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Bone Care, Int'l et al. v. Pentech Pharm.

March 30, 2011


Name of Assigned Judge Sitting Judge if Other or Magistrate Judge Robert M. Dow, Jr than Assigned Judge


Before the Court are Defendants Pentech Pharmaceuticals, Inc. and Cobrek Pharmaceuticals, Inc.'s (collectively, "Defendants") motion for summary judgment [473] of invalidity of claim 7 of U.S. Patent No. 5,602,116 ("the '116 patent") for lack of enablement and lack of written description, and Plaintiffs Bone Care International, LLC and Genzyme Corporation's (collectively, "Plaintiffs") cross-motion for summary judgment [492] that the '116 paten is enabled as of the filing date of its parent patent application. For the reasons below, the Court denies both motions [473, 492].

O[ For further details see text below.] Docketing to mail notices.


I. Background

The factual and procedural history of this case has been described at length in this Court's numerous previous rulings in this litigation. [See 327, 468, 498, 496.]The Court provides only a brief description of the relevant background here.

The U.S. Patent and Trademark Office issued the '116 patent -- entitled "Method for Treating and Preventing Secondary Hyperparathyroidism" -- to Plaintiffs on February 11, 1997. The '116 patent issued from the '488 continuation-in-part patent application, which was filed on April 3, 1995. The '488 application was linked through a chain of continuation and continuation-in-part applications to a parent patent application, the '371 application ("the '371 application" or "the parent application"), which was filed on August 2, 1988.

As construed by the Court [see 468], claim 7 of the '116 patent teaches:

A method for lowering elevated blood concentrations of parathyroid hormone ("PTH") or maintaining lowered blood concentrations of PTH in human patients having increased (i.e., above normal) secretion of PTH by the parathyroid gland as a result of a disease wherein the patients' kidneys no longer function at a level necessary to sustain life and thus require dialysis or kidney transplantation, comprising: administering an amount of 1α-OH-vitamin D2 sufficient to lower and maintain lowered blood concentrations of PTH with a lower incidence of hypercalcemia than would result from using 1α,25-(OH)2 vitamin D3 or 1α-OH vitamin D3 to achieve the same level of PTH suppression.

[468.] In other words, the invention claimed concerns (1) using an amount of doxercalciferol (2) to achieve a lowered PTH level -- (3) which level is the same as that achieved by 1α,25-(OH)2-vitamin D3 ("calcitriol") and 1α-OHD-vitamin D3 ("alfacalcidol") (collectively, "the vitamin D3 compounds") -- (4) while causing an incidence of hypercalcemia (a condition characterized by toxically high levels of calcium in the blood) (5) that is less than the incidence of hypercalcemia caused by the vitamin D3 compounds when those compounds are used at effective doses, (6) in patients with hyperparathyroidism secondary to end-stage renal disease ("ESRD patients").

Defendants sought approval from the U.S. Food and Drug Administration to manufacture, use, or sell a generic form of doxercalciferol in a manner covered by claim 7 of the '116 patent. Consequently, Plaintiffs sued Defendants for infringement of claim 7 of the '116 patent. Defendants have asserted counterclaims and affirmative defenses alleging that claim 7 is invalid. Two invalidity theories that Defendants raise are that claim 7 (1) does not enable the invention as required by 35 U.S.C. § 112 and (2) does not provide a written description of the invention as required by § 112. Plaintiffs contend that not only does claim 7 satisfy the § 112 requirements, but its parent application also satisfies those requirements, thus entitling the '116 patent to claim the August 2, 1988, filing date of the parent application under 35 U.S.C. § 120.

II. Discussion

The summary judgment motions currently before the Court relating to the '116 patent [473, 492] were filed less than two months before the commencement of a bench trial that began on October 5, 2010, and concluded on November 4, 2010. Because the motions were not fully briefed until September 24, 2010, the Court was unable to consider them before trial.

At trial, the Court heard testimony from numerous fact and expert witnesses over 12 trial days. That testimony touched on a wide range of issues, including the enablement and written description issues on which the pending summary judgment motions focus. After the trial concluded, the Court set a schedule for post-trial memoranda and gave the parties leave to file oversized briefs of up to 280 pages per side. ...

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