Richard Wolf Medical Instruments Corp. v. Dory

723 F. Supp. 37, 15 U.S.P.Q. 2d (BNA) 1376, 1989 U.S. Dist. LEXIS 12107, 1989 WL 115621
CourtDistrict Court, N.D. Illinois
DecidedOctober 4, 1989
Docket87 C 1254
StatusPublished
Cited by6 cases

This text of 723 F. Supp. 37 (Richard Wolf Medical Instruments Corp. v. Dory) is published on Counsel Stack Legal Research, covering District Court, N.D. Illinois primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Richard Wolf Medical Instruments Corp. v. Dory, 723 F. Supp. 37, 15 U.S.P.Q. 2d (BNA) 1376, 1989 U.S. Dist. LEXIS 12107, 1989 WL 115621 (N.D. Ill. 1989).

Opinion

MEMORANDUM OPINION

BRIAN BARNETT DUFF, District Judge.

This court has become the primary American setting for a world war between two inventors, Richard Wolf GmbH and Jacques Dory. Wolf is a West German Corporation which has an American subsidiary, Richard Wolf Medical Instruments Corporation. Wolf claims to have invented a device known as an extracorporeal lithotriptor, a device which Wolf has patented overseas. The lithotriptor is a machine which uses sound waves to pulverize kidney and gall stones in the human body without requiring surgery. Dory is a citizen of France, who assigned his own patent for an extracorporeal lithotriptor to EDÁP, S.A., a French company. (The court will refer to Dory and EDAP collectively as “Dory.”) Wolf has been fighting Dory throughout Europe over whether its device infringes on Dory’s device, and vice versa. This court is one of the American theatres in the parties’ conflict.

Wolf filed suit in this court in February 1987 seeking a declaratory judgment that its device did not infringe on Dory’s United States Patent No. 4,617,931. Wolf also sought a declaration that Dory’s patent was invalid, and damages on account of Dory’s violations of the antitrust laws. In August 1987 Dory counterclaimed. Dory charged patent infringement in Count 1 of its Counterclaim; in Count 2, Dory contended that Wolf had violated the Illinois Deceptive Trade Practices Act, Ill.Rev.Stat. ch. 121V2, § 312(8) (1985), and had committed the common law torts of unfair competition and trade disparagement. Dory alleged that these wrongs resulted from a letter which Wolf’s attorney sent to Dory’s potential customers. The letter suggested that Dory had engaged in vexatious litigation and that Dory’s patent was “unenforceable, invalid, and not infringed by Wolf.” Dory alleged that Wolf knew these statements were false when they were made, and that Wolf continues to spread these falsehoods now.

Today this court will rule on two aspects of the parties’ dispute. 1 Dory has asked this court to determine whether it has subject-matter jurisdiction over this suit. Dory questions this court’s jurisdiction in light of a recent decision, Eli Lilly and Co. v. Medtronic, Inc., 872 F.2d 402 (Fed.Cir. 1989). Wolf for its part has moved for judgment on the pleadings under Rule 12(c), Fed.R.Civ.P., on Count 2 of Dory’s Counterclaim.

Subject-Matter Jurisdiction

Dory’s uncertainty as to this court’s jurisdiction stems from recent congressional tinkering with this nation’s patent laws. In the early 1980s, manufacturers of generic drugs anticipated the expiration of patents on numerous drugs. The manufacturers wished to produce these drugs as soon as they reverted to the public domain. As any conscientious manufacturer would recognize, however, one needs approval of a drug from the federal Food and Drug Administration before one can market a drug, generic or otherwise. See U.S. v. Baxter Healthcare Corp., 712 F.Supp. 1352, 1356—57 (N.D.Ill.1989). Hoping to have obtained FDA approval prior to the expiration of the patents, the generic drug manufacturers began the experimental use studies, studies which the FDA requires, while the patents were still effective. Unfortunately, these manufacturers were faced with liability under the patent laws, as 35 U.S.C. § 271(a) (1982) prohibits unauthorized use of a patented invention. As the law stood in 1984, a generic drug manufacturer had to wait until after the patent on a drug expired before it could begin experimental studies on generic equivalents of the drug. See Roche Products, Inc. v. Bolar Pharmaceutical Co., 733 F.2d 858, 865 (Fed.Cir.1984).

*39 Congress quickly remedied this situation. Upon the signing of the Drug Price Competition and Patent Term Restoration Act of 1984, Pub.L. No. 98-417, 98 Stat. 1585, the Patent Code stated: “It-shall not be an act of [patent] infringement to make, use, or sell a patented invention ... 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.” 35 U.S.C. § 271(e)(1) (1985 Supp.). In enacting this legislation, however, Congress did more than allow generic drug manufacturers to get a jump on development and marketing of their products. The Federal Circuit held in Medtronic that Congress granted this same privilege to makers of medical devices. Further, the Medtronic court rejected the argument that Congress intended this exemption to apply only to those who were seeking FDA approval of inventions on which someone else held a patent and had gained FDA approval. Instead, the court concluded that Congress enacted a broad exception to the Patent Code, the only limitation being the reasonable relationship of the uses of the patented drug or device to federal regulatory requirements. See Medtronic, 872 F.2d at 405-06.

How does all this cast this court’s jurisdiction into doubt? At the time Wolf filed its request for declaratory relief, Wolf had obtained permission from the FDA to sell its lithotriptors to a number of American hospitals and universities for use in obtaining data required by the FDA. Wolf’s application for FDA approval of its lithotriptor is still pending. Dory contends that in light of Medtronic, as long as Wolf continues to market its device solely for the purposes of collecting FDA-required data, Wolf is immune from liability for patent infringement. Dory thus argues that there is no case or controversy between it and Wolf, and thus this court lacks subject-matter jurisdiction under Article III of the Constitution. According to Dory, this court must dismiss this case without prejudice under Rule 12(h)(3), Fed.R.Civ.P.

Dory’s argument is flawed in two respects. First, even assuming that Medtronic destroys this court’s jurisdiction over Wolf’s request for declaratory judgment, this court would still have jurisdiction over Wolf’s antitrust claim. Dory purports that the case and controversy requirements for patent declaratory judgment suits and antitrust claims are the same, but the only cases which Dory musters in support of this argument are Indium Corp. of America v. Semi-Alloys, Inc., 566 F.Supp. 1344 (N.D.N.Y.1983), and Papst Motoren GmbH & Co. KG v. Kanematsu-Goshu, 629 F.Supp. 864 (S.D.N.Y. 1986). In Indium, the court dismissed an antitrust claim that formed part of a patent dispute, after dismissing the patent claims for lack of a controversy. Had Dory read Indium closer, it would have noted that the Indium court dismissed the plaintiff’s antitrust claims not for lack of controversy, but for failure to state a claim upon which the court could grant relief. See Indium, 566 F.Supp. at 1354. As for Papst,

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723 F. Supp. 37, 15 U.S.P.Q. 2d (BNA) 1376, 1989 U.S. Dist. LEXIS 12107, 1989 WL 115621, Counsel Stack Legal Research, https://law.counselstack.com/opinion/richard-wolf-medical-instruments-corp-v-dory-ilnd-1989.