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UNION CARBIDE CORPORATION OAK RIDGE, TENNESSEE 3 7 U O Assistant Patent Counsel for Oak Ridge Operations Oak Ridge, Tennessee 37830 Thank you for your recent letter in which you indicated the provisions outlined waiver t o be granted for our invention entitled "Radioiodinated Tellurium LongChain Fatty Acids for Application in Nuclear Cardiology," DOE Dockett s-58,514 Since granting of the waiver would preclude continuation of this research a t ORNL under our program funded by government agencies, we have decided not t o pursue our request fora waiver for this patent, which would not be i n the best interest of our program. We, therefore, withdraw our waiver request and will be applying for the patent through the normal channels. Thank you f o r your help. Health and Safety Research Division ORNL Patent Office
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health and Safety Research LIivision Olt Ridge # atl on il laboratory Oat Ridge, Tmnesrn 37830 WAIVER REWEST URO-125 FOB SUBJECT IYVEKTION EWTITLED 'RAOIQIWIMTED CARDSOLOGY', OOE DOCKET 5-58,514 (CRID 4246) REPGRTED UHPER WE t h a t the request has been authorized by your employer, Unlon CIrelde This POpartuent'r statutory patent poltcy as bplcaented by the re gul it lons In 4 1 QR 59-9.109-6 requires $eftria teras and condtf!ons for ualvers. These pm vl s lons are set fw thin the attached docuatnt ana in dlc atc by letter I n response hereto that t f your waiver I s approved, you will asret toall of tne provisions contained thcrrln. Accordingly. we request that you revfeu the Yon fi roa tory Llcense' Your response to thls letter I n the near future rill be appreciated. If you bare any questions, please feel free t o call a t Assjrtant Patent Counsel for Patent Prosecut Ion
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Enclosed lit accordance with IPI-11-5-79 isa copy of the udirer petitlon which we nave recelved inthe above-identified case. Ye have also p np and and enclose a walvcr request filing report for your . A Asslstant Patent Counsel I or Patent Prorecutf on
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Health dnd h dte ty Kesedrch Uiv. Udk did ge National Laboratory Naiiie Add ress Advance Advance Id.X Ident if ie d-- ----UOE/HU Proyram contact : Ur. Jope Thiessen Technology Involved : Nuclear Car diol o q y Synopsis ot Just it i cation for Ke quest : Ueqree of exclusivity is needed to justify substantial private invest iii ent needed to develop and test imaging agent to point where itis approved for use on tiuinans. Pre li iii in a ryU ec is ion on Waiver Request : brant in view of no further tiovernnent tun ding and need to obtain private funding for testing leading to certification by FUA. Contract Ue tai Is : Petitioners d reUnion Carbide employee - inventors working under Union Carbide contract W-7405-ENti-26. 1. Union Carbide Corporation has nut hori zed petit i un ers to request 2. [he invention inay represent d very s if jn it icd nt drvel1)pinent i n nuc Iea rcd rdi ology. 3, hoverriiiierit tun dir lij essentially finished - last work done i n
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Oak Ridge. Tennessee 37830 U.S. Department of Energy Oak Ridge Operations Office of Patent Counsel Post Office Box E Oak Ridger Tennessee 37830 Re: Patent Waiver Request CNID 4 2 4 6 - Radioiodinated Tellurium LongChain Fatty Acids for Applications Enclosed is the original letter from Union Carbide Corporation authorizing the inventors of the above-identified invention to request greater rights in the invention. Please include this letter with the inventors' patent waiver petition.
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UNION CARBIDE CORPORATION OLD RIDGEBURY ROAD. DANBURY.CT 06817 United States Department of Energy Oak Ridge Operations Oak Ridge, Tennessee 37830 Oak Ridge Patent Group Union Carbide Nuclear Division Invention Disclosure CNID 4246 -Radioiodinated Tellurium LongChain Fatty Acids for Applications and Mark M. Goodman Pursuant to Article LVII(b)(2) of Contract No. W-7405-Eng-26, Union Carbide Corporation hereby authorizes the inventors of the above-identified invention to request greater rights in the invention in accordance with 41 CFR 9-9.109-6. Very truly yours, UNION CARBIDE CORPORATION Executive Vice Presidait
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OAK RIDGE NATIONALL AB ORATORY UNION CARBIDE CORPORATION POST OFFICE BOX X United States Department o f Energy Oak Ridge, Tennessee 37830 Admi nist ration, Oak Ridge Operations Oak Ridge Patent Group Request for Waiver o f DOE Patent Rights(CNID 4246) We hereby request afull waiver o f the United States ' rights subject to the terms and conditions set forth in 41 CFR, Part 9-9.01-6 (i),for an improved agent for the evaluation of heart disease fully described inC NID 4246, "Radioiodinated Tellurium Long-chain Fatty Acids for Applications in Nuclear Cardiology." We are the sole inventors of this type o f agent which was developed under a fixed-fee, research and experimental work, consultant service and operatfon Contract No. W-7405-eng-26. A patent application has not yet been filed on the subject development. are able to obtain a waiver, however, we intend to file before October 8, 1982, since a potential statutory bar exists due to a public presentation made on October 8, 1981, a t the ORNL Health and Safety Research Division Information Meeting, a t which time the subject matter of the invention was made public. Since the announcement of this Qvelopment, we have received several requests for further information from various radiopharmaceutical manufacturers inthe United States. As a result of the potential widespread clinical use of this type of agent for the evaluation of heart disease, we plan to pursue licensing our invention to established organizations, pending approval of this waiver and granting of a patent.
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UNDER SECTION 9 OF P.L. 93-577 Title of Contract Union Carbide Corporation and the U.S. Department o f Energy Title of Subject Invention "Radioiodinated Tellurium Long-chain Fatty Acids for Applications i n Nuclear Cardiology" Petitioner ' s Identification No. CNID 4246 (Name and Address of Petitioner) dots hereby petition the Secretary of the United States Department of Energy for vai ver of domestics rights of the United States of America tothe Subject Invention which vas raade inthe performacce of work under the above-identified tbe conditions set forth in P.L. 93-577. It is understood zhat any vai ver of rights shall be subject to Is Petitioner a small business as defined by 1-1.701 FPR? No In support of this petition, answers tothe following questions are submitted as Identify the specific rights vhich the Petitioner desires to obtain inthe Give a brief description of the Subject Invention. (Field of use, geographic area, exclusivity, term, etc.) Give a brief deSCriptiQh of the scope of work of the above contract. mat is the dQlLar amount and period of performance of this contract ? Briefly describe the Petitioner ' s technical competence in the field of technology i n which th+ Subject Invention lies or t o which it relates in terms of prior experience, know-how and patent position. (Attach ex!!ibits Briefly describe the Petitioner ' s established non-governmental commercial position in the field of technology i n which the Subject Invention lies or sew5ces i n such field outside of sales to the U. S. Government. Attach ex hf bits to substantiate your co mercia1position, e.g. sales brochures, What is the financial and technologicJ1 investment that has been made by the Petitioner with regard t o the field of technology i n uhich ttw invention li csor.to which it relates and with regard to them king and devcloping of the Subject Invention? If these are voluminous a representative sample is sufficient.) (Discuss in tens of selling goods o r providing If these are voluminous a representarive sample Is sufficient.
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f jnr nc j ; l l resources or tcchno1oy.y which will d irc ct ly assist the further development and prow te the COWDCrClal utilization of thc Subject Lnvcntion? the dcvcloprncnt and the com crc i alu till zat i of l of the Subject Invention? mat vi11 be the effect on coa pct it ion and market con cent rath n if the rights requested be likely to place the Petitioner in a preferrcd o r dominant position in this field ? Give reasons for your conclusions. Under vhat other contracts has the Petitioner vorked o r vhat other contracts has thc Petitioner had vith any Branch o r Agency of the U. S. Government vhich Include all or a parr of the scope of vork covered by chis contract or vhich dealt vith the field of technology i n vhich the Sub.juct Invention lies orto vhich it relates ? Would the acquisition of .chc vai ver Is the Petitioner aware of any governmental regulations vhich require or vhich might require the use of the subject matter of the Subj.ect Invention by the general public or a segment there of ? Does the Subject Invention lie in or relate to a field of technology vhich of drugs, medical or safety instruments, anti - pollution devices or such other products that may have a bearing on health, safety or welfare of the If the Petitioner is a nonprofit educaticmal institution,vhat is the technology transfer capability and program of the Petitioner ? Has this technology transfer capability and program been approved by DOE qr aay ocher Clve any other facts the Petitioner believes will establish Chat the interests of the United States and the general public vi11 best be seryed by the granting of this vai ver. Secretary can cpnsider specifically each of the areas and objectives covered Sufficient information is required:so that the State below the. name, address and telephone number of the person t o vhom correspondence is t o be directed. The facts set forth in this request for vai vcr are within the halt ledge of the requestor and are submitted with the intention that the Secretary o r his designee rely on them i n reaching the vai ver determination. mame and title of authorized representative) Health and Safety Research DivisSon Oak Ridge National Laboratory
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Appendix t o Waiver for C NID 4246 "Radi oiodi nated Tellurium Long-Chai n Fatty Acids for Applications in Nuclear Cardiology" 1. The petitioners desire to obtain the right to file a patent application at 2. The subject invention is a new type of radiopharmaceutical for the clinical diagnosis of h e a r t disease. This new type of agent encompasses a unique substitution of the tellurium atom in radio labeled fatty acids which inhibits metabolism resulting in prolonged retention of the agents i n the potenti a1 l y be obtained. In this manner, greater diagnostic information can 3. The scope o f work inthe above contract is broad and covers all aspects o f research conducted atthe Oak Ridge National Laboratory, 4 . Contract W-7405-eng-26 has been in effect between the Union Carbide Corporation and the United States government for over thirty years. The actual dollar amount isnot known by the petitioners, 5. The petitioners plan to pursue licensing the invention to establfshed 6. F. F. Knapp, Jr., obtained his Ph.0. i n 1970 and has been actively working i n the field of radiopharmaceuticals since 1975. He is principle in vest i gator on the development o f these radiopharmaceutical sat ORNL and has been Nuclear Medicine group leader since 1978. M. M. Goodman received his Ph.0. i n 1976 and after pursuing postdoctoral studies in radiopharmaceutical chemistry for four years, joined the ORNL nuclear medicine
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The petitioners will bear the expense of obtaining a patent. The peti ti oners bel ieve industry wou1 d require some degree of exclusive rights to develop and commercialize the subject invention. The petitioners will make the financial investment necessary to obtain the patent.Substantial investment by industry will be required for further development, approval for human use and marketing. Industrial representatives have contacted F. F. Knapp, Jr. and are interested in this new type o f agent. At the present time no other agent has been reported that exhibits the biological properties of this new type of radiopharmaceutical. If this agent i s developed, a variation may be designed by another manufacturer which would decrease market concentration. The subject invention is within a field of technology which concerns public health. The use of this agent could more effectively diagnose and evaluate The petitioners do not represent a non-prof1 t educational institution. The attached copy of the IR-100 award application explains in more detail the properties and benefits of this new agent,
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This modified entry form This entry form should be as complete and accurate as possible. Please attach all additional information you feel is important. 1952 Mail (with $40 entry feel t o I*R 100 Competition,Technical 1.R 100 Publishing Co., 1301 S. Grove Ave., Barrington, TL 60010, t o ENTRY FORV arrive no later than March 1,1982.A separate entry form or facsimile must be used for each product entered. Send eight (8)complete sets. See preceding page for details. NAN€ OF COMPAqY OR ORGANIZATION THAT DEVELOPED THE PRODUCT: Division or Subsidiary (if appropriate) Union Carbide Nuclear Division Oak Ridge National Laboratory Address P.O. Box X City Oak Ridge State TN Zip 37830 Country United States Telephone (615)-574-4192 Description of Product (Each question must be answered) The brand name and model number o f entry: product will be marketed) (Please use name under which the The iodine-123-labeled compound is the active agent. Tell in words what entry is: (Example-gas chromatograph, refinement process, conductive fabric, etc.) nonradioactive tellurium at the C-6 position and a terminal p-(iodophenpl) A structurally modified long-chain fatty acid containing Describe this product's primary function-as clearly as possible-rihat does it do? H o w does it do it? What theories, if any, are involved? The compound has unique biological properties which include high heart specificity, rapid blood clearance, and prolonged retention in the heart muscle. The heart muscle (myocardium) concentrates fatty acids from the blood for energy production. trated in the same manner. Rapid clearance from the blood leads to specific uptake of radioactivity in the heart muscle and low blood radioactivity. Gamma camera imaging thus gives a picture of the distribution of radioactivity The radiolabeled fatty acids are also concen-
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in the myocardium, which is a function of blood flow through the muscle (perfusion), and the metabolic requirement of the muscle for its energy source. These agents can be used for the early detection of heart disease. The unique property of the tellurium fatty acids is the prolonged retention or "metabolic trapping," which is a new concept. These new agents have not yet been studied in humans but are under extensive evaluation in laboratory 4 . List the approximate price of this product per marketing unit (specify). I f price is not available, explain why. it and check here 0. If price is proprietary, list No price can be estimated at this time, because the radiopharmaceutial is still undergoing laboratory evaluation. 5. Does this product provide significant improvements over existing products a. If yes, identify the existing products by manufacturer, brand name, and The principal radiopharmaceutical presently available for clinical measurement of myocardial perfusion is Thallium-201. This widely used radiopharmaceutical is supplied and administered as Thallous Chloride. Thallium-201 is …
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