What I wish I had known when I started my company

In 2004, I started studying for a Bachelor's degree in biotechnology, followed by a Master’s degree in biotechnology with major in computational biology.  After working for almost two years as a junior research fellow, I joined a PhD programme at ETH in Zurich, working in a biophysics group.  My research project was focussed on cell-cell interaction using atomic force microscopy.  Eventually, I landed in a post-doctoral position at the Technical University of Delft (TUD) in the Netherlands, to develop a point-of-care diagnostic test using direct DNA detection.

At that time I came to appreciate the commercial value of the test that we were developing and, importantly, that the commercial route was the way to bring make the test available to end users.

During discussions to establish our company, I was of course quite naïve as to the business side of things, although the university’s tech transfer team was helpful and supportive.  I’m sure that’s normal for a tech start-up.  I certainly wish I had kept better notes of the various early-stage discussion in which I was involved and am certain that this would have resulted in a more favourable outcome. 

From the outset I was aware of the need to consider IP and in particular patents, but knew little about the procedures involved.  Nonetheless, I was concerned that obtaining patent protection for our test would consume excessive amounts of time, distracting the team from its important research work.  This turned out not to be the case, at least to begin with.  Our university tech transfer team took care of most of the work involved in preparing a draft for our first application and our involvement was not overly burdensome.  In particular, the IP team provided the interface to external patent advisers. However, our initial concerns perhaps delayed us in moving forward with the project.  I can imagine that for others this concern might be so serious that commercialisation never gets off the ground.

Having said that my concerns about the burden on the team were unfounded, I must confess that I was subsequently dragged into the patent drafting process.  I fell into the trap of assuming that we were drafting a technical paper for peer review, thinking that we needed experimental data to support all of the assertions made in the draft application.  I did not realise at the time that this is not necessary for a patent application, at least not for all features that are presented.  This resulted in the team working to generate experimental data that we thought would be needed to support the application, work that was probably unnecessary and which certainly delayed the patent filing process.

I should add that I also fell into the trap of worrying that our patent claims were directed to a specific feature, thinking and arguing that they should cover the entire system without specific details.  What I now appreciate is that this is generally not the correct approach:  the purpose of the claims is to focus on a particular feature (or combination of features) that add novelty and inventiveness to the system.  It doesn’t matter how the system is configured or implement as long as it includes the claimed novel and inventive feature.

The question of inventorship also caused us some headaches.  I appreciate now though that this is common, especially for university spin-outs.  We treated the patent application as if it were a scientific paper, equating authors with inventors.  This is not correct and can lead to problems including, ultimately, raising doubts as to ownership.  My advice would be to understand the difference between a patent inventor and an author of a paper at the outset, and be judicious when naming inventors. Getting this right at the outset will help avoid headaches and also reduce the challenges when it comes to collecting the various documentation required to support your patent applications, further down the line.

At the outset I was extremely concerned with our freedom-to-operate (FTO) position, worrying that others may have blocking patent rights.  We obtained a preliminary FTO report that raised some issues.  We did some digging into the availability and cost of licensing-in IP identified in the report just to be aware and have a solid narrative for our investors.  This did not however change our strategy, and we were willing to take the risk without having the full picture.  I now appreciate that the costs of obtaining more comprehensive FTO reports is extremely high, and likely beyond the means of many start-ups.  We probably took the right decision at the time, i.e., a very light touch approach to FTO, although probably more out of ignorance than genuine knowledge.

Turning now to our patent filing strategy, we initially assumed that we should seek patent protection in a large number of countries.  Financial reality set in quickly and pushed us to proceed only in a small number of countries/regions.  Looking back, we could perhaps have spoken to investors with interests in specific regions and sought funding from them, although we would have needed to do that well before the relevant patent filing deadlines.

At the outset I underestimated the effort required to prosecute a patent application after it has been filed.  Trapped in a researcher’s brain that thrives on publications marking an end of a research milestone, I didn’t realise that the filing of a patent application is just a starting point.  I remember being disheartened and overwhelmed reading through the early search report and feeling personally affronted by the Examiner’s comments.   I now appreciate that this goes with the territory; whilst patent offices do want to grant a patent, they must employ a strict approach during examination to ensure the grant of the right, and its scope, is justified. 

Whilst our project ultimately failed, due primarily to our inability to provide a product at a commercially viable cost, putting that to one side, we should definitely have followed up our initial patent application with one or more further applications directed to improvements on the platform technology covered by the original application.  This came down I think to not having an IP strategy at the outset. That strategy only came later at the point when we were forced to produce a strategy to present to investors, rather too late to protect much of the development work.

Lastly, I wish I had known when setting out on our journey the importance of other IP rights, especially, registered design right, which might have been useful to protect the casing of our diagnostic test.  A registered trademark might also have added further credibility to business.  I now appreciate that unlike patents, these rights can be relatively cheap with quick prosecution and can in some cases be funded through IP-specific grants. 

I must emphasize that I couldn’t have progressed without the support of our in-house IP department and external patent advisors.   I am confident in saying that scientific projects look a lot different through an IP lens which brings small intricate technical details to light that might otherwise get lost or remain hidden. 

If you are setting out on your own entrepreneurial journey, I wish you every success!