source: Caselaw Access Project

author: Justice Stevens Justice Breyer, Justice Thomas,

license: Public Domain

text:
    JOHNSON v. CALIFORNIA
    No. 04-6964.
    Argued April 18, 2005
    Decided June 13, 2005

      Stephen B. Bedrick, by appointment of the Court, 543 U. S. 1143, argued the cause for petitioner. With him on the briefs was Eric Schnapper.

      Seth K. Schalit, Supervising Deputy Attorney General of California, argued the cause for respondent. With him on the brief were Bill Lockyer, Attorney General, Robert R. Anderson, Chief Assistant Attorney General, Gerald A. Engler, Senior Assistant Attorney General, and Laurence K. Sullivan, Supervising Deputy Attorney General.

        Theodore M. Shaw, Norman J. Chachkin, Miriam Gohara, Christina A Swarns, Steven R. Shapiro, Alan L. Schlosser, Pamela Harris, Barbara R. Arnwine, Michael L. Foreman, Audrey Wiggins, Sarah Crawford, and Barry Sullivan filed a brief for the NAACP Legal Defense and Educational Fund, Inc., et al. as amici curiae urging reversal.

        Kent S. Scheidegger and Charles L. Hobson filed a brief for the Criminal Justice Legal Foundation as amicus curiae urging affirmance.

   Justice Stevens

delivered the opinion of the Court.

The Supreme Court of California and the United States Court of Appeals for the Ninth Circuit have provided conflicting answers to the following question: “Whether to establish a prima facie case under Batson v. Kentucky, 476 U. S. 79 (1986), the objector must show that it is more likely than not that the other party’s peremptory challenges, if unexplained, were based on impermissible group bias?” Pet. for Cert. i. Because both of those courts regularly review the validity of convictions obtained in California criminal trials, respondent, the State of California, agreed to petitioner’s request that we grant certiorari and resolve the conflict. We agree with the Ninth Circuit that the question presented must be answered in the negative, and accordingly reverse the judgment of the California Supreme Court.

I

Petitioner Jay Shawn Johnson, a black male, was convicted in a California trial court of second-degree murder and assault on a white 19-month-old child, resulting in death. During jury selection, a number of prospective jurors were removed for cause until 43 eligible jurors remained, 3 of whom were black. The prosecutor used 3 of his 12 peremptory challenges to remove the black prospective jurors. The resulting jury, including alternates, was all white.

After the prosecutor exercised the second of his three peremptory challenges against the prospective black jurors, defense counsel objected on the ground that the challenge was unconstitutionally based on race under both the California and United States Constitutions. People v. Johnson, 30 Cal. 4th 1302, 1307, 71 P. 3d 270, 272-273 (2003). Defense counsel alleged that the prosecutor “had no apparent reason to challenge this prospective juror ‘other than [her] racial identity.’ ” Ibid, (alteration in original). The trial judge did not ask the prosecutor to explain the rationale for his strikes. Instead, the judge simply found that petitioner had failed to establish a prima facie case under the governing state precedent, People v. Wheeler, 22 Cal. 3d 258, 583 P. 2d 748 (1978), reasoning “ ‘that there’s not been shown a strong likelihood that the exercise of the peremptory challenges were based upon a group rather than an individual basis,’” 30 Cal. 4th, at 1307, 71 P. 3d, at 272 (emphasis added). The judge did, however, warn the prosecutor that “ ‘we are very close.’ ” People v. Johnson, 105 Cal. Rptr. 2d 727, 729 (Ct. App. 2001).

Defense counsel made an additional motion the next day when the prosecutor struck the final remaining prospective black juror. 30 Cal. 4th, at 1307, 71 P. 3d, at 272. Counsel argued that the prosecutor’s decision to challenge all of the prospective black jurors constituted a “systematic attempt to exclude African-Americans from the jury panel.” 105 Cal. Rptr. 2d, at 729. The trial judge still did not seek an explanation from the prosecutor. Instead, she explained that her own examination of the record had convinced her that the prosecutor’s strikes could be justified by race-neutral reasons. Specifically, the judge opined that the black venire members had offered equivocal or confused answers in their written questionnaires. 30 Cal. 4th, at 1307-1308, 71 P. 3d, at 272-273. Despite the fact that “ ‘the Court would not grant the challenges for cause, there were answers ... at least on the questionnaires themselves [such] that the Court felt that there was sufficient basis’ ” for the strikes. Id., at 1308, 71 P. 3d, at 273 (brackets added). Therefore, even considering that all of the prospective black jurors had been stricken from the pool, the judge determined that petitioner had failed to establish a prima facie case.

The California Court of Appeal set aside the conviction. People v. Johnson, 105 Cal. Rptr. 2d 727 (2001). Over the dissent of one judge, the majority ruled that the trial judge had erred by requiring petitioner to establish a “strong likelihood” that the peremptory strikes had been impermissibly based on race. Instead, the trial judge should have only required petitioner to proffer enough evidence to support an “inference” of discrimination. The Court of Appeal’s holding relied on decisions of this Court, prior California case law, and the decision of the United States Court of Appeals for the Ninth Circuit in Wade v. Terhune, 202 F. 3d 1190 (2000). Applying the proper “reasonable inference” standard, the majority concluded that petitioner had produced sufficient evidence to support a prima facie case.

Respondent appealed, and the California Supreme Court reinstated petitioner’s conviction over the dissent of two justices. The court stressed that Batson v. Kentucky, 476 U. S. 79 (1986), left to state courts the task of establishing the standards used to evaluate the sufficiency of defendants’ prima facie cases. 30 Cal. 4th, at 1314, 71 P. 3d, at 277. The court then reviewed Batson, Wheeler, and those decisions’ progeny, and concluded that “Wheeler’s terms ‘strong likelihood’ and ‘reasonable inference’ state the same standard”— one that is entirely consistent with Batson. 30 Cal. 4th, at 1313, 71 P. 3d, at 277. A prima facie case under Batson establishes a “ ‘legally mandatory, rebuttable presumption,’ ” it does not merely constitute “enough evidence to permit the inference” that discrimination has occurred. 30 Cal. 4th, at 1315, 71 P. 3d, at 278. Batson, the court held, “permits a court to require the objector to present, not merely ‘some evidence’ permitting the inference, but ‘strong evidence’ that makes discriminatory intent more likely than not if the challenges are not explained.” 30 Cal. 4th, at 1316, 71 P. 3d, at 278. The court opined that while this burden is “not onerous,” it remains “substantial.” Ibid., 71 P. 3d, at 279.

Applying that standard, the court acknowledged that the case involved the “highly relevant” circumstance that a black defendant was “charged with killing ‘his White girlfriend’s child,’ ” and that “it certainly looks suspicious that all three African-American prospective jurors were removed from the jury.” Id., at 1326, 71 P. 3d, at 286. Yet petitioner’s Batson showing, the court held, consisted “primarily of the statistical disparity of peremptory challenges between African-Americans and others.” 30 Cal. 4th, at 1327, 71 P. 3d, at 287. Although those statistics were indeed “troubling and, as the trial court stated, the question was close,” id., at 1328, 71 P. 3d, at 287, the court decided to defer to the trial judge’s “carefully considered ruling.” Ibid We granted certio-rari, but dismissed the case for want of jurisdiction because the judgment was not yet final. Johnson v. California, 541 U. S. 428 (2004) (per curiam). After the California Court of Appeal decided the remaining issues, we again granted certiorari. 543 U. S. 1042 (2005).

II

The issue in this case is narrow but important. It concerns the scope of the first of three steps this Court enumerated in Batson, which together guide trial courts’ constitutional review of peremptory strikes. Those three Batson steps should by now be familiar. First, the defendant must make out a prima facie case “by showing that the totality of the relevant facts gives rise to an inference of discriminatory purpose.” 476 U. S., at 93-94 (citing Washington v. Davis, 426 U. S. 229, 239-242 (1976)). Second, once the defendant has made out a prima facie case, the “burden, shifts to the State to explain adequately the racial exclusion” by offering permissible race-neutral justifications for the strikes. 476 U. S., at 94; see also Alexander v. Louisiana, 405 U. S. 625, 632 (1972). Third, “[i]f a race-neutral explanation is tendered, the trial court must then decide . . . whether the opponent of the strike has proved purposeful racial discrimination.” Purkett v. Elem, 514 U. S. 765, 767 (1995) (per curiam).

The question before us is whether Batson permits California to require at step one that “the objector must show that it is more likely than not the other party’s peremptory challenges, if unexplained, were based on impermissible group bias.” 30 Cal. 4th, at 1318, 71 P. 3d, at 280. Although we recognize that States do have flexibility in formulating appropriate procedures to comply with Batson, we conclude that California’s “more likely than not” standard is an inappropriate yardstick by which to measure the sufficiency of a prima facie case.

We begin with Batson itself, which on its own terms provides no support for California’s rule. There, we held that a prima facie case of discrimination can be made out by offering a wide variety of evidence, so long as the sum of the proffered facts gives “rise to an inference of discriminatory purpose.” 476 U. S., at 94. We explained:

“[A] defendant may establish a prima facie case of purposeful discrimination in selection of the petit jury solely on evidence concerning the prosecutor’s exercise of peremptory challenges at the defendant’s trial. To establish such a case, the defendant first must show that he is a member of a cognizable racial group, and that the prosecutor has exercised peremptory challenges to remove from the venire members of the defendant’s race. Second, the defendant is entitled to rely on the fact, as to which there can be no dispute, that peremptory challenges constitute a jury selection practice that permits 'those to discriminate who are of a mind to discriminate.’ Finally, the defendant must show that these facts and any other relevant circumstances raise an inference that the prosecutor used that practice to exclude the veniremen from the petit jury on account of their race.” Id., at 96 (quoting Avery v. Georgia, 345 U. S. 559, 562 (1953); citations omitted).

Indeed, Batson held that because the petitioner had timely objected to the prosecutor’s decision to strike “all black persons on the venire,” the trial court was in error when it “flatly rejected the objection without requiring the prosecutor to give an explanation for his action.” 476 U. S., at 100. We did not hold that the petitioner had proved discrimination. Rather, we remanded the case for farther proceedings because the trial court failed to demand an explanation from the prosecutor — i. e., to proceed to Batson’s second step— despite the fact that the petitioner’s evidence supported an inference of discrimination. Ibid.

Thus, in describing the burden-shifting framework, we assumed in Batson that the trial judge would have the benefit of all relevant circumstances, including the prosecutor’s explanation, before deciding whether it was more likely than not that the challenge was improperly motivated. We. did not intend the first step to be so onerous that a defendant, would have to persuade the judge — on the basis of all the facts, some of which are impossible for the defendant to know with certainty — that the challenge was more likely than not the product of purposeful discrimination. Instead, a defendant satisfies the requirements of Batson’s first step by producing evidence sufficient to permit the trial judge to draw an inference that discrimination has occurred.

Respondent, however, focuses on Batson’s ultimate sentence: “If the trial court decides that the facts establish, prima facie, purposeful discrimination and the prosecutor does not come forward with a neutral explanation for his action, our precedents require that petitioner’s conviction be reversed.” Ibid. For this to be true, respondent contends, a Batson claim must prove the ultimate facts by a preponderance of the evidence in the prima facie case; otherwise, the argument goes, a prosecutor’s failure to respond to a prima facie case would inexplicably entitle a defendant to judgment as a matter of law on the basis of nothing more than an inference that discrimination may have occurred. Brief for Respondent 13-18.

Respondent’s argument is misguided. Batson, of course, explicitly stated that the defendant ultimately carries the “burden of persuasion” to “ 'prove the existence of purposeful discrimination.’ ” 476 U. S., at 93 (quoting Whitus v. Georgia, 385 U. S. 545, 550 (1967)). This burden of persuasion “rests with, and never shifts from, the opponent of the strike.” Purkett, 514 U. S., at 768. Thus, even if the State produces only a frivolous or utterly nonsensical justification for its strike, the case does not end — it merely proceeds to step three. Ibid. The first two Batson steps govern the production of evidence that allows the trial court to determine the persuasiveness of the defendant’s constitutional claim. “It is not until the third step that the persuasiveness of the justification becomes relevant — the step in which the trial court determines whether the opponent of the strike has carried his burden of proving purposeful discrimination.” Purkett, 514 U. S., at 768.

Batson’s purposes further support our conclusion. The constitutional interests Batson sought to vindicate are not limited to the rights possessed by the defendant on trial, see 476 U. S., at 87, nor to those citizens who desire to participate “in the administration of the law, as jurors,” Strauder v. West Virginia, 100 U. S. 303, 308 (1880). Undoubtedly, the overriding interest in eradicating discrimination from our civic institutions suffers whenever an individual is excluded from making a significant contribution to governance on account of his race. Yet the “harm from discriminatory jury selection extends beyond that inflicted on the defendant and the excluded juror to touch the entire community. Selection procedures that purposefully exclude black persons from juries undermine public confidence in the fairness of our system of justice.” Batson, 476 U. S., at 87; see also Smith v. Texas, 311 U. S. 128, 130 (1940) (“For racial discrimination to result in the exclusion from jury service of otherwise qualified groups not only violates our Constitution and the laws enacted under it but is at war with our basic concepts of a democratic society and a representative government” (footnote omitted)).

The Batson framework is designed to produce actual answers to suspicions and inferences that discrimination may have infected the jury selection process. See 476 U. S., at 97-98, and n. 20. The inherent uncertainty present in inquiries of discriminatory purpose counsels against engaging in needless and imperfect speculation when a direct answer can be obtained by asking a simple question. See Paulino v. Castro, 371 F. 3d 1083, 1090 (CA9 2004) (“[I]t does not matter that the prosecutor might have had good reasons ...[;] [w]hat matters is the real reason they were stricken” (emphasis deleted)); Holloway v. Horn, 355 F. 3d 707, 725 (CA3 2004) (speculation “does not aid our inquiry into the reasons the prosecutor actually harbored” for a peremptory strike). The three-step process thus simultaneously serves the public purposes Batson is designed to vindicate and encourages “prompt rulings on objections to peremptory challenges without substantial disruption of the jury selection process.” Hernandez v. New York, 500 U. S. 352, 358-359 (1991) (opinion of Kennedy, J.).

The disagreements among the state-court judges who reviewed the record in this case illustrate the imprecision of relying on judicial speculation to resolve plausible claims of discrimination. In this case the inference of discrimination was sufficient to invoke a comment by the trial judge “that 'we are very close,’ ” and on review, the California Supreme Court acknowledged that “it certainly looks suspicious that all three African-American prospective jurors were removed from the jury.” 30 Cal. 4th, at 1307, 1326, 71 P. 3d, at 273, 286. Those inferences that discrimination may have occurred were sufficient to establish a prima facie case under Batson.

The facts of this case well illustrate that California’s “more likely than not” standard is at odds with the prima facie inquiry mandated by Batson. The judgment of the California Supreme Court is therefore reversed, and the case is remanded for further proceedings not inconsistent with this opinion.

It is so ordered

Justice Breyer,

concurring.

I join the Court’s opinion while maintaining here the views I set forth in my concurring opinion in Miller-El v. Dretke, post, p. 266.

Justice Thomas,

dissenting.

The Court says that States “have flexibility in formulating appropriate procedures to comply with Batson [v. Kentucky, 476 U. S. 79 (1986)],” ante, at 168, but it then tells California how to comply with “the prima facie inquiry mandated by Batson,” ante this page. In Batson itself, this Court disclaimed any intent to instruct state courts on how to implement its holding. 476 U. S., at 99 (“We decline, however, to formulate particular procedures to be followed upon a defendant’s timely objection to a prosecutor’s challenges”); id., at 99-100, n. 24. According to Batson, the Equal Protection Clause requires that prosecutors select juries based on factors other than race — not that litigants bear particular burdens of proof or persuasion. Because Batson’s burden-shifting approach is “a prophylactic framework” that polices racially discriminatory jury selection rather than “an independent constitutional command,” Pennsylvania v. Finley, 481 U. S. 551, 555 (1987), States have “wide discretion, subject to the minimum requirements of the Fourteenth Amendment, to experiment with solutions to difficult problems of policy,” Smith v. Robbins, 528 U. S. 259, 278 (2000); Dickerson v. United States, 530 U. S. 428, 438-439 (2000). California’s procedure falls comfortably within its broad discretion to craft its own rules of criminal procedure, and I therefore respectfully dissent.

       Petitioner’s state objection was made under People v. Wheeler, 22 Cal. 3d 258, 583 P. 2d 748 (1978).

       In reaching this holding, the Court of Appeal rejected the notion that a showing of a ‘“strong likelihood’” is equivalent to a “‘reasonable inference.’ ” To conclude so would “be as novel a proposition as the idea that ‘clear and convincing evidence’ has always meant a ‘preponderance of the evidence.’ ” 105 Cal. Rptr. 2d, at 733.

       In dissent, Justice Kennard argued that “[r]equiring a defendant to persuade the trial court of the prosecutor’s discriminatory purpose at the first Wheeler-Batson stage short-circuits the process, and provides inadequate protection for the defendant’s right to a fair trial....” 30 Cal. 4th, at 1333, 71 P. 3d, at 291. The proper standard for measuring a prima facie case under Batson is whether the defendant has identified actions by the prosecutor that, “if unexplained, permit a reasonable inference of an improper purpose or motive.” 30 Cal. 4th, at 1339, 71 P. 3d, at 294. Trial judges, Justice Kennard argued, should not speculate when it is not “apparent that the [neutral] explanation was the true reason for the challenge.” Id., at 1340, 71 P. 3d, at 295.

       An “inference” is generally understood to be a “conclusion reached by considering other facts and deducing a logical consequence from them.” Black’s Law Dictionary 781 (7th ed. 1999).

       In Batson, we spoke of the methods by which prima facie cases could be proved in permissive terms. A defendant may satisfy his prima facie burden, we said, “by relying solely on the facts concerning [the selection of the venire] in his case.” 476 U. S., at 95 (emphasis in original). We declined to require proof of a pattern or practice because “‘[a] single invidiously discriminatory governmental act’ is not ‘immunized by the absence of such discrimination in the making of other comparable decisions.’” Ibid, (quoting Arlington Heights v. Metropolitan Housing Development Corp., 429 U. S. 252, 266, n. 14 (1977)).

       In the unlikely hypothetical in which the prosecutor declines to respond to a trial judge’s inquiry regarding his justification for making a strike, the evidence before the judge would consist not only of the original facts from which the prima facie case was established, but also the prosecutor's refusal to justify his strike in light of the court's request. Such a refusal would provide additional support for the inference of discrimination raised by a defendant’s prima facie case. Cf. United States ex rel. Vajtauer v. Commissioner of Immigration, 273 U. S. 103, 111 (1927).

       This explanation comports with our interpretation of the burden-shifting framework in eases arising under Title VII of the Civil Rights Act of 1964. See, e. g., Furnco Constr. Corp. v. Waters, 438 U. S. 567, 577 (1978) (noting that the McDonnell Douglas Corp. v. Green, 411 U. S. 792 (1973), framework “is merely a sensible, orderly way to evaluate the evidence in light of common experience as it bears on the critical question of discrimination”); see also St. Mary’s Honor Center v. Hicks, 509 U. S. 502, 509-510, and n. 3 (1993) (holding that determinations at steps one and two of the McDonnell Douglas framework “can involve no credibility assessment” because “the burden-of-production determination necessarily precedes the credibility-assessment stage,” and that the burden-shifting framework triggered by a defendant’s prima face case is essentially just "a means of ‘arranging the presentation of evidence’ ” (quoting Watson v. Fort Worth Bank & Trust, 487 U. S. 977, 986 (1988))).


author: Justice O’Connor Justice Souter, Justice Thomas,

text:
    BRADSHAW, WARDEN v. STUMPF
    No. 04-637.
    Argued April 19, 2005
    Decided June 13, 2005

      Douglas R. Cole, State Solicitor of Ohio, argued the cause for petitioner. With him on the briefs were Jim Petro, Attorney General, Diane Richards Brey, Deputy Solicitor, and Charles L. Wille, Henry G. Appel, Stephen E. Maher, and Franklin E. Crawford, Assistant Solicitors.

      Alan M. Freedman, by appointment of the Court, 543 U. S. 1143, argued the cause for respondent. With him on the brief were Carol R. Heise, Laurence E. Komp, Gary Prich-ard, and Michael J. Benza

        Ellen S. Podgor and Joshua L. Dratel filed a brief for the National Association of Criminal Defense Lawyers as amicus curiae urging affirmance.

   Justice O’Connor

delivered the opinion of the Court.

This case concerns respondent John David Stumpf’s conviction and death sentence for the murder of Mary Jane Stout. In adjudicating Stumpf’s petition for a writ of ha-beas corpus, the United States Court of Appeals for the Sixth Circuit granted him relief on two grounds: that his guilty plea was not knowing, voluntary, and intelligent, and that his conviction and sentence could not stand because the State, in a later trial of Stumpf’s accomplice, pursued a theory of the case inconsistent with the theory it had advanced in Stumpf’s case. We granted certiorari to review both holdings. 543 U. S. 1042 (2005).

I

On May 14, 1984, Stumpf and two other men, Clyde Daniel Wesley and Norman Leroy Edmonds, were traveling in Edmonds’ car along Interstate 70 through Guernsey County, Ohio. Needing money for gas, the men stopped the car along the highway. While Edmonds waited in the car, Stumpf and Wesley walked to the home of Norman and Mary Jane Stout, about Í00 yards away. Stumpf and Wesley, each concealing a gun, talked their way into the home by telling the Stouts they needed to use the phone. Their real object, however, was robbery: Once inside, Stumpf held the Stouts at gunpoint, while Wesley ransacked the house. When Mr. Stout moved toward Stumpf, Stumpf shot him twice in the head, causing Mr. Stout to black out. After he regained consciousness, Mr. Stout heard two male voices coming from another room, and then four gunshots — the shots that killed his wife. Edmonds was arrested shortly afterward, and his statements led the police to issue arrest warrants for Stumpf and Wesley. Stumpf, who surrendered to the police, at first denied any knowledge of the crimes. After he was told that Mr. Stout had survived, however, Stumpf admitted to participating in the robbery and to shooting Mr. Stumpf. But he claimed not to have shot Mrs. Stout, and he has maintained that position ever since.

The proceedings against Stumpf occurred while Wesley, who had been arrested in Texas, was still resisting extradition to Ohio. Stumpf was indicted for aggravated murder, attempted aggravated murder, aggravated robbery, and two counts of grand theft. With respect to the aggravated murder charge, the indictment listed four statutory “specifications” — three of them aggravating circumstances making Stumpf eligible for the death penalty. See App. 117-118; Ohio Rev. Code Ann. §2929.03 (Anderson 1982). The case was assigned to a three-judge panel in the Court of Common Pleas.

Rather than proceed to trial, however, Stumpf and the State worked out a plea agreement: Stumpf would plead guilty to aggravated murder and attempted aggravated murder, and the State would drop most of the other charges; with respect to the aggravated murder charge, Stumpf would plead guilty to one of the three capital specifications, with the State dropping the other two. The plea was accepted after a colloquy with the presiding judge, and after a hearing in which the panel satisfied itself as to the factual basis for the plea.

Because the capital specification to which Stumpf pleaded guilty left him eligible for the death penalty, a contested penalty hearing was held before the same three-judge panel. Stumpf’s mitigation case was based in part on his difficult childhood, limited education, dependable work history, youth, and lack of prior serious offenses. Stumpf’s principal argument, however, was that he had participated in the plot only at the urging and under the influence of Wesley, that it was Wesley who had fired the fatal shots at Mrs. Stout, and that Stumpf’s assertedly minor role in the murder counseled against the death sentence. See § 2929.04(B)(6) (directing the sentencer to consider as a potential mitigating circumstance, “[i]f the offender was a participant in the offense but not the principal offender, the degree of the offender’s participation in the offense”). The State, on the other hand, argued that Stumpf had indeed shot Mrs. Stout. Still, while the prosecutor claimed Stumpf’s allegedly primary role in the shooting as a special reason to reject Stumpf’s mitigation argument, the prosecutor also noted that Ohio law did not restrict the death penalty to those who commit murder by their own hands — an accomplice to murder could also receive the death penalty, so long as he acted with the specific intent to cause death. As a result, the State argued, Stumpf deserved death even if he had not personally shot Mrs. Stout, because the circumstances of the robbery provided a basis from which to infer Stumpf’s intent to cause death. The three-judge panel, agreeing with the State’s first contention, specifically found that Stumpf “was the principal offender” in the aggravated murder of Mrs. Stout. App. 196. Determining that the aggravating factors in Stumpf’s case outweighed any mitigating factors, the panel .sentenced Stumpf to death.

Afterward, Wesley was successfully extradited to Ohio to stand trial. His case was tried to a jury, before the same judge who had presided over the panel overseeing Stumpf’s proceedings, and with the same prosecutor. This time, however, the prosecutor had new evidence: James Eastman, Wesley’s cellmate after his extradition, testified that Wesley had admitted to firing the shots that killed Mrs. Stout. The prosecutor introduced Eastman’s testimony in Wesley’s trial, and in his closing argument he argued for Eastman’s credibility and lack of motive to lie. The prosecutor claimed that Eastman’s testimony, combined with certain circumstantial evidence and with the implausibility of Wesley’s own account of events, proved that Wesley was the principal offender in Mrs. Stout’s murder — and that Wesley therefore deserved to be put to death. One way Wesley countered this argument was by noting that the prosecutor had taken a contrary position in Stumpf’s trial, and that Stumpf had already been sentenced to death for the crime. Wesley also took the stand in his own defense, and testified that Stumpf had shot Mrs. Stout. In the end, the jury sentenced Wesley to life imprisonment with the possibility of parole after 20 years.

After the Wesley trial, Stumpf, whose direct appeal was still pending in the Ohio Court of Appeals, returned to the Court of Common Pleas with a motion to withdraw his guilty plea or vacate his death sentence. Stumpf argued that Eastman’s testimony, and the prosecution’s endorsement of that testimony in Wesley’s trial, cast doubt upon Stumpf’s conviction and sentence. The State (represented again by the same prosecutor who had tried both Wesley’s case and Stumpf’s original case) disagreed. According to the prosecutor, the court’s first task was to decide whether the Eastman testimony was sufficient to alter the court’s prior determination that Stumpf had been the shooter. Id., at 210. Contrary to the argument he had presented in the Wesley trial, however, the prosecutor now noted that Eastman’s testimony was belied by certain other evidence (ballistics evidence and Wesley’s testimony in his own defense) confirming Stumpf to have been the primary shooter. In the alternative, the State noted as it had before that an aider-and-abettor theory might allow the death sentence to be imposed against Stumpf even if he had not shot Mrs. Stout.

Although one judge speculated during oral argument that the court’s earlier conclusion about Stumpf’s principal role in the killing “may very well have had an effect upon” the prior sentencing determination, ibid., the Court of Common Pleas denied Stumpf’s motion in a brief summary order without explanation. That order was appealed together with the original judgment in Stumpf’s case, and the Ohio Court of Appeals affirmed, as did the Ohio Supreme Court. State v. Stumpf, 32 Ohio St. 3d 95, 512 N. E. 2d 598 (1987), cert. denied, 484 U. S. 1079 (1988).

After a subsequent request for state postconviction relief was denied by the state courts, Stumpf filed this federal habeas petition in the United States District Court for the Southern District of Ohio in November 1995. The District Court denied Stumpf relief, but granted permission to appeal on four claims, including the two at issue here. The United States Court of Appeals for the Sixth Circuit reversed, concluding that habeas relief was warranted on “either or both” of “two alternative grounds.” Stumpf v. Mitchell, 367 F. 3d 594, 596 (2004). First, the court determined that Stumpf’s guilty plea was invalid because it had not been entered knowingly and intelligently. More precisely, the court concluded that Stumpf had pleaded guilty to aggravated murder without understanding that specific intent to cause death was a necessary element of the charge under Ohio law. See Ohio Rev. Code Ann. §§ 2903.01(B) and (D). Noting that Stumpf had all along denied shooting Mrs. Stout, and considering those denials inconsistent with an informed choice to plead guilty to aggravated murder, the Court of Appeals concluded that Stumpf must have entered his plea out of ignorance. Second, the court concluded that “Stumpf’s due process rights were violated by the state’s deliberate action in securing convictions of both Stumpf and Wesley for the same crime, using inconsistent theories.” 367 F. 3d, at 596. This violation, the court held, required setting aside “both Stumpf’s plea and his sentence.” Id., at 616. One member of the panel dissented.

II

Because Stumpf filed his habeas petition before enactment of the Antiterrorism and Effective Death Penalty Act of 1996 (AEDPA), we review his claims under the standards of the pre-AEDPA habeas statute. See Lindh v. Murphy, 521 U. S. 320 (1997). Moreover, because petitioner has not argued that Stumpf’s habeas claims were barred as requiring announcement of a new rule, we do not apply the rule of Teague v. Lane, 489 U. S. 288 (1989), to this case. See Schiro v. Farley, 510 U. S. 222, 229 (1994); Godinez v. Moran, 509 U. S. 389, 397, n. 8 (1993).

A

The Court of Appeals concluded that Stumpf’s plea of guilty to aggravated murder was invalid because he was not aware of the specific intent element of the charge — a determination we find unsupportable.

Stumpf’s guilty plea would indeed be invalid if he had not been aware of the nature of the charges against him, including the elements of the aggravated murder charge to which he pleaded guilty. A guilty plea operates as a waiver of important rights, and is valid only if done voluntarily, knowingly, and intelligently, “with sufficient awareness of the relevant circumstances and likely consequences.” Brady v. United States, 397 U. S. 742, 748 (1970). Where a defendant pleads guilty to a crime without having been informed of the crime’s elements, this standard is not met and the plea is invalid. Henderson v. Morgan, 426 U. S. 637 (1976).

But the Court of Appeals erred in finding that Stumpf had not been properly informed before pleading guilty. In Stumpf’s plea hearing, his attorneys represented on the record that they had explained to their client the elements of the aggravated murder charge; Stumpf himself then confirmed that this representation was true. See App. 135, 137-138. While the court taking a defendant’s plea is responsible for ensuring “a record adequate for any review that may be later sought,” Boykin v. Alabama, 395 U. S. 238, 244 (1969) (footnote omitted), we have never held that the judge must himself explain the elements of each charge to the defendant on the record. Rather, the constitutional prerequisites of a valid plea may be satisfied where the record accurately reflects that the nature of the charge and the elements of the crime were explained to the defendant by his own, competent counsel. Cf. Henderson, supra, at 647 (granting relief to a defendant unaware of the elements of his crime, but distinguishing that case from others where “the record contains either an explanation of the charge by the trial judge, or at least a representation by defense counsel that the nature of the offense has been explained to the accused”). Where a defendant is represented by competent counsel, the court usually may rely on that counsel’s assurance that the defendant has been properly informed of the nature and elements of the charge to which he is pleading guilty.

Seeking to counter this natural inference, Stumpf argues, in essence, that his choice to plead guilty to the aggravated murder charge was so inconsistent with his denial of having shot the victim that he could only have pleaded guilty out of ignorance of the charge’s specific intent requirement. But Stumpf’s asserted inconsistency is illusory. The aggravated murder charge’s intent element did not require any showing that Stumpf had himself shot Mrs. Stout. Rather, Ohio law considers aiders and abettors equally in violation of the aggravated murder statute, so long as the aiding and abetting is done with the specific intent to cause death. See In re Washington, 81 Ohio St. 3d 337, 691 N. E. 2d 285 (1998); State v. Scott, 61 Ohio St. 2d 155, 165, 400 N. E. 2d 375, 382 (1980). As a result, Stumpf’s steadfast assertion that he had not shot Mrs. Stout would not necessarily have precluded him from admitting his specific intent under the statute.

That is particularly so given the other evidence in this case. Stumpf and Wesley had gone to the Stouts’ home together, carrying guns and intending to commit armed robbery. Stumpf, by his own admission, shot Mr. Stout in the head at close range. Taken together, these facts could show that Wesley and Stumpf had together agreed to kill both of the Stouts in order to leave no witnesses to the crime. And that, in turn, could make both men guilty of aggravated murder regardless of who actually killed Mrs. Stout. See ibid.

Stumpf also points to aspects of the plea hearing transcript which he says show that both he and his attorneys were confused about the relevance and timing of defenses Stumpf and his attorneys had planned to make. First, at one point during the hearing, the presiding judge stated that by pleading guilty Stumpf would waive his trial rights and his right to testify in his own behalf. Stumpf’s attorney answered that Stumpf “was going to respond but we have informed him that there is, after the plea, a hearing or trial relative to the underlying facts so that he is of the belief that there will be [a] presentation of evidence.” App. 140. The presiding judge responded that “[o]f course in the sentencing portion of this trial you do have those rights to speak in your own behalf [and] to present evidence and testimony on your own behalf.” Ibid. A few moments later, there was another exchange along similar lines, after the judge asked Stumpf whether he was “in fact guilty of” the aggravated murder charge and its capital specification:

“[DEFENSE COUNSEL]:... Your Honor, the defendant has asked me to explain his answer. His answer is yes. He will recite that with obviously his understanding of his right to present evidence at a later time relative to his conduct, but he’ll respond to that.
“JUDGE HENDERSON: At no time am I implying that the defendant will not have the right to present evidence in [the] mitigation hearing .... And I’m going to ask that the defendant, himself, respond to the question that I asked with that understanding that he has the right to present evidence in mitigation. I’m going to ask the defendant if he is in fact guilty of the charge set forth in Count one, including specification one ... ?
“THE DEFENDANT: Yes, sir.” Id., at 142.

Reviewing this exchange, the Court of Appeals concluded that Stumpf “obviously... was reiterating his desire to challenge the [S]tate’s account of his actions” — that is, to show that he did not intend to kill Mrs. Stout. 367 F. 3d, at 607. But the desire to contest the State’s version of events would not necessarily entail the desire to contest the aggravated murder charge or any of its elements. Rather, Stumpf’s desire to put on evidence “relative to the underlying facts” and “relative to his conduct” could equally have meant that Stumpf was eager to make his mitigation case — an interpretation bolstered by the attorney’s and Stumpf’s approving answers after the presiding judge confirmed that the defense could put on evidence “in mitigation” and in “the sentencing” phase. While Stumpf’s mitigation case was premised on the argument that Stumpf had not shot Mrs. Stout, that was fully consistent with his plea of guilty to aggravated murder. See supra, at 183-184.

Finally, Stumpf, like the Court of Appeals, relies on the perception that he obtained a bad bargain by his plea — that the State’s dropping several nonmurder charges and two of the three capital murder specifications was a bad tradeoff for Stumpf’s guilty plea. But a plea’s validity may not be collaterally attacked merely because the defendant made what turned out, in retrospect, to be a poor deal. See Brady, 397 U. S., at 757; Mabry v. Johnson, 467 U. S. 504, 508 (1984). Rather, the shortcomings of the deal Stumpf obtained east doubt on the validity of his plea only if they show either that he made the unfavorable plea on the constitutionally defective advice of counsel, see Tollett v. Henderson, 411 U. S. 258, 267 (1973), or that he could not have understood the terms of the bargain he and Ohio agreed to. Though Stumpf did bring an independent claim asserting ineffective assistance of counsel, that claim is not before us in this case. And in evaluating the validity of Stumpf’s plea, we are reluctant to accord much weight to his post hoc reevaluation of the wisdom of the bargain. Stumpf pleaded guilty knowing that the State had copious evidence against him, including the testimony of Mr. Stout; the plea eliminated two of the three capital specifications the State could rely on in seeking the death penalty; and the plea allowed Stumpf to assert his acceptance of responsibility as an argument in mitigation. Under these circumstances, the plea may well have been a knowing, voluntary, and intelligent reaction to a litigation situation that was difficult, to say the least. The Court of Appeals erred in concluding that Stumpf was uninformed about the nature of the charge he pleaded guilty to, and we reverse that portion of the judgment below.

B

The Court of Appeals was also wrong to hold that prosecu-torial inconsistencies between the Stumpf and Wesley cases required voiding Stumpf’s guilty plea. Stumpf’s assertions of inconsistency relate entirely to the prosecutor’s arguments about which of the two men, Wesley or Stumpf, shot Mrs. Stout. For the reasons given above, see supra, at 183-184, the precise identity of the triggerman was immaterial to Stumpf’s conviction for aggravated murder. Moreover, Stumpf has never provided an explanation of how the prosecution’s postplea use of inconsistent arguments could have affected the knowing, voluntary, and intelligent nature of his plea.

The prosecutor’s use of allegedly inconsistent theories may have a more direct effect on Stumpf’s sentence, however, for it is at least arguable that the sentencing panel’s conclusion about Stumpf’s principal role in the offense was material to its sentencing determination. The opinion below leaves some ambiguity as to the overlap between how the lower court resolved Stumpf’s due process challenge to his conviction, and how it resolved Stumpf’s challenge to his sentence. It is not clear whether the Court of Appeals would have concluded that Stumpf was entitled to resentencing had the court not also considered the conviction invalid. Likewise, the parties’ briefing to this Court, and the question on which we granted certiorari, largely focused on the lower court’s determination about Stumpf’s conviction. See, e. g., Pet. for Cert, ii (requesting review of Stumpf’s conviction, not sentence); Reply Brief for Petitioner 3 (challenge to Court of Appeals’ decision is focused on issue of conviction); Brief for Respondent 15, n. 3 (“arguments regarding Stumpf’s death sentence are not before this Court”). In these circumstances, it would be premature for this Court to resolve the merits of Stumpf’s sentencing claim, and we therefore express no opinion on whether the prosecutor’s actions amounted to a due process violation, or whether any such violation would have been prejudicial. The Court of Appeals should have the opportunity to consider, in the first instance, the question of how Eastman’s testimony and the prosecutor’s conduct in the Stumpf and Wesley cases relate to Stumpf’s death sentencé in particular. Accordingly, we vacate the portion of the judgment below relating to Stumpf’s prosecutorial inconsistency claim, and we remand the case for further proceedings consistent with this opinion.

It is so ordered.

Justice Souter,

with whom Justice Ginsburg joins,

concurring.

I join the opinion of the Court and add this word to explain the issue that I understand we are remanding for further consideration. As the Court notes in its opinion, although respondent John Stumpf challenged both his conviction and his death sentence, his attack on the sentence was not always distinct from the issue raised about the conviction.

I understand Stumpf to claim that it violates the basic due process standard, barring fundamentally unfair procedure, to allow his death sentence to stand in the aftermath of three positions taken by the State: (1) at Stumpf’s sentencing hearing; (2) at the trial of Stumpf’s codefendant, Clyde Wesley; and (8) in response to Stumpf’s motion to withdraw his guilty plea in light of the State’s position at the Wesley trial. At the hearing on Stumpf’s sentence, the State argued that he was the triggerman, and it urged consideration of that fact as a reason to impose a death sentence. App. 186,188-189. The trial court found that Stumpf had pulled the trigger and did sentence him to death, though it did not state that finding Stumpf to be the shooter was dispositive in determining the sentence. App. to Pet. for Cert. 219a. After the sentencing proceeding was over, the State tried the codefendant, Wesley, and on the basis of testimony from a new witness argued that Wesley was in fact the triggerman, App. 282, and should be sentenced to death. The new witness was apparently unconvincing to the jury, which in any event was informed that Stumpf had already been sentenced to death for the crime; the jury rejected the specification that named Wesley as the triggerman, and it recommended a sentence of life, not death. Stumpf then challenged his death sentence (along with his conviction) on the basis of the prosecution’s position in the Wesley case. In response, the State did not repudiate the position it had taken in the codefendant’s case, or explain that it had made a mistake there. Instead, it merely dismissed the testimony of the witness it had vouched for at Wesley’s trial, id., at 125, and maintained that Stumpf’s death sentence should stand for some or all of the reasons it originally argued for its imposition. At the end of the day, the State was on record as maintaining that Stumpf and Wesley should both be executed on the ground that each was the triggerman, when it was undisputed that only one of them could have been.

Stumpf’s claim as I understand it is not a challenge to the evidentiary basis for arguing for the death penalty in either case; nor is it a claim that the prosecution deliberately deceived or attempted to deceive either trial court, as in Mooney v. Holohan, 294 U. S. 103 (1935) (per curiam); nor does it implicate the rule that inconsistent jury verdicts may be enforced, United States v. Powell, 469 U. S. 57 (1984); Dunn v. United States, 284 U. S. 390 (1932). As I see it, Stumpf’s argument is simply that a death sentence may not be allowed to stand when it was imposed in response to a factual claim that the State necessarily contradicted in subsequently arguing for a death sentence in the case of a co-defendant. Stumpf’s position was anticipated by Justice Stevens’s observation 10 years ago that “serious questions are raised when the sovereign itself takes inconsistent positions in two separate criminal proceedings against two of its citizens,” and that “[t]he heightened need for reliability in capital cases only underscores the gravity of those questions ....” Jacobs v. Scott, 513 U. S. 1067, 1070 (1995) (citations and internal quotation marks omitted). Justice Stevens’s statement in turn echoed the more general one expressed by Justice Sutherland in Berger v. United States, 295 U. S. 78, 88 (1935), that the State’s interest in winning some point in a given case is transcended by its interest “that justice shall be done.” Ultimately, Stumpf’s argument appears to be that sustaining a death sentence in circumstances like those here results in a sentencing system that invites the death penalty “to be ... wantonly and ... freakishly imposed.” Lewis v. Jeffers, 497 U. S. 764, 774 (1990) (quoting Gregg v. Georgia, 428 U. S. 153, 188 (1976) (joint opinion of Stewart, Powell, and Stevens, JJ.); internal quotation marks omitted).

If a due process violation is found in the State’s maintenance of such inconsistent positions, there will be remedial questions. May the death sentence stand if the State declines to repudiate its inconsistent position in the codefend-ant’s case? Would it be sufficient simply to reexamine the original sentence and if so, which party should have the burden of persuasion? If more would be required, would a de novo sentencing hearing suffice?

Justice Thomas,

with whom Justice Scalia joins,

concurring.

I join the Court’s opinion. As the Court notes, the State has not argued that Teague v. Lane, 489 U. S. 288 (1989), forecloses Stumpf’s claim that the prosecution’s presentation of inconsistent theories violated his right to due process. Ante, at 182. With certain narrow exceptions, Teague precludes federal courts from granting habeas petitioners relief on the basis of “new” rules of constitutional law established after their convictions become final. 489 U. S., at 310 (plurality opinion). This Court has never hinted, much less held, that the Due Process Clause prevents a State from prosecuting defendants based on inconsistent theories. Moreover, it is “[a] threshold question in every habeas case ... whether the court is obligated to apply the Teague rule to the defendant’s claim,” and “if the State does argue that the defendant seeks the benefit of a new rule of constitutional law, the court must apply Teague before considering the merits of the claim.” Horn v. Banks, 536 U. S. 266, 271 (2002) (per curiam) (internal quotation marks omitted). The State also has not argued that Stumpf procedurally defaulted his due process claim, even though it appears that Stumpf never presented this argument to the Ohio courts. Stumpf did not even raise the inconsistent-theories claim in his first federal habeas filings. See App. to Pet. for Cert. 134a-140a. Instead, the District Court raised the issue for Stumpf sua sponte, and ordered supplemental briefing on the point. See App. 97-98. The Court’s opinion does not preclude the State from advancing either of these procedural defenses on remand in support of Stumpf’s death sentence.

Moreover, I agree with the Court that “Stumpf has never provided an explanation of how the prosecution’s postplea use of inconsistent arguments could have affected the knowing, voluntary, and intelligent nature of his plea.” Ante, at 187. Similar reasoning applies to Stumpf’s sentence. Stumpf equally has never explained how the prosecution’s use of postsentence inconsistent arguments — which were based on evidence unavailable until after Stumpf was sentenced — could have affected the reliability or procedural fairness of his death sentence. At most, the evidence and purportedly inconsistent theory presented at Wesley’s trial would constitute newly discovered evidence casting doubt on the reliability of Stumpf’s death sentence, a sort of claim that our precedents and this Nation’s traditions have long foreclosed, see Herrera v. Collins, 506 U. S. 390, 408-417 (1993); id., at 427-428 (Scalia, J., concurring). The Bill of Rights guarantees vigorous adversarial testing of guilt and innocence and conviction only by proof beyond a reasonable doubt. These guarantees are more than sufficient to deter the State from taking inconsistent positions; a prosecutor who argues inconsistently risks undermining his case, for opposing counsel will bring the conflict to the factfinder’s attention. See ante, at 188 (Souter, J., concurring) (noting that Wesley’s jury was informed that Stumpf had already been sentenced to death for the crime).

       Unless otherwise noted, all citations to Ohio statutes refer to the versions of those statutes in effect in 1984, at the time of the crime and trial.


author: Justice Scalia

text:
    MERCK KGaA v. INTEGRA LIFESCIENCES I, LTD., et al.
    No. 03-1237.
    Argued April 20, 2005
    Decided June 13, 2005

      E. Joshua Rosenkranz argued the cause for petitioner. With him on the briefs were M. Patricia Thayer, James N. Czaban, and Donald R. Dunner.

      Daryl Joseffer argued the cause for the United States as amicus curiae in support of petitioner. With him on the brief were Acting Solicitor General Clement, Assistant Attorney General Keisler, Deputy Solicitor General Hungar, Douglas N. Letter, Mark S. Davies, Alex M. Azar II, Richard Lambert, John M. Whealan, and Heather F. Auyang.

      Mauricio A. Flores argued the cause for respondents. With him on the brief were Raphael V Lupo, Cathryn Campbell, Mark G. Davis, M. Miller Baker, Richard B. Rogers, and David M. Beckwith.

      Briefs of amici curiae urging reversal were filed for AARP by Sarah Lem Lock, Bruce Vignery, and Michael Schuster; for Eli Lilly and Co. et al. by James J. Kelley, Thomas G. Plant, and John A Cleveland, Jr.; for Eon Labs, Inc., by Shashank Upadhye; for Genenteeh, Inc., et al. by Carter G. Phillips, Virginia A Seitz, Jeffrey P. Kushan, and Gary H. Loeb; for the New York Intellectual Property Law Association by David F. Ryan; and for Pharmaceutical Research and Manufacturers of America by Roderick R. McKelvie and Brooks Mackintosh.

      Briefs of amici curiae urging affirmance were filed for Applera Corp. et al. by Edward R. Reines; for Benitec Australia Ltd. by Eric A. Ku-wana, Marc R. Labgold, and Kevin M. Bell; for Invitrogen Corp. et al. by Drew S. Days III, Beth S. Brinkmann, Seth M. Galanter, David C. Doyle,
        and Andrea L. Gross; for Vaccinex, Inc., by Kenneth C. Bass HI and Linda Alcorn; and for the Wisconsin Alumni Research Foundation et al. by Rolf O. Stadheim and George C. Summerfield.

      Briefs of amici curiae were filed for the American Intellectual Property Law Association by Donald R. Ware, Denise W. DeFranco, and Melvin C. Gamer; for the Biotechnology Industry Organization by Richard J. Oparil; for the Consumer Project on Technology et al. by Joshua D. Sar-nojf; for Intellectual Property Professors by John Fitzgerald Duffy and Katherine J. Strandburg; for the Patent, Trademark & Copyright Section of the Bar Association of the District of Columbia by Lynn E. Eccleston and Susan M. Dadio; for the San Diego Intellectual Property Law Association by Madison C. Jellins, Doug E. Olson, and John E. Peterson; and for Sepracor Inc. by Kenneth J. Burchfiel and Michael R. Dzwonczyk.

   Justice Scalia

delivered the opinion of the Court.

This ease presents the question whether uses of patented inventions in preclinieal research, the results of which are not ultimately included in a submission to the Food and Drug Administration (FDA), are exempted from infringement by 35 U. S. C. § 271(e)(1).

I

It is generally an act of patent infringement to “mak[e], us[e], offe[r] to sell, or sel[l] any patented invention ... during the term of the patent therefor.” § 271(a). In 1984, Congress enacted an exemption to this general rule, see Drug Price Competition and Patent Term Restoration Act of 1984, § 202, 98 Stat. 1585, as amended, 35 U. S. C. § 271(e)(1), which provides:

“It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention (other than a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Act of March 4,1913). ..) solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs ....”

The Federal Food, Drug, and Cosmetic Act (FDCA), ch. 675, 52 Stat. 1040, as amended, 21 U. S. C. § 301 et seq., is “a Federal law which regulates the manufacture, use, or sale of drugs.” See § 355(a); Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 665-666, 674 (1990). Under the FDCA, a drugmaker must submit research data to the FDA at two general stages of new-drug development. First, a drug-maker must gain authorization to conduct clinical trials (tests on humans) by submitting an investigational new drug application (IND). See 21 U. S. C. §355(i); 21 CFR §312.1 et seq. (2005). The IND must describe “preclinical tests (including tests on animals) of [the] drug adequate to justify the proposed clinical testing.” 21 U.S. C. §355(i)(l)(A); see 21 CFR §§ 312.23(a)(5) and (a)(8) (specifying necessary information from preclinical tests). Second, to obtain authorization to market a new drug, a drugmaker must submit a new drug application (NDA), containing “full reports of investigations which have been made to show whether or not [the] drug is safe for use and whether [the] drug is effective in use.” 21 U. S. C. § 355(b)(1). Pursuant to FDA regulations, the NDA must include all clinical studies, as well as preclinical studies related to a drug’s efficacy, toxicity, and pharmacological properties. See 21 CFR §§ 314.50(d)(2) (preclinical studies) and (d)(5) (clinical studies).

a

í>

Respondents, Integra Lifesciences I, Ltd., and the Burn-ham Institute, own five patents related to the tripeptide sequence Arg-Gly-Asp, known in single-letter notation as the “RGD peptide.” U. S. Patent Nos. 4,988,621, 4,792,525, 5,695,997, 4,879,237, and 4,789,734, Supp. App. SA11-SA19. The RGD peptide promotes cell adhesion by attaching to oc^ integrins, receptors commonly located on the outer surface of certain endothelial cells. 331 F. 3d 860, 862-863 (CA Fed. 2003).

Beginning in 1988, petitioner Merck KGaA provided funding for angiogenesis research conducted by Dr. David Cheresh at the Scripps Research Institute (Scripps). Telios Pharmaceuticals v. Merck KGaA, Case No. 96-CV-1307 (SD Cal., Sept. 9, 1997), App. 30a. Angiogenesis is the process by which new blood vessels sprout from existing vessels; it plays a critical role in many diseases, including solid tumor cancers, diabetic retinopathy, and rheumatoid arthritis. 331 F. 3d, at 863. In the course of his research, Dr. Cheresh discovered that it was possible to inhibit angiogenesis by blocking the 0^3 integrins on proliferating endothelial cells. Ibid. In 1994, Dr. Cheresh succeeded in reversing tumor growth in chicken embryos, first using a monoclonal antibody (LM609) he developed himself and later using a cyclic RGD peptide (EMD 66203) provided by petitioner. App. 190a. Dr. Cheresh’s discoveries were announced in leading medical journals and received attention in the general media. See Altman, Scientists Report Finding a Way to Shrink Tumors, N. Y. Times, Dec. 30, 1994, p. Al; Brooks et al., Integrin ctyPg Antagonists Promote Tumor Regression by Inducing Apoptosis of Angiogenic Blood Vessels, 79 Cell 1157 (Bee. 30, 1994); Brooks, Clark, & Cheresh, Requirement of Vascular Integrin for Angiogenesis, 264 Science 569 (Apr. 22, 1994).

With petitioner’s agreement to fund research at Scripps due to expire in July 1995, Dr. Cheresh submitted a detailed proposal for expanded collaboration between Scripps and petitioner on February 1, 1995. App. 95a-107a. The proposal set forth a 3-year timetable in which to develop “inte-grin antagonists as angiogenesis inhibitors,” id., at 105a, beginning with in vitro and in vivo testing of RGD peptides at Scripps in year one and culminating with the submission of an IND to the FDA in year three, id., at 106a-107a. Petitioner agreed to the material terms of the proposal on February 20,1995, id., at 124a-125a, and on April 13,1995, pledged $6 million over three years to fund research at Scripps, id., at 126a. Petitioner’s April 13 letter specified that Scripps would be responsible for testing RGD peptides produced by petitioner as potential drug candidates but that, once a primary candidate for clinical testing was in “the pipeline,” petitioner would perform the toxicology tests necessary for FDA approval to proceed to clinical trials. Id., at 127a; see 21 CFR § 312.23(a)(8)(iii) (2005) (requirement that “nonelinical laboratory study” include a certification that it was performed under good laboratory practices); see also § 58.3(d) (2004) (defining “[njonclinical laboratory study”). Scripps and petitioner concluded an agreement of continued collaboration in September 1995. Case No. 96-CV-1307, App. 31a.

Pursuant to the agreement, Dr. Cheresh directed in vitro and in vivo experiments on RGD peptides provided by petitioner from 1995 to 1998. These experiments focused on EMD 66203 and two closely related derivatives, EMD 85189 and EMD 121974, and were designed to evaluate the suitability of each of the peptides as potential drug candidates. 331 F. 3d, at 863. Accordingly, the tests measured the efficacy, specificity, and toxicity of the particular peptides as angio-genesis inhibitors, and evaluated their mechanism of action and pharmacokinetics in animals. Ibid. Based on the test results, Scripps decided in 1997 that EMD 121974 was the most promising candidate for testing in humans. Ibid. Over the same period, Scripps performed similar tests on LM609, a monoclonal antibody developed by Dr. Cheresh. App. 277a, 285a-298a. Scripps also conducted more basic research on organic mimeties designed to block o^Pg inte-grins in a manner similar to the RGD peptides, id., at 223a-224a; it appears that Scripps used the RGD peptides in these tests as “positive controls” against which to measure the efficacy of the mimeties, id., at 188a.

In November 1996, petitioner initiated a formal project to guide one of its RGD peptides through the regulatory approval process in the United States and Europe. Id., at 129a. Petitioner originally directed its efforts at EMD 85189, but switched focus in April 1997 to EMD 121974. Case No. 96-CV-1307, App. 31a. Petitioner subsequently discussed EMD 121974 with officials at the FDA. Id., at 397a. In October 1998, petitioner shared its research on RGD peptides with the National Cancer Institute (NCI), which agreed to sponsor clinical trials. Id., at 214a-217a. Although the fact was excluded from evidence at trial, the lower court’s opinion reflects that NCI filed an IND for EMD 121974 in 1998. 331 F. 3d, at 874 (Newman, J., dissenting).

Opinion of the Court

B

On July 18, 1996, respondents filed a patent-infringement suit against petitioner, Scripps, and Dr. Cheresh in the District Court for the Southern District of California. Respondents’ complaint alleged that petitioner willfully infringed and induced others to infringe respondents’ patents by supplying the RGD peptide to Scripps, and that Dr. Cheresh and Scripps infringed the same patents by using the RGD peptide in experiments related to angiogenesis. Respondents sought damages from petitioner and a declaratory judgment against Dr. Cheresh and Scripps. Id., at 863. Petitioner answered that its actions involving the RGD peptides did not infringe respondents’ patents, and that in any event they were protected by the common-law research exemption and 35 U. S. C. § 271(e)(1). 331 F. 3d, at 863.

At the conclusion of trial, the District Court held that, with one exception, petitioner’s pre-1995 actions related to the RGD peptides were protected by the common-law research exemption, but that a question of fact remained as to whether petitioner’s use of the RGD peptides after 1995 fell within the § 271(e)(1) safe harbor. With the consent of the parties, the District Court gave the following instruction regarding the § 271(e)(1) exemption:

“To prevail on this defense, [petitioner] must prove by a preponderance of the evidence that it would be objectively reasonable for a party in [petitioner’s] and Scripps’ situation to believe that there was a decent prospect that the accused activities would contribute, relatively directly, to the generation of the kinds of information that are likely to be relevant in the processes by which the FDA would decide whether to approve the product in question.
“Each of the accused activities must be evaluated separately to determine whether the exemption applies.
“[Petitioner] does not need to show that the information gathered from a particular activity was actually submitted to the FDA.” App. 57a (one paragraph break omitted).

The jury found that petitioner, Dr. Cheresh, and Scripps infringed respondents’ patents and that petitioner had failed to show that its activities were protected by § 271(e)(1). It awarded damages of $15 million.

In response to post-trial motions, the District Court dismissed respondents’ suit against Dr. Cheresh and Scripps, but affirmed the jury’s damages award as supported by substantial evidence, Civ. Action No. 961307 JMF (SD Cal., Mar. 26, 2001), App. to Pet. for Cert. 52a, and denied petitioner’s motion for judgment as a matter of law, Civ. Action No. 96CV-1307 JMF (SD Cal., Mar. 6, 2001), App. to Pet. for Cert. 50a. With respect to the last, the District Court explained that the evidence was sufficient to show that “any connection between the infringing Scripps experiments and FDA review was insufficiently direct to qualify for the [§ 271(e)(1) exemption].” Id., at 49a.

A divided panel of the Court of Appeals for the Federal Circuit affirmed in part and reversed in part. The panel majority affirmed the denial of judgment as a matter of law to petitioner, on the ground that §271(e)(l)’s safe harbor did not apply because “the Scripps work sponsored by [petitioner] was not clinical testing to supply information to the FDA, but only general biomedical research to identify new pharmaceutical compounds.” 331 F. 3d, at 866. It reversed the District Court’s refusal to modify the damages award and remanded for further proceedings. Id., at 872. Judge Newman dissented on both points. See id., at 874, 877. The panel unanimously affirmed the District Court’s ruling that respondents’ patents covered the cyclic RGD peptides developed by petitioner. Id., at 868-869; id., at 873, n. 7 (Newman, J., dissenting). We granted certiorari to review the Court of Appeals’ construction of § 271(e)(1). 543 U. S. 1041 (2004).

Ill

As described earlier, 35 U. S. C. § 271(e)(1) provides that “[i]t shall not be an act of infringement to . . . use ... or import into the United States a patented invention ... solely for uses reasonably related to the development and submission of information under a Federal law which regulates the ... use ... of drugs.” Though the contours of this provision are not exact in every respect, the statutory text makes clear that it provides a wide berth for the use of patented drugs in activities related to the federal regulatory process.

As an initial matter, we think it apparent from the statutory text that §271(e)(l)’s exemption from infringement extends to all uses of patented inventions that are reasonably related to the development and submission of any information under the FDCA. Cf. Eli Lilly, 496 U. S., at 665-669 (declining to limit §271(e)(l)’s exemption from infringement to submissions under particular statutory provisions that regulate drugs). This necessarily includes preclinical studies of patented compounds that are appropriate for submission to the FDA in the regulatory process. There is simply no room in the statute for excluding certain information from the exemption on the basis of the phase of research in which it is developed or the particular submission in which it could be included.

Respondents concede the breadth of § 271(e)(1) in this regard, but argue that the only preclinical data of interest to the FDA is that which pertains to the safety of the drug in humans. In respondents’ view, preclinical studies related to a drug’s efficacy, mechanism of action, pharmacokinetics, and pharmacology are not reasonably included in an IND or an NDA, and are therefore outside the scope of the exemption. We do not understand the FDA’s interest in information gathered in preclinical studies to be so constrained. To be sure, its regulations provide that the agency’s “primary objectives in reviewing an IND are ... to assure the safety and rights of subjects,” 21 CFR § 312.22(a) (2005), but it does not follow that the FDA is not interested in reviewing information related to other characteristics of a drug. To the contrary, the FDA requires that applicants include in an IND summaries of the pharmacological, toxicological, pharmaco-kinetic, and biological qualities of the drug in animals. See § 312.23(a)(5); U. S. Dept, of Health and Human Services, Guidance for Industry, Good Clinical Practice: Consolidated Guidance 45 (Apr. 1996) (“The results of all relevant nonclinical pharmacology, toxicology, pharmacokinetic, and investi-gational product metabolism studies should be provided in summary form. This summary should address the methodology used, the results, and a discussion of the relevance of the findings to the investigated therapeutic and the possible unfavorable and unintended effects in humans”). The primary (and, in some cases, only) way in which a drugmaker may obtain such information is through preclinical in vitro and in vivo studies.

Moreover, the FDA does not evaluate the safety of proposed clinical experiments in a vacuum; rather, as the statute and regulations reflect, it asks whether the proposed clinical trial poses an “unreasonable risk.” 21 U. S. C. § 355(i)(3)(B)(i); see also 21 CFR § 312.23(a)(8) (2005) (requiring applicants to include pharmacological and toxicological studies that serve as the basis of their conclusion that clinical testing would be “reasonably safe”); § 56.111(a)(2) (2004) (providing that the Institutional Review Boards that oversee clinical trials must consider whether the “[r]isks to subjects are reasonable in relation to anticipated benefits”). This assessment involves a comparison of the risks and the benefits associated with the proposed clinical trials. As the Government’s brief, filed on behalf of the FDA, explains, the “FDA might allow clinical testing of a drug that posed significant safety concerns if the drug had a sufficiently positive potential to address a serious disease, although the agency would not accept similar risks for a drug that was less likely to succeed or that would treat a less serious medical condition.” Brief for United States as Amicus Curiae 10. Accordingly, the FDA directs that an IND must provide sufficient information for the investigator to “make his/her own unbiased risk-benefit assessment of the appropriateness of the proposed trial.” Guidance for Industry, supra, at 43. Such information necessarily includes preclinical studies of a drug’s efficacy in achieving particular results.

Respondents contend that, even accepting that the FDA is interested in preclinical research concerning drug characteristics other than safety, the experiments in question here are necessarily disqualified because they were not conducted in conformity with the FDA’s good laboratory practices regulations. This argument fails for at least two reasons. First, the FDA’s requirement that preclinical studies be conducted under “good laboratory practices” applies only to experiments on drugs “to determine their safety,” 21 CFR § 58.3(d) (2004). See § 58.1(a); § 312.23(a)(8)(iii) (2005) (only “nonclinical laboratory study subject to the good laboratory practice regulations under part 58” must certify compliance with good laboratory practice regulations). The good laboratory practice regulations do not apply to preclinical studies of a drug’s efficacy, mechanism of action, pharmacology, or phar-macokinetics. Second, FDA regulations do not provide that even safety-related experiments not conducted in compliance with good laboratory practices regulations are not suitable for submission in an IND. Rather, such studies must include “a brief statement of the reason for the noncompliance.” Ibid.

The Court of Appeals’ conclusion that § 271(e)(1) did not protect petitioner’s provision of the patented RGD peptides for research at Scripps appeared to rest on two somewhat related propositions. First, the court credited the fact that the “Scripps-Merck experiments did not supply information for submission to the [FDA], but instead identified the best drug candidate to subject to future clinical testing under the FDA processes.” 331 F. 3d, at 865; see also id., at 866 (similar). The court explained:

“The FDA has no interest in the hunt for drugs that may or may not later undergo clinical testing for FDA approval. For instance, the FDA does not require information about drugs other than the compound featured in an [IND] application. Thus, the Scripps work sponsored by [petitioner] was not ‘solely for uses reasonably related’ to clinical testing for FDA.” Ibid.

Second, the court concluded that the exemption “does not globally embrace all experimental activity that at some point, however attenuated, may lead to an FDA approval process.” Id., at 867.

We do not quibble with the latter statement. Basic scientific research on a particular compound, performed without the intent to develop a particular drug or a reasonable belief that the compound will cause the sort of physiological effect the researcher intends to induce, is surely not “reasonably related to the development and submission of information” to the FDA. It does not follow from this, however, that §271(e)(l)’s exemption from infringement categorically excludes either (1) experimentation on drugs that are not ultimately the subject of an FDA submission or (2) use of patented compounds in experiments that are not ultimately submitted to the FDA. Under certain conditions, we think the exemption is sufficiently broad to protect the use of patented compounds in both situations.

As to the first proposition, it disregards the reality that, even at late stages in the development of a new drug, scientific testing is a process of trial and error. In the vast majority of cases, neither the drugmaker nor its scientists have any way of knowing whether an initially promising candidate will prove successful over a battery of experiments. That is the reason they conduct the experiments. Thus, to construe § 271(e)(1), as the Court of Appeals did, not to protect research conducted on patented compounds for which an IND is not ultimately filed is effectively to limit assurance of exemption to the activities necessary to seek approval of a generic drug: One can know at the outset that a particular compound will be the subject of an eventual application to the FDA only if the active ingredient in the drug being tested is identical to that in a drug that has already been approved.

The statutory text does not require such a result. Congress did not limit §271(e)(l)’s safe harbor to the development of information for inclusion in a submission to the FDA; nor did it create an exemption applicable only to the research relevant to filing an ANDA for approval of a generic drug. Rather, it exempted from infringement all uses of patented compounds “reasonably related” to the process of developing information for submission under any federal law regulating the manufacture, use, or distribution of drugs. See Eli Lilly, 496 U. S., at 674. We decline to read the “reasonable relation” requirement so narrowly as to render § 271(e)(l)’s stated protection of activities leading to FDA approval for all drugs illusory. Properly construed, § 271(e)(1) leaves adequate space for experimentation and failure on the road to regulatory approval: At least where a drugmaker has a reasonable basis for believing that a patented compound may work, through a particular biological process, to produce a particular physiological effect, and uses the compound in research that, if successful, would be appropriate to include in a submission to the FDA, that use is “reasonably related” to the “development and submission of information under . . . Federal law.” § 271(e)(1).

For similar reasons, the use of a patented compound in experiments that are not themselves included in a “submission of information” to the FDA does not, standing alone, render the use infringing. The relationship of the use of a patented compound in a particular experiment to the “development and submission of information” to the FDA does not become more attenuated (or less reasonable) simply because the data from that experiment are left out of the submission that is ultimately passed along to the FDA. Moreover, many of the uncertainties that exist with respect to the selection of a specific drug exist as well with respect to the decision of what research to include in an IND or NDA. As a District Court has observed, “[I]t will not always be clear to parties setting out to seek FDA approval for their new product exactly which kinds of information, and in what quantities, it will take to win that agency's approval.” Intermedies, Inc. v. Ventritex, Inc., 775 F. Supp. 1269, 1280 (ND Cal. 1991), aff’d, 991 F. 2d 808 (CA Fed. 1993). This is especially true at the preclinical stage of drug approval. FDA regulations provide only that “[t]he amount of information on a particular drug that must be submitted in an IND . .. depends upon such factors as the novelty of the drug, the extent to which it has been studied previously, the known or suspected risks, and the developmental phase of the drug.” 21 CFR § 312.22(b). We thus agree with the Government that the use of patented compounds in preclinical studies is protected under § 271(e)(1) as long as there is a reasonable basis for believing that the experiments will produce “the types of information that are relevant to an IND or NDA.” Brief for United States as Amicus Curiae 23 (emphasis deleted).

* * *

Before the Court of Appeals, petitioner challenged the sufficiency of the evidence supporting the jury’s finding that it failed to show that “all of the accused activities are covered by [§ 271(e)(1)].” App. 62a. That court rejected the challenge on the basis of a construction of § 271(e)(1) that was not consistent with the text of that provision or the relevant jury instruction. Thus, the evidence presented at trial has yet to be reviewed under the standards set forth in the jury instruction, which we believe to be consistent with, if less detailed than, the construction of § 271(e)(1) that we adopt today. We decline to undertake a review of the sufficiency of the evidence under a proper construction of § 271(e)(1) for the first time here. Accordingly, we vacate the judgment of the Court of Appeals and remand the case for proceedings consistent with this opinion.

It is so ordered.

       Drugmakers that desire to market a generic drug (a drug containing the same active ingredients as a drug already approved for the market) may file an abbreviated new drug application (ANDA) with the FDA. See 21 U. S. C. § 355( j). The sponsor of a generic drug does not have to make an independent showing that the drug is safe and effective, either in preclinical or clinical studies. See § 355(j)(2)(A). It need only show that the drug includes the same active ingredients as, and is bioequiva-lent to, the drug that it is mimicking. See §§355(j)(2)(A)(ii) and (iv); §355(j)(8)(B).

       We cite the current versions of federal statutes and regulations. The provisions cited are materially unchanged since the period of petitioner's alleged infringement.

       In the proceedings below, the Court of Appeals held that respondents’ patents covered the cyclic RGD peptides developed by petitioner. 331 F. 3d 860, 869 (CA Fed. 2003). Petitioner does not contest that ruling here.

       Scripps licensed the patent for the monoclonal antibody to Ixsys, a California biotechnology company. App. 271a. Based on research conducted at Scripps and at Ixsys in consultation with Dr. Cheresh, an IND application for a humanized version of the antibody called Vitaxin was filed with the FDA on December 30, 1996. Id., at 271a-274a, 404a. In addition to toxicology tests, the application included information from Dr. Cheresh’s in vitro and in vivo experiments related to the antibody’s mechanism of action and efficacy as an inhibitor of angiogenesis. Id., at 399a-404a. Ixsys began clinical testing of the antibody as an angiogen-esis inhibitor in February 1997. Id., at 304a.

       On remand, the District Court reduced the damages award to $6,375 million. Civ. Action No. CV.96 CV 1307-B(AJB), 2004 WL 2284001, *1 (SD Cal., Sept. 7, 2004).

       Although the Court of Appeals’ opinion suggests in places that §271(e)(l)’s exemption from infringement is limited to research conducted in clinical trials, see 331 F. 3d, at 866, we do not understand it to have adopted that position. The Court of Appeals recognized that information included in an IND would come within §271(e)(l)’s safe harbor. Ibid. Because an IND must be filed before clinical trials may begin, such information would necessarily be developed in preclinical studies.

       The Court of Appeals also suggested that a limited construction of § 271(e)(1) is necessary to avoid depriving so-called “research tools” of the complete value of their patents." Respondents have never argued the RGD peptides were used at Scripps as research tools, and it is apparent from the record that they were not. See 331 F. 3d, at 878 (Newman, J., dissenting) (“Use of an existing tool in one’s research is quite different from study of the tool itself”). We therefore need not — and do not — express a view about whether, or to what extent, § 271(e)(1) exempts from infringement the use of “research tools” in the development of information for the regulatory process.

       The relevant jury instruction provided only that there must be a “decent prospect that the accused activities would contribute, relatively directly, to the generation of the kinds of information that are likely to be relevant in the processes by which the FDA would decide whether to approve the product in question.” App. 57a. It did not say that, to fall within §271(e)(l)’s exemption from infringement, the patented compound used in experimentation must be the subject of an eventual application to the FDA. And it expressly rejected the notion that the exemption only included experiments that produced information included in an IND or NDA. Ibid.