Case 1:17-cv-01407-CFC-SRF Document 629 Filed 02/12/20 Page 1 of 9 PageID #: 43363
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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF DELAWARE
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`GENENTECH, INC. and CITY OF
`HOPE,
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`Plaintiffs,
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`Civ. No. 17-1407- CFC, Consol.
`
`V.
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`AMGEN INC.,
`
`Defendant.
`
`Michael P. Kelly, Daniel M. Silver, MCCARTER &ENGLISH, LLP, Wilmington,
`Delaware; Paul B. Gaffney, David I. Berl, Thomas S. Fletcher, Teagan J. Gregory,
`Jonathan S. Sidhu, WILLIAMS & CONNOLLY LLP, Washington, D.C. Counsel
`for Plaintiffs.
`
`Melanie K. Sharp, James L. Higgins, YOUNG CONAWAY STARGATT &
`TAYLOR, LLP, Wilmington, Delaware; Siegmund Y. Gutman, PROSKAUER
`ROSE LLP, Los Angeles, California; Steven M. Bauer, PROSKAUER ROSE LLP,
`Boston, Massachusetts. Counsel for Defendant.
`
`MEMORANDUM OPINION
`
`February 12, 2020
`Wilmington, Delaware
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`GENENTECH, INC. and CITY OF
`HOPE,
`
`Plaintiffs,
`
`Civ. No. 17-1407- CFC, Consol.
`
`V.
`
`AMGEN INC.,
`
`Defendant.
`
`Michael P. Kelly, Daniel M. Silver, MCCARTER &ENGLISH, LLP, Wilmington,
`Delaware; Paul B. Gaffney, David I. Berl, Thomas S. Fletcher, Teagan J. Gregory,
`Jonathan S. Sidhu, WILLIAMS & CONNOLLY LLP, Washington, D.C. Counsel
`for Plaintiffs.
`
`Melanie K. Sharp, James L. Higgins, YOUNG CONAWAY STARGATT &
`TAYLOR, LLP, Wilmington, Delaware; Siegmund Y. Gutman, PROSKAUER
`ROSE LLP, Los Angeles, California; Steven M. Bauer, PROSKAUER ROSE LLP,
`Boston, Massachusetts. Counsel for Defendant.
`
`MEMORANDUM OPINION
`
`February 12, 2020
`Wilmington, Delaware
`
`
`
`Case 1:17-cv-01407-CFC-SRF Document 629 Filed 02/12/20 Page 2 of 9 PageID #: 43364
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`This action arises under the Biologics Price Competition and Innovation Act
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`of 2009 ("BPCIA"), 42 U.S.C. § 262. Plaintiffs Genentech, Inc. and City of Hope
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`( collectively "Plaintiffs") have sued Defendant Amgen Inc. ("Amgen") based on
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`Amgen' s submission of an Abbreviated Biologics License Application ("aBLA")
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`seeking approval to market Mvasi, a biosimilar of Genentech' s drug product
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`Avastin. Pending before me is Plaintiffs' Motion for Leave to File a Second
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`Amended and Supplemental Complaint. D.I. 263.
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`I.
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`LEGAL STANDARDS
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`Whether to grant or deny a motion for leave to amend is within the district
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`court's discretion. Foman v. Davis, 371 U.S. 178, 182 (1962). Under Federal Rule
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`of Civil Procedure 15(a)(2), "[t]he court should freely give leave when justice so
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`requires." The Third Circuit has adopted a liberal approach to the amendment of
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`pleadings to ensure that "a particular claim will be decided on the merits rather
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`than on technicalities." Dole v. Arco Chem. Co., 921 F.2d 484, 486-87 (3d Cir.
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`1990). Nevertheless, leave to amend should be denied where amendment is futile,
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`made in bad faith, or causes undue delay or prejudice. Oran v. Stafford, 226 F.3d
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`275, 291 (3d Cir. 2000); In re Burlington Coat Factory Sec. Litig., 114 F.3d 1410,
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`1434 (3d Cir. 1997). In addition, leave should be denied when the amendment
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`"relates only indirectly, if at all, to the original complaint and the alleged cause of
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`1
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`Case 1:17-cv-01407-CFC-SRF Document 629 Filed 02/12/20 Page 3 of 9 PageID #: 43365
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`action arose out [ of] an entirely unrelated set of facts and related to a defendant not
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`implicated in the original complaint." Bohm v. Straw, 2013 WL 100441, at *14
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`(W.D. Pa. Jan. 8, 2013) (quoting Nottingham v. Peoria, 709 F. Supp. 542, 544
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`(M.D. Pa. 1988)). In such circumstances, the unrelated claims "will not promote
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`judicial economy or the speedy disposition of the dispute between the parties." Id.
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`at 14.
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`II. DISCUSSION
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`Amgen objects to many but not all of Plaintiffs' proposed amendments. To
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`the extent Amgen does not object to the proposed amendments, I will grant
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`Plaintiffs' motion for leave to amend. See D.I. 263 at 3 (discussing
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`"housekeeping" amendments).
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`Amgen objects to four categories of proposed amendments. It has specific
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`objections to each category, but objects generally to all the proposed amendments
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`as untimely and prejudicial.
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`I will not deny Plaintiffs' motion based on its general objections. Plaintiffs
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`filed their motion on February 22, 2019, the last day amendments could be made
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`under the then-operative Scheduling Order, and several months before fact and
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`expert discovery were set to close. See D.I. 260. Moreover, Amgen has now
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`launched its biosimilar, Mvasi, and the trial date has been postponed until
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`2
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`Case 1:17-cv-01407-CFC-SRF Document 629 Filed 02/12/20 Page 4 of 9 PageID #: 43366
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`November 2020. See D.I. 504; D.I. 585; D.I. 613. This leaves Amgen's specific
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`objections to each category of proposed amendments, which I address in tum.
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`A. Section 271(g) Claims
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`Plaintiffs propose to add claims for declaratory and legal relief under 35
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`U.S.C. § 271(g) for eight of the method patents asserted in the First Amended
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`Complaint. See D.I. 263-1, Ex. A ,r,r 48, 68, 134, 144, 153, 167, 185,214.
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`Plaintiffs state that these claims arise out of Amgen' s alleged "use or sale of its
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`massive Mvasi stockpile," D.I. 301 at 5, and that "[n]o additional facts are required
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`to establish infringement [of these claims] (or a defense thereto)," id. at 5 n.5.
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`Amgen argues that leave to add these new claims should be denied on futility
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`grounds. Specifically, Amgen argues that the new claims fail to state a claim
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`under § 271 (g), because ( 1) they do not allege "the importation of a product of a
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`patented process practiced abroad," D.I. 293 at 18; and (2) they do not allege that
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`Plaintiffs lack "an adequate remedy separate from§ 27l(g)," id. at 19. Both of
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`these arguments lack merit.
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`First, § 271(g) does not require the importation of a product. Section 271(g)
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`provides in relevant part that "[ w ]hoever without authority imports into the United
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`States or offers to sell, sells, or uses within the United States a product which is
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`made by a process patented in the United States shall be liable as an infringer, if
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`the importation, offer to sell, sale, or use of the product occurs during the term of
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`3
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`Case 1:17-cv-01407-CFC-SRF Document 629 Filed 02/12/20 Page 5 of 9 PageID #: 43367
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`such process patent." 35 U.S.C. § 271(g) (emphasis added). The use of the
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`disjunctive makes clear that importation is not required to establish infringement
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`liability under§ 271(g).
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`Second,§ 271(g) does not require a showing that no remedy separate from§
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`271(g) exists under the Patent Act. Again the relevant language in the statute is
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`clear: "In an action for infringement of a process patent, no remedy may be granted
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`for infringement on account of the noncommercial use or retail sale of a product
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`unless there is no adequate remedy under this title for infringement on account of
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`the importation or other use, offer to sell, or sale of that product." 35 U.S.C. §
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`271(g) (emphasis added). The proposed amended claims do not allege
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`infringement based on noncommercial use or retail sales. Instead, they allege that
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`Amgen infringes under § 2 71 (g) by "making and/ or using ABP 215 in the United
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`States." D.I. 263-1, Ex. A ,r,r48, 68, 134, 144, 153, 167,185,214. Thus,§ 271(g)
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`does not require Plaintiffs to allege the lack of an adequate remedy under other
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`provisions in the Patent Act.
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`Accordingly, I will grant Plaintiffs leave to add their proposed § 2 71 (g)
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`claims.
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`B. The Repatha Claim
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`The First Amended Complaint alleges that Amgen' s manufacture of its
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`cancer drug Mvasi infringes U.S. Patent No. 8,574,869 (the "#869 patent"). The
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`4
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`Case 1:17-cv-01407-CFC-SRF Document 629 Filed 02/12/20 Page 6 of 9 PageID #: 43368
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`#869 patent claims a method for prevention of disulfide bond reduction by,
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`following fermentation, sparging pre-harvested or harvested cell culture fluid.
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`'869 patent at 107 :44-49. The proposed amended complaint adds a claim, based
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`on information obtained during discovery, that Amgen' s manufacture of the
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`cholesterol drug Repatha also infringes the #869 patent. Plaintiffs argue that
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`adding the Repatha claim to this litigation will avoid unnecessary waste, because
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`the claims involve similar issues regarding validity and infringement. I disagree.
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`The drug at issue in the Abbreviated Biologics License Application that gave
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`rise to this BPCIA action is Mvasi, not Repatha. Plaintiffs suggest that adding
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`claims related to Repatha would not greatly expand the scope of this case, but the
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`scope of this case for the Mvasi drug alone is already substantial by any measure.
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`Plaintiffs' initial complaint had 47 counts based on 24 patents, prompting the
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`Honorable Gregory M. Sleet, then presiding, to describe the case as "unwieldly."
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`See Minute Entry {Apr. 11, 2018). Judge Sleet's description was prescient. The
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`case has to date involved more than 11 days of in-person discovery conferences,
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`three days of Markman hearings, several motions, and a preliminary injunction
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`ruling. To expand the scope of the case after two years of intense litigation to add
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`claims that concern a different drug, a different disease, and a different
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`manufacturing process would undermine the.Court's previous efforts to drive the
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`case to a reasonable and efficient conclusion. Accordingly, I will deny Plaintiffs
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`5
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`Case 1:17-cv-01407-CFC-SRF Document 629 Filed 02/12/20 Page 7 of 9 PageID #: 43369
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`leave to add their proposed claims related to Repatha. See Bohm, 2013 WL
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`100441, at * 14 ( denying leave to amend where the addition of unrelated claims
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`"will not promote judicial economy or the speedy disposition of the dispute
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`between the parties").
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`C. Actual Infringement of the #269 Patent
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`The First Amended Complaint alleges that Amgen will infringe U.S. Patent
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`No. 7,060,269 (the "#269 patent") in the future when its customers prescribe
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`and/or administer Mvasi to cancer patients. According to Plaintiffs, discovery
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`showed that Amgen has already infringed the #269 patent during clinical trials
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`undertaken for foreign regulatory approvals. Thus, the proposed amended
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`complaint adds a claim for past infringement of the #269 patent. Amgen asks the
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`court to deny this amendment as futile, because the allegations in the proposed
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`amended complaint are "barebones." D.I. 293 at 14.
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`A claim for infringement need only provide "fair notice of what the claim is
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`and the ground upon which it rests." Disc Disease Sols. Inc. v. VGH Sols., Inc.,
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`888 F.3d 1256, 1260 (Fed. Cir. 2018) (internal ellipses omitted) (quoting Erickson
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`v. Pardus, 551 U.S. 89, 93 (2007)). The proposed amended complaint satisfies this
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`standard, alleging use of a specific product (Mvasi) in a particular manner (during
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`clinical trials) that infringed a specific claim (Claim 2) of the #269 patent. See D.I.
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`6
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`Case 1:17-cv-01407-CFC-SRF Document 629 Filed 02/12/20 Page 8 of 9 PageID #: 43370
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`293-1 ,r,r 85-92. Accordingly, I will grant Plaintiffs leave to add their proposed
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`claim for past infringement of the #269 patent.
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`D. Conditional Amendments
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`For the stated purpose of "avoid[ing] delay should the Court deny Plaintiffs'
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`pending motion to dismiss Amgen's counterclaims" (i.e., the motion at C.A. No.
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`17-1407, D.I. 128), Plaintiffs propose adding two claims and one patent that were
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`not identified during the parties' pre-litigation "patent dance" exchanges. D.I. 263
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`at 3. Specifically, Plaintiffs propose adding U.S. Patent No. 9,714,293 (the "#293
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`patent"), claim 4 of the #869 patent, and claim 81 of U.S. Patent No. 9,441,035
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`(the "#035 patent). D.I. 263 at 3.
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`Yesterday, I granted in part and denied in part Plaintiffs' motion to dismiss
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`Amgen's counterclaims. D.I. 626. It is unclear whether and, if so, in what way,
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`my decision to grant in part and deny in part Amgen's motion to dismiss affects
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`Plaintiffs' request to add to the case the proposed allegations concerning the #293
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`and #869 patents. It is also unclear whether the case management limitations
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`Judge Sleet and I placed on the parties to make it possible to actually litigate this
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`case would allow for the addition of the proposed allegations concerning those
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`patents. Accordingly, I will deny Plaintiffs' motion insofar as it seeks to amend
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`the First Amended Complaint to add allegations relating to the #293 and #869
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`patents, but will permit Plaintiffs to raise the issue of adding the proposed
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`7
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`Case 1:17-cv-01407-CFC-SRF Document 629 Filed 02/12/20 Page 9 of 9 PageID #: 43371
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`allegations concerning those patents at the next status conference convened by the
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`Court. I will deny the proposed addition of the #03 5 patent as moot, since the
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`parties entered into a stipulated judgment of noninfringement for the #035 patent.
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`SeeD.I. 484.
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`III. CONCLUSION
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`For the foregoing reasons, Plaintiffs' motion for leave to file a second
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`amended and supplemental complaint (D.I. 263) is granted in part and denied in
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`part.
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`The Court will issue an Order consistent with this Memorandum Opinion.
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`8
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