1980, October 21. Public Law 96-480. Stevenson-Wydler Technology Innovation Act of 1980.
1980, December 12. As part of Public Law 96-517, the Bayh-Dole Act was enacted into law. It is codified in 35 U.S.C. § 200-212. The original 1980 version of the Bayh-Dole Act included this restriction on exclusive licenses in (c)(7)(B)
“(7) In the case of a nonprofit organization, . .
(B) a prohibition against the granting of exclusive licenses under United States Patents or Patent Applications in a subject invention by the contractor to persons other than small business firms for a period in excess of the earlier of five years from first commercial sale or use of the invention or eight years from the date of the exclusive license excepting that time before regulatory agencies necessary to obtain premarket clearance unless, on a cas~by-case basis, the Federal agency approves a longer exclusive license. If exclusive field of use licenses are granted, commercial sale or use in one field of use shall not be deemed commercial sale or use as to other fields of use, and a first commercial sale or use with respect to a product of the invention shall not be deemed to end the exclusive period to different subsequent products covered by the invention; . ..
(The restriction in (c)(7)(B) on exclusive licenses was eliminated in 1984, in PL 98-620).
1981,July 1. The Bayh-Dole Act became effective.
1982, February 10. The Office of Management and Budget issued OMB Circular A-124 to provide guidance to federal agencies regarding implementation of the Bayh-Dole Act.
1983, February 18. Presidential Memorandum on “Government Patent Policy” was issued. The 1980 Bayh-Dole Act did not give large businesses the right to retain title to their federally funded inventions. The President Reagan Memorandum, followed by an Executive Order in 1987, directed federal agencies, to the extent permitted by law, to extend policies for “all businesses”.
1984, November 8. Bayh-Dole statute was amended by P.L. 98-620. Among other things, the restrictions on the terms of exclusive patent licenses was eliminated. The 1980 Subsec § 202(c)(7)(B), relating to a prohibition against the granting of exclusive licenses to persons other than small business firms for periods in excess of certain specified periods was eliminated.
This was the provision from the 1980 Act that struck.
(B) a prohibition against the granting of exclusive licenses under United States Patents or Patent Applications in a subject invention by the contractor to persons other than small business firms for a period in excess of the earlier of five years from first commercial sale or use of the invention or eight years from the date of the exclusive license excepting that time before regulatory agencies necessary to obtain premarket clearance unless, on a cas~by-case basis, the Federal agency approves a longer exclusive license. If excluwve field of use licenses are granted, commercial sale or use in one field of use shall not be deemed commercial sale or use as to other fields of use, and a first commercial sale or use with respect to a product of the invention shall not be deemed to end the exclusive period to different subsequent products covered by the invention;
The P.L. 98-620 amendments to Bayh-Dole also added a new paragraph to § 203, the march-in statute, to establish an administrative and judicial right of appeal, and a stay pending the exhaustion of appeals or petitions.
“(2) A determination pursuant to this section or section 202(b)(4) shall not be subject to the Contract Disputes Act (41 U.S.C. § 601 et seq.). An administrative appeals procedure shall be established by Regulations. regulations promulgated in accordance with section 206. Additionally, any contractor, inventor, assignee, or exclusive licensee adversely affected by a determination under this section may, at any time within sixty days after the determination is issued, file a petition in the United States Claims Court, which shall have jurisdiction to determine the appeal on the record and to affirm, reverse, remand or modify, “, as appropriate, the determination of the Federal agency. In cases described in paragraphs (a) and (c), the agency’s determination shall be held in abeyance pending the exhaustion of appeals or petitions filed under the preceding sentence.”;
1986, October 20. Enactment of the Federal Technology Transfer Act (FTTA), which authorized federal laboratories to enter into exclusive contracts with corporations to develop and market inventions originating in the federal labs, including under Cooperative Research and Development Agreements (CRADAs). (PL 99-502).
1987, March. The Bayh-Dole Act, OMB Circular A-124 and the Presidential Memorandum, were finalized and consolidated in a Department of Commerce Regulations (37 CFR Part 401).
1987, April 10. President Reagan issued Executive Order 12591 Facilitating Access to Science and Technology, which, among other things, requires executive agencies to promote the commercialization of federally funded inventions in accordance with the 1983 memorandum.
The “reasonable pricing” Licensing/CRADA policy is instituted by the Bush Administration, as a political response to the public outcry over the pricing of AZT by Burroughs Wellcome Co. The policy required firms to sign “reasonable pricing” clauses in return for entering into Cooperative Research and Development Agreements (CRADAs) with the federal government, or exclusive licenses to federal government owned research on pharmaceuticals. This policy applied even when no patent was involved (such as in the taxol case). According to the policy, products developed in part through research at intramural NIH laboratories should reflect a “reasonable relationship between the pricing of the licensed product, the public investment in the product, and the health and safety needs of the public.” There were various versions of the clause in licenses and CRADAs, including modification of the statement below, which also says it “does not permit PHS or any other government agency to set or dictate prices for Licensed Products or Licensed Processes.”
DHHS has responsibility for funding basic biomedical research, for funding medical treatment through programs such as Medicare and Medicaid, for providing direct medical care and, more generally, for protecting the health and safety of the public. Because of these responsibilities, and the public investment in the research that culminated in the Licensed Patents Rights, PHS may require LICENSEE to submit documentation in confidence showing a reasonable relationship between the pricing of a Licensed Product, the public investment in that product and the health and safety needs of the public. This paragraph shall not restrict the right of LICENSEE to price a Licensed Product or Licensed Process so as to obtain a reasonable profit for its sales or use. This Paragraph 5.03 does not permit PHS or any other government agency to set or dictate prices for Licensed Products or Licensed Processes.
1989, August 1. Federal Register Notice for taxol CRADA. The notice included this criteria for selection of CRADA partner.
Criteria for choosing the pharmaceutical company include the following:
. . .
3. Experience and ability to produce, package, market and distribute pharmaceutical products in the United States and to provide the Product at a reasonable price. . . .
1991, October 9. The FDA approves ddI (didanosine), an HIV/AIDS drug that the NIH had been licensed on exclusive basis to Bristol-Myers Squibb. The license to BMS for ddI included, for the first time for an FDA approved drug, a reasonable pricing clause, and also an option for the NIH to terminate the exclusivity 10 years after FDA approval. The initial price for ddI was considerably lower than the price of AZT, a drug in the same class for the treatment of HIV/AIDs.
1991, December 29. The FDA approves Taxol (paclitaxel) as a treatment for ovarian cancer. Taxol was developed by the NIH, and commercialized under a CRADA agreement with BMS that included a reasonable pricing clause.. Background on the disputes over the reasonable pricing clause are found here.
1994. June 15. The DHHS Inspector General June Gibbs Brown issues a report addressed to Phillip R. Lee, M.D., Assistant Secretary for Health, regarding the under-reporting of federal funding of inventions at the Scripps Research Institute.
1994. July 11. The U.S. House of Representatives Subcommittee on Regulation, Business Opportunities, and Technology of the Committee on Small Business, chaired by Rep. Ron Wyden, holds a congressional hearing titled Underreporting federal involvement in new technologies developed at Scripps Research Institute.
1994, July 21. First panel on CRADA fair pricing.
1994, September 8. Second panel on CRADA fair pricing.
1994, December. Reports of the NIH Panels on Cooperative Research and Development Agreements: Perspectives, Outlook and Policy Development. July 21, 1994 and September 8, 1994. A copy of the December 1994 NIH publication of the reports from the two panels here. The NIH convened the first panel with the aim on eliminating the reasonable pricing clause. The make up of the first panel was criticized for industry basis. The second panel was more balanced.
1995, April 11. Pressured by pharmaceutical and biotechnology companies, NIH abandoned the “Reasonable Pricing” clause in licenses and CRADA agreements. The NY Times report on the decision is here.
|1997. March 3. Lloyd N. Cutler and Birch Bayh submit a march-in request to HHS Secretary Donna Shalala on behalf of CellPro over a medical device patents held by Johns Hopkins, infringed by Cellpro’s Ceprate product. This is a list of documents from the case, which are available here.|
|1997. August 1. NIH Director Harold Varmus, M.D, rejects the CellPro march-in petition filed by Lloyd N. Cutler and Birch Bayh on March 3, 1997.|
1999, February 8. Representative Sanders introduced H.R. 626 Health Care Research and Development and Taxpayer Protection Act, seeking re-introduce the CRADA reasonable pricing policy. FAQ on the bill is available here.
|1999. February 16. Access to Treatment, a Thai NGO, wrote a letter to HHS Secretary Donna Shalala asking for a review of the pricing of ddI, a treatment for HIV that was invented by NIH researchers and licensed to BMS. Access to Treatment wanted HHS to grant Thailand the right to manufacture generic versions of the drug.|
|1999. April 20. Dana Delman, a Policy Analyst for the US FDA Executive Secretariat, sends a letter rejecting the ddI request filed by Access to Treatment on February 16, 1999.|
|1999. June 22. Ventana Medical Systems asks the U.S. Secretary of Energy Bill Richardson to use march-in rights over patents related to a method for staining chromosomal DNA by ISH, used for detecting and monitoring genetic abnormalities associated with cancers, held by the University of California and licensed to Vysis, Inc.
The relevant patent was “841 patent” related to blocking DNA which is used in most in-situ hybridization (ISH) assays to chromosomal DNA. The technology used to identify gene sequences was developed at the Energy Department Laboratory and transferred to the University of California. An exclusive license was granted to Vysis, a subsidiary of Abbott laboratories that makes genetic tests for cancer, prenatal disorders, microarrays, and other equipment used by medical and biotechnology researchers. The parties settled the dispute, after a 30-month fact-finding process determination with DOE.
1999. August 12. Keith O. Fultz, Assistant Comptroller General, U.S. General Accounting Office, issues a report to the Chairman of the U.S. Senate Committee on the Judiciary Orrin G. Hatch titled Reporting Requirements for Federally Sponsored Inventions Need Revision.
|1999, September 3. Letter from Ralph Nader, James Love, and Robert Weissman to NIH Director Harold Varmus asking for NIH to give the World Health Organization, WHO, access to US government funded medical inventions.|
1999, September 22. the Public Citizen Health Research group filed five FOIA requests seeking information related to NIH licenses.
|1999, October 19. Letter from NIH Director, Dr. Harold Varmus to Ralph Nader, James Love and Robert Weissman responding to their request calling on the NIH to provide the World Health Organization, WHO, access to US government funded medical inventions.|
2000, June 22. Public Citizen Health Research group filed a FOIA seeking “records concerning the percentage of sales that NIH received as royalties from a) intramural research and b) inventions arising out of CRADAs.
2000, July 31. Public Citizen files lawsuit against the NIH pursuant to 5 USC Section 552(a)4)(B) to compel the Defendant to release information relating to its September 29, 1999 and June 22, 2000, FOIA requests. Pharmaceutical company Johnson & Johnson joined the litigation as an Intervenor-Defendant.
2000, October 26. Maria Freire, representing the NIH, formally denies the Public Citizen Health Research group FOIA requests filed on September 29, 1999 and June 22, 2000, under FOIA exemptions 4 and 5.
2000, November 1. Public Law 106-404, TECHNOLOGY TRANSFER COMMERCIALIZATION ACT OF 2000. The House Committee report is here: H. Rept. 106-129 – TECHNOLOGY TRANSFER COMMERCIALIZATION ACT OF 1999, 106th Congress (1999-2000)
- Several changes were made to the Act, including a minor tweak to § 200, and an extensive rewrite of § 209.
The 2000 amendments took away the discretion of an agency to make a development plan or the reports on the utilization of an invention licensed by the federal government public.
The change to § 200 added the phrase “without unduly encumbering future research and discovery.” In the original 1980 Act, § 209 required a finding that:
“the interests of the Federal Government and the public will best be served by the proposed license.”
The 2000 amendments struck “the interests of the Federal Government” and “best be,” so it read:
“the public will be served by the granting of the license”
The period for public notice on a federally funded license was reduced to 15 days, and the public comment period requirement was eliminated entirely for inventions made under a cooperative research and development agreement (CRADA).
The 2000 Act also amended the Stevenson-Wydler Act provisions that allows the federal government to commit to grant exclusive rights to patents associated with Cooperative Research and Development Agreements (CRADAs), including in the amendments, to patent applications that were filed “before the signing of the agreement” so long as they are “directly within the scope of the agreement.”
|2001, March 28. Letter from Ralph Nader, James Love, and Robert Weissman to US Secretary of Health and Human Services Tommy Thompson, requesting that the DHHS enter into an agreement that would enable the World Health Organization, UNICEF and other public health organizations to use US government rights in patents on medicines and other health care inventions.|
2001, July. NIH Response to the Conference Report: Request for a Plan to Ensure Taxpayers’ Interests are Protected.
|2001. September 5. The NIH used its authority to use march-in and royalty-free rights over patents on stem cell lines resulting from publicly funded research and held by the Wisconsin Alumni Foundation (WARF) as leverage to secure an open license on those patents. The NIH press release on this case is available here and the agreement between the NIH and Wicel is available here.|
2002, March 12. Public Citizen v. NIH et al. was decided in favor of the NIH. A copy of the 30 page decision by District Court Judge Colleen Kollar-Kotelly is available here.
|2002, November 11. Berkeley HeartLab, Inc., asks the U.S. Secretary of Energy Spencer Abraham and Assistant General Counsel for Technology Transfer and Intellectual Property at the Department of Energy Paul A. Gottlieb to use march-in rights over patents related to ion mobility analysis for rapid identification of cardiovascular disease indicators.|
|2004. January 29. Essential Inventions submit a march-in request to the HHS Secretary Tommy Thompson over six patents related to ritonavir, a HIV drug supported by National Institute of Allergy And Infectious Diseases contract AI27220 and marketed by Abbott under the brand name Novir.|
|2004. January 29. Essential Inventions submit a march-in request to HHS Secretary Tommy Thompson over a patent related to latanoprost, a glaucoma drug supported by U.S. Public Health Service Research Grant Numbers EY 00333 and EY 00402 from the National Eye Institute, Department of Health and Human Services, and marketed by Pfizer under the brand name Xalatan. For context, see this 2000 NY Times report on the high cost of the drug and the public funding involved in the R&D, available here.|
|2004. March 10. Essential Inventions requests hearing on the ritonavir march-in rights requests.|
|2004. May 25. The NIH holds a public hearing on the ritonavir march-in right request. To this date, this is the only public hearing the NIH has held on a march-in rights request. The statement submitted by James Love is available here. The agenda of the hearing and other written comments, including written comments submitted by Birch Bayh, are available here.|
|2004. July 29. NIH Director Elias Zerhouni rejects the ritonavir march-in request filed on January 29, 2004 by Essential Inventions involving patents on the AIDS drug Novir/ritonavir.|
|2004. July 29. NIH Director Elias Zerhouni rejects the ritonavir march-in request filed on January 29, 2004 by Essential Inventions involving patents on the AIDS drug Novir/ritonavir.|
|2004. September 17. NIH Director Elias Zerhouni rejects the latanoprost march-in request filed on January 29, 2004 by Essential Inventions involving the Pfizer glaucoma drug.2004, July. NIH report to Congress “Affordability of Inventions and Products“, NIH explained why NIH did not seek to assure fair pricing of federally sponsored inventions.|
2004, November 10. In Campbell Plastics Engineering & Mfg., Inc. v. Les Brownlee, 389 F.3d 1243 (Fed. Cir. 2004), the Federal Circuit held that since the appellant failed to comply with the invention disclosure provisions, the invention was forfeiture and title transferred to the U.S. Army.
|2006. The Centers for Disease Control threatened to use March-In rights to issue compulsory licenses on patents on reverse genetics, which are needed to manufacture vaccines for avian flu.|
Senator Leahy introduced the Public Research in the Public Interest Act at the end of the 109th Congress, to try to ensure that medical product innovations created with federal funds were available in developing countries at the lowest possible cost
|2007, January 5. Essential Inventions request to Robert Portman, Director of the Office of Management and Budget, to take steps to develop and accept alternative competitive sources of supply for federal procurement of two HIV-AIDS medicines: stavudine/d4T and ritonavir. Due to public funding for the development of both drugs, the US government has a royalty free, nonexclusive, worldwide statutory license to the patents for each product. On March 1, 2007, Essential Inventions met with OMB officials, and extended the proposal to include the AIDS drug emtricitabine (Emtriva).|
|2007. February 12. KEI submit a march-in right request to the FTC over patents related to emtricitabine, a HIV drug marketed by Gilead under the brand name Emtriva, for the anti-competitive terms of its voluntary licenses to developing country manufacturers.|
|2007. The FTC declined to decide the march-in case filed by KEI on February 12, 2007, on the grounds that -because the Gilead voluntary license applied to developing countries- the harm was to U.S. taxpayers, not U.S. consumers, and harms caused to U.S. taxpayers for the misuse of publicly-funded inventions is not a cause of action in an U.S. antitrust case.|
The Omnibus Appropriations Act for fiscal year 2009, eliminated on March 11, 2009 the requirement for General Accounting Office (GAO) to study the Bayh Dole Act implementation and submit a report every 5 years.
2009, October. KEI FOIA request to CDC/ DHHS regarding IP aspects of pandemics, specifically “communications or memorandum which address the possibility of the exercise of U.S. government rights in patents under provisions of the Bayh-Dole Act, including but not limited to federal royalty free licenses or March-in rights for patents that benefited from federally funded research”.
|2010. August 2. Three Fabry disease patients, Joseph Carik, Anita Hochendoner and Anita Bova, represented by the Law Office of C. Allen Black, Jr., Ph.D., submit a march-in request to the HHS Secretary Kathleen Sebelius over patents covering agalsidase beta, a drug marketed by Genzyme under the brand name Fabrazyme. The cover letter is here and the petition is here.|
|2010. December 1. NIH Director Francis Collins rejects the Fabrazyme march-in request filed by three Fabry disease patients. A cover letter to this decision, sent by March Rohrbaugh, Director of the NIH Office of Technology Transfer, to the attorney for the Fabry patients is available here.|
|2012. October 25. AMSA, KEI, PIRG, and UAEM asks the NIH Director Francis Collins to use march-in rights and royalty-free rights over patents related to ritonavir, a HIV drug marketed by Abbott under the brand name Novir.|
|2013. March 18. The NIH held a conference call with AMSA, KEI, PIRG, and UAEM regarding their October 25, 2012, march-in and royalty free request over patents related to HIV drug ritonavir.|
|2013. November 1. The NIH Director Francis Collins rejects the ritonavir march-in and royalty-free request filed by AMSA, KEI, PIRG, and UAEM on October 25, 2012.|
|2016, January 14. KEI and UACT submitted a request to the NIH and Department of Defense asking that they exercise their authority under the Bayh-Dole Act to authorize the generic production of enzalutamide, a drug for prostate cancer drug sold by Astellas under the brand name Xtandi. Filing and press release here)|
|2016. June 20. NIH Director Francis Collins rejects the Xtandi march-in and royalty-free request filed by KEI and UACT on January 14, 2016.|
|2017. January 19. KEI asks Daniel R. Levinson, Inspector General at the DHHS, to investigate a failure by Isis Pharmaceuticals (now known as Ionis Pharmaceuticals) and Cold Spring Harbor Laboratory to disclose federal funding in patents related to nusinersen, a treatment for spinal muscular atrophy marketed under the brand name Spinraza.|
|2017. March 16. Matthew Charette, Special Agent in Charge at DHHS Office of Inspector General (OIG) sends a letter to KEI declining to investigate the failure to disclose federal funding in patents related to nusinersen as KEI requested on January 19, 2017.|
|2017. Following the request by KEI on January 19, 2017, Cold Spring Harbor Labs and Isis Pharmaceuticals filed certificates of correction to disclose federal funding for the following seven patents: 8,137,907; 8,273,871; 8,361,977; 8,946,183; 8,993,532; 9,518,259; and 9,624,494.|
|2017. April 29. KEI and UACT appealed the NIH Xtandi march-in and royalty-free decision to the HHS Secretary Tom Price, requesting that the Trump Administration reevaluate the January 14, 2016 request.|
|2017. June 7. NIH Director Francis Collins rejects the Xtandi march-in and royalty-free appeal filed by KEI and UACT on April 29, 2017, despite an explicit request that the appeal not be fielded by his office.|
|2017. July 17. The Senate Armed Services Committee unanimously approves a Directive that links exclusive patent rights to the prices of drugs, vaccines and other medical technologies that are based upon DoD-funded inventions.|
|2017. September 14. KEI submit a march-in and royalty-free request to Andrew Bremberg, an Assistant to the President and the Director of the Domestic Policy Council at the White House, and Keagan Lenihan, a Senior Adviser to HHS Secretary Tom Price, over patents related to daclizumab, a multiple sclerosis drug co-marketed by Biogen and AbbVie by under the brand name Zinbrytra.|
|2018. March 2. Biogen and Abbvie announced a voluntary withdrawal of Zinbryta from the market, noting concerns about the drug’s evolving benefit/risk profile.|
|2018. March 14. KEI asks the DHHS Secretary Alex Azar to investigate a failure by Pharmasset to disclose federal funding in a patent related to sofosbuvir, an HCV drug marketed by Gilead under the brand name Sovaldi.|
|2018. March 19. KEI asks the NIH to investigate the failure by the University of Pennsylvania and Daniel J. Rader to disclose federal funding in six patents related drug the lomitapide, a lipid-lowering agent marketed by Aegerion Pharmaceuticals under the brand name Juxtapid.|
|2018. March 21. KEI asks the NIH to investigate the failure by James Griffin, Dana-Farber Cancer Institute and Novartis to disclose federal funding in patents related to midostaurin, a leukemia drug marketed by Novartis under the brand name Rydapt.|
|2018. April 5. Health GAP, KEI, P4AD, PFAM, SSW, and UAEM asks the NIH to investigate the failure by Sarepta Therapeutics to disclose federal funding in patents related to eteplirsen, a Duchenne Muscular Dystrophy (DMD) drug marketed by Sarepta under the name Exondys 51.|
|2018. May 18. KEI asks the DHHS Secretary Alex Azar to investigate the failure by the University of Pittsburgh to disclose federal funding in patents related to flutemetamol, a radioactive diagnostic agent used to evaluate possible cases of Alzheimer’s disease or other causes of cognitive decline, marketed by GE Healthcare.|
2018, December. NIST Special Publication 1234, Return on Investment Initiative for Unleashing American Innovation