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Bone Care International, LLC v. Pentech Pharmaceuticals

September 17, 2010

BONE CARE INTERNATIONAL, LLC AND GENZYME CORPORATION, PLAINTIFFS,
v.
PENTECH PHARMACEUTICALS, INC., AND COBREK PHARMACEUTICALS, INC., DEFENDANTS.



The opinion of the court was delivered by: Judge Robert M. Dow, Jr.

MEMORANDUM OPINION AND ORDER

Plaintiffs Bone Care International, LLC and Genzyme Corporation (collectively, "Plaintiffs") brought this patent infringement suit against Defendants Pentech Pharmaceuticals, Inc. and Cobrek Pharmaceuticals, Inc. (collectively, "Defendants") for infringement of United States Patent No. 5,206,116 ("'116 Patent"). Defendants asserted affirmative defenses and counterclaims [227] alleging, inter alia, that Claim 7 of the '116 Patent is unenforceable because Plaintiffs engaged in inequitable conduct in prosecution of the patent before the United States Patent and Trademark Office ("PTO"). Defendants also seek to recover attorneys' fees pursuant to 35 U.S.C. § 285. Currently before the Court is Plaintiffs' motion for summary judgment [336] on Defendants' inequitable conduct Affirmative Defenses F and G and Counterclaim IX. For the reasons stated below, Plaintiffs' motion for summary judgment [336] is denied.

I. Background

A. Factual Background

The Court takes the relevant facts primarily from the parties' Local Rule ("L.R.") 56.1*fn1 statements: Plaintiffs' Statement of Facts ("Pls.' SOF") [337], Defendants' Response to Plaintiffs' Statement of Facts and Statement of Additional Facts ("Defs.' Resp. to Pls.' SOF" and "Defs.' SOF") [382], and Plaintiffs' Response to Defendants' Statement of Additional Facts ("Pls.' Resp. to Defs.' SOF") [396].*fn2

The '116 Patent establishes Plaintiffs' right to make, use, or sell 1αOH-vitamin D2 and related vitamin D compounds, collectively known as doxercalciferol, to treat patients with hyperparathyroidism secondary to end-stage renal failure. A simple sketch of the science relevant to the '116 Patent follows: Vitamin D is necessary to the body's absorption of calcium. Patients with end-stage renal failure cannot absorb calcium properly due to the inability of the kidneys to metabolize vitamin D. This leads to low blood levels of calcium ("serum calcium")- a condition known as hypocalcemia. Hypocalcemia signals the parathyroid gland to release increased amounts of parathyroid hormone ("PTH"). PTH in turn triggers the release of calcium from the bones to the bloodstream. In a healthy human, the PTH-triggered release of calcium from the bones would resolve the hypocalcemia. In a patient suffering end-stage renal failure, however, the calcium released from the bones cannot be metabolized because the kidneys cannot process vitamin D. As a result, serum calcium levels remain low and PTH levels remain correspondingly high. This condition is known as hyperparathyroidism secondary to end-stage renal failure, or secondary hyperparathyroidism. As more calcium is leached from the bones, patients with secondary hyperparathyroidism begin to experience hyperparathyroid bone disease, which presents as bone abnormalities and loss of bone mass density. Claim 7 of the '116 Patent established a method for administering doxercalciferol to prevent or mitigate hyperparathyroid bone disease by lowering or maintaining lowered levels of PTH in patients suffering secondary hyperparathyroidism.

The long and winding history of the '116 Patent's prosecution began on August 2, 1988, with the filing of Patent Application No. 227,371 ("Parent Application"). During the ensuing five years, Plaintiffs filed a series of patent applications as continuation or continuations-in-part ("CIP") applications*fn3 of the Parent Application.*fn4 On April 3, 1995, Plaintiffs filed Patent Application No. 415,488 ("'488 Application") as a CIP application of the series of patent applications relating back to the Parent Application. On June 26, 1996, a PTO examiner interviewed Plaintiffs regarding the '488 Application's relation to two prior art references. The following day, Plaintiffs submitted amendments to the '488 Application, asserting that the application related back to the Parent Application. As such, they argued, the '488 Application "claimed priority," or was entitled, to the August 2, 1988, filing date of the Parent Application (which preceded the prior art references) rather than the April 3, 1995, filing date (which post-dated those patents). On February 11, 1997, the PTO issued the '116 Patent on the basis of the '488 Application. The patent expires on February 11, 2014.

On April 6, 2000, the FDA approved Plaintiff Genzyme's New Drug Application ("NDA") for doxercalciferol. Plaintiffs began producing and selling the drug under the brand name Hectorol. Defendant Pentech later submitted an Abbreviated New Drug Application ("ANDA") to the FDA seeking approval to manufacture, use, or sell a generic version of Hectorol. Pentech alleged in the ANDA that its application did not infringe on the '116 Patent because the '116 Patent was invalid and unenforceable.

B. Procedural Background

Plaintiffs filed a complaint against Pentech and Cobrek claiming that Pentech's ANDA infringed on the '116 Patent, and seeking a declaratory judgment, injunctive relief, litigation costs, attorneys' fees, and, in the event that Defendants proceed with the manufacture, use, or sale of doxercalciferol prior to the 2014 expiration of the '116 Patent, money damages. [197] In their answer, Defendants asserted various affirmative defenses and counterclaims alleging, inter alia, that Claim 7 of the '116 Patent is invalid because Plaintiffs engaged in inequitable conduct in the prosecution of the '116 Patent. [227]

Plaintiffs moved to dismiss Defendants' inequitable conduct Affirmative Defenses A-G. [241] The Court granted in part and denied in part Plaintiffs' motion, dismissing Defendants' Affirmative Defenses A, B, C, and E, but denying the motion as to Affirmative Defenses D, F, and G. [327] Plaintiffs now seek summary judgment on Affirmative Defenses F and G, as well as on Counterclaim IX.

II. Legal Standard

Summary judgment is proper where "the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." Fed. R. Civ. P. 56(c). A genuine issue of material fact exists if "the evidence is such that a reasonable jury could return a verdict for the nonmoving party." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986).

To survive a motion for summary judgment, the non-movant must go beyond the pleadings and "set forth specific facts showing that there is a genuine issue for trial." Anderson, 477 U.S. at 250. A mere showing that there is "some metaphysical doubt as to the material facts" is not enough. Matsushita Elect. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 586 (1986). There must be more than a "mere existence of a scintilla of evidence in support of the [non-movant's] position" that a jury could reasonably find in the non-movant's favor. Anderson, 477 U.S. at 252. When the non-movant "fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial," summary judgment is warranted. Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986).

The party moving for summary judgment bears the burden of establishing that the non-movant has not presented any genuine issue of material fact. See Celotex, 477 U.S. at 323. The Court must then "construe the facts and draw all reasonable inferences in the light most favorable to a ...


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