The Technology Transfer Office (TTO) facilitates interactions between NHGRI's research laboratories and other research entities, including universities, non-profit organizations and companies, for the benefit of public health. TTO carries out its mission by assisting in the transfer of NHGRI-developed technologies to the private sector for further development and commercialization and by managing formal relationships with pharmaceutical and life sciences companies through the use of various legal instruments. The TTO also ensures the speedy and efficient exchange of research resources between NHGRI and outside scientific groups and assures compliance with relevant laws and policies. Thirteen (13) new employee invention reports (EIRs) were processed and evaluated in FY2012 by the TTO. Of the 13 EIRs, 8 described either a research material or a research tool (per NIH policy we rarely file for intellectual property protection on research reagents or software, however, we are often able to license non-patented biological materials). A patent filing decision has yet to be made on 1 of the EIRs. In all, 3 new patent applications were filed based on EIRs submitted during FY12;2 were filed by NHGRI, and 1 was filed by a collaborator (Johns Hopkins University). The TTO also processed 6 EIRs for the National Center for Advancing Translational Sciences (NCATS) (formerly National Chemical Genomics Center and National Center for Translational Therapeutics and part of NHGRI) while they were in transition to form a new NIH Center. The titles of the 13 EIRs are as follows: (1) Human Melanoma Cell Lines Harboring Mutations in MITF (Microphthalmia-Associated Transcription Factor) Pathway;(2) Human Melanoma Cell Lines Harboring Mutations in GRIN2A, TRRAP, or PLCB4;(3) Human Melanoma Cell Lines Harboring Mutations in Glutamate Receptor, Metabotropic 3 (GRM3);(4) Serous Endometrial Carcinomas Show High Frequency of Somatic Mutations Within Chromodomain-Helicase-DNA-Binding Protein 4 (CHD4), Speckle-Type POZ Protein (SPOP), F-Box and WD Repeat Domain Containing 7 (FBXW7), E1A Binding Protein 300 (EP 300) and AT Rich Interactive Domain 1A (ARID1A);(5) Single-Cell Lines Derived from Proteus Syndrome Patients;(6) Human Melanoma Cell Lines Harboring the Bcl-2-Like Protein 12 (BCL2L12) Mutation;(7) Silent Mutation in Bcl-2-Like Protein 12 (BCL2L12) for Diagnosing Melanoma;(8) Human Renal Tubular Cells from Subjects with Cystinosis;(9) Recurrent Mutation in Mitogen-Activated Protein Kinase Kinase Kinase 5 (MAP3K5) for Diagnosing and Treating Melanoma;(10) A Synthetic Methylmalonyl-CoA Mutase Transgene for the Treatment of Mut Class Methylmalonic Acidemia (MMA);(11) Human Melanoma Cell Lines Harboring a Recurrent Mutation in Mitogen-Activated Protein Kinase Kinase Kinase 5 (MAP3K5);(12) Discovery of Putative Melanocyte Enhancers Across the Mouse Genome and Development of a Predictive Formula for Finding Additional Murine Enhancer Loci;(13) Human Induced Pluripotent Stem Cell (iPSC) Line With Luciferase Cassette Targeted to RUNX1 Locus. In FY2012, six (6) patents have issued in the NHGRIs portfolio: two in the United States, and four in Europe. The titles of the issued patents are: Methods for Analyzing High Dimensional Data for Classifying, Diagnosing, Prognosticating, and/or Predicting Diseases and Other Biological States (U.S. patent number 8,065,092);and LMNA Gene and Its Involvement in Hutchinson-Gilford Progeria Syndrome (HGPS) and Arteriosclerosis (U.S. patent number 8,034,557, as well as European, German, French, and United Kingdom number EP 1,552,020). In FY2012 NHGRI executed four new conditional gift fund (CGF) agreements with the Diamond Blackfan Anemia Foundation, AKC Canine Health Foundation, Albert-Heim Foundation, and Fanconi Anemia Research Fund, Inc., and we amended one existing CGF agreement (Lejeune Foundation). Three non-NIH fellowships were awarded to NHGRI trainees from the following organizations: the American Society of Hematology, the National Lung Cancer Partnership and the Institute of Molecular Pathology and Immunology of the University of Porto (IPATIMUP). New FY2012 executed conditional gift fund agreements and newly awarded non-NIH research fellowships focused on the following human disease research topics: Diamond Blackfan Anemia, Transitional Cell Carcinoma, and Fanconi Anemia. In FY2012 we executed four new licenses with: (1) Genentech, Inc. (License L-027-2012/0) for patent portfolio titled Single-Cell Lines Derived from Proteus Syndrome Patients (DHHS Reference E-033-2012/0), (2) Pathology Devices, Inc. (License L-101-2012/0) for patent portfolio titled Tumor Tissue Microarrays for Rapid Molecular Profiling (DHHS Reference E-002-1998/0), (3) Quest Diagnostics Incorporated (License L-087-2012/0) for patent portfolio titled Methods for Detecting Cervical Cancer (DHHS Reference E-012-1997/0), and (4) Regeneron Pharmaceuticals, Inc. (License L-128-2012/0) for patent portfolio titled ERBB4 Mutations Identified in Human Melanoma Cell Lines (DHHS Reference E-229-2010/0). We also received 5 license applications from Jackson Laboratory, Koltan Pharmaceuticals, Sanofi Aventis (2 applications), and University of California San Francisco, which are still being negotiated. In addition, in FY 2012 we processed 154 Material Transfer Agreements: 70 for incoming materials and 84 for outgoing samples (of which 31 involved human materials).
