Charo, R.A., “A Political History of RU-₄86,” in Hanna, K.E., ed., Bio-Medical Politics (Washington, D.C.: National Academy Press, 1991), 77; Klitsch, M., “Antiprogestins and the Abortion Controversy: A Progress Report,” 23 Family Planning Perspectives 275 (1991).Google Scholar

In addition, it has been reported that the Chinese government has approved RU ₄86. The New York Times, September 24, 1988, Section 1, p. 1; Chicago Tribune, September 27, 1988, p. 4.Google Scholar

The New York Times, October 29, 1988, Section 1, p.1 and February 12, 1989, Section 6, p. 23; Newsday, May 29, 1989, p. 5 and April 24, 1989, p. 31.Google Scholar

Charo, , supra note 1, at 54–59.Google Scholar

The New York Times, 12 February 1989, supra note 3; Newsday, 29 May 1989, supra note 3; Reuters Library Report, October 28, 1988.Google Scholar

The New York Times, February 12, 1989, supra note 3.Google Scholar

Sunday Telegraph, 30 October 1988, p. 9.Google Scholar

The New York Times, supra note 3.Google Scholar

The New York Times, 12 February 1989, supra note 3.Google Scholar

The New York Times, supra note 3; Le Monde, 30 January 1991.Google Scholar

Code commerce, Brevets d'invention, Section 37. An English translation of this law appears in 78 Patent and Trademark Review 417 and 464 (1978).Google Scholar

The New York Times, supra note 3.Google Scholar

The New York Times, March 26, 1989, Section 4, p. 18; United Press International, March 24, 1989.Google Scholar

Order of November 22, 1988. Journal officiel, December 16, 1988, p. 15713.Google Scholar

Authorization of December 28, 1988 and Order of December 28, 1988. Journal officiel, January 12, 1989, p. 465.Google Scholar

Order of February 20, 1990. Journal officiel, February 25, p. 2542.Google Scholar

Journal officiel, January 16, 1975, p. 671.Google Scholar

Order of 25 January 1991. Revue française de droit administratif 292 (1991).Google Scholar

Order of November 19, 1991. Revue française de droit administratif 321 (1991).Google Scholar

Code de la Santé Publique, Article L.511.Google Scholar

Orders of December 21, 1990. Revue française de droit administratif 208 (1991). These arguments included the following: a) that the Minister of Health had no authority to regulate RU ₄86 under the Code of Public Health; b) that the person who actually signed the order approving RU ₄86 had not been properly delegated to do so by the Minister of Health; c) that the Minister of Health was required to submit proposed regulations on RU ₄86 to national councils of physicians and pharmacists; d) that the timing of the order approving RU ₄86 was irregular; e) that instructions on the use of RU ₄86 were not sufficiently precise to preclude misuse of the drug; f) that regulations on the distribution of RU ₄86 violated legal provisions prohibiting the offering or sale of substances that can provoke abortion; and g) that instructions calling for women using RU ₄86 to be informed that, if this method of abortion fails, they run the risk of giving birth to a deformed fetus should they carry the pregnancy to term, violate legal provisions prohibiting “propaganda” in favor of abortion.Google Scholar

Law No. 75-17 of January 17, 1975 (Journal officiel, January 18, 1975, p. 739), reenacted and amended by Law No. 79-1204 of December 31, 1979 (Journal officiel, January 1, 1980, p. 3). The determination of what constitutes a “situation of distress” is left to the woman. Abortions can be performed later in pregnancy if two physicians certify that the pregnancy poses a serious danger to the woman's health or the fetus is suffering from a serious disease or condition.Google Scholar

Convention for the Protection of Human Rights and Fundamental Freedoms, Article 2. 213 U.N.T.S. 222.Google Scholar

International Covenant on Civil and Political Rights, Article 6. 999 U.N.T.S. 172.Google Scholar

Roe v. Wade, 410 U.S. 113 (1973); R. v. Morgentaler, [1988] 1 S.C.R. 30 and Tremblay v. Daigle, [1989] 2 S.C.R. 530; Judgment of February 25, 1975, 39 BVerfGE 1.Google Scholar

For example, a strong argument can be made that the right to life provisions in the international treaties invoked by the anti-abortion groups in these cases were never intended to apply to fetuses, but, instead, were intended to apply exclusively to criminal proceedings brought against living persons.Google Scholar

265 Journal of the American Medical Association 1628 (1991).Google Scholar

The New York Times, supra note 3.Google Scholar

The State Council decided to make a ruling on this issue because, between the time of the Constitutional Council's decision in 1975 and 1990, intervening jurisprudence had held that French courts did have jurisdiction to hear cases arguing that French law violated the provisions of international conventions to which France is a party. Judgment of the Constitutional Council of October 21, 1988 (Recueil des décisions du Conseil Constitutionnel, 1988, p. 183) and Judgment of the State Council of October 20, 1989 (Recueil des décisions du Conseil d'Etat, 1989, p. 190).Google Scholar

Le Monde, April 10, 1991 and April 13, 1991; The New York Times, April 21, 1991, Section 1, Part 1, p. 3; Chicago Tribune, April 21, 1991, p. 24.Google Scholar

United Press International, April 11, 1991.Google Scholar

Supra note 30.Google Scholar

Ibid.Google Scholar

The Independent, July 4, 1991, p. 4; The New York Times, July 4, 1991, Section A, p. 7; Press Association Newsfile, July 23, 1991.Google Scholar

The Independent, supra note 34; Roussel Laboratories Ltd., Denham. “Press release: U.K. approval for mifepristone” (July 1991). In France four visits are required: One to request the abortion, another to confirm the request and receive RU ₄86, a third to receive prostaglandin, and a fourth for a check-up. See Cook, R.J., “Antiprogestin drugs: Medical and Legal Issues,” 21 Family Planning Perspectives 267 (1989) at 268–269.Google Scholar

The New York Times, supra note 34; The Independent, supra note 34; The Chicago Tribune, July 4, 1991, p. 2. An abortion may be performed within the first 24 weeks of pregnancy if two registered medical practitioners are of the opinion formed in good faith that “the continuation of the pregnancy would involve risk, greater than if the pregnancy were terminated, of injury to the physical or mental health of the pregnant woman or any existing children of her family.” Abortions may be performed later in pregnancy for serious health reasons, including risk to the life of the pregnant woman, or if there is a substantial risk of the birth of a seriously handicapped child. The Abortion Act 1967, as amended by The Human Fertilisation and Embryology Act 1990.Google Scholar

Press Association Newsfile, July 16, 1991 and supra note 34; The Times, July 17, 1991; The New York Times, supra note 34.Google Scholar

The Independent, December 8, 1991, p. 11.Google Scholar

Ibid.Google Scholar

Ibid.Google Scholar

The Times, July 9, 1991 and July 22, 1991; The Daily Telegraph, July 16, 1991, p. 15Google Scholar

Human Fertilisation and Embryology Act 1990.Google Scholar

Morgan, D. and Lee, R.G., Blackstone's Guide to the Human Fertilisation and Embryology Act 1990 (London: Blackstone Press Ltd., 1991), vii.Google Scholar

Human Fertilisation and Embryology Act 1990, Section 37 (3).Google Scholar

It should be noted that, as of early 1992, no other such places have been approved for abortions and there seemed to be little possibility that they would be given the concern of Roussel Laboratories over security of drug supplies and safety. See Roussel Laboratories Ltd., supra note 35.Google Scholar

Baulieu, E.E. and Rosenblum, M., The Abortion Pill (London: Century, 1991), 114.Google Scholar

Press Association Newsfile, supra notes 34 and 37.Google Scholar

Charo, supra note 1; Cook, supra note 35, at 269.Google Scholar

The New York Times, April 10, 1991, p. 25. A representative of the Bush administration also warned the World Health Organization of “negative consequences” if it continued research on RU ₄86. United Press International, June 29, 1991. This threat was subsequently withdrawn under international pressure.Google Scholar

Rust v. Sullivan, 111 S. Ct. 1759 (1991); The New York Times, May 24, 1991, Section A, p. 1Google Scholar

It is not entirely clear which branch of the Hoechst pharmaceutical company is the source of the greatest opposition to the introduction of RU ₄86 into the United States. The parent company Hoechst A.G. expressed its discomfort with the drug at least as far back as 1988 when it contributed to Roussel-Uclaf's initial decision not to market the drug in France (The New York Times, supra note 3), and the drug's key developer has been quoted as saying that Hoechst fears a boycott of its United States products, which earn substantial profits for the company. Reuters, July 31, 1990. Others believe that the strongest opposition to RU ₄86 is coming from Hoechst's United States subsidiary Hoechst-Celanese, said to have been “influential” in Hoechst's decision not to introduce RU ₄86 into the United States. PR Newswire, January 21, 1992; United Press International, January 22, 1992. Whatever the case, it has been left to Roussel-Uclaf to voice publicly corporate concerns about RU ₄86.Google Scholar

The New York Times, July 29, 1990, Section 1, Part 1, p. 1; Klitsch, supra note 3, at 279; Baum, R.M., “RU-486: Abortion Controversy in U.S. Clouds Future of Promising Drug”, Chemical and Engineering News, March 11, 1991, p. 9. The other conditions were that a synthetic prostaglandin be locally available, that the distribution network be strictly controlled, and that patients be required to sign a consent form.Google Scholar

Ibid.Google Scholar

Ibid.Google Scholar

Charo, supra note 1, at 46.Google Scholar

The Washington Post, December 10, 1991. p. 27.Google Scholar

The New York Times, December 5, 1991, Sect. A., p. 22.Google Scholar

Reuters, December 5, 1991; See also, The New York Times, supra note 52.Google Scholar

The Washington Post, supra note 56.Google Scholar

The New York Times, 16 November 1990, Sect. A, p. 2 and supra note 57; Baum, supra note 52, at 11–14; “Commentary. Beyond 'Abortion': RU-486 and the Needs of the Crisis Contingency,” 264 Journal of the American Medical Association 1026 (1990). Some saw Roussel-Uclaf's recent approval of a Canadian trial of RU ₄86 for the treatment of breast cancer, rather than proposed trials in the United States, as the latest evidence of the company's reluctance to supply American researchers. The New York Times, supra note 57; The Washington Post, supra note 56; Roussel-Uclaf's spokesperson, however, denied that this was the reason that the company had not approved the proposed American trials. Ibid. Moreover, in January 1992 Roussel-Uclaf sent an official letter to the Food and Drug Administration confirming that the company “fully agrees to help U.S. investigators to perform clinical studies with RU ₄86 (Mifepristone).” As conditions for cooperation it required that a) the studies not relate to abortion; b) the protocols be medically and ethically acceptable; and 3) the investigators comply with FDA rules and internal Roussel-Uclaf procedures as regards reporting of side-effects, publications, and other matters. Letter of January 2, 1992, from André Ullmann to Dr. Solomon Sobel, Director, Division of Metabolism and Endocrine Drug Products, Food and Drug Administration.Google Scholar

Schade, H., Patents at a Glance: A Survey of Substantive Law and Formalities in 50 Countries (Köln: Heymann, 1980).Google Scholar

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Ibid., Sections 32–33.Google Scholar

Patents Act 1977, Sections 48 and 53. Section 48 establishes additional grounds for compulsory licensing relating to commercial availability of the patented product and other products that may rely on the use of the patented product. Moreover, Section 51 of the Act allows compulsory licensing when a patent is involved in monopolistic or anti-competitive practices.Google Scholar

Ibid., Section 55.Google Scholar

For discussions of the issue of compulsory licensing in the United States see “Comment, Compulsory Licensing in the United States: An Idea Whose Time Has Come,” 8 Northwestern Journal of International Law & Politics 666 (1988); Lauroesch, M.W., “General Compulsory Licensing in the United States: Good in Theory, but not Necessary in Practice,” 6 Santa Clara Computer and High Technology Law Journal 41 (1990); 2 APLA Quarterly Journal (1974), which is entirely devoted to compulsory licensing.Google Scholar

42 U.S.C. Section 2183.Google Scholar

Clean Air Act of 1970, 42 U.S.C. Section 7608. See also the Plant Variety Protection Act, 7 U.S.C. Sections 2402–2404 for another example of compulsory licensing.Google Scholar

Coal Research and Development Act, 30 U.S.C. Section 666; Helium Act, 50 U.S.C. Section 167b; Tennessee Valley Act, 16 U.S.C. Section 183r; 28 U.S.C. Section 1498.Google Scholar

One United States case, Foster v. American Machine & Foundry Co., 492 F.2d 1317 (1974), has held that a compulsory license can be granted without a finding of harm to the public welfare simply because a patent holder has not worked its patent. Although the Supreme Court let the decision stand by denying certiorari, the general view is that the holding of the case is an anomaly because it appears to be in conflict with the Supreme Court's own precedents. Continental Paper Bag Co. v. Eastern Paper Bag Co., 210 U.S. 405 (1908); Hartford-Empire Co. v. United States, 323 U.S. 386, clarified in 324 U.S. 570(1945). See the discussions in APLA Quarterly Journal, supra note 66.Google Scholar

See Walker Process Equip., Inc. v. Food Mach. & Chem. Corp., 382 U.S. 172 (1965); Hartford-Empire Co. v. United States, supra note 70; United States v. United States Gypsum Co., 340 U.S. 76 (1950); Staff of the Subcommittee on Patent, Trademarks, and Copyrights of the Senate Committee on the Judiciary, 86th Congress, 2d Session, Report on Compulsory Patent Licensing under Antitrust Judgments, 1960, p. 5; Moore, “A Study of Compulsory Licensing and Dedication of Patents as Relief Measures in Antitrust Cases,” 24 George Washington Law Review 223 (1955).Google Scholar

Hartford-Empire Co. v. United States, supra note 70.Google Scholar

69 F.2d 577 (1934).Google Scholar

3 F. Cas. 706 (1871).Google Scholar

146 F.2d 941 (1945).Google Scholar

At this point in the opinion, the Court discussed the Supreme Court case, Continental Paper Bag Co. v. Eastern Paper Bag Co., supra note 70, the main precedent for the view that a corporation generally has the right to suppress the use of a patent that it holds. It noted that in Continental Paper Bag suppression of the use of the patent was not found to be against the public interest, and that the Supreme Court expressly left open the question whether such suppression might be unenforceable in a case where it was against the public interest.Google Scholar

It is interesting to note that the Court raised on its own the public health aspects of the appellant's claim with respect to withholding licenses for its patents. In addition, in its amendment to its decision it forcefully condemned the University of Wisconsin, which it considered to be the chief villain in the case. It noted that the University had used its great influence to obtain from the appellee an agreement to refuse licensing of its process for the irradiation of oleomargarine at the time that the appellee was assigned the patent by one of the University's professors, who had initially secured it.Google Scholar

See APLA Quarterly Journal, supra note 66, at 157, 182–183, 197–198, 205; Lauroesch, supra note 66 at 56.Google Scholar

See MacKenzie, I., “The Potential Effects on NHS Resources,” in The Abortion Pill (Mifepristone/RU ₄86): Widening the Choice for Women, London: Birth Control Trust, 1991), 41; Charo, supra note 1, at 45.Google Scholar

Abortions using vacuum aspiration are usually performed about six weeks following a missed period, while abortions using RU ₄86 can be performed as soon as one day after a missed period.Google Scholar

Urquhart, D.R. and Templeton, A.A., “Acceptability of Medical Pregnancy Termination,” 2 The Lancet 1988, p. 106.Google Scholar

For descriptions of these diseases and conditions see Klitsch, supra note 1; Ullmann, A., Teutsch, G. and Philibert, D., “RU ₄86,” 262 Scientific American, 42 (1990); “Commentary. Beyond 'Abortion': RU-486 and the Needs of the Crisis Contingency,” supra note 60.Google Scholar

Until very recently, introduction of RU ₄86 into the United States was in one sense only a theoretical possibility because there was no prostaglandin on the American market that had been tested for use with the drug. This situation was rectified in the spring of 1992 when the French government approved the prostaglandin Cytotec for use with RU ₄86. Cytotec has been licensed in the United States by the FDA for use as a treatment for ulcers. Despite this fact, however, it is not known whether Cytotec's manufacturer will approve use of its drug in conjunction with RU ₄86 for terminating pregnancies and whether legally it can so be used without the warning that its use is contraindicated for pregnant women. Although the drug's manufacturer agreed to change this language in France so that Cytotec could be used with RU ₄86, it may be more reluctant to do so in the United States where opposition to abortion is much more vocal. Similarly, there are difficulties involved in obtaining new drug approval from the FDA for a drug whose patent is held by a party other than that applying for the patent. Under 1984 amendments to the Federal Food, Drug, and Cosmetics Act (21 U.S.C. Sect. 505), a party not holding the patent of a drug and not relying in its application on investigations it has performed itself can submit an application for FDA approval if it claims that the patent is invalid and gives notice to the patent holder of its intentions. The patent holder then has 45 days within which to bring a case of patent infringement or lose the right to oppose FDA approval of the drug. If the patent holder does bring a suit, theoretically, a party seeking FDA approval could at that point assert that a compulsory license be granted to it for reasons of public health. However, potential problems may arise around obtaining the proper investigation results for an application and convincing a court that the patent is invalid within the meaning of Sect. 505.Google Scholar