identifying and resolving “hidden” issues in technology transfer karen maurey chief, technology...
TRANSCRIPT
Identifying and Resolving “Hidden” Issues in Technology Transfer
Karen MaureyChief, Technology Transfer Branch
National Cancer InstituteNational Institutes of Health
September 21, 2006
Why Go Looking for Hidden Issues?
• After all … I’m already more than busy enough as it is!
Why Go Looking for Hidden Issues?
• Time invested looking at the bigger picture saves time (and aggravation)
• Let’s consider:– Routine request from tech transfer– Unexpectedly strong reaction– Coordination of information – Negotiation twist
Addressing a Routine Request
• An NIH scientist is planning to meet with a scientist from a biotech company. She will be discussing some recent unpublished findings and exploring mutual interest in collaboration.
Addressing a Routine Request
• Confidential Disclosure Agreement• Employee Invention Report• Remind scientist to document approval of official
duty activity– http://ethics.od.nih.gov/forms.htm
• Remind scientist to address travel arrangements – At NIH, sponsored travel would rarely be approved in
the context of initiating a research collaboration
Unexpectedly Strong Reaction
• You inform an investigator that you have been unable to come to mutually acceptable terms for him to access a proprietary research material from a company.
• He asks if you are comfortable with knowing that people will continue to suffer and die due to your bureaucratic mentality and obsession with legalistic minutia.
Unexpectedly Strong Reaction
• In this case, the scientist had previously sent out an NIH material using a standard MTA. He was frustrated that he would not be able to receive the modified material in return.
– Next time: involve tech transfer at the start for a more appropriate agreement for the project (e.g., license, CRADA, research collaboration agreement).
Coordination of Information
• Your agency has invented a promising new medical device. You plan to file a patent application and license the technology so that it can be further developed and marketed. In order for this device to be marketed, your licensee will need FDA approval under 510(k).
Coordination of Information
• To obtain a patent will need to demonstrate the device is novel and nonobvious over the prior art
• To obtain 510(k) approval, will need to demonstrate substantial equivalence to a marketed device
Bruno Independent Living Aids v. Acorn Mobility Services (Fed. Cir. 2005)See article by Linda Alcorn, Sterne Kessler Goldstein Fox
http://www.skgf.com/media/news/news.167.pdf
Negotiation Twist
• You are in the midst of a negotiation of a license or a CRADA, and the stakes are high.
• Your counterpart expresses delight in being able to work with someone of your caliber. In fact, you’re just the type of person they are looking for in a new position opening up with their company.
• Adapted from “Dirty Little Tricks We All Play in Licensing” Robert MacWright, UVA Patent Foundation, John Ritter, Princeton University, Alan Bentley, UVA Patent Foundation. www.uvapf.org/documents/dirtytricks.ppt
Negotiation Twist
• Need to immediately resolve conflict of interest
• Are you interested in pursuing a job with them?– No? Explicitly state that not interested.
Inform supervisor and document.– Yes? Immediately withdraw from negotiation
and file recusal.
Karen MaureyChief, Technology Transfer Branch
National Cancer InstituteNational Institutes of Health