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FDCA’s Exclusive Enforcement Provision Reigns Supreme over State Laws

In its first occasion to interpret § 353b of the Federal Food, Drug, and Cosmetic Act (FDCA), the US Court of Appeals for the Ninth Circuit relied on the “implied preemption doctrine” to affirm a district court’s case dismissal for failure to state a claim under Fed. R. Civ. P. 12(b)(6). Nexus Pharmaceuticals, Inc. v. Central Admixture Pharmacy Services, Inc., Case No. 20-56227 (9th Cir. Sept. 13, 2022) (Kleinfeld, Nelson, VanDyke, JJ.)

Nexus developed and trademarked Emerphed, a US Food & Drug Administration (FDA) approved ready-to-use ephedrine sulfate in a vial. Central Admixture operates a network of compounding pharmacies and sells ephedrine sulfate in ready-to-use syringes without FDA approval, because compounding pharmacies do not need FDA approval. Compounding happens when ingredients in medicines are combined, mixed and altered for individual patients. Under 21 U.S.C. § 353b, drug compounding by “outsourcing facilities” is allowed without FDA approval, but the FDCA excludes compounded drugs that are “essentially a copy of one or more approved drugs.”

The FDCA contains an exclusive enforcement provision prohibiting private enforcement, stating that proceedings to enforce or restrain violations of the FDCA, which includes the compounding statute, must be by and in the name of the United States. To avoid the FDCA’s bar on private enforcement, Nexus alleged that Central Admixture violated the laws of several states in which it sells Emerphed, all of which prohibit the sale of drugs not approved by the FDA. Nexus argued that Central Admixture’s ephedrine sulfate was “essentially a copy” of Emerphed and therefore was excluded from the outsourcing facilities exception. The district court disagreed and dismissed the state law claims under the implied preemption doctrine. The district court explained that all of Nexus’s claims depended on the determination of whether Central Admixture’s ephedrine sulphate was “essentially a copy” of Emerphed, and that the “plain text of the [FDCA] left that determination in the first instance to the FDA and its enforcement process.” Nexus appealed.

The Ninth Circuit explained that the Supremacy Clause of the US Constitution is the “source of preemption doctrine, which invalidates state laws that are contrary to federal statutes,” but noted that there is no clear sorting of case law and no rigid formula to determine when state law runs contrary to federal law. Therefore, the Court relied on several controlling cases regarding the statute governing FDA approval of medical devices, not drugs. Medical device cases are distinguishable because the medical device statute includes an express preemption clause prohibiting states from imposing any safety or effectiveness requirement different from or in addition to those imposed by federal law. In explaining these cases, the Court noted that the claims that were allowed to go forward did not rely on noncompliance with FDA requirements (as Nexus did), but rather on traditional tort law duties. The purported violation of a state law that substantively says “comply with the FDCA” is not a traditional common law tort. The Court also explained that these cases taught that despite a presumption against implied preemption, [...]

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PTO Switches to New Public Search Tools, New PTAB Filing System

The US Patent & Trademark Office (PTO) will replace four legacy tools—Public-Examiner’s Automated Search Tool, Public-Web-Based Examiner’s Search Tool, Patent Full-Text and Image Database (PatFT) and Patent Application Full-Text and Image Database (AppFT)—with the new Patent Public Search Tool (PPUBS) on September 30, 2022. The PTO first announced the transition to the new tool in February 2022.

Existing links to US patents and US pre-grant publications in PatFT and AppFT will be terminated following the retirement of these services. US patents and US pre-grant publications can be directly accessed via PPUBS, and links for direct document access to US patents and US pre-grant publications can be set up on a webpage or document. According to the PTO, PPUBS provides more convenient, remote and robust full-text searching of all US patents and US pre-grant publications. PPUBS also streamlines the search process for users, provides alternatives for existing services and incorporates new features. Step-by-step instructions for performing these functions can be found here.

The PTO also announced that as of October 11, 2022, the Patent Trial & Appeal Board E2E system used for electronically filing all documents related to Inter Partes and Post Grant reviews, Transitional Program for Covered Business Mmethod Patents, and Derivation Proceedings will be replaced by the Patent Trial & Appeal Tracking System (P-TACTS) platform. The E2E system will be unavailable starting at 5:00 pm EDT on October 9, 2022, through 11:00 pm EDT on October 10, 2022 (which is a federal holiday). For more information about the platform migration and how to register to use P-TACTS, click here.




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Ninth Circuit Provides Clarity on the Scope of Receiverships

The US Court of Appeals for the Ninth Circuit affirmed an order denying the defendants’ motion to discharge a receiver who had been appointed to aid in the execution of a judgment for violations of the Copyright Act. WB Music Corp et al. v. Royce International Broadcasting Corp., Case No. 21-55264 (9th Cir. Aug. 31, 2022) (Tashima, Watford, Friedland, JJ.)

The receivership in this appeal arises from litigation that commenced in 2016 in the US District Court for the Central District of California by a cohort of music publishers for broadcasting the plaintiffs’ music on radio networks in violation of the Copyright Act. In 2017, the district court found the defendants jointly and severally liable for copyright infringement.

A jury awarded the plaintiffs statutory damages totaling $330,000 and the district court entered a judgment in that amount. The defendants continuously refused to satisfy the judgment, and after much litigation, the court entered an amended judgment for an additional $1.25 million and attorneys’ fees of more than $900,000.

The defendants’ only assets were their Federal Communications Commission (FCC) licenses. The district court ultimately appointed a receiver who was entrusted with “the power and authority to take charge of and manage [the defendants’] [r]adio stations’ assets, businesses, and affairs,” as well as the ability to solicit offers for the sale of the stations. The court’s order also provided that the receiver would incur a monthly fee and a commission on the sale of any of the radio stations.

The defendants moved ex parte for an order to compel the plaintiffs to accept payment of the amended judgment—asserting that they were prepared to wire funds in the amount sufficient to cover the amended judgment and post-judgment interest—but refused to agree to pay costs incurred by the plaintiffs’ post-judgment proceedings. Per the district court’s order, the defendants were to deposit with the court funds sufficient to satisfy the amended judgment. The order further provided that the receivership would not terminate unless the defendants paid all costs incurred post-judgment. The court entered a second amended judgment approximately four months later, which included additional unpaid sanctions and fees.

The defendants ultimately deposited the required funds with the district court; however, the funds were never released to the plaintiffs. The defendants then filed a motion to terminate the receivership and enjoin the sale of their radio stations on three grounds: (1) the receiver did not take an oath as required under California law; (2) the court lacked the discretion to refuse to terminate the receivership and (3) the court abused its discretion in denying the motion. The motion was opposed by the plaintiffs, who argued that the receivership should not be terminated without ensuring that the receiver was compensated for his services. The receiver opposed the motion, arguing that terminating the position would enable the defendants to “evade a range of liabilities” as there were still large creditors with outstanding judgment liens. The district court denied the defendants’ motion and the defendants appealed.

Agreeing with First Circuit [...]

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Nothing Private about Relator’s Qui Tam Action Info

The US Court of Appeals for the Ninth Circuit reversed a district court’s order denying the defendants’ motion to dismiss a qui tam action under the False Claims Act (FCA) and remanded for further proceedings. U.S. ex rel Silbersher v. Allergan, Inc., Case No. 21-15420 (9th Cir. Aug. 25, 2022) (Gould, Bennett, Nelson, JJ)

Relator Silbersher, a patent lawyer, brought his action against the defendants under the FCA. (31 U.S.C. § 3730(b)). Silbersher alleged that the defendants unlawfully obtained several patents related to two drugs used to treat Alzheimer’s disease. He asserted that by fraudulently obtaining these patents, the defendants prevented generic drug competitors from entering the market. As a result, Medicare paid inflated prices for the two drugs in violation of the FCA.

The US Department of Justice, all of the states that have analogues to the federal qui tam provision and the District of Columbia declined to intervene in Silbersher’s action. Additionally, the key factual information in Silbersher’s complaint was all disclosed publicly and much of it could be found on the US Patent & Trademark Office’s (PTO) website as well as on other government websites. The district court denied the defendants’ motion to dismiss, holding that the public disclosure bar did not apply to Silbersher’s claims. The defendants appealed.

The Ninth Circuit reversed and remanded, noting that the “FCA creates civil liability for ‘any person who (A) knowingly presents, or causes to be presented, a false or fraudulent claim for payment or approval; [or] (B) knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim.’ 31 U.S.C. § 3729(a)(1).” The FCA limits who can bring a qui tam action and the sources of information upon which they can base their suit. The public disclosure bar seeks to strike a balance between encouraging suits by whistleblowers with genuinely valuable information and discouraging plaintiffs who have no significant information of their own to contribute. The Court, citing its 2018 case United States ex rel. Solis v. Millennium Pharms., reaffirmed the elements of the test for triggering the bar:

“(1) the disclosure at issue occurred through one of the channels specified in the statute;

 

(2) the disclosure was public; and

 

(3) the relator’s action is substantially the same as the allegation or transaction publicly disclosed.”

The Ninth Circuit determined that only the first element was at issue in this case and that “[i]t is salient and potentially controlling that the key factual information underlying Silbersher’s complaint was all publicly disclosed, and much could be found in websites maintained by the PTO and other government agencies.” Under the public disclosure bar, a court shall dismiss an action or claim if substantially the same allegations or transactions as alleged were publicly disclosed (1) in a federal criminal, civil or administrative hearing in which the government was a party; (2) in a congressional, Government Accountability Office, or other federal report, hearing, audit or investigation or (3) from the news [...]

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Claim at Issue Must Be Substantively Allowable to Qualify for PTA

The US Court of Appeals for the Federal Circuit affirmed two district court decisions, finding that a patent owner who only partially prevailed in one of two appeals was not entitled to any additional patent term adjustments (PTAs) from the US Patent & Trademark Office (PTO) under 35 U.S.C. § 154(b)(1)(C) during the pendency of their district court appeals. SawStop Holding LLC v. Vidal, Case No. 2021-1537 (Fed. Cir. Sept. 14, 2022) (Newman, Linn, and Chen, JJ.)

SawStop owns two patents directed to saws with a safety feature that stops a power-saw blade upon contact with flesh. During prosecution of the application for one of the patents, SawStop appealed an obviousness rejection to the Patent Trial & Appeal Board (Board). The Board affirmed the obviousness rejection but on new grounds. The patent ultimately issued after SawStop amended the claim at issue to overcome the obviousness rejection.

Similarly, during prosecution of the application for the second patent, independent claim 1 was rejected as being anticipated and for obviousness-type double patenting while dependent claim 2 was rejected as anticipated. SawStop appealed the rejections. The Board affirmed both rejections of claim 1 but reversed the rejection of claim 2. SawStop subsequently challenged the Board’s anticipation rejection of claim 1 before the US District Court for the District of Columbia, which reversed the anticipation rejection. SawStop did not challenge the obviousness-type double patenting rejection. On remand to the Board, SawStop cancelled claim 1 and rewrote claim 2 as an independent claim. A patent subsequently issued.

Since issuance of both patents was delayed by appeals before allowance, SawStop requested PTAs under Section 154(b)(1)(C):

Subject to the limitations under paragraph (2), if the issue of an original patent is delayed due to … (iii) appellate review by the Patent Trial and Appeal Board or by a Federal Court in a case in which the patent was issued under a decision in the review reversing an adverse determination of patentability, the term of the patent shall be extended 1 day for each day of the pendency of the proceeding, order, or review, as the case may be.

The Board granted PTA “for the delay incurred in the successful reversal of the rejection of claim 2” of the second patent but denied additional PTA for both patents resulting from the appeals. SawStop filed suits in the US District Court for the Eastern District of Virginia, challenging the Board’s decision. The court granted summary judgment in favor of the PTO in both suits. SawStop then appealed to the Federal Circuit.

The Federal Circuit affirmed, finding that SawStop was interpreting Section 154(b)(1)(C) too broadly. SawStop argued in part that any examiner rejection overturned on appeal qualified as “a reversal of a determination of patentability.” The Court rejected this argument, explaining that the Board’s adverse determination of unpatentability remained before and after the appeal to the Board. That is, “the reversal of a ‘determination of patentability’ requires a determination that the claim in question is substantively allowable, not just free of [...]

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CAFC Pulls Final Loose Thread in Nike-Adidas Patent Row

Issuing a third and final decision, the US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board (Board) decision invalidating the last remaining claim of a Nike footwear textile patent. Nike, Inc. v. Adidas AG, Case No. 21-1903 (Fed. Cir. Sept. 1, 2022) (Prost, Chen, Stoll, JJ.) (non-precedential)

Adidas filed for inter partes review of a patent owned by Nike relating to a knitted shoe upper. After lengthy litigation, including two prior appeals to the Federal Circuit, all claims of the Nike patent were invalidated except for one substitute claim. In its second appeal, Nike successfully argued that the Board did not provide Nike an opportunity to respond to a patentability issue raised sua sponte by the Board, which included reference to a knitting textbook. On remand from the second appeal, the parties were given the opportunity to brief the Board on this new reference and argue which party bears the burden of persuasion for the patentability issue raised sua sponte by the Board.

On the merits, the Board determined that the knitting textbook did teach the disputed limitation, agreeing with adidas that a skilled artisan would have understood the textbook to teach the contested limitation, and that there was adequate reason to combine the textbook’s teachings with those of the other prior art references. The Board also concluded that the burden of persuasion must fall on the Board itself when it raised the patentability issue sua sponte. Nike appealed, arguing that the Board effectively placed the burden of persuasion on Nike.

The Federal Circuit first addressed the burden of persuasion as it relates to the grounds first raised by the Board. The Court found that the Board juxtaposed its arguments with adidas’s and that they both relied on the same disclosures and arguments. Because the Board and adidas’s arguments mirrored each other, the Court found it unnecessary to determine whether the petitioner or the Board bears the burden of persuasion. The Court also rejected Nike’s argument that the Board effectively shifted the burden to Nike by stating in its opinion that Nike’s arguments were “unpersuasive” and “inadequate.” The Court cited to its 2016 holding in In re Magnum Oil Tools International, in which it explained that the Board’s language is not the concern but rather the actual placement of the burden of persuasion. The Court found that both the Board and adidas met the burden, and that the burden was not shifted to Nike.

Turning to the Board’s obviousness determinations, the Federal Circuit rejected all of Nike’s arguments. First, Nike argued that the knitting textbook did not teach the claimed method of creating apertures in the fabric by omitting stitches. The Court found that the Board relied on specific disclosures in the reference describing the use of empty needles to product “loop displacement.” Nike also argued that there was no motivation to combine the textbook reference with the other two references and that the Board could not rely on “common sense” [...]

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Sometimes Inactions Speak Louder Than Words

The US Court of Appeals for the Federal Circuit affirmed a decision granting summary judgment in favor of the US Patent & Trademark Office (PTO) regarding the propriety of imposing a restriction requirement on a pre-General Agreement on Tariffs and Trade (GATT) patent. Hyatt v. PTO, Case No. 2021-2324 (Fed. Cir. Sept. 8, 2022) (Moore, Prost, and Hughes, JJ.)

This action arose from the prosecution of a pre-GATT application that claimed priority to applications filed as early as 1983. The issue stems from changes to US patent law limiting patent terms to 20 years from their filing date. The old law provided a grant that lasted 17 years from a patent issuance. As the Federal Circuit noted in early litigation involving Gilbert Hyatt, tying patent term to the grant date “incentivized certain patentees to delay prosecuting their patents by abandoning applications and filing continuing applications in their place.” But the change in law left a gap for so-called transitional applications—those filed but not yet granted before the new law took effect. This “‘triggered a patent application gold rush in the spring of 1995’ by applicants who wanted their patent claims to be governed under the [old law]­ … This gold rush is ‘often referred to as the ‘GATT Bubble.’’”

Hyatt, a prolific inventor, is named in a series of pre-GATT applications filed in 1995 during the GATT bubble. Since then, he has continued to prosecute these applications. As a result of various litigations, the PTO stayed the prosecution of many of these applications between 2003 and 2012. In 2013, over Hyatt’s objections, the PTO required him to select eight claims from an application containing 200 for prosecution. In 2015, the PTO issued a non-final rejection on said claims. Hyatt responded by essentially rewriting the claims in their entirety. The examiner then issued a restriction requirement between the original and amended claims, which would require Hyatt to submit a new application with the new claims, which would be subject to the new law. The restriction requirement was based on the “applicant-action exception,” which allowed the PTO to issue a restriction requirement when the examiner could not have previously made one because of the actions of the applicant. The authority for the PTO action was rooted in Rule 129 (b)(1) (ii), which in relevant part provides:

(1) In an application … that has been pending for

at least three years as of June 8, 1995 … no requirement

for restriction . . . shall be made or maintained

in the application after June 8, 1995, except where:

(ii) The examiner has not made a requirement for

restriction in the present or parent application

prior to April 8, 1995, due to actions by the applicant

After the PTO issued a restriction requirement, Hyatt filed an action in the US District Court for the Eastern District of Virginia, alleging that the PTO violated the Administrative Procedure Act because the restriction requirement was arbitrary, capricious, an abuse of discretion or otherwise not in [...]

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No Second Bite at the Apple: Dismissal under Duplicative-Litigation Doctrine

The US Court of Appeals for the Federal Circuit affirmed a district court’s dismissal of a second case between the same parties and asserting the same patent under the duplicative-litigation doctrine. Arendi S.A.R.L. v. LG Elecs. Inc., Case No. 2021-1967 (Fed. Cir. Sept. 7, 2022) (Prost, Chen, Stoll, JJ.)

Arendi sued LG and others for infringement of several patents. Pursuant to Delaware’s local rules requiring identification of accused products, Arendi identified hundreds of LG products as infringing four asserted claims of the patent relevant on appeal. For those accused products, Arendi provided one “exemplary” infringement claim chart for LG’s Rebel 4 phone. LG objected to Arendi, stating that it should have provided charts for all accused products.

As the litigation proceeded, the parties agreed on eight products as representative but, despite LG’s repeated objection, Arendi did not provide claim charts for any additional products during fact discovery. Instead, Arendi’s opening expert report on infringement provided claim charts for seven non-Rebel 4 representative products for the first time. LG moved to strike those portions of the expert report. The district court granted that motion. Arendi did not supplement its claim charts in response to the court’s order and instead filed another complaint in Delaware, thus creating a second concurrent case asserting the same patent against LG. After the district court granted LG’s motion to dismiss the second suit, Arendi appealed.

The Federal Circuit explained the standard for assertion of the duplicative-litigation doctrine, which “prevents plaintiffs from ‘maintain[ing] two separate actions involving the same subject matter at the same time in the same court … against the same defendant.’” Whether two cases involve the same subject matter depends on the extent of factual overlap of the asserted patents and accused products. There was no dispute that the same patent was asserted in both cases, but Arendi disputed that the cases involved the same accused products, citing the district court’s order striking its expert report as evidence that the non-Rebel 4 products were not at issue in the first case.

Like the district court, the Federal Circuit disagreed. The Court distinguished between accusing products and satisfying discovery obligations regarding those products. Arendi listed the non-Rebel 4 products in its disclosure of accused products, served interrogatories about them, received discovery on them and included non-Rebel 4 products in its expert report. Thus, even though Arendi “failed to fulfill its discovery obligations” as to those products, which made its expert report untimely, the non-Rebel 4 products were still accused, at issue and litigated in the first case. Thus, dismissal of the second case under the duplicative-litigation doctrine was not an error.

Practice Note: In a footnote, the Federal Circuit acknowledged the similarity of the duplicative-litigation doctrine to res judicata (claim preclusion). Although both doctrines involve an inquiry into whether claims in the second suit are repetitious, unlike res judicata, the duplicative-litigation doctrine does not require a final judgment in the first case.




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It Can Take Three Appeals to Make a Claim Construction Go “Right”—or Three Bites by Apple

In a nonprecedential opinion on remand from the US Court of Appeals for the Federal Circuit and a US Patent & Trademark Office (PTO) Director-granted request for review, the Patent Trial & Appeal Board (Board) reconstrued claim terms it had previously construed in consideration of the patent specification, prosecution history and Federal Circuit construction of similar terms in a related case. Apple Inc. v. Personalized Media Communications, LLC, IPR2016-00754, IPR2016-01520 (P.T.A.B. Sept. 8, 2022) (Turner, APJ.)

In March 2016, Apple filed a petition to institute an inter partes review (IPR) against a patent (’635 patent) owned by Personalized Media Communications, LLC (PMC). After PMC filed its Patent Owner Preliminary Response (POPR), the Board instituted the IPR on some, but not all, of Apple’s requested grounds. Per Board procedure, PMC filed its Patent Owner Response (POR) and a contingent motion to amend its patent’s claims. In response, Apple filed a reply and an opposition to the contingent motion, and PMC filed a reply to Apple’s opposition. After oral argument the Board issued a Final Written Decision (754-FWD) finding all challenged claims unpatentable and denying the contingent motion to amend. PMC first sought rehearing of the Board’s decision and, after rehearing was denied, appealed the Board’s decision to the Federal Circuit.

Similarly, in July 2016, Apple filed another petition against the same PMC patent. After considering PMC’s POPR, the Board instituted an IPR on some of Apple’s requested grounds. PMC again filed a POR and a contingent motion to amend, to which Apple filed a reply and opposition (to which PMC filed its reply and Apple a sur-reply). Again, the Board held an oral hearing and issued a Final Written Decision (FWD) finding all challenged claims unpatentable and denying the contingent motion to amend. PMC again sought rehearing of the Board’s decision and, after rehearing was denied, appealed the Board’s decision to the Federal Circuit.

On appeal of each proceeding, PMC moved, and the Federal Circuit granted remand in light of and consistent with the 2021 Supreme Court decision in U.S. v. Arthrex, Inc., where a five-justice majority found that the appointment of Board administrative patent judges was unconstitutional and a seven-justice majority concluded that the remedy was to vest the PTO Director with authority to overrule Board decisions.

On remand to the PTO, PMC filed a request for director review, which the Commissioner for Patents (performing the functions and duties of the PTO Director) granted. The Commissioner’s Granting Order agreed with PMC’s argument that the Board, in these two cases, had construed the claim terms “encrypted” and “decrypted” in a manner that could include “scrambling and descrambling operations on digital information, but could also include … on analog information” and was inconsistent with the Federal Circuit’s partial reversal of the Board’s construction in yet another IPR proceeding (755-IPR regarding another related PMC patent) between Apple and PMC. As to the related patent IPR, the Federal Circuit ultimately construed “encrypted digital information transmission including encrypted information” as “… limited [...]

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Too Quick to Be Lit—Need to Serve That Complaint First

The US Court of Appeals for the Eleventh Circuit reversed a default judgment and monetary award in favor of the plaintiff, which was issued in a case where the plaintiff filed (but never served) an amended complaint in a copyright infringement action. The Court concluded that the amended complaint stated a new claim for relief but was not properly served on the defendants in accordance with the Federal Rules of Civil Procedure. Anthony Campbell v. Rayshawn Bennett et al., Case No. 21-10978 (11th Cir. Sept. 7, 2022) (Wilson, Branch, Lagoa, JJ.) (Lagoa, J. concurring)

In 2015, Anthony Campbell (professionally known as Rackboy Cam) wrote and recorded a song called “Everything Be Lit,” and registered his copyright with the US Copyright Office in February 2017. Later, in 2018, Rackboy Cam filed suit against June James, Rakim Allen, Rayshawn Bennett (professionally known as YFN Lucci) and Think It’s a Game Records (TIG) for copyright infringement based on Bennett’s 2016 recording and release of a similar song, “Everyday We Lit.” The complaint alleged infringement under 17 U.S.C. §§ 106 and 501 and sought “an award of … actual damages, trebled, as well as all profits Defendants derived from infringing the Plaintiff’s Copyright in the Work,” statutory damages and injunctive relief.

James and Allen failed to respond to the initial complaint and the district court entered a default against them. Rackboy Cam later filed an amended complaint, requesting for the first time an award of actual damages in the form of “all profits Defendants derived, jointly and severally,” from the infringing work. In the amended complaint, Rackboy Cam did not request statutory damages. As before, James and Allen did not respond. Rackboy Cam ultimately settled with the other defendants, and they were dismissed from the action.

The district court ultimately entered a default judgment against James and Allen, awarding almost $1.5 million in profits, jointly and severally, as well as prejudgment interest, a permanent injunction, a perpetual 50% running royalty against future infringement and costs to Rackboy Cam.

James moved the district court to set aside the default, arguing that he was not properly served with the initial complaint—an argument rejected by the district court. The district court concluded that because James defaulted prior to the filing of the amended complaint, and since the amended complaint did “not allege or request new or additional relief from Allen and James,” the plaintiff was not required to have served it on James under Fed. R. Civ. P. 5. Rackboy Cam then moved for entry of a default judgment and requested the above award. The district court granted the motion and James appealed.

The issue before the Eleventh Circuit was whether the amended complaint contained a new claim for relief—joint and several liability for profits—and whether Rackboy Cam was therefore required to serve the amended complaint.

Under Rule 5, service of a pleading filed after the initial complaint is not required on a party who is in default for failing to appear, unless the pleading asserts a [...]

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