Baxter Int'l Inc v. Abbott Laboratories

Court of Appeals for the Seventh Circuit·Decided January 16, 2003·No. 02-2039·Published

Opinion

In the

United States Court of Appeals For the Seventh Circuit

No. 02-2039 BAXTER INTERNATIONAL, INCORPORATED, Plaintiff-Appellant,

v.

ABBOTT LABORATORIES, Defendant-Appellee.

Appeal from the United States District Court for the Northern District of Illinois, Eastern Division.

Nos. 01 C 4809 & 01 C 4839—Ronald A. Guzmán, Judge.

ARGUED OCTOBER 29, 2002—DECIDED JANUARY 16, 2003

Before CUDAHY, COFFEY, and EASTERBROOK, Circuit Judges.

EASTERBROOK, Circuit Judge. Baxter International invented sevoflurane 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.

2 No. 02-2039

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 sublicense 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 Maruishi, 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 sevoflurane, 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

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with Ohmeda’s plans and compete with the sevoflurane 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 Maruishi for Baxter-process sevoflurane. Abbott, which contends that it has spent more than $1 billion to commercialize sevoflurane (including distribution of equipment for administering the drug and marketing to alert anesthesiologists to its benefits) did not welcome competition before the expiration of the Baxter patents. Abbott initiated arbitration under the Baxter-Maruishi agreement (to which it had become a party in 1992) and the Convention on the Recognition and Enforcement of Foreign Arbitral Awards, [1970] 21 U.S.T. 2517, T.I.A.S. No. 6997, implemented by 9 U.S.C. §§ 201-08. The agreement specifies a multi-national tribunal, which consisted of a U.S. attorney , a Spanish attorney, and a Japanese law professor.

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 Ohmeda 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 4 No. 02-2039

from desflurane, isoflurane, and sevoflurane made by any other process (for the sevoflurane molecule is unpatented) is unaffected. 2002 U.S. Dist. LEXIS 5475 (N.D. Ill. Mar. 26, 2002).

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., 248 F.3d 577 (7th Cir. 2001). Section 207 says that “[t]he court shall confirm the award unless it finds one of the grounds for refusal or deferral of recognition or enforcement of the award specified in the said Convention.” Legal errors are not among the grounds that the Convention gives for refusing to enforce international awards. Under domestic law, as well as under the Convention, arbitrators “have completely free rein to decide the law as well as the facts and are not subject to appellate review.” Commonwealth Coatings Corp. v. Continental Casualty Co., 393 U.S. 145, 149 (1968). “Courts thus do not sit to hear claims of factual or legal error by an arbitrator”. Paperworkers v. Misco, Inc., 484 U.S. 29, 38 (1987).

Arbitrators regularly handle claims under federal statutes . See, e.g., Rodriguez de Quijas v. Shearson/American Express, Inc., 490 U.S. 477 (1989) (claims under the Securities Act of 1933); Shearson/American Express, Inc. v. McMahon, 482 U.S. 220 (1987) (claims under the Securities Exchange Act of 1934 and the Racketeer Influenced and Corrupt Organizations Act); Scherk v. Alberto-Culver Co., 417 U.S. 506 (1974) (international arbitration of claims under the Securities Exchange Act of 1934). We do not see any reason why things should be otherwise for antitrust issues—nor, more importantly, does the Supreme Court,

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which held in Mitsubishi Motors Corp. v. Soler Chrysler- Plymouth, Inc., 473 U.S. 614 (1985), that international arbitration of antitrust disputes is appropriate.

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 arbitrable. 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 (473 U.S. at 639 n.21):

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