Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Amgen Inc. v. Alkem Laboratories Ltd.

United States District Court, D. Delaware

December 19, 2017

AMGEN INC., Plaintiff,
v.
ALKEM LABORATORIES Ltd. Defendant. AMGEN INC., Plaintiff.
v.
MACLEODS PHARMACEUTICALS, LTD., and MACLEODS PHARMA USA. INC.. Defendant.

         Contains Confidential Information Pursuant to L.R. 26.2

          MEMORANDUM

         I. INTRODUCTION

         The plaintiff Amgen, Inc. C'Amgen"), pursuant to the Hateh-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. 9375.405 ("'the "405 patent"1) by the filing of its Abbreviated New Drug Applications ("ANDA") No. 209362 with the FDA. Presently before the court is Macleods"s Motion for Judgment on the Pleadings and Motion for Sanctions with respect to Amgcrf 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 AND A. seeking FDA approval to manufacture. use and/or sell a generic version of Amgcn'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 povidone, hydroxypropyl methylcellulose. hydroxypropyl cellulose, sodium carbonxyincthylcellulosc. or a mixture thereof as a binder present in a pharmaceutical composition. Macleodss alleges that its ANDA products do not contain any of the listed cxeipicnts.[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.) Macleods 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. 17-81 7-GMS.)

         III. MOTION FOR JUDGMENT 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. Porl Auth., 598 F.3d 128. 134 (3d Cir. 2010); Sec also Green v. Fund Asset Mgmt., LP., 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 dr. 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." Scheucr 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 dented for two reasons. First, Amgen argues that Macleods's motion should be converted into a motion for summary judgment because it requires resolving factual issues[2] and. if converted, should be denied because there are material tacts in dispute. (D.l. 27 at 7-11 in C.A. No. 17-8I7-GMS.) Second. Amgen insists that if the court does 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. Fesio Corp. v. Shokefsu Kinzoku Kogyo 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. Fcsto 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. Sec Fcsto Corp., 344 F, 3d at 1368 n.3 (“We recognize that rehuttal of the presumption maybe subject to underlying facts . . . [n]onethelcss, the resolution of factual issues underlying a legal question may properly he 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 Fcsto 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 hy 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 ease until one month after the tiling of this motion. At the tune of the tiling of this initial motion and Amgen's response. Amgen had not been provided any information regarding Macleods's generic product except for its public AND A tiling 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. ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.