Case 1:20-cv-00690-DNH-CFH Document 73 Filed 08/12/21 Page 1 of 24
`
`
`
`CIVIL CASE MANAGEMENT PLAN
`
`No. 1:20-CV-690 (TJM/CFH)
`
`UNITED STATES DISTRICT COURT
`NORTHERN DISTRICT OF NEW YORK
`__________________________________
`
`Novartis Pharma AG,
`Novartis Pharmaceuticals Corporation,
`and Novartis Technology LLC,
`
`VS
`
`Regeneron Pharmaceuticals, Inc.
`__________________________________
`
`IT IS HEREBY ORDERED that, pursuant to Rule 16(b), Federal Rules of Civil Procedure, a status
`and scheduling conference will be held in this case before the Honorable Christian F. Hummel,
`United States Magistrate Judge on August 18, 2021 at 10:30 A.M. in Albany.
`
`Counsel for all parties or individuals appearing pro se in the above-captioned action are directed to
`confer in accordance with Fed. R. Civ. P. 26(f) with respect to all of the agenda items listed below.
`That meeting must be attended in person or, if counsel for the parties are not located in the same city
`and do not agree to meet in person, then by telephone, and must be held at least twenty-one (21) days
`before the scheduled Rule 16 Conference. Following that Rule 26(f) meeting, a report of the results of
`that meeting, in the format set forth below, must be filed with the clerk within fourteen (14) days after
`the date of the Rule 26(f) meeting or not later than ten (10) days prior to the scheduled Rule 16
`conference with the Court, whichever date is earlier. Matters which the Court will discuss at the status
`conference will include the following: (insert a separate subparagraph as necessary if parties disagree):
`
`1) JOINDER OF PARTIES: Any application to join any person as a party to this action shall be
`made on or before the 15th day of September, 2021. Third party Vetter Pharma International GMBH
`(“Vetter”) is currently a party to the case pending before the Southern District of New York
`(“SDNY”), Regeneron Pharmaceuticals, Inc. v. Novartis Pharma AG, Novartis Technology LLC,
`Novartis Pharmaceuticals Corporation, Vetter Pharma International GMBH, Case No. 1:20-cv-
`05502-AJN (“SDNY Action”), and Vetter has requested that Regeneron’s antitrust claims in the
`SDNY Action be transferred to this court. Thus, Vetter would need to be added as a party if the SDNY
`Action is transferred here.
`
`2) AMENDMENT OF PLEADINGS: Any application to amend the pleadings to this action shall be
`made on or before the 15th day of September, 2021.
`
`
`
`
`
`
`
`
`
`ACTIVE/111473105.6
`
`
`
`Page 1
`
`
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 73 Filed 08/12/21 Page 2 of 24
`
`
`
`3) DISCOVERY:
`
`Novartis’s Position:
`
`
`All fact and expert discovery in this action shall be completed by May 16, 2022, which is the
`close of all discovery in the related SDNY Action. Local Patent Rule 2.1(b)(1) specifically
`contemplates potential “modification of the obligations or deadlines set forth in these local
`patent rules to ensure that they are suitable for the circumstances of the particular case.”
`Novartis submits that the unique circumstances of this case, including the discovery that took
`place in the companion International Trade Commission patent infringement Investigation In
`the Matter of Certain Pre-filled Syringes for Intravitreal Injection and Components Thereof,
`Investigation No. 337-TA-1207 (the “ITC Action”) and the discovery that is taking place in the
`co-pending and related SDNY Action, make it appropriate to modify the local patent rule
`deadline for the close of discovery so that it is coordinated with discovery in the SDNY
`Action..
`
`It should be noted that Novartis’s proposed schedule is not “expedited” because of Regeneron’s
`request for inter partes review as Regeneron contends. The Local Rules provide that the trial
`date should be within 18 months from the date the complaint is filed unless “the case is of such
`a complex nature that it cannot reasonably be trial ready” by then. Novartis submits that the
`unique circumstances here actually make this case much less complex than an ordinary patent
`case, and make trial within the presumptive 18 months entirely reasonable.
`
`Regardless of the outcome of the ITC Action, this case was going to go forward because the
`ITC cannot award damages for patent infringement. As such, district court actions after ITC
`proceedings are commonplace, and, by statute, should not be delayed. As 28 U.S.C. § 1659(b)
`recognizes, a district court patent litigation following a parallel ITC proceeding, the exact
`situation we have here, should not start from scratch. The statute provides that the record from
`the ITC case “shall be transmitted to the district court and shall be admissible in the civil
`action, subject to such protective order as the district court determines necessary, to the extent
`permitted under the Federal Rules of Evidence and the Federal Rules of Civil Procedure.”
`According to its legislative history, the purpose of the statute is to help “expedite” the district
`court case. See H.R. Rep. No. 103-826(I) at 142 (1994). Here, as explained below, discovery
`can proceed even more efficiently and expeditiously because of the related SDNY Action.1
`
`
`
`
`1 At several points in this submission Regeneron refers to the Staff attorney pre-hearing brief in
`the ITC Action as being somehow relevant to the schedule here. It is not. Regeneron’s unsupported
`speculations aside, the Staff attorney’s brief was not the reason for Novartis’s decision to terminate the
`ITC Investigation. As Novartis stated in its motion to terminate the ITC Action, it “strongly believe[d]
`it would prevail on the merits in this investigation—indeed, the Administrative Law Judge recently
`granted Novartis’s motion for partial summary determination that Regeneron directly infringed [the
`’631 patent]—[and] that the [’631 patent] is valid and that Regeneron cannot prove otherwise.”
`Novartis’s reason for terminating the Investigation and seeking to lift the stay in this action was based
`on the fact that the only remedy available at the ITC was an exclusion order and Novartis was
`concerned that the ITC would significantly delay the implementation of an exclusion order because of,
`among other things, the COVID pandemic. Moreover, as previously explained to the Court, the ITC
`Page 2
`
`
`
`ACTIVE/111473105.6
`
`
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`Case 1:20-cv-00690-DNH-CFH Document 73 Filed 08/12/21 Page 3 of 24
`
`
`As a general matter, discovery in patent cases is related to three issues: infringement of the
`patent, affirmative defenses to infringement, and damages. As set forth below, full discovery
`on Regeneron’s infringement of the patent in suit, Novartis’s U.S. Patent No. 9,220,631 (“the
`ʼ631 patent”), and on Regeneron’s affirmative defenses other than inequitable conduct took
`place in the companion International Trade Commission patent infringement Investigation In
`the Matter of Certain Pre-filled Syringes for Intravitreal Injection and Components Thereof,
`Investigation No. 337-TA-1207 (the “ITC Action”).
`
`Regeneron’s Infringement of the ʼ631 Patent
`
`This case is based on Regeneron’s infringement of Novartis’s ʼ631 patent through its
`manufacture and sale of its EYLEA® pre-filled syringe product (“EYLEA PFS”). The same
`claim of infringement was at issue in the ITC Action. There should be no need for discovery
`on infringement in this case because full discovery on the issue of infringement took place in
`the ITC Action, and Regeneron conceded direct and/or indirect infringement of all the claims
`of the ʼ631 patent that Novartis asserted. Indeed, Regeneron does not argue that additional
`discovery is needed on the issue of infringement. The only remaining related issue is the
`willfulness of Regeneron’s infringement.
`
`
`Regeneron’s Affirmative Defenses and Counterclaim
`
`Regeneron raised the same patent invalidity defenses in the ITC Action, that it does here, and
`the parties took full discovery on those defenses, including production of approximately 6
`million pages of documents, taking of 18 fact depositions, and service of 58 interrogatories.
`The parties have reached a cross-use agreement by which the discovery from the ITC Action,
`including documents, deposition transcripts and interrogatory responses, can be used in this
`case.
`
`Even if Regeneron’s need for additional fact discovery from Novartis as set forth below is
`credited, it is limited to exploring supposed new theories on “conception, diligence and
`reduction to practice” and “enablement.” There is no dispute, however, that document
`production, by far the most time-consuming part of fact discovery, was complete on these
`issues in the ITC Action and can be used in this case. With respect to third-party discovery,
`Regeneron conducted third-party discovery in the ITC Action, and there is no reason to think
`these third parties will be unwilling to enter into the same cross-use agreement for third-party
`
`
`staff attorney is simply a party to an ITC proceeding and its brief was nothing more than a party brief.
`The Administrative Law Judge (“ALJ”) did not have to accept the Staff’s positions on any issue, and,
`in fact, had already rejected some of the Staff attorney’s positions on invalidity. The prehearing briefs
`to which Regeneron repeatedly refers was filed before the final evidentiary hearing, and the Staff
`attorney himself may well have changed his positions based on the evidence.
`
`
`
`
`ACTIVE/111473105.6
`
`
`
`Page 3
`
`
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 73 Filed 08/12/21 Page 4 of 24
`
`discovery that the parties have for party discovery. Any additional third-party discovery can
`easily be completed on the same schedule as the SDNY discovery.
`
`In addition to its invalidity defenses, which, as noted above, were already the subject of full
`discovery in the ITC Action, the only other defense Regeneron raises in this case is
`unenforceability of the ʼ631 patent based on alleged inequitable conduct, which is also the
`subject of its declaratory judgment counterclaim. But discovery on that defense and
`counterclaim is currently taking place in the co-pending SDNY Action, where Regeneron has
`asserted an antitrust claim based on the same alleged inequitable conduct (known as a “Walker
`Process” antitrust claim). As a predicate to succeeding on its Walker Process claim in the
`SDNY Action, Regeneron must prove the same inequitable conduct it has alleged as a defense
`here. Accordingly, this case presents a unique situation in which Regeneron is currently taking
`the exact same inequitable conduct discovery in the SDNY Action that it would be taking in
`this case. As with the ITC Action, there is a cross-use agreement in place so that the SDNY
`discovery can be used here. Regeneron’s claim that discovery in the SDNY Action is
`“significantly advanced relative to this case” is simply not correct. Document production by
`the parties will be completed at the same time in both cases, since everything produced in the
`SDNY Action can be used as if produced in this case under the cross-use agreement. Both
`cases are ready for depositions to begin now. The most efficient and fair course for the parties
`and the witnesses would be coordinating those depositions so deponents need not be deposed
`multiple times.
`
`Damages
`
`Novartis agrees with Regeneron that damages discovery did not take place in the ITC Action,
`but submits that discovery on the issue can proceed efficiently within the discovery period
`proposed by Novartis, especially since discovery has already taken place with respect to
`infringement and Regeneron’s affirmative defenses and counterclaim so would be the only
`subject for which discovery is necessary. Novartis will respond to interrogatories seeking its
`contentions on damages as soon as served by Regeneron.
`
`
`
`
`
`
`
`
`
`In sum, there is no need for the parties here to engage in the time-consuming collection and
`production of documents on liability issues, as all relevant documents have already been
`collected and produced in the ITC and SDNY Actions. Similarly, as further detailed below, all
`potential witnesses that the parties would notice for deposition in this case on those issues have
`already been deposed on the same issues in the ITC Action or will be deposed on the same
`issues in the SDNY Action. As the Court is aware, Novartis filed a motion in SDNY over a
`year ago to stay that case or transfer it here because the SDNY antitrust claims should have
`been filed as compulsory counterclaims here, but there has as of yet been no ruling. As matters
`of both efficiency and fairness, both fact and expert discovery in the cases should be
`coordinated, and should not be cumulative or duplicative of each other.
`
`Regeneron’s Position:
`
`
`This Court’s Local Patent Rules state that these “rules apply to all civil actions filed in or
`transferred to this Court which allege infringement of a patent in a complaint, counterclaim,
`
`
`
`ACTIVE/111473105.6
`
`
`
`Page 4
`
`
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 73 Filed 08/12/21 Page 5 of 24
`
`
`
`cross-claim or third-party claim, or which seek a declaratory judgment that a patent is not
`infringed, is invalid or is unenforceable.” L. Pat. R. 1.2. Novartis, however, has requested that
`the Court disregard the Local Patent Rules without providing a legitimate basis for doing so.
`Indeed, during the teleconference conducted by Magistrate Judge Hummel on June 11, 2021,
`the Court already rejected Novartis’s request to expedite the case schedule, and instead
`explicitly informed the parties that discovery and the case schedule would proceed in
`accordance with the Local Patent Rules.
`
`Nonetheless, Novartis’s proposed schedule entirely disregards this Court’s Local Patent Rules.
`Novartis has proposed eliminating claim construction in its entirety, substantially narrowing the
`discovery period, and setting an unrealistic trial date when the Local Patent Rules are clear that
`a trial date should not be scheduled until after the issuance of a claim construction order and
`completion of all discovery and motions. Novartis cannot plausibly argue that an expedited
`schedule is needed to avoid prejudice given that Novartis abandoned an opportunity to have its
`infringement claim tried at the ITC in April 2021. Instead, Novartis is proposing an expedited
`schedule to support its argument to the PTAB that the Board should deny Regeneron’s request
`for inter partes Review of the 631 Patent without addressing the merits of Regeneron’s IPR
`Petition. Recently, the PTAB has issued discretionary denials of IPR Petitions without
`considering the merits of the invalidity arguments on the ground that a co-pending district court
`case will proceed to trial before the PTAB will issue a final written decision. The PTAB,
`however, is unlikely to issue a discretionary denial if the district court trial is scheduled to take
`place after the PTAB’s final written decision. Novartis’s proposed schedule is a clear attempt
`to leverage the PTAB’s discretionary denial practice to avoid an invalidity decision by the
`PTAB on the merits.2
`
`The Court should reject Novartis’s attempted gamesmanship. As explained below, this case
`requires extensive claim construction and discovery before proceeding to trial, which warrants
`adoption of the schedule set forth in the Local Patent Rules. Moreover, given that one
`objective third party (the ITC Staff) has already concluded that the 631 Patent is invalid as
`obvious, the Court should enter a schedule that provides adequate time for the PTAB to
`conduct a full review of the 631 Patent prior to any trial.
`
`Claim Construction:
`
`Regeneron submits that this case should proceed according to the normal case schedule set
`forth in the local patent rules. In contrast, Novartis’s proposal to expedite the schedule
`improperly eliminates the claim construction process from the case schedule. The claim
`construction briefing and hearing before the ALJ in the ITC Investigation was limited to
`whether certain claim limitations were indefinite. Moreover, after the Markman hearing and
`during expert discovery in the ITC Investigation additional disputes regarding the scope and
`meaning of various claim limitations arose. First, there is a dispute concerning the full scope of
`the claimed silicone oil and force ranges, which was not resolved during the ITC Investigation
`because the ALJ never issued a claim construction decision. Second, there is a dispute
`
`
`2 If the PTAB grants Regeneron’s IPR Petition against the 631 Patent, the Board would be required by
`statute to issue a Final Written Decision no later than October 28, 2022.
`Page 5
`
`
`ACTIVE/111473105.6
`
`
`
`
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 73 Filed 08/12/21 Page 6 of 24
`
`
`
`concerning the conditions at which the claimed break loose and slide forces may be measured.
`Third, there is a dispute regarding the methods by which the claimed silicone oil values may be
`measured. Fourth, there is a dispute concerning the methods by which the claimed particle
`limitations may be measured. Fifth, there is a dispute concerning the meaning of “terminally
`sterilized.”
`
`These and potentially other issues require resolution via the Court’s typical claim construction
`process as set forth in the Local Patent Rules. The subsequent deadlines in the case, including
`the close of fact discovery, expert discovery, and the filing of motions should be based on the
`issuance of the Court’s claim construction order, as set forth in the Local Patent Rules. And
`once discovery is complete and outstanding motions have been resolved, the parties should
`propose a trial date as contemplated by the Local Patent Rules.
`
`
`
`
`
`Regeneron’s IPR Petition:
`
`Regeneron submits that the principal reason that Novartis has proposed an expedited schedule
`is to advance an argument to the Patent Trial and Appeal Board (PTAB) that Regeneron’s
`Petition for inter partes review should be denied on discretionary grounds. Indeed, Novartis
`has already argued to the PTAB that Regeneron’s IPR Petition should be denied because this
`case will purportedly proceed to trial “at or around the October 2022 deadline for a final written
`decision.” IPR2021-00816, Paper 8 at 17. Furthermore, there is no basis for Novartis to argue
`that its infringement claims need to be tried on an expedited basis given that it unilaterally
`abandoned the ITC case on the eve of trial. Accordingly, the Court should reject Novartis’s
`attempted gamesmanship and enter a schedule consistent with the Local Patent Rules, which
`will ensure that the PTAB has sufficient time to evaluate Regeneron’s IPR Petition on the
`merits. Doing so would minimize any unnecessary burdens that this case may place on the
`Court’s limited resources because the IPR will likely result in the invalidity of all asserted
`claims and dispose of this case in its entirety.
`
`Discovery in this case:
`
`Novartis’s proposal for an expedited trial ignores the complexity of the dispute between the
`parties and the extensive discovery that must take place in this case before it is ready for trial.
`First, additional fact discovery from Novartis is necessary in this case because Novartis raised
`substantial new arguments in the ITC Investigation after the close of fact discovery. For
`example, Novartis introduced entirely new theories concerning conception, diligence and
`reduction to practice after fact discovery closed.3 Moreover, Novartis asserted for the first time
`
`
`3 Although Vetter’s contribution to conception will be the subject of discovery in the SDNY Action,
`Novartis’s diligence and reduction to practice theories that were belatedly introduced in the ITC
`investigation are not subject to discovery in the SDNY Action.
`Page 6
`
`
`ACTIVE/111473105.6
`
`
`
`
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 73 Filed 08/12/21 Page 7 of 24
`
`
`
`in its pre-trial brief in the ITC Investigation that it intends to rely on testimony from Novartis
`fact witnesses to argue that certain prior art references were not enabling.
`
`Second, this case requires extensive damages discovery that has not yet been conducted.
`Contrary to Novartis’s assertion, the relevant damages discovery has not been collected in the
`ITC and SDNY. The only available remedy in an ITC investigation is injunctive relief in the
`form of an exclusion order barring the importation of infringing articles, so the parties did not
`conduct any discovery concerning monetary damages that Novartis may make in this case.
`Likewise, the damages discovery that has been conducted in the SDNY Action relates to
`Regeneron’s claim for damages based on Novartis’s violation of antitrust laws, which is
`irrelevant to any damages that Novartis may claim concerning Regeneron’s alleged
`infringement of the 631 Patent.
`
`Although Novartis represents that damages discovery can be conducted in the expedited
`schedule that Novartis has proposed, Novartis has yet to disclose its damages theory to
`Regeneron or identify any information that it intends to rely on to support such a theory.
`Damages is highly fact intensive and may require additional discovery from third party
`licensees Genentech and Vetter depending on the damages theory that Novartis advances.
`Moreover, Novartis has been inconsistent as to whether it is seeking damages based on
`BEOVU or LUCENTIS. Indeed, Novartis has expressly refused to provide fulsome discovery
`on BEOVU in the SDNY Action under the guise that it is irrelevant to the claims in that matter.
`Further, though Novartis has asserted it does not control the US market for LUCENTIS, even
`that claim is belied by Novartis’s recent representation to the PTAB that “Genentech was only
`able to bring Lucentis® PFS to market in 2016 (Ex. 2015), after licensing the ’631 patent from
`[Novartis] and adopting the [Novartis] technology.” Depending on Novartis’s damages theory,
`the required party and non-party discovery of LUCENTIS and BEOVU may be far more
`extensive in NDNY than in SDNY. And, the limited discovery received from Genentech in the
`SDNY Action would be insufficient to proceed in NDNY.
`
`Third, Regeneron must conduct extensive third party discovery in this case to support its
`invalidity defenses, including obtaining additional discovery concerning prior art products.
`Although Regeneron conducted some third party discovery in the ITC Investigation to support
`its invalidity defenses, it was unable to conduct the full scope of desired discovery given the
`abbreviated time period for discovery in the ITC. This includes time-consuming discovery
`from foreign entities under the Hague Convention that was not conducted in the ITC.
`Moreover, Novartis has challenged the prior art status of certain products that Regeneron relied
`upon, in addition to challenging whether those products included the features claimed in the
`631 Patent. Thus, Regeneron must seek additional discovery from third parties to support the
`prior art product invalidity defenses it raised at the ITC, including seeking discovery from third
`parties who were not subpoenaed during the ITC Investigation.
`
`Finally, Regeneron submits that Novartis’s reliance on 28 U.S.C. § 1659(b) to support an
`expedited schedule is misguided. In particular, § 1659(b) provides that “the record of the
`proceeding before the United States International Trade Commission shall be transmitted to the
`district court.” Here, however, the “record of the proceeding” was minimal because Novartis
`withdrew its Complaint prior to the evidentiary hearing once it recognized that Regeneron
`
`
`
`ACTIVE/111473105.6
`
`
`
`Page 7
`
`
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 73 Filed 08/12/21 Page 8 of 24
`
`
`
`would prevail on the merits at the ITC. In particular, the parties never submitted exhibits to the
`Commission, the ALJ never issued an initial determination or a claim construction order, and
`the Commission never issued a final determination regarding the merits of the parties’ claims.
`Although the parties have agreed that discovery materials generated during the ITC
`Investigation may be used in this case, this agreement does not encompass discovery obtained
`from third parties. Thus, Regeneron is required to subpoena each third party to obtain materials
`produced in the ITC Investigation, while also conducting additional third party discovery to
`support its invalidity defenses.
`
`
`(Discovery timetable is to be based on the complexity of the action)
`
`4) MOTIONS:
`
`Novartis’s Position:
`
`
`For the reasons given in paragraph 3 above, and in response to Local Patent Rule 2.1(b)
`question 1 below, all motions, including discovery motions, shall be made by June 27, 2022.
`(Non-Dispositive motions including discovery motions may only be brought after the
`parties have complied with Section IX of General Order #25)
`
`Regeneron’s Position:
`
`
`Consistent with the schedule set forth in the Local Patent Rules, all motions should be due 30
`days after the completion of all discovery.
`
`
`5) PROPOSED DATE FOR THE COMMENCEMENT OF TRIAL:
`
`Novartis’s Position:
`
`
`The action will be ready to proceed to trial in August 2022, which is within 18 months of the
`filing date when the period of the stay is tolled. It is anticipated that the trial will take
`approximately 10 trial days to complete. Trial of this case should take place prior to the trial of
`the SDNY Action, as the SDNY Action should have been filed as a counterclaim here.
`Resolution of Regeneron’s affirmative defenses related to patent invalidity will also address
`central issues in the SDNY Action; for example, if the ’631 Patent is found to be valid and
`enforceable, Regeneron’s antitrust claims would be mooted, and Regeneron would not be able
`to recover purported damages associated with its allegedly delayed launch of EYLEA PFS as
`the ’631 Patent would have barred the legal sale of Eylea PFS. Contrary to Regeneron’s
`assertions, Novartis is not seeking to “jump the NDNY trial ahead of trial in the SDNY
`Action.” The claims in the SDNY case are compulsory counterclaims to Novartis’s patent
`infringement claims here, and should have been filed as such. If Regeneron had properly filed
`them as counterclaims, they would have been subject to the stay that Regeneron itself
`requested. Instead, Regeneron engaged in gamesmanship so that it could have its cake and eat
`it too—stay Novartis’s affirmative claim in NDNY, but have its counterclaim proceed in
`SDNY in the meantime. Over a year ago, Novartis filed a motion in SDNY to stay that case or
`
`
`
`ACTIVE/111473105.6
`
`
`
`Page 8
`
`
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 73 Filed 08/12/21 Page 9 of 24
`
`
`
`transfer it here, but there has as of yet been no ruling. As matters of both efficiency and
`fairness, the SDNY Action should not “jump ahead” of the NDNY Action.
`
`
`
`Regeneron’s Position:
`
`
`Regeneron expects that a trial will require approximately 10 days to complete based on the
`current scope of the case. Consistent with the Local Patent Rules, the parties should propose a
`trial schedule upon the latter of the completion of all discovery or the issuance of the Court’s
`decision on any pending motions.
`
`The status of the SDNY Action does not provide a basis to expedite the schedule in this case,
`and there is no reason why this case should proceed to trial before the SDNY Action. While
`the SDNY Action is about to begin depositions and is scheduled to complete fact discovery in
`December 2021, this case is still in its infancy, as neither fact discovery nor claim construction
`specific to this case has yet to begin. Moreover, the most efficient sequence would be for the
`SDNY Action to proceed to trial first because the discovery is significantly advanced relative to
`this case, and the SDNY Action is likely to obviate the need for this case to proceed to trial. In
`particular, if Regeneron succeeds in its Walker Process claims in the SDNY Action, it will
`moot Novartis’s infringement claims in this case because the only asserted patent at issue
`would be deemed unenforceable. In contrast, proceeding with a trial in this case first would not
`obviate the need to conduct a trial in the SDNY Action because Regeneron has independent
`claims in the SDNY Action that do not depend on the validity or enforceability of the 631
`Patent. Specifically, Regeneron’s stand-alone cause of action under Section 1 of the Sherman
`Act, 15 U.S.C. § 1, against Novartis for conspiring with Vetter to unreasonably restrain trade in
`the United States anti-VEGF pre-filled syringe market. Novartis and Vetter’s wide-ranging
`conspiracy includes much more than just Novartis’s fraudulent procurement of the ‘631 patent,
`and adjudication of Novartis and Vetter’s attempts to expand the temporal scope of the patent
`and otherwise restrict competition should not be delayed.
`
`Moreover, it is fundamentally unfair and against the bedrock principle of Rule 1 requiring the
`“just” and “speedy” resolution of Regeneron’s SDNY Action for Novartis to voluntarily drop
`its ITC action, in the face of certain defeat, and seek to jump the NDNY trial ahead of trial in
`the SDNY Action.
`
`
`
`(The proposed date for the commencement of trial must be within 18 months of the filing date).
`
`6) HAVE THE PARTIES FILED A JURY DEMAND: _X_ (YES) / ___ (NO).
`
`7) DOES THE COURT HAVE SUBJECT MATTER JURISDICTION? ARE THE PARTIES
`SUBJECT TO THE COURT’S JURISDICTION? HAVE ALL PARTIES BEEN SERVED?
`This Court has subject matter jurisdiction over Novartis’s claims and Regeneron’s counterclaim under
`28 U.S.C. §§ 1331 and 1338(a). All of the parties are subject to personal jurisdiction in this Court. All
`parties have been served.
`
`
`
`
`ACTIVE/111473105.6
`
`
`
`Page 9
`
`
`
`

`

`Case 1:20-cv-00690-DNH-CFH Document 73 Filed 08/12/21 Page 10 of 24
`
`
`
`8) WHAT ARE THE FACTUAL AND LEGAL BASES FOR PLAINTIFF’S CLAIMS AND
`DEFENDANT’S DEFENSES
`(INCLUDE COUNTERCLAIMS & CROSSCLAIMS, IF
`APPLICABLE)?
`Novartis’s Position:
`
`
`Novartis asserts that Regeneron’s EYLEA PFS infringes the ʼ631 patent, which is directed to
`pre-filled syringes that permit safe injections into the eye of drugs called VEGF-antagonists
`that are used to treat diseases such as age-related macular degeneration. As noted above,
`infringement should not be in dispute here because Regeneron conceded direct and/or indirect
`infringement of the asserted claims of the ʼ631 patent in the ITC Action. Regeneron’s attempt
`to take an inconsistent position here on infringement, which it ostensibly attributes to
`Novartis’s alleged invalidity positions, should have no effect because (1) Regeneron knew
`Novartis’s invalidity positions when it agreed to summary judgment of infringement in the ITC
`Action and (2) Novartis is not taking any positions on invalidity that are inconsistent with
`infringement, and has never made the invalidity arguments suggested by Regeneron.
`
`Regeneron’s infringement of the ʼ631 patent is, and has been, willful because Regeneron chose
`to manufacture and market the EYLEA® PFS even though it knew that such marketing and
`manufacture would infringe the ʼ631 patent and that the ʼ631 patent was valid and enforceable.
`For the same reasons, Novartis seeks a finding that this case is “exceptional” under 35 U.S.C. §
`285 and an award of attorneys’ fees and costs.
`
`Regeneron’s Position:
`
`
`Defendant contends that Defendant does not infringe any valid and enforceable claim of the
`631 Patent. Although Regeneron did not oppose Novartis’s motion for summary determination
`with respect to infringement of several claims of the 631 Patent during the ITC Investigation,
`Novartis subsequently took several positions concerning the invalidity of the 631 Patent that
`are inconsistent with its infringement theory. First, EYLEA PFS does not comprise a glass
`body forming a barrel, a stopper, and a plunger to the extent Novartis maintains its assertion
`that the plunger and stopper of claim 1 of the ’631 Patent requires a particular design that limits
`movement of the stopper and prevents ingress of gasses during sterilization, as Novartis
`asserted in International Trade Commission Investigation No. 337-TA-1207. Second, the
`EYLEA PFS barrel does not comprise about 1 μg to 100 μg silicone oil to the extent Novartis
`maintains its assertion that silicone oil quantities measured via certain methods are not within
`the scope of claim 1 of the