry, we asked DOAR expert and accomplished academic, Dr. Brenda Wilson, to evaluate the industry – its evolution, the rise of biologics, the effects of AI, and more. Here’s what she had to say:
DOAR: As a respected microbiologist with decades of experience in the industry, what changes have you seen in the biotechnology space since you started?
Dr. Wilson: Certainly, there’s been a huge push towards biologics in terms of their development and use. For example, we saw the impact of biologics with the development of Covid’s new messenger RNA vaccines, and there are various other biologics being developed and used for all kinds of diseases and disorders. Botox was one of the first examples of a biologic toxin used to treat human diseases, but now we have a myriad of other types of biologics being used to treat everything from cancer to arthritis. I think that that’s not going to go away now that the precedent has been set and biologics’ use is going to continue to grow as the industry continues to innovate this technology.
One exciting trend in the industry right now involves microbiome-related technologies. We are seeing a lot of innovation being developed in the use of the microbes that make up the microbiomes. Scientists are researching proprietary uses for particular organisms. And the metabolites, or the products that microbes make, are gaining a lot of momentum in this fashion as well.
Additionally, there is a lot of innovation happening with gene editing and gene technology. The interesting thing about gene technologies is that the products are left such that you don’t know that they’ve been manipulated. Gene editing tools are going to take off in terms of being able to manipulate the genetics of any kind of organism, not just microbes.
DOAR: Do you think that artificial intelligence is going to create conflicts in the industry?
Dr. Wilson: When it comes to artificial intelligence and machine learning, there are going to be a lot of issues with the data sets that are used to train biotech AI platforms because they have to use massive amounts of images, texts, and other data inputs to train the algorithms, which can be extremely invasive. The big question that comes to mind is where are AI companies going to get a high volume of that kind of information without violating privacy?
The problem is, AI tools will look to sources on the internet, which will call into question who owns the data and more importantly, if the information itself is accurate.
Oftentimes, there is no indicator of the source of the data, and no way to ascertain if their data has been stolen. As AI is more heavily used and relied upon in the healthcare space, more conflicts will arise over liability if the AI fails to accurately provide a diagnosis or treatment plan.
To mitigate this, we may need to establish rules on how these platforms are allowed to be trained. But until then, it is going to be very challenging for entities to enforce their IP portfolios under the current circumstances.
DOAR: In addition to AI conflicts, what other issues do you predict will spur litigation in the space over the next two to three years?
Dr. Wilson: In terms of biologics, conflicts will surround defining what exactly the microbes are or the actual biologic is. I remember when patents were first given to a strain of a pivotal bacterium that could be used for a defined purpose, but now there are so many, and it leaves me to wonder: are you actually going to make a patent on every single one of them, especially when you can manipulate and change them very easily? Nowadays, it is so easy to make a mutant; you can do it in a day, and these changes can be expansive.
So, at what point is a biologic organism unique? And because they are living things, can we actually call them patentable? Since anyone can now make similar changes to a biologic that achieve a very similar outcome despite making those changes at different points or places in the genome, the line is blurred when it comes to if this is an IP issue, which is a major problem. There must be a defining line about what is considered the “same” organism so we can understand if a proprietary organism has actually been stolen. That issue is not going to go away, and it is going to get worse especially now with all of these microbiologic therapies and gene-editing technologies that can prevent you from knowing if an organism is naturally occurring or something you have manipulated. That is going to be a huge point of contention.
Additionally, there are now all of these biologics that are antibody-based. And something that I see as problematic is that there is a lot of information indicating that a patient’s personal microbiome can influence the way your body reacts to specific treatments, specifically antibody-based anti-cancer therapeutics. If you are an “anti-responder”, not only is the therapeutic not helpful to you as it might be in the case of “non-responder,” but it makes it worse. So, in the case that a patient passes away from this type of treatment, who is at fault? When you’re dealing with biological systems, the host’s entire life history experience will affect the outcome of some treatments, which opens the door to conflicts over liability.
DOAR: The concept of “lab-grown foods” is a trend that we have observed to rise in prominence in the biotechnology space over the past few years. Where do you think the industry is headed?
Dr. Wilson: Plant-based foods will make an impact on the meat industry which could spur a slew of conflict, but not necessarily concerning the products themselves but around the formulations for making it look more like real meat. Right now, major players know the secret to creating a plant-based food product, but they are still trying to work out specifics when it comes to meat-like texture, which will open the door to disputes over intellectual property as companies attempt to create proprietary formulations for their lab-grown products.
Additionally, another thing that I see rising to prominence, especially after the COVID era, involves food-based vaccines. Innovations in gene technologies can create genetically modified plants, boosting the expression of a vaccine in the plant itself. Nowadays, we can actually generate plants that make a lot of the antigen that we need, and they can be dosed. I am a consultant for a small biotech company incorporating epitopes of vaccines (antigens) into tomatoes. So, you can now modify tomatoes, freeze-dry them, then take a pill to get your vaccine. I think that this is an area that is now very viable. But I see this to be an area ripe for patent issues, especially as more major players break into this burgeoning market.
DOAR: Where do you see competition lying in the industry over the next few years?
Dr. Wilson: Antibiotic resistance is a top threat to human health globally. The industry has been reluctant so far to take up the charge in this area but governments around the world are putting pressure on the industry by putting billions into upfront research funding to incentivize market players to take up the work. The competition in this area is going to be huge, particularly with the patent cliffs coming up. I fear that nobody is going to be working with each other.
DOAR: Looking a little further into the future, do you think any rising areas in the biotechnology industry will generate litigation in the next ten years?
Dr. Wilson: While it is still in its infancy, one future trend that continues coming up in the field looks at 3D printing for generating medical devices and other biotech products. I think that AI will help push this forward, but it will also bring questions surrounding IP regarding ownership of the design, if it is patented, if it is okay to copy, and more.
The Essential Role of Experts
The next five to ten years will see a host of legal issues in the biotechnology industry, and having an experienced biotech testifying expert witness on your side when preparing for complex disputes is essential in creating a successful litigation strategy.
When it comes to intellectual property, Dr. Wilson highlighted that the impending patent cliffs will spur a slew of litigation as companies turn to burgeoning markets in biotech to fill revenue gaps. Further, establishing patents on biologics or microbes could ignite conflicts surrounding the patentability and uniqueness of each specific application. Lastly, patent battles over the formulation of lab-grown foods and machine learning data will also likely hit the courts en masse as these two technologies continue to rise in prominence. Experts in this space can provide assessments on biologic drugs, cellular architecture, and more.
Product liability concerns will also be a point of contention for the industry as companies attempt to define who will be liable for complications associated with artificial intelligence and antibody-based biologics. Highly credentialled academics and technical experts can opine on the complexities of AI, help those in the industry understand machine learning processes, and provide insights into the science behind specific biologics.
At DOAR, we have built teams of biotechnology testifying experts that are prepared to handle all aspects of biotech litigation regarding the ins and outs of complex and novel science and technology. Want to learn more about what’s to come in 2023 for the biotech industry and lab-grown foods space? Reach out for biotech experts who are uniquely qualified to inform your litigation strategy.
