United States General Accounting Office GAO Report to Congressional Committees July 2003 TECHNOLOGY TRANSFER Agencies’ Rights to Federally Sponsored Biomedical Inventions GAO-03-536 July 2003 TECHNOLOGY TRANSFER Agencies’ Rights to Federally Sponsored Highlights of GAO-03-536, a report to Biomedical Inventions Congressional Committees The Bayh-Dole Act gives federal Federal agencies and their authorized funding recipients are eligible to use contractors, grantees, and the government’s licenses to federally funded inventions for the benefit cooperative agreement funding of the government. Government researchers can use the technology without recipients the option to retain paying a royalty, and federal agencies can authorize their funding recipients ownership rights to inventions to use the government’s licenses for specific contracts, grant awards, they create as part of a federally sponsored research project and or cooperative agreements meeting a federal government need. The profit from commercializing government is not entitled to automatic price discounts simply because it them. The act also protects the purchases products that incorporate inventions in which it happens to hold government’s interests, in part by a license. Furthermore, the government’s rights attach only to the inventions requiring that federal agencies and created by federally funded research and do not necessarily extend to later their authorized funding recipients inventions based on them. Thus, the government may have no rights in a retain a license to practice the next-generation invention that builds on federally funded technology if the invention for government purposes. new invention were not itself created by federally sponsored research. GAO examined (1) who is eligible to use and benefit from the Few of the biomedical products that federal agencies most commonly buy government’s license to federally appear to incorporate federally funded inventions. In 2001 the government funded biomedical inventions, (2) the extent to which the federal had licensing rights in only 6 brand name drugs associated with the top 100 government has licenses to those pharmaceuticals that VA procured and in 4 brand name drugs associated biomedical inventions it procures with the top 100 pharmaceuticals that DOD dispensed. GAO was unable to or uses most commonly, and determine the extent to which the government had rights to other types of (3) the extent to which federal biomedical products because there are no databases showing the underlying agencies and authorized federal patents for most of these products and such products may incorporate funding recipients have actually numerous components that might not be covered by identifiable patents. used or benefited from these licenses. GAO focused its work on The federal government uses its licenses to biomedical inventions primarily the Department of Veterans Affairs for research; however, researchers generally do not document such usage. (VA), the Department of Defense These licenses are valuable because researchers can use the inventions (DOD), and the National Institutes of Health (NIH). without concerns about possible challenges for unauthorized use. Neither VA nor DOD has used the government’s licenses to procure biomedical NIH commented that the report products because they cannot readily determine whether products use implies that the government’s right federally funded technologies and they believe they already receive to use its license is more limited favorable pricing through the Federal Supply Schedule and national than it actually is. GAO recognizes contracts. Furthermore, neither VA nor DOD has used the government’s that the right of federal agencies license to manufacture a biomedical product for its use. and their funding recipients to use a federally funded invention is Rights to Federally Sponsored Inventions unrestricted. However, GAO believes that these license rights can be used only to meet needs • Federal agencies and their authorized funding recipients can use the that are reasonably related to the government’s license to federally funded inventions without paying requirements of federal programs. a royalty. • Federal agencies can authorize their contractors to make products that incorporate federally funded inventions for government use without www.gao.gov/cgi-bin/getrpt?GAO-03-536. risking patent infringement. To view the full product, including the scope • The government’s license does not entitle federal agencies to automatic and methodology, click on the link above. price discounts just because a product incorporates a federally funded For more information, contact Robin Nazzaro at (202) 512-3841 or email@example.com. invention. Contents Letter 1 Results in Brief 2 Background 3 The Government’s License Has Limited Applicability 5 The Government Appears to Hold Few Licenses to the Biomedical Products It Purchases 8 The Government Has Used Its Biomedical Licenses Primarily for Research 9 Observations 12 Agency Comments and Our Evaluation 13 Appendix I Objectives, Scope, and Methodology 15 Appendix II The Top 100 Pharmaceuticals Procured by VA on the Basis of Dollar Value, Fiscal Year 2001 18 Appendix III The Top 100 Pharmaceuticals Dispensed by DOD on the Basis of Dollar Value, July 1, 2001– June 30, 2002 21 Appendix IV Comments from the National Institutes of Health 24 Table Table 1: DOD’s and VA’s Expenditures on Drugs Incorporating Federally Sponsored Inventions, Fiscal Year 2001 9 Page i GAO-03-536 Technology Transfer Abbreviations AIDS acquired immunodeficiency syndrome DOD Department of Defense FDA Food and Drug Administration HHS Department of Health and Human Services HIV human immunodeficiency virus NIH National Institutes of Health USPTO U.S. Patent and Trademark Office VA Department of Veterans Affairs This is a work of the U.S. Government and is not subject to copyright protection in the United States. It may be reproduced and distributed in its entirety without further permission from GAO. It may contain copyrighted graphics, images or other materials. Permission from the copyright holder may be necessary should you wish to reproduce copyrighted materials separately from GAO’s product. Page ii GAO-03-536 Technology Transfer United States General Accounting Office Washington, DC 20548 July 1, 2003 Congressional Committees Since 1980, the Bayh-Dole Act and subsequent executive actions generally have given federal contractors, grantees, and cooperative agreement funding recipients the option to retain ownership rights to, and profit from, commercializing the inventions they create as part of federally sponsored research projects. In return for these rights, they are required to file for patent protection, pursue commercialization of the inventions, give preferences to small businesses in licensing, ensure that any products resulting from the inventions are substantially manufactured in the United States, and comply with certain reporting requirements. The Bayh-Dole Act also provides federal agencies and their authorized funding recipients with a “nonexclusive, nontransferable, irrevocable, paid-up license” to practice these federally funded inventions for government purposes. We assessed (1) who is eligible to use and benefit from the government’s licenses to biomedical inventions created under federally sponsored research, (2) the extent to which the federal government has licenses to those biomedical inventions it procures or uses most commonly, and (3) the extent to which those eligible have actually used or benefited from these licenses. We focused our work on the Department of Veterans Affairs (VA) and the Department of Defense (DOD)—which are responsible for the bulk of the government’s biomedical procurements— and the National Institutes of Health (NIH), within the Department of Health and Human Services (HHS), which funds most biomedical research. To determine who is eligible to use and benefit from the government’s licenses to biomedical inventions, we reviewed the Bayh-Dole Act, other statutes, federal agencies’ implementing regulations, applicable case law, and the positions taken by federal agencies in interpreting these laws. To assess the extent to which the government has licenses to the underlying inventions for the biomedical products it uses, we primarily analyzed the patents behind the top 100 pharmaceuticals that VA procured and DOD dispensed during 2001. For our analysis, we used databases maintained by the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO) as well as VA, DOD, and NIH. Finally, to assess the extent to which eligible parties have used or benefited from the government’s licenses, we determined (1) whether VA and DOD Page 1 GAO-03-536 Technology Transfer contracting personnel used them in procuring pharmaceuticals and medical devices and (2) whether VA, DOD, and NIH research personnel used them in conducting research. We conducted our review from April 2002 through April 2003 in accordance with generally accepted government auditing standards. Additional details on our scope and methodology are included in appendix I. Federal agencies and their authorized funding recipients are eligible to Results in Brief use the government’s licenses to federally funded inventions for the benefit of the government. Specifically, government researchers can use the technology without having to pay a royalty, and a federal agency can have a contractor produce the item for its use without obtaining a separate license. Third parties—contractors, grantees, and cooperative agreement funding recipients—can use the government’s licenses when granted this authority for a specific contract, grant award, or cooperative agreement meeting a federal government need. The government is not entitled to automatic price discounts simply because it purchases products that incorporate inventions in which it happens to holds a license. In addition, the government’s rights attach only to the inventions created by federally funded research and do not necessarily extend to later inventions based on them. Thus, the government may have no rights in a next-generation invention that builds on federally funded technology if the new invention were not itself created by federally sponsored research. Few of the biomedical products that the federal government most commonly buys appear to incorporate federally funded inventions. We found, for example, that federally funded inventions were used to make only 6 brand name drugs associated with the top 100 pharmaceuticals that VA procured for use by veterans and 4 brand name drugs associated with the top 100 pharmaceuticals that DOD dispensed in 2001. We could not determine the extent to which the federal government holds rights to other types of biomedical products, such as hospital beds and wheelchairs, because (1) there are no databases showing the underlying patents for most of these products and (2) the products may incorporate numerous components that might not be covered by identifiable patents. However, we found no federal government rights to the selected medical devices we examined; and VA and DOD officials told us that the government would rarely have patent rights in such products. The federal government uses its licenses to biomedical inventions primarily for performing research; however, the extent of such usage cannot be determined because researchers generally do not keep records, Page 2 GAO-03-536 Technology Transfer according to VA, DOD, and NIH officials. Citing a generally accepted practice among government and university scientists, government researchers have typically used the patented technologies of others without obtaining permission or a license. However, patent law does not appear to provide for such use without obtaining permission or a license from the patent owner. Agency officials said that when their scientists’ use of federally funded inventions is challenged, they inform the patent holders of the government’s license. Neither VA nor DOD has used the government’s licenses to procure biomedical products because they cannot readily determine if products incorporate federally funded technologies and they believe they already receive favorable pricing through the Federal Supply Schedule and national contracts. Furthermore, neither VA nor DOD has used the government’s license to hire a contractor to manufacture a biomedical product for its use. In commenting on a draft of this report, NIH stated that because we tie the exercise of the government’s license rights to the needs of the federal government, we give the impression that the government’s license rights are more limited than they actually are. While we agree with NIH that federal agencies and their funding recipients have unrestricted rights to use a federally funded invention for federal government purposes, it is important to recognize that they can use these rights only to meet needs that are reasonably related to the requirements of federal programs. Prior to 1980, federal agencies generally retained title to any inventions Background resulting from federally funded research—whether the research was conducted by contractors and grantees or by federal scientists in their own laboratories—although specific policies varied among the agencies. Increasingly, this situation was a source of dissatisfaction because of a general belief that technology resulting from federally funded research was not being transferred to U.S. businesses for developing new or improved commercial products. For example, there were concerns that biomedical and other technological advances resulting from federally funded research at universities were not leading to new products because the universities had little incentive to seek uses for inventions to which the government held title. Additionally, the complexity of the rules and regulations and the lack of a uniform policy for these inventions often frustrated those who did seek to use the research. Page 3 GAO-03-536 Technology Transfer In 1980, the Congress enacted two laws that have fostered the transfer of federal technology to U.S. businesses.1 The Stevenson-Wydler Technology Innovation Act of 1980 (P.L. 96-480, Oct. 21, 1980) promoted the transfer of technology from federal laboratories to the private sector. The Bayh-Dole Act (P.L. 96-517, Dec. 12, 1980) gave universities, nonprofit organizations, and small businesses the option to retain title to inventions developed with federal funding. It also authorized federal agencies to grant exclusive licenses to patents on federally owned inventions that were made at federal laboratories or that federal agencies patented after a federal funding recipient opted not to retain title. To protect the public’s interest in commercializing federally funded technology, the Bayh-Dole Act required, among other things, that a contractor or grantee that retains title to a federally funded invention (1) file for patent protection and attempt commercialization and (2) comply with certain reporting requirements.2 The act also specified that the government would retain “a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States any subject invention throughout the world.”3 The Bayh-Dole Act did not give large businesses the right to retain title to their federally funded inventions. Subsequently, in February 1983, President Reagan issued a memorandum on patent policy to executive agency heads stating that, to the extent permitted by law, the government’s policy is to extend the policy enunciated in the Bayh-Dole Act to all federally funded inventions arising under research and development contracts, grants, and cooperative agreements. In April 1987, President Reagan issued Executive Order 12591, which, among other things, requires executive agencies to promote the commercialization of federally funded inventions in accordance with the 1983 memorandum. 1 Technology transfer is a process through which research results, including inventions, computer software, and technical information, are provided to potential users in a manner that encourages and accelerates their evaluation and use. 2 See 35 U.S.C. § 202(c)(1)-(3). In addition, 35 U.S.C. § 203 protects the public interest by authorizing a federal agency to “march in” and reassert control over a federally funded invention if, for example, a patent owner fails to take steps to commercialize the invention. If the government invokes its march-in rights, which is believed never to have happened, it could license a third party to commercialize the invention. 3 35 U.S.C. § 202(c)(4). Page 4 GAO-03-536 Technology Transfer Our 1999 report noted that federal agencies were not always aware of the government’s licenses and could not tell us the circumstances under which these licenses had been employed.4 Nevertheless, agency officials said that the government’s license to practice federally funded inventions is important because agency scientists could use these inventions without being concerned that such use would be challenged. Federal agencies and their authorized funding recipients have the right The Government’s to benefit from the use of a federally funded invention without risk of License Has Limited infringing the patents. Government scientists can use these inventions in their research without having to pay royalties. Federal contractors, Applicability grantees, and cooperative agreement funding recipients may use the government’s license if they are authorized to do so. For example, federal agencies can contract with a third party to manufacture products containing such inventions. However, the government’s license to use a federally funded invention does not automatically entitle the government to price discounts when purchasing products that happen to incorporate the invention. The government’s license also does not necessarily extend to later inventions related to or based on the federally funded invention. The Government’s License The Bayh-Dole Act gives the government the right to “practice”—or use—a Protects Its Right to federally funded invention without being liable for patent infringement. Practice the Invention There are two primary ways in which the government can use its right to practice an invention in which it has retained a license. First, the government can contract with a third party to make a product that incorporates the invention for or on behalf of the government without either the government or the contractor being liable for patent infringement. It is our understanding that this right has never been invoked for biomedical products. Second, the government can use the invention itself without obtaining a license from or paying a royalty to the patent owner. As discussed later in this report, federal research officials say that this is a common occurrence in the research arena, making the license to use federally funded inventions a valuable asset to the government. 4 See U.S. General Accounting Office, Technology Transfer: Reporting Requirements for Federally Sponsored Inventions Need Revision, GAO/RCED-99-242 (Washington, D.C.: Aug. 12, 1999). Page 5 GAO-03-536 Technology Transfer The Government’s License The government’s right to practice an invention is limited to federal Is Available to Federal agencies and their funding recipients specifically authorized to use the Agencies and Authorized invention for federal government purposes. The Bayh-Dole Act provides that the license is “nontransferable,” which means that the government Funding Recipients may not sell or otherwise authorize another to practice an invention in its stead. This concept is not unique to the Bayh-Dole Act. Such language appears frequently in patent practice, where nonexclusive licensing agreements are typically construed as restricting assignment of the license without the licensor’s consent. In the Bayh-Dole Act, the term “nontransferable” is followed immediately by qualifying text—language that allows the government to authorize others to practice the invention for or on its behalf but which restricts the purposes for which it may do so. Federal agencies typically have authorized contractors to use the government’s license to develop and produce mission-critical hardware, such as a weapon system. This use of the government’s license satisfies a legitimate federal governmental need in support of a congressionally authorized program. Such linkages to an agency’s mission are less prevalent when grants or cooperative agreements are used, as is typically the case with NIH, which sponsors biomedical research to benefit the public health. This research serves the public good through biomedical advances from publishing scientific results and developing new technology that improve people’s life. This good may represent a sufficient government need for NIH to authorize its grantees to use the government’s license as a basis for using federally funded inventions in their research. However, according to a senior NIH attorney, NIH does not use this rationale to authorize grantees to exercise the government’s licenses and has not included a clause in its grant agreements authorizing the use of federally funded inventions as part of the research. As a result, NIH’s grantees might be sued for infringement and must negotiate any licensing agreements they believe they need to support their work. Furthermore, the government’s license to use a federally funded invention generally does not apply to HHS’s purchases of drugs and vaccines because (1) HHS has never contracted for the manufacture of a pharmaceutical made with federal funds for the government’s use and (2) HHS’s funding assistance for acquiring drugs or Page 6 GAO-03-536 Technology Transfer vaccines for distribution is intended to assist the states’ public health services, rather than to meet a federal agency’s need.5 The Government Is Not The “paid-up license” that the Bayh-Dole Act specifically confers on the Automatically Entitled to federal government6 is often referred to as a “royalty-free license.” The Price Discounts term “royalty-free” license (and even “paid-up license”) has sometimes been misinterpreted in a way that effectively eliminates the conditions set forth in the statute. The license for which the federal government is “paid up” entitles it to practice an invention itself, or to have others practice the invention on the government’s behalf. The statute does not give the federal government the far broader right to purchase, “off the shelf” and royalty free (i.e., at a discounted price), products that happen to incorporate a federally funded invention when they are not produced under the government’s license. The Government’s License An invention rarely represents a completely new form of technology May Not Extend to Related because the inventor almost always has used “prior art” in developing Inventions the ideas that led to an invention. Prior art is the intellectual basis—the knowledge base—upon which the novelty of an invention is established or the basis that determines whether the “invention” would have been obvious to one skilled in the art. In making an invention, an inventor typically would build on the prior art in the particular technology, and some of this prior art might have been developed by either government scientists or federal funding recipients. However, an intellectual property interest in prior art does not in and of itself give one an interest in someone else’s subsequent invention. Also, an invention often is part of a family of related inventions. One research project may spawn multiple inventions that, for example, are separate and distinct or are further developments of a basic invention for specific applications. Similarly, the idea on which the original invention is based may trigger new inventions.7 The question of whether the government has an interest in later inventions also arises in instances 5 For example, HHS provides funding for the states’ pediatric vaccine program. 6 See 35 U.S.C. § 202(c)(4). 7 The patent application for the first invention is referred to as the “parent” if a second application is filed on the basis of the same disclosure and at least one person is named as the inventor on both applications. Page 7 GAO-03-536 Technology Transfer involving the same technologies when the patents to these inventions are related in some fashion. Patents may be related because they protect inventions springing from the same essential technologies or scientists discover additional uses for an invention. For example, while a patent application is pending at USPTO, the applicant may decide to clarify the description of an invention because what initially was viewed as a single invention is found to be two or more inventions or because the USPTO patent examiner determines that patent application claims must be separated and independently supported. Whether the government has the right to practice an invention because it retains a license to use it under the Bayh-Dole Act depends upon whether the invention was developed with federal funding and is, therefore, subject to the act. An invention is a “subject invention” if it is conceived or first actually reduced to practice “in the performance of work under a funding agreement” (contract, grant, or cooperative agreement) to which the act applies. Rights to the parent patent do not automatically generate rights vis-à-vis related subsequent patents. In this regard, the government is not entitled to any different protection than other entities that fund research. There is one exception to the general rule that inclusion depends upon whether each invention was itself conceived or first actually reduced to practice in performing federally funded research. This exception holds that while the owner of a “dominant patent” can block the unlicensed use of that patent and related patents, the owner may not assert that patent either to deprive its licensee’s right to a “subservient patent” or, similarly, block the government’s license to use a subservient patent for a federally funded invention. Thus, if the owner of a dominant patent subsequently makes a new invention in the course of work under a federal contract or other federal assistance, the owner cannot assert the dominant patent to frustrate the government’s exercise of its license to use the second invention. Although determining the extent to which the government has licenses The Government in biomedical products is difficult, the number appears to be small. For Appears to Hold pharmaceuticals, one of the largest sectors of the biomedical market, we found that the government had an interest—either because of its license Few Licenses to the under the Bayh-Dole Act or as the owner or “assignee” of the patent—in Biomedical Products only 6 brand name drugs associated with the top 100 products, by dollar value, that VA procured in fiscal year 2001 and 4 brand name drugs It Purchases associated with the top 100 products, by dollar value, that DOD dispensed from July 2001 to June 2002. (See apps. II and III.) All four of the DOD Page 8 GAO-03-536 Technology Transfer drugs were among the six federally funded pharmaceuticals that VA purchased. As shown in table 1, VA and DOD spent about $120 million on these six drugs in fiscal year 2001. Table 1: DOD’s and VA’s Expenditures on Drugs Incorporating Federally Sponsored Inventions, Fiscal Year 2001 Dollars in millions DOD’s and VA’s Drug name Use expenditures Procrit (epoetin alpha) Treats severe anemia caused by such conditions as cancer, acquired $45.5 immunodeficiency syndrome (AIDS), or surgery Xalatan (latanoprost) Treats eye conditions, including glaucoma and ocular hypertension, in which 21.8 increased pressure can lead to a gradual loss of vision Epogen (epoetin alpha) Treats severe anemia caused by such conditions as cancer, AIDS, or surgery 15.6 Neupogen (filgrastim) Decreases the chance of infection in patients with cancer by promoting the 14.2 growth of white blood cells Taxol (paclitaxel) Treats metastatic breast and ovarian cancer and Kaposi’s sarcoma, as well as 12.2 head and neck cancer, non-small-cell lung cancer, small-cell lung cancer, and bladder cancer Zerit (stavudine) Treats infection caused by the human immunodeficiency virus (HIV) 10.2 Total $119.5 Sources: DOD and VA (data), GAO (analysis). Note: Drug names are presented in terms of brand name products, and the corresponding generic drug name is included in parentheses. We could not determine the extent to which the government holds rights to other types of biomedical products because (1) no databases exist showing the underlying patents for most of these products and (2) products such as hospital beds and wheelchairs may incorporate numerous components that might not be covered by identifiable patents. Our examination found no government rights to any of five medical devices for which the VA Medical Center in Milwaukee, Wisconsin, had spent more than $1 million during fiscal year 2002. The medical devices we analyzed included electric hospital beds, closed circuit televisions, blood pressure monitors, low-air-loss and air-pressure mattresses, and wheelchairs. Officials from VA and DOD believe that the government would rarely have patent rights to such products. Officials from VA, DOD, and NIH said that their agencies use the The Government Has government’s licenses to biomedical inventions primarily in performing Used Its Biomedical research. These officials could not tell us the extent of such usage, however, because researchers generally do not keep records. Instead, Licenses Primarily government researchers often use the technology and inform the patent for Research owner of the government’s rights only if there is a claim of infringement Page 9 GAO-03-536 Technology Transfer or other question regarding the government’s use. In fact, government scientists usually do not obtain licenses for any patented technology they may use in research. They told us that using technology for research purposes without obtaining permission is a generally accepted practice among both government and university scientists. VA and DOD officials said they do not consider the government’s licenses for procurements because they (1) would not be able to determine readily which products incorporate patented technologies or whether the government helped fund the technology’s development, (2) believe they already receive favorable pricing through the Federal Supply Schedule and national contracts, and (3) are not required by law to do so. Similarly, the VA and DOD officials said they had not used the government’s licenses to have a contractor manufacture biomedical products for federal use. Biomedical Licenses Are DOD and NIH attorneys told us that the government primarily uses its Primarily Used for biomedical licenses for research. According to these officials, the Research government’s licenses are valuable because they allow researchers to use the inventions without concern about possible challenges alleging that the use was unauthorized. However, no governmentwide database exists to track how often government researchers actually use the licenses, and agencies did not have records showing how often or under what circumstances these licenses have been employed. NIH officials said that their agency does not routinely document its researchers’ use of patented technologies. Thus, they have no way to readily determine which patented technologies have been used or whether the government had an interest in them. However, the NIH officials cited additional reasons why NIH researchers seldom obtain licenses to conduct research: First, NIH researchers may not really need a license because they can work with the underlying principles behind the technology simply by using the information that has been published. Second, there is a prevailing practice not to enforce patent rights among federal agencies and nonprofit organizations that conduct academic research. Third, under 28 U.S.C. § 1498, federal agencies cannot be enjoined from using patented technology in conducting research; the patent owner’s only recourse is to sue the government for a reasonable royalty. An Army patent attorney told us that he advises researchers to inform him of any patented technologies they are using in their research. He also said, however, that this does not always happen in practice and that he and the researchers generally are not aware of a potentially infringing use until the Page 10 GAO-03-536 Technology Transfer patent owner informs them. At that time, he researches the matter and seeks permission, obtains a license, or informs the patent owner of the government’s interest if there is one. Because the attorney does not have records on government licenses, he has to research each case individually. He added that he had invoked the privileges of the licenses for research purposes but could not readily tell us how often this had occurred. A VA official said that, like NIH, VA researchers usually do not know whether the technology they use for research is patented. Furthermore, information about the government’s interest in the development of products is difficult to obtain because extensive research would be required. She said that VA procures some research materials using Material Transfer Agreements with universities. For the most part, however, VA simply goes about its research assuming it has the right to use the technologies of others unless there is a challenge. She was unaware of any patent infringement cases that had been filed against VA. The “General Research VA, DOD, and NIH have each relied, to some extent, on the concept that Exception” Is Cited a researcher could use patented technology for research as long as the in Using Patented research is for purely scientific endeavors. According to agency officials, such use is a generally accepted practice within the research community Technologies on the basis of what some believe is a “general research exception.” However, some agency officials questioned how this exception might be viewed in light of the decision rendered by the Court of Appeals for the Federal Circuit in Madey v. Duke University, 307 F.3d 1351 (Fed. Cir. 2002). Concerning the availability of the experimental use exception to a university, the court ruled that the experimental use exception is very narrow and strictly limited, extending only to experimental uses that are not in furtherance of the infringer’s legitimate business and are solely for the infringer’s amusement, to satisfy idle curiosity, or for strictly philosophical inquiry. The court also stated that the profit or nonprofit status of the user is not determinative of whether the use qualifies for the experimental use exception. Experimental use may infringe a patent when the use furthers the infringer’s business. For example, the business of a research institution includes conducting research. Some patent owners believe that allowing others to use their patented technologies for research purposes may pose no threat and may actually be to their benefit. In fact, representatives from corporations involved in the research and development of products in the biomedical area told us that they welcome additional research that will continue to advance the state of the art as long as such use is not merely an attempt to use the Page 11 GAO-03-536 Technology Transfer patents for commercial purposes without obtaining a license. They said that there has been an unstated “gentlemen’s agreement” among researchers in this regard that will not be affected by the Madey case. If true, government researchers may, as a practical matter, be able in many cases to continue using the patented technologies of others without obtaining licenses. Licenses Have Not Been VA and DOD procurement officials were unaware of any instances in Used for Biomedical which a federal agency had used the government’s licenses to have Procurements contractors manufacture products that incorporate federally funded inventions. Furthermore, these procurement officials said that, as discussed above, the government’s license does not provide an automatic discount for federal government procurements. They added that even if they wanted to use the license for procurements, they would not know which products incorporate federally funded inventions. The VA and DOD officials also said that the government’s licenses would probably not significantly reduce their procurement costs because they believe they already receive favorable pricing through the Federal Supply Schedule and national contracts. In particular, for a branded pharmaceutical to be listed on the Federal Supply Schedule, the manufacturer must agree to give the government a 24-percent discount over the nonfederal average manufacturer price.8 Furthermore, the federal government has negotiated national contracts that provide even greater discounts for some pharmaceuticals. The government’s license under the Bayh-Dole Act provides protection Observations against claims of patent infringement when federal agencies or their authorized funding recipients use federally funded inventions. Scientists working for federal agencies and their contractors generally are authorized to use federally funded inventions; however, agencies have not necessarily provided similar authorization in their grant agreements for scientists at universities and other institutions. The decision rendered by the Court of Appeals for the Federal Circuit in Madey v. Duke University calls into question the validity of the general research exception that many 8 The Veterans Health Care Act of 1992 (P.L. 102-585) established a 76-percent ceiling for Federal Supply Schedule prices. Page 12 GAO-03-536 Technology Transfer scientists have cited as a basis for using the patented technology of others in their research. We provided NIH with a draft of this report for its review and comment. Agency Comments NIH stated that because our report ties the exercise of the government’s and Our Evaluation license rights to the needs of the federal government, we give the impression that the government’s license rights are more limited than they actually are. While we agree with NIH that federal agencies and their funding recipients have unrestricted rights to use a federally funded invention for federal government purposes, it is important to recognize that they can use these rights only to meet needs that are reasonably related to the requirements of federal programs. NIH also provided comments to improve the report’s technical accuracy, which we incorporated as appropriate. (See app. IV for NIH’s written comments and our responses.) We will send copies of this report to interested Members of Congress; the Secretary of Defense; the Secretary of Health and Human Services; the Secretary of Veterans Affairs; and the Director, Office of Management and Budget. We will also make copies available to others upon request. In addition, the report will be available at no charge on the GAO Web site at http://www.gao.gov. If you have any questions about this report, please contact me at (202) 512-3841. Key contributors to this report were Richard Cheston, Deborah Ortega, Bert Japikse, Frankie Fulton, and Lynne Schoenauer. Robin M. Nazzaro Director, Natural Resources and Environment Page 13 GAO-03-536 Technology Transfer List of Congressional Committees The Honorable Orrin G. Hatch Chairman The Honorable Patrick J. Leahy Ranking Minority Member Committee on the Judiciary United States Senate The Honorable Sam Brownback Chairman The Honorable John B. Breaux Ranking Minority Member Subcommittee on Science, Technology, and Space Committee on Commerce, Science, and Transportation United States Senate The Honorable Lamar Smith Chairman The Honorable Howard L. Berman Ranking Minority Member Subcommittee on Courts, the Internet, and Intellectual Property Committee on the Judiciary House of Representatives The Honorable Sherwood L. Boehlert Chairman The Honorable Ralph M. Hall Ranking Minority Member Committee on Science House of Representatives Page 14 GAO-03-536 Technology Transfer Appendix I: Objectives, Scope, and Appendix I: Objectives, Scope, and Methodology Methodology We examined the manner in which federal agencies administer, use, and benefit from intellectual property created under federally sponsored research programs related to public health, health care, and medical technology. Our objectives were to assess (1) who is eligible to use and benefit from the government’s licenses to biomedical inventions created under federally sponsored research, (2) the extent to which the government has licenses to those biomedical inventions it procures or uses most commonly, and (3) the extent to which those eligible have actually used or benefited from these licenses. To determine who is eligible to use and benefit from the government’s licenses, we reviewed the applicable laws, regulations, and procedures, including an examination of relevant case law. We also obtained the views of a senior attorney responsible for handling these cases in the Office of General Counsel of the Department of Health and Human Services. To assess the extent of the government’s licenses to biomedical inventions, we concentrated on pharmaceuticals because (1) pharmaceuticals represent a major component of the federal government’s biomedical procurements—an estimated $3.5 billion annually—and (2) government databases can be used to identify the underlying patents to pharmaceuticals approved by the Food and Drug Administration (FDA). In conducting our work, we first obtained data on the generic product name, total purchases by dollar amount, and number of prescriptions filled for the top 100 pharmaceuticals purchased by the Department of Veterans Affairs (VA) and the Department of Defense (DOD), which procure most of the government’s biomedical products for use by their hospitals and other medical facilities. VA’s data covered procurements for fiscal year 2001. DOD’s data covered the 12-month period from July 1, 2001, to June 30, 2002, because the agency began consolidating its pharmacy program sales data on July 1, 2001. For each of the VA and DOD pharmaceuticals, we used FDA’s Electronic Orange Book to identify the corresponding brand name product(s) and their patents. We focused on brand name products rather than generics because the former often utilize technologies with protected active patents and typically generate higher sales, whereas generic drugs often enter the market only after a product’s active patents have expired. We examined possible equivalent brand names to ensure that we identified the government’s licenses to available alternative products. FDA’s Electronic Orange Book included 210 of the 217 brand name products we reviewed. We also obtained patent numbers for three of the seven pharmaceuticals not included by examining their product Web sites. Using the patent Page 15 GAO-03-536 Technology Transfer Appendix I: Objectives, Scope, and Methodology numbers, we then accessed the patent records in the U.S. Patent and Trademark Office’s (USPTO) patent database to determine whether the government held any rights to the patented technologies of each brand name pharmaceutical. We identified any cases where the government was the owner or assignee or had a license to use the invention because it sponsored the research. In addition to our own assessment, we examined the National Institutes of Health’s (NIH) July 2001 report entitled NIH Response to the Conference Report Request for a Plan to Ensure Taxpayers’ Interests Are Protected. NIH assessed the return to the taxpayers for therapeutic drugs that use NIH-funded technology and have sales of at least $500 million per year, making them “blockbuster” drugs. From a survey of the pharmaceutical industry, FDA, USPTO, and its own databases, NIH determined that the government had rights to 4 of the 47 blockbuster drugs it identified for 1999—Taxol, Epogen, Procrit, and Neupogen. We found that all 4 of these were among VA’s top 100 pharmaceutical procurements and all but Taxol were among DOD’s top 100. To determine the extent of the government’s ownership of or licenses to use other biomedical products, we explored several methods to locate relevant patent and licensing information for medical devices. However, we found that (1) there are no databases showing the underlying patents for most of these products and (2) products such as hospital beds and wheelchairs typically incorporate numerous components that may or may not be covered by identifiable patents. In addition, VA and DOD procurement officials informed us that they do not have agencywide data showing the most frequently purchased items because many devices are purchased at the local level. Because of these limitations, we identified five medical devices for which the VA Hospital in Milwaukee, Wisconsin—a major procurer of medical devices—had spent more than $1 million during fiscal year 2002. This approach also provided only limited information. We examined the government’s rights to each device by identifying it in the General Services Administration’s on-line supply catalog, which includes the items on the Federal Supply Schedule, and reviewing the corresponding item descriptions. However, we found that the catalog does not provide patent or licensing information for any of the products. We also were unable to determine from the USPTO patent database the specific patents used for each medical device. Finally, our examination of product Web sites found that they do not provide information on the products’ patented Page 16 GAO-03-536 Technology Transfer Appendix I: Objectives, Scope, and Methodology technologies or address whether the government has license rights to them. To examine how the government has used its licenses to federally funded inventions, we interviewed DOD, NIH, and VA officials who procure biomedical products or who are involved in scientific research. Also, we researched relevant statutes and case law and met with knowledgeable officials in NIH and industry to determine whether a general research exception exists regarding patent infringement that applies to government and other researchers conducting research for purely scientific reasons. We conducted our work from April 2002 through April 2003 in accordance with generally accepted government auditing standards. We did not independently verify the data that VA, DOD, or NIH provided or the data obtained from the USPTO and FDA databases. However, agency officials addressed each of our questions regarding their data. Page 17 GAO-03-536 Technology Transfer Appendix II: The Top 100 Pharmaceuticals Appendix II: The Top 100 Pharmaceuticals Procured by VA on the Basis of Dollar Value, Fiscal Year 2001 Procured by VA on the Basis of Dollar Value, Fiscal Year 2001 Dollars in millions Amount Active Rank Drug name procureda government rights 1 Simvastatin $121.7 No 2 Olanzapine 99.6 No 3 Lansoprazole 63.8 No 4 Gabapentin 61.2 No 5 Metformin hydrochloride 59.6 No 6 Epoetin alfab 53.3 Yes 7 Risperidone 49.9 No 8 Sertraline hydrochloride 49.3 No 9 Glucose testc 42.4 Unknown 10 Fluoxetine hydrochloride 39.3 No 11 Felodipine 36.5 No 12 Clopidogrel bisulfate 36.1 No 13 Ipratropium bromide 34.6 No 14 Goserelin acetate 34.3 No 15 Lisinopril 28.9 No 16 Paroxetine hydrochloride 27.7 No 17 Albuterol sulfate and ipratropium 24.8 No bromide 18 Divalproex sodium 24.0 No 19 Rosiglitazone maleate 23.9 No 20 Bupropion hydrochloride 22.0 No 21 Amlodipine besylate 20.8 No 22 Atorvastatin calcium 20.2 No 23 Interferon alfa-2b and ribavirind 20.0 No 24 Buspirone hydrochloride 19.5 No 25 Insuline 19.4 No 26 Bicalutamide 19.0 No 27 Beclomethasone dipropionate 18.9 No 28 Celecoxib 18.8 No 29 Finasteride 17.4 No 30 Salmeterol xinafoate 17.2 No 31 Enoxaparin sodium 16.5 No 32 Diltiazeme 16.3 No 33 Oxycodone hydrochloride 16.0 No 34 Latanoprostf 16.0 Yes 35 Donepezil hydrochloride 15.7 No 36 Lamivudine and zidovudine 15.4 No 37 Nifedipine 15.2 No 38 Fexofenadine hydrochloride 15.1 No 39 Cyclosporine 15.0 No 40 Fluticasone propionate 14.9 No Page 18 GAO-03-536 Technology Transfer Appendix II: The Top 100 Pharmaceuticals Procured by VA on the Basis of Dollar Value, Fiscal Year 2001 Dollars in millions Amount Active a Rank Drug name procured government rights 41 Quetiapine fumarate $14.4 No 42 Citalopram hydrobromide 14.3 No 43 Carvedilol 14.0 No 44 Fentanyle 13.5 No 45 Venlafaxine hydrochloride 12.3 No 46 Albuterole 11.6 No 47 Lovastatin 11.3 No 48 Rofecoxib 11.2 No 49 Levofloxacin 11.1 No 50 Filgrastimg 11.1 Yes 51 Triamcinolonee 10.7 No 52 Fosinopril sodium 10.7 No 53 Carbidopa and levodopa 10.2 No 54 Terbinafine hydrochloride 10.2 No 55 Interferon beta-1ac 10.1 Unknown 56 Sumatriptane 10.0 No 57 Warfarin sodium 10.0 No 58 Paclitaxelh 9.5 Yes 59 Tramadol hydrochloride 9.2 No 60 Nefazodone hydrochloride 9.2 No 61 Mycophenolate mofetile 8.7 No 62 Amoxicillin and clavulanate 8.6 No potassium 63 Etanercepti 8.4 No 64 Nitroglycerin 8.2 No 65 Loratadine 8.1 No 66 Stavudinej 7.9 Yes 67 Fluconazole 7.9 No 68 Alendronate sodium 7.5 No 69 Lamivudine 7.4 No 70 Efavirenz 7.4 No 71 Irinotecan hydrochloride 7.3 No 72 Ranitidine hydrochloride 7.3 No 73 Tamsulosin hydrochloride 7.3 No 74 Cetirizine hydrochloride 7.2 No 75 Sotalol hydrochloride 7.0 No 76 Phenytoine 6.9 No 77 Terazosin hydrochloride 6.9 No 78 Carbamazepine 6.9 No 79 Clozapine 6.7 No 80 Irbesartan 6.7 No 81 Brimonidine tartrate 6.7 No 82 Amiodarone hydrochloride 6.6 No Page 19 GAO-03-536 Technology Transfer Appendix II: The Top 100 Pharmaceuticals Procured by VA on the Basis of Dollar Value, Fiscal Year 2001 Dollars in millions Amount Active a Rank Drug name procured government rights 83 Glipizide $6.5 No 84 Mirtazapine 6.4 No 85 Carboplatin 6.3 No 86 Mesalamine 6.1 No 87 Indinavir sulfate 5.8 No 88 Potassium chloride 5.8 No 89 Nelfinavir mesylate 5.6 No 90 Rituximabc 5.6 Unknown 91 Nicotine 5.6 No 92 Omeprazole 5.6 No 93 Tacrolimus 5.5 No 94 Alprostadil 5.4 No 95 Sildenafil citrate 5.1 No 96 Rabeprazole sodium 5.0 No 97 Azithromycin dihydrate 5.0 No 98 Flutamide 4.2 No 99 Ondansetrone 4.0 No 100 Pioglitazone hydrochloride 3.5 No Sources: VA (data), GAO (analysis). Note: The table provides each drug’s name on the basis of the active ingredients as they are listed in FDA’s Electronic Orange Book. a Based on VA’s prime vendor purchases, excluding any direct purchases. b Patent and licensing information about epoetin alpha was obtained from NIH. Two brand name epoetin alpha products, Epogen and Procrit, appear to use federally sponsored technology. c A patent search for this item was not completed because we did not find a related listing in the Orange Book or locate the product’s patent information. d Interferon alpha-2b and ribavirin is not listed in the Orange Book. However, we obtained relevant patent information from the Web site devoted to the interferon/ribavirin product, Rebetron, http://www.rebetron.com/pro/rebetron/pi.html, accessed on August 26, 2002. e Variations of the drug name appeared in the Orange Book, and we examined the patents underlying each relevant product. f Xalatan, a brand name latanoprost product, appears to use federally sponsored technology. g Patent and licensing information about filgrastim was obtained from NIH. A brand name filgrastim product, Neupogen, appears to use federally sponsored technology. h Taxol, a brand name paclitaxel product, appears to use federally sponsored technology. i Relevant patent information was obtained from the Web site for the etanercept brand name product, Enbrel, http://www.enbrel.com/hcp/about_enbrel/indications.jsp, accessed on August 1, 2002. j Zerit, a brand name stavudine product, appears to use federally sponsored technology. Page 20 GAO-03-536 Technology Transfer Appendix III: The Top 100 Pharmaceuticals Appendix III: The Top 100 Pharmaceuticals Dispensed by DOD on the Basis of Dollar Value, July 1, 2001–June 30, 2002 Dispensed by DOD on the Basis of Dollar Value, July 1, 2001–June 30, 2002 Active government Rank Drug name rights 1 Omeprazole No 2 Simvastatin No 3 Atorvastatin calcium No 4 Celecoxib No 5 Rofecoxib No 6 Lansoprazole No 7 Loratadine No 8 Gabapentin No 9 Esomeprazole magnesium No 10 Clopidogrel bisulfate No 11 Alendronate sodium No 12 Fluoxetine hydrochloride No 13 Sertraline hydrochloride No 14 Paroxetine hydrochloride No 15 Amlodipine besylate No 16 Pravastatin sodium No 17 Pioglitazone hydrochloride No 18 Oxycodone hydrochloride No 19 Fluticasone propionate and salmeterol xinafoate No 20 Metformin hydrochloride No 21 Rosiglitazone maleate No 22 Venlafaxine hydrochloride No 23 Olanzapine No 24 Zolpidem tartrate No 25 Amoxicillin and clavulanate potassium No 26 Cetirizine hydrochloride No 27 Lisinopril No 28 Fluticasone propionate No 29 Fexofenadine hydrochloride No 30 Raloxifene hydrochloride No 31 Tolterodine tartrate No 32 Estrogens, conjugated No 33 Bupropion hydrochloride No a 34 Ciprofloxacin No 35 Pantoprazole sodium No 36 Rabeprazole sodium No 37 Levofloxacin No 38 Diltiazem hydrochloride No 39 Donepezil hydrochloride No 40 Citalopram hydrobromide No b 41 Etanercept No 42 Montelukast sodium No Page 21 GAO-03-536 Technology Transfer Appendix III: The Top 100 Pharmaceuticals Dispensed by DOD on the Basis of Dollar Value, July 1, 2001–June 30, 2002 Active government Rank Drug name rights 43 Epoetin alfac Yes d 44 Blood sugar diagnostic Unknown 45 Tamsulosin hydrochloride No a 46 Fentanyl No 47 Azithromycin dihydrate No 48 Risperidone No 49 Loratadine and pseudoephedrine sulfate No 50 Estrogens, conjugated and medroxyprogesterone No acetate 51 Tramadol hydrochloride No 52 Sumatriptana No d 53 Interferon beta-1a and albumin Unknown 54 Somatropin recombinant No 55 Losartan potassium No 56 Sildenafil citrate No 57 Oxybutynin chloride No 58 Carvedilol No 59 Fenofibratee No 60 Amlodipine besylate and benazepril hydrochloride No 61 Acetaminophen and hydrocodone bitartrate No 62 Topiramate No f 63 Filgrastim Yes 64 Metoprolol succinate No 65 Nifedipine No 66 Tamoxifen citrate No 67 Quetiapine fumarate No 68 Valsartan No 69 Budesonide No 70 Salmeterol xinafoate No g 71 Latanoprost Yes 72 Bicalutamide No 73 Clarithromycin No 74 Mometasone furoate No 75 Warfarin sodium No 76 Calcitonin, salmon No 77 Methylphenidate hydrochloride No 78 Finasteride No 79 Divalproex sodium No 80 Mesalamine No 81 Albuterol sulfate and ipratropium bromide No 82 Mirtazapine No 83 Amphetamine aspartate and amphetamine sulfate and No dextroamphetamine saccharate and dextroamphetamine sulfate Page 22 GAO-03-536 Technology Transfer Appendix III: The Top 100 Pharmaceuticals Dispensed by DOD on the Basis of Dollar Value, July 1, 2001–June 30, 2002 Active government Rank Drug name rights 84 Ipratropium bromide No 85 Lorazepam No 86 Potassium chloride No 87 Hydrochlorothiazide and losartan potassium No a 88 Estradiol No 89 Triamcinolonea No 90 Verapamil hydrochloride No 91 Isotretinoin No 92 Enoxaparin sodium No 93 Buspirone hydrochloride No 94 Risedronate sodium No 95 Meloxicam No 96 Albuterola No 97 Ethinyl estradiol and norgestimate No 98 Ranitidine hydrochloride No 99 Valacyclovir hydrochloride No 100 Amiodarone hydrochloride No Sources: DOD (data), GAO (analysis). Note: The ranking of the drugs is based on the dollar sales volumes for prescriptions filled through national mail order pharmacies and the retail pharmacy network. Dollar sales volumes are not provided here because, at the time of the data request, complete information regarding DOD’s pharmaceutical-dispensing activities was not available. The table provides each drug’s name on the basis of the active ingredients as they are listed in FDA’s Electronic Orange Book. a Variations of the drug’s name appeared in the Orange Book, and we examined the patents underlying each relevant product. b Relevant patent information was obtained from the Web site for the etanercept brand name product, Enbrel, http://www.enbrel.com/hcp/about_enbrel/indications.jsp, accessed on August 1, 2002. c Patent and licensing information about epoetin alpha was obtained from NIH. Two brand name epoetin alpha products, Epogen and Procrit, appear to use federally sponsored technology. d A patent search for this item was not completed because we did not find a related listing in the Orange Book or locate the product’s patent information. e DOD listed “fenofibrate, micronized,” while the Orange Book listed only “fenofibrate.” However, the Orange Book provided additional information specifying which fenofibrate products are micronized. Accordingly, we limited our work to such items. f Patent and licensing information about filgrastim was obtained from NIH. A brand name filgrastim product, Neupogen, appears to use federally sponsored technology. g Xalatan, a brand name latanoprost product, appears to use federally sponsored technology. Page 23 GAO-03-536 Technology Transfer Appendix IV: Comments from the National Appendix IV: Comments from the National Institutes of Health Institutes of Health Note: GAO comments supplementing those in the report text appear at the end of this appendix. Page 24 GAO-03-536 Technology Transfer Appendix IV: Comments from the National Institutes of Health See comment 1. Note: Page numbers in the draft report may differ from those in this report. See comment 2. See comment 3. See comment 4. Page 25 GAO-03-536 Technology Transfer Appendix IV: Comments from the National Institutes of Health The following are GAO’s comments on the National Institutes of Health’s letter dated April 22, 2003. 1. We agree with NIH that federal agencies have unrestricted rights to GAO’s Comments use a federally funded invention for government purposes. It has, indeed, a “nontransferable, irrevocable, paid-up license” to practice the invention. Or it may authorize someone to practice the invention on its behalf. However, these rights cannot be taken so as to undermine the rights that the Bayh-Dole Act clearly intends to accord to inventors. Specifically, the government’s license permits it to practice the invention to meet its needs, i.e., to meet needs that are reasonably associated with the requirements of federal programs, not to act outside of those constraints that normally distinguish public- from private-sector activities. 2. We deleted the footnote. 3. We deleted “generally” from the sentence. 4. We disagree. Related issues have been discussed in several court decisions. See, for example, AMP, Inc. v. United States, 389 F.2d 448, 454 (Ct. Cl. 1968), cert. denied, 391 U.S. 964 (1968). Regarding NIH’s concern that adherence to these cases might have a chilling effect on the willingness of private entities to participate as funding recipients, we point out that the parties can negotiate intellectual property rights dealing with these issues on a case-by-case basis. Moreover, the scope of any exception is limited as required to permit use of the government’s license in the subservient patent. (360203) Page 26 GAO-03-536 Technology Transfer The General Accounting Office, the audit, evaluation and investigative arm of GAO’s Mission Congress, exists to support Congress in meeting its constitutional responsibilities and to help improve the performance and accountability of the federal government for the American people. GAO examines the use of public funds; evaluates federal programs and policies; and provides analyses, recommendations, and other assistance to help Congress make informed oversight, policy, and funding decisions. GAO’s commitment to good government is reflected in its core values of accountability, integrity, and reliability. The fastest and easiest way to obtain copies of GAO documents at no cost is Obtaining Copies of through the Internet. 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Technology Transfer: Agencies' Rights to Federally Sponsored Biomedical Inventions
Published by the Government Accountability Office on 2003-07-01.
Below is a raw (and likely hideous) rendition of the original report. (PDF)