Bialozor TRB DOTMeeting2

Technology Transfer and Intellectual Property : 

Technology Transfer and Intellectual Property Donna L. Bialozor NCI, TTB January 26, 2006

27 Institutes & Centers at NIH: 

27 Institutes & Centers at NIH

NCI’s Primary Mission: 

NCI’s Primary Mission “…is to acquire new knowledge through the conduct and support of biomedical research to improve the health of the American people.” NCI's vision is to eliminate the suffering and death due to cancer by 2015. http://planning.cancer.gov/index.shtml

FY2005 BUDGET REQUEST: 

FY2005 BUDGET REQUEST Intramural Research NCI intramural research focuses on projects conducted by some 400 researchers located on the NIH campus. These researchers build upon the proximity between their research laboratories and the NIH Clinical Center and the synergism among NIH Institutes to support the rapid translation of basic laboratory research to the clinic and to maintain a special focus on long-term epidemiologic and genetics studies.

NIH Tech Transfer Statistics: 

NIH Tech Transfer Statistics

The Customer: 

The Customer

Options for Partnering with NCI: 

Options for Partnering with NCI Industry Office of Technology and Industrial Relations Technology Transfer Branch CCR Office of Science and Technology Partnerships Health Professional Organizations Office of Liaison Activities Office of International Affairs Consumers/Advocates Consumer Advocates in Research and Related Activities (CARRA) Director's Consumer Liaison Group (DCLG) Office of Liaison Activities http://www.cancer.gov/researchandfunding/partner

What is Tech Transfer?: 

What is Tech Transfer? Tech Transfer is sharing of knowledge Tech Transfer is the responsibility of every government scientist and engineer I saw the angel in the marble and carved until I set him free. Michaelangelo

Tech Transfer Statutes: 

Tech Transfer Statutes Stevenson-Wydler Technology Innovation Act (1980) technology transfer a mission of the federal government – licensing of govt inventions Bayh-Dole Patent and Trademark Act (1980) universities, not-for-profits, and small businesses may retain rights to inventions made under federal funding agreements (grants, contracts)

Tech Transfer Statutes: 

Tech Transfer Statutes Federal Technology Transfer Act (1986) authorized CRADAs for GOGOs and formed the FLC for Technology Transfer National Competitiveness Technology Transfer Act (NCTTA) (1989) established tech transfer as a federal laboratory mission and allows CRADAs for GOCOs Codified at 15 USC §3710

Technology Transfer: A Shared Responsibility : 

Technology Transfer: A Shared Responsibility NCI Institute IP issues Employee Invention Reports (EIR) Transactional Agreements (CDA, MTA, CTA, CRADA, CT-CRADA) NIH Office of Technology Transfer Patenting Licensing/Enforcement Policy

Tech Transfer and Collaborative Research: 

Tech Transfer and Collaborative Research Technology Transfer Branch (TTB), NCI Intellectual Property liaison Negotiate transactional agreements Liaison with other NIH offices, such as Office of General Counsel and the NIH Office of Technology Transfer

Tech Transfer and IP: 

Tech Transfer and IP Intellectual Property liaison with NCI labs, for development and commercialization of technologies Communicate Educate Facilitate and manage compliance with NIH policy and procedures for protecting and transferring the IP their research generates

Forms of Intellectual Property: 

Forms of Intellectual Property Patents Trade Secrets Copyrights Trademarks

Intellectual Property-Patents in Particular: 

Intellectual Property-Patents in Particular What is a Patent? “Quid pro quo” In exchange for publicly disclosing everything about your invention, you get a limited time to exploit it exclusively (legalized monopoly) Patent term is 20 years from the first filing date

Why Patent Government Inventions?: 

Why Patent Government Inventions? If they arose from taxpayer-funded research, shouldn’t they be dedicated to the public?

Why the Government Patents Inventions: 

Why the Government Patents Inventions As an incentive for commercial development Provides incentives (e.g. royalties for scientist-inventors) Stimulus for economic growth

EXECUTIVE ORDER 10096: 

EXECUTIVE ORDER 10096 PROVIDING FOR A UNIFORM PATENT POLICY FOR THE GOVERNMENT WITH RESPECT TO INVENTIONS MADE BY GOVERNMENT EMPLOYEES AND FOR THE ADMINISTRATION OF SUCH POLICY The following basic policy is established for all Government agencies with respect to inventions hereafter made by any Government employee: The Government shall obtain the entire right, title and interest in and to all inventions made by any Government employee (1) during working hours, or (2) with a contribution by the Government of facilities, equipment, materials, funds, or information, or of time or services of other Government employees on official duty, or (3) which bear a direct relation to or are made in consequence of the official duties of the inventor.

Invention Reports: 

Invention Reports Inventor submits EIR to NCI TTB NCI review and authorization of costs Transfer to NIH Office of Technology Transfer OTT contracts with patent law firms Application prepared, filed, prosecuted OTT advertises OTT negotiates licenses

Tech Transfer and Collaborative Research: 

Tech Transfer and Collaborative Research Technology Transfer Branch (TTB), NCI Intellectual Property liaison Negotiate transactional agreements Liaison with other NIH offices, such as Office of General Counsel and the NIH Office of Technology Transfer

Negotiate Transactional Agreements: 

Negotiate Transactional Agreements Confidential Disclosure Agreement (CDA) Material Transfer Agreement (MTA) Collaboration Agreement (CA) Clinical Trial Agreement (CTA) Cooperative Research and Development Agreement (CRADA)

NCI TECH TRANSFER AGREEMENTS AND FORMS: 

NCI TECH TRANSFER AGREEMENTS AND FORMS

Cooperative Research and Development Agreement (CRADA): 

Cooperative Research and Development Agreement (CRADA) A Collaborative agreement with a commercial partner Provides an exclusive option to the collaborator to license future inventions Can provide funds and personnel into the NIH lab Requires NIH subcommittee review and Institute Director’s signature Types of CRADAs Materials CRADA Full CRADA Clinical Trial CRADA

Cooperative Research and Development Agreement (CRADA): 

Cooperative Research and Development Agreement (CRADA) The Federal laboratory may provide Personnel Services Facilities, equipment, or other resources The Collaborator may provide Funds Personnel Services Facilities, equipment, or other resources Model PHS CRADA: http://ott.od.nih.gov/NewPages/crada.pdf

CRADA OPPORTUNITIES: 

CRADA OPPORTUNITIES Opportunities for NIH Leverage corporate research resources Access proprietary material Share data Facilitate development of biomedical products Opportunities for Industry Access state-of-the-art research at NIH Publish scientific articles jointly with NIH Acquire options to license NIH inventions

Tech Transfer and Collaborative Research: 

Tech Transfer and Collaborative Research Technology Transfer Branch (TTB), NCI Intellectual Property liaison Negotiate transactional agreements Liaison with other NIH offices, such as Office of General Counsel and the NIH Office of Technology Transfer

CRADA CHALLENGES: 

CRADA CHALLENGES CHALLENGES FOR NIH Identifying optimal collaborator Negotiation of legal terms Obtaining Ethics clearances Conflict of Interest and Fair Access Survery (COIFAS)

Technology Development Opportunities: 

Technology Development Opportunities CRADA Opportunities with the NCI and other select NIH Institutes: http://ttb.nci.nih.gov/cradaopp.html NIH Licensing Opportunities listed by Technology: http://ott.od.nih.gov/licensing_royalties/techabs.html DHHS Computer Retrieval of Information on Scientific Projects (CRISP) database system containing information on research projects and programs supported by the Department of Health and Human Services: http://crisp.cit.nih.gov/crisp/crisp_query.generate_screen Physician Data Query (PDQ): NCI's comprehensive cancer database. It contains peer-reviewed summaries on cancer treatment, screening, prevention, genetics, and supportive care, and complementary and alternative medicine; a registry of approximately 2,600 open and 14,000 closed cancer clinical trials from around the world; and directories of physicians, professionals who provide genetics services, and organizations that provide cancer care. http://www.cancer.gov/cancertopics/pdq NCI Office of Technology and Industrial Relations (OTIR): information on NCI funding, resources, discoveries, and scientists http://otir.nci.nih.gov/index.html Pubmed Central: the U.S. National Library of Medicine's digital archive of life sciences journal literature. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=Pmc NIH Guide for Contracts and Grants: official publication for NIH medical and behavioral research grant policies, guidelines and funding opportunities. http://grants1.nih.gov/grants/guide/index.html FedBizOpps (FBO) database of federal contracts awarded, procurement bidding opportunities, special notices and surplus government sales: http://www.cbd-net.com/

LASER CAPTURE MICRODISSECTION (LCM): 

LASER CAPTURE MICRODISSECTION (LCM) NIH’s (NCI & NICHD) Contribution Conceived the idea of microdissection Invented a special thermoplastic polymer film activated by laser beams Developed a prototype LCM unit that used a carbon dioxide laser Arcturus’ Contribution Contributed the laser diode technology Developed a prototype Laser Diode System LCM Results of Collaboration Product – Laser Capture Microdissection machine More than 700 articles have been published based on LCM technology Nearly a thousand LCM machines have been sold for use in research on breast, prostate, and pancreatic cancers

MULTI-REPLICA BLOTTING KIT: 

MULTI-REPLICA BLOTTING KIT NIH’s (NCI) Contribution Developed Layered Expression Scanning (LES) technology 20/20 GeneSystems’ Contribution Refined the LES system in collaboration with the NCI, NIH Commercialized the Multi-Replica Blotting Kit Results of Collaboration Product – Multi-Replica Blotting Kit The kit allows the simultaneous detection of up to ten different proteins of interest from one protein gel using Western Blot technique

VELCADE®: 

VELCADE® NIH’s (NCI) Contribution Conducted preclinical studies of Velcade® Developed a formulation with a longer, stable shelf life Industrial Partners’ Contribution Myogenetics synthesized the active ingredient for Velcade® ProScript conducted preclinical oncology studies in collaboration with institutions including the NCI, NIH Millennium Pharmaceuticals initiated the clinical trials that resulted in FDA approval Results of Collaboration Product – Anti-cancer drug Velcade® FDA approved Velcade® as treatment for refractory multiple myeloma, which accounts for 2% of all cancer deaths each year Velcade® is being clinically tested against ovarian, colon, pancreatic, lung, and prostate cancers, as well as leukemia and non-Hodgkin’s lymphoma

TAXOL®: 

TAXOL® NIH’s (NCI) Contribution Identified paclitaxel from the Pacific yew tree bark by screening natural products for antitumor activity Conducted pre-clinical testing and clinical trials Developed alternative drug administration methods Bristol-Myers Squibb’s Contribution Developed supplies of Taxol® by licensing Taxol semisynthesis technology from Florida State University Collaborated in the clinical development with the NIH Results of Collaboration Product -- Anti-cancer drug Taxol® FDA approved Taxol® for the treatment of breast, ovarian, lung cancer and Kaposi’s sarcoma Over 1 million patients have received treatment with Taxol® (paclitaxel)

Slide33: 

Specialized MTAs for Repositories Screening Agreements Memorandum of Understanding Letters of Collection Modified IP Clause(s) in a Contracts Special IP Term(s) of Award in Grants Any NCI Agreement Referring to Patent Rights or Other Forms of Intellectual Property Other Duties as Assigned

Discovery Services: Repositories: 

Discovery Services: Repositories Synthetic 140,000 plated compound set and subsets Individual vials Radiolabeled cmpds Tumor & Animal Human, murine cell lines Tumors from humans & numerous rodent species Mice, rats, guinea pigs inbred, outbred, hybrid, congenic, nude Natural Products >50,000 plant >10,000 marine aqueous & organic extracts collected with concern for fair collaboration w/source countries Biologics Murine and Human Cytokines Anti-Murine and Anti-Human MoAbs Growth Factors Interferons Interleukins

RAID: 

RAID Provide pre-clinical contract research resources to Allow studies to occur under investigator or Examples of RAID tasks: Bridge the gap between a LEAD DISCOVERY and a DRUG academic/small business community academic center sponsorship - acquire/formulate bulk drug - produce biologicals - pharmacology/toxicology studies - test efficacy of agent in animals

NCI’s Cancer Therapy Evaluation Program (CTEP): 

NCI’s Cancer Therapy Evaluation Program (CTEP) Currently sponsors over 150 INDs. Nearly 10,000 registered investigators at approximately 2000 institutions. 500 new protocols/year. ~25,000 patients accrued/year. Over 80 collaborative agreements (CRADAs, CTAs) with pharmaceutical companies.

ACKNOWLEDGEMENTS: 

ACKNOWLEDGEMENTS Thomas Stackhouse, Ph.D. Associate Chief, TTB, NCI Debra Elston, Director John Munro, Ph.D. Program Analyst Office of Corporate Research and Technology, TFHRC, FHWA, DOT Kate Sinclair Dunn, CRADA Administrator, Office of Technology Transfer, NIH John Paul Kim, Director, Office of Policy for Extramural Research Administration, NIH