IP Ownership for SaMD

Once you have recognised your key IP assets for your software medical device, the next stage is identifying the ownership of each of those assets.

So you have generated a list of key assets that underpin the value of your company. But where does the ownership of those assets lie? This is the next important question in your IP journey. While you may think ownership of certain assets is obvious, assuming ownership of vital assets is a common pitfall to avoid.  

One reason for investigating ownership is that investors will want to know you have control of and freedom to exploit those assets. The best way of putting yourself in that position is to own them. 

Some common problems relating to IP ownership are: 

• Ownership: knowing where the ownership of an asset lies is not necessarily known about until you start digging in depth. Just because you paid for it, doesn’t mean you own it! For example, if you contract someone to write your code, unless you have an agreement in place, they could still own that code. 

• Collaborations: It is important to consider who will own IP that is created in the course of the collaboration, before entering into that collaboration. This is vital if your business intends to commercialise the outputs of a collaboration. 

• Founders: Initial founders may create a lot of the initial IP before the company was created. Transferring IP ownership into the business is easily done at early stages of the business, but leaving it until later when it has become a valuable asset can be much more complicated. 

• Employees: Many standard employment contracts stipulate that IP created during the course of an employment generally belongs to the employer however it is important to check employment contracts. 

• Relationships: Agreements should be in place to govern all business relationships and any changes in the people or entities should trigger a review of IP agreements.