• Mashelkar Report (December 2006). Report of the Technical Expert Group on Patent Law Issues. .doc document.

• February 19, 2007. R. A. Mashelkar. Letter to the Ministry of Commerce and Industry of Asking for the Report's Withdrawl.
• February 11, 2007, The Lawyers Collective denounced plagiarism on the Mashelkar Report and asked us to provide links to the following documents.
• Table Comparison of similarities between the mashelkar report and the INTERPA-IP institute report
• Flowchart
• INTERPA-IP Institute report. See note 6 where the author notes that the funding came from interpat.
• INTERPAT membership list.
• OPPI Website showing that shahani is md of novartis india and chair of interpat india
• 2004 News article showing that mashelkar was the keynote speaker at a novartis symposium
• Blog (spicyipindia.blogspot.com) by the author of the IP report (shamnad basheer), where he admits that the mashelkar committee lifted his conclusions verbatim
• Interview with Mashelkar in Pharmabiz.com.

• CPTech Page on Indian Patent Legislation Passed March, 2005.
• Information on the WHO Prequalification status of Indian Antiretrovirals on the CPTech WHO Page.

• NGO Documents

  • July 4, 2006. The Initiative for Medicines, Access and Knowledge. The Impact of Article 39.3 In India: A Practical Perspective
  • June 28, 2006. K.K. Abraham, President, Indian Network for People Living with HIV/AIDS. Letter to Prime Minister Dr. Manmohan Singh.
  • January 5, 2007. Dr Milind Antani and Prashant Iyengar for Pharmabiz.com. Towards a Law on Data Exclusivity.

• CPTech Page on Protection of Test Data

• News Stories

  • April 18, 2007. Gireesh Chandra Prasad for the Economic Times. Pharmaceutical companies will have to wait for data exclusivity norms.
  • July 4, 2006. The Organizer Newsmagazine. Conceding data exclusivity will damage domestic drug industry - Dr Joshi.
  • June 25, 2006. The Hindu. Prime Minister urged not to introduce data exclusivity.

• May 18, 2006. Related CPTech Policy Brief by Judit Rius Sanjuan,James Love, and Robert Weissman. A cost sharing model to protect investments in pharmaceutical test data.

Implementation of Product Patents in India

• CPTech Page on Indian Patent Legislation Passed March, 2005.

• Delhi Network of Positive People and the Indian Network for People Living with HIV/AIDS challenge patent for Gilead's Tenofovir.

  • May 10, 2006. MSF Press Release. MSF Supports Opposition to Gilead's Tenofovir Patent Application in India - Patenting Tenofovir Would Set Dangerous Precedent for Global Access to Newer Essential Drugs.
  • May 10, 2006. Gilead Press Release. Gilead Offers Voluntary Licenses for Manufacturing of Viread in Developing World.
  • May 10, 2006. AIDS Healthcare Foundation. AHF Applauds Gilead Sciences for Move to Increase Global Access to Affordable AIDS Drugs.
  • News Stories
    • June 4, 2006. Paul Elias for the Associated Press. Gilead Faces Criticism Over Drug Access.
    • May 21, 2006. Anne-christine d'Adesky in the San Francisco Chronicle. A look at drug firm's story of supplying AIDS patients.
    • May 15, 2006. Sangeeta Shashikant for the Third World Network's South-North Development Monitor. Opposition to drug patents in India highlights access fears.
    • May 14, 2006. Associated Press. US Drug Company Accused Of Making HIV Meds Unaffordable In India .
    • May 13, 2006. Vineeta Pandey for the Diligent Media Corporation. Patent war: Will AIDS cost you dearer?
    • May 12, 2006. Amelia Gentleman and Hari Kumar for the New York Times. \ AIDS Groups in India Sue to Halt Patent for U.S. Drug.
    • May 12, 2006. Kaiser News Network. Drug Access | HIV/AIDS Advocacy Groups File Opposition to Gilead's Request for Patent on Tenofovir in India.
    • May 11, 2006. Amelia Gentleman and Hari Kumar for the International Herald Tribune. AIDS drug provokes patent battle in India.
    • May 11, 2006. Andrew Jack and Jo Johnson for the Financial Times. Indian Aids victims in patents protest.
    • May 11, 2006. Randeep Ramesh for the Guardian. Drug firms seek to stop generic HIV treatment.
    • May 11, 2006. Neelam Raaj for the Times of India. NGOs protest against AIDS drug patent.
    • May 11, 2006. Inside Bay Area. Activists: Deny patent to Gilead.

• Other Documents Related to Implementation of product patents

  • December 20, 2006. US Patent and Trademark Office Press Release. U.S. and India Sign Historic Memorandum of Understanding on Bilateral Cooperation on Intellectual Property.
  • March 30, 2006. Statement by the Indian Network of People Living with HIV/AIDS (INP+), Manipur Network of Positive People (MNP+), and Lawyers’ Collective HIV/AIDS Unit. Patent Apllication for AIDS Drug Opposed for First Time in India: Patents in India Endanger Global Access to Affordable Medicines and Treatment Scale-up.
  • March 2, 2006. Financial Express. Roche gets first product patent in India.
  • 2006. Working paper by Padmashree Gehl Sampath. India's Product Patent Protection Regime: Less or More of "Pills for the Poor?"

301 Report Documentation

• USTR 301 Report Excerpts by year: 2004, 2003, 2002, 2001.
• PhRMA Submissions to USTR for 301 Report by Year: 2004, 2003, 2002, 2001.
• Older PhRMA documents submitted to USTR
  • February 19, 2000, 301 Submission to USTR
  • December 3, 1999, 2000 NTE Submission to USTR.
  • February 16, 1999, 301 Submission to USTR
  • December 4, 1998, 1999 NTE Submission to USTR.

Research Papers

• Septbember 13, 2001. Phillippe Cullet for the International Environmental Law Research Center. Access to Drugs and the Patents Bill.
• October 14, 1999, Jayashree Watal, Visiting Fellow-Indian Council for Research on International Economic Relations Future Issues on IPRs in the WTO.
• June, 1999, Jean Lanjouw, Yale University, The Introduction of Pharmaceutical Product Patents in India: "Heartless Exploitation of the Poor and Suffering?"
• 1998. Pharmaceutical News. Volume 5, No. 6. Overview of the Indian Pharmaceutical Industry.

• November 29, 2000. Letter from Dr. Hamied, Director of Cipla, to J.V.R. Prasada Rao, in which he confirms that child formulations are included in the Cipla offer.
• November 21, 2000. Response from J.V.R. Prasada Rao of the Ministry of Health & Family Welfare, in which he asks about the inclusion of child formulations for nevirapine.
• November 7, 2000. Letter from Dr. Hamied, Director of Cipla, to India's National AIDS Control Organisation, offering to donate generic nevirapine to the government to prevent mother-to-child HIV transmission.

• Bulk Prices for Medicines in India.
• Center for Intellectual Property Rights, Research and Advocacy
• PharmaBiz.com

• August 13, 2005. Financial Express (interview with Harvey Bale, President, IFPMA). Patents, access to drugs is the issue.
• January 21, 2005. Hindu Business Line. Novartis Must Supply Patented Drugs. This refers to the court case betweeen Novartis and leukemia patients in need of Gleevec. For more on this dispute, see the CPTech page on Glivec.
• January 10, 2005. Ranbaxy press release. Ranbaxy Files Antiretrovirals to US FDA for Approval Under the Expedited Review Process of the US Presidents Emergency Plan for AIDS Relief.
• June 9, 2004. Affordable Medicines and Treatment Campaign. Letter to Dr. Anbumani Ramadoss, Minister of Health and Family Welfare.
• December 13, 2003. Speech by Bill Haddad before the Indian Manufacturers Association Annual Meeting. India: the Problem or the Solution.
• February 4, 2003. Ranbaxy press release. Ranbaxy Launches Next Generation Anti-Retroviral for the First Time In India.
• December 23, 2002. Press release from the Ministry of Law and Justice. India Upgrades Legal System for Patnet Related Litigation.
• May 9, 2002. The lower house of the Indian legislature passes a new Patents Bill. Note to reader: if you can find a copy, please email it to mpalmedo@cptech.org. The bill is immediately criticized by the Indian generic pharmaceutical industry for imposing tough restrictions on compulsory licensing.
  • May 15, 2002. BBC News. India reforms drug patent laws.
  • May 15, 2002. Charubala Annuncio for Outlook India. A Bitter Concoction.
  • May 14, 2002 The Hindu.com. The Government Draws Flack on Patent Bill.
  • May 9, 2002. Ananth Iyer for Express Pharma Pulse. Industry heads for a vertical split as rift on IPR widens.
• August 6, 2001. Cipla announces its launch of its new pill, Triomune, which is a combination of stavudine, lamivudine and nevirapine. Each compnent is patented in the west by different companies. See the Reuters story.

• On May 8, 2001, the Indian generic pharmaceutical firm Ranbaxy announced that it had three generic antiretrovirals (AZT, 3TC, and Nevirapine) in the domestic market, and it plans to enter five more into the market in July. See the Times of India story on this announcement.

• On March 7, 2001, the Indian generic pharmaceutical firm CIPLA formally requested compulsory licenses from the government of South Africa for eight HIV/AIDS drugs. For more information, see CPT page on CIPLA.

• Also on the CIPLA page is information on CIPLA's offer (made in February, 2001) to supply triple-combination therapy for HIV/AIDS for $350 per patient per year to Medicins San Frontieres. It has also offered to sell the therapy for $600 per patient per year to poor governments, on the condition that the recipient governments provide the drugs for free to those with HIV/AIDS. The cocktail consists of two 40 milligram tablets of stavudine, two 150 milligram tablets of lamivudine and two 200 milligram tablets of nevirapine. The cost of this regimen in developed nations is $10,000-$15,000 annually.

• May 1, 2007. P B Jayakumar for the Business Standard. Indian pharma firms corner chunk of US drug approvals.
• April 24, 2007. Economic Times. Centre weighs Canada model for price regulation of patented drugs.
• January 2, 2007. Mark Sappenfield for the Christian Science Monitor. India poised for pharmaceutical boom.
• May 30, 2006. James Sturcke in the Guardian. India has most Aids infections.
• August 5, 2005. Rajesh Nair for the Hindu. New Indian law to hit AIDS control.
• January 31, 2005. Pallavi Majumdar for the Business Standard. Drug firms may get limited data cover.
• August 4, 2004. Express Pharma Pulse. A pep for Indian R&D.
• April 5, 2004. Sify Business Line. Novartis seeks tie-ups with Indian companies.
• April 2, 2004. Sabin Russell for the San Francisco Chronicle. With AIDS spreading relentlessly, India launches free drug program - 7 clinics open, but supplies of antiviral drugs are woefully inadequate
• January 12, 2004. Manjeet Kripalani for Business Week. India: Big Pharma's New Promised Land? Drugmakers are heeding the siren call of its well-trained, cheap chemists.
• December 10, 2003. Megha Lodha for Sify. Indian cos stand a good chance of winning against Novartis: Natco.
• November 16, 2003. P.T. Jyothi Datta for the Hindu Business Line. Govt, pharma cos to discuss AIDS drugs price-cut today.
• August 22, 2003. The Financial Express. India Needs To Cash In On Patents, Says Council of Scientific and Industrial Research Chief.
• June 10, 2003. John Lancaster for the Washington Post. AIDS Begins to Widen Its Reach in India.
• May 27, 2003. Ajay Jain for the Financial Express. Pharma Cos In Grip Of Feverish Debate On Data Exclusivity.
• January 8, 2003. Pharmabiz.com. Indian scientists all set to introduce series of vaccines to control dreaded disease.
• October 25, 2002. Economic Times. Patent offices on a hiring binge as applications pile up.
• October 24, 2002. Pharmabiz.com. Healthcare expenditure to double by 2012 contribution to GDP to be 8.5%: CII-Mckinsey study.
• October 23, 2002. K G Narendranath for the India Times. New patent rules leave pharma MNCs bitter.
• October 21, 2002. N. B. Zaveri forthe Hindu Times. Trading on 'undisclosed information'.
• Febrary 6, 2002. Sitaraman Shankar for Reuters. India's new drug policy buoys multinationals.
• February 3, 2002. Interview of GSK Chairman Richard Sykes conducted by R. Sridharan for Business Today. India Will Become Attractive Only When IPR is Protected.
• January 10, 2002. Reuters. Glaxo Chairman Slams India AIDS Drugs Offer.
• January 8, 2002. Mathew and Sanjeev Sharma for the Economic Times. Glaxo Not to Launch New Products: Sykes.
• December 24, 2001. Reuters. Indian drug patent law review upsets foreign firms.
• December 10, 2001. Andrew Tanzer for Forbes. Pill factory to the world.
• September 26, 2001 Editorial by Lanka Srinivas for the Economic Times. We Are as Good a Pharma Company as Any.
• August 22, 2001. Michael McColly for Salon.com. Whisper of Death.
• August 16, 2001. Daniel Pearl and Steve Stecklow for the Wall Street Journal. Drug Firms' Incentives Fuel Abuse by Pharmacists in India.
• August 14, 2001. Jayanta Ghosh for the Times of India. Anti-AIDS drugs to cost less.
• August 10, 2001. Associated Press. U.S.: India Should Join Trade Talks.
• July 12, 2001. Reuters Business News. Cipla cuts AIDS drugs price by 39 pct for India mkt.
• July 8, 2001. Gauri Kamath for the Economic Times. India May Follow Brazil Patent Law.
• June 29, 2001. Reuters. India: Dr. Reddy's Gets Tentative US Nod for Drugs.
• June 25, 2001. The Times of India. India seeks flexibility in TRIPs for affordable drugs.
• June 15, 2001. The Economic Times. Dr Reddy's leads drugmakers to new frontiers.
• May 30, 2001. The WTO Reporter. India Asks for WTO Talks With Argentina on Drug Import Rules.
• May 12, 2001. C Rammanohar Reddy for The Hindu. Universal and free AIDS care.
• April 5, 2001. New York Times. AIDS in India.
• March 31, 2001. K. S. Jayaraman in the New Scientist. Interview with Yusuf Hamied.
• March 7, 2001. Pamela Constable in the Washington Post. Poverty, Prejudice Hinder India's AIDS Fight.
• March 2000. Rajesh Unnikrishnan, in the Business Standard, Patent office may bag sole rights.
• January 4, 2001, P. A. Francis, in Pharmabiz.com R&D Initiatives: Less Talk, More Action
• December 12, 2000, James Love, in Pharmabiz.com, TRIPS provisions for public non-commercial use are liberal.
• December 1, 2000, Donald G. McNeil, Jr., in the New York Times, Selling Cheap 'Generic' Drugs, India's Copycats Irk Industry
• November 29, 2000, Rajesh Unnikrishnan, in the Business Standard, Patent battle in pharma industry
• November 3, 2000, Gauri Kamath, in the Economic Times, Cipla stops export to Ghana on Glaxo allegations
• June 16, 2000, IMS Health, India's Patent Reforms Force Change
• June 7, 1999, Anju Ghangurde, in The Financial Express, Chemists body to take up AIDS drug's selective distribution with Cipla, Glaxo, discribing strategies of drug companies in distributing AIDS medication.