Amgen Inc. v. Alkem Laboratories Ltd., et al, No. 1:2017cv00815 - Document 23 (D. Del. 2017)

Court Description: MEMORANDUM OPINION re 18 Motion for Judgment on the Pleadings, re 20 Motion for Sanctions in C.A. No. 17-817 GMS. Signed by Judge Gregory M. Sleet on 12/19/2017. Associated Cases: 1:17-cv-00815-GMS, 1:17-cv-00817-GMS(asw)
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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE ----------AMGEN INC.. PlaintifL v. I Amgen Inc. v. Alkem Laboratories Ltd., et al ALKEM LABORATORIES Ltd. C.A. No. I 7-CV-815-GMS LEAD CASE Doc. 23 ) Defendant. AMGEN INC.. Plaintiff. I C.A. No. I 7-CV-8 I 7-GMS CONSOLIDATED ) ) ) ) Contains Confidential lnforn1ation Pursuant to L.R. 26.2 \. MACLEODS PHARMACEUTICALS. LTD .• and MACLEODS PHARMA CSA. INC.. Defendant. MEMORANDUM I. INTRODUCTION The plaintiff A1ngen, Inc. ('"Amgen··), pursuant to the Hatch-\\raxman Act. filed a patent infringement action against Macleods Phan11aceuticals LTD and Macleods Phanna USA. Inc. ("'Macleods"') fOr infringen1ent of one or n1ori: clauns of l!.S. flatent No. 9.375.405 (""the ·405 patenf') by the filing of its Ahhrcviated Nev" Drug ..\pplications (.. ANJ)A"') No. 209362 v-:ith the FD.A.. Presently before the court is Mac Icods· s Motion for Judgment on the Pleadings and Motion for Sanctions \Vith respect to 1\1ngcn"o, claims for infringcn1cnt of the ·405 patent. (D.I. 18. D.I. 10 in C.A. No. ! 7-817-GMS) For the reasons that fol!ov-'. the court will deny both n1otions. II. BACKGROUND Macleods triggered this lav. suit 1 tiling its AND.I\. seeking FDA approval to manufacture. use and/or sell a generic version of en ·s Sensipar·" product prior to the expiration of the ·405 patent. The ·405 patent is assigned to Amgen and is listed in the Ff)A ·s Orange Book as covering Sensipar·i<. The '405 patent claims a hinder composition that requires one of povidonc, hydroxypropyl rnethylccllulose. hydroxypropyl cellulose, sodium carhonxyincthylcellulosc. 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 1isted cxcipicnts. 1 therefore the A in gen 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 doctrin<.: of prosecution history estoppel.. (Id.) Additionally. currently pending bc10re the court is .'viacleods · s 1notion for sanctions under Fed. R. Ci,·. I). 11 arguing that .1\mgcn failed to conduct any inguir3 into the details of the accused products and, as a result. has no legal or fi1ctual basis for its suit. (D.I.20inC.A.Nn.17-817-GMS.) III. MOTION FOR JUDCMENT ON THE PLEADINGS A. STANDARD OF REVIEW When deciding a nlotion for judb,rment on the pleadings. the court 1nust vie\\' the facts and inferences drawn fro1n the pleadings in the light n1ost favorable f(1 the non-moving party. /?e1'c// r. l-\Jr/ ./Juth., 598 F.3d 128. 134 (3d Cir. 2010); Sec also (Tref'n r. Fund 11sset I\4gmt., L.P.. 24:5 F.3d 213. 220 (3d Cir. 2001 ). The court is ··not con1pelled to accept unsupported conclusions and un\varranted infercn<.:es. or a legal conclusion couched as a factual allegation." Bara/,a r In support of thio. assertion. r\tacleods points to An1gcn · s illlS\\'er to Mac leo<ls · counterclain1s \\'hen; .t\1ngen ackno\vledged that -according to the docu111cnts produced hy al the time -the generic product.; did not conwin any of the recited in the '405 patent. (D.L 27 at 3: 1).l. 14 26.) At stage in the litigation. the court ,,,.·ill no1 rule on ""'hether tvlacleods has directly infringed. 1ifc(Jreeve}'. 481 F.3d 187 (3d (_'ir. 2007) (internal citations and quotation marks omitted). The issue fOr the court is "not \.vhcther the plaintiff\.vill ultirnately prevail, but \.vhcther the claimant is entitled to offer evidence to support the c[ain1s." ,\'cheuer r Rh(Nfes, 416 lJ.S. 232, 236 ( 1974). B. DISCUSSION Macleods argues that An1gcn ·s claim for infringement under the doctrine of equivalents is barred by the doctrine of prosecution history cstoppel. (I).L 18 at 8 in l'.A. T\o. 17-817-GMS.) Amgen asserts that Macleods's n1otion sl1ould be denied for t\VO reasons. First. An1gcn argues that Mac]co<ls's motion should be converted into a n1otion li)r su1nn1ary judgment because it requires resolving factual issucs1 and. if converted, should be denied because there arc n1aterial facts in dispute. (D.l. 27 at 7-11 in ('.i\.. No. 17-817-GMS.) Second. Amgen insists that if the court docs consider Macleods's n1otion fOr judgn1ent on the pleadings. the court should tind that prosecution history estoppcl does not apply. (IJ.l. 27 at 11-18 in ('.A. No. 17-817-CiMS.) l'hus, the underlying issue before the court is \Vhcther. at the pleadings stage in this 1\Ni)A case \\'here the file history is highly technical and hotly disputed by the rartics. the court should non-suit the plaintiff. ·rhe application and scope of prosecution history cstoppcl is ultimately a n1a11er of la\v for the court to decide. J·'esto ('orJJ. v_ ,\'hoketsu Kinzoku Kog_vo Kuh11s/1iki ('o, 344 F.Jd 1359, 1368 (Fed. Cir. 2003). Where the patentee has narro\ved a clain1 tl1rough an1endn1ent, the court n1ust consider a fact intensive fran1c\vork to dctcr1ninc \Vhcthcr a1ncnd1nent-bascd A1ngcn attacks Macleods·s process in filing this rnotion and asserts that its reliance on the prosecution history requires that this 1notion be treated a.<. one for su1nrnary judg1nent under Ruic 56_ Fed R_ ('iv. P. 12(d); (J)_[_ 27 at 4.) ·rhe t:1cts in the ·405 prosecution history. unlike those in In re Rt'11dan1u.1·1inl!, are disputed by the parties. ·1 he court \\.-ith A1ngen that as il n:sult of the presence of1natcrial fil.ctual disputes, this 1notion should have been brought a surnrnary judgn1cnt 111otion ----ir at all rhe court \\'ill not convert the instant n1otion for judgment on the pleadings into a motion for sunl!nary judg1ncn! rnotiun for t\\.-o reasons. First. as An1gen correctly not permit surnrnary judgincnt practice in AN!JA case:>. Second, initial points out, the court typically started an entire rnonth after this Rule l2(c) \Vas filed on Septetnbcr 1 l. \vhich n1akes both summary judgment and. fi·ankly, the instant 1notion, prcn1aturc. 3 prosecution history estoppel exists and the scope of such cstoppcl. F cs lo CorfJ.• 344 F .3d at I :16()67. First. the court must dctl!rminc if the a1ncndml!nt \Vas narro\ving. /(/.at 1366. lfso. the court must then determine if the amendn1ent v>as 1nadc for reasons substantially related to patentability. Id. at 1366. If there is no clear reason for the amendn1ent. a rebuttable presu1nption is created that the patentee had a substantial reasons relating to patentahility. ill. at 1366. The patentee must rebut the presu1nption using facts fron1 the prosecution history to sho\\" that the an1endment \Vas not made for reasons relating to patcntability. !cl. at 13(16-67. This step necessarily requires the analysis of underlying facts. S'ec Festo Corp .. 344 F.3d at 1368 n.3 ("\\l'e recognize that rebuttal of the presumption may be subject to underlying tacts ... [n ]onethelcs:.. the resolution of factual issues underlying a legal question may properly be decided by the court ..,). Finally. if the court determines that the amendn1ent \vas n1ade fiJr reasons substantially related to patentability. then thl! court n1ust detenninc the scope of the surrender resulting fro1n the narro\ving a1nendn1ent. JJ. at 1367. Herc. there are material disputes of fact het\\'een the parties concen1ing the prosecution history of the "405 patent. 'fhus. the court must first resolve these disputes and that resolution \Viii inform the first two steps of the Fc,,.,·to analysis. Moving on to the scope of the su1Tendcr. absent an understanding of which equivalents arc in question and the equivalents of the listed binder excipients. neither of\vhich is discussed hy either part)' in its briefing, the court is unable to do its 1ob. This case is still in the early stages of litigation. Discovery did not begin in thi.-. case until one month after the filing of this nlotion. .A.I the ti1nc of the filing of this initial 1notion and A1ngen·s response. Amgen had not been provided an.\ infonnation rl!garding Maclcods·s generic product except for its public ANf)/\ filing and Macleods·s June 9. 2017 Notice l.cttcr. (D.l. 27 at 4 20 in C.J\. "\Jo. 17-817-CJMS.) Further, none of the cases cited by !v1aclcods in its briefing support its contention that on this record the court should grant its r11otion for judgn1cnt on the pleadings or con\·ert the motion into 011e for sun1n1ary judgn1cnt. Therefore. the court \.viii deny i\1acleods's motion for judgment on the pleadings. IV. MOTION FOR SANCTIONS Rule 11 of the Federal Rules of C:ivil J>rocedure allov·is a court to sanction a party or attorneys under limited circu1nstanccs. ··J<ule 11 (b) requires an attorney to conduct a reasonable inquiry into the la\\' and facts before filing a pleading in a court and to that the clain1s contained therein arc not tfivolous. legally unreasonable. \.vithout t:1ctual foundation. or as:;crtcd for an in1propcr purpose:· Q-Phltr1na. Inc. 1·. ,·1ndreu· .JerRens ( 'o , 360 F .3d 1295, 1300 (Fed. Cir. 2004). On September 15. 2017, six days atler filing its 1notion for judgn1ent on the pleadings, Macleods filed a motion fOr sanctions nrguing that there is no possibility of infringement of the '405 patent by Maclcods, either liternlly or under the doctrine of equivalents--the san1e argun1ent advanced in its motion fi)r judgment on the pleadings. (0.1. 20 in C'.J\. No. 17-817-({[VtS.) \\.Tith due regard for Macleods vicvvs and thoughts on the 1nattcr. its motion for sanctions is as premature as its pleadings motion, and not \veil taken. CONCLUSION For the foregoing rcaso11s the court \Viti deny the both Macleods's Motion for Judgn1ent on the Pleadings \.\·ith respect to An1gen's claln1s for inlfingernent of the '405 patent and Macl-•ods's Motion for Sanctions. (f).I. 18, J).I. 20 in ('.A. No. 17-817- ' Dated: f)eee1nber _Lj_, 2017 5