Case 1:21-cv-01411-RGA-LDH Document 333 Filed 05/17/24 Page 1 of 7 PageID #: 42458
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`ALLERGAN, INC., ALLERGAN
`PHARMACEUTICALS IRELAND
`UNLIMITED COMP ANY, and
`ALLERGAN USA, INC.,
`
`Plaintiffs,
`
`V.
`
`REV ANCE THERAPEUTICS, INC. and
`AJINOMOTO AL THEA, INC. d/b/a
`AJINOMOTO BIO-PHARMA SERVICES,
`
`Defendants.
`
`Civil Action No. 21-1411-RGA
`
`MEMORANDUM ORDER
`
`Before me is Plaintiffs' Motion for Leave to Amend Complaint. (D.I. 294). I have
`
`considered the parties' briefing. (D.I. 295, 304, 308).
`
`I.
`
`BACKGROUND
`
`Plaintiffs filed the present action on October 1, 2021, alleging that Defendants infringed
`
`U.S. Patent No. 7,354,740 ("the '740 patent"), U.S. Patent No. 8,409,828 ("the '828 patent"),
`
`and seven other patents (collectively, "the Asserted Patents"). (D.I. 1). The Asserted Patents are
`
`directed towards purifying botulinum toxins, which allows them to be used in botulinum
`
`injectable products such as Plaintiffs' BOTOX product. (D.I. 79 ,r,r 14-16).
`
`Plaintiffs have already amended their complaint twice, with the Second Amended
`
`Complaint (the "SAC") having been filed on December 30, 2022. (D.I. 79). Ofrelevance to the
`
`present motion, the SAC cites to Defendants' U.S. Patent No. 9,469,849 ("the '849 patent") as
`
`part of the discussion of Defendants' manufacturing process for its botulinum injectable product.
`
`1
`
`

`

`Case 1:21-cv-01411-RGA-LDH Document 333 Filed 05/17/24 Page 2 of 7 PageID #: 42459
`
`(D.I. 79 ,r,r 69-72). Dr. Curtis Ruegg, Defendant Revance Therapeutic's former Executive Vice
`
`President for Research and Development, is credited as the sole inventor of the '849 patent. (Id.
`
`,r,r 78-79). Plaintiffs now seeks to amend its complaint again, this time to add allegations of
`
`willful infringement claims of the '740 and '828 patents. (D.I. 294; see D.I. 294-1, Ex. A).
`
`On September 23, 2022, Allergan served document requests and an interrogatory
`
`("Interrogatory No. 3") relating to Defendants' knowledge and awareness of the Asserted
`
`Patents. (D.I. 295-1, Ex. 2 at 11; id., Ex. 3 at 4 ). Defendants' October 24, 2022 response to
`
`Plaintiffs' discovery request objected to Interrogatory No. 3 on the basis that it was "not relevant
`
`to any claim or defense in this case ... at least for the reason that Plaintiffs have not alleged
`
`willful infringement." (D.I. 304-1, Ex. A at 13). Defendants' response concluded, "Defendants
`
`do not intend to supply a response to this Interrogatory as currently drafted in view of the above(cid:173)
`
`stated objections." (Id.).
`
`On November 18, 2022, Plaintiffs' counsel wrote a letter to Defendants' counsel
`
`asserting that Interrogatory No. 3 "concerns relevant information in this case, such as
`
`infringement and damages issues" and asking Defendants to "provide a supplemental response to
`
`this interrogatory without delay." (Id., Ex.Bat 4). The parties met and conferred on January 12,
`
`2023. (See id., Ex. F). Defendants' January 25, 2023 letter memorialized the meeting, stating,
`
`"As Allergan conceded during the parties' meet and confer, willfulness and induced
`
`infringement are not at issue in this case. Thus, the information requested in Interrogatory No. 3
`
`... [is] not relevant to any parties' claims or defenses." (Id., Ex. Cat 3).
`
`On February 23, 2023, Defendants sent another letter reiterating their understanding of
`
`Interrogatory No. 3. (Id., Ex. D at 3 ("Requests .. . directed to Defendants' knowledge of the
`
`2
`
`

`

`Case 1:21-cv-01411-RGA-LDH Document 333 Filed 05/17/24 Page 3 of 7 PageID #: 42460
`
`Asserted Patents . .. are not relevant.")). On February 28, 2023, Defendants sent an email to
`
`Plaintiffs that stated:
`
`In your January 27, 2023 letter, Allergan states that it has not "conceded .
`willfulness and induced infringement are not at issue in this case."
`
`When the parties met and conferred on January 12, 2023, . . . Allergan explicitly
`acknowledged that willful and indirect infringement are not part of this case. When
`Defendants memorialized this acknowledgement in their January 17, 2023 email,
`Allergan did not specifically deny these concessions. Instead, Allergan merely
`disagreed that these Requests "are not relevant to claims or defenses in this case."
`Importantly, Allergan never affirmatively stated that it believed willfulness and
`indirect infringement were part of this case, or otherwise disagreed with
`Defendants' statement that willfulness and indirect infringement are not part of this
`case.
`
`Now, Allergan appears to walk back these positions . ... Allergan's shifting
`positions are not productive. If Allergan believes it has pled a claim of willful or
`indirect infringement, please direct us to where it believes such claims were made
`and to any allegations Allergan believes support such claims, so that Defendants
`may consider them.
`
`(Id., Ex. F) (citations omitted). Plaintiffs did not respond to this email. (D.I. 304 at 5).
`
`Roughly six months later, on August 25, 2023 , Plaintiffs served a deposition subpoena on
`
`Dr. Ruegg. (D.I. 207). On August 31, 2023, Plaintiffs informed Defendants that they would be
`
`moving to compel supplementation of Defendants' Interrogatory No. 3 response. (D.I. 304-1,
`
`Ex. G at 4 ). Plaintiffs' letter indicated the basis for its motion was that "Defendants' position
`
`that Plaintiffs have not alleged induced infringement .. . is entirely baseless" and that
`
`"Defendants have never disputed that Plaintiffs have alleged contributory infringement. (Id. at 4
`
`& n. 1 ). Plaintiffs amended its infringement contentions on September 19, 2023 to include
`
`contributory infringement allegations. (D.I. 304 at 5; see D.I. 304-1, Ex. H). Defendants agreed
`
`to supplement its Interrogatory No. 3 response, purportedly because they agreed that knowledge
`
`of the patents was a relevant inquiry for contributory infringement. (D.I. 304 at 5). This
`
`supplemental response was served on October 4, 2023. (D.I. 304-1 , Ex. J).
`
`3
`
`

`

`Case 1:21-cv-01411-RGA-LDH Document 333 Filed 05/17/24 Page 4 of 7 PageID #: 42461
`
`Plaintiffs' counsel deposed Dr. Ruegg on October 6, 2023. (See D.I. 295-1 , Ex. 6). On
`
`November 3, 2023, Defendants produced five documents from Dr. Ruegg's custodial files :
`
`copies of the '740 patent and the '828 patent (D.I. 295-1, Ex. 8; D.I. 295-2, Ex. 9), a copy of a
`
`publication of an earlier patent application leading to those patents (D.I. 295-2, Ex. 10), and
`
`curriculum vitae for two of the inventors of the ' 740 and '828 patents (D.1. 259-1 , Ex. 11- 12).
`
`Fact discovery closed on November 3, 2023. (D.I. 237). Defendants produced the underlying
`
`metadata associated with these documents on November 15, 2023 . (D.1. 295 at 5).
`
`On November 22, 2023, Plaintiffs informed Defendants that they intended to request
`
`leave to amend its complaint. (D.I. 304-2, Ex. K). Plaintiffs subsequently filed the present
`
`motion on January 19, 2024. (D.I. 294). The deadline for filing motions to amend pleadings was
`
`February 2, 2023. (D.I. 54 ,r 2).
`
`II.
`
`LEGAL STANDARD
`
`Federal Rule of Civil Procedure 15(a)(2) states that, apart from amendments as a matter
`
`of course, "a party may amend its pleading only with the opposing party's written consent or the
`
`court's leave." Fed. R. Civ. P. 15(a)(2). "The court should freely give leave when justice so
`
`requires." Id. The Third Circuit has construed Rule 15, instructing that "absent undue or
`
`substantial prejudice, an amendment should be allowed under Rule 15(a) unless 'denial [can] be
`
`grounded in bad faith or dilatory motive, truly undue or unexplained delay, repeated failure to
`
`cure deficiency by amendments previously allowed or futility of amendment. "' Long v. Wilson,
`
`393 F.3d 390,400 (3d Cir. 2004) (quoting Lundy v. Adamar of New Jersey, Inc. , 34 F.3d 1173,
`
`1196 (3d Cir. 1994)) (emphasis omitted).
`
`Federal Rule of Civil Procedure 16(b) also applies when, as here, a party moves to amend
`
`past the date set by the scheduling order. E. Minerals & Chemicals Co. v. Mahan, 225 F.3d 330,
`
`4
`
`

`

`Case 1:21-cv-01411-RGA-LDH Document 333 Filed 05/17/24 Page 5 of 7 PageID #: 42462
`
`340 (3d Cir. 2000); Media Pharm. Inc. v. Teva Pharm. USA, Inc., 2016 WL 6693113, at *1 &
`
`n.2 (D. Del. Nov. 14, 2016). Rule 16(b)(4) provides, "A schedule may be modified only for
`
`good cause and with the judge's consent." FED. R. Crv. P. 16(b)(4). "Good cause is present when
`
`the schedule cannot be met despite the moving party's diligence." Media Pharm., 2016 WL
`
`6693113, at * 1. "In contrast to Rule 15(a), the good cause standard under Rule 16(b) hinges on
`
`diligence of the movant, and not on prejudice to the non-moving party." S. Track & Pump, Inc.
`
`v. Terex Corp., 722 F. Supp. 2d 509, 521 (D. Del. 2010).
`
`III. ANALYSIS
`
`Defendants argue that Plaintiffs cannot show good cause because Plaintiffs did not
`
`diligently pursue the discovery on which their proposed amendment rests. (D.I. 304 at 11).
`
`Defendants note that a total of six-and-a-half months elapsed between the amended pleadings
`
`deadline and the Plaintiffs' deposition subpoena to Dr. Ruegg. (Id. at 12).
`
`Plaintiffs argue that Defendants "misleadingly frame[] the timeline of the parties'
`
`interactions," but Plaintiffs do not assert any material differences to Defendants' version of
`
`events. (D.I. 308 at 4). The record demonstrates that, between October 2022 and February 2023,
`
`Defendants repeatedly made clear their understanding that willful infringement and induced
`
`infringement were not at issue in this case and, therefore, they did not intend to supplement their
`
`Interrogatory No. 3 response or produce evidence related to knowledge of the Asserted Patents.
`
`Plaintiffs did not pursue any courses of action to further the production of relevant discovery.
`
`For example, Plaintiff did not raise any discovery disputes resulting from Defendants' clear
`
`indication that they would not produce evidence related to willfulness. Nor did Plaintiffs
`
`respond to Defendants' February 28, 2023 email which sought clarification on Plaintiffs' posture
`
`in light of perceived disparities between the positions Plaintiffs expressed at the January 12,
`
`5
`
`

`

`Case 1:21-cv-01411-RGA-LDH Document 333 Filed 05/17/24 Page 6 of 7 PageID #: 42463
`
`2024 meet and confer and in their January 27, 2024 email. 1 Plaintiffs instead waited six months
`
`before taking their next step to advance willfulness-related discovery by serving a deposition
`
`subpoena of Dr. Ruegg.2
`
`Plaintiffs provide no explanation for their failure to engage in diligent discovery efforts
`
`between February 2023 and August 2023. Plaintiffs instead attempt to center the diligence
`
`inquiry on the period starting in August 2023, when they began their discovery efforts that led to
`
`the acquisition of "new" information related to willfulness. (D.I. 295 at 7- 9; D.I. 308 at 2----6).
`
`Even accepting Plaintiffs' diligence from August 2023 onwards, Plaintiffs' later diligence does
`
`not excuse half a year of inaction.
`
`In sum, Plaintiffs fail to establish good cause where, instead of diligently pursuing
`
`discovery, they idled for six months before launching earnest efforts to obtain the relevant
`
`evidence. I therefore decline to grant Plaintiffs leave to amend their complaint to add willful
`
`infringement claims.
`
`I need not address Defendants' remaining arguments.
`
`IV. CONCLUSION
`
`For the reasons set forth above, Plaintiffs' Motion for Leave to Amend Complaint (D.I.
`
`294) is DENIED.
`
`1 Though the February 28, 2023 email came after the February 2, 2023 deadline, it was written as
`a response to Plaintiffs' January 27, 2023 letter. (D.I. 304-1, Ex. F). Plaintiffs' diligence
`argument would be more credible had Plaintiffs pursued timely action in response to this email.
`
`2 Plaintiffs' August 31, 2023 letter suggests the basis for their seeking patent-related discovery
`was not related to willful infringement claims. (See D.I. 304-1, Ex. G at 4 & n. 1). I
`nevertheless assume the opposite for the purposes of this motion, as making that assumption
`does not affect my conclusion.
`
`6
`
`

`

`Case 1:21-cv-01411-RGA-LDH Document 333 Filed 05/17/24 Page 7 of 7 PageID #: 42464
`
`IT IS SO ORDERED.
`
`Entered this /7 ~ of May, 2024
`
`7
`
`