`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
`
`
`REGENERON PHARMACEUTICALS, INC.,
`
`
`
`Plaintiff/Counter-Defendant,
`
`
`v.
`
`
`
`
`
`
`
`
`
`
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`
`
`
`Defendant/Counter-Claimant.
`
`
` CIVIL NO. 1:22-CV-61
`
`
` (KLEEH)
`
`MEMORANDUM OPINION AND ORDER DENYING MYLAN’S SECOND
`MOTION TO AMEND [ECF NO. 505] AND GRANTING REGENERON’S
`MOTION FOR JUDGMENT ON THE PLEADINGS [ECF NO. 175]
`
`Pending before the Court is Mylan’s second motion to amend
`
`its answer, defenses, and counterclaims [ECF No. 505], which
`relates to Regeneron’s motion for judgment on the pleadings [ECF
`No. 175]. For the reasons discussed herein, the Court DENIES
`Mylan’s motion and GRANTS Regeneron’s.
`Rule 15 of the Federal Rules of Civil Procedure provides that
`“a party may amend its pleading only with the opposing party’s
`written consent or the court’s leave” and that “[t]he court should
`freely give leave when justice so requires.” Leave to amend
`“should be denied only when the amendment would be prejudicial to
`the opposing party, there has been bad faith on the part of the
`moving party, or the amendment would have been futile.” Sciolino
`v. Newport News, 480 F.3d 642, 651 (4th Cir. 2007) (citation
`omitted). The Court finds that Mylan’s proposed amendment would
`
`
`
`Case 1:22-cv-00061-TSK-JPM Document 524 Filed 06/06/23 Page 2 of 4 PageID #: 41445
`REGENERON V. MYLAN
`
`
`
`
`
` 1:22-CV-61
`MEMORANDUM OPINION AND ORDER DENYING MYLAN’S SECOND
`MOTION TO AMEND [ECF NO. 505] AND GRANTING REGENERON’S
`MOTION FOR JUDGMENT ON THE PLEADINGS [ECF NO. 175]
`
`be prejudicial to Regeneron due to its untimeliness and the volume
`of new allegations proposed. For these reasons and the reasons
`discussed during the pretrial conference on May 30, 2023, the Court
`DENIES Mylan’s second motion to amend [ECF No. 505].
`
`As for Regeneron’s motion for judgment on the pleadings, the
`Court agrees with Regeneron that Mylan has failed to adequately
`plead its inequitable conduct defenses and counterclaims. The
`judicially-created doctrine of inequitable conduct renders a
`patent unenforceable when an alleged infringer demonstrates that
`the patent holder engaged in “egregious affirmative acts of
`misconduct” intended to deceive the PTO or failed to disclose
`material information to the PTO in seeking the patent. Therasense,
`Inc. v. Becton, Dickinson & Co., 649 F.3d 1276, 1287 (Fed. Cir.
`2011). A party alleging inequitable conduct as either a defense
`or a counterclaim must plead the circumstances of the conduct with
`particularity. Central Admixture Pharmacy Servs., Inc. v.
`Advanced Cardiac Solutions, P.C., 482 F.3d 1347, 1356–57 (Fed.
`Cir. 2007). The Federal Circuit requires that the pleading party
`“identif[y] . . . the specific who, what, when, where, and how of
`the material misrepresentation or omission committed before the
`PTO.” Exergen Corp. v. Wal-Mart Stores, Inc., 575 F.3d 1312, 1327
`(Fed. Cir. 2009). The pleading party must allege facts supporting
`
`
`
`2
`
`
`
`Case 1:22-cv-00061-TSK-JPM Document 524 Filed 06/06/23 Page 3 of 4 PageID #: 41446
`REGENERON V. MYLAN
`
`
`
`
`
` 1:22-CV-61
`MEMORANDUM OPINION AND ORDER DENYING MYLAN’S SECOND
`MOTION TO AMEND [ECF NO. 505] AND GRANTING REGENERON’S
`MOTION FOR JUDGMENT ON THE PLEADINGS [ECF NO. 175]
`
`an inference “that a specific individual (1) knew of the withheld
`material information or of the falsity of the material
`misrepresentation, and (2) withheld or misrepresented this
`information with a specific intent to deceive the PTO.” Id. at
`1328–29.
`Specifically, the Court finds that Mylan has failed to plead
`intent. It has not sufficiently pled the “who, what, when, where,
`and how.” See Exergen, 575 F.3d at 1327. Even if Mylan had
`satisfied intent, Mylan’s allegations also fail because the cited
`statements were attorney argument. “While the law prohibits
`genuine misrepresentations of material fact, a prosecuting
`attorney is free to present argument in favor of patentability
`without fear of committing inequitable conduct.” Rothman v. Target
`Corp., 556 F.3d 1310, 1328–29 (Fed. Cir. 2009). As such, Mylan
`has not sufficiently pled its inequitable conduct defenses and
`counterclaims, and Regeneron’s motion for judgment on the
`pleadings is GRANTED [ECF No. 175].
`It is so ORDERED.
`
`The Clerk is DIRECTED to transmit copies of this Order to
`
`counsel of record.
`
`
`
`
`
`3
`
`
`
`Case 1:22-cv-00061-TSK-JPM Document 524 Filed 06/06/23 Page 4 of 4 PageID #: 41447
`REGENERON V. MYLAN
`
`
`
`
`
` 1:22-CV-61
`MEMORANDUM OPINION AND ORDER DENYING MYLAN’S SECOND
`MOTION TO AMEND [ECF NO. 505] AND GRANTING REGENERON’S
`MOTION FOR JUDGMENT ON THE PLEADINGS [ECF NO. 175]
`DATED: June 6, 2023
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`____________________________
`THOMAS S. KLEEH, CHIEF JUDGE
`NORTHERN DISTRICT OF WEST VIRGINIA
`
`
`
`4
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
