Novartis Corp v. Ben Venue Laboratories
| Decision Date | 07 November 2001 |
| Parties | (Fed. Cir. 2001) NOVARTIS CORPORATION, Plaintiff-Appellant, v. BEN VENUE LABORATORIES, INC., and BEDFORD LABORATORIES, Defendants-Appellees. 01-1122 DECIDED: |
| Court | U.S. Court of Appeals — Federal Circuit |
Brian V. Slater, Fitzpatrick, Cella, Harper & Scinto, of New York, New York, argued for plaintiff-appellant. With him on the brief were Robert L. Baechtold, Henry J. Renk, Nicholas N. Kallas, and Douglas Sharrott. Of counsel on the brief was John J. Francis, Jr., Drinker, Biddle & Shanley, L.L.P., of Florham Park, New Jersey.
F. Dominic Cerrito, Pennie & Edmonds LLP, of New York, New York, argued for defendants-appellees. With him on the brief were Brian D. Coggio and Jonathan A. Marshall.
Before CLEVENGER, Circuit Judge, FRIEDMAN, Senior Circuit Judge, and SCHALL, Circuit Judge.
Novartis Corporation ("Novartis") appeals from the decision of the United States District Court for the District of New Jersey granting the motion of Ben Venue Laboratories, Inc., and Bedford Laboratories ("Ben Venue") for summary judgment of noninfringement of U.S. Patent No. 4,711,880. Because we conclude that Novartis has not set forth sufficient facts to entitle it to a trial on the merits of its claim, we affirm the district court's grant of summary judgment.
The drug pamidronate disodium (phosphonic acid (3-amino-1- hydroxypropylidene) bis-, disodium salt) is a bone-resorption inhibitor used to treat disorders of bone metabolism, including bone metastases, cancer-associated hypercalcemia, and Paget's disease. Appellant Novartis markets pamidronate disodium under the trade name Aredia. Novartis enjoyed a period of new drug exclusivity for pamidronate disodium under 21 U.S.C. 355(c)(3)(D), based on a new indication for treatment of bone metastases in breast cancer. Novartis's period of exclusivity expired on July 16, 1999.
Novartis sells pamidronate disodium as a lyophilized solid that is reconstituted with sterile water for injection into a patient. In Novartis's formulation, the drug takes the form of pamidronate disodium pentahydrate, a crystalline material in which each molecule of pamidronate disodium occupies a defined position in a crystal lattice and is complexed with five water molecules. The water molecules bound to the pamidronate disodium in the crystal are termed the water of crystallization. Although the substance pamidronate disodium itself is unpatented, crystalline formulations of pamidronate disodium are the subject of U.S. Patent No. 4,711,880 ("the '880 patent"). The '880 patent, owned by Novartis, claims all forms of crystalline pamidronate disodium containing water of crystallization, including pamidronate disodium pentahydrate.
Appellee Ben Venue Laboratories, in the name of its subsidiary Bedford Laboratories, filed a "paper" New Drug Application (NDA 21-113)1 with the Food and Drug Administration (FDA) on February 26, 1999, seeking approval for its own formulation of pamidronate disodium. Instead of Novartis's crystalline form of pamidronate disodium, Ben Venue's NDA described a liquid formulation in which the pamidronate disodium was already dissolved in water and ready for injection. Ben Venue planned to begin selling its liquid formulation when Novartis's period of exclusivity expired on July 16, 1999. Ben Venue's filing included a "Paragraph IV certification," by which a drug manufacturer seeking FDA approval of a drug claimed by a patent certifies its belief either that the patent is invalid, or that the patent will not be infringed by the manufacture, use or sale of the proposed new drug. 21 U.S.C. 355(b)(2)(A)(iv) (1994).2 Ben Venue's Paragraph IV certification asserted that since its pamidronate disodium was already dissolved in water, neither its formulation nor its manufacturing process involved the crystalline form of the drug claimed by the '880 patent.
As required by 21 U.S.C. 355(b)(3)(A), Ben Venue notified Novartis, the patent holder, of its Paragraph IV certification. Novartis promptly filed suit against Ben Venue for infringement of the '880 patent under 35 U.S.C. 271(e)(2)(A), which makes the filing of an NDA for a patented drug an act of infringement. By filing its lawsuit against Ben Venue within 45 days of receiving notice of Ben Venue's Paragraph IV certification, Novartis forestalled, at least temporarily, FDA approval of Ben Venue's product. 21 U.S.C. 355(c)(3)(C) (1994). A second infringement suit, initiated by Novartis when Ben Venue amended its NDA to include a higher dosage formulation, was later consolidated into the original infringement action.
Ben Venue moved for summary judgment of noninfringement. Following discovery, the submission of expert affidavits by both sides, and oral argument, the district court granted Ben Venue's motion, holding that Novartis had failed to present any evidence that the claimed crystalline pamidronate disodium actually forms in Ben Venue's process. Novartis appeals the district court's grant of summary judgment. We exercise our jurisdiction pursuant to 28 U.S.C. 1295(a)(1).
Summary judgment is appropriate when, after opportunity for discovery and upon motion, there is no genuine dispute of material fact for trial and one party is entitled to judgment as a matter of law. Fed. R. Civ. P. 56(c). Summary judgment must be granted against a party who has failed to introduce evidence sufficient to establish the existence of an essential element of that party's case, on which the party will bear the burden of proof at trial. Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986). The summary judgment movant, however, has the initial responsibility of identifying the legal basis of its motion, and of pointing to those portions of the record that it believes demonstrate the absence of a genuine issue of material fact. Id. at 323. Once the movant has made this showing, the burden shifts to the nonmovant to designate specific facts showing that there is a genuine issue for trial. Id. at 324.
Since the ultimate burden of proving infringement rests with the patentee, an accused infringer seeking summary judgment of noninfringement may meet its initial responsibility either by providing evidence that would preclude a finding of infringement, or by showing that the evidence on file fails to establish a material issue of fact essential to the patentee's case. Vivid Tech., Inc. v. American Sci. & Eng'g, Inc., 200 F.3d 795, 807, 53 USPQ2d 1289, 1297 (Fed. Cir. 1999). Summary judgment of noninfringement may only be granted if, after viewing the alleged facts in the light most favorable to the nonmovant and drawing all justifiable inferences in the nonmovant's favor, there is no genuine issue whether the accused device is encompassed by the patent claims. Pitney Bowes, Inc. v. Hewlett Packard Co., 182 F.3d 1298, 1304, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999).
When a district court grants summary judgment, we review without deference whether disputed material facts exist, and review independently whether the prevailing party is entitled to judgment as a matter of law. SunTiger, Inc. v. Scientific Research Funding Group, 189 F.3d 1327, 1333, 51 USPQ2d 1811, 1814 (Fed. Cir. 1999).
The '880 patent discloses a crystalline form of pamidronate disodium, in which each molecule of the pamidronate disodium salt is complexed with five molecules of water. Unlike the forms of pamidronate disodium known in the prior art, this crystalline form is said to have a defined water content and not to absorb additional water during storage. Formulations with defined and stable water content are desirable for pharmaceuticals, since they allow for extended storage and accurate dispensation by weight. Claim 1 of the '880 patent recites pamidronate disodium in a crystalline form that contains water of crystallization. Dependent claim 3 recites the crystalline form of the drug in which five water molecules are associated with each molecule of pamidronate disodium.
For purposes of summary judgment, the parties contest neither the validity of the '880 patent nor the construction of its claims. With the agreement of the parties, the district court gave claim 1 its broadest possible scope and construed the claim to read on pamidronate disodium in any crystalline form containing water of crystallization. While the '880 patent describes other, less well-defined crystalline forms of pamidronate disodium, the parties and the district court refer to the pentahydrate crystalline form of claim 3 interchangeably with crystalline pamidronate disodium in the broader sense of claim 1, and for purposes of summary judgment the parties seem to assume that any crystalline material formed in Ben Venue's process would be the pentahydrate form.
What is disputed by the parties narrows to a single question of fact: whether the crystalline form of pamidronate disodium exists at any point during Ben Venue's process for manufacturing pamidronate disodium in solution. Ben Venue asserts that the pamidronate disodium remains dissolved in solution throughout its manufacturing process, which would preclude the formation of any crystalline material. In contrast, Novartis contends that crystalline pamidronate disodium could form transiently at a particular step in Ben Venue's process. Because the district court did not find Novartis's expert testimony probative of events that might occur during Ben Venue's manufacturing process, the district court granted Ben Venue's motion for summary judgment of noninfringement.
When a patentee seeks to block FDA approval of an NDA under 35 U.S.C. 271(e)(2)(A), the infringement inquiry focuses on the hypothetical infringement that would occur if the defendant's NDA were approved and the defendant began to make and sell the drug. Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1569, 42...
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