MEMORANDUM

Contains Confidential Information Pursuant to L.R. 26.2

GREGORY M. SLEET, District Judge.

I. INTRODUCTION

The plaintiff Amgen, Inc. ("Amgen"), pursuant to the Hatch-Waxman Act. filed a patent infringement action against Macleods Pharmaceuticals LTD and Macleods Phanna USA, Inc. ("Macleods") for infringement of one or more claims of U.S. Patent No. 9,375,405 ("the '405 patent") by the filing of its Abbreviated New Drug Applications ("ANDA") No. 209362 with the FDA. Presently before the court is MacIeods's Motion for Judgment on the Pleadings and Motion for Sanctions with respect to Amgen's, claims for infringement of the '405 patent. (D.I. 18. D.I. 20 in C.A. No. 17-817-GMS) For the reasons that follow the court will deny both motions.

II. BACKGROUND

Macleods triggered this lawsuit by filing its ANDA seeking FDA approval to manufacture. use and/or sell a generic version of Amgen's Sensipar® product prior to the expiration of the '405 patent. The '405 patent is assigned to Amgen and is listed in the FDA's Orange Book as covering Sensipar®. The '405 patent claims a binder composition that requires one of povidonc, hydroxypropyl methylcellulose, hydroxypropyl cellulose, sodium carbonxyinethyl cellulose or a mixture thereof as a binder present in a pharmaceutical composition. Macleods's alleges that its ANDA products do not contain any of the listed exeipients.1 therefore the Amgen could only assert a claim under the doctrine of equivalents. (D.I. 18 at 1 in C.A. No. 17-817-GMS.) Maclcods argues that Amgen's potential claim under the doctrine of equivalents is barred by the doctrine of prosecution history estoppel. (Id.) Additionally, currently pending before the court is Macleods's motion for sanctions under Fed. R. Civ. P. 11 arguing that Amgen failed to conduct any inquiry into the details of the accused products and as a result has no legal or factual basis for its suit. (D.I. 20 in C.A. No. 17-817-GMS.)

III. MOTION FOR JUDCMENT ON THE PLEADINGS

A. STANDARD OF REVIEW

When deciding a motion for judgment on the pleadings, the court must view the facts and inferences drawn from the pleadings in the light most favorable to the non-moving party. Revell v. Port Auth., 598 F.3d 128, 134 (3d Cir. 2010); Sec also Green v. Fund Asset Mgmt., L.P., 245 F.3d 213, 220 (3d Cir. 2001). The court is "not compelled to accept unsupported conclusions and unwarranted inferences, or a legal conclusion couched as a factual allegation." Baraka v. McGreevey, 481 F.3d 187 (3d Cir. 2007)(internal citations and quotation marks omitted). The issue for the court is "not whether the plaintiff will ultimately prevail, but whether the claimant is entitled to offer evidence to support the claims." Scheuer v. Rhodes, 416 U.S. 232, 236 (1974).

B. DISCUSSION

Macleods argues that Amgen's claim for infringement under the doctrine of equivalents is barred by the doctrine of prosecution history estoppel. (D.I. 18 at 8 in C.A. No. 17-817-GMS.) Amgen asserts that Macleods's motion should be denied for two reasons. First, Amgen argues that Macleods's motion should be converted into a motion for summary judgment because it requires resolving factual issues2 and if converted, should be denied because there are material facts in dispute. (D.I. 27 at 7-11 in C.A. No. 17-817-GMS.) Second, Amgen insists that if the court docs consider Macleods's motion for judgment on the pleadings, the court should find that prosecution history estoppel does not apply. (D.I. 27 at 11-18 in C.A. No. 17-817-GMS.) Thus, the underlying issue before the court is whether, at the pleadings stage in this ANDA case where the file history is highly technical and hotly disputed by the parties, the court should non-suit the plaintiff.

The application and scope of prosecution history estoppel is ultimately a matter of law for the court to decide. Festo Corp. v. Shoketsu Kinzoku Kogvo Kabushiki Co. 344 F.3d 1359, 1368 (Fed. Cir. 2003). Where the patentee has narrowed a claim through amendment, the court must consider a three-part, fact intensive framework to determine whether amendment-based prosecution history estoppel exists and the scope of such estoppel. Festo Corp., 344 F.3d at 1366-67. First, the court must determine if the amendment was narrowing. Id. at 1366. If so, the court must then determine if the amendment was made for reasons substantially related to patentability. Id. at 1366. If there is no clear reason for the amendment, a rebuttable presumption is created that the patentee had a substantial reasons relating to patentability. Id. at 1366. The patentee must rebut the presumption using facts from the prosecution history to show that the amendment was not made for reasons relating to patentability. Id. at 1366-67. This step necessarily requires the analysis of underlying facts. See Festo Corp., 344 F.3d at 1368 n.3 ("We recognize that rebuttal of the presumption may be subject to underlying tacts . . . [n]onetheless, the resolution of factual issues underlying a legal question may properly be decided by the court."). Finally, if the court determines that the amendment was made for reasons substantially related to patentability, then the court must determine the scope of the surrender resulting from the narrowing amendment. Id. at 1367.

Here, there are material disputes of fact between the parties concerning the prosecution history of the '405 patent. Thus, the court must first resolve these disputes and that resolution will inform the first two steps of the Festo analysis. Moving on to the scope of the surrender, absent an understanding of which equivalents are in question and the equivalents of the listed binder excipients, neither of which is discussed by either party in its briefing, the court is unable to do its job.

This case is still in the early stages of litigation. Discovery did not begin in this case until one month after the filing of this motion. At the time of the filing of this initial motion and Amgen's response. Amgen had not been provided any information regarding Maclcods's generic product except for its public ANDA filing and Macleods's June 9, 2017 Notice letter. (D.I. 27 at 20 in C.A. No. 17-817-GMS.) Further, none of the cases cited by Macleods in its briefing support its contention that on this record the court should grant its motion for judgment on the pleadings or convert the motion into one for summary judgment. Therefore, the court will deny Macleods's motion for judgment on the pleadings.

IV. MOTION FOR SANCTIONS

Rule 11 of the Federal Rules of Civil Procedure allows is a court to sanction a party or attorneys under limited circumstances. "Rule 11 (b) requires an attorney to conduct a reasonable inquiry into the law and facts before filing a pleading in a court and to certify, that the claims contained therein arc not frivolous, legally unreasonable, without factual foundation, or asserted for an improper purpose" Q-Pharma. Inc. v. Andrew Jergens Co., 360 F.3d 1295, 1300 (Fed. Cir. 2004). On September 15, 2017, six days atler filing its motion for judgment on the pleadings, Macleods filed a motion for sanctions arguing that there is no possibility of infringement of the '405 patent by Maclcods, either literally or under the doctrine of equivalents—the same argument advanced in its motion for judgment on the pleadings. (D.I. 20 in C.A. No. 17-817-GMS.) With due regard for Macleods views and thoughts on the matter, its motion for sanctions is as premature as its pleadings motion, and not well taken.

CONCLUSION

For the foregoing reasons the court will deny the both Macleods's Motion for Judgment on the Pleadings with respect to Amgen's claims for infringement of the '405 patent and Macleods's Motion for Sanctions. (D.I. 18, D.I. 20 in C.A. No. 17-817-GMS.)