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TARGETED ASSASSINATIONS On Nov. 3, an unmanned CIA plane fired a missile in Yemen, killing an aide of Osama bin Laden and five associates. In a recent editorial (“Sauce for the Goose,” Nov. 11, 2002, 170 N.J.L.J. 494), we asked how the action in Yemen squares with past U.S. opposition to Israel’s “targeted killing” of Palestinians. State Department spokesman Richard Boucher said, “If you look back at what we have said about targeted killings in the Israeli-Palestinian context, you will find that the reasons we have given do not necessarily apply in other circumstances.” So much for consistency. President George Bush, campaigning during the week of Nov. 3, reiterated that he was determined to break up Al Qaeda. “The only way to treat them is (for) what they are: international killers,” the president said, referring to Al Qaeda operatives. “And the only way to find them is to be patient, and steadfast, and hunt them down.” Secretary of Defense Donald Rumsfeld said, “The only way to deal with terrorists is to take the battle to them, and find them and root them out, and that’s self-defense.” Neither man used the word killing. Amnesty International said, “If this [Yemen incident] was the deliberate killing of suspects in lieu of arrest, in circumstances in which they did not pose an immediate threat, the killings would be extra-judicial executions in violation of international human rights law.” Sweden’s foreign minister said, “If the U.S.A. is behind this with Yemen’s consent, it is nevertheless a summary execution that violates human rights. . . . Even terrorists must be treated according to international law. Otherwise, any country can start executing those whom they consider terrorists.” Jeffrey Smith, former general counsel at the CIA, said, “This ought to be a last resort for the United States” because such pinpoint targeting of individuals might after a while “suggest that it’s acceptable behavior to assassinate people.” The preferable route, he said, would be to capture and try terrorists, and share the evidence of guilt with the world. To explain why a free society should respect the human rights of those who planned the killing of innocent civilians on Sept. 11 is virtually impossible. Every natural impulse calls for revenge. The best that can be said is that “[l]aw triumphs when the natural impulses aroused by a shocking crime yield to the safeguards which our civilization has evolved for an administration of criminal justice at once rational and effective.” Watts v. Indiana, 338 U.S. 49, 55, (1949). Like the Cold War, the war on terror is also a battle for the minds and hearts of men and women. President Ronald Reagan often spoke of the United States as a shining city on a hill, a beacon of human rights, as evidenced by an enlightened constitution, a strong tradition of free speech and press freedom, and respect for the rule of law. In part because the people of the Soviet bloc countries admired what we stood for, the Iron Curtain fell without a shot being fired. At the end of World War II, nations of the world, finding that “disregard and contempt for human rights [had] resulted in barbarous acts which have outraged the conscience of mankind,” resolved that “recognition of the inherent dignity and of the equal and inalienable rights of all members of the human family [be] the foundation of freedom, justice and peace in the world.” Article 11 of the United Nation’s Universal Declaration of Human Rights guarantees the “right [of every member of the human family] to be presumed innocent until proved guilty according to law in a public trial at which one has had all the guarantees necessary for a defence.” The members of Al Qaeda have no respect for human rights. Still, Alfred Rubin, professor of law and diplomacy at Tufts University, cautions that if the U.S. sanctions targeted assassination, “It means that Al Qaeda will have won the battle of changing the rules of war.” We can win the war on terror without dimming the beacon of human rights. DRUGS AND THE ORANGE BOOK President Bush’s late October resolution to restructure the Drug Price Competition and Patent Term Restoration Act, better know as the Hatch-Waxman Act, has spurred considerable debate. With the ever-rising costs of prescription drugs in the forefront of the news, the underlying tension between innovative pharmaceutical companies that own patents on drugs and generic manufacturers who produce less costly versions is garnering public and congressional attention. When Hatch-Waxman was passed in 1984, it was touted as a major change in patent reform in the pharmaceutical industry. Today, the act has come under considerable criticism due to a loophole that allows major drug companies to slow down generic drug company competition and constructively extend patent protection in bad faith. Hatch-Waxman was seen by many as an act that would help reduce the cost of prescription drugs by giving generic drug companies the means for faster entry into the marketplace. Under the act, and through the Food and Drug Administration’s Abbreviated New Drug Application (ANDA), a generic drug company is allowed to cite clinical data already collected by the major pharmaceutical companies without conducting its own trials when preparing FDA applications. Moreover, generics have only to show that their drug is the bioequivalent of the particular blockbuster drug, and are allowed to begin clinical trials before the patent on the innovator drug expires. Pre-Hatch-Waxman, this type of activity would have resulted in a suit for patent infringement. The practical effect of these stipulations is that generic companies can begin selling off-patent drugs immediately after the expiration of the leader’s patented drug without expending considerable efforts. Through ANDA’s paragraph IV provisions, a generic drug company can seek marketplace advantage over other generic drug companies by filing a certificate with the FDA claiming that its drug does not infringe the patent on a drug listed in the FDA Orange Book, or that the listed patent of the innovator drug company is invalid. The first generic drug company that successfully files such a certificate is allowed a 180-day exclusive marketplace right over other generics attempting to market the same drug. Upon this filing, the patent owner is notified and is given the opportunity to institute a patent infringement suit against the generic drug applicant. The mere filing of such a suit, which is likely, triggers a 30-month stay of FDA approval for the generic drug in question � thus the loophole. The crux of the problem is that a pharmaceutical company can obtain multiple 30-month stays by claiming infringement of several of its patents listed in the Orange Book, regardless of whether the listing is proper or not. The FDA does not evaluate the patents listed or the infringement claim. The 30-month stay is applied as soon as the FDA is informed of the patent infringement claim. Although Bush’s proposal brings attention to the problem and seeks to limit the stay to a single 30-month period, it falls short. It does not require that litigation be filed in good faith, it does not impose sanctions for frivolous suits and it does not penalize for a patent incorrectly listed in the Orange Book. Compared to the more rigid Greater Access to Affordable Pharmaceuticals Act, which recently passed through the Senate only to die in the House, Bush’s proposal seems almost to favor the name brand companies it was seemingly designed to reign in. The president and Congress should think carefully about the loophole and any proposed changes to ensure continued innovative development of drugs for the benefit of society while providing consumers access to such drugs at a fair price. Editorial Board Chairman Rosemary Alito, Vice-Chairman James Hirschhorn and members Andrew Berry and William Dreier recused theselves from participation in the preparation of this editorial.

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