Boehringer Ingelheim Vetmedica v. Schering-Plough

• Citation: 68 F.Supp.2d 508
• Decision Date: 26 October 1999
• Docket Number: No. CIV. 98-5703(HAA).,CIV. 98-5703(HAA).
• Parties: BOEHRINGER INGELHEIM VETMEDICA, INC., Boehringer Ingelheim/Nobl Laboratories, Inc., Regents of University of Minnesota and South Dakota State University, Plaintiffs, v. SCHERING-PLOUGH CORPORATION and Schering Corporation, Defendants.
• Court: U.S. District Court — District of New Jersey

68 F.Supp.2d 508

BOEHRINGER INGELHEIM VETMEDICA, INC., Boehringer Ingelheim/Nobl Laboratories, Inc., Regents of University of Minnesota and South Dakota State University, Plaintiffs, v. SCHERING-PLOUGH CORPORATION and Schering Corporation, Defendants.

No. CIV. 98-5703(HAA).

United States District Court, D. New Jersey.

October 26, 1999.

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Jennifer Gordon, Jonathan A. Marshall, Scott D. Simpson, Pennie & Edmonds, New York City, H. Curtis Meanor, William Sandelands, Podvey, Sachs, Meanor, Catenacci, Hildner & Cocoziello, Newark, NJ, for Plaintiffs.

Sidney David, Paul H. Konchanski, Lerner, David, Littenberg, Krumholz & Mentlik, Westfield, NJ, for Defendants.

OPINION

HAROLD A. ACKERMAN, District Judge.

This matter comes before the court on a motion filed by Boehringer Ingelheim Vetmedica, Inc. Boehringer Ingelheim/Nobl Laboratories, Inc., Regents of University of Minnesota and South Dakota State University (hereinafter collectively "Plaintiffs" or "Boehringer") seeking a preliminary injunction against Schering-Plough Corporation and Schering Corporation (hereinafter collectively "Defendants" or "Schering") pursuant to 35 U.S.C. § 283 (1988) for violating its patent.¹ For the reasons discussed below, Plaintiffs' motion is DENIED.

I. Background

A. Procedural History

This action and Plaintiffs' motion for a preliminary injunction follows this Court's denial of Plaintiffs' motion for a preliminary injunction with respect to Patent No. 5,476,778 ("the '778 Patent"), see Boehringer Ingelheim v. Schering-Plough, 984 F.Supp. 239 (D.N.J.1997) (hereinafter "Boehringer I"), and denial of both parties' motions for summary judgment regarding that patent. See Boehringer Ingelheim v. Schering-Plough, 6 F.Supp.2d 324 (D.N.J.1998) (hereinafter "Boehringer II"). Although the current action addresses Patent No. 5,840,563 ("the '563 Patent") rather than the '778 Patent, this action is based upon the same conflict between the parties over a vaccine for a disease known as Porcine Reproductive Respiratory Syndrome ("PRRS"). Familiarity with the Court's previous opinions is assumed.

In June 1997, this Court held a hearing pursuant to Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed.Cir.1995). On October 6, 1997 this Court denied Boehringer's preliminary injunction motion finding that Boehringer failed to demonstrate a likelihood of success on the merits given Schering's substantial defense of obviousness pursuant to 35 U.S.C. § 103(a). See Boehringer I, 984 F.Supp. at 258-259. Specifically, the Court found that Schering had presented a substantial defense that using MA-104 cells to grow the PRRS virus had been obvious to one of ordinary skill in the art at the time of Boehringer's invention based upon prior art relating to the growth of the swine influenza virus. In addition, in Boehringer I, this Court also found that Boehringer was not entitled to a preliminary injunction because it failed to establish irreparable harm from the Defendants' sale of a competing swine vaccine. Id. at 264. For those reasons, the Court declined to issue a preliminary injunction.

Shortly after the denial of Boehringer's motion for preliminary injunction, Schering filed a motion for summary judgment, Boehringer filed its own summary judgment motion and Boehringer renewed its motion for a preliminary injunction. By written opinion issued on April 27, 1998, this Court denied each of those motions. See Boehringer II, 6 F.Supp.2d 324. First, the Court denied Boehringer's motion for summary judgment finding that genuine issues of material fact remained regarding obviousness and infringement pursuant to the doctrine of equivalents. The Court also rejected Boehringer's renewed preliminary injunction motion finding that Boehringer still had not demonstrated either irreparable harm or that Schering's validity defense was devoid of substantial merit and thus it was "far from certain that Boehringer would be likely to succeed on the merit of its infringement claim." Id. at 338.

While the '778 Patent litigation was pending, Boehringer's patent application with the United States Patent Office (hereinafter either "Patent Office" or "USPO") for its '563 Patent was also pending. In November 1998, after the motion practice in the '778 Patent litigation was completed, the Patent Office issued to Boehringer the '563 Patent entitled "Method for Growing Swine Infertility and Respiratory Syndrome Virus" which named Danny Chladek, David Gorcyca and Louis Harris as inventors. Shortly thereafter on December 17, 1998, Boehringer commenced the present action alleging that Schering had infringed its newly-issued '563 and '805 Patents and by motion filed on January 22, 1999 Boehringer moved for a preliminary injunction to preclude Schering from selling its allegedly infringing swine vaccine. Schering opposes Boehringer's newest request for a preliminary injunction and another preliminary injunction hearing was held before this Court in June 1999.

B. Brief Factual History

The disease at the center of this dispute, PRRS, also known as Mystery Swine Disease ("MSD") and Swine Infertility and Respiratory Syndrome ("SIRS"),² infects pigs and causes them to give birth to dead or sickly piglets. In addition to these reproductive failure, PRRS also causes serious respiratory symptoms and other symptoms such as anorexia, fever, dyspnea, and neurological impairment. Both Plaintiffs and Defendants have marketed a vaccine for PRRS since June 1994 and July 1996, respectively. Tr. at 2.79, 2.92

As discussed supra Boehringer possesses several patents relating to its PRRS vaccine. According to Plaintiffs, "the '778 patent, ..., claims methods of growing, isolating, and attenuating PRRS viruses in simian cells for vaccine preparation .... the '563 patent claims methods of growing the PRRS virus on simian cells, while the '805 patent claims cultures and compositions containing the PRRS virus." Pl. Br. at pp. 1-2.

While Plaintiffs' claim against Defendants for infringement of the '778 Patent is still pending and is scheduled for trial in approximately two weeks, the Court considers Plaintiffs' newly filed motion for preliminary injunction which alleges that Defendants have infringed Plaintiffs' '563 patent.³ Specifically, the subject of the instant motion is Plaintiffs' contention that Defendants' sale of a swine vaccine for the prevention of PRRS has violated Claim 3 of the '563 Patent. Pl. Br. at p. 2.

Claim 1 of the '563 Patent, upon which Claim 3 is dependent, claims:

A method of growing swine infertility and respiratory syndrome virus comprising: (a) inoculating the swine infertility and respiratory syndrome virus on simian cells; and

(b) incubating the inoculated simian cells.

Pl. Br. Ex. A, col. 23, lines 14-18. Claim 2 states, "[t]he method of claim 1 wherein the simian cells are simian kidney cells." Id. at lines 19-20. Finally, Claim 3, the Claim in dispute, states, "[t]he method of claim 2 wherein the simian kidney cells are MA-104 simian kidney cells." Id. at lines 21-22. Plaintiffs contend that Defendants' swine vaccine literally infringes the '563 Patent and infringes that patent under the doctrine of equivalents.

II. Brief Summary of the Arguments

Boehringer has requested a preliminary injunction to enjoin Schering from selling its swine vaccine and seeks a recall of Schering's current PRRS vaccines. Boehringer argues that the prior art which was the basis of this Court's denial of Boehringer's request for a preliminary injunction in the '778 litigation is not relevant to this patent based upon additional evidence gathered by Boehringer since the '778 preliminary injunction hearing. Specifically, Boehringer relies on the deposition testimony of six of Schering's experts to support its argument that growing the PRRS virus on MA-104 cells was not obvious. Therefore, Boehringer argues that this Court should enjoin Schering from infringing Boehringer's '563 Patent because there is no longer an issue that its invention is obvious and because it also satisfies the other requirements necessary for a preliminary injunction.

In opposition to Boehringer's motion for a preliminary injunction, Schering challenges the validity and enforceability of Boehringer's '563 patent as well as Boehringer's ability to meet the other heavy showing required for a preliminary injunction. With respect to the likelihood of Boehringer's success on the merits, Schering asserts three defenses to the '563 Patent. First, Schering argues that the '563 Patent was not patentable under 35 U.S.C. § 103(a). Essentially, Schering argues that since "one of ordinary skill in the art would have a reasonable expectation that the SIRS virus would grow on simian cells and in particular MA-104," the '563 Patent is not valid. Def. Br. at p. 4.

Second, Schering argues that Boehringer's inequitable conduct during its presentation of the '563 and '778 Patents to the USPO invalidates the '563 Patent. Specifically, Schering argues that Boehringer's failure to direct the Patent Office's attention to the relevant prior art and provide the Patent Office with the pleadings, briefs and opinions of this Court from the'778 litigation amounted to inequitable conduct which invalidates the '563 Patent. Schering also argues that Boehringer's inequitable conduct before the USPO in its prosecution of the '778 Patent taints the '563 patent rendering it unenforceable. Third, Schering argues that the '563 Patent violates the written description requirement for a patent as articulated in 35 U.S.C. § 112 (hereinafter "section 112") because, in part, the specification is limited to virus ATCC-VR2322 and does not support Boehringer's broad generic claim.

With respect to Boehringer's showing of irreparable harm, Schering argues that Boehringer is not entitled to a presumption of irreparable harm because it has not made a strong showing of patent validity. Schering also argues...