Listening to a podcast in my ever-growing queue this week, I heard an interview with the CEO of Segment, a tech company that provides a platform for communicating data to a variety of analytic tools. The part of the story that caught my attention came before the big breakthroughs that made Segment a viable company. Early on the founders were attempting to construct software to provide feedback in college classrooms. Apparently, it was a dud. The founders did what most would say was a smart move – they pivoted to something new, something that eventually morphed into Segment.
As a software company, it’s unlikely that they were filing patents early on related to their first idea of the classroom software. The pivot to a new product, while having its own hurdles, didn’t bring along an IP dilemma.
But what happens in biotech when you pivot? Patent filing is almost de rigueur in early biotech. What happens to those filings? Can you rescue anything and bring it along as the company changes direction? Can you plan for that? It depends on a number of factors.
The first (and obvious question) is how big is the pivot? If you started working on a small molecule cancer therapy and pivot to a digital health app, it’s unlikely that your early chemistry filings are going to be applicable. However, if the pivot is to a new indication with the same or similar molecule, then your patent applications may still be of use.
The adaptability of the patent filings will depend on the breadth and scope of what is described within the applications as compared to the direction of your pivot. In some cases, the modifications you make to your R&D goals may still fall under your original IP. For example, perhaps you have patent applications on a platform technology and now seek to apply it to a different antibody or drug. The description of the platform in the applications may be target agnostic or provide enough description of multiple potential uses to now cover your new direction. In another instance, your pivot may be just a small curve in the road, like selecting one variant of a protein sequence over another. This minor change should be covered.
A lot depends on how you approached your patent application from the outset. Did you envision your technology broadly? Does the application describe variations of the active compounds and use of the technologies for a variety of purposes? While you may not be pivoting now, and think that you will not need to, a proactive approach to drafting patents to accommodate changes in your R&D pipeline can be helpful when unanticipated circumstances later arise.
As covered in a previous blog, there are some risks to initially drafting broad applications. The upside is flexibility to pivot and a possible “land grab” of patentable subject matter. The potential downside is that your application becomes a prior art bomb for your future filings. Namely, you describe something at a surface level, enough to be a prior art disclosure in the eyes of the patent office, but not with enough depth to support claims on this subject matter. It’s circumstance specific, but likely there is a reasonable middle ground where there is enough breadth and depth to cover more routine (and somewhat expected pivots). Then the more distant subject matter can be left for future filings in the eventuality that directions expand or change.
The status of your patent filings will also influence their flexibility.
Nonpublished applications and provisional applications are not yet public. These can be abandoned without ever entering the public sphere. In some cases, you may want to pull back applications, tailor them to your pivot and then re-file them as new applications. While this will change the priority date for the application, the additional information can provide the breadth and scope as well as specialized disclosure you will need to cover your new R&D direction.
Published applications are in the public domain (i.e., on the internet), so abandoning them, while saving cost, becomes public knowledge. This can be a red-flag for some investors. It can also provide your competition with a bit of an edge, as abandoned published inventions are dedicated to the public (i.e., free for the taking). However, particularly with pivots that change your goals substantially, the cost of pursuing these earlier filings may be too great and the effect on your financing and competition may be inconsequential in comparison.
In some cases, there may be sufficient information in the application to evolve the claims to cover your new R&D direction. In that case, depending on what stage the application has advanced in prosecution before the patent office, there are a variety of methods for amending the claims and/or filing new claims.
Issued patents have claims that are generally set in stone, absent filing for a reissue or reexamination. However, if the patent family remains pending (e.g., a pending application claiming priority to the same parent application), then it may be possible to generate additional patents from the original parent (keeping the original priority date) by filing applications on other variations and uses described in the body of the patent.
If, however, your pivot is a huge turn in another direction, then the issued patent may no longer be relevant. A few options here, you could license the patent to others. You could sell the patent outright to another company. You could stop paying the maintenance fees and let it go abandoned. It will likely depend if there are any takers on the technology.
Pivoting is bound to happen. Whether it will be a major pivot like Segment, or something much subtler is hard to predict. Proactive thought in generating a flexible patent portfolio can help ease the transition and keep the value of your initial investment in IP.
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.