This is work in progress, and is part of a larger project on timelines. This particular timeline is unfinished, and may contain errors.
Timeline of privileged regarding the commercialization and use of knowledge
Part 2: 1980 to 1999
- June 16, 1980. The U.S. Supreme Court ruled in Diamond v. Chakrabarty, 447 U.S. 303 (1980), that micro-organisms could be patented.
- December 12, 1980. The United States amended section 101 of title 17 of the U.S. copyright law to include reference to computer programs, and added two exceptions to exclusive rights in computer programs, in section 117. (See Public Law 96-517).
- December 12, 1980. The U.S. Bayh-Dole Act was enacted (also in Public Law 96-517), codified in 35 U.S.C. § 200-212
- April 2, 1980. The Federal Courts Improvement Act of 1982 was enacted as Public Law 97-164, creating the United States Court of Appeals for the Federal Circuit (CAFC), which then was given the sole subject matter jurisdiction for patent disputes.
- January 3, 1983. The U.S. Congress enacted the Orphan Drug Act (Public Law 97-414), creating seven years of market exclusivity for products for rare diseases.
- February 18, 1983. A U.S. 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”.
- Oct. 19, 1983. The USPTO, EPO and JPO meet in the First Trilateral Conference held in Washington.
- The International Intellectual Property Alliance (IIPA) is formed by eight copyright industry trade associations.
- 1984. The federal government of Canada established the Commission of Inquiry on the Pharmaceutical Industry (Eastman Commission), to make recommendations on patent protection for the pharmaceutical industry.
- Australia amended its copyright law for computer software.
- September 17, 1984. Senator Lautenberg offered two succesful amendments to the Omnibus Trade and Tariff Act of 1984. Senate Amendment 4249 to H.R.3398, which had 10 cosponsors, expressed express the sense of the Congress concerning copyright protection of computer software.
“Expresses the sense of Congress that copyright protection is essential for computer software and lack of such protection or the use of other legal protections incorporating compulsory licensing would undermine the computer software industry here and abroad. States that any nation’s withdrawal of copyright protection or instigation of broad compulsory licensing of software should be opposed under the Universal Copyright Convention or through other avenues.”
Senate Amendment 4250 to H.R.3398 was titled “To provide further protections of intellectual property rights,” which had no cosponsors, was also agreed to in Senate by a voice vote:
Title V: Generalized System of Preferences Renewal – Generalized System of Preferences Renewal Act of 1984 – Amends the Trade Act of 1974. . . . Directs the President, in determining whether to designate a country a beneficiary developing country, to consider: (1) the extent to which such country is providing the means for foreign nationals to exercise exclusive rights in intellectual property, including a patent, trademark, and copyright rights; (2) the extent to which such country has taken action to reduce trade distorting investment practices and policies and to reduce or eliminate barriers to trade in services; and (3) whether such country has taken or is taking steps to give to workers internationally recognized worker rights.
- September 24, 1984. The U.S. Drug Price Competition and Patent Term Restoration Act of 1984 became law (Public Law 98-417). Popularly known as the Hatch-Waxman Act, the landmark legislation created a regulatory pathway to register generic drugs, while also providing for patent extensions and a period of exclusive rights in pharmaceutical test data.
- October 30, 1984. U.S. Public Law 98-551 eliminated the means test for Orphan Drug exclusivity.
- October 30, 1984. The Trade and Tariff Act of 1984 (P.L. 98-573) as passed.
- November 8, 1984. Public Law 98-620. Included in Title III the Semiconductor Chip Protection Act of 1984, which created a 10 year sui generis exclusive right in certain designs of semiconductor chips, and in Title V, provisions that allowed private companies, regardless of size, to obtain exclusive licenses for the life of a government funded patent.
- Japan, Germany, France and the UK amended copyright laws to provide for protection of computer software.
- Korea was involved in a GSP case with the US concerning the lack of patent protection for pharmaceutical products
- March 12, 1985. In a report to WIPO and UNESCO, Wanda Noel recommends a new international instrument on copyright exceptions to facilitate cross-border sharing of works for persons with disabilities created under copyright exceptions.
- June 1985. Japan amended its copyright law to address the protection of computer software programs.
- December 1985. The Reagan Administration published OMB Circular A-130, which in its original form, created a policy of relying upon the commercial private sector to disseminate government information to the public.
- Korea agrees to extend patent protection to pharmaceutical products.
- Spain and Portugal entered the EU in 1986. Both agreed to introduce patent protection for pharmaceutical products. Because both countries did not yet have patents on pharmaceutical products, the European Union would introduce a system of exclusive rights in pharmaceutical test data to insure a period of market exclusivity for unpatented medicines.
- March 1986. The Intellectual Property Committee (IPC) formed with a general mission to develop international support for improved protection of patents, copyrights, trademarks and trade secrets, and the specific objective of obtaining support for including intellectual property rights as a subject in the WTO, a topic that would be discussed in September 1986 in Punta Del Este, Uruguay. The founding members of the IPC inlcuded Bristol-Myers, DuPont, FMC Corporation, General Electric, General Motors, Hewlett-Packard, IBM, Johnson & Johnson, Merck, Monsanto, Pfizer, Rockwell International and Warner Communications.
- September 20, 1986. Agreement was reached in Punta Del Este, Uruguay to include intellectual property as a subject in the discussions to create the WTO. The relevant document was the Punta Del Este Declaration Ministerial Declaration of 20 September 1986.
Trade-related aspects of intellectual property rights, including trade in counterfeit goods
In order to reduce the distortions and impediments to international trade, and taking into account the need to promote effective and adequate protection of intellectual property rights, and to ensure that measures and procedures to enforce intellectual property rights do not themselves become barriers to legitimate trade, the negotiations shall aim to clarify GATT provisions and elaborate as appropriate new rules and disciplines.
Negotiations shall aim to develop a multilateral framework of principles, rules and disciplines dealing with international trade in counterfeit goods, taking into account work already undertaken in the GATT.
These negotiations shall be without prejudice to other complementary initiatives that may be taken in the World Intellectual Property Organization and elsewhere to deal with these matters.
- December 22, 1986. The European Union issued Council Directive 87/21/EEC of 22 December 1986 amending Directive 65/65/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products. Among other things, this directive mandated from six to ten years of exclusive rights in pharmaceutical test data.
- 1987. Mexico was sanctioned by loss of GSP benefits for not adopting pharmaceutical patents.
- 1987. Canadian Bill C-22 amended the compulsory licensing system for patented medicines. Companies selling patented brand name drugs were given a guaranteed 10 years of protection against compulsory licences to import and seven years’ protection against compulsory licences to manufacture.
- May 28, 1987. PMA (now known as PhRMA) files a petition with the US Government to withdraw benefits under the GSP to the Kingdom of Thailand.
- June 11, 1987, PMA filed a complaint with USTR objecting to the lack of product and process patents for pharmaceutical inventions in Brazil.
- July 23, 1987. USTR launches an investigation into the PMA Brazil complaint.
- September 14, 1987. USTR hearings on Brazil and Pharmaceutical patents, in response to PMA’s 301 complaint.
- 1988. Brazil extended copyright protection to computer software.
- July 21, 1988. President Reagan publicly stated Brazil’s policy on patent protection was “unreasonable and imposed restriction upon United States commerce,” and that he would take appropriate action under section 301.
- July 26, 1988. Within the GATT trade negotiations committee, Brazil and the United States have a difficult exchange (MTN. TNC/6, 17 August 1988, paragraph 21) over the U.S. unilateral trade pressures on patent protection for pharmaceutical products.
- August 10, 1998. PMA files 301 petition against Argentina, regarding patent protection.
- US: Aug. 23, 1988. PL 100-418, the Omnibus Trade and Competitiveness Act. This law creating the Special 301 list. Also included was the “Process Patent Amendments Act of 1988,” which, among other things, gave the right to exclude others from importing into the United States products made by a patented process.
- October 20, 1988. President Reagan announced section 301 authority to increase tariffs to 100 percent ad valorem for certain paper products, non-benzenoid drugs, and consumer electronic items, effective October 30, 1988. The retaliatory tariffs virtually prohibited most Brazilian exports of these products from entering the US market during 1989 and the first half of 1990.
- October 31, 1988. Brazil submits a paper in the TRIPS negotiating group, highly critical of excessive protections for IPR.
- October 31, 1988. The U.S. Congress enacted the Berne Convention Implementation Act of 1988 as Public Law 100-568.
- May 25, 1989. The first USTR Special 301 list was published. The first priority watch list included the following countries: Brazil, China (People’s Republic of), India, Mexico, Korea (Republic of), Saudi Arabia, Taiwan and Thailand. The first “watch list” included Argentina, Canada, Chile, Colombia, Egypt, Greece, Indonesia, Italy, Japan, Malaysia, Pakistan, Philippines, Portugal, Spain, Turkey, Venezuela and Yugoslavia.
- On July 3, 1989. A meeting of the Negotiating Group on Trade Related Aspects of Intellectual Property Rights, including trade in Counterfeit Goods, received complaint from “a number of participants” [MTN.GNG/NG11/13, paragraph 4] that the U.S. Special 301 priority watch list was “jeopardising the work of the Negotiating Groups and threatened to wreck the Uruguay Round.”
- August 22, 1989. Thailand introduced a pharmaceutical Safety Monitoring Program (SMP), designed to create monopolies for products that lack patent protection. The period of the monopoly was originally two years. It was later extended in 1993, following pressure from USTR, to five or six years.
- September 23, 1989. The PMA withdrew its 301 complaint against Argentina, following promises by the government of Argentina to modify its patent laws.
- February 15, 1990. The WIPO International Bureau distributed a Draft Patent Law Treaty.
- March 27, 1990. The European Union provided a draft agreement on trade related aspects of intellectual property rights to the GATT Negotiating Group on Trade-Related Aspects of Intellectual Property Rights, including Trade in Counterfeit Goods. The proposal was a comprehensive draft of the entire TRIPS agreement. The proposal by Europe, and a subsequent proposal by the U.S., were greatly influenced if not written by lobbyists for large pharmaceutical, publishing, and computer industry lobbies, led by Pfizer and IBM.
- April 2, 1990. Notes from a TRIPS negotiating meeting report the European Union called for restrictions on unilateral trade sanctions relating to IPR policies.
- May 11, 1990. The United States tabled its own “Draft Agreement on the trade-related aspects of intellectual property rights” as MTN.GNG/NG11/W/70.
- June 26, 1990. the President of Brazil announced his intention to enact legislation that would provide patent protection for pharmaceutical products and production processes of pharmaceuticals.
- June 27, 1990. USTR “determined that it was in the interest of the United States to terminate the application of the increased duties…effective July 2, 1990”
- July 23,1990. The Chairman’s Report to the GNG presented a draft consolidated text for the TRIPS Agreement. (MTN.GNG/NG11/W/76). This included, among other subjects, in Part IX, a proposal for an agreement on “Trade in Counterfeit and Pirated Goods.”
- US. Congress enacts rules concerning patents on inventions in outer space. 35 U.S.C. 105, Nov. 15, 1990, Public Law 101-580.
- December 1990. The Brussels Draft of the TRIPS
- 1991. Mexico, Indonesia, Chile and Belarus extended patent protection to pharmaceutical products.
- January 30, 1991. PhRMA files a GSP petition under section 302 of the US Trade Act, alleging that the Government of Thailand does not provide adequate and effective patent protection for pharmaceutical products.
- March 19, 1991. Major revisions of International Convention For The Protection Of New Varieties Of Plants (UPOV) were adopted.
- March 27, 1991. In Feist Publications, Inc., v. Rural Telephone Service Co., the U.S. Supreme Court held that facts were not subject to copyright, rejecting the “sweat of the brow” argument for copyright protection.
- December 20, 1991. GATT Director General Dunkel tabled a “Draft Final Act Embodying the Results of the Uruguay Round of Mulitnational Trade Negotiations,” which was later referred to as the “Dunkel Draft.” (MtN.TNC/W/FA 20 December 1991)
- 1992. Romania, Taiwan, Russia, Thailand, Ukraine and Spain extended patent protection to pharmaceutical products.
- June 5, 1992. The Convention on Biodiversity was opened for signature at the Rio Earth Summit.
- June 1992. The Canada federal government introduced Bill C-91, which became the Patent Act Amendment Act, 1992, and was passed by Parliament in 1993. This bill effectively eliminated the general compulsory licensing of pharmaceutical products in Canada, and facilitated Canada’s entry into NAFTA.
- December 29, 1992. Bristol Myers-Squibb registered Taxol (paclitaxel) with the US FDA as a treatment for ovarian cancer. Taxol was an unpatented NIH developed invention. The only significant barrier to competition was the exclusive rights in test data that had been licensed from the NIH. In the next several years the U.S. government pressured more than a dozen trading partners to keep generic versions of paclitaxel off the market, and provided a strong rationale to the USTR to promote the global protection of pharmaceutical test data.
- 1993. China, Yugoslavia, Poland, the Philippines, Portugal, Sloevnia and Macedonia adopted patent protection for pharmacuetical products.
- 1994. The U.S. based Pharmaceutical Manufacturers Association (PMA), which was founded in 1958, changed its name to the Pharmaceutical Research and Manufacturers of America (PhRMA).
- January 1, 1994. NAFTA came into force.
- December 9-11, 1994. Negotiations for a new Free Trade Area for the Americas (FTAA) were launced in Miami.
- January 1, 1995. The WTO and the TRIPS come into force.
- February 10, 1995. A key U.S. Congressional Committee rejected a proposed amendment to a federal statute that would have created a sui generis right in “value added” to government information.
- April 6, 1995, Antitrust Guidelines for the Licensing of Intellectual Property, Issued by the U.S. Department of Justice and the Federal Trade Commission
- April 6, 1995. The European Court of Justice decided the case of Radio Telefis Eireann (RTE) and Independent Television Publications Ltd. (ITP), v. the Commission of the European Communities, popularly known as the Magill decision. The case concerned the right of the Commission to order a compulsory license when there is a refusal to license intellectual property.
- April 11, 1995. Pressured by pharmaceutical and biotechnology companies, NIH abandoned its “Reasonable Pricing” clause in licenses and CRADA agreements. The NY Times report on the decision is here. A subsequent rationale was offered here.
- August 12, 1995. The Eurasian Patent Convention entered into force.
- March 11, 1996. The European Union adopted “Directive 96/9/EC of the European Parliament and of the Council of 11 March 1996 on the legal protection of databases.”
- December 1996. In the fact of opposition from civil society, U.S. enthusiasts of sports statistics, genealogy researchers, the U.S. academic scientific research community, and a number of U.S. database companies, a WIPO Diplomatic Conference rejected a proposal for a WIPO treaty on the protection of databases.
- December 20, 1996. The WIPO Copyright Treaty (WCT) was adopted in Geneva.
- December 20, 1996. WIPO Performances and Phonograms Treaty (WPPT), adopted in Geneva.
- The United States engaged in extensive trade pressures against South Africa to prevent the legalization of parallel trade in medicines. This dispute would be broadened, and led to a major confrontations between U.S. AIDS activists and Vice President Al Gore in 1999.
- January 15th, 1997. USTR-Designate Barshefsky announced GSP sanctions against Argentina for continuing IPR Problems. Among the complaints detailed in the USTR press release was this: “Argentine pharmaceutical interests continue to work aggressively to frustrate our efforts to achieve improved intellectual property protection in other countries.”
- August 1997. Cellpro’s March-In Rights petition was rejected by the NIH.
- October 20, 1997. The U.S. Department of Justice (DOJ) filed an antitrust case against Microsoft for violating an earlier consent decree by bundling its Internet Explorer web browser with the Windows Operating System. Among the remedies eventually applied in this case were compulsory licenses in the United States and Europe. Microsoft was already active in global trade policy relating to software piracy. The antitrust case would stimulate Bill Gates to take an interest in global norms concerning intellectual property, including those relating to medical inventions.
- January 27, 1998. The WHO Executive Board forwards EB101.R24 to the WHA, which will met in May. This draft resolution, first proposed by Zimbabwe and later championed by South Africa, will lead to the first major global debate over intellectual property rights and health.
- May 1998. The World Health Assembly engaged in a bitter debate over a proposed resolution on a Revised Drug Strategy. This May 27, 1998 U.S. Department of State cable provides a summary of the debate from the perspective of the United States.
- July 6, 1998. Directive 98/44/EC of the European Parliament and of the Council on the legal protection of biotechnological inventions. Among other things, the EU Directive ensured that certain biotechnology innovations would be protected by patents, while creating a mandatory compulsory license on both patents and plant breeder rights, for persons who made improvements to either.
- May 1998. The WHO’s World Health Assembly meeting is deadlocked over a resolution dealing with intellectual property rights and health.
- October 27, 1998. The Sony Bono Copyrigtht Extension Act extended copyright terms in the United States by 20 years.
- Feb 23, 1999, Jesse Jackson, Jr. and 74 co-sponsors introduce HR 772 in the 106th Congress, which includes this proposal:
SEC. 601. REQUIREMENTS RELATING TO SUB-SAHARAN AFRICA INTELLECTUAL PROPERTY AND COMPETITION LAW. Funds appropriated or otherwise made available to any department or agency of the United States may not be used to seek, through negotiation or otherwise, the revocation or revisions of any sub-Saharan African intellectual property or competition law or policy that is designed to promote access to pharmaceuticals or other medical technologies and such law or policy, as the case may be, complies with the Agreement on Trade-Related Aspects of Intellectual Property Rights referred to in section 101(d)(15) of the Uruguay Round Agreements Act.
While HR 772 did not become law, versions of this provision were later incorporated in a 2000 Executive Order by President Clinton, and in subsequent trade legislation.
- February 24, 1999. The Bangui Agreement was revised. Among other things, the new agreement did not permit compulsory licenses on patents to be used for imports.
- March 25-27, 1999. MSF, CPTech and HAI hosted a Geneva meeting on compulsory licensing of essential medical technologies.
- May 24, 1999. The World Health Assembly adopted WHA52.19, the Revised Drug Strategy. The text of the resolution was the result of a negotiation in the fall of 1998. Among other things, the resolution urged member states: (1) to reaffirm their commitment of developing, implementing and monitoring national drug policies and to taking all necessary concrete, measures in order to ensure equitable access to essential drugs; (2) to ensure that public health interests are paramount in pharmaceutical and health policies; and (3) to explore and review their options under relevant international agreements, including trade agreements, to safeguard access to essential drugs.
- June 16, 1999. US AIDS activists beging a series of “zaps” of the Al Gore presidential compaign, to highlight concerns over US trade policy on intellectual property rights for medicines in South Africa.
- US Supreme Court ruling in Florida Prepaid Postsecondary Education Expense Board v. College Savings Bank et al. (98-531) 527 U.S. 627 (1999), Argued April 20, 1999–Decided June 23, 1999, holds that States are not liable for infringement of patents under doctrine of state sovereign immunity. This is later extended to copyrights, trademarks and other intellectual property rights.
- December 1, 1999. Following a speech by President Clinton to the WHO ministerial meeting held in in Seattle, USTR issued a press release regarding new U.S. trade policies as regards The Protection Of Intellectual Property and Health Policy.
This is from Peter Drahos, Developing Countries and International Intellectual Property Standard-Setting, Journal of World Intellectual Property, 2002.
Source: Harvey E. Bale, Jr., Ph.D., Senior Vice President International , Pharmaceutical Research and Manufacturers of America, PATENT PROTECTION FOR PHARMACEUTICALS: A PLATFORM FOR INVESTMENT, MARKETS AND IMPROVED HEALTH IN THE AMERICAS, (Paper presented to Workshop ID, Cartagena, March 1996. http://www.sice.oas.org/ip/Phrma_e.asp
|U.S. – PTE||1984*||Romania||1992||Poland||1993|
|Korea||1986||Taiwan||1992||EU – PTE||1993*|
|Japan – PTE||1987*||New Zealand||1992**||Philippines||1993|
|Indonesia||1991||Canada||1987, 1993**||Andean Pact||1994|
* PTE = Patent Term Extension
** Improvements in Protection from Compulsory Licensing
Appendix 3 Some other timelines
- Four Years of Struggles to Free the Law, Background Comments for Conference on Computers, Freedom and Privacy, 1995 (CFP-95), Panel on “Who Owns the Law”, March 31, 1995.
- Time-line of Disputes over Compulsory Licensing and Parallel Importation in South Africa, 1994-1999.
- Jennifer Ellen Mattson, “1999 Collaboration between the US government and pharmaceutical industry to oppose Philippine government effort to promote expanded use of generics for off-patented drugs,” February 9, 2005.
- Jennifer Ellen Mattson, Timeline of US-Argentina Dispute on Pharmaceutical Patents, 1989 to 2000.
- KEI’s Bayh-Dole Timeline.
- KEI’s web page on USTR Special 301 lists, 1989-2010.
- Margaret Smith, Patent Protection For Pharmaceutical Products In Canada – Chronology Of Significant Events, Law and Government Division 30 March 2000.
- Susannah Markandya, Timeline of disputes over pharmaceutical patent protection in the Dominican Republic, 1992 to 2001.
- Susannah Markandya, Timeline of Trade Disputes involving Thailand and access to medicines, 1979 to 2001.
- Susannah Markandya and James Love, Timeline of Paclitaxel disputes, 1971-2001.
- Timeline: Addressing Copyright Related Barriers to Overcoming Reading Disabilities
Appendix 4 – Selected biography
- Adrian Otten, and Hannu Wage, Compliance with TRIPS: The Emerging World View; 29 Vand. Journal of Transnational Law 391 (1996)
- Carlos Correa, Trade Related Aspects of Intellectual Property Rights, A Commentary on the TRIPS Agreement, 2007
- Carlos M. Correa (Editor), Abdulqawi A. Yusuf (Editor), Intellectual Property and International Trade: The TRIPS Agreement, 2008.
- Daniel Gervais, TRIPS Agreement – Drafting History and Analysis -2003.
- Duncan Matthews, Globalising Intellectual Property Rights: The TRIPS Agreement, 2002.
- Ellen F.M. ‘t Hoen, The Global Politics of Pharmaceutical Monopoly Power, Drug patents, access, innovation and the application of the WTO Doha Declaration on TRIPS and Public Health. 2009
- Jacques Gorlin, An analysis of the pharmaceutical-related provisions of the WTO TRIPs (Intellectual Property) Agreement, 1999
- Jayashree Watal, Intellectual property rights in the WTO and developing countries, 2001.
- Michael Ryan,Knowledge Diplomacy: Global Competition and the Politics of Intellectual Property, 1998
- Mitchel B. Wallerstein, Mary E. Mogee, and Robin A. Schoen, Editors; National Research Council, Global Dimensions of Intellectual Property Rights in Science and Technology, 1993
- Peter Drahos, John Braithewaite. Information Feudalism: Who Owns the Knowledge Economy? 2003.
- Peter Yu, Intellectual property rights in the WTO and developing countries, 2006.
- Robert Weissman, A Long, Strange Trips: The Pharmaceutical Industry Drive to Harmonize Global Intellectual Property Rules, and the Remaining WTO Legal Alternatives Available to Third World Countries, University of Pennsylvania, Journal of International Economics and Law, Vol. 17:4 1996.
- Ruth Okediji, Public Welfare and the Role of the WTO: Reconsidering the Trips Agreement, 7 Emory Int’l L. Rev. 819 (2003)
- Susan Sell, Private Power, Public Law: The Globalization of Intellectual Property Rights. 2003.
- Terence Steward The GATT Uruguay Round: A Negotiating History (1986-1994) 1999.