{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,21]],"date-time":"2025-11-21T12:09:32Z","timestamp":1763726972969},"reference-count":46,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2015,12,2]],"date-time":"2015-12-02T00:00:00Z","timestamp":1449014400000},"content-version":"vor","delay-in-days":1,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Milbank Quarterly"],"published-print":{"date-parts":[[2015,12]]},"abstract":"<jats:sec><jats:label \/><jats:p><jats:boxed-text content-type=\"box\" position=\"anchor\"><jats:caption><jats:title>Policy Points:<\/jats:title><\/jats:caption><jats:p><jats:list list-type=\"bullet\">\n<jats:list-item><jats:p>The Bayh\u2010Dole Act of 1980 formalized the ability of institutions receiving federal research funding to commercialize discoveries by issuing exclusive licenses for patents that emerge. This legislation also contained a march\u2010in rights provision, allowing the US government to cancel the exclusive license if the product was not available to the American public on reasonable terms.<\/jats:p><\/jats:list-item>\n<jats:list-item><jats:p>Since 1980, there have been 5 march\u2010in rights petitions for 4 different health care\u2013related products, most recently in cases of drugs discovered with federal funding made available only at exorbitant prices. The National Institutes of Health (NIH) has rejected each petition. In our qualitative analysis of experts and participants involved in these march\u2010in rights petitions, we found little prospect NIH will ever invoke march\u2010in rights in such cases.<\/jats:p><\/jats:list-item>\n<\/jats:list><\/jats:p><\/jats:boxed-text><\/jats:p><\/jats:sec><jats:sec><jats:title>Context<\/jats:title><jats:p>The high cost of new prescription drugs and other medical products is a growing health policy issue. Many of the most transformative drugs and vaccines had their origins in public\u2010sector funding to nonprofit research institutions. Although the Bayh\u2010Dole Act of 1980 provides for \u201cmarch\u2010in rights\u201d through which the government can invoke some degree of control over the patents protecting products developed from public funding to ensure public access to these medications, the applicability of this provision to current policy options is not clear.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We conducted a primary\u2010source document review of the Bayh\u2010Dole Act's legislative history as well as of hearings of past march\u2010in rights petitions to the National Institutes of Health (NIH). We then conducted semistructured interviews of 12 key experts in the march\u2010in rights of the Bayh\u2010Dole Act to identify the sources of the disputes and the main themes in the statute's implementation. We analyzed the interview transcripts using standard qualitative techniques.<\/jats:p><\/jats:sec><jats:sec><jats:title>Findings<\/jats:title><jats:p>Since 1980, the NIH has fully reviewed only 5 petitions to invoke governmental march\u2010in rights for 4 health\u2010related technologies or medical products developed from federally funded research. Three of these requests related to reducing the high prices of brand\u2010name drugs, one related to relieving a drug shortage, and one related to a potentially patent\u2010infringing medical device. In each of these cases, the NIH rejected the requests. Interviewees were split on the implications of these experiences, finding the NIH's reluctance to implement its march\u2010in rights to be evidence of either a system working as intended or of a flawed system needing reform.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The Bayh\u2010Dole Act's march\u2010in rights continue to be invoked by policymakers and health advocates, most recently in the context of new, high\u2010cost products originally discovered with federally funded research. We found that the existence of march\u2010in rights may select for government research licensees more likely to commercialize the results and that they can be used to extract minor concessions from licensees. But as currently specified in the statute, such march\u2010in rights are unlikely to serve as a counterweight to lower the prices of medical products arising from federally funded research.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1468-0009.12164","type":"journal-article","created":{"date-parts":[[2015,12,2]],"date-time":"2015-12-02T07:38:02Z","timestamp":1449041882000},"page":"761-787","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Do March\u2010In Rights Ensure Access to Medical Products Arising From Federally Funded Research? A Qualitative Study"],"prefix":"10.1111","volume":"93","author":[{"given":"CAROLYN L.","family":"TREASURE","sequence":"first","affiliation":[{"name":"Brigham and Women's Hospital and Harvard Medical School"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"JERRY","family":"AVORN","sequence":"additional","affiliation":[{"name":"Brigham and Women's Hospital and Harvard Medical School"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"AARON S.","family":"KESSELHEIM","sequence":"additional","affiliation":[{"name":"Brigham and Women's Hospital and Harvard Medical School"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2015,12,2]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1377\/hlthaff.2014.1038"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsa1008268"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2013.49.1845"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp1004026"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0062709"},{"key":"e_1_2_6_7_1","unstructured":"Senator Leahy petition for Myriad genetic tests.http:\/\/www.leahy.senate.gov\/download\/07\u201012\u201013\u2010pjl\u2010to\u2010nih\u2010re_\u2010myriad\u2010march\u2010in(accessed September 10 2015)."},{"key":"e_1_2_6_8_1","unstructured":"ArnoPS DavisMH.The new face of US health care: $1 000 per pill. December 23 2014.Truth\u2010out.org.http:\/\/www.truth\u2010out.org\/news\/item\/28171\u2010the\u2010new\u2010face\u2010of\u2010us\u2010health\u2010care\u20101\u2010000\u2010per\u2010pill#(accessed September 10 2015)."},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp1500848"},{"key":"e_1_2_6_10_1","volume-title":"Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs","author":"Avorn J","year":"2005"},{"key":"e_1_2_6_11_1","unstructured":"Taxpayers may be paying twice for some drugs.New York Times. July 12 1994.http:\/\/www.nytimes.com\/1994\/07\/12\/science\/taxpayers\u2010may\u2010be\u2010paying\u2010twice\u2010for\u2010some\u2010drugs.html(accessed September 10 2015)."},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp1306553"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2014.404"},{"key":"e_1_2_6_14_1","volume-title":"Qualitative Data Analysis: An Expanded Sourcebook","author":"Miles MB","year":"1994"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.3102\/00028312029002253"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.285.20.2604"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.1525\/maq.1990.4.4.02a00020"},{"key":"e_1_2_6_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.respol.2006.04.009"},{"key":"e_1_2_6_19_1","doi-asserted-by":"publisher","DOI":"10.1038\/nbt.2382"},{"key":"e_1_2_6_20_1","unstructured":"35 USC 203(2) (2013)."},{"key":"e_1_2_6_21_1","unstructured":"37 CFR 401.6 (March 18 1987)."},{"key":"e_1_2_6_22_1","unstructured":"CivinCI. Human stem cells and monoclonal antibodies (patent 4 965 204). October 23 1990.http:\/\/www.google.com\/patents\/US4965204(accessed September 10 2015)."},{"key":"e_1_2_6_23_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V67.3.842.842"},{"key":"e_1_2_6_24_1","doi-asserted-by":"publisher","DOI":"10.1111\/1468-0009.00027"},{"key":"e_1_2_6_25_1","unstructured":"BirchB CutlerL.Letter to Department of Health and Human Services requesting march\u2010in rights use. March 1997.http:\/\/web.archive.org\/web\/20060127092258\/http:\/www.nih.gov\/icd\/od\/foia\/cellpro\/pdfs\/foia_cellpro1.pdf(accessed September 10 2015)."},{"issue":"3","key":"e_1_2_6_26_1","first-page":"1095","article-title":"Patents, products, and public health: an analysis of the CellPro March\u2010in Petition","volume":"14","author":"McGarey BM","year":"1999","journal-title":"Berkeley Tech Law J"},{"key":"e_1_2_6_27_1","unstructured":"Johns Hopkins University v CellPro 978 F Supp. 184 (D De 1997)."},{"key":"e_1_2_6_28_1","unstructured":"Testimony of John Erickson. NIH Meeting on March\u2010in Rights for Ritonavir.http:\/\/www.ott.nih.gov\/sites\/default\/files\/documents\/2004NorvirMtg\/2004NorvirMtg.pdf(accessed September 10 2015)."},{"key":"e_1_2_6_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.antiviral.2009.10.003"},{"key":"e_1_2_6_30_1","unstructured":"Essential Inventions Petition for Ritonavir. January 2004.http:\/\/www.essentialinventions.org\/legal\/norvir\/norvir\u201029jan04petition.pdf(accessed September 10 2015)."},{"key":"e_1_2_6_31_1","article-title":"Group says U.S. should claim AIDS drug patents","author":"Brown D.","year":"2004","journal-title":"Washington Post"},{"key":"e_1_2_6_32_1","unstructured":"KEI\/UAEM\/AMSA\/PIRG Petition for Ritonavir. October 2013.http:\/\/keionline.org\/node\/1573(accessed September 10 2015)."},{"key":"e_1_2_6_33_1","unstructured":"National Institutes of Health Office of the Director. Determination in the case of Norvir manufactured by AbbVie.http:\/\/www.ott.nih.gov\/sites\/default\/files\/documents\/policy\/March\u2010In\u2010Norvir2013.pdf(accessed September 10 2015)."},{"key":"e_1_2_6_34_1","unstructured":"Essential Inventions Petition for Xalatan. January 2004.http:\/\/www.essentialinventions.org\/legal\/xalatan\/xalatan\u201029jan04petition.pdf(accessed September 10 2015)."},{"key":"e_1_2_6_35_1","unstructured":"Clinical features of Fabry disease.http:\/\/www.uptodate.com\/contents\/clinical\u2010features\u2010and\u2010diagnosis\u2010of\u2010fabry\u2010disease?detectedLanguage=en&source=search_result&search=fabry\u00b1disease&selectedTitle=1\u223c39&provider=noProvider(accessed September 10 2015)."},{"key":"e_1_2_6_36_1","unstructured":"European Medicines Agency. EPAR summary for the public: Replagal (agalsidase alfa).http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_\u2010_Summary_for_the_public\/human\/000369\/WC500053606.pdf(accessed September 10 2015)."},{"key":"e_1_2_6_37_1","unstructured":"SilvermanE. FTC urged to probe Shire Sanofi & Icahn Med School over a \u201cconspiracy.\u201d July 15 2014.http:\/\/blogs.wsj.com\/pharmalot\/2014\/07\/15\/ftc\u2010urged\u2010to\u2010probe\u2010shire\u2010sanofi\u2010icahn\u2010med\u2010school\u2010over\u2010fabry\u2010drugs\/(accessed September 10 2015)."},{"key":"e_1_2_6_38_1","unstructured":"AZT's inhuman cost.New York Times. August 28 1989."},{"key":"e_1_2_6_39_1","article-title":"Our law helps patients get new drugs sooner","author":"Bayh B","year":"2002","journal-title":"Washington Post"},{"key":"e_1_2_6_40_1","doi-asserted-by":"publisher","DOI":"10.1377\/hlthaff.2009.0917"},{"key":"e_1_2_6_41_1","first-page":"631","article-title":"Why don't we enforce existing drug price controls? The unrecognized and unenforced reasonable pricing requirements imposed upon patents deriving in whole or in part from federally funded research","volume":"75","author":"Arno PS","year":"2001","journal-title":"Tulane Law Rev"},{"key":"e_1_2_6_42_1","unstructured":"LauerG. Drug price transparency bill shelved in California push continues.California Healthline. May 7 2015.http:\/\/www.californiahealthline.org\/insight\/2015\/drug\u2010price\u2010transparency\u2010bill\u2010shelved\u2010in\u2010california\u2010push\u2010continues(accessed September 10 2015)."},{"key":"e_1_2_6_43_1","first-page":"203","article-title":"Asking for money back: chilling commercialization or recouping public trust in the context of stem cell research?","volume":"9","author":"Herder M","year":"2008","journal-title":"Columbia Sci Technol Law Rev"},{"key":"e_1_2_6_44_1","unstructured":"McCaughanM. NIH as partner: new director Collins will stress royalties not price oversight.In Vivo Blog. August 21 2009.http:\/\/invivoblog.blogspot.com\/2009\/08\/nih\u2010as\u2010partner\u2010new\u2010director\u2010collins.html(accessed September 10 2015)."},{"key":"e_1_2_6_45_1","unstructured":"28 USC 1498 (2013)."},{"key":"e_1_2_6_46_1","unstructured":"ReichmanJH. Compulsory licensing of patented pharmaceutical inventions: evaluating the options.http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC2893582\/(accessed September 10 2015)."},{"key":"e_1_2_6_47_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.295.4.434"}],"container-title":["The Milbank Quarterly"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2F1468-0009.12164","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2F1468-0009.12164","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/1468-0009.12164","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,5]],"date-time":"2023-10-05T09:09:22Z","timestamp":1696496962000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/1468-0009.12164"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,12]]},"references-count":46,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2015,12]]}},"alternative-id":["10.1111\/1468-0009.12164"],"URL":"https:\/\/doi.org\/10.1111\/1468-0009.12164","archive":["Portico"],"relation":{},"ISSN":["0887-378X","1468-0009"],"issn-type":[{"value":"0887-378X","type":"print"},{"value":"1468-0009","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,12]]},"assertion":[{"value":"2015-12-02","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}