This document is from the collections at the Dole Archives, University of Kansas http://dolearchives.ku.edu BOB DOLE KANSAS (handwritten note) Copy of letter sent from Sheila United States Senate OFFICE OF THE MAJORITY LEADER WASHINGTON, DC 20510 April 8, 1986 The Honorable Otis M. Bowen, M.D. Secretary Department of Health and Human Services Hubert H. Humphrey Building 200 Independence Avenue, S.W. Washington, D.C. 20201 Dear Secretary Bowen: I am writing concerning legislation I sponsored, the University and Small Business Patent Act Amendments (P.L. 98-620) which the President signed into law in 1984. The statute builds on the experience of the University and Small Business Patent Act (the Bayh-Dole Act), which gives universities and small businesses the right to license federally-sponsored inventions. An important aspect of P.L. 98-620 repealed the statutory constraints that had prohibited federal contractors from granting large businesses long-term licenses to market inventions developed with federal assistance. Previously, licenses were limited, by statute, to five or eight year terms, and extensions of the license terms required approval of the funding agency. The new law allows licenses to be granted for the life of the patent, if that is the desire of the contractor. When the bill passed Congress, Senator DeConcini and I entered into a colloquy stating that it was our intent, as the authors of legislation, to ensure retroactive application of the amendments. Specifically I stated, "It is our intent, in enacting this legislation, to create a uniform patent and licensing policy applicable to all federally-funded inventions. Although the bill is silent on the question of retroactivity, it is certainly our intent to strongly encourage agencies administering university patents filed before the current amendments to permit companies marketing products under these patents to extend their exclusive licenses for the life of the patent, consistent with the provisions of this bill, provided that the companies that request such an extension have complied with the requirements of the IPA and have acted responsibly in commercializing the invention." lead_223_008_001_A1b.pdf Page 1 of 4 This document is from the collections at the Dole Archives, University of Kansas http://dolearchives.ku.edu -2- The Department of Commerce has issued proposed regulations that would apply the statutory provision in question retroactively. 50 Fed. Reg. 13, 524 (April 4, 1985). While these regulations have not yet been issued in final form, it is my understanding that there is no disagreement within the Administration concerning this provision. Notwithstanding the above, I am informed that HHS is not acting promptly on requests for license extensions and that the process continues to be laborious and time-consuming. In fact, I am informed that there are some within HHS who believe that my statement endorsing retroactive application of the amendments was actually intended as a spur to HHS to undertake detailed reviews of such petitions. As a consequence, I wanted to again reiterate that the purpose of the 1984 amendments was to make it a matter of routine for contractors to grant exclusive licenses to licensees, and licensees holding licenses granted prior to enactment of the 1984 amendments should be treated no differently than new licensees. Processing of petitions to extend existing licenses should be swift and sure. Absent truly exceptional circumstances, to the extent that HHS is not acting promptly on petitions to extend existing licenses, it is thwarting the intent of the law and wasting agency resources on needless reviews. I hope that you will take steps to ensure that all your agencies follow the procedures laid out in the proposed regulations implementing P.L. 98-630, consistent with the legislative intent of the law, and, in keeping with those guidelines, to promptly grant all requests for license extensions, "unless there is a significant reason not to." S401.13(c), 50 Fed. Reg. 13, 532 (April 4, 1985). Your attention to this matter is greatly appreciated. Sincerely, BOB DOLE Majority Leader BD: sbm lead_223_008_001_A1b.pdf Page 2 of 4 This document is from the collections at the Dole Archives, University of Kansas http://dolearchives.ku.edu [seal of the USA Department of Health and Human Services] (handwritten note) Pete Velde THE SECRETARY OF HEALTH AND HUMAN SERVICES WASHINGTON, D.C. 20201 JUN 6 1986 The Honorable Robert Dole United States Senate Washington, D.C. 20510 Dear Senator Dole: This is in response to your letter of April 8 regarding your interest in the retroactive application of the provision in the University and Small Business Patent Act Amendments (P.L. 98- 620) that allows large businesses to be given long-term licenses to market inventions. Requests for approval to extend license terms are being and will continue to be granted whenever contractors and licensees are acting expeditiously to make the invention available to the public. We have taken steps to review, in a timely manner, requests from institutions and their contractors for exclusive licenses and licensees, and in particular those licensees holding licenses granted prior to the enactment of the 1984 amendments. We strongly endorse the collaborative effort of the Universities, their agent(s), and industries brought about by your patent law. In the interest of sound public health policy, our involvement in granting extensions of exclusive licenses is that of understanding the commitment of these parties and monitoring their progress in bringing valuable drugs to patients in a timely and cost effective manner. Attached is a letter that illustrates this approach in a request involving "Malonato Platinum Antitumor Compounds (Carboplatin)." Your leadership in creating a uniform patent and licensing policy is applauded. These efforts are a vital part of creating the proper atmosphere for transfer of technology and the movement of research results from the laboratory into the hands of physicians. Your interest is appreciated. Sincerely, [signature] Otis R. Bowen, M.D. Secretary Enclosure lead_223_008_001_A1b.pdf Page 3 of 4 This document is from the collections at the Dole Archives, University of Kansas http://dolearchives.ku.edu [logo of the USA Department of Health and Human Services] DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Office of the Assistant Secretary for Health Washington DC 20201 JUN 3 1986 Our Ref: G-60-72A Alan R. Bennett, Esquire Kay, Scholer, Fierman, Hays & Handler 1575 Eye Street, N.W. Washington, D.C. 20005 Re: ROSENBERG, et al., "Malonato Platinum Antitumor Compounds (Carboplatin)" Dear Mr. Bennett: This refers to the request submitted by Research Corporation for this Department to approve an extension for the life of the patent of the current exclusive license to Bristol-Myers Company. The period of exclusivity is due to expire on October 12, 1987. We are pleased to learn of this request and are prepared to expedite it upon gaining further information on the extent of your client's commitment to make this invention available to the public. In the interest of promoting and protecting public health, I would appreciate receiving at this time a detailed plan, projected by year, for the development and marketing of Carboplatin. The plan should include the anticipated investment of capital, the scientific resources you plan to commit, types of cancer that this drug will be tested against, what your plan for Phase I and III of the required FDA testing is at this time, and other information regarding what you believe will be required in the future to bring the invention to practical application. If you have questions, please do not hesitate to contact Mr. Leroy B. Randall, Chief, Patent Branch, on 496-7056. Thank you for your interest and cooperation in this matter. Sincerely yours, [signature] Donald Ian Macdonald, M.D. Acting Assistant Secretary for Health cc: Dr. John P. Schaefer Research Corporation lead_223_008_001_A1b.pdf Page 4 of 4