It is not unusual for me to hear a startup inquire about a freedom-to-operate (FTO) search.
Often, the requesting company is in its nascent stages. I don’t discourage the idea of keeping a good view of the competition and path to market. However, it is often too early for what I would consider a true FTO analysis.
Why? FTO implies that the product or service that will be launched to the market be free of third party IP issues, that it will not infringe issued patents. But to do such an analysis requires that the product or service be fully developed, so that all its constituent parts can be analyzed, as well as the whole.
For instance, if the product is an antibody treatment, FTO analysis will include the antibody (and any potential sequence and post-translational modifications), methods of producing it, formulation, method of administration and indications to be treated. If research is still in early stages, it may not yet be clear which version of the antibody works best or the optimal mode of production. There may be several potential indications under investigation. Formulation may not yet be developed, or may evolve as storage and treatment parameters are refined.
So, what’s a company to do? Ignoring the entire issue isn’t the answer. That would lead to trouble down the road. But a full FTO on all of the possibilities, alone and in combination, is a large draw on resources. One potential solution is a landmine analysis.
I use the term landmine analysis to describe an analysis that looks for the “biggie” issues, the show-stoppers. Using the antibody example, looking for whether 3rd parties have issued patents on the antibody generally, and the longevity of these rights. As the details are further refined through more R&D, then more detailed searches and analysis can be undertaken.
Some of this initial analysis is deciding what is being clear about what is a landmine (that you don’t want to drive over) and what is more akin to a pothole. Searches often turn up patent applications. These are not issued patents and whether they will ever issue and in what form is often the question. They may be landmines, but it may be the case that the filed and published claims at the application stage are far broader than what will appear in the granted form. Again, this doesn’t mean ignore patent applications. A “watch list” may be appropriate for some of them to see what matures and what ends up getting abandoned along the way. But reserve the bulk of the worry on the landmines and just be aware of the potholes.
Some thoughts in the sorting of landmines and potholes:
- Is it an issued patent or a patent application?
- If issued , is it n a country where you plan to make, sell, import or use the product/service?
- When does the patent expire?
- Is it really a show-stopper? The issued claims are what matters for FTO and this often takes a combination of technical and legal knowledge to make such a determination.
- Is the patent owner a competitor, a potential collaborator or perhaps in a separate field altogether? There may be amenable licensing or collaboration solutions if it does become necessary to have rights to use the IP.
Drive on start-ups – and keep your eyes on the road!
The content of this blog is for informational purposes only and does not offer legal advice. Circumstances are fact-specific and you should consult an attorney for legal advice concerning your individual issues.