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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 the '116 patent is unenforceable because of Plaintiffs' alleged inequitable conduct in prosecution of the patent before the United States Patent and Trademark Office ("PTO"). Currently before the Court is Plaintiffs' motion for summary judgment [336] on Defendants' inequitable conduct affirmative defense "D." For the reasons stated below, Plaintiffs' motion for summary judgment [336] is granted.

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") [333], Defendants' Response to Plaintiffs' Statement of Facts and Statement of Additional Facts ("Defs.' Resp. to Pls'. SOF" and "Defs.' SOF") [378], and Plaintiffs' Response to Defendants' Statement of Additional Facts ("Pls.' Resp. to Defs.' SOF") [394].

The '116 patent establishes a method for using the vitamin D compound doxercalciferol to treat patients suffering from hyperparathyroidism secondary to end-stage renal failure. The '116 patent issued from the '488 application, which was the last in a chain of related applications that Bone Care filed with the PTO over the course of seven years. Specifically, the '488 application was filed on April 3, 1995, as a continuation-in-part application ofthe '895 application, which was filed on September 10, 1993, as a continuation of the '056 application, which was filed on December 17, 1991, as a continuation of patent application No. 596,412, which was filed on August 17, 1990, as a continuation of the August 2, 1988, '371 application. The '371, '412, '056, and '895 applications are thus "ancestor applications" to the '488 application. PTO Examiner Theodore J. Criares was assigned to review the '412, '056, '895, and '488 applications-which means that he examined all but the original '371 application.

Plaintiffs and their attorneys submitted the same eight prior art references during prosecution of each of the '371, '412, and '056 applications. Plaintiffs did not re-submit any of these eight references during prosecution of the '488 application. They did, however, indicate in the '488 application itself that it was a continuation-in-part application and list the genealogy of the ancestor applications; they also subsequently submitted an Information Disclosure Statement ("IDS") identifying the '488 application as a continuation-in-part application. 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, and 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 as the 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]

Defendants asserted affirmative defenses and counterclaims arguing, inter alia, that the '116 patent is invalid because Plaintiffs engaged in inequitable conduct during its prosecution. [227]

Plaintiffs moved to dismiss Defendants' inequitable conduct affirmative defenses and counterclaims A-G. [241]. The Court granted in part and denied in part Plaintiffs' motion, dismissing Defendants' affirmative defenses and counterclaims A, B, C, and E, but denying the motion to dismiss as to affirmative defenses and counterclaims D, F, and G.*fn2 [327] Plaintiffs now seek summary judgment on affirmative defense and counterclaim D.

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 ...


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