For more information, KEI general website on the Bayh Dole Act
On December 12, 1980, P.L. 96-517, the Bayh-Dole Act was enacted into law. It is codified in 35 U.S.C. § 200-212
The Stevenson-Wydler Acts is enacted into law
The Bayh-Dole Act became effective on July 1, 1981
On February 10, 1982, the Office of Management and Budget issued OMB Circular A-124 to provide guidance to federal agencies regarding implementation of the Bayh-Dole Act.
On February 18, 1983, a 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”.
In November 1984, the original Bayh-Dole statute was amended by P.L. 98-620. Among other things, the restrictions on the terms of exclusive patent licenses was eliminated.
Congress passed the Federal Technology Transfer Act, which authorized federal laboratories to enter into exclusive contracts with corporations to develop and market inventions originating in the federal labs. (PL 99-502).
In March 1987, the Bayh-Dole Act, the amendment, OMB Circular A-124, and the Presidential Memorandum, were finalized and consolidated in a Department of Commerce Regulations (37 CFR Part 401).
In April 1987, 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 went further than the Bayh-Dole Act in some respects. 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.” The clause also said “exclusive commercialization licenses granted for NIH/ADAMHA intellectual property rights may require that this relationship be supported by reasonable evidence.”
An NIH owned patent on DDI (didanosine) that had been licensed on exclusive basis to Bristol-Myers Squibb, was approved for marketing by the FDA on October 9, 1991. The license to BMS for ddI included, for the first time for an FDA approved drug, a reasonable pricing clause.
On December 29, 1991, the FDA approved 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.
NIH sponsored two panels to examine the Licensing/ CRADA reasonable pricing clause after being criticized for the Taxol & BMS pricing agreement. The first panel in July 1994 had no consumer representative. The Second NIH CRADA Forum in September 2004 did. For a consumers perspective on the issue: Pricing of Drugs Developed with Public Funds.
Pressureed by pharmaceutical and biotechnology companies, on April 11, 1995, NIH abandoned the “Reasonable Pricing” clause in licenses and CRADA agreements. The NY Times report on the decision is here. A subsequent rationale was offered here.
In August 1997, a March-In Rights petition by Cell-Pro, Inc. was denied, and ultimately their patent infringing stem cell selection device was pulled from the market despite its clinical advantages and lack of a licensed and FDA approved alternative. In its petition, CellPro argued that The Johns Hopkins University and Baxter Healthcare failed to take reasonable steps to commercialize the technology and that Johns Hopkins should be forced to license Cellpro the patent necessary to keep its machine on the market. The NIH rejected the petition determined that by working to obtain FDA approval for its own product and making its product available to patients through clinical trials, the exclusive sub-licensee, Baxter, had satisfied the requirements under the Bayh-Dole Act. The NIH also denied Cellpro’s claim that it needed Johns Hopkins’s patents to keep its device on the market for health and safety reasons. More information: CPTech website on the case.
Representative Sanders presented a bill proposal H.R. 626 Health Care Research and Development and Taxpayer Protection Act, in the House to re-introduce the CRADA reasonable pricing policy. FAQ on the bill is available here.
September 3, 1999. 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.
October 19, 1999. 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.
In 1999, Ventana Medical Systems, Inc (now a division of Roche Diagnostics) petitioned the U.S. Department of Energy to use Bayh Dole Acts on University of California patents and the exclusive licensed, Vysis. 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 entirely 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 settle the dispute, after a 30-month fact-finding process determination with DOE. (More information about this case is on record with KEI and available upon request. The information was obtained with a KEI FOIA request in 2010).
DHHS used its authority to exercise March-In rights for 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. More information here and here.
March 28, 2001. Letter from Ralph Nader, James Love, and Robert Weissman to US Secretary of Health and Human Services Tommy Thompson.
In a footnote in the experimental use case, Madey v. Duke University, 307 F.3d 1351 (Fed. Cir. 2002), the court mentioned that where a subject invention exists and the defendant is a recipient of government funding, “in light of the Bayh-Dole Act… use of the patents that has been authorized by the government does not constitute patent infringement.”
In July 2004, NIH report to Congress “Affordability of Inventions and Products“, NIH explained why NIH did not seek to assure fair pricing of federally sponsored inventions.
In August 2004, NIH refused to grant March-In rights in a case brought by Essential Inventions involving patents on the AIDS drug ritonavir/Norvir. Abbott Laboratories had increased their U.S. price of the drug by 400% in one day to promote sales of their new combination therapy and undermine sales of competitors’ drugs.
In September 2004, a similar request by Essential Inventions for march-in rights to patents involving the Pfizer glaucoma drug latanoprost /Xalatan was also denied by NIH. The NY Times reported on the high cost of the drug and the public funding involved in the R&D process on an article that is available here.
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 transfered to the U.S. Army.
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
In January 2007, Essential Inventions requested 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).
In February 2007, KEI requested the FTC to exercise March In Rights in Gilead’s HIV/AIDS drug, emtricitabine (Emtriva) for the anti-competitive terms of its voluntary licenses to developing country manufacturers.
In October 2007, U.S. Senate hearing on “The Role of Federally-Funded University Research in the Patent System”. Webcast and testimonies available here.
In July 2007, the U.S. House of Representatives Committee on Science and Technology hearings on the Future of the Bayh-Dole Act
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.
In October 2009, KEI presented a 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, a request for a March-In to the patents on Fabrazyme was filed by Joseph Carik and two other Fabrazyme patients.