Aaron S. Kesselheim

Brigham and Women's Hospital/Harvard Medical School

Professor of Medicine

1620 Tremont St

Suite 3030

Boston, MA 02120

United States

http://www.PORTALresearch.org

  • Brigham and Women's Hospital/Harvard Medical School

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    • Tel: 617-278-0930
    • Fax: 617-232-8602
SCHOLARLY PAPERS

42

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11

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29

Scholarly Papers (42)

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1.

Pharmaceutical Marketing and the New Social Media

New England Journal of Medicine, Vol. 363, No. 22, pp. 2087-2089, 2010
Number of pages: 3 Posted: 21 Dec 2011
Jeremy A. Greene, Jeremy A. Greene and Aaron S. Kesselheim
Harvard University - Brigham and Women's HospitalHarvard University - Department of the History of Science and Brigham and Women's Hospital/Harvard Medical School
Downloads 1,346 (25,970)

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2.

Using Antitrust Law to Challenge Turing's Daraprim Price Increase

31 Berkeley Technology Law Journal 1379 (2017)
Number of pages: 30 Posted: 29 Jan 2016 Last Revised: 14 Jul 2017
Michael A. Carrier, Nicole Levidow and Aaron S. Kesselheim
Rutgers Law School, Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics and Brigham and Women's Hospital/Harvard Medical School
Downloads 761 (58,030)

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Turing, Shkreli, antitrust, monopolization, drugs, pharmaceuticals, Daraprim, pyrimethamine

3.

Effect of Financial Relationships on the Behaviors of Health Care Professionals: A Review of the Evidence

40 Journal of Law, Medicine, & Ethics 452 (2012), Arizona Legal Studies Discussion Paper No. 12-30
Number of pages: 44 Posted: 02 Aug 2012 Last Revised: 14 Apr 2013
Christopher T. Robertson, Susannah L. Rose and Aaron S. Kesselheim
Boston University, Cleveland Clinic, Department of Bioethics and Brigham and Women's Hospital/Harvard Medical School
Downloads 353 (147,529)

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incentives, conflicts of interest, medical decision making, bias, self-referral, industry, insurance, pay for performance

4.

Improving Antibiotic Markets for Long Term Sustainability

Yale Journal of Health Policy, Law & Ethics, Vol. 11, Winter 2011, Boston Univ. School of Law Working Paper (Law & Economics) No. 10-42, Boston Univ. School of Law Working Paper (Public Law & Legal Theory) No. 10-42
Number of pages: 71 Posted: 07 Dec 2010 Last Revised: 16 Apr 2013
Aaron S. Kesselheim and Kevin Outterson
Brigham and Women's Hospital/Harvard Medical School and Boston University School of Law
Downloads 336 (155,571)
Citation 1

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antibiotic, resistance, intellectual property, patent, conservation, prize

5.

Generic But Expensive: Why Prices Can Remain High for Off-Patent Drugs

Hastings Law Journal, Volume 71, Issue 4, 1019-1052 (May 2020)
Number of pages: 34 Posted: 21 Aug 2019 Last Revised: 12 May 2020
Frazer Tessema, Frazer Tessema, Aaron S. Kesselheim and Michael S. Sinha
Yale UniversityProgram On Regulation, Therapeutics, And Law (PORTAL), Brigham & Women's Hospital / Harvard Medical School, Brigham and Women's Hospital/Harvard Medical School and Saint Louis University - School of Law
Downloads 335 (156,061)
Citation 1

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Food and Drug Administration, FDA, Drug Prices, Generic Drugs, Importation, Drug Shortages, Off-Patent Drugs, Niche Markets

6.

Off-Label Drug Use and Promotion: Balancing Public Health Goals and Commercial Speech

American Journal of Law and Medicine, Vol. 37, No. 2-3, 2011
Number of pages: 33 Posted: 23 Mar 2014
Aaron S. Kesselheim
Brigham and Women's Hospital/Harvard Medical School
Downloads 238 (221,377)
Citation 2

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Prescription drug, FDA, off-label, pharmaceutical marketing

7.

Approval and Withdrawal of New Antibiotics and Other Antiinfectives in the U.S., 1980-2009

Journal of Law, Medicine and Ethics, p. 688, Fall 2013, Boston Univ. School of Law, Law and Economics Research Paper No. 13-47
Number of pages: 10 Posted: 18 Sep 2013 Last Revised: 08 Aug 2015
Kevin Outterson, John Powers, Enrique Seoane, Rosa Rodriguez-Monguio and Aaron S. Kesselheim
Boston University School of Law, George Washington University, Director International Center for Pharmaceutical Economics and Policy, University of Massachusetts and Brigham and Women's Hospital/Harvard Medical School
Downloads 235 (224,167)
Citation 1

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antibiotics, innovation, resistance

8.

Implementing a Public Health Perspective in FDA Drug Regulation

Food and Drug Law Journal, Vol. 73, pp. 221-256, 2018, Georgia State University College of Law, Legal Studies Research Paper No. 2018-21
Number of pages: 37 Posted: 11 Jun 2018 Last Revised: 27 Sep 2018
Patricia J. Zettler, Margaret Foster Riley and Aaron S. Kesselheim
Ohio State University (OSU) - Michael E. Moritz College of Law, University of Virginia School of Law and Brigham and Women's Hospital/Harvard Medical School
Downloads 222 (236,681)
Citation 1

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opioid, FDA, public health, public health law, health law, food and drug administration, drug regulation, drug approval, Food Drug and Cosmetic Act, opioid misuse, food and drug law, law, administrative law, agency

9.

Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection

North Carolina Law Review, Vol. 92, 2014
Number of pages: 62 Posted: 20 Mar 2014
Aaron S. Kesselheim and Michelle M. Mello
Brigham and Women's Hospital/Harvard Medical School and Stanford Law School
Downloads 220 (238,713)

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FDA, regulation, commercial speech, First Amendment, off-label, prescription drug

10.

Blinding as a Solution to Bias: Strengthening Biomedical Science, Forensic Science, and Law

Blinding as a Solution to Bias: Strengthening Biomedical Science, Forensic Science, and Law (Elsevier 2016), Arizona Legal Studies Discussion Paper No. 16-03
Number of pages: 20 Posted: 08 Feb 2016
Christopher T. Robertson and Aaron S. Kesselheim
Boston University and Brigham and Women's Hospital/Harvard Medical School
Downloads 187 (276,786)
Citation 2

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blinding, bias, forensic science, scientific research, courts, medicine, biomedical science

11.

When Markets Fail: Patents and Infectious Disease Products

73(3) Food & Drug L J 361 (2018)
Number of pages: 26 Posted: 22 Aug 2019
Jonathan J. Darrow, Michael S. Sinha and Aaron S. Kesselheim
Harvard Medical School, Saint Louis University - School of Law and Brigham and Women's Hospital/Harvard Medical School
Downloads 122 (392,195)
Citation 2

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12.

Reputation and Authority: The FDA and the Fight over U.S. Prescription Drug Importation

Downloads 97 (461,807)

Reputation and Authority: The FDA and the Fight over U.S. Prescription Drug Importation

Vanderbilt Law Review, Forthcoming
Number of pages: 56 Posted: 11 Sep 2020
Thomas J. Bollyky and Aaron S. Kesselheim
Council on Foreign Relations and Brigham and Women's Hospital/Harvard Medical School
Downloads 72 (560,034)

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trade, regulatory, FDA, pharmaceutical, importation, administrative law, mutual recognition

Reputation and Authority: The FDA and the Fight over U.S. Prescription Drug Importation

Vanderbilt Law Review, Vol. 73, No. 5, 1331
Number of pages: 70 Posted: 31 Dec 2020
Thomas J. Bollyky and Aaron S. Kesselheim
Council on Foreign Relations and Brigham and Women's Hospital/Harvard Medical School
Downloads 25 (865,515)

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trade, regulatory, FDA, pharmaceutical, importation, administrative law, mutual recognition

13.

FDA and Chevron Deference: A Case Review

78 Food & Drug L. J., Forthcoming
Number of pages: 27 Posted: 24 Aug 2023
Liam Bendicksen, Aaron S. Kesselheim and C. Joseph Ross Daval
Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital and Harvard Medical School, Brigham and Women's Hospital/Harvard Medical School and Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital and Harvard Medical School
Downloads 86 (498,390)

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14.

Transferable Exclusivity Vouchers and Incentives for Antimicrobial Development in the European Union

Van de Wiele VL., Raymakers A., Kesselheim AS., Rome BN. Transferable Exclusivity Vouchers and Incentives for Antimicrobial Development in the European Union. Journal of Law, Medicine & Ethics, Forthcoming
Number of pages: 5 Posted: 03 Apr 2023
Victor Van de Wiele, Adam Raymakers, Aaron S. Kesselheim and Benjamin N. Rome
University of Cambridge, Faculty of Law, Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital and Harvard Medical School, Brigham and Women's Hospital/Harvard Medical School and Independent
Downloads 84 (505,594)

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Transferable Exclusivity Vouchers, Antibiotics, European Union, Healthcare, Innovation, Spending, Antimicrobial

15.

How Medicare Could Get Better Prices On Prescription Drugs

Health Affairs, Vol. 28, No. 5, 2009
Number of pages: 10 Posted: 22 Nov 2009 Last Revised: 16 Apr 2013
Kevin Outterson and Aaron S. Kesselheim
Boston University School of Law and Brigham and Women's Hospital/Harvard Medical School
Downloads 76 (536,300)

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Drug costs, Medicare Part D, therapeutic substitution, drug importation

16.

Market-Based Licensing for HPV Vaccines in Developing Countries

Health Affairs, Vol. 27, No. 1, 2008
Number of pages: 14 Posted: 22 Nov 2009 Last Revised: 11 Feb 2014
Kevin Outterson and Aaron S. Kesselheim
Boston University School of Law and Brigham and Women's Hospital/Harvard Medical School
Downloads 51 (655,522)

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Compulsory license, HPV vaccine, generic open license, access to vaccines

17.

Fighting Antibiotic Resistance: Marrying New Financial Incentives to Meeting Public Health Goals

Health Affairs, Vol. 29, No. 9, September 2010 , Boston Univ. School of Law Working Paper No. 10-40
Number of pages: 8 Posted: 16 Nov 2010 Last Revised: 08 Aug 2015
Kevin Outterson and Aaron S. Kesselheim
Boston University School of Law and Brigham and Women's Hospital/Harvard Medical School
Downloads 45 (691,169)
Citation 1

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antibiotic resistance, antibiotics, drug development, patenting of antibiotics

18.

Characteristics of Trials and Regulatory Pathways Leading to US Approval of Innovative vs. Non-Innovative Oncology Drugs

Number of pages: 16 Posted: 05 Sep 2018
Kerstin Noëlle Vokinger and Aaron S. Kesselheim
Harvard University - Brigham and Women's Hospital and Brigham and Women's Hospital/Harvard Medical School
Downloads 27 (822,309)

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first-generation drug, second-generation drug, tyrosine-kinase inhibitor, monoclonal antibody, drug approval, FDA

19.

The Prevalence of Drug Patent Term Extensions in the United States, 2000-2018

Nature Biotechnology, Vol. 41, p. 903-906 (2023), WVU College of Law Research Paper Forthcoming
Posted: 09 Nov 2023
Victor Van de Wiele, Aaron S. Kesselheim, Sarosh Nagar and S. Sean Tu
University of Cambridge, Faculty of Law, Brigham and Women's Hospital/Harvard Medical School, Harvard University and West Virginia University College of Law

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Patents, Patent Term Extension, Expiration

20.

Changes in the Number of Continuation Patents on Drugs Approved by the FDA between 2000-2015

JAMA, Vol. 330(5), p. 469-470 (2023), WVU College of Law Research Paper Forthcoming
Posted: 09 Nov 2023
S. Sean Tu, Aaron S. Kesselheim, Kathrine Wetherbee and William Feldman
West Virginia University College of Law, Brigham and Women's Hospital/Harvard Medical School, Independent and Harvard University - Harvard Medical School

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Patents, patent, continuation, USPTO

21.

Five-Year Sales for Newly Marketed Prescription Drugs With and Without Initial Orphan Drug Act Designation

JAMA, Vol. 329(18), p. 1607-1608, 2023 doi:10.1001/jama.2023.3079, WVU College of Law Research Paper, No. 2023-014
Posted: 19 Jul 2023 Last Revised: 09 Sep 2023
S. Sean Tu, Sarosh Nagar, Aaron S. Kesselheim, Zhigang Lu and Benjamin N. Rome
West Virginia University College of Law, Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital and Harvard Medical School, Brigham and Women's Hospital/Harvard Medical School, Harvard University - Division of Pharmacoepidemiology and Pharmacoeconomics and Independent

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Orphan Drug Act, pharmaceutical investment, statutory incentive, FDA, Orphan Drug Designations and Approvals

22.

Recent Patent Reform Bills and Their Implications for Prescription Drugs

JAMA, Vol. 329(6), p. 459-460, Link to full text at JAMA: https://jamanetwork.com/journals/jama/fullarticle/2800700, WVU College of Law Research Paper No. 2023-005
Posted: 21 Mar 2023
S. Sean Tu, Sarosh Nagar and Aaron S. Kesselheim
West Virginia University College of Law, Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital and Harvard Medical School and Brigham and Women's Hospital/Harvard Medical School

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pharmaceutical, FDA, patent, prescription drug, legislation

23.

Antibody Patent Evolution

WVU College of Law Research Paper No. 2022-020, IEEE Pulse, This article was published in IEEE Pulse. The version of record is available at: https://pubmed.ncbi.nlm.nih.gov/36301809/, Vol. 13, Issue 5, p. 33-37, 2022
Posted: 03 Nov 2022
Theodore Teng, Aaron S. Kesselheim and S. Sean Tu
Independent, Brigham and Women's Hospital/Harvard Medical School and West Virginia University College of Law

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therapeutic antibodies, antibody patents, USPTO, pharmaceutical patents, drug patents

24.

Government Patent Use to Promote Public Health in the United States: Overcoming Nonpatent Exclusivities

American Journal of Public Health (2022)
Posted: 11 Jul 2022
Rebecca E. Wolitz, Aaron S. Kesselheim and Jonathan J. Darrow
Ohio State University (OSU) - Michael E. Moritz College of Law, Brigham and Women's Hospital/Harvard Medical School and affiliation not provided to SSRN

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access to medications, patent law, FDA, non-patent exclusivities, Section 1498

25.

Reference Check: A Simple Strategy to Improve Drug Patent Quality

WVU College of Law Research Paper No. 2022-012 Health Affairs Forefront https://www.healthaffairs.org/do/10.1377/forefront.20220615.404330
Posted: 28 Jun 2022 Last Revised: 20 Aug 2022
S. Sean Tu, Dennis David Crouch and Aaron S. Kesselheim
West Virginia University College of Law, University of Missouri School of Law and Brigham and Women's Hospital/Harvard Medical School

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USPTO, patent, pharmaceutical, orange book, patent examination, PTO

26.

The Supreme Court's Latest Ruling on Drug Liability and its Implications for Future Failure-to-Warn Litigation

47 Journal of Law, Medicine & Ethics 783 (January 19, 2020)
Posted: 19 Oct 2020 Last Revised: 03 Aug 2021
Christopher Morten, Aaron S. Kesselheim and Joseph Ross
Columbia Law School, Brigham and Women's Hospital/Harvard Medical School and Yale University

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27.

An 'Export-Only' Exception to Pharmaceutical Patents in Europe: Should the U.S. Follow Suit?

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An 'Export-Only' Exception to Pharmaceutical Patents in Europe: Should the U.S. Follow Suit?

Nature Biotechnology, Vol.37, No. 1, pp. 21-22 (2019); DOI: 10.1038/nbt.4324
Posted: 27 Jun 2019
Timo Minssen, Aaron S. Kesselheim and Jonathan J. Darrow
University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) - Faculty of Law, Brigham and Women's Hospital/Harvard Medical School and Harvard Medical School

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An 'Export-Only' Exception to Pharmaceutical Patents in Europe: Should the U.S. Follow Suit?

Nature Biotechnology, Vol. 37, No. 1, 03.01.2019, p. 21-22.
Posted: 24 Apr 2019
Timo Minssen, Aaron S. Kesselheim and Jonathan J. Darrow
University of Copenhagen - Centre for Advanced Studies in Biomedical Innovation Law (CeBIL) - Faculty of Law, Brigham and Women's Hospital/Harvard Medical School and Harvard Medical School

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28.

'Government Patent Use': A Legal Approach to Reducing Drug Spending

Health Affairs, Vol. 35, No. 5, 2016
Posted: 05 May 2016
Amy Kapczynski and Aaron S. Kesselheim
Yale University - Law School and Brigham and Women's Hospital/Harvard Medical School

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Medicines, Drug Pricing, Government Use, Patents, 28 USC 1498, Cost of Health Care, Legal and Regulatory Issues, Pharmaceuticals

29.

FDA Regulation of Mobile Health Technologies

370 New England Journal of Medicine 372 (2014) , Harvard Public Law Working Paper No. 14-40
Posted: 22 Oct 2014 Last Revised: 04 Dec 2014
Nathan Cortez, I. Glenn Cohen and Aaron S. Kesselheim
Southern Methodist University - Dedman School of Law, Harvard Law School and Brigham and Women's Hospital/Harvard Medical School

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mobile health, FDA, liability, congress, premarket, postmarket

30.

Distributions of Industry Payments to Massachusetts Physicians

New England Journal of Medicine, 2013, Arizona Legal Studies Discussion Paper No. 12-27
Posted: 07 May 2013 Last Revised: 22 May 2013
Aaron S. Kesselheim, Christopher T. Robertson, Kent Siri, Puneet Batra and Jessica Franklin
Brigham and Women's Hospital/Harvard Medical School, Boston University, Independent, Independent and Independent

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distributions of payments, payments to health care practitioners, industry payments

31.

A Randomized Study of How Physicians Interpret Research Funding Disclosures

369 New England Journal of Medicine 1119 (2012), Arizona Legal Studies Discussion Paper No. 12-33
Posted: 20 Oct 2012
Aaron S. Kesselheim, Christopher T. Robertson, Jessica Myers, Susannah L. Rose, Victoria Gillet, Kathryn Ross, Robert Glynn, Steven Joffe and Jerry Avorn
Brigham and Women's Hospital/Harvard Medical School, Boston University, Harvard University - Brigham and Women's Hospital, Cleveland Clinic, Department of Bioethics, Harvard University - Brigham and Women's Hospital, American Board of Internal Medicine (ABIM), Harvard University - Brigham and Women's Hospital, Dana-Farber Cancer Center and Harvard University - Brigham and Women's Hospital

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clinical trial funding, trial results, industry sponsorship

32.

Why Do the Same Drugs Look Different? Pills, Trade Dress, and Public Health

New England Journal of Medicine, Vol. 365, No. 1, pp. 83-89, 2011
Posted: 21 Dec 2011
Jeremy A. Greene, Jeremy A. Greene and Aaron S. Kesselheim
Harvard University - Brigham and Women's HospitalHarvard University - Department of the History of Science and Brigham and Women's Hospital/Harvard Medical School

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33.

Using Market Exclusivity Incentives to Promote Pharmaceutical Innovation

New England Journal of Medicine, Vol. 363, No. 19, pp. 1855-1862, 2010
Posted: 10 Nov 2010
Aaron S. Kesselheim
Brigham and Women's Hospital/Harvard Medical School

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patent, orphan drug, Bayh-Dole, pediatric exclusivity

34.

Whistleblower-Initiated Enforcement Actions Against Health Care Fraud and Abuse in the United States, 1996 to 2005

Annals of Internal Medicine, Vol. 149, No. 5, pp. 342-349, September 2008
Posted: 22 Nov 2009
Aaron S. Kesselheim and David M. Studdert
Brigham and Women's Hospital/Harvard Medical School and University of Melbourne - Faculty of Law & Faculty of Medicine, Dentistry and Health Sciences

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Health care fraud, qui tam, whistleblowers, pharmaceutical industry

35.

Expert Review of Drug Patent Applications: Improving Health in the Developing World

Health Affairs, Vol. 28, No. 5, 2009
Posted: 22 Nov 2009
Tahir Amin, Rahul Rajkumar, Priti Radhakrishnan and Aaron S. Kesselheim
Initiative for Medicines, Access & Knowledge (I-MAK), Harvard University - Brigham and Women's Hospital, Initiative for Medicines, Access & Knowledge (I-MAK) and Brigham and Women's Hospital/Harvard Medical School

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patents, TDF, Indian patent act, TRIPS agreement

36.

Using Patent Data to Assess the Value of Pharmaceutical Innovation

Journal of Law, Medicine, and Ethics, Vol. 37, No. 2, 2009
Posted: 22 Nov 2009
Aaron S. Kesselheim and Jerry Avorn
Brigham and Women's Hospital/Harvard Medical School and Harvard University - Brigham and Women's Hospital

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patents, pharmaceutical, innovation

37.

Professional Oversight of Physician Expert Witnesses: An Analysis of Complaints to the Professional Conduct Committee of the American Association of Neurological Surgeons, 1992-2006

Annals of Surgery, Vol. 249, No. 1, pp. 168-172, 2009
Posted: 22 Nov 2009
Aaron S. Kesselheim and David M. Studdert
Brigham and Women's Hospital/Harvard Medical School and University of Melbourne - Faculty of Law & Faculty of Medicine, Dentistry and Health Sciences

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Expert witness, medical malpractice, medical professional society

38.

The International Pharmaceutical Market as a Source of Low-Cost Prescription Drugs for U.S. Patients

Annals of Internal Medicine, Vol. 148, No. 8, pp. 614-619, April 2008
Posted: 22 Nov 2009
Aaron S. Kesselheim and Niteesh K. Choudhry
Brigham and Women's Hospital/Harvard Medical School and Harvard University - Harvard Medical School

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Drug importation, generic drugs

39.

University-Based Science and Biotechnology Products: Defining the Boundaries of Intellectual Property

Downloads 0 (1,061,289)

University-Based Science and Biotechnology Products: Defining the Boundaries of Intellectual Property

JAMA, Vol. 293, pp. 850-854, 2005
Posted: 04 Dec 2006
Aaron S. Kesselheim and Jerry Avorn
Brigham and Women's Hospital/Harvard Medical School and Harvard University - Brigham and Women's Hospital

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Patent, Technology Transfer, Intellectual Property

University-Based Science and Biotechnology Products: Defining the Boundaries of Intellectual Property

University of Illinois at Urbana-Champaign's Academy for Entrepreneurial Leadership Historical Research Reference in Entrepreneurship
Posted: 18 Nov 2009
Aaron S. Kesselheim and Jerry Avorn
Brigham and Women's Hospital/Harvard Medical School and Harvard University - Brigham and Women's Hospital

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Patent pools, U.S. Patent & Trademark Office (USPTO), Colleges & universities, Commercialization, Intellectual property, Patent law, Patents, Pharmaceutical industry, Academic research, Arbitration, Bayh-Dole Act of 1980, Biotechnology industry, Scientists

40.

Extensions of Intellectual Property Rights and Delayed Adoption of Generic Drugs: Effects on Medicaid Expenditures

Health Affairs, Vol. 25, pp. 1637-1647, 2006
Posted: 04 Dec 2006
Aaron S. Kesselheim, Jerry Avorn and Michael Fischer
Brigham and Women's Hospital/Harvard Medical School, Harvard University - Brigham and Women's Hospital and Harvard University - Brigham and Women's Hospital

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Patent, Drug Costs, Intellectual Property, Generic Drugs

41.

The Rise and Fall of Natrecor for Congestive Heart Failure: Implications for Drug Policy

Health Affairs, Vol. 25, pp. 1095-1102, 2006
Posted: 04 Dec 2006
Aaron S. Kesselheim
Brigham and Women's Hospital/Harvard Medical School

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FDA, Drug policy, Post-marketing surveillance

42.

Medical Process Patents - Monopolizing the Delivery of Health Care

New England Journal of Medicine, Vol. 355, pp. 2036-2041, 2006
Posted: 09 Nov 2006
Aaron S. Kesselheim and Michelle M. Mello
Brigham and Women's Hospital/Harvard Medical School and Stanford Law School

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patents, medical, process, intellectual property