UNITED STATES PATENT AND TRADEMARK OFFICE
`
`---------------------------------------
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`---------------------------------------
`
`LANNETT HOLDINGS, INC.
`Petitioner
`
`v.
`
`ASTRAZENECA AB
`Patent Owner
`---------------------------------------
`
`Case IPR2015-01629
`Patent No. 6,750,237
`---------------------------------------
`
`
`
`LANNETT HOLDINGS, INC.’S REPLY TO
`ASTRAZENECA AB’S PRELIMINARY RESPONSE
`
`
`
`
`---------------------------------------
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`---------------------------------------
`
`LANNETT HOLDINGS, INC.
`Petitioner
`
`v.
`
`ASTRAZENECA AB
`Patent Owner
`---------------------------------------
`
`Case IPR2015-01629
`Patent No. 6,750,237
`---------------------------------------
`
`
`
`LANNETT HOLDINGS, INC.’S REPLY TO
`ASTRAZENECA AB’S PRELIMINARY RESPONSE
`
`
`
`
`
`
`
`
`AstraZeneca AB’s (“Astra AB’s”) argument that the Petition is time-barred
`
`lacks legal and factual support. A valid complaint must be properly served on a
`
`petitioner in order to trigger the 35 U.S.C. § 315(b) time-bar. Here, Astra AB did
`
`not properly serve a complaint on Lannett Holdings, Inc. (“Lannett”) but instead
`
`carried-out ineffective service on a registered agent. Because Astra AB failed to
`
`comply with the Delaware statute governing service on a registered agent, Lannett
`
`was not served prior to July 28, 2014, with a complaint alleging infringement. As
`
`the Petition was filed on July 28, 2015, the § 315(b) time bar is inapplicable. In
`
`any event, there was no service of a valid complaint because, by Astra AB’s own
`
`admission, the complaint it filed does not establish subject matter jurisdiction in
`
`the Delaware District Court and could not be a time bar even if it had been served.
`
`I.
`
`
`
`Facts
`
`On July 25, 2014, Astra AB and Impax Laboratories, Inc. (“Impax”) filed a
`
`complaint against Lannett in the District of Delaware. The complaint alleged
`
`infringement of the ‘237 patent (the “First Action”), and stated, in part: “[Astra
`
`AB] is the owner by assignment of the ‘237 patent and has the right to sue for
`
`infringement thereof.” See Ex. 2001 at ¶ 24. On July 29, a proof of service was
`
`filed in the form of an affidavit from a process server. See Ex. 2002. The affidavit
`
`fails to identify the individual who was served, notwithstanding that it specifically
`
`calls for the “name of [the] individual” receiving service. See id.
`
`
`
`
`
`
`
`Five days later, Astra AB and Impax, now joined by AstraZeneca UK
`
`Limited (“Astra UK”), filed a second complaint against Lannett again alleging
`
`infringement of the ‘237 patent (the “Second Action”). The only significant
`
`difference between the complaints was in the purported ownership of the patent.
`
`Specifically, the plaintiffs represented in the second complaint that “[Astra AB]
`
`and [Astra UK] own all rights, title, and interest in the ‘237 patent and have the
`
`right to sue for infringement thereof.” 1 See Ex. 2005 at ¶ 25. A proof of service
`
`was filed in the form of a new affidavit from a process server, and identified the
`
`specific individual who was served. See Ex. 1030
`
`Lannett moved to dismiss, without answering, the First Action for lack of
`
`subject matter jurisdiction, asserting that the named plaintiffs lacked standing
`
`because co-owner Astra UK was missing from that action. The court consolidated
`
`the actions and dismissed the motion “without prejudice to its renewal after
`
`discovery is complete.”2 Ex. 2011, at 3. Pointedly, the court noted that it did not
`
`need to address the standing issue at that point because “[t]he consolidated case has
`
`all necessary plaintiffs.” Id.
`
`
`
`1 The District Court characterized the First and Second Actions as “just the same
`
`case, albeit with an extra plaintiff in the second case.” Ex. 2011 at 2.
`
`2 The current discovery cutoff date in the consolidated action is March 18, 2016.
`
`
`
`2
`
`
`
`
`
`II. Argument
`
`A.
`
`The Complaint in the First Action was not Properly Served
`
`The one-year period under § 315(b) did not begin to run until July 31, 2014,
`
`the date that the service requirements of the applicable Delaware statutes were first
`
`satisfied by service of the complaint in the Second Action. Because the Petition
`
`was filed within one year from this date, on July 28, 2015, the Petition was timely.
`
`
`
`Astra AB has provided no evidence that any person was served and has
`
`therefore failed to establish that the complaint in the First Action was served as
`
`required by Delaware law. While Delaware law allows service via registered
`
`agent, Astra AB neglects to mention the requirements for service of a limited
`
`liability company such as CSC Entity Services, LLC (“CSC”): “[s]ervice of legal
`
`process upon any domestic limited liability company shall be made by delivering a
`
`copy personally to any manager of the limited liability company in the State of
`
`Delaware . . . .” Del. Code Title 6, § 18-105 (Ex. 1031) (emphasis added).
`
`
`
`Astra AB was required to produce evidence that delivery was “personally to
`
`any manager” of CSC. Astra AB has not produced any such evidence. The only
`
`evidence on the record is a facially deficient affidavit that lists “CSC Entity
`
`Services LLC” as the name of the individual served with the complaint for the First
`
`Action. See Ex. 2002 (below) (yellow highlighting added).
`
`
`
`3
`
`
`
`
`
`
`
`
`
`The summons clearly requires a person to be named and identified so that
`
`compliance with the statute can be demonstrated – this plainly was not done.
`
`Accordingly, service has not been made. See Church-El v. Bank of New York,
`
`2013 WL 1190013, *5 (D. Del. Mar. 21, 2013) (holding service not proper where
`
`plaintiff failed to follow all steps necessary under relevant Delaware statute) (Ex.
`
`1032); see also Hovde Acquisition, LLC v. Thomas, 2002 WL 1271681, *6 (Del.
`
`Ch. June 5, 2002) (same) (Ex. 1031). Because there was no service of the first
`
`complaint, the time bar of § 315(b) was not triggered.
`
`Astra AB’s waiver argument is a red herring. Waiver, even if it had
`
`occurred, does not remove § 315(b)’s statutory requirement of effective service.
`
`See Macauto U.S.A. v. BOS GmbH & KG, IPR2012-00004 (PTAB Jan. 24, 2013)
`
`(Paper 18 at 15) (“The statute requires that the service date of the complaint be
`
`more than a year before the petition was filed.”). Any action by Lannett that may
`
`have resulted in waiver of its own rights cannot somehow cure Astra AB’s
`
`defective service. See Advanced Surgery Ctr. v. Connecticut Gen. Life, Ins. Co.,
`
`2012 WL 3598815, *10 (D.N.J. July 31, 2012) (holding that waiver of challenge to
`
`service that occurred when defendant’s motion to dismiss did not contest service
`
`
`
`4
`
`
`
`
`
`did not “make the plaintiff’s improper service proper”) (Ex. 1034). Moreover, “the
`
`effective date of service is the date when the party commits the act of waiver.” Id.
`
`Here, the earliest possible service date is September 24, 2014, when Lannett filed a
`
`motion to dismiss the First Action. See Ex. 2008. Accordingly, regardless of
`
`whether waiver occurred, the § 315(b) time bar is inapplicable.
`
`B.
`
`The Petition Cannot be Time Barred Because the District Court
`Never Had Subject Matter Jurisdiction Over the First Action
`
`The District Court lacked subject matter jurisdiction over the First Action
`
`
`
`because, by Astra AB’s own admission, a co-owner of the ‘237 patent was not
`
`named in that action. Therefore, the complaint in that action, regardless of when
`
`served, cannot constitute a basis for barring this Petition under § 315(b).
`
` The time bar of § 315(b) does not apply if a complaint alleged to trigger the
`
`bar was effectively never legally filed. See, e.g., Shaw Indus. Group, Inc. v.
`
`Automated Creel Sys., Inc., IPR2013-00584 (PTAB Dec. 31, 2013) (Paper 16 at
`
`13) (“a dismissal without prejudice leaves the parties as though the action had
`
`never been brought”); Samsung Elecs. Am., Inc. v. LED Tech Dev., LLC, IPR2014-
`
`00590 (PTAB Sept. 3, 2014) (Paper 23 at 6). Indeed, Astra AB has acknowledged
`
`that the effects of service may be nullified if the action is jurisdictionally defective
`
`for lack of standing. Astra AB Prelim. Resp., at 4.
`
`Standing is a threshold jurisdictional issue. Lujan v. Defenders of Wildlife,
`
`
`
`5
`
`
`
`
`
`504 U.S. 555, 560–61 (1992). “[I]n a patent infringement action, the plaintiff must
`
`demonstrate that it held enforceable title to the patent at the inception of the
`
`lawsuit to assert standing.” Abraxis Bioscience, Inc., v. Navinta, 625 F.3d 1359,
`
`1364 (Fed. Cir. 2010) (internal quotation omitted). Moreover, the Federal Circuit
`
`“has long applied the rule that a patent co-owner seeking to maintain an
`
`infringement suit must join all other co-owners.” STC.UNM v. Intel Corp., 754
`
`F.3d 940, 944 (Fed. Cir. 2014); see also Ethicon, Inc. v. United States Surgical
`
`Corp., 135 F.3d 1456 (Fed. Cir. 1998) (emphasis added).
`
`Here, a co-owner of the ‘237 patent, Astra UK, was not a party to the First
`
`Action. Specifically, the plaintiffs in the Second Action admitted that “[Astra AB]
`
`and [Astra UK] own all rights, title, and interest” in the ‘237 patent. Ex. 2005 at
`
`¶ 25 (emphasis added). Because Astra AB has admitted that at the time the
`
`complaint was filed they did not constitute all of the co-owners of the ‘237 patent,
`
`standing was never established, and “. . . the plaintiff[s] cannot pursue [that]
`
`infringement suit.” Ethicon, 135 F.3d at 1456. Consequently, even if the
`
`complaint in the First Action had been effectively served on Lannett–and it was
`
`not–service of a fatally defective complaint cannot trigger the § 315(b) time bar.
`
`Astra AB contends that it had standing in the First Action “because it holds
`
`legal title to the ‘237 patent.” It is legally irrelevant if Astra AB today holds legal
`
`title to the ‘237 patent. In any event, Astra AB is wrong as a matter of law. A co-
`
`
`
`6
`
`
`
`
`
`owner ordinarily does not have standing in an infringement action in which another
`
`co-owner is not a party, and Astra AB has not identified why any of the limited
`
`exceptions to the general rule would apply here. See STC.UNM, 754 F.3d at 945-
`
`47 (finding that patent co-owner bringing infringement action lacked standing due
`
`to absence of another co-owner from suit, and upholding dismissal on this basis).
`
`Astra AB has not identified any authority holding that a jurisdictionally-
`
`deficient action can trigger the § 315(b) time bar.3 Astra AB asserts that because
`
`the First Action was consolidated rather than dismissed, the absence of co-owner
`
`Astra UK does not nullify the effects of service of the first complaint. Astra AB is
`
`wrong. The court expressly noted that the dismissal of Lannett’s motion to
`
`dismiss was “without prejudice to its renewal after discovery is complete.” In fact,
`
`the District Court acknowledged the jurisdictional deficiency of the First Action
`
`when it noted that “[t]he consolidated case has all necessary plaintiffs.”
`
`Dated: December 18, 2015
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`/Joseph F. Posillico/
`Joseph F. Posillico, Reg. No. 32,290
`Fox Rothschild LLP
`
`Attorneys for Petitioner
`
`
`
`3 Apple Inc. v. Rensselaer Polytechnic Inst., IPR2014-00319, cited by Astra AB, is
`
`inapposite because subject matter jurisdiction was not at issue. Instead, the parties
`
`stipulated to consolidation of two actions for convenience.
`
`
`
`7
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. §§ 42.6(e) and 42.105(b), the undersigned certifies
`
`that on the 18th day of December 2015 a complete and entire copy of this the
`
`above-captioned “Petitioner’s Reply to AstraZeneca AB’s Preliminary Response,”
`
`including its supporting evidence (Exhibits LAN 1030 – 1034) was provided via
`
`email to the Patent Owner by serving the following email addresses:
`
`
`
`michael.flibbert@finnegan.com
`
`maureen.queler@finnegan.com
`
`
`
`Electronic service was used with the consent of the Patent Owner’s counsel.
`
`
`
`Dated: December 18, 2015
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`
`Joseph F. Posillico, Reg. No. 32,290
`Fox Rothschild LLP
`2000 Market Street, 20th Floor
`Philadelphia, PA 19103
`Tele: 215-299-2000
`Fax: 215-299-2150
`Attorneys for Petitioner
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
