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Q&A: University of Cambridge Researchers on a Roadmap for Patenting Microfluidic Devices

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Microfluidic devices have the potential to revolutionize PCR and molecular biology, in general. They promise to bring hand-held diagnostics to the developing world and save lives. But what is the best way to get original technologies from the hands of engineers and into the hands they were designed for?

Researchers at the University of Cambridge, Ali Yetisen and Lisa Volpatti, perceived a gap in the way their colleagues were thinking about this transition.

In a paper titled Patent Protection and Licensing in Microfluidics, published last month in Lab on Chip, they argue that thinking about patenting and commercialization at early stages in the engineering process is crucial to give new devices the escape velocity needed to leave the lab.

And they don't just argue this position; Yetisen and Volpatti did all the legwork for their colleagues, providing both the rationale for patenting microfluidics as well as details about the process. They also have a paper in press with Trends in Biotechnology which describes commercialization of microfluidics.

Aiming to patent and commercialize may seem anathema to some academics, but Yetisen and Volpatti suggest it could be the best way to ultimately do the most good. Incidentally, it may also lend vitality to the global microfluidics market, which is estimated to double in value to over $8 billion in the next ten years, according to the paper, and includes major players such as Illumina, Agilent, Life Technologies, Fluidigm, Bio-Rad, RainDance, and Cepheid, to name a few.

Volpatti and Yetisen discussed their roadmap to patenting microfluidics with PCR Insider this week. The following is an edited version of the conversation.


Your paper is very thorough — you have a whole section detailing the steps and costs of obtaining a patent, so I don't want to make you retell that story. In general, if someone wanted to patent a microfluidics device through the US patent and technology office, how much time does it usually take and how much does it cost?

Yetisen: It takes about three to five years to get a technology patent. The cost at the filing stage is $2,600, but every year you have to maintain the patent, so you also pay fees along the way.

Why do you think it is so important to patent microfluidics, and why would you want to write a paper about how to do it?

Yetisen: In this paper, we wanted to raise awareness of commercialization among academics. One of the problems that we noted was that when academics start their work in the lab every day, they don't get to think about how to commercialize it. They tend to focus on [publishing] papers. So there is a gap between the academic efforts and what people in the industry are doing.

The idea was to make an attempt to bridge this gap. Also, a lot of academics find it a bit hard to read legal documents such as these different types of patents. We wanted to make it a little bit easier for academics to understand the legal language, because scientific papers are written in a different way.

In terms of legalese, do academics need to hire legal counsel to be able to write a patent?

Volpatti: Yes. We definitely recommend hiring a patent attorney to help with the wording of the claims, because that can be quite difficult. You don't want the claims to be too wide, or your patent will be invalid. But you don't want them to be too narrow either, or you're not covering enough space and then someone else can easily design around your patent. That's a key piece, and it might be beneficial to get someone with legal expertise to help in the wording.

Is the disconnect between academic research and commercialization more than just not understanding the process?

Yetisen: The main problem in the microfluidics field is that a lot of scientists and engineers tend to over-engineer their technology, to make these devices a little bit fancy so that they can market it in scientific journals. Science is pushing the boundaries in this case, but what the industry is doing is something different.

Volpatti: In that case, a lot of users want more of a black box type system, where you can just input your sample and get a reading, to make it as user-friendly as possible. To come up with all these [approaches] at the first design stage, rather than to try to change it at the end to get it to be usable and marketable, is something we are promoting — to start thinking about the end user and who you are going to market the product to from the very beginning.

So you're saying, before I think "I am going make the fanciest chip ever," I should think about what the industry wants?

Yetisen: You want to think about the implications of this technology, where it can be used, and maybe integrate the patent protection process in the meantime.

[However] one needs to wait until the technology comes to a mature state to get it right. For example, you need to make certain claims, and in order to optimize these claims you need to have a developed, or at least advanced, prototype. Some people tend to rush into patenting and they miss out a lot in the process.

Volpatti: Then, on the other hand, you don't want to wait too long and then have competitors scoop your product. So there is a balance to be reached.

Yetisen: Also, a lot of academics rush into trying to file patents, but there are other options. For example, the knowledge can be diffused through consulting, or by other means. That's were the technology transfer offices [at universities] need to come into play, and make a decision whether a technology should be patented or not.

You cite the Leahy-Smith America Invents Act from 2011, which upholds the right to leave out the best mode of operation of a device — can you explain that?

Yetisen: Let's say I'm making a device, but in the patent I'm not telling a crucial part of the fabrication or production process, so somebody else can't reproduce, even though they see the patent. This has been a problem in the past. What we are recommending is not to do this. Disclose what you have, and don't try to pursue patent protection and a trade secret at the same time.

Because it will cause your patent to be rejected?

Volpatti: Yes. In your patent you have to file a mode of operation. If you don't describe in detail how people can use it, then it may not be accepted. Even if you do end up getting a patent, it could also be contested in court. The idea is you either decide to go with a patent where you disclose all the information, or you just keep it a trade secret and not tell anyone anything.

Yetisen: Yes, in the US failure to disclose the best mode is not a basis for rendering unenforceable an issued patent. So the law changed in 2011, but we do recommend putting in the best mode. It's always an advantage if someone can replicate at the highest quality, in the case of defending the patent.

You've put a lot of thought into the landscape of the microfluidics development space. Do you see room for small labs and universities as well as bigger players, and how do they all fit together in this process? Do you feel there is a level playing field?

Volpatti: It obviously may be difficult for an individual who has a product to compete against a company. That's why we also discuss and encourage other modes of knowledge transfer. Maybe the individual could obtain a patent, and then license it to a large company to market. We think that each set of people — in startup companies, pharmaceutical companies, and small engineering labs — all play a very important part. It's typically the larger companies with more resources that can market [a device] more effectively. They have resources to hire a marketing team, and that sort of thing. But the smaller labs are also important. [They can] come up with different designs and obtain patents, then think about consulting or licensing.

Yetisen: One more point to add. If you're at a university and you come up with an idea, and you patent the idea, what happens is the university technology offices tend to approach large corporations and ask their opinions. In this process, a lot of these companies dismiss the technology offices so that they can bring the potential cost down. Or, they actually wait for the universities or whoever is pursuing to give up on the patent, not to be able to pay the yearly fees of this patent, and at that point they take the idea. The larger the company, the higher the advantage is going to be, and they tend to prey on smaller individual companies. It is a very common practice.

You write in your paper, "Striking a balance between academic publishing, consultancy to industry and patent protection can increase commercial potential, enhance economic growth, and create social impact." What do you mean by social impact, and why would a researcher be concerned with this?

Volpatti: We tend to think that researchers in the field are trying to create technologies that can help improve some process — maybe help other researchers in running PCR, for instance. There are a lot of microfluidic technologies that target the developing world. Social impact is to get the knowledge that the researchers come up with and spread it to the people that need it the most. Patenting is very good. But if you make a patent and you don't let anyone use it, and you don't end up doing anything with it, then that wouldn't have a very big social impact. If you decide to license it to a company, or market your product, and help as many people as possible, then that would have much more of an impact.

Yetisen: Also, a lot of researchers need motivation. It's good to just keep in the back of our minds that we're not just pipetting all day long, but we're also thinking about the potential impact [of our work].

Discussion of patenting or intellectual property isn't always a part of graduate training, but you are saying that if researchers are aware of this process it can change how they work or how they feel about their work?

Yetisen: It's a good point. Both of us did our undergraduate degrees in the US, but there was no formal training in thinking about how to file patents or anything like that. In the long term it will be an advantage, for industry as well as academia, if at least one lecture can be incorporated into undergraduate or graduate curriculums, to be able to teach some of the fundamentals of filing or maintaining a patent.

Some people might say, I'm not interested in business, I'm interested in saving the world, but you are saying it is through the commercial process that you can have social impact, or find a way to get ideas out of the lab and research papers.

Yetisen: Also, if you are trying to set up a company and you have a patent portfolio, it will give you an advantage compared to other companies with no intellectual property. So, it is always an asset to have a patent. But when I say patents, I mean optimized patents that can solve an important problem.

Volpatti: A lot of microfluidics technologies are fancy, they miniaturize, which is a plus for sure. But a lot of these technologies don't solve problems that are otherwise unsolvable. If you come up with something that solves a problem that you couldn't do any other way, then that would have a greater impact and be an optimized patent for a certain problem.

You took time away from your own research to write this paper and explain to other researchers how to file patents. Why?

Yetisen: There is actually a gap. There are not many academics willing to write about their experiences in early start-up companies. I realized that a lot of people think that it is not valuable to publish this sort of information. We were given an opportunity to talk about this specific topic, but I think in the coming years more and more academics will start thinking about commercialization, filing patents, as well as other important problems and issues often faced, for example [US Food and Drug Administration] regulations. There are different things that scientists need to keep in their minds when they're designing their projects, at the very beginning, rather than just going in and trying to publish papers.

Volpatti: Also, we were talking about how this is something that we feel is lacking in curriculums and in the literature. We actually had some people read our paper before it was published and say, "Oh that's just like a tutorial on patent law, that doesn't belong in an academic or a microfluidics journal." When it got published, we actually got great reviews from people who said this actually is very useful. I think some people just don't realize that it's important to talk about.

Yetisen: An important point a lot of academics miss is that if they want their ideas to become a reality, they need to think about patents and starting up companies. For example, if you have a very fundamental idea about biomedical research, and you discover something in your lab, the main way to take this idea forward and make it reality is to patent the idea and start up a company, so that this company can receive investments in the future. I'm not talking about small grants. I'm talking about $10 to $50 million of investment, so you can also hire specialized people who will only work on this idea and make this technology a reality. That's where the patents come into play. They are absolutely critical.

If you look at big labs, especially in the US, they are very aggressive in filing patents and starting companies, so that they can move into these translational science and medicine areas.

What do you each work on now, and has writing this paper helped you in your own work?

Yetisen: In my current work, I specialize in diagnostics. I make low-cost, reusable devices to diagnose patients, particularly diabetic patients, in the developing world. But in the past, I also did work on microfluidic devices. In my own research, [writing this paper] allowed me to broaden my vision in my current research area, and think where my current abilities or efforts can be applied in the future. Also it helped me in writing papers and things like that, because the broader you think about the ideas, the higher impact you can get for your research. In this process I realized a lot of scientists do not tend to read patents, and a lot of companies tend to keep their information in the patents but do not publish. So there is a big gap. I think academics need to start thinking about how they can analyze or understand the information in the patent literature.

Volpatti: For me, I'm using microfluidic technology to make biomaterials that can be used for different applications, such as drug delivery and tissue engineering. I think this impacted my work the most when we were [researching] the field and commercialization, and learning about how you should start at the design stage. I started thinking, I can do this on the bench top because I've done it so many times and I know exactly what I'm doing, but could other people do a similar thing, and can I make this very reproducible, in the sense that other people can also come up with the same results. It's kind of changed the way I think about what I'm doing, and [I'm now] trying to make sure that it can hopefully one day get a patent and lead into a commercial product.

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