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Bone Care International, LLC v. Pentech Pharmaceuticals

July 30, 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

On June 4, 2010, this Court issued a memorandum opinion and order [363] construing the single disputed claim at issue in this litigation. Currently before the Court is Defendants'motion for reconsideration [389] of that claim construction order. For the reasons set forth below, Defendants' motion [389] is granted in part and denied in part.

I. Background

The parties asked the Court to construe only one claim -- claim 7 -- of United States Patent No. 5,602,116 (the "' 116 patent"). Claim 7 provides:

A method for lowering or maintaining lowered serum parathyroid hormone in human patients suffering from hyperparathyroidism secondary to end stage renal disease, comprising: administering to said patients an effective amount of 1α-OH-vitamin D2 to lower and maintain lowered serum parathyroid hormone levels.

After holding a tutorial and claim construction hearing and considering the parties' claim construction briefs, the Court construed claim 7 of the ' 116 patent as follows:

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 chronic dialysis or kidney transplantation, comprising: administering an effective amount of 1α-OH-vitamin D2 to lower and maintain lowered blood concentrations of PTH with a lower incidence of hypercalcemia than is associated with the extant conventional Vitamin D3 treatments.

Defendants request reconsideration of the claim construction order in two respects. First, Defendants maintain that the Court committed a manifest error of law by construing claim 7 to include a limitation for "a lower incidence of hypercalcemia than is associated with the extant conventional Vitamin D3 treatments." Second, Defendants contend that the Court misapprehended the evidence when it construed claim 7 as applying to "human patients having increased (i.e., above normal) secretion of PTH," as opposed to patients with "substantially elevated PTH levels." In further regard to their second contention, Defendants submit that new evidence -- namely, statements made by Plaintiff' s expert Dr. Langman in a deposition taken after the Markman hearing -- also compels reconsideration of the Court' s construction of the claim terms "hyperparathyroidism secondary to ESRD."

II. Legal Standard

A motion to reconsider is proper when "the Court has patently misunderstood a party, or has made a decision outside the adversarial issues presented to the Court by the parties, or has made an error not of reasoning but of apprehension." Bank of Waunakee v. Rochester Cheese Sales, Inc., 906 F.2d 1185, 1191 (7th Cir. 1990). A motion for reconsideration "does not provide a vehicle for a party to undo its own procedural failures, and it certainly does not allow a party to introduce new evidence or advance arguments that could and should have been presented to the district court prior to the judgment." Bordelon v. Chicago School Reform Bd. of Trustees, 233 F.3d 524, 529 (7th Cir. 2000). In the specific context of claim construction, a motion for reconsideration may be raised at any stage of the case. See, e.g., Jack Guttman, Inc. v. Kopykake Enterprises, Inc., 302 F.3d 1352, 1361 (Fed. Cir. 2002) (after preliminary injunction ruling); The Chamberlain Group, Inc. v. Lear Corp., 2007 WL 551579 (N.D. Ill. Feb. 20, 2007) (after claim construction), rev'd, 516 F.3d 1331 (Fed. Cir. 2008); Cornell University v. Hewlett-Packard Co., 654 F. Supp. 2d 119, 128 (N.D.N.Y. 2009) (in post-trial motion for judgment as a matter of law). Indeed, the Federal Circuit has commented that "[d]istrict courts may engage in a rolling claim construction, in which the court revisits and alters its interpretation of the claim terms as its understanding of the technology evolves." Jack Guttman, 302 F.3d at 1361.*fn1

III. Analysis

To set the stage, the Court recounts the rationale for the portions of its prior construction with which Defendants take issue in their motion for reconsideration. Defendants'principal objections are directed toward the Court' s construction of the term "effective amount" to include a hypercalcemia limitation. As to that term, after undertaking its analysis of the pertinent case law, evidence, and argument, the Court was not persuaded that either party's proposed construction was entirely correct. Contrary to Defendants'position, the Court felt that the disputed term was not clear on its face, and thus required construction. After review of the claim language, the specification, the prosecution history, and the remaining intrinsic and extrinsic evidence presented by the parties, the Court determined that a proper construction must include a hypercalcemia limitation. However, the Court concluded that Plaintiffs' proposed construction -- seeking a limitation based on a low incidence of hypercalcemia -- went further than the language of the claim and specification would permit. Accordingly, although the Court adopted Plaintiff's proposed construction of that term in many respects, the Court adopted its own construction in part. See Federal Judicial Center, PATENT CASE MANAGEMENT JUDICIAL GUIDE § 5.1.4.4, at 5- 24 (2009) ("The court is free to devise its own construction of claim terms rather than adopt a construction proposed by either of the parties").

After careful review of the parties'briefs on the motion for reconsideration, the Court remains persuaded that a hypercalcemia limitation is appropriate. As the Court stressed in its initial construction, time and again, the ' 116 patent specification focuses on the toxic side effects associated with the use of 1 α,25-(OH)2 vitamin D3 and 1α-OH vitamin D3 to treat hyperparathyroidism secondary to end stage renal disease. See ' 116 patent, col. 2, ll. 6-9; id., col. 2, ll. 26-29; id., col. 4, ll. 11-17; id., col. 5, ll. 58-62. In particular, the specification states that "the hormonally active vitamin D3 compounds are limited in their therapeutic usefulness due to their inherent toxicities." ' 116 patent, col. 3, ll. 22-4. It then asserts that the "treatment method of the present invention is an alternative to conventional therapy with 1α,25-(OH)2 vitamin D3 and 1α-OH vitamin D3; the method is characterized by providing an active vitamin D compound having equivalent bioactivity but much lower toxicity than these conventional therapies" and thus touts that "the method addresses a long felt need in secondary hyperparathyroidism therapy."*fn2 Id., col. 4, ll. 11-19 (emphasis added).

The portions of the specification quoted above, as well as other similar references noted in the Court' s original construction opinion, support the Court' s conclusions that the term "effective amount" as used in claim 7 incorporates two key comparisons to the prior art. See PATENT CASE MANAGEMENT JUDICIAL GUIDE § 5.2.3.2.3.2, at 5-57 (explaining that "the patentee' s manner of distinguishing his invention over the prior art may be definitional" and that "the specification's emphasis on the importance of a particular feature in solving the problems of the prior art is an important factor in defining the claims"). In particular, the Court concludes that an "effective amount" is an amount that has (1) equivalent bioactivity to the prior art --i.e., is equally effective in lowering PTH levels -- and (2) lower toxicity than the prior art --i.e., is more effective in preventing the harmful side effect of hypercalcemia. See Minn. Mining & Mfg. Co. v. Johnson & Johnson Orthopaedics, Inc., 976 F.2d 1559, 1566 (Fed. Cir. 1992) (affirming claim construction that looked to specification to determine "fundamental ...


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