Bone Care Int'l, LLC v. Pentech Pharms., Inc.
| Decision Date | 29 March 2012 |
| Docket Number | Case No. 08-cv-1083 |
| Parties | BONE CARE INTERNATIONAL, LLC and GENZYME CORPORATION, Plaintiffs, v. PENTECH PHARMACEUTICALS, INC., and COBREK PHARMACEUTICALS, INC., Defendants. |
| Court | U.S. District Court — Northern District of Illinois |
MEMORANDUM OPINION AND ORDER
This matter is before the Court on Defendants' motion for summary judgment for attorneys fees based on frivolous suit [641], Defendants' motion to deem admitted certain of Defendants' statements and counter-statements of material facts [642], and Plaintiffs' cross-motion for summary judgment of no exceptional case [259]. For the reasons set forth below, the Court denies all three motions [259, 641, and 642]. This case is set for further status on May 4, 2012, at 9:00 a.m.
When ruling on summary judgment motions, the Court takes all relevant facts from the parties' local rule ("L.R.") 56.1 statements. L.R. 56.1 requires that statements of fact contain allegations of material fact, and that the factual allegations be supported by admissible record evidence. See L.R. 56.1; Malec v. Sanford, 191 F.R.D. 581, 583-85 (N.D. Ill. 2000). The Seventh Circuit teaches that a district court has broad discretion to require strict compliance with L.R. 56.1. See, e.g., Koszola v. Bd. of Educ. of the City of Chicago, 385 F.3d 1104, 1109 (7thCir.2004); Curran v. Kwon, 153 F.3d 481, 486 (7th Cir.1998) (citing Midwest Imports, Ltd. v. Coval, 71 F.3d 1311, 1317 (7th Cir.1995) (collecting cases)). Where a party has offered a legal conclusion or a statement of fact without offering proper evidentiary support, the Court will not consider the statement. See, e.g., Malec, 191 F.R.D. at 583. Additionally, where a party improperly denies a statement of fact by failing to provide adequate or proper record support for the denial, the Court deems admitted that statement of fact. See L.R. 56.1(a), (b)(3) (B); see also Malec, 191 F.R.D. at 584. The requirements for a response under Local Rule 56.1 are "not satisfied by evasive denials that do not fairly meet the substance of the material facts asserted." Bordelon v. Chicago Sch. Reform Bd. of Trs., 233 F.3d 524, 528 (7th Cir. 2000). In addition, the Court disregards any additional statements of fact contained in a party's response brief but not in its L.R. 56.1(b)(3)(B) statement of additional facts. See, e.g., Malec, 191 F.R.D. at 584 (citing Midwest Imports, 71 F.3d at 1317). Similarly, the Court disregards a denial that, although supported by admissible record evidence, does more than negate its opponent's fact statement— that is, it is improper for a party to smuggle new facts into its response to a party's 56.1 statements of fact. See, e.g., Ciomber v. Coop. Plus, Inc., 527 F.3d 635, 643 (7th Cir. 2008).
With these principles in mind, the Court denies Defendants' motion to deem admitted certain of Defendants' statements and counter-statements of material facts. The Court is well aware of what it may consider on summary judgment. In fact, on the Court's web page (see http://www.ilnd.uscourts.gov/home/JudgeInfo.aspx), the Court included among its Case Management Procedures a link for Summary Judgment Local Rule 56.1 Submissions. That link contains the following statement: Defendants have in essence asked the Court to strike Plaintiffs' responses and deem their facts admitted. As with motions to strike, the relief Defendants that have asked for should have been included in its reply brief. The separate motion is unnecessary.
In any event, the Court is capable of disregarding unfounded assertions of fact found in Defendants' statements or Plaintiffs' denials. Any statements or responses that contain legal conclusions or argument, are evasive, contain hearsay or are not based on personal knowledge, are irrelevant, or are not supported by evidence in the record will not be considered by the Court in ruling on Defendants' motion for summary judgment. Consistent with its obligations under the federal and local rules, the Court will rely only on material statements of fact which are both admissible and supported by the record compiled at the summary judgment stage. See Fed. R. Civ. P. 56(e); L.R. 56.1; see also Davis v. Elec. Ins. Trs., 519 F. Supp. 2d 834, 836 (N.D. Ill. 2007); Lawrence v. Bd. of Election Com'rs of City of Chicago, 524 F. Supp. 2d 1011, 1014 (N.D. Ill. 2007). To the extent that Plaintiffs' denials are evasive and Defendants' statements are supported by admissible evidence, those statements will be admitted. And to the extent Defendants have put forth legal conclusions in their statements, the Court will disregard the legal conclusions. Defendants' motion to deem facts admitted [642] is denied.
Although a lengthy history exists between the parties in this litigation, the Court sets forth only the facts relevant to the disposition of the cross motions for summary judgment. This case arises under the Hatch-Waxman Act which governs the Food and Drug Administration's approval of new and generic drugs. Plaintiffs Bone Care International, LLC and GenzymeCorporation (collectively "Plaintiffs"), hold approved New Drug Application ("NDA") No. 021-027 for Hectorol® injectable, which contains the active ingredient doxercalciferol. Plaintiffs have ownership in United States Patent Nos. 6,903,083 ("'083 patent") and 5,602,116 ("'116 patent"). Defendants Pentech Pharmaceuticals, Inc. and Cobrek Pharmaceuticals, Inc. (collectively "Defendants") sought approval of a generic drug by filing Abbreviated New Drug Application ("ANDA") No. 90-040. The ANDA included Paragraph IV certifications that, in Defendants' opinion, the '083 patent and '116 patent are invalid or will not be infringed by the manufacture, use, or sale of its generic drug. See 21 U.S.C. § 355(j)(2)(A)(vii). The filing of Defendants' Paragraph IV certifications constitutes an act of patent infringement (see 35 U.S.C. § 271(e)(2)(A)), and Plaintiffs subsequently filed the instant action alleging infringement of both patents. Defendants filed an answer and included counterclaims seeking, inter alia, a declaratory judgment that they did not infringe the '083 patent and that the '083 patent is invalid.
U.S. Patent No. 6,903,083 (the "'083 patent"), assigned to Plaintiff Bone Care International LLC's (and subsequently sold to Genzyme Corporation), has an effective filing date of July 18, 2000. The parties agree that under 35 U.S.C. § 102(b), the one-year statutory bar date for the '083 patent is July 18, 1999.1 The '083 patent covers a stabilized form of 1a-hydroxyvitamin D2 ("vitamin D2"). One of the named inventors of the '083 patent, Dr. Charles Bishop ("Bishop") was Bone Care's President, CEO, and a director) as of July 18, 1999.
Before March 1999, Bone Care acquired twelve lots2 of vitamin D2 from Hauser, Inc. ("Hauser").3 Dr. Bishop admitted under oath that the Hauser lots embodied the claims of thesubsequently-filed '083 patent. Dr. Joyce C. Knutson, a co-inventor of the '083 patent, testified that Hauser synthesized the vitamin D2 material of Example 2 of the '083 patent. Example 2 of the '083 patent is a compound within the claims of the '083 patented invention. According to Dr. Bishop, Bone Care was "stockpiling lots" of vitamin D2 made by Hauser "for the purposes of commercialization after FDA approval of Bone Care's first NDA." The last five of those nine lots are designated as Lot Nos. K52-K56. As set forth in invoices for Lot Nos. K52-K56, Hauser charged Bone Care $78,100 per lot. Transfers of all five of those lots occurred between October of 1998 and February of 1999, prior to the July 18, 1999 date at issue. Lot Nos. K52-K56 cumulatively contained 33.395 grams of vitamin D2. The largest single dose of HECTOROL® contains 2.5 µg (micrograms - i.e., 2.5 millionths of a gram) of vitamin D2. By way of deduction, this would mean that Lot Nos. K52-K56 cumulatively contained several million doses of vitamin D2.4
In a letter dated February 10, 1999, Hauser offered5 Bone Care five additional lots of vitamin D2 for $99,000 per lot.6 The offer was for vitamin D2 having the same specifications as the vitamin D2 lots in K52-K56. Andrew Morgan, Plaintiffs' Federal Rule of Civil Procedure 30(b)(6) deposition witness, conceded that the letter (, the offer to transfer additional lots at $99,000 per run) constituted an "agreement in principle." Dr. Bishop was copied on the letter from Hauser offering five additional lots. The February 1999 Hauser release control specifications reads identically to the compositional limits of claim 1 of the '083 patent.7 Dr. Bishop testified that his recollection was that vitamin D2 embodying the claims of the '083 patent was reduced to practice during the first half of 1998.
The FDA approved Bone Care's NDA No. 20-862 for an oral dosage form of the vitamin D2 product on June 9, 1999. In October 1999, Bone Care began commercially selling vitamin D2 under the name HECTOROL®, which contained the vitamin D2 manufactured by Hauser and acquired by Bone Care prior to July 18, 1999. Bishop admitted that he knew of Bone Care's payments to Hauser (and Hauser's invoices) at the time they were made. Bishop also testified that he knew the potential ramifications of such "transfers," i.e., that they could bar patentability. He further testified that Bone Care's patent attorneys were made aware of the potential ramifications. The Patent Office was never informed of...
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