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Bioterrorism Countermeasure Development: Issues in Patents and Homeland Security [May 6, 2005]
Congressional interest in the development of bioterrorism countermeasures remains strong, even after passage of legislation establishing Project BioShield. In the 109th Congress, several bills have been introduced, including S. 3, the Protecting America in the War on Terror Act, and S. 975, the Project Bioshield II Act, that would generate additional incentives for the creation of new technologies to counteract potential biological threats. These bills propose reforms to current policies and practices associated with intellectual property, particularly patents, and the marketing of pharmaceuticals and related products.
Library of Congress. Congressional Research Service
Thomas, John R.; Schacht, Wendy H.
2005-05-06
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Cooperative R&D: Federal Efforts to Promote Industrial Competitiveness [Update August 20, 2008]
This CRS report offers an update to more recent Federal actions in an attempt to encourage collaborative research and development across academia, government, and industry. From the text: "In response to the foreign challenge in the global marketplace, the United States Congress has explored ways to stimulate technological advancement in the private sector. The government has supported various efforts to promote cooperative research and development activities among industry, universities, and the federal R&D establishment designed to increase the competitiveness of American industry and to encourage the generation of new products, processes, and services. Collaborative ventures are intended to accommodate the strengths and responsibilities of all sectors involved in innovation and technology development. Academia, industry, and government often have complementary functions. Joint projects allow for the sharing of costs, risks, facilities, and expertise. Cooperative activity covers various institutional and legal arrangements including industry-industry, industry-university, and industry-government efforts. Proponents of joint ventures argue that they permit work to be done that is too expensive for one company to support and allow for R&D that crosses traditional boundaries of expertise and experience. Such arrangements make use of existing, and support the development of new, resources, facilities, knowledge, and skills. Opponents argue that these endeavors dampen competition necessary for innovation. Federal efforts to encourage cooperative activities include the National Cooperative Research Act; the National Cooperative Production Act; tax changes permitting credits for industry payments to universities for R&D and deductions for contributions of equipment used in academic research; and amendments to the patent laws vesting title to inventions made under federal funding in universities."
Library of Congress. Congressional Research Service
Schacht, Wendy H.
2008-08-20
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Bioterrorism Countermeasure Development: Issues in Patents and Homeland Security [Updated January 17, 2006]
From the Document: "Congressional interest in the development of bioterrorism countermeasures remains strong, even after passage of legislation establishing Project BioShield. In the 109th Congress, several bills have been introduced, including S. 3, the Protecting America in the War on Terror Act, S. 975, the Project Bioshield II Act, and S. 1873, the Biodefense and Pandemic Vaccine and Drug Development Act, that would generate additional incentives for the creation of new technologies to counteract potential biological threats. These bills propose reforms to current policies and practices associated with intellectual property, particularly patents, and the marketing of pharmaceuticals and related products...Encouraging the development of new counterterrorism technologies and ensuring affordable access to new drugs and medical devices are both significant goals. These aspirations may potentially conflict, however. Introducing augmented patent- and exclusivity-based incentives may stimulate innovative firms to engage in the R&D for new countermeasures, as well as to shepherd these products through time-consuming and costly marketing approval procedures. Commentators have expressed concern, however, over whether such heightened protections for innovators will be in proportion with the risks and costs of developing new countermeasures. Striking a balance between encouraging the development of new countermeasures and maintaining the traditional goals of our public health system is a central concern of the current discussion with respect to homeland security."
Library of Congress. Congressional Research Service
Thomas, John R.; Schacht, Wendy H.
2006-01-17
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Advanced Technology Program [Updated November 28, 2005]
"The Advanced Technology Program (ATP) was created by P.L. 100-418, the Omnibus Trade and Competitiveness Act of 1988, to encourage public-private cooperation in the development of pre-competitive technologies with broad application across industries. Administered by the National Institute of Standards and Technology (NIST), a laboratory of the Department of Commerce, this activity has been targeted for elimination as a means to cut federal spending. Since FY2000, the original House passed appropriation bills have not included funding for ATP. Many of the Administrations budget requests have proposed termination of the program. However, ATP continues to be supported, although at levels below that achieved in FY1995 when the activity was expanded significantly. The FY2005 Omnibus Appropriations Act, P.L. 108-447, financed the program at $136.5 million (after mandated rescissions), which reflected a 20% decrease from the earlier fiscal year. For FY2006, both the Administrations budget proposal and the original House-passed version of H.R. 2862, the FY2006 Science, State, Justice, and Commerce appropriations bill, contained no funding for ATP. H.R. 2862, as initially passed by the Senate, provided ATP with $140 million. The final FY2006 appropriation, as enacted in P.L. 109-108, finances the program at $80 million, 41% below the previous fiscal year (prior to a mandated 0.28% rescission on all discretionary budget authority)."
Library of Congress. Congressional Research Service
Schacht, Wendy H.
2005-11-28
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Hatch-Waxman Act: Proposed Legislative Changes Affecting Pharmaceutical Patents [Updated January 5, 2004]
Congressional interest in the cost of pharmaceuticals, particularly for the elderly, has focused attention on several areas where the federal government has programs and policies associated with the development and accessibility of drugs in the marketplace. One of the most prominent legislative initiatives in
this area is P.L. 98-417, the Drug Price Competition and Patent Term Restoration Act of 1984 (commonly known as the Hatch-Waxman
Act) which made several significant changes to the patent laws as they apply to
pharmaceutical products. These changes include provisions for extending the term of a patent to reflect regulatory delays encountered in obtaining marketing approval by the Food and Drug Administration (FDA); a statutory
exemption from patent infringement for activities associated with regulatory marketing approval; establishment of mechanisms to challenge the validity of a pharmaceutical patent; and a reward for disputing the validity, enforceability, or infringement of a patented and approved drug. The Hatch-Waxman Act
also provides the FDA with certain authorities to offer periods of marketing exclusivity for a pharmaceutical independent of the rights
conferred by patents. The provisions contained in the Act were designed to balance the need for innovative new pharmaceuticals and the availability of
less expensive generic drugs. Over the 18 years since passage of the Hatch-Waxman Act, questions have been raised as to whether or not implementation of certain portions of the law has led to unintended consequences that have affected this balance. Some argue that brand name companies and/or generic firms have exploited provisions of the Act to prevent the timely introduction
of lower cost drugs. Other observers assert that no such pattern of abuse is evident and that while a few isolated cases of "misinterpretation" of the law have arisen, these can be addressed through existing procedures. Several bills were introduced in the past several years, as well as in the 108th Congress, that would amend the Hatch-Waxman Act. The Medicare Prescription Drug and Modernization Act of 2003, as signed into law on December 8, 2003, makes changes to the current law to address issues of pharmaceutical patents listed
in the Orange Book maintained by the Food and Drug Administration, patent challenges by generic firms, and the award of market exclusivity, among other things.
Library of Congress. Congressional Research Service
Thomas, John R.; Schacht, Wendy H.
2004-01-05
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Small Business Innovation Research (SBIR) Program [August 4, 2010]
"In 1982, the Small Business Innovation Development Act (P.L. 97-219) established Small Business Innovation Research (SBIR) programs within the major federal research and development (R&D) agencies designed to increase participation of small innovative companies in federally funded R&D. Government agencies with R&D budgets of $100 million or more are required to set aside a portion of these funds to finance the SBIR activity. Through FY2007, over $22.3 billion in awards have been made for more than 100,016 projects. Extended several times, the program was scheduled to sunset on September 30, 2008. Although, to date, no specific legislation has reauthorized the program, the Small Business Administration determined that P.L. 110-235 temporarily extended the SBIR activity through March 20, 2009. Subsequently, P.L. 111- 10 provided an additional extension of the program through July 31, 2009; P.L. 111-43 extended it through September 30, 2009; and P.L. 111-66 extended the effort through October 31, 2009. The SBIR program was once again extended through April 30, 2010, by P.L. 111-89 and through September 30, 2010, by P.L. 111-214. On July 8, 2009, H.R. 2965, a bill to reauthorize and alter the SBIR initiative, passed the House; the Senate substituted the language of S. 1233 (amended) and passed its version of H.R. 2965 on July 13, 2009. For further information on SBIR reauthorization activity see CRS Report RS22865, The Small Business Innovation Research (SBIR) Program: Reauthorization Efforts, by Wendy H. Schacht."
Library of Congress. Congressional Research Service
Schacht, Wendy H.
2010-08-04
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Cooperative R&D: Federal Efforts to Promote Industrial Competitiveness [December 7, 2011]
"In response to the foreign challenge in the global marketplace, the United States Congress has explored ways to stimulate technological advancement in the private sector. The government has supported various efforts to promote cooperative research and development activities among industry, universities, and the federal R&D [research and development] establishment designed to increase the competitiveness of American industry and to encourage the generation of new products, processes, and services. Collaborative ventures are intended to accommodate the strengths and responsibilities of all sectors involved in innovation and technology development. Academia, industry, and government often have complementary functions. Joint projects allow for the sharing of costs, risks, facilities, and expertise. […] Federal efforts to encourage cooperative activities include the National Cooperative Research Act; the National Cooperative Production Act; tax changes permitting credits for industry payments to universities for R&D and deductions for contributions of equipment used in academic research; and amendments to the patent laws vesting title to inventions made under federal funding in universities. Technology transfer from the government to the private sector is facilitated by several laws. In addition, there are various ongoing cooperative programs supported by multiple federal departments and agencies. Given the increased popularity of cooperative programs, questions might be raised as to whether they are meeting expectations. Among the issues before Congress are whether joint ventures contribute to industrial competitiveness and what role, if any, the government has in facilitating such arrangements."
Library of Congress. Congressional Research Service
Schacht, Wendy H.
2011-12-07
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Bayh-Dole Act: Selected Issues in Patent Policy and the Commercialization of Technology [Updated April 3, 2008]
From the Summary: "Congressional interest in facilitating U.S. technological innovation led to the passage of P.L. 96-517, Amendments to the Patent and Trademark Act (commonly referred to as the Bayh-Dole Act after its two main sponsors). The act grants patent rights to inventions arising out of government-sponsored research and development (R&D) to certain types of entities with the expressed purpose of encouraging the commercialization of new technologies through cooperative ventures between and among the research community, small business, and industry. […] However, others point out that collaboration may provide an increased opportunity for conflict of interest, redirection of research, less openness in sharing of scientific discovery, and a greater emphasis on applied rather than basic research. Additional concerns have been expressed, particularly in relation to the pharmaceutical and biotechnology industries, that the government and the public are not receiving benefits commensurate with the federal contribution to the initial research and development. Actual experience and cited studies suggest that companies which do not control the results of their investments -- either through ownership of patent title, exclusive license, or pricing decisions -- tend to be less likely to engage in related R&D. The importance of control over intellectual property is reinforced by the positive effect P.L. 96-517 has had on the emergence of new technologies and techniques generated by U.S. companies. This report will be updated as events warrant."
Library of Congress. Congressional Research Service
Schacht, Wendy H.
2008-04-03
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Small Business Innovation Research (SBIR) Program [November 14, 2012]
"In 1982, the Small Business Innovation Development Act (P.L. 97-219) established Small Business Innovation Research (SBIR) programs within the major federal research and development (R&D) agencies designed to increase participation of small innovative companies in federally funded R&D. Government agencies with R&D budgets of $100 million or more are required to set aside a portion of these funds to finance the SBIR activity. Through FY2009, over 112,500 awards have been made totaling more than $26.9 billion. Reauthorized several times over the years, the SBIR program was scheduled to terminate on September 30, 2008. A companion pilot activity, the Small Business Technology Transfer (STTR) program, was scheduled to end the following year. A series of temporary extensions kept both programs in operation until the SBIR/STTR Reauthorization Act of 2011 was enacted as Title LI of the National Defense Authorization Act for Fiscal Year 2012, P.L. 112-81. In general, the new legislation reauthorizes the SBIR and STTR programs through September 30, 2017; incrementally increases the set aside for the SBIR effort to 3.2% by FY2017 and beyond; incrementally expands the set aside for the STTR activity to 0.45% in FY2016 and beyond; increases the amount of Phase I and Phase II awards; allows the National Institutes of Health, the Department of Energy, and the National Science Foundation to award up to 25% of SBIR funds to small businesses that are majority-owned by venture capital companies, hedge funds, or private equity firms and other agencies to award up to 15% of SBIR funds to such firms; creates commercialization pilot programs; and expands oversight activities, among other things."
Library of Congress. Congressional Research Service
Schacht, Wendy H.
2012-11-14
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Bayh-Dole Act: Selected Issues in Patent Policy and the Commercialization of Technology [December 3, 2012]
From the Introduction: "Congressional interest in facilitating U.S. technological innovation led to the passage of P.L. [Public Law] 96- 517, Amendments to the Patent and Trademark Act, commonly referred to as the 'Bayh-Dole Act' after its two main sponsors former Senators Robert Dole and Birch Bayh. Under this 1980 law, as amended, title to inventions made with government support may be provided to the contractor if that contractor is a small business, a university, or other non-profit institution. The legislation is intended to use patent ownership as an incentive for private sector development and commercialization of federally funded research and development (R&D). As a response to congressional efforts to create a unified government patent policy pertaining to inventions made with federal support, the Bayh-Dole Act promotes cooperative activities among academia, small business, and industry leading to new products and processes for the marketplace. This report discusses the rationale behind the passage of P.L. 96-517, its provisions, and implementation of the law. Observers generally agree that the Bayh-Dole Act has successfully met its objectives. However, some experts argue that the issues associated with the law's patent policies should be revisited given the current R&D environment. Much of the renewed interest is a result of the legislation's effect on the biotechnology and pharmaceutical industries where critics assert that the private sector is receiving benefits to the detriment of the public interest. Other analysts, particularly in the defense arena, maintain that the existing rights maintained by the government are too restrictive and prevent industry from meeting national needs. Many of these issues and concerns are similar, if not identical to those addressed during the 15 to 20 years of deliberation prior to enactment of the law. These too will be explored to provide a context for current discussions."
Library of Congress. Congressional Research Service
Schacht, Wendy H.
2012-12-03
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Industrial Competitiveness and Technological Advancement: Debate Over Government Policy [December 3, 2012]
"There is ongoing interest in the pace of U.S. technological advancement due to its influence on U.S. economic growth, productivity, and international competitiveness. Because technology can contribute to economic growth and productivity increases, congressional attention has focused on how to augment private-sector technological development. Legislative activity over the past 30 or more years has created a policy for technology development, albeit an ad hoc one. Because of the lack of consensus on the scope and direction of a national policy, Congress has taken an incremental approach aimed at creating new mechanisms to facilitate technological advancement in particular areas and making changes and improvements as necessary. […] The proper role of the federal government in technology development and the competitiveness of U.S. industry continues to be a topic of congressional debate. Legislation affecting the research and development (R&D) environment has included both direct and indirect measures to facilitate technological innovation. In general, direct measures are those which involve budget outlays and the provision of services by government agencies. Indirect measures include financial incentives and legal changes (e.g., liability or regulatory reform; new antitrust arrangements). As the Congress develops its appropriation priorities, the manner by which the government encourages technological progress in the private sector again may be explored and/or redefined."
Library of Congress. Congressional Research Service
Schacht, Wendy H.
2012-12-03
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Cooperative R&D: Federal Efforts to Promote Industrial Competitiveness [December 3, 2012]
"In response to the foreign challenge in the global marketplace, the United States Congress has explored ways to stimulate technological advancement in the private sector. The government has supported various efforts to promote cooperative research and development [R&D] activities among industry, universities, and the federal R&D establishment designed to increase the competitiveness of American industry and to encourage the generation of new products, processes, and services. Collaborative ventures are intended to accommodate the strengths and responsibilities of all sectors involved in innovation and technology development. Academia, industry, and government often have complementary functions. Joint projects allow for the sharing of costs, risks, facilities, and expertise. Cooperative activity covers various institutional and legal arrangements including industry-industry, industry-university, and industry-government efforts. Proponents of joint ventures argue that they permit work to be done that is too expensive for one company to support and allow for R&D that crosses traditional boundaries of expertise and experience. Such arrangements make use of existing, and support the development of new, resources, facilities, knowledge, and skills. Opponents argue that these endeavors dampen competition necessary for innovation. Federal efforts to encourage cooperative activities include the National Cooperative Research Act; the National Cooperative Production Act; tax changes permitting credits for industry payments to universities for R&D and deductions for contributions of equipment used in academic research; and amendments to the patent laws vesting title to inventions made under federal funding in universities. Technology transfer from the government to the private sector is facilitated by several laws. In addition, there are various ongoing cooperative programs supported by multiple federal departments and agencies."
Library of Congress. Congressional Research Service
Schacht, Wendy H.
2012-12-03
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Leahy-Smith America Invents Act: Innovation Issues [January 15, 2013]
From the Document: "Following several years of legislative discussion concerning patent reform, the Congress enacted P.L. 112-29, signed into law on September 16, 2011. […] The AIA [Leahy-Smith American Invents Act] introduced a number of additional changes to the patent law, including changes to the venue and joinder statutes, the introduction of supplemental examination, and a clarification of the law of willful infringement. Although the AIA arguably made the most significant changes to the U.S. patent statute since the 19th century, the legislation did not reflect all of the issues that were the subject of congressional discussion including the assessment of damages during infringement litigation and the publication of all pending patent applications prior to grant."
Library of Congress. Congressional Research Service
Schacht, Wendy H.; Thomas, John R.
2013-01-15
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Bayh-Dole Act: Selected Issues in Patent Policy and the Commercialization of Technology [March 16, 2012]
From the Introduction: "Congressional interest in facilitating U.S. technological innovation led to the passage of P.L. 96- 517, Amendments to the Patent and Trademark Act, commonly referred to as the 'Bayh-Dole Act' after its two main sponsors former Senators Robert Dole and Birch Bayh. Under this 1980 law, as amended, title to inventions made with government support may be provided to the contractor if that contractor is a small business, a university, or other non-profit institution. The legislation is intended to use patent ownership as an incentive for private sector development and commercialization of federally funded research and development (R&D). As a response to congressional efforts to create a unified government patent policy pertaining to inventions made with federal support, the Bayh-Dole Act promotes cooperative activities among academia, small business, and industry leading to new products and processes for the marketplace. This report discusses the rationale behind the passage of P.L. 96-517, its provisions, and implementation of the law. Observers generally agree that the Bayh-Dole Act has successfully met its objectives. However, some experts argue that the issues associated with the law's patent policies should be revisited given the current R&D environment. Much of the renewed interest is a result of the legislation's effect on the biotechnology and pharmaceutical industries where critics assert that the private sector is receiving benefits to the detriment of the public interest."
Library of Congress. Congressional Research Service
Schacht, Wendy H.
2012-03-16
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Industrial Competitiveness and Technological Advancement: Debate Over Government Policy [March 13, 2012]
"There is ongoing interest in the pace of U.S. technological advancement due to its influence on U.S. economic growth, productivity, and international competitiveness. Because technology can contribute to economic growth and productivity increases, congressional attention has focused on how to augment private-sector technological development. Legislative activity over the past 25 or more years has created a policy for technology development, albeit an ad hoc one. Because of the lack of consensus on the scope and direction of a national policy, Congress has taken an incremental approach aimed at creating new mechanisms to facilitate technological advancement in particular areas and making changes and improvements as necessary. Congressional action has mandated specific technology development programs and obligations in federal agencies. Many programs were created based upon what individual committees judged appropriate within the agencies over which they had authorization or appropriation responsibilities. However, there has been recent legislative activity directed at eliminating or significantly curtailing many of these federal efforts. Several programs have been terminated and the budgets for other initiatives have declined. The proper role of the federal government in technology development and the competitiveness of U.S. industry continues to be a topic of congressional debate. Legislation affecting the research and development (R&D) environment has included both direct and indirect measures to facilitate technological innovation. In general, direct measures are those which involve budget outlays and the provision of services by government agencies. Indirect measures include financial incentives and legal changes (e.g., liability or regulatory reform; new antitrust arrangements). As the Congress develops its appropriation priorities, the manner by which the government encourages technological progress in the private sector again may be explored and/or redefined."
Library of Congress. Congressional Research Service
Schacht, Wendy H.
2012-03-13
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Cooperative R&D: Federal Efforts to Promote Industrial Competitiveness [March 12, 2012]
"In response to the foreign challenge in the global marketplace, the United States Congress has explored ways to stimulate technological advancement in the private sector. The government has supported various efforts to promote cooperative research and development [R&D] activities among industry, universities, and the federal R&D establishment designed to increase the competitiveness of American industry and to encourage the generation of new products, processes, and services. Collaborative ventures are intended to accommodate the strengths and responsibilities of all sectors involved in innovation and technology development. Academia, industry, and government often have complementary functions. Joint projects allow for the sharing of costs, risks, facilities, and expertise. Cooperative activity covers various institutional and legal arrangements including industry-industry, industry-university, and industry-government efforts. Proponents of joint ventures argue that they permit work to be done that is too expensive for one company to support and allow for R&D that crosses traditional boundaries of expertise and experience. Such arrangements make use of existing, and support the development of new, resources, facilities, knowledge, and skills. Opponents argue that these endeavors dampen competition necessary for innovation. […] Technology transfer from the government to the private sector is facilitated by several laws. In addition, there are various ongoing cooperative programs supported by multiple federal departments and agencies. Given the increased popularity of cooperative programs, questions might be raised as to whether they are meeting expectations. Among the issues before Congress are whether joint ventures contribute to industrial competitiveness and what role, if any, the government has in facilitating such arrangements."
Library of Congress. Congressional Research Service
Schacht, Wendy H.
2012-03-12
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Industrial Competitiveness and Technological Advancement: Debate Over Government Policy [Updated August 10, 2007]
"There is ongoing interest in the pace of U.S. technological advancement due to its influence on U.S. economic growth, productivity, and international competitiveness. Because technology can contribute to economic growth and productivity increases, congressional attention has focused on how to augment private-sector technological development. Legislative activity over the past two decades has created a policy for technology development, albeit an ad hoc one. Because of the lack of consensus on the scope and direction of a national policy, Congress has taken an incremental approach aimed at creating new mechanisms to facilitate technological advancement in particular areas and making changes and improvements as necessary. Congressional action has mandated specific technology development programs and obligations in federal agencies that did not initially support such efforts. Many programs were created based upon what individual committees judged appropriate within the agencies over which they had authorization or appropriation responsibilities. The use of line item funding for these activities, including the Advanced Technology Program and the Manufacturing Extension Program of the National Institute of Standards and Technology, as well as for the Undersecretary for Technology at the Department of Commerce, is viewed by proponents as a way to ensure that the government encourages technological advance in the private sector. […]Questions have been raised concerning the proper role of the federal government in technology development and the competitiveness of U.S. industry. As the 110th Congress begins to develop its budget priorities, how the government encourages technological progress in the private sector again may be explored and/or redefined."
Library of Congress. Congressional Research Service
Schacht, Wendy H.
2007-08-10
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Industrial Competitiveness and Technological Advancement: Debate Over Government Policy [Updated August 1, 2007]
"There is ongoing interest in the pace of U.S. technological advancement due to its influence on U.S. economic growth, productivity, and international competitiveness. Because technology can contribute to economic growth and productivity increases, congressional attention has focused on how to augment private-sector technological development. Legislative activity over the past two decades has created a policy for technology development, albeit an ad hoc one. Because of the lack of consensus on the scope and direction of a national policy, Congress has taken an incremental approach aimed at creating new mechanisms to facilitate technological advancement in particular areas and making changes and improvements as necessary. Congressional action has mandated specific technology development programs and obligations in federal agencies that did not initially support such efforts. Many programs were created based upon what individual committees judged appropriate within the agencies over which they had authorization or appropriation responsibilities. The use of line item funding for these activities, including the Advanced Technology Program and the Manufacturing Extension Program of the National Institute of Standards and Technology, as well as for the Undersecretary for Technology at the Department of Commerce, is viewed by proponents as a way to ensure that the government encourages technological advance in the private sector. Some legislative activity, beginning in the 104th Congress, has been directed at eliminating or significantly curtailing many of these federal efforts. Although this approach has not been adopted, the budgets for several programs have declined."
Library of Congress. Congressional Research Service
Schacht, Wendy H.
2007-08-01
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Bioterrorism Countermeasure Development: Issues in Patents and Homeland Security [Updated August 3, 2007]
From the Document: "Congressional interest in the development of bioterrorism countermeasures remains strong, even after passage of legislation establishing Project BioShield. While, to date, no relevant bills have been introduced in the 110th Congress, the issue is under discussion. During the 109th Congress, several bills were introduced (although not enacted) that would have generated additional incentives for the creation of new technologies to counteract potential biological threats. These bills proposed reforms to current policies and practices associated with intellectual property, particularly patents, and the marketing of pharmaceuticals and related products. Patent ownership appears to be important in the promotion of innovation, particularly in the pharmaceutical sector. Patent title provides a limited-time monopoly over the use of a discovery in exchange for the public dissemination of information contained in the patent application. This permits the inventor to receive a return on the expenditure of resources but does not guarantee that the patent will generate commercial benefits. The requirement for patent publication is expected to stimulate additional innovation to meet similar demands in the marketplace. Currently, the Bayh-Dole Act and the Hatch-Waxman Act include provisions that utilize patent ownership to facilitate the development and commercialization of new pharmaceuticals. The Hatch-Waxman Act also contains FDA marketing approval policies that are designed to promote the creation of new drugs. Similar market-exclusivity provisions are contained in the Orphan Drug Act."
Library of Congress. Congressional Research Service
Thomas, John R.; Schacht, Wendy H.
2007-08-03
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Industrial Competitiveness and Technological Advancement: Debate Over Government Policy [Updated May 30, 2006]
"There is ongoing interest in the pace of U.S. technological advancement due to its influence on U.S. economic growth, productivity, and international competitiveness. Because technology can contribute to economic growth and productivity increases, congressional interest has focused on how to augment private-sector technological development. Legislative activity over the past two decades has created a policy for technology development, albeit an ad hoc one. Because of the lack of consensus on the scope and direction of a national policy, Congress has taken an incremental approach aimed at creating new mechanisms to facilitate technological advancement in particular areas and making changes and improvements as necessary. Congressional action has mandated specific technology development programs and obligations in federal agencies that did not initially support such efforts. Many programs were created based upon what individual committees judged appropriate within the agencies over which they had authorization or appropriation responsibilities. The use of line item funding for these activities, including the Advanced Technology Program and the Manufacturing Extension Program of the National Institute of Standards and Technology, as well as for the Undersecretary for Technology at the Department of Commerce, is viewed by proponents as a way to ensure that the government encourages technological advance in the private sector."
Library of Congress. Congressional Research Service
Schacht, Wendy H.
2006-05-30
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Cooperative R&D: Federal Efforts to Promote Industrial Competitiveness [Updated August 3, 2006]
"In response to the foreign challenge in the global marketplace, the United States Congress has explored ways to stimulate technological advancement in the private sector. The government has supported various efforts to promote cooperative research and development activities among industry, universities, and the federal R&D establishment designed to increase the competitiveness of American industry and to encourage the generation of new products, processes, and services. Collaborative ventures are intended to accommodate the strengths and responsibilities of all sectors involved in innovation and technology development. Academia, industry, and government often have complementary functions. Joint projects allow for the sharing of costs, risks, facilities, and expertise. Cooperative activity covers various institutional and legal arrangements including industry-industry, industry-university, and industry-government efforts. Proponents of joint ventures argue that they permit work to be done that is too expensive for one company to support and allow for R&D that crosses traditional boundaries of expertise and experience. Such arrangements make use of existing, and support the development of new, resources, facilities, knowledge, and skills. Opponents argue that these endeavors dampen competition necessary for innovation."
Library of Congress. Congressional Research Service
Schacht, Wendy H.
2006-08-03
-
Industrial Competitiveness and Technological Advancement: Debate Over Government Policy [Updated August 3, 2006]
"There is ongoing interest in the pace of U.S. technological advancement due to its influence on U.S. economic growth, productivity, and international competitiveness. Because technology can contribute to economic growth and productivity increases, congressional attention has focused on how to augment private-sector technological development. Legislative activity over the past two decades has created a policy for technology development, albeit an ad hoc one. Because of the lack of consensus on the scope and direction of a national policy, Congress has taken an incremental approach aimed at creating new mechanisms to facilitate technological advancement in particular areas and making changes and improvements as necessary. Congressional action has mandated specific technology development programs and obligations in federal agencies that did not initially support such efforts. Many programs were created based upon what individual committees judged appropriate within the agencies over which they had authorization or appropriation responsibilities. The use of line item funding for these activities, including the Advanced Technology Program and the Manufacturing Extension Program of the National Institute of Standards and Technology, as well as for the Undersecretary for Technology at the Department of Commerce, is viewed by proponents as a way to ensure that the government encourages technological advance in the private sector."
Library of Congress. Congressional Research Service
Schacht, Wendy H.
2006-08-03
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Industrial Competitiveness and Technological Advancement: Debate over Government Policy [July 7, 2006]
"There is ongoing interest in the pace of U.S. technological advancement due to its influence on U.S. economic growth, productivity, and international competitiveness. Because technology can contribute to economic growth and productivity increases, congressional attention has focused on how to augment private-sector technological development. Legislative activity over the past two decades has created a policy for technology development, albeit an ad hoc one. Because of the lack of consensus on the scope and direction of a national policy, Congress has taken an incremental approach aimed at creating new mechanisms to facilitate technological advancement in particular areas and making changes and improvements as necessary. Congressional action has mandated specific technology development programs and obligations in federal agencies that did not initially support such efforts. Many programs were created based upon what individual committees judged appropriate within the agencies over which they had authorization or appropriation responsibilities. The use of line item funding for these activities, including the Advanced Technology Program and the Manufacturing Extension Program of the National Institute of Standards and Technology, as well as for the Undersecretary for Technology at the Department of Commerce, is viewed by proponents as a way to ensure that the government encourages technological advance in the private sector."
Library of Congress. Congressional Research Service
Schacht, Wendy H.
2006-07-07
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Cooperative R&D: Federal Efforts to Promote Industrial Competitiveness [July 7, 2006]
"In response to the foreign challenge in the global marketplace, the United States Congress has explored ways to stimulate technological advancement in the private sector. The government has supported various efforts to promote cooperative research and development activities among industry, universities, and the federal R&D establishment designed to increase the competitiveness of American industry and to encourage the generation of new products, processes, and services. Collaborative ventures are intended to accommodate the strengths and responsibilities of all sectors involved in innovation and technology development. Academia, industry, and government often have complementary functions. Joint projects allow for the sharing of costs, risks, facilities, and expertise. Cooperative activity covers various institutional and legal arrangements including industry-industry, industry-university, and industry-government efforts. Proponents of joint ventures argue that they permit work to be done that is too expensive for one company to support and allow for R&D that crosses traditional boundaries of expertise and experience. Such arrangements make use of existing, and support the development of new, resources, facilities, knowledge, and skills. Opponents argue that these endeavors dampen competition necessary for innovation. Federal efforts to encourage cooperative activities include the National Cooperative Research Act; the National Cooperative Production Act; tax changes permitting credits for industry payments to universities for R&D and deductions for contributions of equipment used in academic research; and amendments to the patent laws vesting title to inventions made under federal funding in universities. Technology
transfer from the government to the private sector is facilitated by several laws. In addition, there are various ongoing cooperative programs supported by various federal departments and agencies."
Library of Congress. Congressional Research Service
Schacht, Wendy H.
2006-07-07
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Cooperative R&D: Federal Efforts to Promote Industrial Competitiveness [Updated May 30, 2006]
"In response to the foreign challenge in the global marketplace, the United States Congress has explored ways to stimulate technological advancement in the private sector. The government has supported various efforts to promote cooperative research and development activities among industry, universities, and the federal R&D establishment designed to increase the competitiveness of American industry and to encourage the generation of new products, processes, and services. Among the issues before Congress are whether joint ventures contribute to industrial competitiveness and what role, if any, the government has in facilitating such arrangements. Collaborative ventures are intended to accommodate the strengths and responsibilities of all sectors involved in innovation and technology development. Academia, industry, and government often have complementary functions. Joint projects allow for the sharing of costs, risks, facilities, and expertise. Cooperative activity covers various institutional and legal arrangements including industry-industry, industry-university, and industry-government efforts. Proponents of joint ventures argue that they permit work to be done that is too expensive for one company to support and allow for R&D that crosses traditional boundaries of expertise and experience."
Library of Congress. Congressional Research Service
Schacht, Wendy H.
2006-05-30
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Manufacturing Extension Partnership Program: An Overview [Updated October 20, 2006]
"The Omnibus Trade and Competitiveness Act of 1988, P.L. 100-418, created a program of regional centers to assist small and medium-sized manufacturing companies in using knowledge and technologies developed under the auspices of the National Institute of Standards and Technology (NIST), a laboratory of the Department of Commerce. Now known as the Hollings Manufacturing Extension Partnership (MEP), centers in all 50 states and Puerto Rico provide technical and managerial assistance to firms. Federal funding is matched by non-federal sources. As the program expanded, funding increased until FY1999, when support declined reflecting a decrease in the federal portion of financing from one-half to one-third as individual centers operated longer than six years. Through FY2004, funding remained fairly constant despite the Administration's FY2003 budget that proposed an 88% reduction in support such that MEP centers '... with more than six years' experience operate without federal contribution.' Support was cut 63% in FY2004, but restored in FY2005. The $46.8 million for MEP in the President's FY2006 budget proposal reflected another substantial reduction in funding; however, P.L. 109-108, the FY2006 appropriations legislation, provided financing of $104.6 million for the program (after mandated rescissions). The Administration's FY2007 budget again includes a large cut in support for MEP which would be funded at $46.3 million. H.R. 5672, the FY2007 appropriations bill that passed the House on June 29, 2006, finances the program at $92 million. The version of this bill reported from the Senate Committee on Appropriations provides MEP with $106 million."
Library of Congress. Congressional Research Service
Schacht, Wendy H.
2006-10-20
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Industrial Competitiveness and Technological Advancements: Debate Over Government Policy [Updated December 11, 2006]
"There is ongoing interest in the pace of U.S. technological advancement due to its influence on U.S. economic growth, productivity, and international competitiveness. Because technology can contribute to economic growth and productivity increases, congressional attention has focused on how to augment private-sector technological development. Legislative activity over the past two decades has created a policy for technology development, albeit an ad hoc one. Because of the lack of consensus on the scope and direction of a national policy, Congress has taken an incremental approach aimed at creating new mechanisms to facilitate technological advancement in particular areas and making changes and improvements as necessary. Congressional action has mandated specific technology development programs and obligations in federal agencies that did not initially support such efforts. Many programs were created based upon what individual committees judged appropriate within the agencies over which they had authorization or appropriation responsibilities. The use of line item funding for these activities, including the Advanced Technology Program and the Manufacturing Extension Program of the National Institute of Standards and Technology, as well as for the Undersecretary for Technology at the Department of Commerce, is viewed by proponents as a way to ensure that the government encourages technological advance in the private sector. Some legislative activity, beginning in the 104th Congress, has been directed at eliminating or significantly curtailing many of these federal efforts."
Library of Congress. Congressional Research Service
Schacht, Wendy H.
2006-12-11
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Industrial Competitiveness and Technological Advancement: Debate Over Government Policy [Updated March 19, 2007]
"There is ongoing interest in the pace of U.S. technological advancement due to its influence on U.S. economic growth, productivity, and international competitiveness. Because technology can contribute to economic growth and productivity increases, congressional attention has focused on how to augment private-sector technological development. Legislative activity over the past two decades has created a policy for technology development, albeit an ad hoc one. Because of the lack of consensus on the scope and direction of a national policy, Congress has taken an incremental approach aimed at creating new mechanisms to facilitate technological advancement in particular areas and making changes and improvements as necessary. Congressional action has mandated specific technology development programs and obligations in federal agencies that did not initially support such efforts. Many programs were created based upon what individual committees judged appropriate within the agencies over which they had authorization or appropriation responsibilities. The use of line item funding for these activities, including the Advanced Technology Program and the Manufacturing Extension Program of the National Institute of Standards and Technology, as well as for the Undersecretary for Technology at the Department of Commerce, is viewed by proponents as a way to ensure that the government encourages technological advance in the private sector. […] Questions have been raised concerning the proper role of the federal government in technology development and the competitiveness of U.S. industry. As the 110th Congress begins to develop its budget priorities, how the government encourages technological progress in the private sector again may be explored and/or redefined."
Library of Congress. Congressional Research Service
Schacht, Wendy H.
2007-03-19
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Advanced Technology Program [Updated February 16,2007]
"The Advanced Technology Program (ATP) was created by P.L. 100-418, the Omnibus Trade and Competitiveness Act of 1988, to encourage public-private cooperation in the development of pre-competitive technologies with broad application across industries. Administered by the National Institute of Standards and Technology (NIST), a laboratory of the Department of Commerce, this activity has been targeted for elimination as a means to cut federal spending. Since FY2000, the original House passed appropriation bills have not included funding for ATP. Many of the Administration's budget requests have proposed termination of the program. However, ATP continues to be supported, although at levels below that achieved in FY1995 when the activity was expanded significantly. The FY2005 appropriations were 20% lower than the earlier fiscal year. For FY2006, both the Administration's budget proposal and the original House-passed version of the appropriations bill, contained no funding for ATP although P.L. 109-108, the final FY2006 appropriation legislation, financed the program at $79 million, 42% below the previous fiscal year (after a mandated rescission). The Administration's FY2007 budget request again did not include funding for ATP, nor did the appropriation bill passed by the House and reported by the Senate Committee on Appropriations in the previous Congress. While no final FY2007 appropriations legislation was enacted during the 109th Congress, a series of continuing resolutions financed ATP at FY2006 levels through February 15, 2007. In the current Congress, P.L. 110-5 provides the program $79 million for FY2007. The President's FY2008 budget request contains no funding for ATP. This report will be updated as events warrant."
Library of Congress. Congressional Research Service
Schacht, Wendy H.
2007-02-16
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Follow-On Biologics: Intellectual Property and Innovation Issues [June 4, 2007]
"Biologics, which are sometimes termed biopharmaceutials or biotechnology drugs, have begun to play an increasingly important role in U.S. health care. Not only are sales of biologics growing rapidly, some experts estimate that in coming years half of all newly approved drugs will result from biotechnology. […] Legislation introduced in the 110th Congress would create an expedited marketing approval pathway for follow-on biologics within the Public Health Service Act. The Access to Life-Saving Medicine Act, introduced as H.R. 1038 and S. 623, would grant the Secretary of Health and Human Service certain discretion to determine, on a case-by-case basis, what studies were necessary to establish comparability. Under these bills, an applicant for a comparable biological product would be allowed optionally to elect to establish 'interchangeability' with the brandname product. The other two bills, H.R. 1956 and S. 1505, instead call for the publication of a number of administrative guidance documents that stipulate the particular data required to file a marketing approval application for a particular category of biologics. Interested parties would then be permitted to file applications for similar biological products within that category. Certain of these bills also address the patent consequences of follow-on generics practice."
Library of Congress. Congressional Research Service
Schacht, Wendy H.; Thomas, John R.
2007-06-04
