The opinion of the court was delivered by: Sidney H. Stein, U.S. District Judge.
This document relates to: ‐against‐
Defendants Varam, Inc. and KVK‐Tech, Inc. (collectively "Varam") bring this motion for summary judgment against plaintiffs (collectively "Purdue") in four related Hatch‐Waxman Act actions. Varam asks this Court to rule that U.S. Patent No. 5,508,042 (the "'042 patent" (Hu Decl., Ex. 1)) is invalid and that, in any event, Varam's generic product will not infringe that patent. For the reasons set forth below, and for the reasons exhaustively elaborated in five prior written opinions concerning the '042 patent, Varam's motion is denied.
1.Purdue's Controlled‐Release Oxycodone Patents
Purdue is the maker of OxyContin, a brand‐name drug designed to treat moderate to severe pain. In 1991, Purdue applied for a patent claiming products and methods relating to a controlled‐release oxycodone formulation. This formulation releases the drug's active ingredient into a patient over an extended period of time in a controlled manner, hence the name. The U.S. Patent and Trademark Office granted Purdue's application, which issued in 1993 as U.S. Patent No. 5,266,331 (the "'331 patent" (Hu Decl., Ex. 6)).
A few months before the '331 patent issued, Purdue applied for another patent covering controlled‐release oxycodone. (Hermes Decl., Ex. 34.) This application, No. 08/81,302 (the "'302 application"), was a continuation‐in‐part from the '331 patent. (Id. at 186.) Like the '331 patent, the '302 application claimed both products and methods. (Id. at 134--37.) The patent examiner concluded that the product and method claims were patentably distinct, and required Purdue to either restrict its application or select one of these classes of claims to pursue. (Id. at 162--65.) Purdue elected to pursue the product claims in the '302 application and pursue the method claims in a divisional application. (Id. at 166.) After Purdue filed a terminal disclaimer, the '302 patent issued in August 1996 as U.S. Patent No. 5,549,912 (the "'912 patent" (Hu Decl., Ex. 5)).
In March 1996, while the '302 application was still pending, Purdue filed yet another application-a continuation‐in‐part of the '302 application, which was itself a continuation‐in‐part of the '331 patent. This application covered controlled‐release oxycodone and once again claimed both products and methods. The Patent Office granted this application, subject to another terminal disclaimer, without requiring Purdue to limit its claims to either products or methods. This patent issued on August 12, 1997 as U.S. Patent No. 5,656,295 (the "'295 patent" (Hu Decl., Ex. 4)).
With that background, the Court turns to the '042 patent, the subject of Varam's motion. This patent issued as a division of the '302 application and contains only two process claims:
1. A method for reducing the range in daily dosages required to control pain in human patients, comprising administering an oral controlled release dosage formulation comprising from about 10 to about 40 mg oxycodone or a salt thereof which provides a mean maximum plasma concentration of oxycodone from about 6 to about 60 ng/ml from a mean of about 2 to about 4.5 hours after administration, and a mean minimum plasma concentration from about 3 to about 30 ng/ml from a mean of about 10 to about 14 hours after repeated administration every 12 hours through steady‐state conditions.
2. A method for reducing the range in daily dosages required to control pain in substantially all human patients, comprising administering an oral solid controlled release dosage formulation comprising from about 10 mg to about 160 mg oxycodone or a salt thereof which provides a mean maximum plasma concentration of oxycodone up to about 240 ng/ml from a mean of up to about 2 to about 4.5 hours after administration, and a mean minimum plasma concentration up to about 120 ng/ml from a mean of about 10 to about 14 hours after repeated administration every 12 hours through steady‐state conditions.
(Hu Decl., Ex. 1 at 20:18--39.) The '042 patent is due to expire shortly. (Purdue 56.1 ¶ 9.)
Finally, Varam has stressed the relevance of a patent issued before the '331 patent that Varam argues renders the '042 patent invalid. That patent, U.S. Patent No. 4,861,598 (the "'598 patent" (Hu Decl., Ex. 3)), claims a particular formulation to be used for controlled‐release oral administration of drugs, not just oxycodone. It is undisputed that the '598 patent is prior art to the '042 patent. (Purdue 56.1 ¶ 2.) The '598 patent has long since expired and was never owned by Purdue.
B. Prior Actions and Procedural History
This is not this Court's first encounter with the '042 patent. Twice this Court has issued extensive opinions concerning that patent. The U.S. Court of Appeals for the Federal Circuit has heard three appeals concerning that patent. Because those prior determinations bear directly on many of the arguments Varam raises in its motion for ...