Ritonavir (Norvir)



Compulsory License Request and Response from NIH
August 4, 2004, Essential Inventions response to NIH refusal to March-In on Norvir Patent

August 4, 2004, NIH decision rejecting Essential Inventions Norvir March-In Petition

January 29, 2004, Petition to Use Authority Under Bayh-Dole Act to Promote Access to Ritonavir, Supported by National Institute of Allergy and Infectious Diseases Contract No. AI27220.

Also see the Essential Inventions Page on May 25, 2004 NIH Public Meeting on Norvir March-In Request. Includes the statements delivered by the speakers, as well as the news coverage of the meeting.
Legal Documents Submitted by Essential Inventions

May 25, 2004. Statement of James Love at the NIH Public Meeting on the Norvir March-In Request.

March 10, 2004. LETTER TO THE DIRECTOR OF THE OFFICE OF TECHNOLOGY TRANSFER, NIH, REQUESTING A HEARING ON ESSENTIAL INVENTIONS' MARCH-IN REQUESTS.

January 29, 2004, cover letter and PETITION TO USE AUTHORITY UNDER BAYH-DOLE ACT TO PROMOTE ACCESS TO RITONAVIR, SUPPORTED BY NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES CONTRACT NO. AI27220

January 29, 2004 Complaint to the Federal Trade Commission (FTC) of antitrust law violations by Abbott Laboratories

January 28, 2004 Affidavit Submitted by John Erickson on the Development of Ritonavir
DHHS Documents
March 12, 2004. Letter from Mark L. Rohrbaugh, Director of the NIH Office of Technology Transfer to James Love and Sean Flynn, informing Essential Inventions that NIH is close to a decision.

February 12, 2004, DHHS Secretary Thompson assigns NIH to review March-In Requests on Xalatan and Norvir
Press Releases and Backround Documents
June 3, 2004. James Love for Essential Inventions. How much has the public invested in ritonavir, and how much has Abbott?

May 24, 2004. Public Patent Foundation. PUBPAT Executive Director Testifies Before NIH Regarding Key AIDS Drug Patents.

March 30, 2004. Joint release from the AIDS Treatment Activists Coalition and the Consumer Project on Technology. Pressure Mounts for U.S. to Open Competition on Two Government Funded Medicines.

January 29, 2004. Essential Inventions. Press release on Norvir and Xalatan march-in.

January 29, 2004. Essential Inventions. March-in backgrounder

Government funding for Norvir
Letters of Support for the March-In Application
August 17, 2004. Rep. Sherrod Brown. Letter to Tommy Thompson Urging a Reversal of the NIH Norvir Decision.

May 11, 2004. Letter from Eight Senators to NIH Director Elias A. Zerhouni, requesting that Federal Trade Commission Director Timothy Muris be invited to participate in the NIH's May 25 Public Meeting on the march-in request.

April 30, 2004. Letter from Six Representatives to Rep. Joe Barton, Chairman of the House Committee on Energy and Commerce, requesting a hearing on the Norvir price hike.

April 29, 2004. Dan Ravicher for the Public Patent Foundation. Letter to Mark Rohrbaugh, Director of the NIH Office of Technology Transfer, concerning the ritonavir patent landscape.

March 25, 2004. Letter from over 100 AIDS groups and doctors to DHHS Secretary Tommy Thompson in support of the Norvir March-In effort.

March 12, 2004. Letter from 23 AIDS groups to DHHS Scretary Tommy Thompson and Dr. Mark Rohrbaugh from the NIH's Office of Technology Transfer requesting a hearing on the Norvir March-In effort.

March 3, 2004. Letter from 55 Doctors to DHHS Scretary Tommy Thompson and Dr. Mark Rohrbaugh from the NIH's Office of Technology Transfer in Support of the Norvir March-In Effort.

February 27, 2004. Letter from Six Representatives to DHHS Secretary Tommy Thompson.

February 26, 2004. Letter from 36 AIDS groups to DHHS Secretary Tommy Thompson.
Letters Opposing the March-In Application
April 20, 2004. C. Peter Magrath, Nils Hasselmo and David Ward (presidents of the National Association of State Universities and Land-Grant Colleges; the Association of American Universities; and the American Council on Education, repectively). Letter to Mark Rohrbaugh, Director of the NIH Office of Technology Transfer.

April 14, 2004. Norman Latker. Letter to Mark Rohrbaugh, Director of the NIH Office of Technology Transfer.

March 31, 2004. Joseph P. Allen, President of the National Technology Transfer Center. Letter to Mark Rohrbaugh, Director of the NIH Office of Technology Transfer.
Documents Relating to the Procedure of a March-In
Text of the Bayh-Dole Act. - In particular, see Section 203: March-in Rights, as well as Section 200(f), which defines "practical application:"
The term ''practical application'' means to manufacture in the case of a composition or product, to practice in the case of a process or method, or to operate in the case of a machine or system; and, in each case, under such conditions as to establish that the invention is being utilized and that its benefits are to the extent permitted by law or Government regulations available to the public on reasonable terms.
Federal Regulations on Procedure Governing the March-In Right Under the Bayh-Dole Act.

March 27, 2004. Rep. Sherrod Brown. Letter to NIH Director Elias A. Zerhouni.

May, 2001. David Halperin. The Bayh-Dole Act and March-In Rights.
Misc.
CPTech Page on the Ritonavir Price Hike. This includes information on the price-hike not directly related to Essential Inventions' March-In request, such as information on the various lawsuits, antitrust investigations, protests, and calls for boycotts - as well as general news stories on the price hike and its fallout.

May 19, 2004. Senators McCain, Schumer and Hollings. Letter to FTC Chairman Timothy Muris on the antitrust complaint filed against Abbott.

April 5, 2004. Statement of Essential Inventions to the World Health Organization Commission on Intellectual Property Rights, Innovation and Public Health.

March 25, 2004. Excerpt from transcript on hearings of the Health Subcommittee of the House Energy and Commerce Committee.
News stories
Click here for more news stories from the May 25 NIH hearings.

September 14, 2004. Susan Morrissey for the Chemical and Engineering News. 'Marching In' On NIH-Funded Drugs - Consumer group asks agency to use its rights under Bayh-Dole Act to ensure reasonable drug prices.

August 5, 2004. Leila Abboud for the Wall Steet Journal. Price of AIDS Drug Allowed to Stand.

August 5, 2004. Bruce Japsen for the Chicago Tribune. Abbott Wins on AIDS Drug Price

August 5, 2004. Lauren Neergaard for the Associated Press. US Won't Overide AIDS Drug Patents

August 5, 2004. Ceci Connolly for the Washington Post. NIH Declines to Enter AIDS Drug Price Battle

August 5, 2004. CBS News. NIH Refuses to Cut AIDS Drug Price

August 5, 2004. NBC 3 New York. AIDS Drug Price

August 5, 2004. Maureen Groppe for Gannett News. Drug Pricing Issue is one for Congress, Agency says

August 5, 2004. Dorsey Griffith for Sacremento Bee. HIV Drug Price Left Alone

August 5, 2004. Ed Silverman for The Star Ledger. AIDS drug rights stay with Abbott

August 5, 2004. Kaiser Networks. NIH Rejects Request To Override Abbott's Norvir Patent After 400% Price Increase

August 5, 2004. The Mercury News. Health Officials maintain patents for AIDS Drugs

August 4, 2004. Lisa Richwine for Reuters. US NIH rejects generic copies of Abbott AIDS Drug

August 4, 2004. Bruce Japsen for the Chicago Tribune Abbott backed on AIDS drug price

August 4, 2004. CNN Money. Not For Sale: generic AIDS copies

August 4, 2004. Estadao. Governo dos EUA se recusa a quebrar patente de remédio

June 8, 2004. Fox News. Battle Over AIDS Drug Pricing.

June 7, 2004. Gloria Lau for Investors Business Daily. Price Hike Of Abbott Drug Brews Up A Controversy.

June 6, 2004. Bruce Japsen for the Chicago Tribune. Abbott's Norvir receipts to climb.

June 4, 2004. David Malakoff for Science Magazine (requires subscription). NIH Weighs Demand to Force Sharing of AIDS Drug Patents.

June 2, 2004, Bob Roehr for the Windy City Times. Norvir Patent Under Fire at NIH Meeting.

June 1, 2004. Op-ed in the L.A. Times by James Glassman and Nick Schulz. Activists Put Drug Research on Chopping Block.

This is the June 5 the response by essential inventions.

May 31, 2004. Rick Mullin for Chemical and Engineering News. Abbott Defends Norvir Price Hike: Consumer group seeks U.S. intervention over 400% increase for AIDS drug.

May 28, 2004. Associated Press. 400% increase in cost of drug for AIDS sparks federal threat.

May 26, 2004, Dorsey Griffith, Plea issued on AIDS drug's 400% price hike, Sacramento Bee.

May 26, 2004. David Brown, Group Says U.S. Should Claim AIDS Drug Patents, Washington Post.

May 26, 2004, Kaiser Daily Health Report, NIH To Rule on Essential Inventions' Request To Produce Generic Version of Abbott Antiretroviral Norvir .

May 25, 2004. Randolph Schmid for the Associated Press. Advocates urge cutting cost of AIDS drug.

May 25, 2004. Lisa Richwine for Reuters. Abbott defends AIDS drug price rise to U.S. panel.

May 25, 2004. Bloomberg News. Abbott AIDS drug patent at issue.

May 25, 2004. Maureen Groppe for Gannett. Debate targets U.S.-funded drugs..

May 24, 2004. Leila Abbound for the Wall Street Journal. Drug-Pricing Rules Face Review.

May 24, 2004. Robert Steyer for The Street.com. Abbott Labs Defends Pricing Policy.

May 23, 2004. Mark Sullivan for Medill News Service. Will U.S. try to circumvent drug firms patent?

May 22, 2004. Theresa Agovino for the Associated Press. Barging in on drug factories - Government may intervene to lower price.

May 21, 2004. Bruce Japsen for the Chicago Tribune. Abbott AIDS drug pricing leads to review of patent.

May 13, 2004. Leila Abbound for the Wall Street Journal. Abbott Laboratories Faces Heat Over Raising Price of AIDS Drug.

May 6, 2004. Erika Check for nature Magazine. AIDS drug price hike prompts calls for intervention.

April 30, 2004. Bloomberg. Abbott Laboratories: Exclusive U.S. rights to Norvir challenged.

April 28, 2004. Reuters. U.S. sets hearing on Abbott AIDS drug license.

April 23, 2004. Editorial by Mubarak Dahir for the Houston Voice. Allow imported HIV/AIDS drugs - Abbott Labs’ decision to raise by 500 percent the price of the AIDS drug Norvir underscores why the U.S. government must allow cheaper drugs to be imported into this country.

April 14, 2004. Gardiner Harris for the New York Times. Price of AIDS Drug Intensifies Debate on Legal Imports.

February 18, 2004, David Scales and Sanjay Basu in the Yale Daily News, Gov't should use power to make drugs affordable

February 10, 2004, Gus Cairns in UK.GAY.COM, Ritonavir price hike – the protests continue

January 31, 2004-February 2, 2004, The Advocate, Nonprofit group calls for investigation into Abbott's price increase of Norvir

January 28, 2004, Lisa Richwine, in Reuters, US firm seeks license for Pfizer, Abbott drugs

January 28, 2004, Forbes.com (earlier version of Lisa Richwine's piece in Reuters), US firm seeks license for Pfizer, Abbott drugs