Pfizer and the NIH have taken sides on who owns background intellectual property (IP) rights to the blockbuster arthritis drug Xeljanz. Its undisputed that Pfizer invested over $1B in the drug, and its undisputed that Pfizer and NIH had an joint R&D contract, called a CRADA, in place during the early stages of research for the drug. The dispute, as the New York Times and other media outlets have reported, centers on three basic questions:
- Who owned what IP before the CRADA?
- When did new knowledge assets emerged from the joint research (whether formally protected by IP or not)?
- What can each party do with these knowledge assets (again, whether IP protected or not)?
This is the same story we've heard before: Stanford University v. Roche Molecular Systems, Genentech v. University of California... these are among the highest profile cases, but the list of disputed who-owned-what-when cases is 30+ years in the making.
Its often said that innovation is a team sport. In the era of Open Innovation, companies now have to proactively manage their supply chain of knowledge and ideas. Each of these are cases that rely on connecting the dots: projects, research results, background IP, and contractual obligations. This is a step above project management, which traditionally focuses on goals and deliverables against those goals.
Here's three ways to organize your internal systems to support effective collaboration projects and reduce disputes later on.
1. Start by Connecting the Dots. Keep an updated knowledge management system. Store not just project data goals (which most everyone does well), but also IP developed and other research assets created (such as test results) along with the contracts in one system. We often manage these in separate systems throughout the organization by ownership: purchasing has contracts, project managers have goals and milestones, and our IP attorneys maintain up-to-date patent filings. But, we're all within the same team, and ultimately the project teams need clarity and purview.
2. Be Transparent about Background IP. Collaborative projects are well informed when patents and trademarks are filed on the work together during the project, but often fail to declare openly what we all started with. Present a list of background IP with some non-enabling descriptions before the project and let your partner know about what's already happening.
3. Finish with a List. Keep an agreed inventory of resources developed during the project and close out with agreement as to what was accomplished. This does not require a formal certification of IP rights. List the general test results, high level findings, staff involved, and other resources in a system that both parties can review and reference throughout. The value comes from both a general consensus as to what was accomplished as well as encouraging discussion about background and related work that came from other efforts.