By Memorandum Order entered by The Honorable Gregory M. Sleet in Amgen Inc. v. Macleods Pharmaceuticals, Ltd., Civil Action No. 17-817-GMS (D.Del. December 19, 2017) (consolidated), the Court denied the Motion for Judgment on the Pleadings of defendants Macleods Pharmaceuticals, Ltd. and Macleods Pharma USA, Inc. (collectively, “Macleods”).

Plaintiff Amgen filed the patent infringement action against Macleods s for infringement of one or more claims of Amgen’s U.S. Patent No. 9,375,405 (“the ‘405 patent”) after Macleods filed its Abbreviated New Drug Application (“ANDA”) seeking approval to manufacture, use and/or sell of a generic version of Amgen’s Sensipar® product prior to the expiration of the ‘405 patent. In its Motion for Judgment on the Pleadings, Macleods claimed that its ANDA products do not contain any of the listed excipients required by the ‘405 patent; thus, Amgen could only assert a claim under the doctrine of equivalents. Id. at *2. Macleods also asserted that any claim by Amgen under the doctrine of equivalents was barred by the doctrine of prosecution history estoppel. Id.

In response, among other things, Amgen argued that Macleods motion should be converted into a motion for summary judgment because it required resolving factual issues and, if converted, should be denied because there are material facts in dispute. Id. at *3. The Court agreed that the motion should have been brought as a motion for summary judgment given the presence of material factual disputes, but decided not to convert the motion into a motion for summary judgment. Id. Instead, the Court found that there are material disputes of facts between the parties concerning the prosecution history of the ‘405 patent and denied Macleods’ Motion for Judgment on the Pleadings. Id. at *3-5.

A copy of the Memorandum Order is attached.