1. One Case, Many Lessons Mojdeh Bahar, J.D.,M.A. Chief, Cancer Branch Office of Technology Transfer National Institutes of Health U.S. Department of Health & Human Services The Good, The Bad and The Ugly FLC MA Annual Meeting Rocky Gap, Maryland September 2008

2. Road Map Receipt of the EIR Learning about the Collaborator: My! NIH is an inventor?! IIA or Let’s Play Together! Dealing with what has already happened… Licensee’s New Paradigm: Let’s Cut Out the Middleman Negotiation of an “Exclusive License” Lessons Learned…

3. Receipt of the EIR Filing the patent by the joint owner predated the receipt of the EIR by OTT. Patent was filed in August 2003. EIR was received in early 2004. Not only had the co-owner filed a patent on the technology, they had licensed the technology too!

4. Learning about the Collaborator: My! NIH is an inventor?! OTT, having learned from the IC about the licensing of the technology, called the collaborator to inquire. The collaborating institution “was not sure” that the PI at the NIH was an inventor! This was not a previously agreed upon collaboration. The NIH inventor was the PI and one of his employees had left to go to the collaborator’s institution. The former NIH employee had continued research on the technology and was under an obligation to assign his rights to the Institution. So…What happens to the rights of the first phase of the invention at the NIH?

5. IIA or Let’s Play Together! An informal inventorship analysis was done in the form of a teleconference with OTT, OTT’s contract attorneys, the two inventors from NIH and the Institution, and the Institution’s attorneys. The NIH inventor was indeed an inventor. Putting an IIA-Institution lead would solve the problem…right?

6. Dealing with what has already happened… (1) After months of negotiation, Institution decides that it does not want to negotiate an IIA. To recap, we have: –No IIA with the collaborating institution –A third party who has exclusively licensed the technology from the collaborating institution –Patent application filed and managed by the collaborating institution

7. Dealing with what has already happened… (2) A joint owner of a patent may license without accounting to others (absent contract provision 35 U.S.C. 262) license without accounting to others (absent contract provision 35 U.S.C. 262) grant immunity from suit by other owners, Schering v. Roussell, 104 F.3d 341 (Fed. Cir. 1997) A joint owner of a patent may not grant an exclusive license *although may grant exclusive license as to its own interest.

8. Licensee’s New Paradigm: Let’s Cut Out the Middleman The only remaining option was to negotiate an exclusive license for NIH’s rights with the already existing exclusive licensee. Licensee wanted to expedite matters. Licensee decided to deal with OTT in a license negotiation. IIA file closed. OTT received an application for an exclusive license.

9. Negotiation of an “Exclusive License” Application was received on September 30, 2004. License was signed on May 31, 2007! Every provision presented its own particular challenges. Given that the licensee had an agreement in place with the collaborator, at every stage they had to make sure that none of our provisions conflict with the already signed exclusive license. One of the compounds is already in the clinic and walking away from the license is not an option.

10. Lessons Learned Put an IIA in place sooner rather than later. Know about the wants and desires of all interested parties. Be flexible and ready to accommodate a change in position/paradigm/negotiation technique. Be comfortable to advocate your position, even when you know that you have the weaker position. Keep our mission in mind and know that sometimes you cannot walk away. Keep our mission in mind and know that sometimes you cannot walk away.