Mallinckrodt Medical, Inc. v. Sonus Pharmaceuticals, Inc.

989 F. Supp. 265, 45 U.S.P.Q. 2d (BNA) 1811, 1998 U.S. Dist. LEXIS 136, 1998 WL 6546
CourtDistrict Court, District of Columbia
DecidedJanuary 5, 1998
DocketCivil Action 97-1732(PLF)
StatusPublished
Cited by24 cases

This text of 989 F. Supp. 265 (Mallinckrodt Medical, Inc. v. Sonus Pharmaceuticals, Inc.) is published on Counsel Stack Legal Research, covering District Court, District of Columbia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Mallinckrodt Medical, Inc. v. Sonus Pharmaceuticals, Inc., 989 F. Supp. 265, 45 U.S.P.Q. 2d (BNA) 1811, 1998 U.S. Dist. LEXIS 136, 1998 WL 6546 (D.D.C. 1998).

Opinion

OPINION

PAUL L. FRIEDMAN, District Judge.

I. BACKGROUND

Braceo Diagnostics, Inc., DuPont Merck Pharmaceutical Co., ImaRx Pharmaceutical Corp. and Sonus Pharmaceuticals, Inc. are all manufacturers of injectable contrast imaging agents for use with diagnostic ultrasound equipment in the diagnosis of cardiac dysfunction. Each product contains a fluorinat-ed gas (perfluoropropane) or a fluorinated chemical encapsulated in a microspheric membrane or microbubble. • On April 14, 1997, each of these companies brought a lawsuit in this Court against the Food and Drug Administration alleging that they were being harmed by the FDA’s decision to treat their products as drugs for purposes of the FDA approval process, while treating the virtually identical product of a competitor, Molecular Biosystems, Inc. (“MBI”), as a medical device with a simpler, speedier application and approval process. The Court eon- *267 solidated the three cases. MBI sought leave to intervene, and the Court granted its motion. By Opinion and Order of April 21, 1997, the Court concluded that plaintiffs were likely to succeed on the merits of their claim that the FDA had acted arbitrarily and capriciously by failing to treat similarly situated products in the same fashion. The Court therefore enjoined the FDA from continuing any approval or review procedures with respect to any applications for approval of ultrasound contrast agents until ten days after the FDA resolved the Citizens’ Petitions fried by Braceo, DuPont Merck and ImaRx, and Sonus. See Braceo Diagnostics Inc. v. Shalala, 963 F.Supp. 20 (D.D.C.1997).

On July 25, 1997, the Food and Drug Administration provided a consolidated response to the Citizens’ Petitions regarding the regulation of ultrasound contrast agents. In that response, the FDA announced that it would treat all ultrasound contrast agents as drugs under the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301, et seq., and would assign primary oversight and review responsibility to the Center for Drug Evaluation and Research. On August 1, 1997, having negotiated numerous extensions of time with the other parties, MBI, as defendant-intervenor in the Braceo, DuPont Merck and Sonus lawsuits, filed its consolidated answer to the complaints and asserted counterclaims against Braceo, DuPont Merck and ImaRx, Sonus and two new parties, Ny-eomed Imaging AS and Braceo’s foreign counterpart, Braceo International BV. MBI’s counterclaims brought wholly different issues to the table, involving claims under the patent law. The counterclaims generally stemmed from MBI’s fear that the counterclaim defendants would sue MBI for infringing their patents (for the use and prospective marketing of its ultrasound contrast agent), which allegedly cover the use of perfluoro-earbon gases in ultrasound contrast agents. In its counterclaims, MBI sought declaratory and injunctive relief that would either render the counterclaim defendants’ patents invalid and unenforceable or enjoin them from enforcing their patent claims.

By Memorandum Opinion and Order of September 10, 1997, the Court concluded that the three consolidated cases had become moot on July 25,1997 when the FDA provided its consolidated response to the plaintiffs’ Citizen Petitions. Braceo Diagnostics, Inc., et al. v. Food and Drug Administration, et al., Civ. Action Nos. 97-0739, 97-0740, 97-0742, Opinion at 4 (D.D.C. July 25, 1997). Finding that plaintiffs had received all the relief they had sought. by that date, the Court concluded that MBI’s answer and counterclaim were filed too late: “The case was already moot and there was no live case or controversy before this Court when MBI filed its answer and counterclaim on August 1, 1997.” See id. at 5. Because the cases were moot before MBI filed its answers and counterclaims, the Court granted the motions of Sonus, DuPont Merck and ImaRx, and Braceo to strike the counterclaims and dismiss the three cases in their entirety.

Meanwhile, on July 31, 1997, MBI and Mallinckrodt Medical, Inc. (the marketer for MBI’s ultrasound contrasting agent) filed a separate complaint, giving birth to this separate action. MBI and Mallinckrodt brought claims against Braceo and Braceo International, DuPont Merck and ImaRx, and Sonus, as well as Nycomed Imaging AS, seeking essentially, the same relief they had sought in their counterclaims in the original FDA lawsuit.

In this case, MBI and Mallinckrodt claim that the FDA is on the verge of approving their ultrasound contrasting agent, Optison. They contend that this otherwise positive development has been frustrated because the defendant companies have, in one way or another, threatened to bring patent infringement actions against them once Optison is approved. In Count One, they seek a declaration that the patents filed by Sonus, Ny-comed, ImaRx and DuPont, and Braceo and Braceo International are invalid and unenforceable for failure to comply with the requirements of the patent laws and/or a declaration that the manufacture, use and sale of Optison will not infringe any valid and enforceable patent of any of the defendants. 1 *268 In Count Two, MBI and Mallinckrodt request that, in the event the Court concludes that any one of defendants’ patents is valid, the Court determine which defendant holds the patent covering the use of perfluorocar-bon gas in ultrasound contrasting agents. 2 Alternatively, MBI and Mallinckrodt seek a declaration and/or injunction requiring defendants to invoke patent interference proceedings in the Patent and Trademark Office or to initiate an interfering patent suit in this case pursuant to 35 U.S,C. § 291 in order to resolve defendants’ allegedly conflicting claims of priority of invention. Finally, in Count Three MBI and Mallinckrodt seek compensatory and injunctive relief against Sonus for making false and defamatory statements about (1) the scope of Sonus’ patent rights to the use of perfluorocarbon gas in ultrasound contrast agents (2) MBI’s alleged infringement of Sonus’ patents through its product Optison and (3) the order in which the FDA will approve MBI’s and Sonus’ ultrasound contrast agents.

On September 2, 1997, Nycomed answered the complaint and brought a counterclaim against MBI and Mallinckrodt. In Count One of its counterclaim, Nycomed seeks a declaratory judgment that MBI and Mal-linckrodt have infringed Nycomed’s patent, which allegedly covers Óptison’s use of per-fluorocarbon gas. In Count Two, it seeks a declaratory judgment that Nycomed’s patent is valid and enforceable against MBI and Mallinckrodt. In Count Three, Nycomed seeks a declaration that MBI is not entitled to a royalty-free license under Nycomed’s patent. In addition to its counterclaim against MBI and Mallinckrodt, Nycomed has brought a cross-claim against Sonus seeking a declaration, pursuant to an interfering patent action under 35 U.S.C. § 291, that either Nycomed’s patent claims preceded those of Sonus or that Sonus’ patent is invalid under one or more provisions of the patent law.

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Bluebook (online)
989 F. Supp. 265, 45 U.S.P.Q. 2d (BNA) 1811, 1998 U.S. Dist. LEXIS 136, 1998 WL 6546, Counsel Stack Legal Research, https://law.counselstack.com/opinion/mallinckrodt-medical-inc-v-sonus-pharmaceuticals-inc-dcd-1998.