Transcript Document
Technology Transfer and Licensing with a University Partner September 14, 2006 John P. Warren, Jr. Associate Vice Chancellor for Intellectual Property Management Associate General Counsel for Research and Intellectual Property Management University of Houston System University Technology Transfer AUTM 2002 Survey (www.autm.net): • $37 billion sponsored research expenditures •15,573 Invention Disclosures •7741 New US Patent Applications •450 start-up companies •4673 new licenses/options •$1.2 billion adjusted gross license income University Technology Transfer • Disclosure • Marketing Analysis • Patent or other form of protection • License or start-up • Income/equity partition University Technology Transfer Offices •Interact with faculty/staff to assist in developing ideas into inventions •Obtain complete invention disclosures •Work closely with inventors throughout entire process •Interact with business community to ensure inventions are available for development University Legal Offices •Assist technology transfer offices with license and patent issues •Help faculty understand the law of inventions •Work with outside counsel in protecting IP •Approve technology transfer contracts Types of Licenses (Grant) A. Non-exclusive worldwide or geographically limited • Royalty-free for non-commercial use • Royalty-bearing for commercial use • No sub-licenses B. Exclusive worldwide or geographically limited With right to sublicense Terms of Licenses A. Running with patents or copyrights B. Unlimited based on know-how/trade secrets C. Limited term Definitions A. Invention rights • Discoveries, know-how, information, inventions/copyrights • Patent or application number and date B. Products and processes C. Territory D. Net Sales=Billed of invoice less • Customary trade, quantity or cash discounts, agents commission • Repaid for rejection or return • Taxes or other governmental charges E. Field of use F. Affiliates Royalties A. Initial lump sum B. Minimum annual payments C. Milestone payments • Research goals • Clinical trials • FDA or other governmental approvals • Single payment • Maximum payment • Running royalties Warranty/Indemnification • Universities are not risk-takers • Limited or no warranty by University • Insurance – important if risk to University Termination and Assignment A. Payments B. Performance C. Insolvency D. Licensee/Sub-licensee rights E. Assignment to Sub-license F. Assignment to Third Parties Bayh-Dole Act Before the Bayh-Dole Act: •the federal government retained ownership of patents; •non-exclusive licenses were available to any interested party; •companies were not eager to invest in these technologies; •taxpayers received little benefit. Bayh-Dole Act Objectives: •Promote the use of inventions; •Encourage small businesses; •Promote collaborations; •Promote commercialization by U.S. industry; •Ensure that the federal government has the right to protect against non-use. Bayh-Dole Act The Bayh-Dole Act: •created a uniform patent policy; •provided recipients of federal funding with the right to retain ownership of inventions; •charged universities with the responsibility of ensuring commercial use; •made each federal agency responsible for monitoring inventions created with its funding. Bayh-Dole Act The federal government retains: • a non-exclusive, non-transferable, irrevocable, paidup right to practice (or have practiced) the invention; • the right to retain title to the invention if the decision is made in writing before entering into the funding agreement with the university; • the right to require the university to grant a license to a third party if the invention is not commercialized in a reasonable time, for health and safety issues, or if other legal requirements are not met. Bayh-Dole Act Universities must: •have agreements with employees to disclose and assign inventions to the university; •share licensing proceeds with the inventors and use remaining revenue to support scientific research and education; •make certain disclosures and reports to the federal government; •claim title to the invention; •file patent applications within certain time frames. Bayh-Dole Act Licensee requirements: •Universities must give preference to small business firms (less than 500 employees) when feasible unless the research that led to the invention was supported by a large company. •Any exclusive license to a product that is to be sold in the U.S. must be substantially manufactured in the U.S. unless a waiver is granted. •Universities cannot assign patents to third parties. University License Diligent Commercialization Diligent commercialization is required to: •comply with the Bayh-Dole Act; •benefit taxpayers; •ensure a royalty stream to the university; •measure the ability of the licensee; •provide universities with the ability to terminate a license for non-performance. University License Diligent Commercialization License terms for diligent commercialization include: •a standard diligence clause; •specific timelines related to certain milestones; •other diligence language proposed by licensees. University License Diligent Commercialization Terms vary based on several factors: •the type of technology (device, diagnostic, therapeutic, etc.); •the stage of the technology at licensing; •inventor input; •history of licensee performance. University License Reservation of Rights Rights reserved by the University: •the right to publish the general scientific findings related to the licensed subject matter; •the right to use the licensed subject matter in research, teaching, patient care and other educational purposes. University License Reservation of Rights Universities reserve certain rights for the federal government as required under the Bayh-Dole Act, including: •a non-exclusive, non-transferable, irrevocable, paid-up right for the federal government to practice (or have practiced) the invention; •“march-in” rights. Publication • Absolute Right to Publish • No “control” or “approval” of contents • Principal Investigator owns the copyright (Faculty Exception to Work-for-hire) Publication Timing • Review periods Must be reasonable • 30 - 60 days typical with 60 – 90 additional days for patent filing •