Baxter International, Incorporated v. Abbott LaboratoriesBaxter International, Incorporated v. Abbott Laboratories
Lead Opinion
Baxter International invented sevoflu-rane in the 1960s. This substance, a gas at room temperature, has good anesthetic properties. But it was too difficult and costly to produce commercially until the early 1980s, when Baxter devised an efficient process for its manufacture. Baxter obtained two process patents, the latter of which expires in December 2005. But the anesthetic gas still could not be sold in the United States unless it first received the fda’s approval, and Baxter was not willing to bear the costs of the required medical testing. So in 1988 it granted to Maruishi Pharmaceutical Company, of Japan, an exclusive worldwide license to practice the sevoflurane process patents Baxter owned or was pursuing. Maruishi obtained approval to sell the anesthetic in Japan, where it was a great success, as it has become in other nations since. This suggested that it would be worth obtaining the fda’s approval to sell in the United States. Abbott Laboratories took a subli-cense from Maruishi in 1992, obtained the fda’s approval after spending approximately $60 million on testing, and in 1995 began selling sevoflurane in the United States. Maruishi remains the sole manufacturer under the Baxter patents; Abbott resells sevoflurane that it purchases from Marui-shi, which pays Baxter a royalty based on its total sales. Today sevoflurane is the best-selling gas used for anesthesia in the United States, with approximately 58% of sales. Desflurane holds 35% of this market, and isoflurane accounts for almost all of the remaining sales. Isoflurane is not protected by any patent and sells for less, but it is slower in both onset and recovery and has an irritating taste and smell. Desflurane likewise has an annoying smell and aftertaste, though its properties otherwise are comparable to sevoflurane — which therefore has become the anesthetic of choice and commands a premium price.
Sevoflurane’s success gave rivals an incentive to invent around Baxter’s process patents. Ohio Medical Associates (now known as Ohmeda) set out in 1997 to do just this. In 1999 Ohmeda obtained a patent for a new way of making sevoflu-rane, distinct from Baxter’s process but equivalently cheap and effective. It planned to introduce a rival sevoflurane anesthetic, which it could do by filing a “me too” application with the fda. Ohmeda could receive approval without costly tests just by showing that the finished product is identical to Abbott’s.
Before Ohmeda could bring sevoflurane to market, it was acquired (in 1998) by Baxter — which decided to proceed with Ohmeda’s plans and compete with the se-voflurane made by Maruishi and sold in the United States by Abbott. Baxter concluded that it would make more from selling Ohmeda-process sevoflurane than it would lose in reduced royalties from Ma-ruishi for Baxter-process sevoflurane.
Abbott contended that Baxter’s sale of Ohmeda-process sevoflurane before the Baxter patents expired would violate the exclusivity term of the license; Baxter replied, first, that the license does not explicitly forbid Baxter itself from competing with Maruishi (in other words, that exclusivity means only that Baxter can not issue any other licenses), and, second, that if the license does forbid Baxter from competing, then it violates U.S. antitrust law, particularly § 1 of the Sherman Act, 15 U.S.C. § 1, and is unenforceable. The arbitrators ruled against Baxter on both issues. The tribunal held that the license is exclusive in the strong sense and that any reduction in competition is attributable to Baxter’s decision to purchase the competing Ohme-da process while bound by this promise not to compete with its licensee. On cross suits filed by Abbott and Baxter, the district judge then directed Baxter to comply with the award, rejecting its contention that the license, as construed by the tribunal, violates the Sherman Act or the public policy of the United States. The judge observed that competition from desflurane, isoflurane, and sevoflurane made by any other process (for the sevoflurane molecule is unpatented) is unaffected.
Baxter argues at length in this court that the Baxter-Maruishi license, construed to keep Ohmeda-process sevoflurane off the U.S. market until 2006, is a territorial allocation unlawful per se under § 1 of the Sherman Act. But the initial question is whether Baxter is entitled to reargue an issue that was resolved by the arbitral tribunal. We think not; a mistake of law is not a ground on which to set aside an award. See George Watts & Son, Inc. v. Tiffany & Co.,
Arbitrators regularly handle claims under federal statutes. See, e.g., Rodriguez de Quijas v. Shearson/American Express, Inc.,
Mitsubishi did not contemplate that, once arbitration was over, the federal courts would throw the result in the waste basket and litigate the antitrust issues anew. That would just be another way of saying that antitrust matters are not arbi-trable. Yet this is Baxter’s position. It wants us to disregard the panel’s award and make our own decision. The Supreme Court’s approach in Mitsubishi was different. It observed (
The utility of the Convention in promoting the process of international commercial arbitration depends upon the willingness of national courts to let go of matters they normally would think of as their own. Doubtless, Congress may specify categories of claims it wishes to reserve for decision by our own courts without contravening this Nation’s obligations under the Convention. But we decline to subvert the spirit of the United States’ accession to the Convention by recognizing subject-matter exceptions where Congress has not expressly directed the courts to do so.
Starting from scratch in court, as Baxter proposes, would subvert the promises the United States made by acceding to the Convention.
According to Baxter, there is a difference between arbitrating an antitrust issue (the subject of Mitsubishi) and creating one — which it accuses these arbitrators of doing. If the tribunal had construed the Baxter-Maruishi agreement differently, there would have been no antitrust problem. Baxter relies on the observation in George Watts that arbitrators are not allowed to command the parties to violate rules of positive law. That’s true enough, but whether the tribunal’s construction of the Baxter-Maruishi agreement has that effect was a question put to, and resolved by, the arbitrators. They answered no, and as between Baxter and Abbott their answer is conclusive. This is a point anticipated in Mitsubishi, which observed (id. at 638,
Treating Baxter as bound (vis-a-vis Abbott) by the tribunal’s conclusion that the license (as construed to provide strong exclusivity) is lawful does not condemn the public to tolerate a monopoly. If the three-corner arrangement among Baxter, Maruishi, and Abbott really does offend the Sherman Act, then the United States, the FTC, or any purchaser of sevoflurane is free to sue and obtain relief. None of them would be bound by the award. As far as we can see, however, only Baxter is distressed by the award — and Baxter, as a producer, is a poor champion of consumers. See Atlantic Richfield Co. v. USA Petroleum Co.,
What relief the Antitrust Division, the ftc, or a consumer would obtain, if there is an antitrust problem, is an interesting
Affirmed
Dissenting Opinion
dissenting.
To understand fully why the majority’s enforcement of this dubious arbitration award is misguided, a brief synopsis of the background material not fully described by the majority is essential. In 1988 and in 1988 Baxter gave options to Maruishi to license patents covering the one-step process of manufacturing sevoflurane. By 1992, when negotiations with Abbott concerning the introduction of sevoflurane in the United States were undertaken, Baxter’s product and method-of-use patents for sevoflurane had expired. Arbitration Transcript at 675-83 (“Arb.Tr.”). Hence, the only patents that Baxter could license to Maruishi and that Maruishi could in turn sublicense to Abbott were those covering the one-step manufacturing process, which were still in effect. In its negotiations with Baxter, Maruishi considered attempting to obtain a covenant not to compete not only with respect to the one-step process but also as to sevoflurane itself, but instead turned its attention elsewhere. Maruishi concluded that the exclusive license for the one-step process and related intellectual property was “sufficient protection.” See Arb. Tr. at 523-24. The 1992 negotiations with Abbott dealt only with the one-step process. Arb. Tr. at 386-91.
In 1992, when sublicensing to Abbott was negotiated, two distinct sets of agreements were involved in the negotiations. First, there were the Sevoflurane Agreements establishing the terms of the licenses, and granting exclusive rights to Maruishi and to Abbott to manufacture sevoflurane under the one-step patent, to all improvements on the one-step patents and to all technology and confidential proprietary information (“know-how”) acquired during the development of the one-step process. Next, all the parties entered into a Dispute Resolution Agreement (DRA), first, to ensure that in the event of a dispute commercialization of se-voflurane would go forward and, second, to provide a mechanism (arbitration) for
By the late 1990s, Ohmeda had developed and patented a different, three-step process to make sevoflurane suitable to be marketed as a generic drug. Subsequently, Baxter acquired Ohmeda. Faced with the threat of generic competition — always anticipated, but now apparently to be undertaken by Baxter — Abbott sought arbitration. The arbitration panel conceded that the Baxter-Maruishi licensing agreement would not preclude Baxter’s offering generic competition because this licensing agreement covered only the one-step manufacturing process, which bore no relation to the three-step process. But a two-member majority of the panel found that, under the Dispute Resolution Agreement invoking the Original Commercial Relationship, Baxter’s proposed sales of generic sevoflurane could be enjoined because they would reduce Abbott’s revenues below monopoly levels, even though the expectation of generic competition was nothing new. The third member of the arbitral panel (the only American) dissented since he concluded that the arbitrators were not authorized to act independent of the licensing agreement itself. The majority also found a breach of an Illinois state duty of good faith, which the dissenting arbitrator thought specious.
The majority upholds the arbitration award here by declaring that, once the arbitrators have spoken to the antitrust issues and in effect commanded the parties to violate the Sherman Act, the courts have no business intervening. Of course, the doctrine that requires extreme deference by the courts to arbitration awards is based on the theory that the parties to a contract may cede broad, almost unlimited, power to an arbitration panel to interpret their agreement. See First Options of Chicago, Inc. v. Kaplan,
But other considerations enter the mix when the issue becomes a matter of the arbitrators’, in interpreting a statute, commanding the parties to break the law or to violate clearly established norms of public policy.
For some considerable time not long in the past, the law of the land was that antitrust disputes were not arbitrable. See Am. Safety Equip. Corp. v. J.P. Maguire & Co.,
The growing fondness for arbitration, however, eventually eliminated the prohibition on submitting antitrust matters to arbitration. Mitsubishi Motors Corp. v. Soler Chrysler-Plymouth, Inc.,
The present case is a good example of the extent to which arbitration has come to pervade the legal culture. First, the parties here constructed an elaborate,, pre-dispute arbitration agreement that not only served to regulate the licensing agreement itself, but also, in an extraordinary spasm of creativity during the arbitration, generated a new and seemingly boundless cause of action, entirely separate from the license itself, under which the parties could presumably proceed. Then, during the arbitral process, Baxter submitted to the arbitrators the supplemental argument
Now, the majority has taken the process one giant step further and has found that Mitsubishi not only allows submission of statutory and antitrust claims to arbitration, but denies our prerogative to refuse to enforce awards that command unlawful conduct.
This cannot be correct. While Mitsubishi and its progeny make clear that the choice of the arbitral forum is to be respected, they do not confer on the arbitrators a prerogative to preemptively review their own decisions and receive deference on that review in subsequent judicial evaluations.
Therefore, I do not think we can simply note the arbitration panel’s resolution of the antitrust issue and consider our work done. Instead, we must fulfill our judicial responsibilities and examine the effect of the outcome commanded by the arbitral award.
Sometimes,, of course, a horizontal restraint is a necessary part of an endeavor that, in the whole, benefits consumers. Nat’l Collegiate Athletic Ass’n v. Bd. of Regents of Univ. of Oklahoma,
The majority unquestioningly accepts the contrary proposition of Abbott, that this broad implied noncompete covenant was “a lawful ancillary agreement designed to induce Maruishi and its sublicen-sees to make the investments needed to bring the new drug to market.” Maj. Op. at 823. First, as I have already noted, Maruishi has never argued that it needed, or believed it had received, the broad non-compete found by the arbitrators. Second, this statement begs the question of what possible added incentive Abbott could have received from this additional guarantee of monopoly above and beyond the scope of the one-step patent.
Arbitration proceedings aside, and given that a covenant not to compete was not essential to Abbott’s market development, Abbott and Baxter could not lawfully agree to this arrangement without violating the Sherman Act, and I fail to see why a panel of arbitrators, on behalf of the parties, can interpret a prior agreement of these parties to reach the same unlawful result.
It is, of course, not the interests of the parties themselves that are primarily at stake in the outcome of this arbitration. Instead the interest of the consuming public is at stake. That public faces higher prices and a constrained supply of sevoflu-rane as a result of Abbott’s monopoly, conferred by the arbitrators. When public rights are at stake, there is good reason to be more reluctant to defer totally to the arbitrators, since they are acting as delegates of the private parties, not of the consuming public. Too deferential an attitude by the courts when the rights of the consuming public are at stake can severely undermine the foundations of our economy. For there can be little doubt that granting Abbott a monopoly to produce sevoflurane in the United States will raise prices and restrict supply. And applying the analysis of the majority to arbitration awards yet to come will open a royal detour around the antitrust laws.
Nor would a denial of the remedy imposed by the arbitrators result in a real loss to Abbott, since Abbott admitted at the arbitration hearing that it had anticipated and planned for generic competition and had specifically anticipated competition from Ohmeda. Arb. Tr. at 323-25; Supp.App. at 19. In fact, Abbott negotiated with Maruishi provisions that would “account! ] for the downsides of generic competition.” Arb. Tr. at 323. The purchase of Ohmeda by Baxter produced a windfall for Abbott whereby Abbott was able to manipulate the arbitration to its advantage and escape the competition it had earlier anticipated.
It is not my role to critique the arbitration decision — however flawed — except in this case to object to its anti-competitive outcome, which orders the parties to violate the antitrust laws. The interest of consumers was not represented on the arbitration panel and the panel’s decision ignored consumer interests. Defense of public interests is sometimes better fulfilled by courts than by arbitration panels.
Nor am I much reassured by the substitute antitrust enforcement possibilities mentioned by the majority. It is conceivable that the Federal Trade Commission
So while I agree with the majority that antitrust claims are arbitrable, and I also agree that the grounds for refusing to enforce an arbitration award are limited, I do not agree that there is support in the law for the majority’s excision of antitrust arbitration from the general framework of judicial review that prohibits an arbitration panel’s award from commanding illegal conduct. And in the case before us, the arbitration panel’s ruling granting Abbott a monopoly in the United States sevoflu-rane market commands illegal conduct on the part both of Baxter and Abbott and is unenforceable.
I would remand with instructions not to enforce the arbitral award, and I therefore respectfully Dissent.
Notes
. As the majority notes, the present case is governed by the 1958 Convention on the Rec
. There is no dispute that Baxter's Ohmeda is the only generic competitor in the sevoflurane market for the foreseeable future, nor is there a dispute that the arbitral decision’s prohibition on the sale of generic sevoflurane by Baxter preserves monopoly prices and levels of output of Abbott’s sevoflurane product.
. It is an important distinction that this rather meta-juridical antitrust claim "decided” by the arbitrators was not a simple claim by Baxter against Abbott, but rather a request by Baxter that the arbitrators step back and consider the larger implications of their underly
.The Convention itself provides grounds for refusing to confirm an award under “public policy” principles. This circuit has recognized grounds (under the Federal Arbitration Act) for refusing to confirm if an arbitration panel acts in manifest disregard of the law, or, as otherwise viewed, if the arbitrators' decision commands a party to act unlawfully. George Watts & Son, Inc. v. Tiffany & Co.,
. It is clear that the arbitrators were doing exactly that — reviewing their own decision— and not deciding issues of law necessary to interpret the various agreements. The panel’s "decision” on the antitrust issues is that "[i]t considers that no illegality results from the interpretation of the Sevoflurane Agreements in this Award.” Supp.App. at 18-19.
. My analysis takes place in the context that the meaning of the Sevoflurane Agreements, as interpreted by the arbitrators, is not contested by Baxter. Therefore, although the arbitrators' findings seem a bit far-fetched to me, I take as a given that the DRA contains a broad, if implied, covenant not to compete that prohibits Baxter from competing with Abbott in any way in the sevoflurane market. This, of course, does not respond to the issue of lawfulness, which is the subject of my substantive analysis.
. The majority bolsters its deference argument by glossing over some significant nuances in the various Baxter-Maruishi-Abbott agreements and the arbitral decision. The arbitrators did not hold "that the license is exclusive in the strong sense.” Maj. Op. at 831. In fact, the arbitrators found that the license, which is limited solely to the one-step process and all associated know-how and technology, was not violated in any way by Baxter's actions regarding the three-step process. Supp.App. at 13-14. The "strong” noncompete was implied from the DRA, which the arbitration panel found contained its own independent cause of action and provided relief to Abbott for any conduct by Baxter that reduced the monopoly revenue Abbott would otherwise receive under the one-step licenses. In theory, under the broad language of the arbitral award, even if Baxter invented and brought to market (before 2005) a completely new and different inhalable anesthetic that competed with sevoflurane and reduced Abbott's revenues from it, Baxter would be in violation of the DRA and enjoined from any manufacture and sale. See Supp.App. at 15, ¶¶ 25, 26.
. I note briefly the questions raised by the Fourth Circuit’s decision in Compton v. Metal Products, Inc.,
. In fact, an argument can be made that Baxter was disadvantaged compared to other competitors by virtue of its agreement with Abbott and association with the one-step process. Baxter would face, as it did in the arbitration in the present case, the hurdle of showing that it did not succumb to the temptation to use any of its existing knowledge and technology base, a hurdle not faced by an outside competitor.